[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 830 Enrolled Bill (ENR)]
S.830
One Hundred Fifth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the seventh day of January, one thousand nine hundred and ninety-seven
An Act
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to improve the regulation of food, drugs, devices, and
biological products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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(a) Short Title.--This Act may be cited as the ``Food and Drug
Administration Modernization Act of 1997''.
(b) References.--Except as otherwise specified, whenever in this
Act an amendment or repeal is expressed in terms of an amendment to or
a repeal of a section or other provision, the reference shall be
considered to be made to that section or other provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(c) Table of Contents.--The table of contents for this Act is as
follows:

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TITLE I

-IMPROVING REGULATION OF DRUGS

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297303ac62bd90b0227b62831ab9ccb5cd938fc89c0d15dc036f932973251e55

0eb31f675742cb8ed87cb050163a349807a4e69991c1428f334b7108d736ab23

TITLE II

-IMPROVING REGULATION OF DEVICES

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TITLE IV

-GENERAL PROVISIONS

In this Act, the terms ``drug'', ``device'', ``food'', and
``dietary supplement'' have the meaning given such terms in section 201
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
Subtitle A--Fees Relating to Drugs

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TITLE V

-EFFECTIVE DATE

Congress finds that--
(1) prompt approval of safe and effective new drugs and other
therapies is critical to the improvement of the public health so
that patients may enjoy the benefits provided by these therapies to
treat and prevent illness and disease;
(2) the public health will be served by making additional funds
available for the purpose of augmenting the resources of the Food
and Drug Administration that are devoted to the process for review
of human drug applications;
(3) the provisions added by the Prescription Drug User Fee Act
of 1992 have been successful in substantially reducing review times
for human drug applications and should be--
(A) reauthorized for an additional 5 years, with certain
technical improvements; and
(B) carried out by the Food and Drug Administration with
new commitments to implement more ambitious and comprehensive
improvements in regulatory processes of the Food and Drug
Administration; and
(4) the fees authorized by amendments made in this subtitle
will be dedicated toward expediting the drug development process
and the review of human drug applications as set forth in the goals
identified, for purposes of part 2 of subchapter C of chapter VII
of the Federal Food, Drug, and Cosmetic Act, in the letters from
the Secretary of Health and Human Services to the chairman of the
Committee on Commerce of the House of Representatives and the
chairman of the Committee on Labor and Human Resources of the
Senate, as set forth in the Congressional Record.

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Section 735 (21 U.S.C. 379g) is amended--
(1) in the second sentence of paragraph (1)--
(A) by striking ``Service Act, and'' and inserting
``Service Act,''; and
(B) by striking ``September 1, 1992.'' and inserting the
following: ``September 1, 1992, does not include an application
for a licensure of a biological product for further
manufacturing use only, and does not include an application or
supplement submitted by a State or Federal Government entity
for a drug that is not distributed commercially. Such term does
include an application for licensure, as described in
subparagraph (D), of a large volume biological product intended
for single dose injection for intravenous use or infusion.'';
(2) in the second sentence of paragraph (3)--
(A) by striking ``Service Act, and'' and inserting
``Service Act,''; and
(B) by striking ``September 1, 1992.'' and inserting the
following: ``September 1, 1992, does not include a biological
product that is licensed for further manufacturing use only,
and does not include a drug that is not distributed
commercially and is the subject of an application or supplement
submitted by a State or Federal Government entity. Such term
does include a large volume biological product intended for
single dose injection for intravenous use or infusion.'';
(3) in paragraph (4), by striking ``without'' and inserting
``without substantial'';
(4) by amending the first sentence of paragraph (5) to read as
follows:
``(5) The term `prescription drug establishment' means a
foreign or domestic place of business which is at one general
physical location consisting of one or more buildings all of which
are within five miles of each other and at which one or more
prescription drug products are manufactured in final dosage
form.'';
(5) in paragraph (7)(A)--
(A) by striking ``employees under contract'' and all that
follows through ``Administration,'' the second time it occurs
and inserting ``contractors of the Food and Drug
Administration,''; and
(B) by striking ``and committees,'' and inserting ``and
committees and to contracts with such contractors,'';
(6) in paragraph (8)--
(A) in subparagraph (A)--
(i) by striking ``August of'' and inserting ``April
of''; and
(ii) by striking ``August 1992'' and inserting ``April
1997''; and
(B) in subparagraph (B)--
(i) by striking ``section 254(d)'' and inserting
``section 254(c)'';
(ii) by striking ``1992'' and inserting ``1997''; and
(iii) by striking ``102d Congress, 2d Session'' and
inserting ``105th Congress, 1st Session''; and
(7) by adding at the end the following:
``(9) The term `affiliate' means a business entity that has a
relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control, both
of the business entities.''.

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(a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
(1) by striking ``Beginning in fiscal year 1993'' and inserting
``Beginning in fiscal year 1998'';
(2) in paragraph (1)--
(A) by striking subparagraph (B) and inserting the
following:
``(B) Payment.--The fee required by subparagraph (A) shall
be due upon submission of the application or supplement.'';
(B) in subparagraph (D)--
(i) in the subparagraph heading, by striking ``not
accepted'' and inserting ``refused'';
(ii) by striking ``50 percent'' and inserting ``75
percent'';
(iii) by striking ``subparagraph (B)(i)'' and inserting
``subparagraph (B)''; and
(iv) by striking ``not accepted'' and inserting
``refused''; and
(C) by adding at the end the following:
``(E) Exception for designated orphan drug or indication.--
A human drug application for a prescription drug product that
has been designated as a drug for a rare disease or condition
pursuant to section 526 shall not be subject to a fee under
subparagraph (A), unless the human drug application includes an
indication for other than a rare disease or condition. A
supplement proposing to include a new indication for a rare
disease or condition in a human drug application shall not be
subject to a fee under subparagraph (A), if the drug has been
designated pursuant to section 526 as a drug for a rare disease
or condition with regard to the indication proposed in such
supplement.
``(F) Exception for supplements for pediatric
indications.--A supplement to a human drug application
proposing to include a new indication for use in pediatric
populations shall not be assessed a fee under subparagraph (A).
``(G) Refund of fee if application withdrawn.--If an
application or supplement is withdrawn after the application or
supplement was filed, the Secretary may refund the fee or a
portion of the fee if no substantial work was performed on the
application or supplement after the application or supplement
was filed. The Secretary shall have the sole discretion to
refund a fee or a portion of the fee under this subparagraph. A
determination by the Secretary concerning a refund under this
paragraph shall not be reviewable.'';
(3) by striking paragraph (2) and inserting the following:
``(2) Prescription drug establishment fee.--
``(A) In general.--Except as provided in subparagraph (B),
each person that--
``(i) is named as the applicant in a human drug
application; and
``(ii) after September 1, 1992, had pending before the
Secretary a human drug application or supplement,
shall be assessed an annual fee established in subsection (b)
for each prescription drug establishment listed in its approved
human drug application as an establishment that manufactures
the prescription drug product named in the application. The
annual establishment fee shall be assessed in each fiscal year
in which the prescription drug product named in the application
is assessed a fee under paragraph (3) unless the prescription
drug establishment listed in the application does not engage in
the manufacture of the prescription drug product during the
fiscal year. The establishment fee shall be payable on or
before January 31 of each year. Each such establishment shall
be assessed only one fee per establishment, notwithstanding the
number of prescription drug products manufactured at the
establishment. In the event an establishment is listed in a
human drug application by more than one applicant, the
establishment fee for the fiscal year shall be divided equally
and assessed among the applicants whose prescription drug
products are manufactured by the establishment during the
fiscal year and assessed product fees under paragraph (3).
``(B) Exception.--If, during the fiscal year, an applicant
initiates or causes to be initiated the manufacture of a
prescription drug product at an establishment listed in its
human drug application--
``(i) that did not manufacture the product in the
previous fiscal year; and
``(ii) for which the full establishment fee has been
assessed in the fiscal year at a time before manufacture of
the prescription drug product was begun;
the applicant will not be assessed a share of the establishment
fee for the fiscal year in which the manufacture of the product
began.''; and
(4) in paragraph (3)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``is listed'' and
inserting ``has been submitted for listing''; and
(ii) by striking ``Such fee shall be payable'' and all
that follows through ``section 510.'' and inserting the
following: ``Such fee shall be payable for the fiscal year
in which the product is first submitted for listing under
section 510, or is submitted for relisting under section
510 if the product has been withdrawn from listing and
relisted. After such fee is paid for that fiscal year, such
fee shall be payable on or before January 31 of each year.
Such fee shall be paid only once for each product for a
fiscal year in which the fee is payable.''; and
(B) in subparagraph (B), by striking ``505(j).'' and
inserting the following: ``505(j), under an abbreviated
application filed under section 507 (as in effect on the day
before the date of enactment of the Food and Drug
Administration Modernization Act of 1997), or under an
abbreviated new drug application pursuant to regulations in
effect prior to the implementation of the Drug Price
Competition and Patent Term Restoration Act of 1984.''.
(b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is amended to
read as follows:
``(b) Fee Amounts.--Except as provided in subsections (c), (d),
(f), and (g), the fees required under subsection (a) shall be
determined and assessed as follows:
``(1) Application and supplement fees.--
``(A) Full fees.--The application fee under subsection
(a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 in
each of fiscal years 1999 and 2000, $267,606 in fiscal year
2001, and $258,451 in fiscal year 2002.
``(B) Other fees.--The fee under subsection (a)(1)(A)(ii)
shall be $125,352 in fiscal year 1998, $128,169 in each of
fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and
$129,226 in fiscal year 2002.
``(2) Total fee revenues for establishment fees.--The total fee
revenues to be collected in establishment fees under subsection
(a)(2) shall be $35,600,000 in fiscal year 1998, $36,400,000 in
each of fiscal years 1999 and 2000, $38,000,000 in fiscal year
2001, and $36,700,000 in fiscal year 2002.
``(3) Total fee revenues for product fees.--The total fee
revenues to be collected in product fees under subsection (a)(3) in
a fiscal year shall be equal to the total fee revenues collected in
establishment fees under subsection (a)(2) in that fiscal year.''.
(c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 379h(c))
is amended--
(1) in the subsection heading, by striking ``Increases and'';
(2) in paragraph (1)--
(A) by striking ``(1) Revenue'' and all that follows
through ``increased by the Secretary'' and inserting the
following: ``(1) Inflation adjustment.--The fees and total fee
revenues established in subsection (b) shall be adjusted by the
Secretary'';
(B) in subparagraph (A), by striking ``increase'' and
inserting ``change'';
(C) in subparagraph (B), by striking ``increase'' and
inserting ``change''; and
(D) by adding at the end the following flush sentence:
``The adjustment made each fiscal year by this subsection will be
added on a compounded basis to the sum of all adjustments made each
fiscal year after fiscal year 1997 under this subsection.'';
(3) in paragraph (2), by striking ``October 1, 1992,'' and all
that follows through ``such schedule.'' and inserting the
following: ``September 30, 1997, adjust the establishment and
product fees described in subsection (b) for the fiscal year in
which the adjustment occurs so that the revenues collected from
each of the categories of fees described in paragraphs (2) and (3)
of subsection (b) shall be set to be equal to the revenues
collected from the category of application and supplement fees
described in paragraph (1) of subsection (b).''; and
(4) in paragraph (3), by striking ``paragraph (2)'' and
inserting ``this subsection''.
(d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is
amended--
(1) by redesignating paragraphs (1), (2), (3), and (4) as
subparagraphs (A), (B), (C), and (D), respectively and indenting
appropriately;
(2) by striking ``The Secretary shall grant a'' and all that
follows through ``finds that--'' and inserting the following:
``(1) In general.--The Secretary shall grant a waiver from or a
reduction of one or more fees assessed under subsection (a) where
the Secretary finds that--'';
(3) in subparagraph (C) (as so redesignated in paragraph (1)),
by striking ``, or'' and inserting a comma;
(4) in subparagraph (D) (as so redesignated in paragraph (1)),
by striking the period and inserting ``, or'';
(5) by inserting after subparagraph (D) (as so redesignated in
paragraph (1)) the following:
``(E) the applicant involved is a small business submitting
its first human drug application to the Secretary for
review.''; and
(6) by striking ``In making the finding in paragraph (3),'' and
all that follows through ``standard costs.'' and inserting the
following:
``(2) Use of standard costs.--In making the finding in
paragraph (1)(C), the Secretary may use standard costs.
``(3) Rules relating to small businesses.--
``(A) Definition.--In paragraph (1)(E), the term `small
business' means an entity that has fewer than 500 employees,
including employees of affiliates.
``(B) Waiver of application fee.--The Secretary shall waive
under paragraph (1)(E) the application fee for the first human
drug application that a small business or its affiliate submits
to the Secretary for review. After a small business or its
affiliate is granted such a waiver, the small business or its
affiliate shall pay--
``(i) application fees for all subsequent human drug
applications submitted to the Secretary for review in the
same manner as an entity that does not qualify as a small
business; and
``(ii) all supplement fees for all supplements to human
drug applications submitted to the Secretary for review in
the same manner as an entity that does not qualify as a
small business.''.
(e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 379h(f)(1))
is amended--
(1) by striking ``fiscal year 1993'' and inserting ``fiscal
year 1997''; and
(2) by striking ``fiscal year 1992'' and inserting ``fiscal
year 1997 (excluding the amount of fees appropriated for such
fiscal year)''.
(f) Crediting and Availability of Fees.--Section 736(g) (21 U.S.C.
379h(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
``Such sums as may be necessary may be transferred from the Food
and Drug Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account for
salaries and expenses with such fiscal year limitation. The sums
transferred shall be available solely for the process for the
review of human drug applications.'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``Acts'' and inserting
``Acts, or otherwise made available for obligation,''; and
(B) in subparagraph (B), by striking ``over such costs for
fiscal year 1992'' and inserting ``over such costs, excluding
costs paid from fees collected under this section, for fiscal
year 1997''; and
(3) by striking paragraph (3) and inserting the following:
``(3) Authorization of appropriations.--There are authorized to
be appropriated for fees under this section--
``(A) $106,800,000 for fiscal year 1998;
``(B) $109,200,000 for fiscal year 1999;
``(C) $109,200,000 for fiscal year 2000;
``(D) $114,000,000 for fiscal year 2001; and
``(E) $110,100,000 for fiscal year 2002,
as adjusted to reflect adjustments in the total fee revenues made
under this section and changes in the total amounts collected by
application, supplement, establishment, and product fees.
``(4) Offset.--Any amount of fees collected for a fiscal year
under this section that exceeds the amount of fees specified in
appropriation Acts for such fiscal year shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the amount
of fees that would otherwise be authorized to be collected under
this section pursuant to appropriation Acts for a subsequent fiscal
year.''.
(g) Requirement for Written Requests for Waivers, Reductions, and
Refunds.--Section 736 (21 U.S.C. 379h) is amended--
(1) by redesignating subsection (i) as subsection (j); and
(2) by inserting after subsection (h) the following:
``(i) Written Requests for Waivers, Reductions, and Refunds.--To
qualify for consideration for a waiver or reduction under subsection
(d), or for a refund of any fee collected in accordance with subsection
(a), a person shall submit to the Secretary a written request for such
waiver, reduction, or refund not later than 180 days after such fee is
due.''.
(h) Special Rule for Waivers and Refunds.--Any requests for waivers
or refunds for fees assessed under section 736 of the Federal Food,
Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the date of enactment
of this Act shall be submitted in writing to the Secretary of Health
and Human Services within 1 year after the date of enactment of this
Act. Any requests for waivers or refunds pertaining to a fee for a
human drug application or supplement accepted for filing prior to
October 1, 1997 or to a product or establishment fee required by such
Act for a fiscal year prior to fiscal year 1998, shall be evaluated
according to the terms of the Prescription Drug User Fee Act of 1992
(as in effect on September 30, 1997) and part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act (as in effect
on September 30, 1997). The term ``person'' in such Acts shall continue
to include an affiliate thereof.

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(a) Performance Report.--Beginning with fiscal year 1998, not later
than 60 days after the end of each fiscal year during which fees are
collected under part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of
Health and Human Services shall prepare and submit to the Committee on
Commerce of the House of Representatives and the Committee on Labor and
Human Resources of the Senate a report concerning the progress of the
Food and Drug Administration in achieving the goals identified in the
letters described in section 101(4) during such fiscal year and the
future plans of the Food and Drug Administration for meeting the goals.
(b) Fiscal Report.--Beginning with fiscal year 1998, not later than
120 days after the end of each fiscal year during which fees are
collected under the part described in subsection (a), the Secretary of
Health and Human Services shall prepare and submit to the Committee on
Commerce of the House of Representatives and the Committee on Labor and
Human Resources of the Senate a report on the implementation of the
authority for such fees during such fiscal year and the use, by the
Food and Drug Administration, of the fees collected during such fiscal
year for which the report is made.

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Notwithstanding section 105 of the Prescription Drug User Fee Act
of 1992, the Secretary shall retain the authority to assess and collect
any fee required by part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act for a human drug application or
supplement accepted for filing prior to October 1, 1997, and to assess
and collect any product or establishment fee required by such Act for a
fiscal year prior to fiscal year 1998.

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The amendments made by this subtitle shall take effect October 1,
1997.

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The amendments made by sections 102 and 103 cease to be effective
October 1, 2002, and section 104 ceases to be effective 120 days after
such date.
Subtitle B--Other Improvements

