Notice2023-26300
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications
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
November 30, 2023
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
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<title>Federal Register, Volume 88 Issue 229 (Thursday, November 30, 2023)</title>
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[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83551-83552]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26300]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2562]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Temporary Marketing
Permit Applications
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: Submit written comments (including recommendations) on the
collection of information by January 2, 2024.
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 0910-0133. 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
[[Page 83552]]
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 301-796-8867, <a href="/cdn-cgi/l/email-protection#134341524067727575537577723d7b7b603d747c65"><span class="__cf_email__" data-cfemail="de8e8c9f8daabfb8b89eb8babff0b6b6adf0b9b1a8">[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.
Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)
OMB Control Number 0910-0133--Extension
This information collection request supports FDA regulations found
in 21 CFR 130.17 (section 130.17). Section 401 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341) directs FDA to issue
regulations establishing definitions and standards of identity (SOIs)
for food. Under section 403(g) of the FD&C Act (21 U.S.C. 343(g)), a
food that is subject to a definition and SOI prescribed by regulation
is misbranded if it does not conform to such definition and SOI.
Section 130.17 provides for the issuance by FDA of temporary marketing
permits (TMPs) that enable the food industry to test consumer
acceptance and measure the technological and commercial feasibility in
interstate commerce of experimental packs of food that deviate from
applicable definitions and SOIs. Section 130.17(c) enables the Agency
to monitor the manufacture, labeling, and distribution of experimental
packs of food that deviate from applicable definitions and SOIs. The
information so obtained can be used in support of a petition to
establish or amend the applicable definition or SOI to provide for the
variations. Section 130.17(i) specifies the information that a firm
must submit to FDA to obtain an extension of a TMP. To assist
respondents with the TMP process, we have developed guidance entitled
``Temporary Permits for Interstate Shipment of Experimental Packs of
Food Varying from the Requirements of Definitions and Standards of
Identity: Guidance for Industry'' (November 2021). This resource can be
found on our website <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements</a>.
Description of Respondents: Respondents to this collection of
information include private sector businesses including institutional
and/or industrial customers and food industry members such as
manufacturers, packers, or distributors desiring to apply for a TMP or
TMP extension.
In the Federal Register of July 17, 2023 (88 FR 45431), 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\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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130.17(c); Request for TMP...... 13 2 26 25 650
130.17(i); Request for TMP 1 2 2 2 4
extension......................
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Total....................... .............. .............. .............. .............. 654
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26300 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P
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