[Congressional Bills 110th Congress]
[From the U.S. Government Printing Office]
[H.R. 6432 Enrolled Bill (ENR)]
H.R.6432
One Hundred Tenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and eight
An Act
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the animal drug user fee program, to establish a program of fees
relating to generic new animal drugs, to make certain technical
corrections to the Food and Drug Administration Amendments Act of 2007,
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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The table of contents of this Act is as follows:

dc8797d95be2bf683ae9488e5f7eb1861c91baed38e4a046f3482e8f9f8e6f32

4931cb020dab1a0e345deb2dd36ce9348f8c23c4e143a1e336645f6727e6aeee

TITLE II

-ANIMAL GENERIC DRUG USER FEE

Except as otherwise specified, amendments made by this Act to a
section or other provision of law are amendments to such section or
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).

9fa845299d87a702f9eb3888f5f5587b532f84be9cb27714abfee34f31136f5a

TITLE III

-TECHNICAL CORRECTIONS TO FDAAA

(a) Short Title.--This title may be cited as the ``Animal Drug User
Fee Amendments of 2008''.
(b) Finding.--Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward expediting the
animal drug development process and the review of new and supplemental
animal drug applications and investigational animal drug submissions as
set forth in the goals identified, for purposes of part 4 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 Energy and Commerce of the House of Representatives
and the Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate as set forth in the Congressional Record.

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TITLE I

-ANIMAL DRUG USER FEE AMENDMENTS

Section 739 (21 U.S.C. 379j-11) is amended--
(1) in paragraph (6), by striking ``, except for an approved
application for which all subject products have been removed from
listing under section 510'' and inserting ``that has not been
withdrawn by the applicant and for which approval has not been
withdrawn by the Secretary'';
(2) in paragraph (8)(H), by striking ``but not such activities
after an animal drug has been approved'' and inserting ``but not
after such application has been approved'';
(3) in paragraph (10), by striking ``year being 2003'' and
inserting ``month being October 2002'';
(4) by redesignating paragraph (11) as paragraph (12); and
(5) by inserting after paragraph (10) the following:
``(11) The term `person' includes an affiliate thereof.''.

04833ed21b20a71ef109cd03c533c372ec244f5190d4e4324bc2699fca24a285

(a) Types of Fees.--Section 740(a) (21 U.S.C. 379j-12(a)) is
amended--
(1) in paragraph (1)(A)(i), by inserting after ``for an animal
drug application'' the following: ``, except an animal drug
application subject to the criteria set forth in section
512(d)(4)''; and
(2) by amending paragraph (1)(A)(ii) to read as follows:
``(ii) A fee established in subsection (b), in an
amount that is equal to 50 percent of the amount of the fee
under clause (i), for--
``(I) a supplemental animal drug application for
which safety or effectiveness data are required; and
``(II) an animal drug application subject to the
criteria set forth in section 512(d)(4).''.
(b) Fee Amounts.--
(1) Total fee revenues for application and supplement fees.--
Section 740(b)(1) (21 U.S.C. 379j-12(b)(1)) is amended--
(A) by striking ``and supplemental animal drug application
fees'' and inserting ``and supplemental and other animal drug
application fees''; and
(B) by striking ``$1,250,000'' and all that follows through
the period at the end and inserting ``$3,815,000 for fiscal
year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for
fiscal year 2011, $5,442,000 for fiscal year 2012, and
$6,061,000 for fiscal year 2013.''.
(2) Total fee revenues for product fees.--Section 740(b)(2) (21
U.S.C. 379j-12(b)(2)) is amended by striking ``$1,250,000'' and all
that follows through the period at the end and inserting
``$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010,
$4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012,
and $6,061,000 for fiscal year 2013.''.
(3) Total fee revenues for establishment fees.--Section
740(b)(3) (21 U.S.C. 379j-12(b)(3)) is amended by striking
``$1,250,000'' and all that follows through the period at the end
and inserting ``$3,815,000 for fiscal year 2009, $4,320,000 for
fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for
fiscal year 2012, and $6,061,000 for fiscal year 2013.''.
(4) Total fee revenues for sponsor fees.--Section 740(b)(4) (21
U.S.C. 379j-12(b)(4)) is amended by striking ``$1,250,000'' and all
that follows through the period at the end and inserting
``$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010,
$4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012,
and $6,061,000 for fiscal year 2013.''.
(c) Adjustments to Fees.--Section 740(c) (21 U.S.C. 379j-12(c)) is
amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (5) as paragraphs
(1) through (4), respectively;
(3) in paragraph (1), as so redesignated--
(A) in the matter preceding subparagraph (A), by striking
``After the fee revenues are adjusted for inflation in
accordance with paragraph (1), the fee revenues shall be
further adjusted each fiscal year after fiscal year 2004'' and
inserting ``The fee revenues shall be adjusted each fiscal year
after fiscal year 2009''; and
(B) in subparagraph (B), by striking ``, as adjusted for
inflation under paragraph (1)''; and
(4) in paragraph (2), as so redesignated--
(A) by striking ``2008'' each place it appears and
inserting ``2013''; and
(B) by striking ``2009'' and inserting ``2014''.
(d) Authorization of Appropriations.--Subparagraphs (A) through (E)
of section 740(g)(3) (21 U.S.C. 379j-12(g)(3)) are amended to read as
follows:
``(A) $15,260,000 for fiscal year 2009;
``(B) $17,280,000 for fiscal year 2010;
``(C) $19,448,000 for fiscal year 2011;
``(D) $21,768,000 for fiscal year 2012; and
``(E) $24,244,000 for fiscal year 2013;''.
(e) Offset.--Section 740(g)(4) (21 U.S.C. 379j-12(g)(4)) is amended
to read as follows:
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for fiscal years 2009 through 2011 and
the amount of fees estimated to be collected under this section for
fiscal year 2012 exceeds the cumulative amount appropriated under
paragraph (3) for the fiscal years 2009 through 2012, the excess
amount 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 fiscal year 2013.''.

