[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 15 Enrolled Bill (ENR)]
S.15
One Hundred Eighth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twentieth day of January, two thousand and four
An Act
To amend the Public Health Service Act to provide protections and
countermeasures against chemical, radiological, or nuclear agents that
may be used in a terrorist attack against the United States by giving
the National Institutes of Health contracting flexibility,
infrastructure improvements, and expediting the scientific peer review
process, and streamlining the Food and Drug Administration approval
process of countermeasures.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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This Act may be cited as the ``Project BioShield Act of 2004''.

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AUTHORITIES.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F
the following section:
``SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING
QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT
ACTIVITIES.
``(a) In General.--
``(1) Authority.--In conducting and supporting research and
development activities regarding countermeasures under section
319F(h), the Secretary may conduct and support such activities in
accordance with this section and, in consultation with the Director
of the National Institutes of Health, as part of the program under
section 446, if the activities concern qualified countermeasures.
``(2) Qualified countermeasure.--For purposes of this section,
the term `qualified countermeasure' means a drug (as that term is
defined by section 201(g)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that
term is defined by section 351(i) of this Act (42 U.S.C. 262(i))),
or device (as that term is defined by section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that the Secretary
determines to be a priority (consistent with sections 302(2) and
304(a) of the Homeland Security Act of 2002) to--
``(A) treat, identify, or prevent harm from any biological,
chemical, radiological, or nuclear agent that may cause a
public health emergency affecting national security; or
``(B) treat, identify, or prevent harm from a condition
that may result in adverse health consequences or death and may
be caused by administering a drug, biological product, or
device that is used as described in subparagraph (A).
``(3) Interagency cooperation.--
``(A) In general.--In carrying out activities under this
section, the Secretary is authorized, subject to subparagraph
(B), to enter into interagency agreements and other
collaborative undertakings with other agencies of the United
States Government.
``(B) Limitation.--An agreement or undertaking under this
paragraph shall not authorize another agency to exercise the
authorities provided by this section.
``(4) Availability of facilities to the secretary.--In any
grant, contract, or cooperative agreement entered into under the
authority provided in this section with respect to a biocontainment
laboratory or other related or ancillary specialized research
facility that the Secretary determines necessary for the purpose of
performing, administering, or supporting qualified countermeasure
research and development, the Secretary may provide that the
facility that is the object of such grant, contract, or cooperative
agreement shall be available as needed to the Secretary to respond
to public health emergencies affecting national security.
``(5) Transfers of qualified countermeasures.--Each agreement
for an award of a grant, contract, or cooperative agreement under
section 319F(h) for the development of a qualified countermeasure
shall provide that the recipient of the award will comply with all
applicable export-related controls with respect to such
countermeasure.
``(b) Expedited Procurement Authority.--
``(1) Increased simplified acquisition threshold for qualified
countermeasure procurements.--
``(A) In general.--For any procurement by the Secretary of
property or services for use (as determined by the Secretary)
in performing, administering, or supporting qualified
countermeasure research or development activities under this
section that the Secretary determines necessary to respond to
pressing research and development needs under this section, the
amount specified in section 4(11) of the Office of Federal
Procurement Policy Act (41 U.S.C. 403(11)), as applicable
pursuant to section 302A(a) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 252a(a)), shall
be deemed to be $25,000,000 in the administration, with respect
to such procurement, of--
``(i) section 303(g)(1)(A) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its implementing regulations; and
``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b))
and its implementing regulations.
``(B) Application of certain provisions.--Notwithstanding
subparagraph (A) and the provision of law and regulations
referred to in such subparagraph, each of the following
provisions shall apply to procurements described in this
paragraph to the same extent that such provisions would apply
to such procurements in the absence of subparagraph (A):
``(i) Chapter 37 of title 40, United States Code
(relating to contract work hours and safety standards).
``(ii) Subsections (a) and (b) of section 7 of the
Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
``(iii) Section 304C of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 254d)
(relating to the examination of contractor records).
``(iv) Section 3131 of title 40, United States Code
(relating to bonds of contractors of public buildings or
works).
``(v) Subsection (a) of section 304 of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
254(a)) (relating to contingent fees to middlemen).
``(vi) Section 6002 of the Solid Waste Disposal Act (42
U.S.C. 6962).
``(vii) Section 1354 of title 31, United States Code
(relating to the limitation on the use of appropriated
funds for contracts with entities not meeting veterans
employment reporting requirements).
``(C) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for procurements
that are under this paragraph, including requirements with
regard to documenting the justification for use of the
authority in this paragraph with respect to the procurement
involved.
``(D) Authority to limit competition.--In conducting a
procurement under this paragraph, the Secretary may not use the
authority provided for under subparagraph (A) to conduct a
procurement on a basis other than full and open competition
unless the Secretary determines that the mission of the
