condition’’ the following: ‘‘or if the Secretary determines 
under section 505E that the drug is a qualified infectious 
disease product’’. 
SEC. 6. CLINICAL TRIALS. 
(a) REVIEW AND REVISION OF GUIDELINES.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, and not later 
than 4 years thereafter, the Secretary shall— 
(A) review the guidelines of the Food and 
Drug Administration for the conduct of clinical 
trials with respect to antibiotic drugs; and 
(B) as appropriate, revise such guidelines 
to reflect developments in scientific and medical 
information and technology and to ensure clar-
ity regarding the procedures and requirements 
for approval of an antibiotic drug under chapter 
V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.) or section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(2) ISSUES FOR REVIEW.—At a minimum, the 
review under paragraph (1) shall address the appro-
priate animal models of infection, in vitro tech-
niques, valid micro-biological surrogate markers, the 
use of non-inferiority versus superiority trials, and 
appropriate delta values for non-inferiority trials. 
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(3) REPORTS TO CONGRESS.—Not later than 1 
year after the date of the enactment of this Act, and 
annually thereafter for the next 4 years, the Sec-
retary shall submit a report to the Congress on the 
progress of the review under paragraph (1). 
(4) RULE OF CONSTRUCTION.—Except to the 
extent to which the Secretary of Health and Human 
Services makes revisions under paragraph (1)(B), 
nothing in this section shall be construed to repeal 
or otherwise affect the guidelines of the Food and 
Drug Administration. 
(b) RECOMMENDATIONS FOR INVESTIGATIONS.— 
(1) REQUEST.—The sponsor of a drug intended 
to be used to treat, detect, prevent, or identify a 
qualifying pathogen may request that the Secretary 
provide written recommendations for nonclinical and 
clinical investigations which may be conducted with 
the drug before— 
(A) it may be approved for such use under 
section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355); or 
(B) if the drug is a biological product, it 
may be licensed for such use under section 351 
of the Public Health Service Act. 
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(2) RECOMMENDATIONS.—If the Secretary has 
reason to believe that a drug for which a request is 
made under this subsection is a qualified infectious 
disease product, the Secretary shall provide the per-
son making the request written recommendations for 
the nonclinical and clinical investigations which the 
Secretary believes, on the basis of information avail-
able to the Secretary at the time of the request, 
would be necessary for— 
(A) approval under section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355) of such drug for the use described in para-
graph (1); or 
(B) licensing under section 351 of the 
Public Health Service Act (42 U.S.C. 262) of 
such drug for such use. 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘biological product’’ has the 
meaning given to such term in section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(2) The term ‘‘drug’’ has the meaning given to 
such term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(3) The term ‘‘qualifying pathogen’’ has the 
meaning given such term in section 505E of the 
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Federal Food, Drug, and Cosmetic Act, as added by 
section 3. 
(4) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
Æ 
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