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‘‘(2) UNAPPROVED USE.—With respect to the 
emergency use of a product that is an unapproved 
use of an approved product: 
‘‘(A) The Secretary may, for manufactur-
ers of the product who choose to carry out one 
or more activities for which the authorization is 
issued, establish any of the conditions described 
in clauses (i) through (iv) of paragraph (1)(A). 
‘‘(B)(i) If the authorization under this sec-
tion 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), an authorization under this section 
regarding the emergency use may, for persons 
who do not manufacture the product and who 
choose to act under this clause, authorize such 
persons to provide information on the product 
in addition to the labeling provided by the man-
ufacturer, subject to compliance with clause (i).
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Such additional information shall not be consid-
ered labeling for purposes of section 502. 
‘‘(f) DURATION OF AUTHORIZATION.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (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 EFFEC-
TIVE PERIOD.—Notwithstanding the termination of 
the declaration under subsection (b) or a revocation 
under subsection (g), an authorization shall continue 
to be effective for continued use with respect to pa-
tients to whom it was administered during the pe-
riod described by paragraph (1), to the extent found 
necessary by such patients’ attending physicians. 
‘‘(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, in the Sec-
retary’s unreviewable discretion, the criteria under 
subsection (c) for issuance of such authorization are 
no longer met.
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‘‘(h) PUBLICATION.—The Secretary shall promptly 
publish in the Federal Register a notice of each authoriza-
tion, and each termination or revocation of an authoriza-
tion, and an explanation of the reasons therefor, under 
this section. 
‘‘(i) ACTIONS COMMITTED
TO AGENCY DISCRE-
TION.—Actions under the authority of this section by the 
Secretary, by the Secretary of Defense, or by the Sec-
retary of Homeland Security are committed to agency dis-
cretion. 
‘‘(j) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to impair or otherwise affect—
‘‘(1) the authority of the President as Com-
mander in Chief of the Armed Forces of the United 
States under article II, section 2 of the United 
States Constitution; 
‘‘(2) the authority of the Secretary of Defense 
with respect to the Department of Defense, includ-
ing the armed forces, under other provisions of Fed-
eral law; or 
‘‘(3) the authority of the Secretary under sec-
tion 319F–2 to manage the stockpile under such 
section. 
‘‘(k) 
APPLICATION
TO
MEMBERS
OF
ARMED 
FORCES.—
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‘‘(1) WAIVER OF REQUIREMENT RELATING TO 
OPTION TO REFUSE.—In the case of administration 
of a countermeasure to members of the armed 
forces, 
a 
requirement, 
under 
subsection 
(e)(1)(A)(ii)(III), designed to ensure that individuals 
are informed of an option to accept or refuse admin-
istration of a product, may be waived by the Presi-
dent if the President determines, in writing, that 
complying with such requirement is not feasible, is 
contrary to the best interests of the members af-
fected, or is not in the interests of national security. 
‘‘(2) PROVISION OF INFORMATION TO MEMBER 
OF THE ARMED FORCES.—If the Secretary makes a 
determination that it is not feasible for the informa-
tion required by subsection (e)(1)(A)(ii) to be pro-
vided to a member of the armed forces prior to the 
administration of the product, such information shall 
be provided to such member of the armed forces (or 
next-of-kin in the case of the death of a member) to 
whom the product was administered as soon as pos-
sible, but not later than 30 days, after such adminis-
tration. Information concerning the administration 
of the product shall be recorded in the medical 
record of the member.
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‘‘(3) EFFECT ON STATUTE PERTAINING TO IN-
VESTIGATIONAL NEW DRUGS.—In the case of an au-
thorization based on a determination by the Sec-
retary of Defense under subsection (b)(1)(B), sec-
tion 1107 of title 10, United States Code, shall not 
apply to use of a product that is the subject of such 
authorization, within the scope of such authorization 
and while such authorization is effective. 
‘‘(l) RELATION TO OTHER PROVISIONS.—If a prod-
uct is the subject of an authorization under this section, 
the use of such product within the scope of the authoriza-
tion —
‘‘(1) shall not be subject to any requirements 
pursuant to section 505(i) or 520(g); and 
‘‘(2) shall not be subject to any requirements 
otherwise applicable to clinical investigations pursu-
ant to other provisions of this Act. 