BioShield Program under the Project BioShield Act of 2004 would
be seriously impaired without such a limitation.
``(2) Procedures other than full and open competition.--
``(A) In general.--In using the authority provided in
section 303(c)(1) of title III of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to
use procedures other than competitive procedures in the case of
a procurement described in paragraph (1) of this subsection,
the phrase `available from only one responsible source' in such
section 303(c)(1) shall be deemed to mean `available from only
one responsible source or only from a limited number of
responsible sources'.
``(B) Relation to other authorities.--The authority under
subparagraph (A) is in addition to any other authority to use
procedures other than competitive procedures.
``(C) Applicable government-wide regulations.--The
Secretary shall implement this paragraph in accordance with
government-wide regulations implementing such section 303(c)(1)
(including requirements that offers be solicited from as many
potential sources as is practicable under the circumstances,
that required notices be published, and that submitted offers
be considered), as such regulations apply to procurements for
which an agency has authority to use procedures other than
competitive procedures when the property or services needed by
the agency are available from only one responsible source or
only from a limited number of responsible sources and no other
type of property or services will satisfy the needs of the
agency.
``(3) Increased micropurchase threshold.--
``(A) In general.--For a procurement described by paragraph
(1), the amount specified in subsections (c), (d), and (f) of
section 32 of the Office of Federal Procurement Policy Act (41
U.S.C. 428) shall be deemed to be $15,000 in the administration
of that section with respect to such procurement.
``(B) Internal controls to be instituted.--The Secretary
shall institute appropriate internal controls for purchases
that are under this paragraph and that are greater than $2,500.
``(C) Exception to preference for purchase card
mechanism.--No provision of law establishing a preference for
using a Government purchase card method for purchases shall
apply to purchases that are under this paragraph and that are
greater than $2,500.
``(4) Review.--
``(A) Review allowed.--Notwithstanding subsection (f),
section 1491 of title 28, United States Code, and section 3556
of title 31 of such Code, review of a contracting agency
decision relating to a procurement described in paragraph (1)
may be had only by filing a protest--
``(i) with a contracting agency; or
``(ii) with the Comptroller General under subchapter V
of chapter 35 of title 31, United States Code.
``(B) Override of stay of contract award or performance
committed to agency discretion.--Notwithstanding section 1491
of title 28, United States Code, and section 3553 of title 31
of such Code, the following authorizations by the head of a
procuring activity are committed to agency discretion:
``(i) An authorization under section 3553(c)(2) of
title 31, United States Code, to award a contract for a
procurement described in paragraph (1) of this subsection.
``(ii) An authorization under section 3553(d)(3)(C) of
such title to perform a contract for a procurement
described in paragraph (1) of this subsection.
``(c) Authority to Expedite Peer Review.--
``(1) In general.--The Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under this section,
employ such expedited peer review procedures (including
consultation with appropriate scientific experts) as the Secretary,
in consultation with the Director of NIH, deems appropriate to
obtain assessment of scientific and technical merit and likely
contribution to the field of qualified countermeasure research, in
place of the peer review and advisory council review procedures
that would be required under sections 301(a)(3), 405(b)(1)(B),
405(b)(2), 406(a)(3)(A), 492, and 494, as applicable to a grant,
contract, or cooperative agreement--
``(A) that is for performing, administering, or supporting
qualified countermeasure research and development activities;
and
``(B) the amount of which is not greater than $1,500,000.
``(2) Subsequent phases of research.--The Secretary's
determination of whether to employ expedited peer review with
respect to any subsequent phases of a research grant, contract, or
cooperative agreement under this section shall be determined
without regard to the peer review procedures used for any prior
peer review of that same grant, contract, or cooperative agreement.
Nothing in the preceding sentence may be construed to impose any
requirement with respect to peer review not otherwise required
under any other law or regulation.
``(d) Authority for Personal Services Contracts.--
``(1) In general.--For the purpose of performing,
administering, or supporting qualified countermeasure research and
development activities, the Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under this section,
obtain by contract (in accordance with section 3109 of title 5,
United States Code, but without regard to the limitations in such
section on the period of service and on pay) the personal services
of experts or consultants who have scientific or other professional
qualifications, except that in no case shall the compensation
provided to any such expert or consultant exceed the daily
equivalent of the annual rate of compensation for the President.
``(2) Federal tort claims act coverage.--
``(A) In general.--A person carrying out a contract under
paragraph (1), and an officer, employee, or governing board
member of such person, shall, subject to a determination by the
Secretary, be deemed to be an employee of the Department of
Health and Human Services for purposes of claims under sections
1346(b) and 2672 of title 28, United States Code, for money
damages for personal injury, including death, resulting from
performance of functions under such contract.
``(B) Exclusivity of remedy.--The remedy provided by
subparagraph (A) shall be exclusive of any other civil action
or proceeding by reason of the same subject matter against the
entity involved (person, officer, employee, or governing board
member) for any act or omission within the scope of the Federal
Tort Claims Act.
``(C) Recourse in case of gross misconduct or contract
violation.--
``(i) In general.--Should payment be made by the United
States to any claimant bringing a claim under this
paragraph, either by way of administrative determination,
settlement, or court judgment, the United States shall
