
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47533-47534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22053]


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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, 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: Fax written comments on the collection of information by 
November 13, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0133. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7729, 
PRAStaff@fda.hhs.gov.

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 supports Agency regulations. 
Specifically, section 401 of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 341) directs FDA to issue regulations 
establishing definitions and standards of identity for food ``whenever 
. . . such action will promote honesty and fair dealing in the interest 
of consumers . . . .'' 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.
    In the Federal Register of June 15, 2017 (82 FR 27489), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    We therefore estimate the burden of this collection of information 
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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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...............
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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.


[[Page 47534]]

    The estimated number of temporary marketing permit applications and 
hours per response is an average based on our experience with 
applications received for the past 3 years, and information from firms 
that have submitted recent requests for temporary marketing permits. 
Based on this information, we estimate that there will be, on average, 
approximately 13 firms submitting requests for 2 temporary marketing 
permits per year over the next 3 years.
    Thus, we estimate that 13 respondents will submit 2 requests for 
temporary marketing permits annually pursuant to Sec.  130.17(c). The 
estimated number of respondents for Sec.  130.17(i) is minimal because 
this section is seldom used by the respondents; therefore, the Agency 
estimates that there will be one or fewer respondents annually with two 
or fewer requests for extension of the marketing permit under Sec.  
130.17(i). The estimated number of hours per response is an average 
based on the Agency's experience and information from firms that have 
submitted recent requests for temporary marketing permits. We estimate 
that 13 respondents each will submit 2 requests for temporary marketing 
permits under Sec.  130.17(c) and that it will take a respondent 25 
hours per request to comply with the requirements of that section, for 
a total of 650 hours. We estimate that one respondent will submit two 
requests for extension of its temporary marketing permits under Sec.  
130.17(i) and that it will take a respondent 2 hours per request to 
comply with the requirements of that section, for a total of 4 hours.

    Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22053 Filed 10-11-17; 8:45 am]
BILLING CODE 4164-01-P