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Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after
section 505 the following:
``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
``(a) Market Exclusivity for New Drugs.--If, prior to approval of
an application that is submitted under section 505(b)(1), the Secretary
determines that information relating to the use of a new drug in the
pediatric population may produce health benefits in that population,
the Secretary makes a written request for pediatric studies (which
shall include a timeframe for completing such studies), and such
studies are completed within any such timeframe and the reports thereof
submitted in accordance with subsection (d)(2) or accepted in
accordance with subsection (d)(3)--
``(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii)
of section 505, and in subsection (j)(4)(D)(ii) of such section, is
deemed to be five years and six months rather than five years, and
the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of
such section to four years, to forty-eight months, and to seven and
one-half years are deemed to be four and one-half years, fifty-four
months, and eight years, respectively; or
``(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and (iv)
of subsection (j)(4)(D) of such section, is deemed to be three
years and six months rather than three years; and
``(B) if the drug is designated under section 526 for a rare
disease or condition, the period referred to in section 527(a) is
deemed to be seven years and six months rather than seven years;
and
``(2)(A) if the drug is the subject of--
``(i) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
of section 505 and for which pediatric studies were submitted
prior to the expiration of the patent (including any patent
extensions); or
``(ii) a listed patent for which a certification has been
submitted under subsections (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved under
section 505(c)(3) or section 505(j)(4)(B) shall be extended by a
period of six months after the date the patent expires (including
any patent extensions); or
``(B) if the drug is the subject of a listed patent for which a
certification has been submitted under subsection (b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV) of section 505, and in the patent infringement
litigation resulting from the certification the court determines
that the patent is valid and would be infringed, the period during
which an application may not be approved under section 505(c)(3) or
section 505(j)(4)(B) shall be extended by a period of six months
after the date the patent expires (including any patent
extensions).
``(b) Secretary To Develop List of Drugs for Which Additional
Pediatric Information May Be Beneficial.--Not later than 180 days after
the date of enactment of the Food and Drug Administration Modernization
Act of 1997, the Secretary, after consultation with experts in
pediatric research shall develop, prioritize, and publish an initial
list of approved drugs for which additional pediatric information may
produce health benefits in the pediatric population. The Secretary
shall annually update the list.
``(c) Market Exclusivity for Already-Marketed Drugs.--If the
Secretary makes a written request to the holder of an approved
application under section 505(b)(1) for pediatric studies (which shall
include a timeframe for completing such studies) concerning a drug
identified in the list described in subsection (b), the holder agrees
to the request, the studies are completed within any such timeframe,
and the reports thereof are submitted in accordance with subsection
(d)(2) or accepted in accordance with subsection (d)(3)--
``(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii)
of section 505, and in subsection (j)(4)(D)(ii) of such section, is
deemed to be five years and six months rather than five years, and
the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of
such section to four years, to forty-eight months, and to seven and
one-half years are deemed to be four and one-half years, fifty-four
months, and eight years, respectively; or
``(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and (iv)
of subsection (j)(4)(D) of such section, is deemed to be three
years and six months rather than three years; and
``(B) if the drug is designated under section 526 for a rare
disease or condition, the period referred to in section 527(a) is
deemed to be seven years and six months rather than seven years;
and
``(2)(A) if the drug is the subject of--
``(i) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
of section 505 and for which pediatric studies were submitted
prior to the expiration of the patent (including any patent
extensions); or
``(ii) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved under
section 505(c)(3) or section 505(j)(4)(B) shall be extended by a
period of six months after the date the patent expires (including
any patent extensions); or
``(B) if the drug is the subject of a listed patent for which a
certification has been submitted under subsection (b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV) of section 505, and in the patent infringement
litigation resulting from the certification the court determines
that the patent is valid and would be infringed, the period during
which an application may not be approved under section 505(c)(3) or
section 505(j)(4)(B) shall be extended by a period of six months
after the date the patent expires (including any patent
extensions).
``(d) Conduct of Pediatric Studies.--
``(1) Agreement for studies.--The Secretary may, pursuant to a
written request from the Secretary under subsection (a) or (c),
after consultation with--
``(A) the sponsor of an application for an investigational
new drug under section 505(i);
``(B) the sponsor of an application for a new drug under
section 505(b)(1); or
``(C) the holder of an approved application for a drug
under section 505(b)(1),
agree with the sponsor or holder for the conduct of pediatric
studies for such drug. Such agreement shall be in writing and shall
include a timeframe for such studies.
``(2) Written protocols to meet the studies requirement.--If
the sponsor or holder and the Secretary agree upon written
protocols for the studies, the studies requirement of subsection
(a) or (c) is satisfied upon the completion of the studies and
submission of the reports thereof in accordance with the original
written request and the written agreement referred to in paragraph
(1). Not later than 60 days after the submission of the report of
the studies, the Secretary shall determine if such studies were or
were not conducted in accordance with the original written request
and the written agreement and reported in accordance with the
requirements of the Secretary for filing and so notify the sponsor
or holder.
``(3) Other methods to meet the studies requirement.--If the
sponsor or holder and the Secretary have not agreed in writing on
the protocols for the studies, the studies requirement of
subsection (a) or (c) is satisfied when such studies have been
completed and the reports accepted by the Secretary. Not later than
90 days after the submission of the reports of the studies, the
Secretary shall accept or reject such reports and so notify the
sponsor or holder. The Secretary's only responsibility in accepting
or rejecting the reports shall be to determine, within the 90 days,
whether the studies fairly respond to the written request, have
been conducted in accordance with commonly accepted scientific
principles and protocols, and have been reported in accordance with
the requirements of the Secretary for filing.
``(e) Delay of Effective Date for Certain Application.--If the
Secretary determines that the acceptance or approval of an application
under section 505(b)(2) or 505(j) for a new drug may occur after
submission of reports of pediatric studies under this section, which
were submitted prior to the expiration of the patent (including any
patent extension) or the applicable period under clauses (ii) through
(iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section
505(j)(4)(D), but before the Secretary has determined whether the
requirements of subsection (d) have been satisfied, the Secretary shall
delay the acceptance or approval under section 505(b)(2) or 505(j)
until the determination under subsection (d) is made, but any such
delay shall not exceed 90 days. In the event that requirements of this
section are satisfied, the applicable six-month period under subsection
(a) or (c) shall be deemed to have been running during the period of
delay.
``(f) Notice of Determinations on Studies Requirement.--The
Secretary shall publish a notice of any determination that the
requirements of subsection (d) have been met and that submissions and
approvals under subsection (b)(2) or (j) of section 505 for a drug will
be subject to the provisions of this section.
``(g) Definitions.--As used in this section, the term `pediatric
studies' or `studies' means at least one clinical investigation (that,
at the Secretary's discretion, may include pharmacokinetic studies) in
pediatric age groups in which a drug is anticipated to be used.
``(h) Limitations.--A drug to which the six-month period under
subsection (a) or (b) has already been applied--
``(1) may receive an additional six-month period under
subsection (c)(1)(A)(ii) for a supplemental application if all
other requirements under this section are satisfied, except that
such a drug may not receive any additional such period under
subsection (c)(2); and
``(2) may not receive any additional such period under
subsection (c)(1)(B).
``(i) Relationship to Regulations.--Notwithstanding any other
provision of law, if any pediatric study is required pursuant to
regulations promulgated by the Secretary and such study meets the
completeness, timeliness, and other requirements of this section, such
study shall be deemed to satisfy the requirement for market exclusivity
pursuant to this section.
``(j) Sunset.--A drug may not receive any six-month period under
subsection (a) or (c) unless the application for the drug under section
505(b)(1) is submitted on or before January 1, 2002. After January 1,
2002, a drug shall receive a six-month period under subsection (c) if--
``(1) the drug was in commercial distribution as of the date of
enactment of the Food and Drug Administration Modernization Act of
1997;
``(2) the drug was included by the Secretary on the list under
subsection (b) as of January 1, 2002;
``(3) the Secretary determines that there is a continuing need
for information relating to the use of the drug in the pediatric
population and that the drug may provide health benefits in that
population; and
``(4) all requirements of this section are met.
``(k) Report.--The Secretary shall conduct a study and report to
Congress not later than January 1, 2001, based on the experience under
the program established under this section. The study and report shall
examine all relevant issues, including--
``(1) the effectiveness of the program in improving information
about important pediatric uses for approved drugs;
``(2) the adequacy of the incentive provided under this
section;
``(3) the economic impact of the program on taxpayers and
consumers, including the impact of the lack of lower cost generic
drugs on patients, including on lower income patients; and
``(4) any suggestions for modification that the Secretary
determines to be appropriate.''.

88bb4678b14ae49690c157deb3475879272b3fb0fe408395024dd7b2230579b1

(a) In General.--Chapter V (21 U.S.C. 351 et seq.), as amended by
section 125, is amended by inserting before section 508 the following:
``SEC. 506. FAST TRACK PRODUCTS.
``(a) Designation of Drug as a Fast Track Product.--
``(1) In general.--The Secretary shall, at the request of the
sponsor of a new drug, facilitate the development and expedite the
review of such drug if it is intended for the treatment of a
serious or life-threatening condition and it demonstrates the
potential to address unmet medical needs for such a condition. (In
this section, such a drug is referred to as a `fast track
product'.)
``(2) Request for designation.--The sponsor of a new drug may
request the Secretary to designate the drug as a fast track
product. A request for the designation may be made concurrently
with, or at any time after, submission of an application for the
investigation of the drug under section 505(i) or section 351(a)(3)
of the Public Health Service Act.
``(3) Designation.--Within 60 calendar days after the receipt
of a request under paragraph (2), the Secretary shall determine
whether the drug that is the subject of the request meets the
criteria described in paragraph (1). If the Secretary finds that
the drug meets the criteria, the Secretary shall designate the drug
as a fast track product and shall take such actions as are
appropriate to expedite the development and review of the
application for approval of such product.
``(b) Approval of Application for a Fast Track Product.--
``(1) In general.--The Secretary may approve an application for
approval of a fast track product under section 505(c) or section
351 of the Public Health Service Act upon a determination that the
product has an effect on a clinical endpoint or on a surrogate
endpoint that is reasonably likely to predict clinical benefit.
``(2) Limitation.--Approval of a fast track product under this
subsection may be subject to the requirements--
``(A) that the sponsor conduct appropriate post-approval
studies to validate the surrogate endpoint or otherwise confirm
the effect on the clinical endpoint; and
``(B) that the sponsor submit copies of all promotional
materials related to the fast track product during the
preapproval review period and, following approval and for such
period thereafter as the Secretary determines to be
appropriate, at least 30 days prior to dissemination of the
materials.
``(3) Expedited withdrawal of approval.--The Secretary may
withdraw approval of a fast track product using expedited
procedures (as prescribed by the Secretary in regulations which
shall include an opportunity for an informal hearing) if--
``(A) the sponsor fails to conduct any required post-
approval study of the fast track drug with due diligence;
``(B) a post-approval study of the fast track product fails
to verify clinical benefit of the product;
``(C) other evidence demonstrates that the fast track
product is not safe or effective under the conditions of use;
or
``(D) the sponsor disseminates false or misleading
promotional materials with respect to the product.
``(c) Review of Incomplete Applications for Approval of a Fast
Track Product.--
``(1) In general.--If the Secretary determines, after
preliminary evaluation of clinical data submitted by the sponsor,
that a fast track product may be effective, the Secretary shall
evaluate for filing, and may commence review of portions of, an
application for the approval of the product before the sponsor
submits a complete application. The Secretary shall commence such
review only if the applicant--
``(A) provides a schedule for submission of information
necessary to make the application complete; and
``(B) pays any fee that may be required under section 736.
``(2) Exception.--Any time period for review of human drug
applications that has been agreed to by the Secretary and that has
been set forth in goals identified in letters of the Secretary
(relating to the use of fees collected under section 736 to
expedite the drug development process and the review of human drug
applications) shall not apply to an application submitted under
paragraph (1) until the date on which the application is complete.
``(d) Awareness Efforts.--The Secretary shall--
``(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies, and
other appropriate persons a description of the provisions of this
section applicable to fast track products; and
``(2) establish a program to encourage the development of
surrogate endpoints that are reasonably likely to predict clinical
benefit for serious or life-threatening conditions for which there
exist significant unmet medical needs.''.
(b) Guidance.--Within 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services shall issue guidance
for fast track products (as defined in section 506(a)(1) of the Federal
Food, Drug, and Cosmetic Act) that describes the policies and
procedures that pertain to section 506 of such Act.

4b4e275ee5ade34d3ce4162b2cf639147526f8663fba4d504c86cb1169645224

LIFE-THREATENING DISEASES.
(a) In General.--Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended--
(1) by redesignating subsections (j) and (k) as subsections (k)
and (l), respectively; and
(2) by inserting after subsection (i) the following:
``(j)(1)(A) The Secretary, acting through the Director of NIH,
shall establish, maintain, and operate a data bank of information on
clinical trials for drugs for serious or life-threatening diseases and
conditions (in this subsection referred to as the `data bank'). The
activities of the data bank shall be integrated and coordinated with
related activities of other agencies of the Department of Health and
Human Services, and to the extent practicable, coordinated with other
data banks containing similar information.
``(B) The Secretary shall establish the data bank after
consultation with the Commissioner of Food and Drugs, the directors of
the appropriate agencies of the National Institutes of Health
(including the National Library of Medicine), and the Director of the
Centers for Disease Control and Prevention.
``(2) In carrying out paragraph (1), the Secretary shall collect,
catalog, store, and disseminate the information described in such
paragraph. The Secretary shall disseminate such information through
information systems, which shall include toll-free telephone
communications, available to individuals with serious or life-
threatening diseases and conditions, to other members of the public, to
health care providers, and to researchers.
``(3) The data bank shall include the following:
``(A) A registry of clinical trials (whether federally or
privately funded) of experimental treatments for serious or life-
threatening diseases and conditions under regulations promulgated
pursuant to section 505(i) of the Federal Food, Drug, and Cosmetic
Act, which provides a description of the purpose of each
experimental drug, either with the consent of the protocol sponsor,
or when a trial to test effectiveness begins. Information provided
shall consist of eligibility criteria for participation in the
clinical trials, a description of the location of trial sites, and
a point of contact for those wanting to enroll in the trial, and
shall be in a form that can be readily understood by members of the
public. Such information shall be forwarded to the data bank by the
sponsor of the trial not later than 21 days after the approval of
the protocol.
``(B) Information pertaining to experimental treatments for
serious or life-threatening diseases and conditions that may be
available--
``(i) under a treatment investigational new drug
application that has been submitted to the Secretary under
section 561(c) of the Federal Food, Drug, and Cosmetic Act; or
``(ii) as a Group C cancer drug (as defined by the National
Cancer Institute).
The data bank may also include information pertaining to the
results of clinical trials of such treatments, with the consent of
the sponsor, including information concerning potential toxicities
or adverse effects associated with the use or administration of
such experimental treatments.
``(4) The data bank shall not include information relating to an
investigation if the sponsor has provided a detailed certification to
the Secretary that disclosure of such information would substantially
interfere with the timely enrollment of subjects in the investigation,
unless the Secretary, after the receipt of the certification, provides
the sponsor with a detailed written determination that such disclosure
would not substantially interfere with such enrollment.
``(5) For the purpose of carrying out this subsection, there are
authorized to be appropriated such sums as may be necessary. Fees
collected under section 736 of the Federal Food, Drug, and Cosmetic Act
shall not be used in carrying out this subsection.''.
(b) Collaboration and Report.--
(1) In general.--The Secretary of Health and Human Services,
the Director of the National Institutes of Health, and the
Commissioner of Food and Drugs shall collaborate to determine the
feasibility of including device investigations within the scope of
the data bank under section 402(j) of the Public Health Service
Act.
(2) Report.--Not later than two years after the date of
enactment of this section, the Secretary of Health and Human
Services shall prepare and submit to the Committee on Labor and
Human Resources of the Senate and the Committee on Commerce of the
House of Representatives a report--
(A) of the public health need, if any, for inclusion of
device investigations within the scope of the data bank under
section 402(j) of the Public Health Service Act;
(B) on the adverse impact, if any, on device innovation and
research in the United States if information relating to such
device investigations is required to be publicly disclosed; and
(C) on such other issues relating to such section 402(j) as
the Secretary determines to be appropriate.

28ee240e58888bdfbaf19d417f7f60261af3328c93066b6cd224471c65cb2ae9

(a) In General.--Section 502(a) (21 U.S.C. 352(a)) is amended by
adding at the end the following: ``Health care economic information
provided to a formulary committee, or other similar entity, in the
course of the committee or the entity carrying out its responsibilities
for the selection of drugs for managed care or other similar
organizations, shall not be considered to be false or misleading under
this paragraph if the health care economic information directly relates
to an indication approved under section 505 or under section 351(a) of
the Public Health Service Act for such drug and is based on competent
and reliable scientific evidence. The requirements set forth in section
505(a) or in section 351(a) of the Public Health Service Act shall not
apply to health care economic information provided to such a committee
or entity in accordance with this paragraph. Information that is
relevant to the substantiation of the health care economic information
presented pursuant to this paragraph shall be made available to the
Secretary upon request. In this paragraph, the term `health care
economic information' means any analysis that identifies, measures, or
compares the economic consequences, including the costs of the
represented health outcomes, of the use of a drug to the use of another
drug, to another health care intervention, or to no intervention.''.
(b) Study and Report.--The Comptroller General of the United States
shall conduct a study of the implementation of the provisions added by
the amendment made by subsection (a). Not later than 4 years and 6
months after the date of enactment of this Act, the Comptroller General
of the United States shall prepare and submit to Congress a report
containing the findings of the study.

e9ebfe8fc48ef8589a40b0168a9bbf20cd67b40476cd8349abf5f5a5293df2a3

(a) Clarification of the Number of Required Clinical Investigations
for Approval.--Section 505(d) (21 U.S.C. 355(d)) is amended by adding
at the end the following: ``If the Secretary determines, based on
relevant science, that data from one adequate and well-controlled
clinical investigation and confirmatory evidence (obtained prior to or
after such investigation) are sufficient to establish effectiveness,
the Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.''.
(b) Women and Minorities.--Section 505(b)(1) (21 U.S.C. 355(b)(1))
is amended by adding at the end the following: ``The Secretary shall,
in consultation with the Director of the National Institutes of Health
and with representatives of the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).''.

02070c30456d70fe7f2a63fb6dc53d986e11a5f301743b0a8bfdfab0fd49a053

(a) In General.--Chapter V, as amended by section 112, is amended
by inserting after section 506 the following section:
``SEC. 506A. MANUFACTURING CHANGES.
``(a) In General.--With respect to a drug for which there is in
effect an approved application under section 505 or 512 or a license
under section 351 of the Public Health Service Act, a change from the
manufacturing process approved pursuant to such application or license
may be made, and the drug as made with the change may be distributed,
if--
``(1) the holder of the approved application or license
(referred to in this section as a `holder') has validated the
effects of the change in accordance with subsection (b); and
``(2)(A) in the case of a major manufacturing change, the
holder has complied with the requirements of subsection (c); or
``(B) in the case of a change that is not a major manufacturing
change, the holder complies with the applicable requirements of
subsection (d).
``(b) Validation of Effects of Changes.--For purposes of subsection
(a)(1), a drug made with a manufacturing change (whether a major
manufacturing change or otherwise) may be distributed only if, before
distribution of the drug as so made, the holder involved validates the
effects of the change on the identity, strength, quality, purity, and
potency of the drug as the identity, strength, quality, purity, and
potency may relate to the safety or effectiveness of the drug.
``(c) Major Manufacturing Changes.--
``(1) Requirement of supplemental application.--For purposes of
subsection (a)(2)(A), a drug made with a major manufacturing change
may be distributed only if, before the distribution of the drug as
so made, the holder involved submits to the Secretary a
supplemental application for such change and the Secretary approves
the application. The application shall contain such information as
the Secretary determines to be appropriate, and shall include the
information developed under subsection (b) by the holder in
validating the effects of the change.
``(2) Changes qualifying as major changes.--For purposes of
subsection (a)(2)(A), a major manufacturing change is a
manufacturing change that is determined by the Secretary to have
substantial potential to adversely affect the identity, strength,
quality, purity, or potency of the drug as they may relate to the
safety or effectiveness of a drug. Such a change includes a change
that--
``(A) is made in the qualitative or quantitative
formulation of the drug involved or in the specifications in
the approved application or license referred to in subsection
(a) for the drug (unless exempted by the Secretary by
regulation or guidance from the requirements of this
subsection);
``(B) is determined by the Secretary by regulation or
guidance to require completion of an appropriate clinical study
demonstrating equivalence of the drug to the drug as
manufactured without the change; or
``(C) is another type of change determined by the Secretary
by regulation or guidance to have a substantial potential to
adversely affect the safety or effectiveness of the drug.
``(d) Other Manufacturing Changes.--
``(1) In general.--For purposes of subsection (a)(2)(B), the
Secretary may regulate drugs made with manufacturing changes that
are not major manufacturing changes as follows:
``(A) The Secretary may in accordance with paragraph (2)
authorize holders to distribute such drugs without submitting a
supplemental application for such changes.
``(B) The Secretary may in accordance with paragraph (3)
require that, prior to the distribution of such drugs, holders
submit to the Secretary supplemental applications for such
changes.
``(C) The Secretary may establish categories of such
changes and designate categories to which subparagraph (A)
applies and categories to which subparagraph (B) applies.
``(2) Changes not requiring supplemental application.--
``(A) Submission of report.--A holder making a
manufacturing change to which paragraph (1)(A) applies shall
submit to the Secretary a report on the change, which shall
contain such information as the Secretary determines to be
appropriate, and which shall include the information developed
under subsection (b) by the holder in validating the effects of
the change. The report shall be submitted by such date as the
Secretary may specify.
``(B) Authority regarding annual reports.--In the case of a
holder that during a single year makes more than one
manufacturing change to which paragraph (1)(A) applies, the
Secretary may in carrying out subparagraph (A) authorize the
holder to comply with such subparagraph by submitting a single
report for the year that provides the information required in
such subparagraph for all the changes made by the holder during
the year.
``(3) Changes requiring supplemental application.--
``(A) Submission of supplemental application.--The
supplemental application required under paragraph (1)(B) for a
manufacturing change shall contain such information as the
Secretary determines to be appropriate, which shall include the
information developed under subsection (b) by the holder in
validating the effects of the change.
``(B) Authority for distribution.--In the case of a
manufacturing change to which paragraph (1)(B) applies:
``(i) The holder involved may commence distribution of
the drug involved 30 days after the Secretary receives the
supplemental application under such paragraph, unless the
Secretary notifies the holder within such 30-day period
that prior approval of the application is required before
distribution may be commenced.
``(ii) The Secretary may designate a category of such
changes for the purpose of providing that, in the case of a
change that is in such category, the holder involved may
commence distribution of the drug involved upon the receipt
by the Secretary of a supplemental application for the
change.
``(iii) If the Secretary disapproves the supplemental
application, the Secretary may order the manufacturer to
cease the distribution of the drugs that have been made
with the manufacturing change.''.
(b) Transition Rule.--The amendment made by subsection (a) takes
effect upon the effective date of regulations promulgated by the
Secretary of Health and Human Services to implement such amendment, or
upon the expiration of the 24-month period beginning on the date of the
enactment of this Act, whichever occurs first.

391d09ea6b4f63ef5b972b9e502c2938ae18e25c9a4d03c7b9f60a4a489480de

Section 505(i) (21 U.S.C. 355(i)) is amended--
(1) by redesignating paragraphs (1) through (3) as
subparagraphs (A) through (C), respectively;
(2) by inserting ``(1)'' after ``(i)'';
(3) by striking the last two sentences; and
(4) by inserting after paragraph (1) (as designated by
paragraph (2) of this section) the following new paragraphs:
``(2) Subject to paragraph (3), a clinical investigation of a new
drug may begin 30 days after the Secretary has received from the
manufacturer or sponsor of the investigation a submission containing
such information about the drug and the clinical investigation,
including--
``(A) information on design of the investigation and adequate
reports of basic information, certified by the applicant to be
accurate reports, necessary to assess the safety of the drug for
use in clinical investigation; and
``(B) adequate information on the chemistry and manufacturing
of the drug, controls available for the drug, and primary data
tabulations from animal or human studies.
``(3)(A) At any time, the Secretary may prohibit the sponsor of an
investigation from conducting the investigation (referred to in this
paragraph as a `clinical hold') if the Secretary makes a determination
described in subparagraph (B). The Secretary shall specify the basis
for the clinical hold, including the specific information available to
the Secretary which served as the basis for such clinical hold, and
confirm such determination in writing.
``(B) For purposes of subparagraph (A), a determination described
in this subparagraph with respect to a clinical hold is that--
``(i) the drug involved represents an unreasonable risk to the
safety of the persons who are the subjects of the clinical
investigation, taking into account the qualifications of the
clinical investigators, information about the drug, the design of
the clinical investigation, the condition for which the drug is to
be investigated, and the health status of the subjects involved; or
``(ii) the clinical hold should be issued for such other
reasons as the Secretary may by regulation establish (including
reasons established by regulation before the date of the enactment
of the Food and Drug Administration Modernization Act of 1997).
``(C) Any written request to the Secretary from the sponsor of an
investigation that a clinical hold be removed shall receive a decision,
in writing and specifying the reasons therefor, within 30 days after
receipt of such request. Any such request shall include sufficient
information to support the removal of such clinical hold.
``(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the sponsor of
the investigation, requiring that experts using such drugs for
investigational purposes certify to such manufacturer or sponsor that
they will inform any human beings to whom such drugs, or any controls
used in connection therewith, are being administered, or their
representatives, that such drugs are being used for investigational
purposes and will obtain the consent of such human beings or their
representatives, except where it is not feasible or it is contrary to
the best interests of such human beings. Nothing in this subsection
shall be construed to require any clinical investigator to submit
directly to the Secretary reports on the investigational use of
drugs.''.

ed20334247ce6c46f50f22becbebfba42d25bb51df120a5c5fe062fb50e8c888

Within 12 months after the date of enactment of this Act, the
Secretary of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall issue guidance that describes when abbreviated
study reports may be submitted, in lieu of full reports, with a new
drug application under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)) and with a biologics license
application under section 351 of the Public Health Service Act (42
U.S.C. 262) for certain types of studies. Such guidance shall describe
the kinds of studies for which abbreviated reports are appropriate and
the appropriate abbreviated report formats.