have, notwithstanding any provision of State law, the right
to recover against any entity identified in subparagraph
(B) for that portion of the damages so awarded or paid, as
well as interest and any costs of litigation, resulting
from the failure of any such entity to carry out any
obligation or responsibility assumed by such entity under a
contract with the United States or from any grossly
negligent or reckless conduct or intentional or willful
misconduct on the part of such entity.
``(ii) Venue.--The United States may maintain an action
under this subparagraph against such entity in the district
court of the United States in which such entity resides or
has its principal place of business.
``(3) Internal controls to be instituted.--
``(A) In general.--The Secretary shall institute
appropriate internal controls for contracts under this
subsection, including procedures for the Secretary to make a
determination of whether a person, or an officer, employee, or
governing board member of a person, is deemed to be an employee
of the Department of Health and Human Services pursuant to
paragraph (2).
``(B) Determination of employee status to be final.--A
determination by the Secretary under subparagraph (A) that a
person, or an officer, employee, or governing board member of a
person, is or is not deemed to be an employee of the Department
of Health and Human Services shall be final and binding on the
Secretary and the Attorney General and other parties to any
civil action or proceeding.
``(4) Number of personal services contracts limited.--The
number of experts and consultants whose personal services are
obtained under paragraph (1) shall not exceed 30 at any time.
``(e) Streamlined Personnel Authority.--
``(1) In general.--In addition to any other personnel
authorities, the Secretary may, as the Secretary determines
necessary to respond to pressing qualified countermeasure research
and development needs under this section, without regard to those
provisions of title 5, United States Code, governing appointments
in the competitive service, and without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of such title relating
to classification and General Schedule pay rates, appoint
professional and technical employees, not to exceed 30 such
employees at any time, to positions in the National Institutes of
Health to perform, administer, or support qualified countermeasure
research and development activities in carrying out this section.
``(2) Limitations.--The authority provided for under paragraph
(1) shall be exercised in a manner that--
``(A) recruits and appoints individuals based solely on
their abilities, knowledge, and skills;
``(B) does not discriminate for or against any applicant
for employment on any basis described in section 2302(b)(1) of
title 5, United States Code;
``(C) does not allow an official to appoint an individual
who is a relative (as defined in section 3110(a)(3) of such
title) of such official;
``(D) does not discriminate for or against an individual
because of the exercise of any activity described in paragraph
(9) or (10) of section 2302(b) of such title; and
``(E) accords a preference, among equally qualified
persons, to persons who are preference eligibles (as defined in
section 2108(3) of such title).
``(3) Internal controls to be instituted.--The Secretary shall
institute appropriate internal controls for appointments under this
subsection.
``(f) Actions Committed to Agency Discretion.--Actions by the
Secretary under the authority of this section are committed to agency
discretion.''.
(b) Technical Amendment.--Section 481A of the Public Health Service
Act (42 U.S.C. 287a-2) is amended--
(1) in subsection (a)(1), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center'';
(2) in subsection (c)--
(A) in paragraph (1), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(B) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``subsection (i)'' and inserting ``subsection
(i)(1)'';
(3) in subsection (d), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center'';
(4) in subsection (e)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by
inserting ``or the Director of the National Institute of
Allergy and Infectious Diseases'' after ``Director of the
Center'';
(ii) in subparagraph (A), by inserting ``(or, in the
case of the Institute, 75 percent)'' after ``50 percent'';
and
(iii) in subparagraph (B), by inserting ``(or, in the
case of the Institute, 75 percent)'' after ``40 percent'';
(B) in paragraph (2), by inserting ``or the Director of the
National Institute of Allergy and Infectious Diseases'' after
``Director of the Center''; and
(C) in paragraph (4), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director'';
(5) in subsection (f)--
(A) in paragraph (1), by inserting ``in the case of an
award by the Director of the Center,'' before ``the
applicant''; and
(B) in paragraph (2), by inserting ``of the Center or the
Director of the National Institute of Allergy and Infectious
Diseases'' after ``Director''; and
(6) in subsection (i)--
(A) by striking ``Appropriations.--For the purpose of
carrying out this section,'' and inserting the following:
``Appropriations.--
``(1) Center.--For the purpose of carrying out this section
with respect to the Center,''; and
(B) by adding at the end the following:
``(2) National institute of allergy and infectious diseases.--
For the purpose of carrying out this section with respect to the
National Institute of Allergy and Infectious Diseases, there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2004 and 2005.''.
(c) Additional Authorizations of Appropriations.--Section 2106 of
the Public Health Service Act (42 U.S.C. 300aa-6) is amended--
(1) in subsection (a), by striking ``authorized to be
appropriated'' and all that follows and inserting the following:
``authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2004 and 2005.''; and
(2) in subsection (b), by striking ``authorized to be
appropriated'' and all that follows and inserting the following:
``authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2004 and 2005.''.
(d) Technical Amendments.--Section 319F of the Public Health
Service Act (42 U.S.C. 247d-6) is amended--
(1) in subsection (a), by inserting ``the Secretary of Homeland
Security,'' after ``Management Agency,''; and
(2) in subsection (h)(4)(B), by striking ``to diagnose
conditions'' and inserting ``to treat, identify, or prevent
conditions''.
(e) Rule of Construction.--Nothing in this section has any legal
effect on sections 302(2), 302(4), 304(a), or 304(b) of the Homeland
Security Act of 2002.

