‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) The term ‘qualified infectious disease 
product’ means a drug that is determined to be a 
qualified infectious disease product under section 
505E. 
‘‘(2) The term ‘qualifying pathogen’ has the 
meaning given to such term in section 505E.’’. 
SEC. 5. PRIORITY REVIEW. 
(a) AMENDMENT.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 524 (21 U.S.C. 360n) the following: 
‘‘SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS 
DISEASE PRODUCTS. 
‘‘(a) IN GENERAL.—If the Secretary makes a deter-
mination under section 505E(c) that a drug is a qualified 
infectious disease product, then the Secretary shall give 
priority review to any application submitted for approval 
for such drug under section 505(b). 
‘‘(b) DEFINITION.—In this section, the term ‘priority 
review’, with respect to an application described in sub-
section (a), means review and action by the Secretary on 
such application not later than 6 months after receipt by 
the Secretary of such application.’’. 
(b) APPLICATION.—Section 524A of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
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(a), applies only with respect to an application that is sub-
mitted under section 505(b) (21 U.S.C. 355(b)) on or 
after the date of the enactment of this Act. 
SEC. 6. FAST TRACK PRODUCT. 
Paragraph (1) of section 506(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(a)) is amended 
by inserting after ‘‘if it is intended for the treatment of 
a serious or life-threatening condition and it demonstrates 
the potential to address unmet medical needs for such a 
condition’’ the following: ‘‘or if the Secretary determines 
under section 505E that the drug is a qualified infectious 
disease product’’. 
SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFEC-
TIOUS DISEASE BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall— 
(1) conduct a study on the need for incentives 
to encourage the research, development, and mar-
keting of qualified infectious disease biological prod-
ucts; and 
(2) not later than 1 year after the date of the 
enactment of this Act, submit a report to the Con-
gress on the results of such study, including any rec-
ommendations of the Comptroller General on appro-
priate incentives for addressing such need. 
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(b) 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 ‘‘qualified infectious disease bio-
logical product’’ means a biological product for 
treating, detecting, preventing, or identifying a 
qualifying pathogen. 
(3) The term ‘‘qualifying pathogen’’ has the 
meaning given to such term in section 505E of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 3 of this Act. 
SEC. 8. 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 
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V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.). 
(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. 
(3) 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 it may be approved for such use 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355). 
(2) RECOMMENDATIONS.—If the Secretary has 
reason to believe that a drug for which a request is 
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made under this subsection is a qualified infections 
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 approval under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) of such drug for the use described in 
paragraph (1). 
(c) DEFINITIONS.—In this section: 
(1) 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). 
(2) The term ‘‘qualifying pathogen’’ has the 
meaning given to such term in section 505E of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 3 of this Act. 
(3) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
Æ 
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