4ffe68cd85d499db4a4c8aa1758a4b844e66482e50731c47dabea9b9fa1db543

(a) Section 505(b).--Section 505(b) (21 U.S.C. 355(b)) is amended
by adding at the end the following:
``(4)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1) or under section 351
of the Public Health Service Act, which shall relate to promptness in
conducting the review, technical excellence, lack of bias and conflict
of interest, and knowledge of regulatory and scientific standards, and
which shall apply equally to all individuals who review such
applications.
``(B) The Secretary shall meet with a sponsor of an investigation
or an applicant for approval for a drug under this subsection or
section 351 of the Public Health Service Act if the sponsor or
applicant makes a reasonable written request for a meeting for the
purpose of reaching agreement on the design and size of clinical trials
intended to form the primary basis of an effectiveness claim. The
sponsor or applicant shall provide information necessary for discussion
and agreement on the design and size of the clinical trials. Minutes of
any such meeting shall be prepared by the Secretary and made available
to the sponsor or applicant upon request.
``(C) Any agreement regarding the parameters of the design and size
of clinical trials of a new drug under this paragraph that is reached
between the Secretary and a sponsor or applicant shall be reduced to
writing and made part of the administrative record by the Secretary.
Such agreement shall not be changed after the testing begins, except--
``(i) with the written agreement of the sponsor or applicant;
or
``(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division, that a
substantial scientific issue essential to determining the safety or
effectiveness of the drug has been identified after the testing has
begun.
``(D) A decision under subparagraph (C)(ii) by the director shall
be in writing and the Secretary shall provide to the sponsor or
applicant an opportunity for a meeting at which the director and the
sponsor or applicant will be present and at which the director will
document the scientific issue involved.
``(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance division personnel unless such field or compliance
division personnel demonstrate to the reviewing division why such
decision should be modified.
``(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary to
assure the marketing of a safe and effective drug.
``(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of a
drug under this subsection or section 351 of the Public Health Service
Act (including all scientific and medical matters, chemistry,
manufacturing, and controls).''.
(b) Section 505(j).--
(1) Amendment.--Section 505(j) (21 U.S.C 355(j)) is amended--
(A) by redesignating paragraphs (3) through (8) as
paragraphs (4) through (9), respectively; and
(B) by adding after paragraph (2) the following:
``(3)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1), which shall relate
to promptness in conducting the review, technical excellence, lack of
bias and conflict of interest, and knowledge of regulatory and
scientific standards, and which shall apply equally to all individuals
who review such applications.
``(B) The Secretary shall meet with a sponsor of an investigation
or an applicant for approval for a drug under this subsection if the
sponsor or applicant makes a reasonable written request for a meeting
for the purpose of reaching agreement on the design and size of
bioavailability and bioequivalence studies needed for approval of such
application. The sponsor or applicant shall provide information
necessary for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the Secretary
and made available to the sponsor or applicant.
``(C) Any agreement regarding the parameters of design and size of
bioavailability and bioequivalence studies of a drug under this
paragraph that is reached between the Secretary and a sponsor or
applicant shall be reduced to writing and made part of the
administrative record by the Secretary. Such agreement shall not be
changed after the testing begins, except--
``(i) with the written agreement of the sponsor or applicant;
or
``(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division, that a
substantial scientific issue essential to determining the safety or
effectiveness of the drug has been identified after the testing has
begun.
``(D) A decision under subparagraph (C)(ii) by the director shall
be in writing and the Secretary shall provide to the sponsor or
applicant an opportunity for a meeting at which the director and the
sponsor or applicant will be present and at which the director will
document the scientific issue involved.
``(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance office personnel unless such field or compliance
office personnel demonstrate to the reviewing division why such
decision should be modified.
``(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary to
assure the marketing of a safe and effective drug.
``(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of a
drug under this subsection (including scientific matters, chemistry,
manufacturing, and controls).''.
(2) Conforming amendments.--Section 505(j) (21 U.S.C. 355(j)),
as amended by paragraph (1), is further amended--
(A) in paragraph (2)(A)(i), by striking ``(6)'' and
inserting ``(7)'';
(B) in paragraph (4) (as redesignated in paragraph (1)), by
striking ``(4)'' and inserting ``(5)'';
(C) in paragraph (4)(I) (as redesignated in paragraph (1)),
by striking ``(5)'' and inserting ``(6)''; and
(D) in paragraph (7)(C) (as redesignated in paragraph (1)),
by striking ``(5)'' each place it occurs and inserting ``(6)''.

4a646cedfc6b8ba04a77f24fa261ee9bed6aafd2c71569ea2b552acd6768e88e

Section 505 (21 U.S.C. 355) is amended by adding at the end the
following:
``(n)(1) For the purpose of providing expert scientific advice and
recommendations to the Secretary regarding a clinical investigation of
a drug or the approval for marketing of a drug under section 505 or
section 351 of the Public Health Service Act, the Secretary shall
establish panels of experts or use panels of experts established before
the date of enactment of the Food and Drug Administration Modernization
Act of 1997, or both.
``(2) The Secretary may delegate the appointment and oversight
authority granted under section 904 to a director of a center or
successor entity within the Food and Drug Administration.
``(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall consist of--
``(A) members who are qualified by training and experience to
evaluate the safety and effectiveness of the drugs to be referred
to the panel and who, to the extent feasible, possess skill and
experience in the development, manufacture, or utilization of such
drugs;
``(B) members with diverse expertise in such fields as clinical
and administrative medicine, pharmacy, pharmacology,
pharmacoeconomics, biological and physical sciences, and other
related professions;
``(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing industry not
directly affected by the matter to be brought before the panel; and
``(D) two or more members who are specialists or have other
expertise in the particular disease or condition for which the drug
under review is proposed to be indicated.
Scientific, trade, and consumer organizations shall be afforded an
opportunity to nominate individuals for appointment to the panels. No
individual who is in the regular full-time employ of the United States
and engaged in the administration of this Act may be a voting member of
any panel. The Secretary shall designate one of the members of each
panel to serve as chairman thereof.
``(4) Each member of a panel shall publicly disclose all conflicts
of interest that member may have with the work to be undertaken by the
panel. No member of a panel may vote on any matter where the member or
the immediate family of such member could gain financially from the
advice given to the Secretary. The Secretary may grant a waiver of any
conflict of interest requirement upon public disclosure of such
conflict of interest if such waiver is necessary to afford the panel
essential expertise, except that the Secretary may not grant a waiver
for a member of a panel when the member's own scientific work is
involved.
``(5) The Secretary shall, as appropriate, provide education and
training to each new panel member before such member participates in a
panel's activities, including education regarding requirements under
this Act and related regulations of the Secretary, and the
administrative processes and procedures related to panel meetings.
``(6) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or
otherwise engaged in its business, shall be entitled to receive
compensation for each day so engaged, including traveltime, at rates to
be fixed by the Secretary, but not to exceed the daily equivalent of
the rate in effect for positions classified above grade GS-15 of the
General Schedule. While serving away from their homes or regular places
of business, panel members may be allowed travel expenses (including
per diem in lieu of subsistence) as authorized by section 5703 of title
5, United States Code, for persons in the Government service employed
intermittently.
``(7) The Secretary shall ensure that scientific advisory panels
meet regularly and at appropriate intervals so that any matter to be
reviewed by such a panel can be presented to the panel not more than 60
days after the matter is ready for such review. Meetings of the panel
may be held using electronic communication to convene the meetings.
``(8) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and Drug
Administration official responsible for the matter shall review the
conclusions and recommendations of the panel, and notify the affected
persons of the final decision on the matter, or of the reasons that no
such decision has been reached. Each such final decision shall be
documented including the rationale for the decision.''.

7f44580df020dc14fcc5d0ac202d65e56ca0f6da4be0256a264a69fb3aa7899b

(a) Regulation of Compounded Positron Emission Tomography Drugs.--
Section 201 (21 U.S.C. 321) is amended by adding at the end the
following:
``(ii) The term `compounded positron emission tomography drug'--
``(1) means a drug that--
``(A) exhibits spontaneous disintegration of unstable
nuclei by the emission of positrons and is used for the purpose
of providing dual photon positron emission tomographic
diagnostic images; and
``(B) has been compounded by or on the order of a
practitioner who is licensed by a State to compound or order
compounding for a drug described in subparagraph (A), and is
compounded in accordance with that State's law, for a patient
or for research, teaching, or quality control; and
``(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer program to
be used in the preparation of such a drug.''.
(b) Adulteration.--
(1) In general.--Section 501(a) (21 U.S.C. 351(a)) is amended
by striking ``; or (3)'' and inserting the following: ``; or (C) if
it is a compounded positron emission tomography drug and the
methods used in, or the facilities and controls used for, its
compounding, processing, packing, or holding do not conform to or
are not operated or administered in conformity with the positron
emission tomography compounding standards and the official
monographs of the United States Pharmacopoeia to assure that such
drug meets the requirements of this Act as to safety and has the
identity and strength, and meets the quality and purity
characteristics, that it purports or is represented to possess; or
(3)''.
(2) Sunset.--Section 501(a)(2)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years
after the date of enactment of this Act or 2 years after the date
on which the Secretary of Health and Human Services establishes the
requirements described in subsection (c)(1)(B), whichever is later.
(c) Requirements for Review of Approval Procedures and Current Good
Manufacturing Practices for Positron Emission Tomography.--
(1) Procedures and requirements.--
(A) In general.--In order to take account of the special
characteristics of positron emission tomography drugs and the
special techniques and processes required to produce these
drugs, not later than 2 years after the date of enactment of
this Act, the Secretary of Health and Human Services shall
establish--
(i) appropriate procedures for the approval of positron
emission tomography drugs pursuant to section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
(ii) appropriate current good manufacturing practice
requirements for such drugs.
(B) Considerations and consultation.--In establishing the
procedures and requirements required by subparagraph (A), the
Secretary of Health and Human Services shall take due account
of any relevant differences between not-for-profit institutions
that compound the drugs for their patients and commercial
manufacturers of the drugs. Prior to establishing the
procedures and requirements, the Secretary of Health and Human
Services shall consult with patient advocacy groups,
professional associations, manufacturers, and physicians and
scientists licensed to make or use positron emission tomography
drugs.
(2) Submission of new drug applications and abbreviated new
drug applications.--
(A) In general.--Except as provided in subparagraph (B),
the Secretary of Health and Human Services shall not require
the submission of new drug applications or abbreviated new drug
applications under subsection (b) or (j) of section 505 (21
U.S.C. 355), for compounded positron emission tomography drugs
that are not adulterated drugs described in section
501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a
period of 4 years after the date of enactment of this Act, or
for 2 years after the date on which the Secretary establishes
procedures and requirements under paragraph (1), whichever is
longer.
(B) Exception.--Nothing in this Act shall prohibit the
voluntary submission of such applications or the review of such
applications by the Secretary of Health and Human Services.
Nothing in this Act shall constitute an exemption for a
positron emission tomography drug from the requirements of
regulations issued under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)).
(d) Revocation of Certain Inconsistent Documents.--Within 30 days
after the date of enactment of this Act, the Secretary of Health and
Human Services shall publish in the Federal Register a notice
terminating the application of the following notices and rule:
(1) A notice entitled ``Regulation of Positron Emission
Tomography Radiopharmaceutical Drug Products; Guidance; Public
Workshop'', published in the Federal Register on February 27, 1995,
60 Fed. Reg. 10594.
(2) A notice entitled ``Draft Guideline on the Manufacture of
Positron Emission Tomography Radiopharmaceutical Drug Products;
Availability'', published in the Federal Register on February 27,
1995, 60 Fed. Reg. 10593.
(3) A final rule entitled ``Current Good Manufacturing Practice
for Finished Pharmaceuticals; Positron Emission Tomography'',
published in the Federal Register on April 22, 1997, 62 Fed. Reg.
19493 (codified at part 211 of title 21, Code of Federal
Regulations).
(e) Definition.--As used in this section, the term ``compounded
positron emission tomography drug'' has the meaning given the term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321).

286107de0bdf907860fc5906f66e2812c964664376f5cfbeda2c639c02bd447a

(a) Requirements.--
(1) Regulations.--
(A) Proposed regulations.--Not later than 180 days after
the date of enactment of this Act, the Secretary of Health and
Human Services, after consultation with patient advocacy
groups, associations, physicians licensed to use
radiopharmaceuticals, and the regulated industry, shall issue
proposed regulations governing the approval of
radiopharmaceuticals. The regulations shall provide that the
determination of the safety and effectiveness of such a
radiopharmaceutical under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C. 262) shall include
consideration of the proposed use of the radiopharmaceutical in
the practice of medicine, the pharmacological and toxicological
activity of the radiopharmaceutical (including any carrier or
ligand component of the radiopharmaceutical), and the estimated
absorbed radiation dose of the radiopharmaceutical.
(B) Final regulations.--Not later than 18 months after the
date of enactment of this Act, the Secretary shall promulgate
final regulations governing the approval of the
radiopharmaceuticals.
(2) Special rule.--In the case of a radiopharmaceutical, the
indications for which such radiopharmaceutical is approved for
marketing may, in appropriate cases, refer to manifestations of
disease (such as biochemical, physiological, anatomic, or
pathological processes) common to, or present in, one or more
disease states.
(b) Definition.--In this section, the term ``radiopharma-ceutical''
means--
(1) an article--
(A) that is intended for use in the diagnosis or monitoring
of a disease or a manifestation of a disease in humans; and
(B) that exhibits spontaneous disintegration of unstable
nuclei with the emission of nuclear particles or photons; or
(2) any nonradioactive reagent kit or nuclide generator that is
intended to be used in the preparation of any such article.

8f521c4c2c9b187f111dfffb3cd6d0510fbfd6957cb85ff74069239bf36dbabc

(a) Licenses.--
(1) In general.--Section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)) is amended to read as follows:
``(a)(1) No person shall introduce or deliver for introduction into
interstate commerce any biological product unless--
``(A) a biologics license is in effect for the biological
product; and
``(B) each package of the biological product is plainly marked
with--
``(i) the proper name of the biological product contained
in the package;
``(ii) the name, address, and applicable license number of
the manufacturer of the biological product; and
``(iii) the expiration date of the biological product.
``(2)(A) The Secretary shall establish, by regulation, requirements
for the approval, suspension, and revocation of biologics licenses.
``(B) The Secretary shall approve a biologics license application--
``(i) on the basis of a demonstration that--
``(I) the biological product that is the subject of the
application is safe, pure, and potent; and
``(II) the facility in which the biological product is
manufactured, processed, packed, or held meets standards
designed to assure that the biological product continues to be
safe, pure, and potent; and
``(ii) if the applicant (or other appropriate person) consents
to the inspection of the facility that is the subject of the
application, in accordance with subsection (c).
``(3) The Secretary shall prescribe requirements under which a
biological product undergoing investigation shall be exempt from the
requirements of paragraph (1).''.
(2) Elimination of existing license requirement.--Section
351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is
amended--
(A) by striking ``(d)(1)'' and all that follows through
``of this section.'';
(B) in paragraph (2)--
(i) by striking ``(2)(A) Upon'' and inserting ``(d)(1)
Upon'' and
(ii) by redesignating subparagraph (B) as paragraph
(2); and
(C) in paragraph (2) (as so redesignated by subparagraph
(B)(ii))--
(i) by striking ``subparagraph (A)'' and inserting
``paragraph (1)''; and
(ii) by striking ``this subparagraph'' each place it
appears and inserting ``this paragraph''.
(b) Labeling.--Section 351(b) of the Public Health Service Act (42
U.S.C. 262(b)) is amended to read as follows:
``(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or mark on the
package or container of the biological product so as to falsify the
label or mark.''.
(c) Inspection.--Section 351(c) of the Public Health Service Act
(42 U.S.C. 262(c)) is amended by striking ``virus, serum,'' and all
that follows and inserting ``biological product.''.
(d) Definition; Application.--Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(i) In this section, the term `biological product' means a virus,
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, or analogous product, or arsphenamine
or derivative of arsphenamine (or any other trivalent organic arsenic
compound), applicable to the prevention, treatment, or cure of a
disease or condition of human beings.''.
(e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 353(g)(4))
is amended--
(1) in subparagraph (A)--
(A) by striking ``section 351(a)'' and inserting ``section
351(i)''; and
(B) by striking ``262(a)'' and inserting ``262(i)''; and
(2) in subparagraph (B)(iii), by striking ``product or
establishment license under subsection (a) or (d)'' and inserting
``biologics license application under subsection (a)''.
(f) Special Rule.--The Secretary of Health and Human Services shall
take measures to minimize differences in the review and approval of
products required to have approved biologics license applications under
section 351 of the Public Health Service Act (42 U.S.C. 262) and
products required to have approved new drug applications under section
505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)(1)).
(g) Application of Federal Food, Drug, and Cosmetic Act.--Section
351 of the Public Health Service Act (42 U.S.C. 262), as amended by
subsection (d), is further amended by adding at the end the following:
``(j) The Federal Food, Drug, and Cosmetic Act applies to a
biological product subject to regulation under this section, except
that a product for which a license has been approved under subsection
(a) shall not be required to have an approved application under section
505 of such Act.''.
(h) Examinations and Procedures.--Paragraph (3) of section 353(d)
of the Public Health Service Act (42 U.S.C. 263a(d)) is amended to read
as follows:
``(3) Examinations and procedures.--The examinations and
procedures identified in paragraph (2) are laboratory examinations
and procedures that have been approved by the Food and Drug
Administration for home use or that, as determined by the
Secretary, are simple laboratory examinations and procedures that
have an insignificant risk of an erroneous result, including those
that--
``(A) employ methodologies that are so simple and accurate
as to render the likelihood of erroneous results by the user
negligible, or
``(B) the Secretary has determined pose no unreasonable
risk of harm to the patient if performed incorrectly.''.

1208fca2a5e205d93da53c5c7bed2e35b5bb03e9d2166ce990bb4f752b52eb1a

(a) Human Drugs.--Section 505(c) (21 U.S.C. 355(c)) is amended by
adding at the end the following:
``(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the safety and effectiveness of the drug and to
obtain approval for the drug prior to manufacture of the drug in a
larger facility, unless the Secretary makes a determination that a full
scale production facility is necessary to ensure the safety or
effectiveness of the drug.''.
(b) Animal Drugs.--Section 512(c) (21 U.S.C. 360b(c)) is amended by
adding at the end the following:
``(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the safety and effectiveness of the drug and to
obtain approval for the drug prior to manufacture of the drug in a
larger facility, unless the Secretary makes a determination that a full
scale production facility is necessary to ensure the safety or
effectiveness of the drug.''.