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(a) In General.--Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) is amended to read as follows:
``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
``(a) In General.--
``(1) Emergency uses.--Notwithstanding sections 505, 510(k),
and 515 of this Act and section 351 of the Public Health Service
Act, and subject to the provisions of this section, the Secretary
may authorize the introduction into interstate commerce, during the
effective period of a declaration under subsection (b), of a drug,
device, or biological product intended for use in an actual or
potential emergency (referred to in this section as an `emergency
use').
``(2) Approval status of product.--An authorization under
paragraph (1) may authorize an emergency use of a product that--
``(A) is not approved, licensed, or cleared for commercial
distribution under a provision of law referred to in such
paragraph (referred to in this section as an `unapproved
product'); or
``(B) is approved, licensed, or cleared under such a
provision, but which use is not under such provision an
approved, licensed, or cleared use of the product (referred to
in this section as an `unapproved use of an approved product').
``(3) Relation to other uses.--An emergency use authorized
under paragraph (1) for a product is in addition to any other use
that is authorized for the product under a provision of law
referred to in such paragraph.
``(4) Definitions.--For purposes of this section:
``(A) The term `biological product' has the meaning given
such term in section 351 of the Public Health Service Act.
``(B) The term `emergency use' has the meaning indicated
for such term in paragraph (1).
``(C) The term `product' means a drug, device, or
biological product.
``(D) The term `unapproved product' has the meaning
indicated for such term in paragraph (2)(A).
``(E) The term `unapproved use of an approved product' has
the meaning indicated for such term in paragraph (2)(B).
``(b) Declaration of Emergency.--
``(1) In general.--The Secretary may declare an emergency
justifying the authorization under this subsection for a product on
the basis of--
``(A) a determination by the Secretary of Homeland Security
that there is a domestic emergency, or a significant potential
for a domestic emergency, involving a heightened risk of attack
with a specified biological, chemical, radiological, or nuclear
agent or agents;
``(B) a determination by the Secretary of Defense that
there is a military emergency, or a significant potential for a
military emergency, involving a heightened risk to United
States military forces of attack with a specified biological,
chemical, radiological, or nuclear agent or agents; or
``(C) a determination by the Secretary of a public health
emergency under section 319 of the Public Health Service Act
that affects, or has a significant potential to affect,
national security, and that involves a specified biological,
chemical, radiological, or nuclear agent or agents, or a
specified disease or condition that may be attributable to such
agent or agents.
``(2) Termination of declaration.--
``(A) In general.--A declaration under this subsection
shall terminate upon the earlier of--
``(i) a determination by the Secretary, in consultation
as appropriate with the Secretary of Homeland Security or
the Secretary of Defense, that the circumstances described
in paragraph (1) have ceased to exist; or
``(ii) the expiration of the one-year period beginning
on the date on which the declaration is made.
``(B) Renewal.--Notwithstanding subparagraph (A), the
Secretary may renew a declaration under this subsection, and
this paragraph shall apply to any such renewal.
``(C) Disposition of product.--If an authorization under
this section with respect to an unapproved product ceases to be
effective as a result of a termination under subparagraph (A)
of this paragraph, the Secretary shall consult with the
manufacturer of such product with respect to the appropriate
disposition of the product.
``(3) Advance notice of termination.--The Secretary shall
provide advance notice that a declaration under this subsection
will be terminated. The period of advance notice shall be a period
reasonably determined to provide--
``(A) in the case of an unapproved product, a sufficient
period for disposition of the product, including the return of
such product (except such quantities of product as are
necessary to provide for continued use consistent with
subsection (f)(2)) to the manufacturer (in the case of a
manufacturer that chooses to have such product returned); and
``(B) in the case of an unapproved use of an approved
product, a sufficient period for the disposition of any
labeling, or any information under subsection (e)(2)(B)(ii), as
the case may be, that was provided with respect to the
emergency use involved.
``(4) Publication.--The Secretary shall promptly publish in the
Federal Register each declaration, determination, advance notice of
termination, and renewal under this subsection.
``(c) Criteria for Issuance of Authorization.--The Secretary may
issue an authorization under this section with respect to the emergency
use of a product only if, after consultation with the Director of the
National Institutes of Health and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the circumstances of the emergency involved), the Secretary
concludes--
``(1) that an agent specified in a declaration under subsection
(b) can cause a serious or life-threatening disease or condition;
``(2) that, based on the totality of scientific evidence
available to the Secretary, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to
believe that--
``(A) the product may be effective in diagnosing, treating,
or preventing--
``(i) such disease or condition; or
``(ii) a serious or life-threatening disease or
