80 FR 72068 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Tropical Disease Priority Review Vouchers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 222 (November 18, 2015)

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Notices]
[Pages 72068-72069]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29406]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0530]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Tropical Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by 
December 18, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Guidance for Industry on Tropical Disease Priority Review 
Vouchers.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Tropical Disease Priority Review Vouchers--OMB 
Control Number 0910-NEW

    Section 1102 of the Food and Drug Administration Amendments Act 
(FDAAA) adds new section 524 to the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360n). Section 524 is designed to 
encourage development of new drug or biological products for prevention 
and treatment of certain tropical diseases affecting millions of people 
throughout the world and makes provisions for awarding priority review 
vouchers for future applications to sponsors of tropical disease 
products. By enacting section 524, Congress intended to stimulate new 
drug development for drugs to treat certain tropical diseases for which 
there are no or few available treatments by offering additional 
incentives for obtaining FDA approval for pharmaceutical treatments for 
these diseases. Under section 524, a sponsor of a human drug 
application for a

[[Page 72069]]

qualified tropical disease may be eligible for a voucher that can be 
used to obtain a priority review for any application submitted under 
section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 
of the Public Health Service Act (the PHS Act). The guidance explains 
to internal and external stakeholders how FDA intends to implement the 
provisions of section 524, and provides information on using the 
priority review vouchers and on transferring priority review vouchers 
to other sponsors.
    Under the guidance, sponsors of certain tropical disease drug 
product applications submitted under section 505(b)(1) of the FD&C Act 
and section 351 of the PHS Act may request a priority review voucher. 
Based on inquiries and discussions with industry about section 524, we 
estimate that we will receive annually approximately five requests from 
five sponsors, and that each request will take approximately 8 hours to 
prepare and submit to FDA.
    The guidance also states that sponsors should notify FDA of their 
intent to use a priority review voucher, including the date on which 
the sponsor intends to submit the application, at least 90 days before 
use. We estimate that we will receive annually approximately five 
notifications of intent to use a voucher from five sponsors, and that 
each notification will take approximately 8 hours to prepare and submit 
to FDA.
    The guidance also permits the transfer of a priority review voucher 
from one sponsor to another, and states that each transfer should be 
documented with a letter of transfer. We estimate that we will receive 
approximately two letters indicating the transfer of a voucher from two 
application holders, and two letters from two new voucher owners 
acknowledging the transfer, and that it will take approximately 8 hours 
to prepare and submit each letter to FDA.
    In the Federal Register of October 20, 2008 (73 FR 62298), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The comments we received did not pertain to 
the information collection that would result from the guidance (that 
is, the four types of submissions estimated in table 1).
    FDA estimates the burden of this collection of information as 
follows:
    Description of Respondents: Sponsors submitting applications under 
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.

                                 Table 1--Estimated Annual Reporting Burden \1\
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    Guidance for Industry on                         Number of
Tropical Disease Priority Review     Number of     responses per   Total annual   Average burden    Total hours
            Vouchers                respondents     respondent       responses     per response
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Priority Review Voucher Request.               5               1               5               8              40
Notifications of Intent To Use a               5               1               5               8              40
 Voucher........................
Letters Indicating the Transfer                2               1               2               8              16
 of a Voucher Letter............
Acknowledging the Receipt of a                 2               1               2               8              16
 Transferred Voucher............
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    Total.......................  ..............  ..............  ..............  ..............             112
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29406 Filed 11-17-15; 8:45 am]
BILLING CODE 4164-01-P