1a3290a17dda14215fec22ed585213cb7281aaf6694117856ffb0f2f8990ff0d

(a) Certification of Drugs Containing Insulin.--
(1) Amendment.--Section 506 (21 U.S.C. 356), as in effect
before the date of the enactment of this Act, is repealed.
(2) Conforming amendments.--
(A) Section 301(j) (21 U.S.C. 331(j)) is amended by
striking ``506, 507,''.
(B) Subsection (k) of section 502 (21 U.S.C. 352) is
repealed.
(C) Sections 301(i)(1), 510(j)(1)(A), and 510(j)(1)(D) (21
U.S.C. 331(i)(1), 360(j)(1)(A), 360(j)(1)(D)) are each amended
by striking ``, 506, 507,''.
(D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by
inserting after ``503(b)'' the following: ``or composed wholly
or partly of insulin''.
(E) Section 8126(h)(2) of title 38, United States Code, is
amended by inserting ``or'' at the end of subparagraph (B), by
striking ``; or'' at the end of subparagraph (C) and inserting
a period, and by striking subparagraph (D).
(b) Certification of Antibiotics.--
(1) Amendment.--Section 507 (21 U.S.C. 357) is repealed.
(2) Conforming amendments.--
(A) Section 201(aa) (21 U.S.C. 321(aa)) is amended by
striking out ``or 507'', section 201(dd) (21 U.S.C. 321(dd)) is
amended by striking ``507,'', and section 201(ff)(3)(A) (21
U.S.C. 321(ff)(3)(A)) is amended by striking ``, certified as
an antibiotic under section 507,''.
(B) Section 301(e) (21 U.S.C. 331(e)) is amended by
striking ``507(d) or (g),''.
(C) Section 306(d)(4)(B)(ii) (21 U.S.C. 335a(d)(4)(B)(ii))
is amended by striking ``or 507''.
(D) Section 502 (21 U.S.C. 352) is amended by striking
subsection (l).
(E) Section 520(l) (21 U.S.C. 360j(l)) is amended by
striking paragraph (4) and by striking ``or Antibiotic Drugs''
in the subsection heading.
(F) Section 525(a) (21 U.S.C. 360aa(a)) is amended by
inserting ``or'' at the end of paragraph (1), by striking
paragraph (2), and by redesignating paragraph (3) as paragraph
(2).
(G) Section 525(a) (21 U.S.C. 360aa(a)) is amended by
striking ``, certification of such drug for such disease or
condition under section 507,''.
(H) Section 526(a)(1) (21 U.S.C. 360bb) is amended by
striking ``the submission of an application for certification
of the drug under section 507,'', by inserting ``or'' at the
end of subparagraph (A), by striking subparagraph (B), and by
redesignating subparagraph (C) as subparagraph (B).
(I) Section 526(b) (21 U.S.C. 360bb(b)) is amended--
(i) in paragraph (1), by striking ``, a certificate was
issued for the drug under section 507,''; and
(ii) in paragraph (2) by striking ``, a certificate has
not been issued for the drug under section 507,'' and by
striking ``, approval of an application for certification
under section 507,''.
(J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by
inserting ``or'' at the end of paragraph (1), by striking
paragraph (2), by redesignating paragraph (3) as paragraph (2),
and by striking ``, issue another certification under section
507,''.
(K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by
striking ``, if a certification is issued under section 507 for
such a drug,'', ``, of the issuance of the certification under
section 507,'', ``, issue another certification under section
507,'', ``, of such certification,'', ``, of the
certification,'', and ``, issuance of other certifications,''.
(L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by
striking ``, section 507 (d) or (g),''.
(M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended by
inserting ``or'' at the end of subparagraph (B), by striking
subparagraph (C), and by redesignating subparagraph (D) as
subparagraph (C).
(N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) of
the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A), 360ee(b)(1)(B))
are each amended by striking ``or 507''.
(O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue
Code of 1986 is amended by striking ``or 507''.
(P) Section 156(f)(4)(B) of title 35, United States Code,
is amended by striking ``507,'' each place it occurs.
(c) Exportation.--Section 802 (21 U.S.C. 382) is amended by adding
at the end the following:
``(i) Insulin and antibiotic drugs may be exported without regard
to the requirements in this section if the insulin and antibiotic drugs
meet the requirements of section 801(e)(1).''.
(d) Transition.--
(1) In general.--An application that was approved by the
Secretary of Health and Human Services before the date of the
enactment of this Act for the marketing of an antibiotic drug under
section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
357), as in effect on the day before the date of the enactment of
this Act, shall, on and after such date of enactment, be considered
to be an application that was submitted and filed under section
505(b) of such Act (21 U.S.C. 355(b)) and approved for safety and
effectiveness under section 505(c) of such Act (21 U.S.C. 355(c)),
except that if such application for marketing was in the form of an
abbreviated application, the application shall be considered to
have been filed and approved under section 505(j) of such Act (21
U.S.C. 355(j)).
(2) Exception.--The following subsections of section 505 (21
U.S.C. 355) shall not apply to any application for marketing in
which the drug that is the subject of the application contains an
antibiotic drug and the antibiotic drug was the subject of any
application for marketing received by the Secretary of Health and
Human Services under section 507 of such Act (21 U.S.C. 357) before
the date of the enactment of this Act:
(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii),
(j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
(ii) The third and fourth sentences of subsection (b)(1)
(regarding the filing and publication of patent information);
and
(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if
the investigations relied upon by the applicant for approval of
the application were not conducted by or for the applicant and
for which the applicant has not obtained a right of reference
or use from the person by or for whom the investigations were
conducted.
(3) Publication.--For purposes of this section, the Secretary
is authorized to make available to the public the established name
of each antibiotic drug that was the subject of any application for
marketing received by the Secretary for Health and Human Services
under section 507 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 357) before the date of enactment of this Act.
(e) Definition.--Section 201 (21 U.S.C. 321), as amended by section
121(a)(1), is further amended by adding at the end the following:
``(jj) The term `antibiotic drug' means any drug (except drugs for
use in animals other than humans) composed wholly or partly of any kind
of penicillin, streptomycin, chlortetracycline, chloramphenicol,
bacitracin, or any other drug intended for human use containing any
quantity of any chemical substance which is produced by a micro-
organism and which has the capacity to inhibit or destroy micro-
organisms in dilute solution (including a chemically synthesized
equivalent of any such substance) or any derivative thereof.''.

5b9df1a5054f51ac8e1e47fa0d0841a740fb999c8cdcde079785ad7fb1379ee4

(a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 353(b)(4)) is
amended to read as follows:
``(4)(A) A drug that is subject to paragraph (1) shall be deemed to
be misbranded if at any time prior to dispensing the label of the drug
fails to bear, at a minimum, the symbol `Rx only'.
``(B) A drug to which paragraph (1) does not apply shall be deemed
to be misbranded if at any time prior to dispensing the label of the
drug bears the symbol described in subparagraph (A).''.
(b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is
repealed.
(c) Conforming Amendments.--
(1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
(A) by striking subparagraph (A); and
(B) by redesignating subparagraphs (B) and (C) as
subparagraphs (A) and (B), respectively.
(2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by
striking ``section 502(d) and''.
(3) Section 102(9)(A) of the Controlled Substances Act (21
U.S.C. 802(9)(A)) is amended--
(A) in clause (i), by striking ``(i)''; and
(B) by striking ``(ii)'' and all that follows.

29e9b4b2a7935d13df39034e1d1d5ff1a032dc84c8a88d51cee4fe2cf7c8c053

COMPOUNDING.
(a) Amendment.--Chapter V is amended by inserting after section 503
(21 U.S.C. 353) the following:
``SEC. 503A. PHARMACY COMPOUNDING.
``(a) In General.--Sections 501(a)(2)(B), 502(f)(1), and 505 shall
not apply to a drug product if the drug product is compounded for an
identified individual patient based on the unsolicited receipt of a
valid prescription order or a notation, approved by the prescribing
practitioner, on the prescription order that a compounded product is
necessary for the identified patient, if the drug product meets the
requirements of this section, and if the compounding--
``(1) is by--
``(A) a licensed pharmacist in a State licensed pharmacy or
a Federal facility, or
``(B) a licensed physician,
on the prescription order for such individual patient made by a
licensed physician or other licensed practitioner authorized by
State law to prescribe drugs; or
``(2)(A) is by a licensed pharmacist or licensed physician in
limited quantities before the receipt of a valid prescription order
for such individual patient; and
``(B) is based on a history of the licensed pharmacist or
licensed physician receiving valid prescription orders for the
compounding of the drug product, which orders have been generated
solely within an established relationship between--
``(i) the licensed pharmacist or licensed physician; and
``(ii)(I) such individual patient for whom the prescription
order will be provided; or
``(II) the physician or other licensed practitioner who
will write such prescription order.
``(b) Compounded Drug.--
``(1) Licensed pharmacist and licensed physician.--A drug
product may be compounded under subsection (a) if the licensed
pharmacist or licensed physician--
``(A) compounds the drug product using bulk drug
substances, as defined in regulations of the Secretary
published at section 207.3(a)(4) of title 21 of the Code of
Federal Regulations--
``(i) that--
``(I) comply with the standards of an applicable
United States Pharmacopoeia or National Formulary
monograph, if a monograph exists, and the United States
Pharmacopoeia chapter on pharmacy compounding;
``(II) if such a monograph does not exist, are drug
substances that are components of drugs approved by the
Secretary; or
``(III) if such a monograph does not exist and the
drug substance is not a component of a drug approved by
the Secretary, that appear on a list developed by the
Secretary through regulations issued by the Secretary
under subsection (d);
``(ii) that are manufactured by an establishment that
is registered under section 510 (including a foreign
establishment that is registered under section 510(i)); and
``(iii) that are accompanied by valid certificates of
analysis for each bulk drug substance;
``(B) compounds the drug product using ingredients (other
than bulk drug substances) that comply with the standards of an
applicable United States Pharmacopoeia or National Formulary
monograph, if a monograph exists, and the United States
Pharmacopoeia chapter on pharmacy compounding;
``(C) does not compound a drug product that appears on a
list published by the Secretary in the Federal Register of drug
products that have been withdrawn or removed from the market
because such drug products or components of such drug products
have been found to be unsafe or not effective; and
``(D) does not compound regularly or in inordinate amounts
(as defined by the Secretary) any drug products that are
essentially copies of a commercially available drug product.
``(2) Definition.--For purposes of paragraph (1)(D), the term
`essentially a copy of a commercially available drug product' does
not include a drug product in which there is a change, made for an
identified individual patient, which produces for that patient a
significant difference, as determined by the prescribing
practitioner, between the compounded drug and the comparable
commercially available drug product.
``(3) Drug product.--A drug product may be compounded under
subsection (a) only if--
``(A) such drug product is not a drug product identified by
the Secretary by regulation as a drug product that presents
demonstrable difficulties for compounding that reasonably
demonstrate an adverse effect on the safety or effectiveness of
that drug product; and
``(B) such drug product is compounded in a State--
``(i) that has entered into a memorandum of
understanding with the Secretary which addresses the
distribution of inordinate amounts of compounded drug
products interstate and provides for appropriate
investigation by a State agency of complaints relating to
compounded drug products distributed outside such State; or
``(ii) that has not entered into the memorandum of
understanding described in clause (i) and the licensed
pharmacist, licensed pharmacy, or licensed physician
distributes (or causes to be distributed) compounded drug
products out of the State in which they are compounded in
quantities that do not exceed 5 percent of the total
prescription orders dispensed or distributed by such
pharmacy or physician.
The Secretary shall, in consultation with the National Association
of Boards of Pharmacy, develop a standard memorandum of
understanding for use by the States in complying with subparagraph
(B)(i).
``(c) Advertising and Promotion.--A drug may be compounded under
subsection (a) only if the pharmacy, licensed pharmacist, or licensed
physician does not advertise or promote the compounding of any
particular drug, class of drug, or type of drug. The pharmacy, licensed
pharmacist, or licensed physician may advertise and promote the
compounding service provided by the licensed pharmacist or licensed
physician.
``(d) Regulations.--
``(1) In general.--The Secretary shall issue regulations to
implement this section. Before issuing regulations to implement
subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the
Secretary shall convene and consult an advisory committee on
compounding unless the Secretary determines that the issuance of
such regulations before consultation is necessary to protect the
public health. The advisory committee shall include representatives
from the National Association of Boards of Pharmacy, the United
States Pharmacopoeia, pharmacy, physician, and consumer
organizations, and other experts selected by the Secretary.
``(2) Limiting compounding.--The Secretary, in consultation
with the United States Pharmacopoeia Convention, Incorporated,
shall promulgate regulations identifying drug substances that may
be used in compounding under subsection (b)(1)(A)(i)(III) for which
a monograph does not exist or which are not components of drug
products approved by the Secretary. The Secretary shall include in
the regulation the criteria for such substances, which shall
include historical use, reports in peer reviewed medical
literature, or other criteria the Secretary may identify.
``(e) Application.--This section shall not apply to--
``(1) compounded positron emission tomography drugs as defined
in section 201(ii); or
``(2) radiopharmaceuticals.
``(f) Definition.--As used in this section, the term `compounding'
does not include mixing, reconstituting, or other such acts that are
performed in accordance with directions contained in approved labeling
provided by the product's manufacturer and other manufacturer
directions consistent with that labeling.''.
(b) Effective Date.--Section 503A of the Federal Food, Drug, and
Cosmetic Act, added by subsection (a), shall take effect upon the
expiration of the 1-year period beginning on the date of the enactment
of this Act.

30f011377959b985bc45e1b514d4d7d8f1467c2117a8499476352e39ec0c5082

Section 2 of Public Law 102-222 (105 Stat. 1677) is amended--
(1) in subsection (a), by striking ``a grant'' and all that
follows through ``Such grant'' and inserting the following:
``grants for a pilot program for the training of individuals in
clinical pharmacology at appropriate medical schools. Such
grants''; and
(2) in subsection (b), by striking ``to carry out this
section'' and inserting ``, and for fiscal years 1998 through 2002
$3,000,000 for each fiscal year, to carry out this section''.

bb1f54c0720ac752b05fd4ed829abf109047e4e6715a228b058a23c34a4223f0

Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall issue regulations for
over-the-counter sunscreen products for the prevention or treatment of
sunburn.

2186af73f00b4ce156ac0cb8559bae9ae2b64be7732e58a313c36e769fae107f

(a) In General.--Chapter V, as amended by section 116, is further
amended by inserting after section 506A the following:
``SEC. 506B. REPORTS OF POSTMARKETING STUDIES.
``(a) Submission.--
``(1) In general.--A sponsor of a drug that has entered into an
agreement with the Secretary to conduct a postmarketing study of a
drug shall submit to the Secretary, within 1 year after the
approval of such drug and annually thereafter until the study is
completed or terminated, a report of the progress of the study or
the reasons for the failure of the sponsor to conduct the study.
The report shall be submitted in such form as is prescribed by the
Secretary in regulations issued by the Secretary.
``(2) Agreements prior to effective date.--Any agreement
entered into between the Secretary and a sponsor of a drug, prior
to the date of enactment of the Food and Drug Administration
Modernization Act of 1997, to conduct a postmarketing study of a
drug shall be subject to the requirements of paragraph (1). An
initial report for such an agreement shall be submitted within 6
months after the date of the issuance of the regulations under
paragraph (1).
``(b) Consideration of Information as Public Information.--Any
information pertaining to a report described in subsection (a) shall be
considered to be public information to the extent that the information
is necessary--
``(1) to identify the sponsor; and
``(2) to establish the status of a study described in
subsection (a) and the reasons, if any, for any failure to carry
out the study.
``(c) Status of Studies and Reports.--The Secretary shall annually
develop and publish in the Federal Register a report that provides
information on the status of the postmarketing studies--
``(1) that sponsors have entered into agreements to conduct;
and
``(2) for which reports have been submitted under subsection
(a)(1).''.
(b) Report to Congressional Committees.--Not later than October 1,
2001, the Secretary shall prepare and submit to the Committee on Labor
and Human Resources of the Senate and the Committee on Commerce of the
House of Representatives a report containing--
(1) a summary of the reports submitted under section 506B of
the Federal Food, Drug, and Cosmetic Act;
(2) an evaluation of--
(A) the performance of the sponsors referred to in such
section in fulfilling the agreements with respect to the
conduct of postmarketing studies described in such section of
such Act; and
(B) the timeliness of the Secretary's review of the
postmarketing studies; and
(3) any legislative recommendations respecting the
postmarketing studies.

eeb0348417cf437536ab9ff377835c69fbc9e2efcbe7fc01fb09e37665857363

(a) In General.--Chapter V, as amended by section 130, is further
amended by inserting after section 506B the following:
``SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT.
``(a) In General.--A manufacturer that is the sole manufacturer of
a drug--
``(1) that is--
``(A) life-supporting;
``(B) life-sustaining; or
``(C) intended for use in the prevention of a debilitating
disease or condition;
``(2) for which an application has been approved under section
505(b) or 505(j); and
``(3) that is not a product that was originally derived from
human tissue and was replaced by a recombinant product,
shall notify the Secretary of a discontinuance of the manufacture of
the drug at least 6 months prior to the date of the discontinuance.
``(b) Reduction in Notification Period.--The notification period
required under subsection (a) for a manufacturer may be reduced if the
manufacturer certifies to the Secretary that good cause exists for the
reduction, such as a situation in which--
``(1) a public health problem may result from continuation of
the manufacturing for the 6-month period;
``(2) a biomaterials shortage prevents the continuation of the
manufacturing for the 6-month period;
``(3) a liability problem may exist for the manufacturer if the
manufacturing is continued for the 6-month period;
``(4) continuation of the manufacturing for the 6-month period
may cause substantial economic hardship for the manufacturer;
``(5) the manufacturer has filed for bankruptcy under chapter 7
or 11 of title 11, United States Code; or
``(6) the manufacturer can continue the distribution of the
drug involved for 6 months.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute information on the discontinuation of the
drugs described in subsection (a) to appropriate physician and patient
organizations.''.

4875b9da8393db7806ed85a465b9e3a59c021a6239a30471f9bd80836dbfb25b

(a) In General.--Section 520(g) (21 U.S.C. 360j(g)) is amended by
adding at the end the following:
``(6)(A) Not later than 1 year after the date of the enactment of
the Food and Drug Administration Modernization Act of 1997, the
Secretary shall by regulation establish, with respect to a device for
which an exemption under this subsection is in effect, procedures and
conditions that, without requiring an additional approval of an
application for an exemption or the approval of a supplement to such an
application, permit--
``(i) developmental changes in the device (including
manufacturing changes) that do not constitute a significant change
in design or in basic principles of operation and that are made in
response to information gathered during the course of an
investigation; and
``(ii) changes or modifications to clinical protocols that do
not affect--
``(I) the validity of data or information resulting from
the completion of an approved protocol, or the relationship of
likely patient risk to benefit relied upon to approve a
protocol;
``(II) the scientific soundness of an investigational plan
submitted under paragraph (3)(A); or
``(III) the rights, safety, or welfare of the human
subjects involved in the investigation.
``(B) Regulations under subparagraph (A) shall provide that a
change or modification described in such subparagraph may be made if--
``(i) the sponsor of the investigation determines, on the basis
of credible information (as defined by the Secretary) that the
applicable conditions under subparagraph (A) are met; and
``(ii) the sponsor submits to the Secretary, not later than 5
days after making the change or modification, a notice of the
change or modification.
``(7)(A) In the case of a person intending to investigate the
safety or effectiveness of a class III device or any implantable
device, the Secretary shall ensure that the person has an opportunity,
prior to submitting an application to the Secretary or to an
institutional review committee, to submit to the Secretary, for review,
an investigational plan (including a clinical protocol). If the
applicant submits a written request for a meeting with the Secretary
regarding such review, the Secretary shall, not later than 30 days
after receiving the request, meet with the applicant for the purpose of
reaching agreement regarding the investigational plan (including a
clinical protocol). The written request shall include a detailed
description of the device, a detailed description of the proposed
conditions of use of the device, a proposed plan (including a clinical
protocol) for determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the expected
performance from the device.
``(B) Any agreement regarding the parameters of an investigational
plan (including a clinical protocol) that is reached between the
Secretary and a sponsor or applicant shall be reduced to writing and
made part of the administrative record by the Secretary. Any such
agreement shall not be changed, except--
``(i) with the written agreement of the sponsor or applicant;
or
``(ii) pursuant to a decision, made in accordance with
subparagraph (C) by the director of the office in which the device
involved is reviewed, that a substantial scientific issue essential
to determining the safety or effectiveness of the device involved
has been identified.
``(C) A decision under subparagraph (B)(ii) by the director shall
be in writing, and may be made only after the Secretary has provided to
the sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant are present and at which the
director documents the scientific issue involved.''.
(b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C.
360e(d)(1)(B)) is amended by adding at the end the following:
``(iii) The Secretary shall accept and review statistically valid
and reliable data and any other information from investigations
conducted under the authority of regulations required by section 520(g)
to make a determination of whether there is a reasonable assurance of
safety and effectiveness of a device subject to a pending application
under this section if--
``(I) the data or information is derived from investigations of
an earlier version of the device, the device has been modified
during or after the investigations (but prior to submission of an
application under subsection (c)) and such a modification of the
device does not constitute a significant change in the design or in
the basic principles of operation of the device that would
invalidate the data or information; or
``(II) the data or information relates to a device approved
under this section, is available for use under this Act, and is
relevant to the design and intended use of the device for which the
application is pending.''.

30ae94851df9a2a1327d997177117cfa58a9ba345033a34c31c7816aafb8e1bc

Section 515(d) (21 U.S.C. 360e(d)) is amended--
(1) by redesignating paragraph (3) as paragraph (4); and
(2) by adding at the end the following:
``(5) In order to provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human diseases or
conditions, the Secretary shall provide review priority for devices--
``(A) representing breakthrough technologies,
``(B) for which no approved alternatives exist,
``(C) which offer significant advantages over existing approved
alternatives, or
``(D) the availability of which is in the best interest of the
patients.''.