condition caused by a product authorized under this
section, approved or cleared under this Act, or licensed
under section 351 of the Public Health Service Act, for
diagnosing, treating, or preventing such a disease or
condition caused by such an agent; and
``(B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product;
``(3) that there is no adequate, approved, and available
alternative to the product for diagnosing, preventing, or treating
such disease or condition; and
``(4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
``(d) Scope of Authorization.--An authorization of a product under
this section shall state--
``(1) each disease or condition that the product may be used to
diagnose, prevent, or treat within the scope of the authorization;
``(2) the Secretary's conclusions, made under subsection
(c)(2)(B), that the known and potential benefits of the product,
when used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product; and
``(3) the Secretary's conclusions, made under subsection (c),
concerning the safety and potential effectiveness of the product in
diagnosing, preventing, or treating such diseases or conditions,
including an assessment of the available scientific evidence.
``(e) Conditions of Authorization.--
``(1) Unapproved product.--
``(A) Required conditions.--With respect to the emergency
use of an unapproved product, the Secretary, to the extent
practicable given the circumstances of the emergency, shall,
for a person who carries out any activity for which the
authorization is issued, establish such conditions on an
authorization under this section as the Secretary finds
necessary or appropriate to protect the public health,
including the following:
``(i) Appropriate conditions designed to ensure that
health care professionals administering the product are
informed--
``(I) that the Secretary has authorized the
emergency use of the product;
``(II) of the significant known and potential
benefits and risks of the emergency use of the product,
and of the extent to which such benefits and risks are
unknown; and
``(III) of the alternatives to the product that are
available, and of their benefits and risks.
``(ii) Appropriate conditions designed to ensure that
individuals to whom the product is administered are
informed--
``(I) that the Secretary has authorized the
emergency use of the product;
``(II) of the significant known and potential
benefits and risks of such use, and of the extent to
which such benefits and risks are unknown; and
``(III) of the option to accept or refuse
administration of the product, of the consequences, if
any, of refusing administration of the product, and of
the alternatives to the product that are available and
of their benefits and risks.
``(iii) Appropriate conditions for the monitoring and
reporting of adverse events associated with the emergency
use of the product.
``(iv) For manufacturers of the product, appropriate
conditions concerning recordkeeping and reporting,
including records access by the Secretary, with respect to
the emergency use of the product.
``(B) Authority for additional conditions.--With respect to
the emergency use of an unapproved product, the Secretary may,
for a person who carries out any activity for which the
authorization is issued, establish such conditions on an
authorization under this section as the Secretary finds
necessary or appropriate to protect the public health,
including the following:
``(i) Appropriate conditions on which entities may
distribute the product with respect to the emergency use of
the product (including limitation to distribution by
government entities), and on how distribution is to be
performed.
``(ii) Appropriate conditions on who may administer the
product with respect to the emergency use of the product,
and on the categories of individuals to whom, and the
circumstances under which, the product may be administered
with respect to such use.
``(iii) Appropriate conditions with respect to the
collection and analysis of information, during the period
when the authorization is in effect, concerning the safety
and effectiveness of the product with respect to the
emergency use of such product.
``(iv) For persons other than manufacturers of the
product, appropriate conditions concerning recordkeeping
and reporting, including records access by the Secretary,
with respect to the emergency use of the product.
``(2) Unapproved use.--With respect to the emergency use of a
product that is an unapproved use of an approved product:
``(A) For a manufacturer of the product who carries out any
activity for which the authorization is issued, the Secretary
shall, to the extent practicable given the circumstances of the
emergency, establish conditions described in clauses (i) and
(ii) of paragraph (1)(A), and may establish conditions
described in clauses (iii) and (iv) of such paragraph.
``(B)(i) If the authorization under this section regarding
the emergency use authorizes a change in the labeling of the
product, but the manufacturer of the product chooses not to
make such change, such authorization may not authorize
distributors of the product or any other person to alter or
obscure the labeling provided by the manufacturer.
``(ii) In the circumstances described in clause (i), for a
person who does not manufacture the product and who chooses to
act under this clause, an authorization under this section
regarding the emergency use shall, to the extent practicable
given the circumstances of the emergency, authorize such person
to provide appropriate information with respect to such product
in addition to the labeling provided by the manufacturer,
subject to compliance with clause (i). While the authorization
under this section is effective, such additional information
shall not be considered labeling for purposes of section 502.
``(C) The Secretary may establish with respect to the
