Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications, 45431-45432 [2023-15045]

Download as PDF Federal Register / Vol. 88, No. 135 / Monday, July 17, 2023 / Notices FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that ELEVIDYS, manufactured by Sarepta Therapeutics, Inc., meets the criteria for a priority review voucher. ELEVIDYS is indicated for treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with confirmed mutation in the DMD gene. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/industry/ developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For further information about ELEVIDYS, go to the Center for Biologics Evaluation and Research’s Approved Cellular and Gene Therapy Products website at https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products. SUPPLEMENTARY INFORMATION: Dated: July 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–15079 Filed 7–14–23; 8:45 am] BILLING CODE 4164–01–P 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. 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 ddrumheller on DSK120RN23PROD with NOTICES1 17:10 Jul 14, 2023 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 SUMMARY: VerDate Sep<11>2014 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 https:// www.regulations.gov 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. Jkt 259001 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 45431 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • 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 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 E:\FR\FM\17JYN1.SGM 17JYN1 45432 Federal Register / Vol. 88, No. 135 / Monday, July 17, 2023 / Notices Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. 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 https://www.fda.gov/ regulatory-information/search-fdaguidance-documents/guidanceindustry-temporary-permits-interstateshipment-experimental-packs-foodvarying-requirements. 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 Number of respondents 21 CFR section; activity Total annual responses Average burden per response Total hours 130.17(c); Request for TMP ................................................ 130.17(i); Request for TMP extension ................................. 13 1 2 2 26 2 25 2 650 4 Total .............................................................................. ........................ ........................ ........................ ........................ 654 1 There ddrumheller on DSK120RN23PROD with NOTICES1 Number of responses per respondent 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: July 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. Agency Father Generic Information Collection Request: 30-Day Public Comment Request [FR Doc. 2023–15045 Filed 7–14–23; 8:45 am] AGENCY: BILLING CODE 4164–01–P [Document Identifier: OS–0990–0379] Office of the Secretary, Health and Human Service, HHS. ACTION: Notice and request for comments. Office of the Assistant Secretary for Public Affairs is requesting OMB approval for a new father Generic Clearance. In compliance with the requirement of the Paperwork SUMMARY: VerDate Sep<11>2014 17:10 Jul 14, 2023 Jkt 259001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before August 16, 2023. ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Sherrette Funn, Sherrette.Funn@hhs.gov or (202) 264–0041. When requesting information, please include the document identifier 0990–0379–30D and project title for reference. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments E:\FR\FM\17JYN1.SGM 17JYN1

Agencies

[Federal Register Volume 88, Number 135 (Monday, July 17, 2023)]
[Notices]
[Pages 45431-45432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15045]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 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.govinfo.gov/content/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, 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, 
[email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-permits-interstate-shipment-experimental-packs-food-varying-requirements.
    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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
130.17(c); Request for TMP......              13               2              26              25             650
130.17(i); Request for TMP                     1               2               2               2               4
 extension......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             654
----------------------------------------------------------------------------------------------------------------
\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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