‘‘(m) DISCRETION REGARDING USE OF AUTHORIZA-
TION.—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 Sec-
retary that the person will not be carrying out such activ-
ity, except that a manufacturer of a sole-source unap-
proved product authorized for emergency use shall notify
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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 an activity or 
activities under the authorization. This section does not 
have any legal effect on a person who does not carry out 
any activity for which an authorization under this section 
is issued, or who carries out such an activity pursuant to 
other provisions of this Act or section 351 of the Public 
Health Service Act. 
‘‘(n) ENFORCEMENT.—A person who carries out an 
activity pursuant to an authorization under this section, 
but who fails to comply with applicable conditions under 
subsection (e), is with respect to that act of noncompliance 
subject to the provisions of law specified in subsection (a) 
and to the enforcement of such provisions under section 
301.’’. 
SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS 
ACT. 
(a) SECRETARY
OF HEALTH
AND HUMAN SERV-
ICES.—
(1) ANNUAL REPORTS ON PARTICULAR EXER-
CISES OF AUTHORITY.—
(A) RELEVANT
AUTHORITIES.—The Sec-
retary of Health and Human Services (referred 
to in this subsection as the ‘‘Secretary’’) shall
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submit reports in accordance with subpara-
graph (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) (re-
lating to simplified acquisition proce-
dures). 
(II) Subsection (c)(7)(C)(iv) (re-
lating to procedures other than full 
and open competition).
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(III) Subsection (c)(7)(C)(v) (re-
lating to premium provision in mul-
tiple-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 Sec-
retary shall annually submit to the designated 
congressional committees a report that summa-
rizes—
(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 counter-
measure with respect to which the author-
ity was used;
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(ii) the reasons underlying the deci-
sion to use such authorities, including, as 
applicable, the options that were consid-
ered and rejected with respect to the use of 
such authorities; 
(iii) the identification of each person 
or entity that received, or was considered 
and rejected for, grants, cooperative agree-
ments, or contracts pursuant to the use of 
such authorities; and 
(iv) whether, with respect to each pro-
curement 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):
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(A) Subsection (b)(3) (relating to in-
creased 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 pe-
riod 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. 
(b) NATIONAL ACADEMY OF SCIENCES REVIEW.—
(1) IN GENERAL.—Not later than four years 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall request 
the National Academy of Sciences to enter into an 
agreement for a review of the biomedical counter-
measure research and development authorities estab-
lished in this Act to determine whether and to what 
extent activities undertaken pursuant to such au-
thorities have enhanced the development of bio-
medical countermeasures affecting national security, 
and to recommend any legislative or administrative 
changes necessary to improve the ability of the Sec-
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retary to carry out these activities in the future. The 
Secretary shall ensure that the results of the study 
are submitted to the designated congressional com-
mittees not later than five years after such date of 
enactment. 
(2) CERTAIN
CONTENTS.—The report under 
paragraph (1) shall include—
(A) a summary of the most recent analysis 
by the Department of Homeland Security and 
the intelligence community of the domestic 
threat from chemical, biological, radiological, 
and nuclear agents; 
(B) the Academy’s assessment of the cur-
rent availability of countermeasures to address 
such threats; 
(C) the Academy’s assessment of the ex-
tent to which programs and activities under this 
Act will reduce any gap between the threat and 
the availability of countermeasures to an ac-
ceptable level of risk; and 
(D)(i) the Academy’s assessment of threats 
to national security that are posed by tech-
nology that will enable, during the 10-year pe-
riod beginning on the date of the enactment of 
this Act, the development of antibiotic resistant,
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mutated, or bioengineered strains of biological 
agents; and 
(ii) recommendations on short-term and 
long-term governmental strategies for address-
ing such threats, including recommendations for 
Federal policies regarding research priorities, 
the development of countermeasures, and in-
vestments in technology. 
(c) GENERAL ACCOUNTING OFFICE REVIEW.—Four 
years after the date of the enactment of this Act, the 
Comptroller General of the United States shall initiate a 
study—
(1)(A) to review the Secretary of Health and 
Human Services’ utilization of the authorities grant-
ed under this Act with respect to simplified acquisi-
tion procedures, procedures other than full and open 
competition, increased micropurchase thresholds, 
personal services contracts, streamlined personnel 
authority, and the purchase of security counter-
measures under the special reserve fund; and 
(B) to recommend any legislative or administra-
tive changes necessary to improve the utilization or 
effectiveness of such authorities in the future;
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(2)(A) to review the internal controls instituted 
by such Secretary with respect to such authorities, 
where required by this Act; and 
(B) to recommend any legislative or administra-
tive changes necessary to improve the effectiveness 
of such controls; and 
(3)(A) to review such Secretary’s utilization of 
the authority granted under this Act to authorize an 
emergency use of a biomedical countermeasure, in-
cluding the means by which the Secretary deter-
mines 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 
(B) to recommend any legislative or administra-
tive changes necessary to improve the utilization or 
effectiveness of such authority and to enhance pro-
tection of the public health. 
