ing to classification of positions and General Sched-
ule pay rates, except that the rate of pay for the Di-
rector and staff of the Commission may not exceed 
the daily equivalent of the annual rate in effect for 
grade GS–15 of the General Schedule. 
‘‘(4) EXPERTS AND CONSULTANTS.—The Com-
mission may procure temporary and intermittent 
services under section 3109(b) of title 5, United 
States Code. 
‘‘(5) STAFF OF FEDERAL AGENCIES.—Upon the 
request of the Commission, the head of any Federal 
agency may detail, without reimbursement, any of 
the personnel of such agency to the Commission to 
assist in carrying out the duties of the Commission. 
Any such detail shall not interrupt or otherwise af-
fect the civil service status or privileges of the Fed-
eral employee. 
‘‘(f) POWERS OF COMMISSION.— 
‘‘(1) HEARINGS AND SESSIONS.—The Commis-
sion may, for the purpose of carrying out this Act, 
hold hearings, sit and act at times and places, take 
testimony, and receive evidence as the Commission 
considers appropriate. 
‘‘(2) POWERS OF MEMBERS AND AGENTS.—Any 
member or agent of the Commission may, if author-
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ized by the Commission, take any action which the 
Commission is authorized to take by this section. 
‘‘(3) MAILS.—The Commission may use the 
United States mails in the same manner and under 
the same conditions as other departments and agen-
cies of the United States. 
‘‘(4) ADMINISTRATIVE
SUPPORT
SERVICES.— 
Upon the request of the Commission, the Adminis-
trator of General Services shall provide to the Com-
mission, on a reimbursable basis, the administrative 
support services necessary for the Commission to 
carry out its responsibilities under this section. 
‘‘(g) ANNUAL REPORTS.— 
‘‘(1) IN GENERAL.—Not later than the end of 
calendar year 2007 and annually thereafter, the 
Commission shall prepare and submit to the Presi-
dent, the appropriate committees of the Congress, 
and the Secretary of Health and Human Services a 
report that contains a detailed statement of the rec-
ommendations, findings, and conclusions of the 
Commission, including— 
‘‘(A) an updated list of the infectious 
pathogens identified by the Commission pursu-
ant to subsection (b)(1)(A); and 
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‘‘(B) an updated assessment of challenges 
faced by small biotechnology companies in se-
curing financing for infectious disease research 
and development. 
‘‘(2) FIRST REPORT.—In addition to the con-
tents required by paragraph (1), the first report 
under this subsection shall include an examination 
of— 
‘‘(A) the impact of medical liability insur-
ance payment obligations on the financing of 
infectious disease research and development; 
and 
‘‘(B) the potential benefits of medical li-
ability relief to infectious disease research and 
development. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) The term ‘Commission’ means the Com-
mission on Infectious Diseases Product Development 
established under this section. 
‘‘(2) The term ‘qualified infectious disease 
product’ has the meaning given to that term in sec-
tion 3 of the Beating Infections through Research 
and Development Act of 2007. 
‘‘(i) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
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priated $3,000,000 for fiscal year 2008 and such sums 
as may be necessary for each subsequent fiscal year.’’. 
SEC. 10. CLINICAL TRIAL GUIDELINES FOR ANTIBIOTIC 
DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 510 the following: 
‘‘SEC. 511. CLINICAL TRIAL GUIDELINES FOR ANTIBIOTIC 
DRUGS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of the Beating Infections through Re-
search and Development
Act of 2007, the Secretary, act-
ing through the Commissioner of Food and Drugs, shall 
issue guidelines for the conduct of clinical trials with re-
spect to antibiotic drugs, including antimicrobials to treat 
resistant pathogens, bacterial meningitis, acute bacterial 
sinusitis, acute bacterial otitis media, and acute exacer-
bation of chronic bronchitis. Such guidelines shall indicate 
the appropriate animal models of infection, in vitro tech-
niques, and valid microbiologic surrogate markers. 
‘‘(b) REVIEW.—Not later than 5 years after the date 
of enactment of the Beating Infections through Research 
and Development
Act of 2007, the Secretary, acting 
through the Commissioner of Food and Drugs, shall re-
view and update the guidelines described under subsection 
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(a) to reflect developments in scientific and medical infor-
mation and technology.’’. 
Æ 
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