[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32556-32557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice invites comments on reporting requirements 
contained in existing FDA regulations governing temporary marketing 
permit applications.

DATES: Submit either electronic or written comments on the collection 
of information by August 4, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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 (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.
    We estimate the burden of this collection of information as 
follows:

[[Page 32557]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
     21 CFR Section/activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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130.17(c)/Request for Permit....              13               2              26              25             650
130.17(i)/Request for Extension.               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 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: May 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13041 Filed 6-4-14; 8:45 am]
BILLING CODE 4160-01-P