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Part 4 of subchapter C of chapter VII (21 U.S.C. 379j-11 et seq.)
is amended by inserting after section 740 the following:
``SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2009, not
later than 60 days after the end of each fiscal year during which fees
are collected under this part, the Secretary shall prepare and submit
to the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions 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(b) of the Animal Drug User Fee Amendments of
2008 toward expediting the animal drug development process and the
review of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal year, the
future plans of the Food and Drug Administration for meeting the goals,
the review times for abbreviated new animal drug applications, and the
administrative procedures adopted by the Food and Drug Administration
to ensure that review times for abbreviated new animal drug
applications are not increased from their current level due to
activities under the user fee program.
``(b) Fiscal Report.--Beginning with fiscal year 2009, not later
than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions 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.
``(c) Public Availability.--The Secretary shall make the reports
required under subsections (a) and (b) available to the public on the
Internet Web site of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to present
to the Congress with respect to the goals, and plans for meeting
the goals, for the process for the review of animal drug
applications for the first 5 fiscal years after fiscal year 2013,
and for the reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations with
the regulated industry on the reauthorization of this part, the
Secretary shall--
``(A) publish a notice in the Federal Register requesting
public input on the reauthorization;
``(B) hold a public meeting at which the public may present
its views on the reauthorization, including specific
suggestions for changes to the goals referred to in subsection
(a);
``(C) provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes
to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every 4 months during negotiations with the regulated industry, the
Secretary shall hold discussions with representatives of
veterinary, patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under paragraph
(2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the Congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than January
15, 2013, the Secretary shall transmit to the Congress the revised
recommendations under paragraph (4), a summary of the views and
comments received under such paragraph, and any changes made to the
recommendations in response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through (5) to
the Congress, the Secretary shall make publicly available, on
the Internet Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any party
to the negotiations as well as significant controversies or
differences of opinion during the negotiations and their
resolution.''.

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(a) Reports.--Section 512(l) (21 U.S.C. 360b(l)) is amended by
adding at the end the following:
``(3)(A) In the case of each new animal drug described in paragraph
(1) that contains an antimicrobial active ingredient, the sponsor of
the drug shall submit an annual report to the Secretary on the amount
of each antimicrobial active ingredient in the drug that is sold or
distributed for use in food-producing animals, including information on
any distributor-labeled product.
``(B) Each report under this paragraph shall specify the amount of
each antimicrobial active ingredient--
``(i) by container size, strength, and dosage form;
``(ii) by quantities distributed domestically and quantities
exported; and
``(iii) by dosage form, including, for each such dosage form, a
listing of the target animals, indications, and production classes
that are specified on the approved label of the product.
``(C) Each report under this paragraph shall--
``(i) be submitted not later than March 31 each year;
``(ii) cover the period of the preceding calendar year; and
``(iii) include separate information for each month of such
calendar year.
``(D) The Secretary may share information reported under this
paragraph with the Antimicrobial Resistance Task Force established
under section 319E of the Public Health Service Act.
``(E) The Secretary shall make summaries of the information
reported under this paragraph publicly available, except that--
``(i) the summary data shall be reported by antimicrobial
class, and no class with fewer than 3 distinct sponsors of approved
applications shall be independently reported; and
``(ii) the data shall be reported in a manner consistent with
protecting both national security and confidential business
information.''.
(b) First Report.--For each new animal drug that is subject to the
reporting requirement under section 512(l)(3) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), and for which an
approval of an application filed pursuant to section 512(b) or 571 of
such Act is in effect on the date of the enactment of this title, the
Secretary of Health and Human Services shall require the sponsor of the
drug to submit the first report under such section 512(l)(3) for the
drug not later than March 31, 2010.
(c) Separate Report.--The reports required under section 512(l)(3)
of the Federal Food, Drug, and Cosmetic Act, as added by subsection
(a), shall be separate from periodic drug experience reports that are
required under section 514.80(b)(4) of title 21, Code of Federal
Regulations (as in effect on the date of the enactment of this title).