distribution and administration of the product for the
unapproved use conditions no more restrictive than those
established by the Secretary with respect to the distribution
and administration of the product for the approved use.
``(3) Good manufacturing practice.--With respect to the
emergency use of a product for which an authorization under this
section is issued (whether an unapproved product or an unapproved
use of an approved product), the Secretary may waive or limit, to
the extent appropriate given the circumstances of the emergency,
requirements regarding current good manufacturing practice
otherwise applicable to the manufacture, processing, packing, or
holding of products subject to regulation under this Act, including
such requirements established under section 501.
``(4) Advertising.--The Secretary may establish conditions on
advertisements and other promotional descriptive printed matter
that relate to the emergency use of a product for which an
authorization under this section is issued (whether an unapproved
product or an unapproved use of an approved product), including, as
appropriate--
``(A) with respect to drugs and biological products,
requirements applicable to prescription drugs pursuant to
section 502(n); or
``(B) with respect to devices, requirements applicable to
restricted devices pursuant to section 502(r).
``(f) Duration of Authorization.--
``(1) In general.--Except as provided in paragraph (2), an
authorization under this section shall be effective until the
earlier of the termination of the declaration under subsection (b)
or a revocation under subsection (g).
``(2) Continued use after end of effective period.--
Notwithstanding the termination of the declaration under subsection
(b) or a revocation under subsection (g), an authorization shall
continue to be effective to provide for continued use of an
unapproved product with respect to a patient to whom it was
administered during the period described by paragraph (1), to the
extent found necessary by such patient's attending physician.
``(g) Revocation of Authorization.--
``(1) Review.--The Secretary shall periodically review the
circumstances and the appropriateness of an authorization under
this section.
``(2) Revocation.--The Secretary may revoke an authorization
under this section if the criteria under subsection (c) for
issuance of such authorization are no longer met or other
circumstances make such revocation appropriate to protect the
public health or safety.
``(h) Publication; Confidential Information.--
``(1) Publication.--The Secretary shall promptly publish in the
Federal Register a notice of each authorization, and each
termination or revocation of an authorization under this section,
and an explanation of the reasons therefor (which may include a
summary of data or information that has been submitted to the
Secretary in an application under section 505(i) or section 520(g),
even if such summary may indirectly reveal the existence of such
application).
``(2) Confidential information.--Nothing in this section alters
or amends section 1905 of title 18, United States Code, or section
552(b)(4) of title 5 of such Code.
``(i) Actions Committed to Agency Discretion.--Actions under the
authority of this section by the Secretary, by the Secretary of
Defense, or by the Secretary of Homeland Security are committed to
agency discretion.
``(j) Rules of Construction.--The following applies with respect to
this section:
``(1) Nothing in this section impairs the authority of the
President as Commander in Chief of the Armed Forces of the United
States under article II, section 2 of the United States
Constitution.
``(2) Nothing in this section impairs the authority of the
Secretary of Defense with respect to the Department of Defense,
including the armed forces, under other provisions of Federal law.
``(3) Nothing in this section (including any exercise of
authority by a manufacturer under subsection (e)(2)) impairs the
authority of the United States to use or manage quantities of a
product that are owned or controlled by the United States
(including quantities in the stockpile maintained under section
319F-2 of the Public Health Service Act).
``(k) Relation to Other Provisions.--If a product is the subject of
an authorization under this section, the use of such product within the
scope of the authorization shall not be considered to constitute a
clinical investigation for purposes of section 505(i), section 520(g),
or any other provision of this Act or section 351 of the Public Health
Service Act.
``(l) Option to Carry Out Authorized Activities.--Nothing in this
section provides the Secretary any authority to require any person to
carry out any activity that becomes lawful pursuant to an authorization
under this section, and no person is required to inform the Secretary
that the person will not be carrying out such activity, except that a
manufacturer of a sole-source unapproved product authorized for
emergency use shall report to the Secretary within a reasonable period
of time after the issuance by the Secretary of such authorization if
such manufacturer does not intend to carry out any activity under the
authorization. This section only has legal effect on a person who
carries out an activity for which an authorization under this section
is issued. This section does not modify or affect activities carried
out pursuant to other provisions of this Act or section 351 of the
Public Health Service Act. Nothing in this subsection may be construed
as restricting the Secretary from imposing conditions on persons who
carry out any activity pursuant to an authorization under this
section.''.
(b) Repeal of Termination Provision.--Subsection (d) of section
1603 of the National Defense Authorization Act for Fiscal Year 2004 (10
U.S.C. 1107a note) is repealed.