6d61da18f4a64e6a37ef32b5377428d957df1245b13c02464fb0f96bbd7b35ca

Section 520(m) (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (2), by adding after and below subparagraph
(C) the following sentences:
``The request shall be in the form of an application submitted to the
Secretary. Not later than 75 days after the date of the receipt of the
application, the Secretary shall issue an order approving or denying
the application.'';
(2) in paragraph (4)--
(A) in subparagraph (B), by inserting after ``(2)(A)'' the
following: ``, unless a physician determines in an emergency
situation that approval from a local institutional review
committee can not be obtained in time to prevent serious harm
or death to a patient''; and
(B) by adding after and below subparagraph (B) the
following:
``In a case described in subparagraph (B) in which a physician uses a
device without an approval from an institutional review committee, the
physician shall, after the use of the device, notify the chairperson of
the local institutional review committee of such use. Such notification
shall include the identification of the patient involved, the date on
which the device was used, and the reason for the use.'';
(3) by amending paragraph (5) to read as follows:
``(5) The Secretary may require a person granted an exemption under
paragraph (2) to demonstrate continued compliance with the requirements
of this subsection if the Secretary believes such demonstration to be
necessary to protect the public health or if the Secretary has reason
to believe that the criteria for the exemption are no longer met.'';
and
(4) by amending paragraph (6) to read as follows:
``(6) The Secretary may suspend or withdraw an exemption from the
effectiveness requirements of sections 514 and 515 for a humanitarian
device only after providing notice and an opportunity for an informal
hearing.''.

c13a38955586c97f13ad6ad70ba592088919a6b40097f07c86d85987da5a5cae

(a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended
by adding at the end the following:
``Recognition of a Standard
``(c)(1)(A) In addition to establishing a performance standard
under this section, the Secretary shall, by publication in the Federal
Register, recognize all or part of an appropriate standard established
by a nationally or internationally recognized standard development
organization for which a person may submit a declaration of conformity
in order to meet a premarket submission requirement or other
requirement under this Act to which such standard is applicable.
``(B) If a person elects to use a standard recognized by the
Secretary under subparagraph (A) to meet the requirements described in
such subparagraph, the person shall provide a declaration of conformity
to the Secretary that certifies that the device is in conformity with
such standard. A person may elect to use data, or information, other
than data required by a standard recognized under subparagraph (A) to
meet any requirement regarding devices under this Act.
``(2) The Secretary may withdraw such recognition of a standard
through publication of a notice in the Federal Register if the
Secretary determines that the standard is no longer appropriate for
meeting a requirement regarding devices under this Act.
``(3)(A) Subject to subparagraph (B), the Secretary shall accept a
declaration of conformity that a device is in conformity with a
standard recognized under paragraph (1) unless the Secretary finds--
``(i) that the data or information submitted to support such
declaration does not demonstrate that the device is in conformity
with the standard identified in the declaration of conformity; or
``(ii) that the standard identified in the declaration of
conformity is not applicable to the particular device under review.
``(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of conformity
with respect to a standard recognized under paragraph (1).
``(C) A person making a declaration of conformity with respect to a
standard recognized under paragraph (1) shall maintain the data and
information demonstrating conformity of the device to the standard for
a period of two years after the date of the classification or approval
of the device by the Secretary or a period equal to the expected design
life of the device, whichever is longer.''.
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding
at the end the following:
``(x) The falsification of a declaration of conformity submitted
under section 514(c) or the failure or refusal to provide data or
information requested by the Secretary under paragraph (3) of such
section.''.
(c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended--
(1) by striking ``(e)'' and inserting ``(e)(1)''; and
(2) by inserting at the end the following:
``(2) If it is declared to be, purports to be, or is represented
as, a device that is in conformity with any standard recognized under
section 514(c) unless such device is in all respects in conformity with
such standard.''.
(d) Conforming Amendments.--Section 514(a) (21 U.S.C. 360d(a)) is
amended--
(1) in paragraph (1), in the second sentence, by striking
``under this section'' and inserting ``under subsection (b)'';
(2) in paragraph (2), in the matter preceding subparagraph (A),
by striking ``under this section'' and inserting ``under subsection
(b)'';
(3) in paragraph (3), by striking ``under this section'' and
inserting ``under subsection (b)''; and
(4) in paragraph (4), in the matter preceding subparagraph (A),
by striking ``this section'' and inserting ``this subsection and
subsection (b)''.

ca36bb4458756249245497cb50a84a7d62f8c0a9a6ad4378bbbea42d2bb7d4f6

DATA REQUIREMENTS.
(a) Section 513(a).--Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is
amended by adding at the end the following:
``(C) In making a determination of a reasonable assurance of the
effectiveness of a device for which an application under section 515
has been submitted, the Secretary shall consider whether the extent of
data that otherwise would be required for approval of the application
with respect to effectiveness can be reduced through reliance on
postmarket controls.
``(D)(i) The Secretary, upon the written request of any person
intending to submit an application under section 515, shall meet with
such person to determine the type of valid scientific evidence (within
the meaning of subparagraphs (A) and (B)) that will be necessary to
demonstrate for purposes of approval of an application the
effectiveness of a device for the conditions of use proposed by such
person. The written request shall include a detailed description of the
device, a detailed description of the proposed conditions of use of the
device, a proposed plan for determining whether there is a reasonable
assurance of effectiveness, and, if available, information regarding
the expected performance from the device. Within 30 days after such
meeting, the Secretary shall specify in writing the type of valid
scientific evidence that will provide a reasonable assurance that a
device is effective under the conditions of use proposed by such
person.
``(ii) Any clinical data, including one or more well-controlled
investigations, specified in writing by the Secretary for demonstrating
a reasonable assurance of device effectiveness shall be specified as
result of a determination by the Secretary that such data are necessary
to establish device effectiveness. The Secretary shall consider, in
consultation with the applicant, the least burdensome appropriate means
of evaluating device effectiveness that would have a reasonable
likelihood of resulting in approval.
``(iii) The determination of the Secretary with respect to the
specification of valid scientific evidence under clauses (i) and (ii)
shall be binding upon the Secretary, unless such determination by the
Secretary could be contrary to the public health.''.
(b) Section 513(i).--Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is
amended by adding at the end the following:
``(C) To facilitate reviews of reports submitted to the Secretary
under section 510(k), the Secretary shall consider the extent to which
reliance on postmarket controls may expedite the classification of
devices under subsection (f)(1) of this section.
``(D) Whenever the Secretary requests information to demonstrate
that devices with differing technological characteristics are
substantially equivalent, the Secretary shall only request information
that is necessary to making substantial equivalence determinations. In
making such request, the Secretary shall consider the least burdensome
means of demonstrating substantial equivalence and request information
accordingly.
``(E)(i) Any determination by the Secretary of the intended use of
a device shall be based upon the proposed labeling submitted in a
report for the device under section 510(k). However, when determining
that a device can be found substantially equivalent to a legally
marketed device, the director of the organizational unit responsible
for regulating devices (in this subparagraph referred to as the
`Director') may require a statement in labeling that provides
appropriate information regarding a use of the device not identified in
the proposed labeling if, after providing an opportunity for
consultation with the person who submitted such report, the Director
determines and states in writing--
``(I) that there is a reasonable likelihood that the device
will be used for an intended use not identified in the proposed
labeling for the device; and
``(II) that such use could cause harm.
``(ii) Such determination shall--
``(I) be provided to the person who submitted the report within
10 days from the date of the notification of the Director's
concerns regarding the proposed labeling;
``(II) specify the limitations on the use of the device not
included in the proposed labeling; and
``(III) find the device substantially equivalent if the
requirements of subparagraph (A) are met and if the labeling for
such device conforms to the limitations specified in subclause
(II).
``(iii) The responsibilities of the Director under this
subparagraph may not be delegated.
``(iv) This subparagraph has no legal effect after the expiration
of the five-year period beginning on the date of the enactment of the
Food and Drug Administration Modernization Act of 1997.''.
(c) Section 515(d).--Section 515(d) (21 U.S.C. 360e(d)) is
amended--
(1) in paragraph (1)(A), by adding after and below clause (ii)
the following:
``In making the determination whether to approve or deny the
application, the Secretary shall rely on the conditions of use included
in the proposed labeling as the basis for determining whether or not
there is a reasonable assurance of safety and effectiveness, if the
proposed labeling is neither false nor misleading. In determining
whether or not such labeling is false or misleading, the Secretary
shall fairly evaluate all material facts pertinent to the proposed
labeling.''; and
(2) by adding after paragraph (5) (as added by section 202(2))
the following:
``(6)(A)(i) A supplemental application shall be required for any
change to a device subject to an approved application under this
subsection that affects safety or effectiveness, unless such change is
a modification in a manufacturing procedure or method of manufacturing
and the holder of the approved application submits a written notice to
the Secretary that describes in detail the change, summarizes the data
or information supporting the change, and informs the Secretary that
the change has been made under the requirements of section 520(f).
``(ii) The holder of an approved application who submits a notice
under clause (i) with respect to a manufacturing change of a device may
distribute the device 30 days after the date on which the Secretary
receives the notice, unless the Secretary within such 30-day period
notifies the holder that the notice is not adequate and describes such
further information or action that is required for acceptance of such
change. If the Secretary notifies the holder that a supplemental
application is required, the Secretary shall review the supplement
within 135 days after the receipt of the supplement. The time used by
the Secretary to review the notice of the manufacturing change shall be
deducted from the 135-day review period if the notice meets appropriate
content requirements for premarket approval supplements.
``(B)(i) Subject to clause (ii), in reviewing a supplement to an
approved application, for an incremental change to the design of a
device that affects safety or effectiveness, the Secretary shall
approve such supplement if--
``(I) nonclinical data demonstrate that the design modification
creates the intended additional capacity, function, or performance
of the device; and
``(II) clinical data from the approved application and any
supplement to the approved application provide a reasonable
assurance of safety and effectiveness for the changed device.
``(ii) The Secretary may require, when necessary, additional
clinical data to evaluate the design modification of the device to
provide a reasonable assurance of safety and effectiveness.''.

fe5c41dcc4e243ff5fec667636af5af8df95de9e875111013260abfee7ea61f7

(a) Section 510.--Section 510 (21 U.S.C. 360) is amended--
(1) in subsection (k), in the matter preceding paragraph (1),
by adding after ``report to the Secretary'' the following: ``or
person who is accredited under section 523(a)''; and
(2) by adding at the end the following subsections:
``(l) A report under subsection (k) is not required for a device
intended for human use that is exempted from the requirements of this
subsection under subsection (m) or is within a type that has been
classified into class I under section 513. The exception established in
the preceding sentence does not apply to any class I device that is
intended for a use which is of substantial importance in preventing
impairment of human health, or to any class I device that presents a
potential unreasonable risk of illness or injury.
``(m)(1) Not later than 60 days after the date of enactment of the
Food and Drug Administration Modernization Act of 1997, the Secretary
shall publish in the Federal Register a list of each type of class II
device that does not require a report under subsection (k) to provide
reasonable assurance of safety and effectiveness. Each type of class II
device identified by the Secretary as not requiring the report shall be
exempt from the requirement to provide a report under subsection (k) as
of the date of the publication of the list in the Federal Register.
``(2) Beginning on the date that is 1 day after the date of the
publication of a list under this subsection, the Secretary may exempt a
class II device from the requirement to submit a report under
subsection (k), upon the Secretary's own initiative or a petition of an
interested person, if the Secretary determines that such report is not
necessary to assure the safety and effectiveness of the device. The
Secretary shall publish in the Federal Register notice of the intent of
the Secretary to exempt the device, or of the petition, and provide a
30-day period for public comment. Within 120 days after the issuance of
the notice in the Federal Register, the Secretary shall publish an
order in the Federal Register that sets forth the final determination
of the Secretary regarding the exemption of the device that was the
subject of the notice. If the Secretary fails to respond to a petition
within 180 days of receiving it, the petition shall be deemed to be
granted.''.
(b) Section 513(f).--Section 513(f) (21 U.S.C. 360c(f)) is amended
by adding at the end the following:
``(5) The Secretary may not withhold a determination of the initial
classification of a device under paragraph (1) because of a failure to
comply with any provision of this Act unrelated to a substantial
equivalence decision, including a finding that the facility in which
the device is manufactured is not in compliance with good manufacturing
requirements as set forth in regulations of the Secretary under section
520(f) (other than a finding that there is a substantial likelihood
that the failure to comply with such regulations will potentially
present a serious risk to human health).''.
(c) Section 513(i).--Section 513(i)(1) (21 U.S.C. 360c(i)), as
amended by section 205(b), is amended--
(1) in subparagraph (A)(ii)--
(A) in subclause (I), by striking ``clinical data'' and
inserting ``appropriate clinical or scientific data'' and by
inserting ``or a person accredited under section 523'' after
``Secretary''; and
(B) in subclause (II), by striking ``efficacy'' and
inserting ``effectiveness''; and
(2) by adding at the end the following:
``(F) Not later than 270 days after the date of the enactment of
the Food and Drug Administration Modernization Act of 1997, the
Secretary shall issue guidance specifying the general principles that
the Secretary will consider in determining when a specific intended use
of a device is not reasonably included within a general use of such
device for purposes of a determination of substantial equivalence under
subsection (f) or section 520(l).''.

ae8d2c2dd9c15597eb0a118c2f6991e178b839e6c958a85797e21ab64b58f96b

Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b),
is amended--
(1) in paragraph (1)--
(A) in subparagraph (B), by striking ``paragraph (2)'' and
inserting ``paragraph (3)''; and
(B) in the last sentence, by striking ``paragraph (2)'' and
inserting ``paragraph (2) or (3)'';
(2) by redesignating paragraphs (2) and (3) as paragraphs (3)
and (4), respectively; and
(3) by inserting after paragraph (1) the following:
``(2)(A) Any person who submits a report under section 510(k) for a
type of device that has not been previously classified under this Act,
and that is classified into class III under paragraph (1), may request,
within 30 days after receiving written notice of such a classification,
the Secretary to classify the device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1). The person may, in
the request, recommend to the Secretary a classification for the
device. Any such request shall describe the device and provide detailed
information and reasons for the recommended classification.
``(B)(i) Not later than 60 days after the date of the submission of
the request under subparagraph (A), the Secretary shall by written
order classify the device involved. Such classification shall be the
initial classification of the device for purposes of paragraph (1) and
any device classified under this paragraph shall be a predicate device
for determining substantial equivalence under paragraph (1).
``(ii) A device that remains in class III under this subparagraph
shall be deemed to be adulterated within the meaning of section
501(f)(1)(B) until approved under section 515 or exempted from such
approval under section 520(g).
``(C) Within 30 days after the issuance of an order classifying a
device under this paragraph, the Secretary shall publish a notice in
the Federal Register announcing such classification.''.

fbea185684c70359c55af8ee802ab15dd3cd7389f48ea646bcfbe4baa4a958ea

Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end
the following:
``(5) Classification panels covering each type of device shall be
scheduled to meet at such times as may be appropriate for the Secretary
to meet applicable statutory deadlines.
``(6)(A) Any person whose device is specifically the subject of
review by a classification panel shall have--
``(i) the same access to data and information submitted to a
classification panel (except for data and information that are not
available for public disclosure under section 552 of title 5,
United States Code) as the Secretary;
``(ii) the opportunity to submit, for review by a
classification panel, information that is based on the data or
information provided in the application submitted under section 515
by the person, which information shall be submitted to the
Secretary for prompt transmittal to the classification panel; and
``(iii) the same opportunity as the Secretary to participate in
meetings of the panel.
``(B) Any meetings of a classification panel shall provide adequate
time for initial presentations and for response to any differing views
by persons whose devices are specifically the subject of a
classification panel review, and shall encourage free and open
participation by all interested persons.
``(7) After receiving from a classification panel the conclusions
and recommendations of the panel on a matter that the panel has
reviewed, the Secretary shall review the conclusions and
recommendations, shall make a final decision on the matter in
accordance with section 515(d)(2), and shall notify the affected
persons of the decision in writing and, if the decision differs from
the conclusions and recommendations of the panel, shall include the
reasons for the difference.
``(8) A classification panel under this subsection shall not be
subject to the annual chartering and annual report requirements of the
Federal Advisory Committee Act.''.

fdae22ac3da63849a2a0ae15eb3ff3d5fd4143534441531788927c3673521ac9

PROCESS.
(a) Certainty of Review Timeframes.--Section 510 (21 U.S.C. 360),
as amended by section 206(a)(2), is amended by adding at the end the
following subsection:
``(n) The Secretary shall review the report required in subsection
(k) and make a determination under section 513(f)(1) not later than 90
days after receiving the report.''.
(b) Collaborative Review Process.--Section 515(d) (21 U.S.C.
360e(d)), as amended by section 202(1), is amended by inserting after
paragraph (2) the following:
``(3)(A)(i) The Secretary shall, upon the written request of an
applicant, meet with the applicant, not later than 100 days after the
receipt of an application that has been filed as complete under
subsection (c), to discuss the review status of the application.
``(ii) The Secretary shall, in writing and prior to the meeting,
provide to the applicant a description of any deficiencies in the
application that, at that point, have been identified by the Secretary
based on an interim review of the entire application and identify the
information that is required to correct those deficiencies.
``(iii) The Secretary shall notify the applicant promptly of--
``(I) any additional deficiency identified in the application,
or
``(II) any additional information required to achieve
completion of the review and final action on the application,
that was not described as a deficiency in the written description
provided by the Secretary under clause (ii).
``(B) The Secretary and the applicant may, by mutual consent,
establish a different schedule for a meeting required under this
paragraph.

1f5e69d81f63f11e6f92eff609b11d9ed102fd02219da9d80f825c71ed887722

NOTIFICATION REPORTS.
(a) In General.--Subchapter A of chapter V is amended by adding at
the end the following:
``SEC. 523. ACCREDITED PERSONS.
``(a) In General.--
``(1) Review and classification of devices.--Not later than 1
year after the date of the enactment of the Food and Drug
Administration Modernization Act of 1997, the Secretary shall,
subject to paragraph (3), accredit persons for the purpose of
reviewing reports submitted under section 510(k) and making
recommendations to the Secretary regarding the initial
classification of devices under section 513(f)(1).
``(2) Requirements regarding review.--
``(A) In general.--In making a recommendation to the
Secretary under paragraph (1), an accredited person shall
notify the Secretary in writing of the reasons for the
recommendation.
``(B) Time period for review.--Not later than 30 days after
the date on which the Secretary is notified under subparagraph
(A) by an accredited person with respect to a recommendation of
an initial classification of a device, the Secretary shall make
a determination with respect to the initial classification.
``(C) Special rule.--The Secretary may change the initial
classification under section 513(f)(1) that is recommended
under paragraph (1) by an accredited person, and in such case
shall provide to such person, and the person who submitted the
report under section 510(k) for the device, a statement
explaining in detail the reasons for the change.
``(3) Certain devices.--
``(A) In general.--An accredited person may not be used to
perform a review of--
``(i) a class III device;
``(ii) a class II device which is intended to be
permanently implantable or life sustaining or life
supporting; or
``(iii) a class II device which requires clinical data
in the report submitted under section 510(k) for the
device, except that the number of class II devices to which
the Secretary applies this clause for a year, less the
number of such reports to which clauses (i) and (ii) apply,
may not exceed 6 percent of the number that is equal to the
total number of reports submitted to the Secretary under
such section for such year less the number of such reports
to which such clauses apply for such year.
``(B) Adjustment.--In determining for a year the ratio
described in subparagraph (A)(iii), the Secretary shall not
include in the numerator class III devices that the Secretary
reclassified into class II, and the Secretary shall include in
the denominator class II devices for which reports under
section 510(k) were not required to be submitted by reason of
the operation of section 510(m).
``(b) Accreditation.--
``(1) Programs.--The Secretary shall provide for such
accreditation through programs administered by the Food and Drug
Administration, other government agencies, or by other qualified
nongovernment organizations.
``(2) Accreditation.--
``(A) In general.--Not later than 180 days after the date
of the enactment of the Food and Drug Administration
Modernization Act of 1997, the Secretary shall establish and
publish in the Federal Register criteria to accredit or deny
accreditation to persons who request to perform the duties
specified in subsection (a). The Secretary shall respond to a
request for accreditation within 60 days of the receipt of the
request. The accreditation of such person shall specify the
particular activities under subsection (a) for which such
person is accredited.
``(B) Withdrawal of accreditation.--The Secretary may
suspend or withdraw accreditation of any person accredited
under this paragraph, after providing notice and an opportunity
for an informal hearing, when such person is substantially not
in compliance with the requirements of this section or poses a
threat to public health or fails to act in a manner that is
consistent with the purposes of this section.
``(C) Performance auditing.--To ensure that persons
accredited under this section will continue to meet the
standards of accreditation, the Secretary shall--
``(i) make onsite visits on a periodic basis to each
accredited person to audit the performance of such person;
and
``(ii) take such additional measures as the Secretary
determines to be appropriate.
``(D) Annual report.--The Secretary shall include in the
annual report required under section 903(g) the names of all
accredited persons and the particular activities under
subsection (a) for which each such person is accredited and the
name of each accredited person whose accreditation has been
withdrawn during the year.
``(3) Qualifications.--An accredited person shall, at a
minimum, meet the following requirements:
``(A) Such person may not be an employee of the Federal
Government.
``(B) Such person shall be an independent organization
which is not owned or controlled by a manufacturer, supplier,
or vendor of devices and which has no organizational, material,
or financial affiliation with such a manufacturer, supplier, or
vendor.
``(C) Such person shall be a legally constituted entity
permitted to conduct the activities for which it seeks
accreditation.
``(D) Such person shall not engage in the design,
manufacture, promotion, or sale of devices.
``(E) The operations of such person shall be in accordance
with generally accepted professional and ethical business
practices and shall agree in writing that as a minimum it
will--
``(i) certify that reported information accurately
reflects data reviewed;
``(ii) limit work to that for which competence and
capacity are available;
``(iii) treat information received, records, reports,
and recommendations as proprietary information;
``(iv) promptly respond and attempt to resolve
complaints regarding its activities for which it is
accredited; and
``(v) protect against the use, in carrying out
subsection (a) with respect to a device, of any officer or
employee of the person who has a financial conflict of
interest regarding the device, and annually make available
to the public disclosures of the extent to which the
person, and the officers and employees of the person, have
maintained compliance with requirements under this clause
relating to financial conflicts of interest.
``(4) Selection of accredited persons.--The Secretary shall
provide each person who chooses to use an accredited person to
receive a section 510(k) report a panel of at least two or more
accredited persons from which the regulated person may select one
for a specific regulatory function.
``(5) Compensation of accredited persons.--Compensation for an
accredited person shall be determined by agreement between the
accredited person and the person who engages the services of the
accredited person, and shall be paid by the person who engages such
services.
``(c) Duration.--The authority provided by this section
terminates--
``(1) 5 years after the date on which the Secretary notifies
Congress that at least 2 persons accredited under subsection (b)
are available to review at least 60 percent of the submissions
under section 510(k), or
``(2) 4 years after the date on which the Secretary notifies
Congress that the Secretary has made a determination described in
paragraph (2)(B) of subsection (a) for at least 35 percent of the
devices that are subject to review under paragraph (1) of such
subsection,
whichever occurs first.''.
(b) Recordkeeping.--Section 704 (21 U.S.C. 374) is amended by
adding at the end the following:
``(f)(1) A person accredited under section 523 to review reports
made under section 510(k) and make recommendations of initial
classifications of devices to the Secretary shall maintain records
documenting the training qualifications of the person and the employees
of the person, the procedures used by the person for handling
confidential information, the compensation arrangements made by the
person, and the procedures used by the person to identify and avoid
conflicts of interest. Upon the request of an officer or employee
designated by the Secretary, the person shall permit the officer or
employee, at all reasonable times, to have access to, to copy, and to
verify, the records.
``(2) Within 15 days after the receipt of a written request from
the Secretary to a person accredited under section 523 for copies of
records described in paragraph (1), the person shall produce the copies
of the records at the place designated by the Secretary.''.
(c) Conforming Amendment.--Section 301 (21 U.S.C. 331), as amended
by section 204(b), is amended by adding at the end the following:
``(y) In the case of a drug, device, or food--
``(1) the submission of a report or recommendation by a person
accredited under section 523 that is false or misleading in any
material respect;
``(2) the disclosure by a person accredited under section 523
of confidential commercial information or any trade secret without
the express written consent of the person who submitted such
information or secret to such person; or
``(3) the receipt by a person accredited under section 523 of a
bribe in any form or the doing of any corrupt act by such person
associated with a responsibility delegated to such person under
this Act.''.
(d) Reports on Program of Accreditation.--
(1) Comptroller general.--
(A) Implementation of program.--Not later than 5 years
after the date of the enactment of this Act, the Comptroller
General of the United States shall submit to the Committee on
Commerce of the House of Representatives and the Committee on
Labor and Human Resources of the Senate a report describing the
extent to which the program of accreditation required by the
amendment made by subsection (a) has been implemented.
(B) Evaluation of program.--Not later than 6 months prior
to the date on which, pursuant to subsection (c) of section 523
of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)), the authority provided under subsection (a) of
such section will terminate, the Comptroller General shall
submit to the Committee on Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate a report describing the use of accredited persons
under such section 523, including an evaluation of the extent
to which such use assisted the Secretary in carrying out the
duties of the Secretary under such Act with respect to devices,
and the extent to which such use promoted actions which are
contrary to the purposes of such Act.
(2) Inclusion of certain devices within program.--Not later
than 3 years after the date of the enactment of this Act, the
Secretary of Health and Human Services shall submit to the
Committee on Commerce of the House of Representatives and the
Committee on Labor and Human Resources of the Senate a report
providing a determination by the Secretary of whether, in the
program of accreditation established pursuant to the amendment made
by subsection (a), the limitation established in clause (iii) of
section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act
(relating to class II devices for which clinical data are required
in reports under section 510(k)) should be removed.

1c2588729ff8534b832a6899a3403e9c0f5590f853f7321d4394185a88c334ba

Effective 90 days after the date of the enactment of this Act,
section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows:
``Device Tracking
``(e)(1) The Secretary may by order require a manufacturer to adopt
a method of tracking a class II or class III device--
``(A) the failure of which would be reasonably likely to have
serious adverse health consequences; or
``(B) which is--
``(i) intended to be implanted in the human body for more
than one year, or
``(ii) a life sustaining or life supporting device used
outside a device user facility.
``(2) Any patient receiving a device subject to tracking under
paragraph (1) may refuse to release, or refuse permission to release,
the patient's name, address, social security number, or other
identifying information for the purpose of tracking.''.

9b11541a30428467c8af7a5fcf267a9764899fd4e1b8f289ca2bd613a9210092

Effective 90 days after the date of the enactment of this Act,
section 522 (21 U.S.C. 360l) is amended to read as follows:
``postmarket surveillance
``Sec. 522. (a) In General.--The Secretary may by order require a
manufacturer to conduct postmarket surveillance for any device of the
manufacturer which is a class II or class III device the failure of
which would be reasonably likely to have serious adverse health
consequences or which is intended to be--
``(1) implanted in the human body for more than one year, or
``(2) a life sustaining or life supporting device used outside
a device user facility.
``(b) Surveillance Approval.--Each manufacturer required to conduct
a surveillance of a device shall, within 30 days of receiving an order
from the Secretary prescribing that the manufacturer is required under
this section to conduct such surveillance, submit, for the approval of
the Secretary, a plan for the required surveillance. The Secretary,
within 60 days of the receipt of such plan, shall determine if the
person designated to conduct the surveillance has appropriate
qualifications and experience to undertake such surveillance and if the
plan will result in the collection of useful data that can reveal
unforeseen adverse events or other information necessary to protect the
public health. The Secretary, in consultation with the manufacturer,
may by order require a prospective surveillance period of up to 36
months. Any determination by the Secretary that a longer period is
necessary shall be made by mutual agreement between the Secretary and
the manufacturer or, if no agreement can be reached, after the
completion of a dispute resolution process as described in section
562.''.

6ddeaa1c816c252ed15ec8b006c394b1024ed031e8d227dec407bc118b064e35

(a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``manufacturer, importer, or distributor'' and inserting
``manufacturer or importer'';
(B) in paragraph (4), by striking ``manufacturer, importer,
or distributor'' and inserting ``manufacturer or importer'';
(C) in paragraph (7), by adding ``and'' after the semicolon
at the end;
(D) in paragraph (8)--
(i) by striking ``manufacturer, importer, or
distributor'' each place such term appears and inserting
``manufacturer or importer''; and
(ii) by striking the semicolon at the end and inserting
a period;
(E) by striking paragraph (9); and
(F) by inserting at the end the following sentence: ``The
Secretary shall by regulation require distributors to keep
records and make such records available to the Secretary upon
request. Paragraphs (4) and (8) apply to distributors to the
same extent and in the same manner as such paragraphs apply to
manufacturers and importers.'';
(2) by striking subsection (d); and
(3) in subsection (f), by striking ``, importer, or
distributor'' each place it appears and inserting ``or importer''.
(b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended--
(1) by redesignating paragraph (4) as paragraph (5);
(2) by inserting after paragraph (3) the following:
``(4) any distributor who acts as a wholesale distributor of
devices, and who does not manufacture, repackage, process, or
relabel a device; or''; and
(3) by adding at the end the following flush sentence:
``In this subsection, the term `wholesale distributor' means any person
(other than the manufacturer or the initial importer) who distributes a
device from the original place of manufacture to the person who makes
the final delivery or sale of the device to the ultimate consumer or
user.''.
(c) Device User Facilities.--
(1) In general.--Section 519(b) (21 U.S.C. 360i(b)) is
amended--
(A) in paragraph (1)(C)--
(i) in the first sentence, by striking ``a semi-annual
basis'' and inserting ``an annual basis'';
(ii) in the second sentence, by striking ``and July
1''; and
(iii) by striking the matter after and below clause
(iv); and
(B) in paragraph (2)--
(i) in subparagraph (A), by inserting ``or'' after the
comma at the end;
(ii) in subparagraph (B), by striking ``, or'' at the
end and inserting a period; and
(iii) by striking subparagraph (C).
(2) Sentinel system.--Section 519(b) (21 U.S.C. 360i(b)) is
amended--
(A) by redesignating paragraph (5) as paragraph (6); and
(B) by inserting after paragraph (4) the following
paragraph:
``(5) With respect to device user facilities:
``(A) The Secretary shall by regulation plan and implement a
program under which the Secretary limits user reporting under
paragraphs (1) through (4) to a subset of user facilities that
constitutes a representative profile of user reports for device
deaths and serious illnesses or serious injuries.
``(B) During the period of planning the program under
subparagraph (A), paragraphs (1) through (4) continue to apply.
``(C) During the period in which the Secretary is providing for
a transition to the full implementation of the program, paragraphs
(1) through (4) apply except to the extent that the Secretary
determines otherwise.
``(D) On and after the date on which the program is fully
implemented, paragraphs (1) through (4) do not apply to a user
facility unless the facility is included in the subset referred to
in subparagraph (A).
``(E) Not later than 2 years after the date of the enactment of
the Food and Drug Administration Modernization Act of 1997, the
Secretary shall submit to the Committee on Commerce of the House of
Representatives, and to the Committee on Labor and Human Resources
of the Senate, a report describing the plan developed by the
Secretary under subparagraph (A) and the progress that has been
made toward the implementation of the plan.''.

0d047c7e151b40f128a553348738d4ba50dde7b0ab69ca142424cf07338fbf5b

Chapter IX is amended by adding at the end the following:
``SEC. 906. PRACTICE OF MEDICINE.
``Nothing in this Act shall be construed to limit or interfere with
the authority of a health care practitioner to prescribe or administer
any legally marketed device to a patient for any condition or disease
within a legitimate health care practitioner-patient relationship. This
section shall not limit any existing authority of the Secretary to
establish and enforce restrictions on the sale or distribution, or in
the labeling, of a device that are part of a determination of
substantial equivalence, established as a condition of approval, or
promulgated through regulations. Further, this section shall not change
any existing prohibition on the promotion of unapproved uses of legally
marketed devices.''.

1bf176191cf3f6a51e36bcdca10b664188509f6ffaaca25d3888334578a48b21

(a) Findings.--The Congress finds that--
(1) diabetes and its complications are a leading cause of death
by disease in America;
(2) diabetes affects approximately 16,000,000 Americans and
another 650,000 will be diagnosed in 1997;
(3) the total health care-related costs of diabetes total
nearly $100,000,000,000 per year;
(4) diabetes is a disease that is managed and controlled on a
daily basis by the patient;
(5) the failure to properly control and manage diabetes results
in costly and often fatal complications including but not limited
to blindness, coronary artery disease, and kidney failure;
(6) blood testing devices are a critical tool for the control
and management of diabetes, and existing blood testing devices
require repeated piercing of the skin;
(7) the pain associated with existing blood testing devices
creates a disincentive for people with diabetes to test blood
glucose levels, particularly children;
(8) a safe and effective noninvasive blood glucose meter would
likely improve control and management of diabetes by increasing the
number of tests conducted by people with diabetes, particularly
children; and
(9) the Food and Drug Administration is responsible for
reviewing all applications for new medical devices in the United
States.
(b) Sense of Congress.--It is the sense of the Congress that the
availability of a safe, effective, noninvasive blood glucose meter
would greatly enhance the health and well-being of all people with
diabetes across America and the world.

d89c557043c35ad851ebae4d12e07ed0ae86c6e1eef7467fe413b86ce9831c65

DEVELOPMENT PROTOCOL.
(a) Use of Data Relating to Premarket Approval.--
(1) In general.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is
amended to read as follows:
``(4)(A) Any information contained in an application for premarket
approval filed with the Secretary pursuant to section 515(c) (including
information from clinical and preclinical tests or studies that
demonstrate the safety and effectiveness of a device, but excluding
descriptions of methods of manufacture and product composition and
other trade secrets) shall be available, 6 years after the application
has been approved by the Secretary, for use by the Secretary in--
``(i) approving another device;
``(ii) determining whether a product development protocol has
been completed, under section 515 for another device;
``(iii) establishing a performance standard or special control
under this Act; or
``(iv) classifying or reclassifying another device under
section 513 and subsection (l)(2).
``(B) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by
paragraph (1)(A) shall be available for use by the Secretary as the
evidentiary basis for the agency actions described in subparagraph
(A).''.
(2) Conforming amendments.--Section 517(a) (21 U.S.C. 360g(a))
is amended--
(A) in paragraph (8), by adding ``or'' at the end;
(B) in paragraph (9), by striking ``, or'' and inserting a
comma; and
(C) by striking paragraph (10).
(b) Product Development Protocol.--Section 515(f)(2) (21 U.S.C.
360e(f)(2)) is amended by striking ``he shall'' and all that follows
and inserting the following: ``the Secretary--
``(A) may, at the initiative of the Secretary, refer the
proposed protocol to the appropriate panel under section 513 for
its recommendation respecting approval of the protocol; or
``(B) shall so refer such protocol upon the request of the
submitter, unless the Secretary finds that the proposed protocol
and accompanying data which would be reviewed by such panel
substantially duplicate a product development protocol and
accompanying data which have previously been reviewed by such a
panel.''.

7e6394718b64ed3efd7346037d787fe74c7092c89e84bc319493c443d854c1a3

INVESTIGATIONS FOR APPROVAL.
Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by
striking ``clinical investigations'' and inserting ``1 or more clinical
investigations''.

e954924ac6aaa68f89b3c5d6648affcf9ebb3d5cdeb10e45eb1cde15a9333108

Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end
the following:
``(7) The Secretary may make proposed regulations issued under this
paragraph effective upon publication pending consideration of public
comment and publication of a final regulation if the Secretary
determines that such action is necessary--
``(A) to enable the Secretary to review and act promptly on
petitions the Secretary determines provide for information
necessary to--
``(i) enable consumers to develop and maintain healthy
dietary practices;
``(ii) enable consumers to be informed promptly and
effectively of important new knowledge regarding nutritional
and health benefits of food; or
``(iii) ensure that scientifically sound nutritional and
health information is provided to consumers as soon as
possible; or
``(B) to enable the Secretary to act promptly to ban or modify
a claim under this paragraph.
Such proposed regulations shall be deemed final agency action for
purposes of judicial review.''.

6cb7837d314641a6d8c7dac58e3e6b02642d80379520b32901f203a88c59e230

TITLE III

-IMPROVING REGULATION OF FOOD

Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended--
(1) by adding after the second sentence the following: ``If the
Secretary does not act within such 100 days, the petition shall be
deemed to be denied unless an extension is mutually agreed upon by
the Secretary and the petitioner.'';
(2) in the fourth sentence (as amended by paragraph (1)) by
inserting immediately before the comma the following: ``or the
petition is deemed to be denied''; and
(3) by adding at the end the following: ``If the Secretary does
not act within such 90 days, the petition shall be deemed to be
denied unless an extension is mutually agreed upon by the Secretary
and the petitioner. If the Secretary issues a proposed regulation,
the rulemaking shall be completed within 540 days of the date the
petition is received by the Secretary. If the Secretary does not
issue a regulation within such 540 days, the Secretary shall
provide the Committee on Commerce of the House of Representatives
and the Committee on Labor and Human Resources of the Senate the
reasons action on the regulation did not occur within such 540
days.''.

f8e248dd801bd731dc9e0f2a6c4540ee066a7e639edd8455fcefc13c9347cc50

Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the
end thereof the following:
``(C) Notwithstanding the provisions of clauses (A)(i) and (B), a
claim of the type described in subparagraph (1)(B) which is not
authorized by the Secretary in a regulation promulgated in accordance
with clause (B) shall be authorized and may be made with respect to a
food if--
``(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, about the relationship between a nutrient and
a disease or health-related condition to which the claim refers;
``(ii) a person has submitted to the Secretary, at least 120
days (during which the Secretary may notify any person who is
making a claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which shall
include the exact words used in the claim and shall include a
concise description of the basis upon which such person relied for
determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III) a
balanced representation of the scientific literature relating to
the relationship between a nutrient and a disease or health-related
condition to which the claim refers;
``(iii) the claim and the food for which the claim is made are
in compliance with clause (A)(ii) and are otherwise in compliance
with paragraph (a) and section 201(n); and
``(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred to
in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to understand
the relative significance of such information in the context of a
total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause (i)
only if the statement is published by the scientific body and shall not
include a statement of an employee of the scientific body made in the
individual capacity of the employee.
``(D) A claim submitted under the requirements of clause (C) may be
made until--
``(i) such time as the Secretary issues a regulation under the
standard in clause (B)(i)--
``(I) prohibiting or modifying the claim and the regulation
has become effective, or
``(II) finding that the requirements of clause (C) have not
been met, including finding that the petitioner has not
submitted all the information required by such clause; or
``(ii) a district court of the United States in an enforcement
proceeding under chapter III has determined that the requirements
of clause (C) have not been met.''.

1324af292561f2ed7d732f4dde553fdd0c6f9ff9a02c9f5f0551b29984c4fb17

Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at the
end the following:
``(G) A claim of the type described in subparagraph (1)(A) for a
nutrient, for which the Secretary has not promulgated a regulation
under clause (A)(i), shall be authorized and may be made with respect
to a food if--
``(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, which identifies the nutrient level to which
the claim refers;
``(ii) a person has submitted to the Secretary, at least 120
days (during which the Secretary may notify any person who is
making a claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which shall
include the exact words used in the claim and shall include a
concise description of the basis upon which such person relied for
determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III) a
balanced representation of the scientific literature relating to
the nutrient level to which the claim refers;
``(iii) the claim and the food for which the claim is made are
in compliance with clauses (A) and (B), and are otherwise in
compliance with paragraph (a) and section 201(n); and
``(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred to
in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to understand
the relative significance of such information in the context of a
total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause (i)
only if the statement is published by the scientific body and shall not
include a statement of an employee of the scientific body made in the
individual capacity of the employee.
``(H) A claim submitted under the requirements of clause (G) may be
made until--
``(i) such time as the Secretary issues a regulation--
``(I) prohibiting or modifying the claim and the regulation
has become effective, or
``(II) finding that the requirements of clause (G) have not
been met, including finding that the petitioner had not
submitted all the information required by such clause; or
``(ii) a district court of the United States in an enforcement
proceeding under chapter III has determined that the requirements
of clause (G) have not been met.''.

a6639ea8ab175ea77c777ba890bdc45affdad8734462213615120e2300263452

Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read as
follows:
``(B) If a claim described in subparagraph (1)(A) is made with
respect to a nutrient in a food and the Secretary makes a determination
that the food contains a nutrient at a level that increases to persons
in the general population the risk of a disease or health-related
condition that is diet related, the label or labeling of such food
shall contain, prominently and in immediate proximity to such claim,
the following statement: `See nutrition information for ____ content.'
The blank shall identify the nutrient associated with the increased
disease or health-related condition risk. In making the determination
described in this clause, the Secretary shall take into account the
significance of the food in the total daily diet.''.

3d6494e831177c9386e57ec9b8ab7ce3f7ece255b5566372443ae7fb0e5706cf

Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after
section 403B the following:
``disclosure
``Sec. 403C. (a) No provision of section 201(n), 403(a), or 409
shall be construed to require on the label or labeling of a food a
separate radiation disclosure statement that is more prominent than the
declaration of ingredients required by section 403(i)(2).
``(b) In this section, the term `radiation disclosure statement'
means a written statement that discloses that a food has been
intentionally subject to radiation.''.

c81654e29a5fedce1f0cfd09e7e0c93f5407693b9ee4a747111ebacc9d4c17f9

Not later than 60 days following the date of the enactment of this
Act, the Secretary of Health and Human Services shall make a final
determination on any petition pending with the Food and Drug
Administration that would permit the irradiation of red meat under
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the
Secretary does not make such determination, the Secretary shall, not
later than 60 days following the date of the enactment of this Act,
provide the Committee on Commerce of the House of Representatives and
the Committee on Labor and Human Resources of the Senate an explanation
of the process followed by the Food and Drug Administration in
reviewing the petition referred to in paragraph (1) and the reasons
action on the petition was delayed.

2effca776a5612deb5568e207a5881055c44318da40aa6b7b075227a9efd1848

(a) In General.--The Secretary may not implement any requirement
which would ban, as an unapproved food additive, lead and cadmium based
enamel in the lip and rim area of glass and ceramic ware before the
expiration of one year after the date such requirement is published.
(b) Lead and Cadmium Based Enamel.--Unless the Secretary
determines, based on available data, that lead and cadmium based enamel
on glass and ceramic ware--
(1) which has less than 60 millimeters of decorating area below
the external rim, and
(2) which is not, by design, representation, or custom of usage
intended for use by children,
is unsafe, the Secretary shall not take any action before January 1,
2003, to ban lead and cadmium based enamel on such glass and ceramic
ware. Any action taken after January 1, 2003, to ban such enamel on
such glass and ceramic ware as an unapproved food additive shall be
taken by regulation and such regulation shall provide that such
products shall not be removed from the market before 1 year after
publication of the final regulation.

3081f71e2d37ca079b3ba8440d38d5bb4585a9a58040dace5f66cb98060a0e7d

(a) Food Contact Substances.--Section 409(a) (21 U.S.C. 348(a)) is
amended--
(1) in paragraph (1)--
(A) by striking ``subsection (i)'' and inserting
``subsection (j)''; and
(B) by striking at the end ``or'';
(2) by striking the period at the end of paragraph (2) and
inserting ``; or'';
(3) by inserting after paragraph (2) the following:
``(3) in the case of a food additive as defined in this Act
that is a food contact substance, there is--
``(A) in effect, and such substance and the use of such
substance are in conformity with, a regulation issued under
this section prescribing the conditions under which such
additive may be safely used; or
``(B) a notification submitted under subsection (h) that is
effective.''; and
(4) by striking the matter following paragraph (3) (as added by
paragraph (3)) and inserting the following flush sentence:
``While such a regulation relating to a food additive, or such a
notification under subsection (h)(1) relating to a food additive that
is a food contact substance, is in effect, and has not been revoked
pursuant to subsection (i), a food shall not, by reason of bearing or
containing such a food additive in accordance with the regulation or
notification, be considered adulterated under section 402(a)(1).''.
(b) Notification for Food Contact Substances.--Section 409 (21
U.S.C. 348), as amended by subsection (a), is further amended--
(1) by redesignating subsections (h) and (i), as subsections
(i) and (j), respectively;
(2) by inserting after subsection (g) the following:
``Notification Relating to a Food Contact Substance
``(h)(1) Subject to such regulations as may be promulgated under
paragraph (3), a manufacturer or supplier of a food contact substance
may, at least 120 days prior to the introduction or delivery for
introduction into interstate commerce of the food contact substance,
notify the Secretary of the identity and intended use of the food
contact substance, and of the determination of the manufacturer or
supplier that the intended use of such food contact substance is safe
under the standard described in subsection (c)(3)(A). The notification
shall contain the information that forms the basis of the determination
and all information required to be submitted by regulations promulgated
by the Secretary.
``(2)(A) A notification submitted under paragraph (1) shall become
effective 120 days after the date of receipt by the Secretary and the
food contact substance may be introduced or delivered for introduction
into interstate commerce, unless the Secretary makes a determination
within the 120-day period that, based on the data and information
before the Secretary, such use of the food contact substance has not
been shown to be safe under the standard described in subsection
(c)(3)(A), and informs the manufacturer or supplier of such
determination.
``(B) A decision by the Secretary to object to a notification shall
constitute final agency action subject to judicial review.
``(C) In this paragraph, the term `food contact substance' means
the substance that is the subject of a notification submitted under
paragraph (1), and does not include a similar or identical substance
manufactured or prepared by a person other than the manufacturer
identified in the notification.
``(3)(A) The process in this subsection shall be utilized for
authorizing the marketing of a food contact substance except where the
Secretary determines that submission and review of a petition under
subsection (b) is necessary to provide adequate assurance of safety, or
where the Secretary and any manufacturer or supplier agree that such
manufacturer or supplier may submit a petition under subsection (b).
``(B) The Secretary is authorized to promulgate regulations to
identify the circumstances in which a petition shall be filed under
subsection (b), and shall consider criteria such as the probable
consumption of such food contact substance and potential toxicity of
the food contact substance in determining the circumstances in which a
petition shall be filed under subsection (b).
``(4) The Secretary shall keep confidential any information
provided in a notification under paragraph (1) for 120 days after
receipt by the Secretary of the notification. After the expiration of
such 120 days, the information shall be available to any interested
party except for any matter in the notification that is a trade secret
or confidential commercial information.
``(5)(A)(i) Except as provided in clause (ii), the notification
program established under this subsection shall not operate in any
fiscal year unless--
``(I) an appropriation equal to or exceeding the applicable
amount under clause (iv) is made for such fiscal year for carrying
out such program in such fiscal year; and
``(II) the Secretary certifies that the amount appropriated for
such fiscal year for the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds the
amount appropriated for the Center for fiscal year 1997, excluding
any amount appropriated for new programs.
``(ii) The Secretary shall, not later than April 1, 1999, begin
accepting and reviewing notifications submitted under the notification
program established under this subsection if--
``(I) an appropriation equal to or exceeding the applicable
amount under clause (iii) is made for the last six months of fiscal
year 1999 for carrying out such program during such period; and
``(II) the Secretary certifies that the amount appropriated for
such period for the Center for Food Safety and Applied Nutrition of
the Food and Drug Administration (exclusive of the appropriation
referred to in subclause (I)) equals or exceeds an amount
equivalent to one-half the amount appropriated for the Center for
fiscal year 1997, excluding any amount appropriated for new
programs.
``(iii) For the last six months of fiscal year 1999, the applicable
amount under this clause is $1,500,000, or the amount specified in the
budget request of the President for the six-month period involved for
carrying out the notification program in fiscal year 1999, whichever is
less.
``(iv) For fiscal year 2000 and subsequent fiscal years, the
applicable amount under this clause is $3,000,000, or the amount
specified in the budget request of the President for the fiscal year
involved for carrying out the notification program under this
subsection, whichever is less.
``(B) For purposes of carrying out the notification program under
this subsection, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 1999 through fiscal year
2003, except that such authorization of appropriations is not effective
for a fiscal year for any amount that is less than the applicable
amount under clause (iii) or (iv) of subparagraph (A), whichever is
applicable.
``(C) Not later than April 1 of fiscal year 1998 and February 1 of
each subsequent fiscal year, the Secretary shall submit a report to the
Committees on Appropriations of the House of Representatives and the
Senate, the Committee on Commerce of the House of Representatives, and
the Committee on Labor and Human Resources of the Senate that provides
an estimate of the Secretary of the costs of carrying out the
notification program established under this subsection for the next
fiscal year.
``(6) In this section, the term `food contact substance' means any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.'';
(3) in subsection (i), as so redesignated by paragraph (1), by
adding at the end the following: ``The Secretary shall by
regulation prescribe the procedure by which the Secretary may deem
a notification under subsection (h) to no longer be effective.'';
and
(4) in subsection (j), as so redesignated by paragraph (1), by
striking ``subsections (b) to (h)'' and inserting ``subsections (b)
to (i)''.

f73858ea686e50650b8b22aee9ca960d6e71f442f7e64214543eb710ae72c416

c97f2898b6972db24588e96b53b49c75c2ac49d98cdf83f55599f83682734cd3

DIAGNOSTICS.
Chapter V (21 U.S.C. 351 et seq.), as amended in section 401, is
further amended by adding at the end the following:
``Subchapter E--General Provisions Relating to Drugs and Devices
``SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
``(a) Emergency Situations.--The Secretary may, under appropriate
conditions determined by the Secretary, authorize the shipment of
investigational drugs or investigational devices for the diagnosis,
monitoring, or treatment of a serious disease or condition in emergency
situations.
``(b) Individual Patient Access to Investigational Products
Intended for Serious Diseases.--Any person, acting through a physician
licensed in accordance with State law, may request from a manufacturer
or distributor, and any manufacturer or distributor may, after
complying with the provisions of this subsection, provide to such
physician an investigational drug or investigational device for the
diagnosis, monitoring, or treatment of a serious disease or condition
if--
``(1) the licensed physician determines that the person has no
comparable or satisfactory alternative therapy available to
diagnose, monitor, or treat the disease or condition involved, and
that the probable risk to the person from the investigational drug
or investigational device is not greater than the probable risk
from the disease or condition;
``(2) the Secretary determines that there is sufficient
evidence of safety and effectiveness to support the use of the
investigational drug or investigational device in the case
described in paragraph (1);
``(3) the Secretary determines that provision of the
investigational drug or investigational device will not interfere
with the initiation, conduct, or completion of clinical
investigations to support marketing approval; and
``(4) the sponsor, or clinical investigator, of the
investigational drug or investigational device submits to the
Secretary a clinical protocol consistent with the provisions of
section 505(i) or 520(g), including any regulations promulgated
under section 505(i) or 520(g), describing the use of the
investigational drug or investigational device in a single patient
or a small group of patients.
``(c) Treatment Investigational New Drug Applications and Treatment
Investigational Device Exemptions.--Upon submission by a sponsor or a
physician of a protocol intended to provide widespread access to an
investigational drug or investigational device for eligible patients
(referred to in this subsection as an `expanded access protocol'), the
Secretary shall permit such investigational drug or investigational
device to be made available for expanded access under a treatment
investigational new drug application or treatment investigational
device exemption if the Secretary determines that--
``(1) under the treatment investigational new drug application
or treatment investigational device exemption, the investigational
drug or investigational device is intended for use in the
diagnosis, monitoring, or treatment of a serious or immediately
life-threatening disease or condition;
``(2) there is no comparable or satisfactory alternative
therapy available to diagnose, monitor, or treat that stage of
disease or condition in the population of patients to which the
investigational drug or investigational device is intended to be
administered;
``(3)(A) the investigational drug or investigational device is
under investigation in a controlled clinical trial for the use
described in paragraph (1) under an investigational drug
application in effect under section 505(i) or investigational
device exemption in effect under section 520(g); or
``(B) all clinical trials necessary for approval of that use of
the investigational drug or investigational device have been
completed;
``(4) the sponsor of the controlled clinical trials is actively
pursuing marketing approval of the investigational drug or
investigational device for the use described in paragraph (1) with
due diligence;
``(5) in the case of an investigational drug or investigational
device described in paragraph (3)(A), the provision of the
investigational drug or investigational device will not interfere
with the enrollment of patients in ongoing clinical investigations
under section 505(i) or 520(g);
``(6) in the case of serious diseases, there is sufficient
evidence of safety and effectiveness to support the use described
in paragraph (1); and
``(7) in the case of immediately life-threatening diseases, the
available scientific evidence, taken as a whole, provides a
reasonable basis to conclude that the investigational drug or
investigational device may be effective for its intended use and
would not expose patients to an unreasonable and significant risk
of illness or injury.
A protocol submitted under this subsection shall be subject to the
provisions of section 505(i) or 520(g), including regulations
promulgated under section 505(i) or 520(g). The Secretary may inform
national, State, and local medical associations and societies,
voluntary health associations, and other appropriate persons about the
availability of an investigational drug or investigational device under
expanded access protocols submitted under this subsection. The
information provided by the Secretary, in accordance with the preceding
sentence, shall be the same type of information that is required by
section 402(j)(3) of the Public Health Service Act.
``(d) Termination.--The Secretary may, at any time, with respect to
a sponsor, physician, manufacturer, or distributor described in this
section, terminate expanded access provided under this section for an
investigational drug or investigational device if the requirements
under this section are no longer met.
``(e) Definitions.--In this section, the terms `investigational
drug', `investigational device', `treatment investigational new drug
application', and `treatment investigational device exemption' shall
have the meanings given the terms in regulations prescribed by the
Secretary.''.

6d18d75dd3c8ac7a7b7bc36b801a35b56ce667ff9fecad66af27ccbe42e8e885

PRODUCTS.
(a) Standards.--Not later than 180 days after the date of enactment
of this Act, the Secretary of Health and Human Services shall publish
in the Federal Register standards for the prompt review of supplemental
applications submitted for approved articles under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the
Public Health Service Act (42 U.S.C. 262).
(b) Guidance to Industry.--Not later than 180 days after the date
of enactment of this Act, the Secretary shall issue final guidances to
clarify the requirements for, and facilitate the submission of data to
support, the approval of supplemental applications for the approved
articles described in subsection (a). The guidances shall--
(1) clarify circumstances in which published matter may be the
basis for approval of a supplemental application;
(2) specify data requirements that will avoid duplication of
previously submitted data by recognizing the availability of data
previously submitted in support of an original application; and
(3) define supplemental applications that are eligible for
priority review.
(c) Responsibilities of Centers.--The Secretary shall designate an
individual in each center within the Food and Drug Administration
(except the Center for Food Safety and Applied Nutrition) to be
responsible for--
(1) encouraging the prompt review of supplemental applications
for approved articles; and
(2) working with sponsors to facilitate the development and
submission of data to support supplemental applications.
(d) Collaboration.--The Secretary shall implement programs and
policies that will foster collaboration between the Food and Drug
Administration, the National Institutes of Health, professional medical
and scientific societies, and other persons, to identify published and
unpublished studies that may support a supplemental application, and to
encourage sponsors to make supplemental applications or conduct further
research in support of a supplemental application based, in whole or in
part, on such studies.

476be22b5af3ea071beeeeb8e1a876a1383771fe93657df0c0b5c9d9f1d6d3ae

Subchapter E of chapter V, as added by section 402, is amended by
adding at the end the following:
``SEC. 562. DISPUTE RESOLUTION.
``If, regarding an obligation concerning drugs or devices under
this Act or section 351 of the Public Health Service Act, there is a
scientific controversy between the Secretary and a person who is a
sponsor, applicant, or manufacturer and no specific provision of the
Act involved, including a regulation promulgated under such Act,
provides a right of review of the matter in controversy, the Secretary
shall, by regulation, establish a procedure under which such sponsor,
applicant, or manufacturer may request a review of such controversy,
including a review by an appropriate scientific advisory panel
described in section 505(n) or an advisory committee described in
section 515(g)(2)(B). Any such review shall take place in a timely
manner. The Secretary shall promulgate such regulations within 1 year
after the date of the enactment of the Food and Drug Administration
Modernization Act of 1997.''.

b35ed5db2493557f00cad7000c418038df5c79ff5c506ad60af8fa7025511cac

Section 701 (21 U.S.C. 371) is amended by adding at the end the
following:
``(h)(1)(A) The Secretary shall develop guidance documents with
public participation and ensure that information identifying the
existence of such documents and the documents themselves are made
available to the public both in written form and, as feasible, through
electronic means. Such documents shall not create or confer any rights
for or on any person, although they present the views of the Secretary
on matters under the jurisdiction of the Food and Drug Administration.
``(B) Although guidance documents shall not be binding on the
Secretary, the Secretary shall ensure that employees of the Food and
Drug Administration do not deviate from such guidances without
appropriate justification and supervisory concurrence. The Secretary
shall provide training to employees in how to develop and use guidance
documents and shall monitor the development and issuance of such
documents.
``(C) For guidance documents that set forth initial interpretations
of a statute or regulation, changes in interpretation or policy that
are of more than a minor nature, complex scientific issues, or highly
controversial issues, the Secretary shall ensure public participation
prior to implementation of guidance documents, unless the Secretary
determines that such prior public participation is not feasible or
appropriate. In such cases, the Secretary shall provide for public
comment upon implementation and take such comment into account.
``(D) For guidance documents that set forth existing practices or
minor changes in policy, the Secretary shall provide for public comment
upon implementation.
``(2) In developing guidance documents, the Secretary shall ensure
uniform nomenclature for such documents and uniform internal procedures
for approval of such documents. The Secretary shall ensure that
guidance documents and revisions of such documents are properly dated
and indicate the nonbinding nature of the documents. The Secretary
shall periodically review all guidance documents and, where
appropriate, revise such documents.
``(3) The Secretary, acting through the Commissioner, shall
maintain electronically and update and publish periodically in the
Federal Register a list of guidance documents. All such documents shall
be made available to the public.
``(4) The Secretary shall ensure that an effective appeals
mechanism is in place to address complaints that the Food and Drug
Administration is not developing and using guidance documents in
accordance with this subsection.
``(5) Not later than July 1, 2000, the Secretary after evaluating
the effectiveness of the Good Guidance Practices document, published in
the Federal Register at 62 Fed. Reg. 8961, shall promulgate a
regulation consistent with this subsection specifying the policies and
procedures of the Food and Drug Administration for the development,
issuance, and use of guidance documents.''.

5fae7e8d7e7510cc5bc74c05b5355ef71bfdc57507f6dd0059490473c3613839

(a) Mission.--Section 903 (21 U.S.C. 393) is amended--
(1) by redesignating subsections (b) and (c) as subsections (d)
and (e), respectively; and
(2) by inserting after subsection (a) the following:
``(b) Mission.--The Administration shall--
``(1) promote the public health by promptly and efficiently
reviewing clinical research and taking appropriate action on the
marketing of regulated products in a timely manner;
``(2) with respect to such products, protect the public health
by ensuring that--
``(A) foods are safe, wholesome, sanitary, and properly
labeled;
``(B) human and veterinary drugs are safe and effective;
``(C) there is reasonable assurance of the safety and
effectiveness of devices intended for human use;
``(D) cosmetics are safe and properly labeled; and
``(E) public health and safety are protected from
electronic product radiation;
``(3) participate through appropriate processes with
representatives of other countries to reduce the burden of
regulation, harmonize regulatory requirements, and achieve
appropriate reciprocal arrangements; and
``(4) as determined to be appropriate by the Secretary, carry
out paragraphs (1) through (3) in consultation with experts in
science, medicine, and public health, and in cooperation with
consumers, users, manufacturers, importers, packers, distributors,
and retailers of regulated products.''.
(b) Annual Report.--Section 903 (21 U.S.C. 393), as amended by
subsection (a), is further amended by adding at the end the following:
``(f) Agency Plan for Statutory Compliance.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Food and Drug Administration Modernization Act of
1997, the Secretary, after consultation with appropriate scientific
and academic experts, health care professionals, representatives of
patient and consumer advocacy groups, and the regulated industry,
shall develop and publish in the Federal Register a plan bringing
the Secretary into compliance with each of the obligations of the
Secretary under this Act. The Secretary shall review the plan
biannually and shall revise the plan as necessary, in consultation
with such persons.
``(2) Objectives of agency plan.--The plan required by
paragraph (1) shall establish objectives and mechanisms to achieve
such objectives, including objectives related to--
``(A) maximizing the availability and clarity of
information about the process for review of applications and
submissions (including petitions, notifications, and any other
similar forms of request) made under this Act;
``(B) maximizing the availability and clarity of
information for consumers and patients concerning new products;
``(C) implementing inspection and postmarket monitoring
provisions of this Act;
``(D) ensuring access to the scientific and technical
expertise needed by the Secretary to meet obligations described
in paragraph (1);
``(E) establishing mechanisms, by July 1, 1999, for meeting
the time periods specified in this Act for the review of all
applications and submissions described in subparagraph (A) and
submitted after the date of enactment of the Food and Drug
Administration Modernization Act of 1997; and
``(F) eliminating backlogs in the review of applications
and submissions described in subparagraph (A), by January 1,
2000.
``(g) Annual Report.--The Secretary shall annually prepare and
publish in the Federal Register and solicit public comment on a report
that--
``(1) provides detailed statistical information on the
performance of the Secretary under the plan described in subsection
(f);
``(2) compares such performance of the Secretary with the
objectives of the plan and with the statutory obligations of the
Secretary; and
``(3) identifies any regulatory policy that has a significant
negative impact on compliance with any objective of the plan or any
statutory obligation and sets forth any proposed revision to any
such regulatory policy.''.

3891fbde447768ce4b10c198cf90f3cbd837dac1072c827e9ea94e4dc2aafe1b

(a) Amendment.--Chapter VII (21 U.S.C. 371 et seq.) is amended by
adding at the end the following:
``Subchapter D--Information and Education
``SEC. 741. INFORMATION SYSTEM.
``The Secretary shall establish and maintain an information system
to track the status and progress of each application or submission
(including a petition, notification, or other similar form of request)
submitted to the Food and Drug Administration requesting agency
action.''.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services shall submit a
report to the Committee on Labor and Human Resources of the Senate and
the Committee on Commerce of the House of Representatives on the status
of the system to be established under the amendment made by subsection
(a), including the projected costs of the system and concerns about
confidentiality.

723775f9659ff1167939d1746a76586f6aec26aeb25e090e0164a0e80c49bb53

(a) Food and Drug Administration.--Chapter VII (21 U.S.C. 371 et
seq.), as amended by section 407, is further amended by adding at the
end the following section:
``SEC. 742. EDUCATION.
``(a) In General.--The Secretary shall conduct training and
education programs for the employees of the Food and Drug
Administration relating to the regulatory responsibilities and policies
established by this Act, including programs for--
``(1) scientific training;
``(2) training to improve the skill of officers and employees
authorized to conduct inspections under section 704;
``(3) training to achieve product specialization in such
inspections; and
``(4) training in administrative process and procedure and
integrity issues.
``(b) Intramural Fellowships and Other Training Programs.--The
Secretary, acting through the Commissioner, may, through fellowships
and other training programs, conduct and support intramural research
training for predoctoral and postdoctoral scientists and physicians.''.
(b) Centers for Disease Control and Prevention.--
(1) In general.--Part B of title III of the Public Health
Service Act is amended by inserting after section 317F (42 U.S.C.
247b-7) the following:
``SEC. 317G. FELLOWSHIP AND TRAINING PROGRAMS.
``The Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall establish fellowship and training
programs to be conducted by such Centers to train individuals to
develop skills in epidemiology, surveillance, laboratory analysis, and
other disease detection and prevention methods. Such programs shall be
designed to enable health professionals and health personnel trained
under such programs to work, after receiving such training, in local,
State, national, and international efforts toward the prevention and
control of diseases, injuries, and disabilities. Such fellowships and
training may be administered through the use of either appointment or
nonappointment procedures.''.
(2) Effective date.--The amendment made by this subsection is
deemed to have taken effect July 1, 1995.

af5474e1c3e460fabb903b891a41c5c091c8aebfc51825194e46843e268dbfc6

Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.)
is amended by adding at the end of part A the following new section:
``SEC. 905. DEMONSTRATION PROGRAM REGARDING CENTERS FOR EDUCATION AND
RESEARCH ON THERAPEUTICS.
``(a) In General.--The Secretary, acting through the Administrator
and in consultation with the Commissioner of Food and Drugs, shall
establish a demonstration program for the purpose of making one or more
grants for the establishment and operation of one or more centers to
carry out the activities specified in subsection (b).
``(b) Required Activities.--The activities referred to in
subsection (a) are the following:
``(1) The conduct of state-of-the-art clinical and laboratory
research for the following purposes:
``(A) To increase awareness of--
``(i) new uses of drugs, biological products, and
devices;
``(ii) ways to improve the effective use of drugs,
biological products, and devices; and
``(iii) risks of new uses and risks of combinations of
drugs and biological products.
``(B) To provide objective clinical information to the
following individuals and entities:
``(i) Health care practitioners or other providers of
health care goods or services.
``(ii) Pharmacy benefit managers.
``(iii) Health maintenance organizations or other
managed health care organizations.
``(iv) Health care insurers or governmental agencies.
``(v) Consumers.
``(C) To improve the quality of health care while reducing
the cost of health care through--
``(i) the appropriate use of drugs, biological
products, or devices; and
``(ii) the prevention of adverse effects of drugs,
biological products, and devices and the consequences of
such effects, such as unnecessary hospitalizations.
``(2) The conduct of research on the comparative effectiveness
and safety of drugs, biological products, and devices.
``(3) Such other activities as the Secretary determines to be
appropriate, except that the grant may not be expended to assist
the Secretary in the review of new drugs.
``(c) Application for Grant.--A grant under subsection (a) may be
made only if an application for the grant is submitted to the Secretary
and the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the Secretary
determines to be necessary to carry out this section.
``(d) Peer Review.--A grant under subsection (a) may be made only
if the application for the grant has undergone appropriate technical
and scientific peer review.
``(e) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $2,000,000
for fiscal year 1998, and $3,000,000 for each of fiscal years 1999
through 2002.''.

526820af7e041d929586dbde94aa8546eccfd4321a9754f84aa4b0cfe1b58a4f

(a) Good Manufacturing Practice Requirements.--Section 520(f)(1)(B)
(21 U.S.C. 360j(f)(1)(B)) is amended--
(1) in clause (i), by striking ``, and'' at the end and
inserting a semicolon;
(2) in clause (ii), by striking the period and inserting ``;
and''; and
(3) by inserting after clause (ii) the following:
``(iii) ensure that such regulation conforms, to the extent
practicable, with internationally recognized standards defining
quality systems, or parts of the standards, for medical devices.''.
(b) Harmonization Efforts.--Section 803 (21 U.S.C. 383) is amended
by adding at the end the following:
``(c)(1) The Secretary shall support the Office of the United
States Trade Representative, in consultation with the Secretary of
Commerce, in meetings with representatives of other countries to
discuss methods and approaches to reduce the burden of regulation and
harmonize regulatory requirements if the Secretary determines that such
harmonization continues consumer protections consistent with the
purposes of this Act.
``(2) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of Commerce,
in efforts to move toward the acceptance of mutual recognition
agreements relating to the regulation of drugs, biological products,
devices, foods, food additives, and color additives, and the regulation
of good manufacturing practices, between the European Union and the
United States.
``(3) The Secretary shall regularly participate in meetings with
representatives of other foreign governments to discuss and reach
agreement on methods and approaches to harmonize regulatory
requirements.
``(4) The Secretary shall, not later than 180 days after the date
of enactment of the Food and Drug Administration Modernization Act of
1997, make public a plan that establishes a framework for achieving
mutual recognition of good manufacturing practices inspections.
``(5) Paragraphs (1) through (4) shall not apply with respect to
products defined in section 201(ff).''.

c7c2ba4f3cef4683081008fc50b4a6effdaa3cbc9171dc763fbb52c36b60d77f

Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407, is
further amended by adding at the end the following:
``Subchapter E--Environmental Impact Review
``SEC. 746. ENVIRONMENTAL IMPACT.
``Notwithstanding any other provision of law, an environmental
impact statement prepared in accordance with the regulations published
in part 25 of title 21, Code of Federal Regulations (as in effect on
August 31, 1997) in connection with an action carried out under (or a
recommendation or report relating to) this Act, shall be considered to
meet the requirements for a detailed statement under section 102(2)(C)
of the National Environmental Policy Act of 1969 (42 U.S.C.
4332(2)(C)).''.

74e20d5b7030df096f1d7a5d0c0bb9d14e2cabf9b0d86a5eb11e7a098e958b62

COSMETICS.
(a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et seq.), as
amended by section 411, is further amended by adding at the end the
following:
``Subchapter F--National Uniformity for Nonprescription Drugs and
Preemption for Labeling or Packaging of Cosmetics
``SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.
``(a) In General.--Except as provided in subsection (b), (c)(1),
(d), (e), or (f), no State or political subdivision of a State may
establish or continue in effect any requirement--
``(1) that relates to the regulation of a drug that is not
subject to the requirements of section 503(b)(1) or 503(f)(1)(A);
and
``(2) that is different from or in addition to, or that is
otherwise not identical with, a requirement under this Act, the
Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.),
or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
``(b) Exemption.--
``(1) In general.--Upon application of a State or political
subdivision thereof, the Secretary may by regulation, after notice
and opportunity for written and oral presentation of views, exempt
from subsection (a), under such conditions as may be prescribed in
such regulation, a State or political subdivision requirement
that--
``(A) protects an important public interest that would
otherwise be unprotected, including the health and safety of
children;
``(B) would not cause any drug to be in violation of any
applicable requirement or prohibition under Federal law; and
``(C) would not unduly burden interstate commerce.
``(2) Timely action.--The Secretary shall make a decision on
the exemption of a State or political subdivision requirement under
paragraph (1) not later than 120 days after receiving the
application of the State or political subdivision under paragraph
(1).
``(c) Scope.--
``(1) In general.--This section shall not apply to--
``(A) any State or political subdivision requirement that
relates to the practice of pharmacy; or
``(B) any State or political subdivision requirement that a
drug be dispensed only upon the prescription of a practitioner
licensed by law to administer such drug.
``(2) Safety or effectiveness.--For purposes of subsection (a),
a requirement that relates to the regulation of a drug shall be
deemed to include any requirement relating to public information or
any other form of public communication relating to a warning of any
kind for a drug.
``(d) Exceptions.--
``(1) In general.--In the case of a drug described in
subsection (a)(1) that is not the subject of an application
approved under section 505 or section 507 (as in effect on the day
before the date of enactment of the Food and Drug Administration
Modernization Act of 1997) or a final regulation promulgated by the
Secretary establishing conditions under which the drug is generally
recognized as safe and effective and not misbranded, subsection (a)
shall apply only with respect to a requirement of a State or
political subdivision of a State that relates to the same subject
as, but is different from or in addition to, or that is otherwise
not identical with--
``(A) a regulation in effect with respect to the drug
pursuant to a statute described in subsection (a)(2); or
``(B) any other requirement in effect with respect to the
drug pursuant to an amendment to such a statute made on or
after the date of enactment of the Food and Drug Administration
Modernization Act of 1997.
``(2) State initiatives.--This section shall not apply to a
State requirement adopted by a State public initiative or
referendum enacted prior to September 1, 1997.
``(e) No Effect on Product Liability Law.--Nothing in this section
shall be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of any State.
``(f) State Enforcement Authority.--Nothing in this section shall
prevent a State or political subdivision thereof from enforcing, under
any relevant civil or other enforcement authority, a requirement that
is identical to a requirement of this Act.''.
(b) Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) is
amended by striking ``prescription drugs'' each place it appears and
inserting ``prescription drugs, nonprescription drugs intended for
human use,''.
(c) Misbranding.--Subparagraph (1) of section 502(e) (21 U.S.C.
352(e)(1)) is amended to read as follows:
``(1)(A) If it is a drug, unless its label bears, to the exclusion
of any other nonproprietary name (except the applicable systematic
chemical name or the chemical formula)--
``(i) the established name (as defined in subparagraph (3)) of
the drug, if there is such a name;
``(ii) the established name and quantity or, if determined to
be appropriate by the Secretary, the proportion of each active
ingredient, including the quantity, kind, and proportion of any
alcohol, and also including whether active or not the established
name and quantity or if determined to be appropriate by the
Secretary, the proportion of any bromides, ether, chloroform,
acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,
mercury, ouabain, strophanthin, strychnine, thyroid, or any
derivative or preparation of any such substances, contained
therein, except that the requirement for stating the quantity of
the active ingredients, other than the quantity of those
specifically named in this subclause, shall not apply to
nonprescription drugs not intended for human use; and
``(iii) the established name of each inactive ingredient listed
in alphabetical order on the outside container of the retail
package and, if determined to be appropriate by the Secretary, on
the immediate container, as prescribed in regulation promulgated by
the Secretary, except that nothing in this subclause shall be
deemed to require that any trade secret be divulged, and except
that the requirements of this subclause with respect to
alphabetical order shall apply only to nonprescription drugs that
are not also cosmetics and that this subclause shall not apply to
nonprescription drugs not intended for human use.
``(B) For any prescription drug the established name of such drug
or ingredient, as the case may be, on such label (and on any labeling
on which a name for such drug or ingredient is used) shall be printed
prominently and in type at least half as large as that used thereon for
any proprietary name or designation for such drug or ingredient, except
that to the extent that compliance with the requirements of subclause
(ii) or (iii) of clause (A) or this clause is impracticable, exemptions
shall be established by regulations promulgated by the Secretary.''.
(d) Cosmetics.--Subchapter F of chapter VII, as amended by
subsection (a), is further amended by adding at the end the following:
``SEC. 752. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS.
``(a) In General.--Except as provided in subsection (b), (d), or
(e), no State or political subdivision of a State may establish or
continue in effect any requirement for labeling or packaging of a
cosmetic that is different from or in addition to, or that is otherwise
not identical with, a requirement specifically applicable to a
particular cosmetic or class of cosmetics under this Act, the Poison
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair
Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
``(b) Exemption.--Upon application of a State or political
subdivision thereof, the Secretary may by regulation, after notice and
opportunity for written and oral presentation of views, exempt from
subsection (a), under such conditions as may be prescribed in such
regulation, a State or political subdivision requirement for labeling
or packaging that--
``(1) protects an important public interest that would
otherwise be unprotected;
``(2) would not cause a cosmetic to be in violation of any
applicable requirement or prohibition under Federal law; and
``(3) would not unduly burden interstate commerce.
``(c) Scope.--For purposes of subsection (a), a reference to a
State requirement that relates to the packaging or labeling of a
cosmetic means any specific requirement relating to the same aspect of
such cosmetic as a requirement specifically applicable to that
particular cosmetic or class of cosmetics under this Act for packaging
or labeling, including any State requirement relating to public
information or any other form of public communication.
``(d) No Effect on Product Liability Law.--Nothing in this section
shall be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of any State.
``(e) State Initiative.--This section shall not apply to a State
requirement adopted by a State public initiative or referendum enacted
prior to September 1, 1997.''.

1b731c3e93428041f44980cfd253605f46fddcd9ffe54a40522ef0b7b9f2d98a

IN DRUGS AND FOOD.
(a) List and Analysis.--The Secretary of Health and Human Services
shall, acting through the Food and Drug Administration--
(1) compile a list of drugs and foods that contain
intentionally introduced mercury compounds, and
(2) provide a quantitative and qualitative analysis of the
mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1) within 2
years after the date of enactment of the Food and Drug Administration
Modernization Act of 1997 and shall provide the analysis required by
paragraph (2) within 2 years after such date of enactment.
(b) Study.--The Secretary of Health and Human Services, acting
through the Food and Drug Administration, shall conduct a study of the
effect on humans of the use of mercury compounds in nasal sprays. Such
study shall include data from other studies that have been made of such
use.
(c) Study of Mercury Sales.--
(1) Study.--The Secretary of Health and Human Services, acting
through the Food and Drug Administration and subject to
appropriations, shall conduct, or shall contract with the Institute
of Medicine of the National Academy of Sciences to conduct, a study
of the effect on humans of the use of elemental, organic, or
inorganic mercury when offered for sale as a drug or dietary
supplement. Such study shall, among other things, evaluate--
(A) the scope of mercury use as a drug or dietary
supplement; and
(B) the adverse effects on health of children and other
sensitive populations resulting from exposure to, or ingestion
or inhalation of, mercury when so used.
In conducting such study, the Secretary shall consult with the
Administrator of the Environmental Protection Agency, the Chair of
the Consumer Product Safety Commission, and the Administrator of
the Agency for Toxic Substances and Disease Registry, and, to the
extent the Secretary believes necessary or appropriate, with any
other Federal or private entity.
(2) Regulations.--If, in the opinion of the Secretary, the use
of elemental, organic, or inorganic mercury offered for sale as a
drug or dietary supplement poses a threat to human health, the
Secretary shall promulgate regulations restricting the sale of
mercury intended for such use. At a minimum, such regulations shall
be designed to protect the health of children and other sensitive
populations from adverse effects resulting from exposure to, or
ingestion or inhalation of, mercury. Such regulations, to the
extent feasible, should not unnecessarily interfere with the
availability of mercury for use in religious ceremonies.

539afee97f9b2139a36ac2ef2a015d351ab37f43a8b35386a3db29388e0b0a4f

Section 903 (21 U.S.C. 393), as amended by section 406, is further
amended by inserting after subsection (b) the following:
``(c) Interagency Collaboration.--The Secretary shall implement
programs and policies that will foster collaboration between the
Administration, the National Institutes of Health, and other science-
based Federal agencies, to enhance the scientific and technical
expertise available to the Secretary in the conduct of the duties of
the Secretary with respect to the development, clinical investigation,
evaluation, and postmarket monitoring of emerging medical therapies,
including complementary therapies, and advances in nutrition and food
science.''.

7135a8e60643bd7c75dcd084c227fab1b300466f4355ddd327ada3d2143b8a9c

Chapter IX (21 U.S.C. 391 et seq.), as amended by section 214, is
further amended by adding at the end the following:
``SEC. 907. CONTRACTS FOR EXPERT REVIEW.
``(a) In General.--
``(1) Authority.--The Secretary may enter into a contract with
any organization or any individual (who is not an employee of the
Department) with relevant expertise, to review and evaluate, for
the purpose of making recommendations to the Secretary on, part or
all of any application or submission (including a petition,
notification, and any other similar form of request) made under
this Act for the approval or classification of an article or made
under section 351(a) of the Public Health Service Act (42 U.S.C.
262(a)) with respect to a biological product. Any such contract
shall be subject to the requirements of section 708 relating to the
confidentiality of information.
``(2) Increased efficiency and expertise through contracts.--
The Secretary may use the authority granted in paragraph (1)
whenever the Secretary determines that use of a contract described
in paragraph (1) will improve the timeliness of the review of an
application or submission described in paragraph (1), unless using
such authority would reduce the quality, or unduly increase the
cost, of such review. The Secretary may use such authority whenever
the Secretary determines that use of such a contract will improve
the quality of the review of an application or submission described
in paragraph (1), unless using such authority would unduly increase
the cost of such review. Such improvement in timeliness or quality
may include providing the Secretary increased scientific or
technical expertise that is necessary to review or evaluate new
therapies and technologies.
``(b) Review of Expert Review.--
``(1) In general.--Subject to paragraph (2), the official of
the Food and Drug Administration responsible for any matter for
which expert review is used pursuant to subsection (a) shall review
the recommendations of the organization or individual who conducted
the expert review and shall make a final decision regarding the
matter in a timely manner.
``(2) Limitation.--A final decision by the Secretary on any
such application or submission shall be made within the applicable
prescribed time period for review of the matter as set forth in
this Act or in the Public Health Service Act (42 U.S.C. 201 et
seq.).''.

2b3a34d0c5c99d34f4b785c510c86af78e83b69a6743469a356cd5a4b6fce560

Subchapter E of chapter V, as amended by section 404, is further
amended by adding at the end the following:
``SEC. 563. CLASSIFICATION OF PRODUCTS.
``(a) Request.--A person who submits an application or submission
(including a petition, notification, and any other similar form of
request) under this Act for a product, may submit a request to the
Secretary respecting the classification of the product as a drug,
biological product, device, or a combination product subject to section
503(g) or respecting the component of the Food and Drug Administration
that will regulate the product. In submitting the request, the person
shall recommend a classification for the product, or a component to
regulate the product, as appropriate.
``(b) Statement.--Not later than 60 days after the receipt of the
request described in subsection (a), the Secretary shall determine the
classification of the product under subsection (a), or the component of
the Food and Drug Administration that will regulate the product, and
shall provide to the person a written statement that identifies such
classification or such component, and the reasons for such
determination. The Secretary may not modify such statement except with
the written consent of the person, or for public health reasons based
on scientific evidence.
``(c) Inaction of Secretary.--If the Secretary does not provide the
statement within the 60-day period described in subsection (b), the
recommendation made by the person under subsection (a) shall be
considered to be a final determination by the Secretary of such
classification of the product, or the component of the Food and Drug
Administration that will regulate the product, as applicable, and may
not be modified by the Secretary except with the written consent of the
person, or for public health reasons based on scientific evidence.''.

ac6fea40ff0093876525b077a5d6e89be35f8eb591d7fc3e67716020430725e5

Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows:
``(i)(1) Any establishment within any foreign country engaged in
the manufacture, preparation, propagation, compounding, or processing
of a drug or a device that is imported or offered for import into the
United States shall register with the Secretary the name and place of
business of the establishment and the name of the United States agent
for the establishment.
``(2) The establishment shall also provide the information required
by subsection (j).
``(3) The Secretary is authorized to enter into cooperative
arrangements with officials of foreign countries to ensure that
adequate and effective means are available for purposes of determining,
from time to time, whether drugs or devices manufactured, prepared,
propagated, compounded, or processed by an establishment described in
paragraph (1), if imported or offered for import into the United
States, shall be refused admission on any of the grounds set forth in
section 801(a).''.

1587f771e7342e832b450cd45dad515386ce5cf91ea6e877e6a6570aca5d077b

Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
(1) in the fifth sentence, by striking ``paragraphs (1) and (2)
of section 801(e)'' and inserting ``subparagraphs (A) and (B) of
section 801(e)(1)''; and
(2) by inserting after the fifth sentence the following: ``Any
person seeking to export an imported article pursuant to any of the
provisions of this subsection shall establish that the article was
intended for export at the time the article entered commerce.''.

8c411af3bf5c5fda7e989f8c4c6eecb60d43e597466e80dc08aa3c067f5f9416

Section 709 (21 U.S.C. 379a) is amended by striking ``a device''
and inserting ``a device, food, drug, or cosmetic''.

1bea8453ca9c217423e96e8ec21429f940adde6319133f98b5fc4ed41e180696

Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412, is
further amended by adding at the end the following:
``Subchapter G--Safety Reports
``SEC. 756. SAFETY REPORT DISCLAIMERS.
``With respect to any entity that submits or is required to submit
a safety report or other information in connection with the safety of a
product (including a product that is a food, drug, device, dietary
supplement, or cosmetic) under this Act (and any release by the
Secretary of that report or information), such report or information
shall not be construed to reflect necessarily a conclusion by the
entity or the Secretary that the report or information constitutes an
admission that the product involved malfunctioned, caused or
contributed to an adverse experience, or otherwise caused or
contributed to a death, serious injury, or serious illness. Such an
entity need not admit, and may deny, that the report or information
submitted by the entity constitutes an admission that the product
involved malfunctioned, caused or contributed to an adverse experience,
or caused or contributed to a death, serious injury, or serious
illness.''.

7ed9632b7b142f7c3cc7d989583849c30a9a345e215d59041a72f42a52f47993

STATUTORY REQUIREMENTS.
Section 301 (21 U.S.C. 331) is amended by striking paragraph (l).

551ecfeb8e70f8eb4430b78683f96dd52d4ae480816e25d7dee638f838cfad50

Nothing in this Act or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health and
Human Services has any authority to regulate any tobacco product,
tobacco ingredient, or tobacco additive. Such authority, if any, shall
be exercised under the Federal Food, Drug, and Cosmetic Act as in
effect on the day before the date of the enactment of this Act.

23edc9655dfb2257f29e1631af36146a2b221447895452620ab618c129b0b030

Except as otherwise provided in this Act, this Act and the
amendments made by this Act, other than the provisions of and the
amendments made by sections 111, 121, 125, and 307, shall take effect
90 days after the date of enactment of this Act.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

d2baf1a6e8e79e6d1690a3f053fd78db1a8a33076cf132e2e5d073321f4cbcbd

Prescription Drug bill — S. 830

Other Sections

TITLE I

TITLE II

TITLE IV

TITLE V

TITLE III

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