Document ID: FDA-2011-N-0424-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Temporary Marketing Permit Applications
Posted Date: 2011-08-18T04:00Z

[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51370-51371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21039]

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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 
September 19, 2011.

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 e-mailed 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 (the FD&C 
Act) (21 U.S.C. 341) directs FDA to issue regulations establishing 
definitions and standards of identity for food ``[w]henever * * * 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 (Sec.  
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 10, 2011 (76 FR 34080), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      No. of
         21 CFR section               No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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130.17(c).......................              13               2              26              25             650

[[Page 51371]]

 
130.17(i).......................               1               2               2               2               4
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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.

    The estimated number of temporary marketing permit applications and 
hours per response is an average based on the Agency's 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 two temporary marketing 
permits per year over the next 3 years.
    Thus, FDA estimates that 13 respondents will submit 2 requests for 
temporary marketing permits annually under 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: August 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21039 Filed 8-17-11; 8:45 am]
BILLING CODE 4160-01-P