[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35788-35789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12622]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: Submit written comments (including recommendations) on the 
collection of information by July 13, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0822. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-769-8867, 
<a href="/cdn-cgi/l/email-protection#a0f0f2e1f3d4c1c6c6e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="7c2c2e3d2f081d1a1a3c1a181d5214140f521b130a">[email protected]</span></a>.

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--Extension

    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. Section 524 of 
the FD&C Act serves to stimulate new drug development for drugs to 
treat a ``tropical disease'' (as defined in section 524(a)(3)) 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 ``tropical disease product application,'' as 
defined in section 524(a)(4), may be eligible for a voucher that can be 
used to obtain a priority review for any other 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 (PHS Act).
    Accordingly, we have developed the guidance for industry entitled 
``Tropical Disease Priority Review Vouchers'' (available at https://www.fda.gov/media/72569/download). The guidance explains how FDA 
implements provisions of section 524 of the FD&C Act and how sponsors 
may qualify for a priority review voucher based on eligibility criteria 
set forth in the statute, how to use priority review vouchers, and how 
priority review vouchers may be transferred to other sponsors.
    The guidance also communicates that, under the FDA Reauthorization 
Act of 2017, section 524 requires attestation by the sponsor of 
eligibility for a priority review voucher upon submission of the 
marketing application.
    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 December 2, 2021 (86 FR 68503), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Priority Review Voucher Request.               4               1               4               8              32
Notifications of Intent to Use a               2               1               2               8              16
 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......               4               1               4               2               8
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              88
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our evaluation of the information collection since last 
OMB review and approval, the burden estimate decreased based on receipt 
of fewer vouchers and other information collection activities. Our 
estimated burden for the information collection reflects an overall 
decrease of 34 hours

[[Page 35789]]

and a corresponding decrease of 5 responses.

    Dated: June 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12622 Filed 6-10-22; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>