0b0f089a8a5f14cffb07613f3e81b1b6dc60234988e4950ceba0b9be66ac057e

(a) Secretary of Health and Human Services.--
(1) Annual reports on particular exercises of authority.--
(A) Relevant authorities.--The Secretary of Health and
Human Services (referred to in this subsection as the
``Secretary'') shall submit reports in accordance with
subparagraph (B) regarding the exercise of authority under the
following provisions of law:
(i) With respect to section 319F-1 of the Public Health
Service Act (as added by section 2 of this Act):
(I) Subsection (b)(1) (relating to increased
simplified acquisition threshold).
(II) Subsection (b)(2) (relating to procedures
other than full and open competition).
(III) Subsection (c) (relating to expedited peer
review procedures).
(ii) With respect to section 319F-2 of the Public
Health Service Act (as added by section 3 of this Act):
(I) Subsection (c)(7)(C)(iii) (relating to
simplified acquisition procedures).
(II) Subsection (c)(7)(C)(iv) (relating to
procedures other than full and open competition).
(III) Subsection (c)(7)(C)(v) (relating to premium
provision in multiple-award contracts).
(iii) With respect to section 564 of the Federal Food,
Drug, and Cosmetic Act (as added by section 4 of this Act):
(I) Subsection (a)(1) (relating to emergency uses
of certain drugs and devices).
(II) Subsection (b)(1) (relating to a declaration
of an emergency).
(III) Subsection (e) (relating to conditions on
authorization).
(B) Contents of reports.--The Secretary shall annually
submit to the designated congressional committees a report that
summarizes--
(i) the particular actions that were taken under the
authorities specified in subparagraph (A), including, as
applicable, the identification of the threat agent,
emergency, or the biomedical countermeasure with respect to
which the authority was used;
(ii) the reasons underlying the decision to use such
authorities, including, as applicable, the options that
were considered and rejected with respect to the use of
such authorities;
(iii) the number of, nature of, and other information
concerning the persons and entities that received a grant,
cooperative agreement, or contract pursuant to the use of
such authorities, and the persons and entities that were
considered and rejected for such a grant, cooperative
agreement, or contract, except that the report need not
disclose the identity of any such person or entity; and
(iv) whether, with respect to each procurement that is
approved by the President under section 319F-2(c)(6) of the
Public Health Service Act (as added by section 3 of this
Act), a contract was entered into within one year after
such approval by the President.
(2) Annual summaries regarding certain activity.--The Secretary
shall annually submit to the designated congressional committees a
report that summarizes the activity undertaken pursuant to the
following authorities under section 319F-1 of the Public Health
Service Act (as added by section 2 of this Act):
(A) Subsection (b)(3) (relating to increased micropurchase
threshold).
(B) Subsection (d) (relating to authority for personal
services contracts).
(C) Subsection (e) (relating to streamlined personnel
authority).
With respect to subparagraph (B), the report shall include a
provision specifying, for the one-year period for which the report
is submitted, the number of persons who were paid amounts greater
than $100,000 and the number of persons who were paid amounts
between $50,000 and $100,000.
(3) Report on additional barriers to procurement of security
countermeasures.--Not later than one year after the date of the
enactment of this Act, the Secretary, in consultation with the
Secretary of Homeland Security, shall report to the designated
congressional committees any potential barriers to the procurement
of security countermeasures that have not been addressed by this
Act.
(b) General Accounting Office Review.--
(1) In general.--Four years after the date of the enactment of
this Act, the Comptroller General of the United States shall
initiate a study--
(A)(i) to review the Secretary of Health and Human
Services' utilization of the authorities granted under this Act
with respect to simplified acquisition procedures, procedures
other than full and open competition, increased micropurchase
thresholds, personal services contracts, streamlined personnel
authority, and the purchase of security countermeasures under
the special reserve fund; and
(ii) to make recommendations to improve the utilization or
effectiveness of such authorities in the future;
(B)(i) to review and assess the adequacy of the internal
controls instituted by such Secretary with respect to such
authorities, where required by this Act; and
(ii) to make recommendations to improve the effectiveness
of such controls;
(C)(i) to review such Secretary's utilization of the
authority granted under this Act to authorize an emergency use
of a biomedical countermeasure, including the means by which
the Secretary determines whether and under what conditions any
such authorizations should be granted and the benefits and
adverse impacts, if any, resulting from the use of such
authority; and
(ii) to make recommendations to improve the utilization or
effectiveness of such authority and to enhance protection of
the public health;
(D) to identify any purchases or procurements that would
not have been made or would have been significantly delayed
except for the authorities described in subparagraph (A)(i);
and
(E)(i) to determine whether and to what extent activities
undertaken pursuant to the biomedical countermeasure research
and development authorities established in this Act have
enhanced the development of biomedical countermeasures
affecting national security; and
(ii) to make recommendations to improve the ability of the
Secretary to carry out these activities in the future.
(2) Additional provisions regarding determination on
development of biomedical countermeasures affecting national
security.--In the report under paragraph (1), the determination
under subparagraph (E) of such paragraph shall include--
(A) the Comptroller General's assessment of the current
availability of countermeasures to address threats identified
by the Secretary of Homeland Security;
(B) the Comptroller General's assessment of the extent to
which programs and activities under this Act will reduce any
gap between the threat and the availability of countermeasures
to an acceptable level of risk; and
(C)(i) the Comptroller General's assessment of threats to
national security that are posed by technology that will
enable, during the 10-year period beginning on the date of the
enactment of this Act, the development of antibiotic resistant,
mutated, or bioengineered strains of biological agents; and
(ii) recommendations on short-term and long-term
governmental strategies for addressing such threats, including
recommendations for Federal policies regarding research
priorities, the development of countermeasures, and investments
in technology.
(3) Report.--A report providing the results of the study under
paragraph (1) shall be submitted to the designated congressional
committees not later than five years after the date of the
enactment of this Act.
(c) Report Regarding Biocontainment Facilities.--Not later than 120
days after the date of the enactment of this Act, the Secretary of
Homeland Security and the Secretary of Health and Human Services shall
jointly report to the designated congressional committees whether there
is a lack of adequate large-scale biocontainment facilities necessary
for the testing of security countermeasures in accordance with Food and
Drug Administration requirements.
(d) Designated Congressional Committees.--For purposes of this
section, the term ``designated congressional committees'' means the
following committees of the Congress:
(1) In the House of Representatives: the Committee on Energy
and Commerce, the Committee on Appropriations, the Committee on
Government Reform, and the Select Committee on Homeland Security
(or any successor to the Select Committee).
(2) In the Senate: the appropriate committees.