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Notwithstanding section 5 of the Animal Drug User Fee Act of 2003
(21 U.S.C. 379j-11 note), and notwithstanding the amendments made by
this title, part 4 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as in effect on the
day before the date of the enactment of this title, shall continue to
be in effect with respect to animal drug applications and supplemental
animal drug applications (as defined in such part as of such day) that
on or after September 1, 2003, but before October 1, 2008, were
accepted by the Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2009.

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The amendments made by sections 102, 103, and 104 shall take effect
on October 1, 2008, and fees under part 4 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, as amended by this
title, shall be assessed for all animal drug applications and
supplemental animal drug applications received on or after such date,
regardless of the date of the enactment of this title.

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(a) Authorization.--The amendments made by sections 102 and 103
cease to be effective October 1, 2013.
(b) Reporting Requirements.--The amendment made by section 104
ceases to be effective January 31, 2014.

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(a) Short Title.--This title may be cited as the ``Animal Generic
Drug User Fee Act of 2008''.
(b) Findings.--Congress finds as follows:
(1) Prompt approval of abbreviated applications for safe and
effective generic new animal drugs will reduce animal healthcare
costs and promote the well-being of animal health and the public
health.
(2) Animal health and 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 the review of abbreviated applications for the
approval of generic new animal drugs.
(3) The fees authorized by this title will be dedicated toward
expediting the generic new animal drug development process and the
review of abbreviated applications for generic new animal drugs,
supplemental abbreviated applications for generic new animal drugs,
and investigational submissions for generic new animal drugs as set
forth in the goals identified in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Energy and Commerce of the House of Representatives and the
Chairman of the Committee on Health, Education, Labor, and Pensions
of the Senate as set forth in the Congressional Record.

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Part 5 of subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379f et seq.), as added by section 202, is
amended by inserting after section 741 the following:
``SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Reports.--Beginning with fiscal year 2009, not
later than 60 days after the end of each fiscal year during which fees
are collected under this part, the Secretary shall prepare and submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate, and the Committee on Energy and Commerce of the House of
Representatives a report concerning the progress of the Food and Drug
Administration in achieving the goals identified in the letters
described in section 201(3) of the Animal Generic Drug User Fee Act of
2008 toward expediting the generic new animal drug development process
and the review of abbreviated applications for generic new animal
drugs, supplemental abbreviated applications for generic new animal
drugs, and investigational submissions for generic new animal drugs
during such fiscal year.
``(b) Fiscal Report.--Beginning with fiscal year 2009, not later
than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives 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.
``(c) Public Availability.--The Secretary shall make the reports
required under subsections (a) and (b) available to the public on the
Internet Web site of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to present
to Congress with respect to the goals, and plans for meeting the
goals, for the process for the review of abbreviated applications
for generic new animal drugs for the first 5 fiscal years after
fiscal year 2013, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations with
the regulated industry on the reauthorization of this part, the
Secretary shall--
``(A) publish a notice in the Federal Register requesting
public input on the reauthorization;
``(B) hold a public meeting at which the public may present
its views on the reauthorization, including specific
suggestions for changes to the goals referred to in subsection
(a);
``(C) provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes
to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every 4 months during negotiations with the regulated industry, the
Secretary shall hold discussions with representatives of
veterinary, patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under paragraph
(2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than January
15, 2013, the Secretary shall transmit to Congress the revised
recommendations under paragraph (4), a summary of the views and
comments received under such paragraph, and any changes made to the
recommendations in response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through (5) to
Congress, the Secretary shall make publicly available, on the
Internet Web site of the Food and Drug Administration, minutes
of all negotiation meetings conducted under this subsection
between the Food and Drug Administration and the regulated
industry.
``(B) Content.--The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any party
to the negotiations as well as significant controversies or
differences of opinion during the negotiations and their
resolution.''.

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(a) Authorization.--The amendments made by section 202 shall cease
to be effective October 1, 2013.
(b) Reporting Requirements.--The amendment made by section 203
shall cease to be effective January 31, 2014.

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Subparagraph (A) of section 505(q)(1) (21 U.S.C. 355(q)(1)) is
amended by adding at the end the following:
``Consideration of the petition shall be separate and apart
from review and approval of any application.''.

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Paragraph (3) of section 402(j) of the Public Health Service Act
(42 U.S.C. 282(j)) is amended--
(1) in the matter preceding clause (i) in subparagraph (C), by
striking ``the following elements'' and all that follows through
``520(m) of such Act:'' and inserting ``for each applicable
clinical trial for a drug that is approved under section 505 of the
Federal Food, Drug, and Cosmetic Act or licensed under section 351
of this Act or a device that is cleared under section 510(k) of the
Federal Food, Drug, and Cosmetic Act or approved under section 515
or 520(m) of such Act, the following elements:''; and
(2) in clauses (i) and (iii) of subparagraph (I), by striking
the term ``drugs described in subparagraph (C)'' each place such
term appears and inserting ``applicable clinical trials described
in subparagraph (C)''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

3e8508f28d3b34c12c7ae5dc8611157a753f80d1db7f4b42e00d2a0a721c5003

Animal Drug User Fee Amendments of 2008

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes.

Animal Drug User Fee Amendments of 2008

Other Sections

TITLE II

TITLE III

TITLE I

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