Notice2022-12622
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 113 (Monday, June 13, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35788-35789]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="https://www.fda.gov/media/72569/download">https://www.fda.gov/media/72569/download</a>). 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>Indexed from Federal Register on June 13, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.