[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47793-47794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17168]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0424]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Temporary Marketing 
Permit Applications

AGENCY: Food and Drug Administration, Health and Human Services (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 September 8, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://

[[Page 47794]]

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)

OMB Control Number 0910-0133--Extension

    Section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341) (FD&C Act) directs FDA to issue regulations establishing 
definitions and standards of identity 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 standard of identity prescribed by regulation is misbranded if it 
does not conform to such definition and standard of identity. Section 
130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary 
marketing permits 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 standards of identity. 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 standards of identity. The information so obtained can 
be used in support of a petition to establish or amend the applicable 
definition or standard of identity 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 temporary marketing permit.
    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 
temporary marketing permit or permit extension.
    In the Federal Register of April 16, 2020 (85 FR 21247), we 
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\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden  per
    21 CFR section; activity        respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
----------------------------------------------------------------------------------------------------------------
130.17(c); Request for temporary              13               2              26              25             650
 marketing permit...............
130.17(i); Request to extend                   1               2               2               2               4
 marketing permit...............
                                 -------------------------------------------------------------------------------
    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: July 31, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17168 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P