Notice2023-15045
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 135 (Monday, July 17, 2023)</title>
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[Federal Register Volume 88, Number 135 (Monday, July 17, 2023)]
[Notices]
[Pages 45431-45432]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15045]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2562]
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 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: Either electronic or written comments on the collection of
information must be submitted by September 15, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 15, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-2562 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
[[Page 45432]]
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#6a3a382b391e0b0c0c2a0c0e0b44020219440d051c"><span class="__cf_email__" data-cfemail="9acac8dbc9eefbfcfcdafcfefbb4f2f2e9b4fdf5ec">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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
This information collection request supports FDA regulations found
in 21 CFR 130.17 (section 130.17). 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
(SOIs) for food. Under section 403(g) of the FD&C Act (21 U.S.C.
343(g)), a food that is subject to a definition and SOI prescribed by
regulation is misbranded if it does not conform to such definition and
SOI. Section 130.17 provides for the issuance by FDA of temporary
marketing permits (TMPs) 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 SOIs. 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 SOIs. The
information so obtained can be used in support of a petition to
establish or amend the applicable definition or SOI 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 TMP. To assist
respondents with the TMP process, we have developed guidance entitled
``Temporary Permits for Interstate Shipment of Experimental Packs of
Food Varying from the Requirements of Definitions and Standards of
Identity: Guidance for Industry'' (November 2021). This resource can be
found on our website <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements</a>.
Description of Respondents: Respondents to this collection of
information include private sector businesses including institutional
and/or industrial customers and food industry members such as
manufacturers, packers, or distributors desiring to apply for a TMP or
TMP extension.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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130.17(c); Request for TMP...... 13 2 26 25 650
130.17(i); Request for TMP 1 2 2 2 4
extension......................
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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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15045 Filed 7-14-23; 8:45 am]
BILLING CODE 4164-01-P
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