[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Pages 15619-15620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07464]


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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; 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.

DATES: Fax written comments on the collection of information by May 16, 
2019.

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 0910-0822. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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.

Tropical Disease Priority Review Vouchers

OMB Control Number 0910-0822--Revision

    Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360n) 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

[[Page 15620]]

524 of the FD&C Act, 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 of the FD&C Act, a sponsor of a human 
drug application for a 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).
    Accordingly, we have developed the guidance document entitled, 
``Guidance for Industry (GFI): Tropical Disease Priority Review 
Vouchers.'' The guidance explains how FDA will implement the provisions 
of section 524 of the FD&C Act, how sponsors may use priority review 
vouchers, and how priority review vouchers may be transferred to other 
sponsors. The guidance also explains eligibility criteria for tropical 
disease drug product applications submitted under section 505(b)(1) of 
the FD&C Act and section 351 of the PHS Act, and provides instructions 
to sponsors on how they may:
     Request a priority review voucher; and
     notify FDA of their intent to use a priority review 
voucher, including the date on which the sponsor intends to submit the 
application.
    The guidance also explains that transfer of a priority review 
voucher from one sponsor to another is permitted and that each transfer 
should be documented with a letter of transfer. Finally, the guidance 
will be revised to include new information collection established by 
section 611 of the FDA Reauthorization Act of 2017 (FDARA). As amended, 
section 524 of the FD&C Act requires the sponsor of a tropical disease 
product application to include an attestation regarding its eligibility 
for a priority review voucher. The guidance is available at https://www.fda.gov/downloads/Drugs/Guidances/UCM080599.pdf.
    Description of Respondents: Sponsors submitting applications under 
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.
    In the Federal Register of November 7, 2018 (83 FR 55720), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    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............
Attestation of Eligibility......               5               1               5               2              10
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    Total.......................  ..............  ..............  ..............  ..............             122
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have increased our burden estimate since last approval to 
account for attestations added by FDARA; however, all other information 
collection elements remain unchanged.

    Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-07464 Filed 4-15-19; 8:45 am]
 BILLING CODE 4164-01-P