identified in letters of the Secretary (relating to the 
use of fees collected under section 736 to expedite 
the drug development process and the review of 
human drug applications) shall not apply to an ap-
plication submitted under paragraph (1) until the 
date on which the application is complete. 
‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 
‘‘(1) develop and disseminate to physicians, pa-
tient 
organizations, 
pharmaceutical 
and 
bio-
technology companies, and other appropriate persons 
a description of the provisions of this section appli-
cable to accelerated approval and fast track prod-
ucts; and 
‘‘(2) establish a program to encourage the de-
velopment of surrogate and clinical endpoints, in-
cluding biomarkers, and other scientific methods and 
tools that can assist the Secretary in determining 
whether the evidence submitted in an application is 
reasonably likely to predict clinical benefit for seri-
ous or life-threatening conditions for which there 
exist significant unmet medical needs.’’. 
SEC. 4. GUIDANCE; AMENDED REGULATIONS. 
(a) INITIAL GUIDANCE.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services (hereinafter ‘‘the Secretary’’) 
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shall issue draft guidance to implement the amendments 
made by section 3. 
(b) FINAL GUIDANCE.—Not later than one year after 
the issuance of draft guidance under subsection (a), after 
an opportunity for public comment, the Secretary shall 
issue— 
(1) final guidance to implement the amend-
ments made by section 3; and 
(2) amend the regulations governing accelerated 
approval in parts 314 and 601 of title 21, Code of 
Federal Regulations, as necessary to conform such 
regulations with the amendments made by section 3. 
(c) CONSIDERATIONS.—In developing the guidance 
under subsections (a) and (b)(1) and the amendments 
under subsection (b)(2), the Secretary shall consider— 
(1) issues arising under the accelerated ap-
proval and fast track processes under section 506 of 
the Federal Food, Drug, and Cosmetic Act (as 
amended by section 3) for drugs designated for a 
rare disease or condition under section 526 of the 
Federal, Food, Drug, and Cosmetic Act; and 
(2) how to incorporate novel approaches to the 
review of surrogate endpoints based on patho-
physiologic and pharmacologic evidence in such guid-
ance, especially in instances where the low preva-
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lence of a disease renders the existence or collection 
of other types of data unlikely or impractical. 
(d) NO DELAY
IN REVIEW
OR APPROVAL.—The 
issuance (or non-issuance) of guidance or conforming reg-
ulations implementing the amendments made by section 
3 shall not preclude the review of, or action on, a request 
for designation or an application for approval submitted 
pursuant to section 506 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 3. 
SEC. 5. INDEPENDENT REVIEW. 
(a) IN GENERAL.—The Secretary shall, in conjunc-
tion with other planned reviews of the new drug review 
process, contract with an independent entity with expertise 
in assessing the quality and efficiency of biopharma-
ceutical development and regulatory review programs, to 
evaluate the Food and Drug Administration’s application 
of the processes described in section 506 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 3, 
and the impact of such processes on the development and 
timely availability of innovative treatments for patients 
suffering from serious or life-threatening conditions. 
(b) CONSULTATION.—Any evaluation under sub-
section (a) shall include consultation with regulated indus-
tries, patient advocacy and disease research foundations, 
and relevant academic medical centers. 
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SEC. 6. RULE OF CONSTRUCTION. 
The amendments made to section 506(b) of the Fed-
eral Food, Drug and Cosmetic Act by this Act shall be 
construed in a manner that encourages the Secretary to 
utilize innovative approaches for the assessment of prod-
ucts under accelerated approval while maintaining appro-
priate safety and effectiveness standards for such prod-
ucts. 
Æ 
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