ff7461e7a5010be3802c1aafa711d86c4dddab5f070b8ffe510681b574a4dc7d

The Secretary of Health and Human Services shall develop outreach
measures to ensure to the extent practicable that diverse institutions,
including Historically Black Colleges and Universities and those
serving large proportions of Black or African Americans, American
Indians, Appalachian Americans, Alaska Natives, Asians, Native
Hawaiians, other Pacific Islanders, Hispanics or Latinos, or other
underrepresented populations, are meaningfully aware of available
research and development grants, contracts, cooperative agreements, and
procurements conducted under sections 2 and 3 of this Act.

da223c7f3c697c7d3c7ec8f379af83480f5f0f66b95f124ebfe29bbd3600b426

COUNTERMEASURES.
Upon the award of any grant, contract, or cooperative agreement
under section 2 or 3 of this Act for the research, development, or
procurement of a qualified countermeasure or a security countermeasure
(as those terms are defined in this Act), the Secretary of Health and
Human Services shall, in consultation with the heads of other
appropriate Federal agencies, determine whether the countermeasure
involved in such grant, contract, or cooperative agreement is subject
to existing export-related controls and, if not, may make a
recommendation to the appropriate Federal agency or agencies that such
countermeasure should be included on the list of controlled items
subject to such controls.

ade9b16307297f69ae533f512e11a87d429bf4318cb05d3011ebda8ca1c2a91a

UNNECESSARY DUPLICATION IN PROGRAMS DESIGNED TO PROTECT THE HOMELAND
FROM BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND NUCLEAR AGENTS.
(a) Ensuring Coordination of Programs.--The Secretary of Health and
Human Services, the Secretary of Homeland Security, and the Secretary
of Defense shall ensure that the activities of their respective
Departments coordinate, complement, and do not unnecessarily duplicate
programs to identify potential domestic threats from biological,
chemical, radiological or nuclear agents, detect domestic incidents
involving such agents, analyze such incidents, and develop necessary
countermeasures. The aforementioned Secretaries shall further ensure
that information and technology possessed by the Departments relevant
to these activities are shared with the other Departments.
(b) Designation of Agency Coordination Officer.--The Secretary of
Health and Human Services, the Secretary of Homeland Security, and the
Secretary of Defense shall each designate an officer or employee of
their respective Departments who shall coordinate, through regular
meetings and communications, with the other aforementioned Departments
such programs and activities carried out by their Departments.

792eb32c919b80fdde80f8f899b9e4281cc4996b53de23e96c93b2b7cd861a73

NATIONAL EMERGENCIES.
Section 1135(b) of the Social Security Act (42 U.S.C. 1320b-5(b))
is amended--
(1) by striking paragraph (3) and inserting the following:
``(3) actions under section 1867 (relating to examination and
treatment for emergency medical conditions and women in labor)
for--
``(A) a transfer of an individual who has not been
stabilized in violation of subsection (c) of such section if
the transfer is necessitated by the circumstances of the
declared emergency in the emergency area during the emergency
period; or
``(B) the direction or relocation of an individual to
receive medical screening in an alternate location pursuant to
an appropriate State emergency preparedness plan;'';
(2) in paragraph (5), by striking ``and'' at the end;
(3) in paragraph (6), by striking the period and inserting ``;
and'';
(4) by inserting after paragraph (6), the following:
``(7) sanctions and penalties that arise from noncompliance
with the following requirements (as promulgated under the authority
of section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note)--
``(A) section 164.510 of title 45, Code of Federal
Regulations, relating to--
``(i) requirements to obtain a patient's agreement to
speak with family members or friends; and
``(ii) the requirement to honor a request to opt out of
the facility directory;
``(B) section 164.520 of such title, relating to the
requirement to distribute a notice; or
``(C) section 164.522 of such title, relating to--
``(i) the patient's right to request privacy
restrictions; and
``(ii) the patient's right to request confidential
communications.''; and
(5) by adding at the end the following: ``A waiver or
modification provided for under paragraph (3) or (7) shall only be
in effect if such actions are taken in a manner that does not
discriminate among individuals on the basis of their source of
payment or of their ability to pay, and shall be limited to a 72-
hour period beginning upon implementation of a hospital disaster
protocol. A waiver or modification under such paragraph (7) shall
be withdrawn after such period and the provider shall comply with
the requirements under such paragraph for any patient still under
the care of the provider.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

3fa7bce377202b9dee885323cee5053d66e11ad0ea79465d212cce42ee58f238

Vaccine Compensation bill — S. 15

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