The results of the study shall be submitted to the des-
ignated congressional committees not later than five years 
after the date of the enactment of this Act. 
(d) REPORT REGARDING BARRIERS TO PROCURE-
MENT OF SECURITY COUNTERMEASURES.—
(1) BIOCONTAINMENT
FACILITIES.—Not later 
than 120 days after the date of the enactment of
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this Act, the Secretary of Homeland Security and 
the Secretary of Health and Human Services shall 
jointly report to the designated congressional com-
mittees whether there is a lack of adequate large-
scale biocontainment facilities necessary for the test-
ing of security countermeasures in accordance with 
Food and Drug Administration requirements. 
(2) ADDITIONAL
BARRIERS.—Not later than 
one year after the date of enactment of this Act, 
such Secretaries shall jointly report to the des-
ignated congressional committees any other potential 
barriers to the procurement of security counter-
measures that have not been addressed by this Act. 
(e) STATUS
OF PROGRAM
FOR CHEMICAL TER-
RORISM PREPAREDNESS.—Not later than 270 days after 
the date of the enactment of this Act, the Secretary of 
Homeland Security shall submit to the designated con-
gressional committees a report describing the status of the 
program carried out by the Secretary to enhance the pre-
paredness of the United States to respond to terrorist at-
tacks involving chemical agents. 
(f) DESIGNATED CONGRESSIONAL COMMITTEES.—
For purposes of this section, the term ‘‘designated con-
gressional committees’’ means the following committees of 
the Congress:
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(1) In the House of Representatives: the Com-
mittee on Energy and Commerce, the Committee on 
Appropriations, the Committee on Government Re-
form, and the Select Committee on Homeland Secu-
rity (or any successor to the Select Committee). 
(2) In the Senate: the Committee on Health, 
Education, Labor, and Pensions, the Committee on 
Appropriations, and the Committee on Government 
Affairs. 
SEC. 6. OUTREACH. 
The Secretary of Health and Human Services shall 
develop outreach measures to ensure to the extent prac-
ticable that diverse institutions, including Historically 
Black Colleges and Universities and those serving large 
proportions of Hispanics, Native Americans, Asian-Pacific 
Americans, or other underrepresented populations, are 
meaningfully aware of available research and development 
grants, contracts, cooperative agreements, and procure-
ments conducted under sections 2 and 3 of this Act. 
SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON 
CERTAIN BIOMEDICAL COUNTERMEASURES. 
Upon the award of any grant, contract, or cooperative 
agreement under section 2 or 3 of this Act for the re-
search, development, or procurement of a qualified coun-
termeasure or a security countermeasure (as those terms
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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 coop-
erative agreement is subject to existing export-related con-
trols and, if not, may make a recommendation to the ap-
propriate Federal agency or agencies that such counter-
measure should be included on the list of controlled items 
subject to such controls. 
SEC. 8. ENSURING COORDINATION, COOPERATION AND 
THE ELIMINATION OF UNNECESSARY DUPLI-
CATION IN PROGRAMS DESIGNED TO PRO-
TECT 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 dupli-
cate programs to identify potential domestic threats from 
biological, chemical, radiological or nuclear agents, detect 
domestic incidents involving such agents, analyze such in-
cidents, and develop necessary countermeasures. The 
aforementioned Secretaries shall further ensure that infor-
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mation and technology possessed by the Departments rel-
evant to these activities are shared with the other Depart-
ments. 
(b) DESIGNATION OF AGENCY COORDINATION OFFI-
CER.—The Secretary of Health and Human Services, the 
Secretary of Homeland Security, and the Secretary of De-
fense shall each designate an officer or employee of their 
respective Departments who shall coordinate, through reg-
ular meetings and communications, with the other afore-
mentioned Departments such programs and activities car-
ried out by their Departments.
Passed the House of Representatives July 16, 2003. 
Attest: 
JEFF TRANDAHL, 
Clerk.
Calendar No. 214
108TH CONGRESS 
1ST SESSION 
H. R. 2122
AN ACT 
To enhance research, development, procurement, 
and use of biomedical countermeasures to re-
spond to public health threats affecting national 
security, and for other purposes. 
JULY 17, 2003
Received; read twice and placed on the calendar