[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27489-27491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12438]


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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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension/reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits 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 14, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 14, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov/. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov/ 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov/.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0424 for ``Temporary Marketing Permit Applications.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov/ or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the

[[Page 27490]]

claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites 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 ``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.
    FDA estimates the burden of this collection of information as 
follows:

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

[[Page 27491]]

take a respondent 2 hours per request to comply with the requirements 
of that section, for a total of 4 hours.

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12438 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P