2023-26300. 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.

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 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 0910–0133. 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 White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, [e-mail].

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 https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements.

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

21 CFR section; activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
130.17(c); Request for TMP	13	2	26	25	650
130.17(i); Request for TMP extension	1	2	2	2	4
Total					654
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.