82 FR 27489 - Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27489-27491
FR Document		2017-12438

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.

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27489-27491]
From the Federal Register Online [www.thefederalregister.org]
[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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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...............
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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

[[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

Document Created: 2017-06-15 01:04:03
Document Modified: 2017-06-15 01:04:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 14, 2017.
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]
FR Citation		82 FR 27489

82 FR 27489 - Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration