Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry; Availability, 72487-72489 [2023-23156]

Download as PDF Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices collected under these authorities to help ensure that such products are quickly and efficiently removed from the market. As required under section 1005(f) of FDAAA and to assist industry, we have issued the guidance entitled, ‘‘Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007,’’ which is available at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/ guidance-industry-questions-andanswers-regarding-reportable-foodregistry-established-food-and-drug. The guidance contains questions and answers relating to the requirements 72487 a domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States (‘‘responsible parties’’) who have information on a reportable food. Voluntary respondents to this collection of information are Federal, State, and local public health officials who have information on a reportable food. In the Federal Register of May 22, 2023 (88 FR 32775), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: under section 417 of the FD&C Act, including: (1) how, when, and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food. The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 7.46 of FDA’s regulations have been approved under OMB control number 0910–0249. Description of Respondents: Mandatory respondents to this collection of information are the owners, operators, or agents in charge of TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents Activity Total annual disclosures Average burden per disclosure Total hours Notifying immediate previous source of the article of food under section 417(d)(6)(B)(i) of the FD&C Act (mandatory reporters only). Notifying immediate subsequent recipient of the article of food under section 417(d)(6)(B)(ii) of the FD&C Act (mandatory reporters only). Notifying immediate previous source of the article of food under section 417(d)(7)(C)(i) of the FD&C Act (mandatory reporters only). Notifying immediate subsequent recipient of the article of food under section 417(d)(7)(C)(ii) of the FD&C Act (mandatory reporters only). 1,200 1 1,200 0.6 (36 minutes) ......... 720 1,200 1 1,200 0.6 (36 minutes) ......... 720 1,200 1 1,200 0.6 (36 minutes) ......... 720 1,200 1 1,200 0.6 (36 minutes) ......... 720 Total .................................................................................................. ........................ ........................ ........................ ..................................... 2,880 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Third Party Disclosure: Although it is not mandatory under section 1005 of FDAAA that responsible persons notify the sources and recipients of instances of reportable food, for purposes of the burden estimate we are assuming FDA would exercise its authority and require such notifications in all such instances for mandatory reporters. This notification burden does not affect voluntary reporters of reportable food events. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity Total annual records Average burden per recordkeeping Total hours Maintenance of reportable food records under section 417(g) of the FD&C Act—mandatory reports. Maintenance of reportable food records under section 417(g) of the FD&C Act—voluntary reports. 1,200 1 1,200 0.25 (15 minutes) ....... 300 4 1 4 0.25 (15 minutes) ....... 1 Total .................................................................................................. ........................ ........................ ........................ ..................................... 301 1 There ddrumheller on DSK120RN23PROD with NOTICES1 Number of records per recordkeeper are no capital costs or operating and maintenance costs associated with this collection of information. Recordkeeping: As noted previously, section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods reports and notifications for a period of 2 years. However, we do not expect that records will always be kept in relation to voluntary reportable food reports. 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: October 16, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–23117 Filed 10–19–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–0745] Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry; Availability AGENCY: ACTION: VerDate Sep<11>2014 18:20 Oct 19, 2023 Jkt 262001 PO 00000 Food and Drug Administration, HHS. Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM Notice of availability. 20OCN1 72488 Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry.’’ The guidance document describes a standards recognition program for regenerative medicine therapies (SRP–RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify Voluntary Consensus Standards (VCS) that might be used in the preparation and evaluation of submissions for Regenerative Medicine Therapy (RMT) products regulated by CBER when such standards are appropriate. The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. This program is modeled after the formal standards and conformity assessment program (S–CAP) for medical devices where the term ‘‘recognize’’ refers to FDA’s formal identification of a standard after the determination that the standard is appropriate to meet relevant requirements as defined by law. CBER encourages the use of appropriate standards in the development of CBERregulated products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2022. DATES: The announcement of the guidance is published in the Federal Register on October 20, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 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. VerDate Sep<11>2014 18:20 Oct 19, 2023 Jkt 262001 • 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. [insert docket number FDA–2022–D–0745] for ‘‘Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.’’ Received comments 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 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry.’’ The guidance describes a program at FDA’s CBER for recognition of VCS relevant to RMT products regulated in CBER. The SRP–RMT is designed to identify and recognize VCS to facilitate the development and assessment of RMT products. The voluntary use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. The program parallels the S–CAP for medical devices. The guidance describes the purpose of the program, how the SRP–RMT is expected to facilitate RMT development, and describes how the Office of Therapeutic Products in CBER generally intends to evaluate VCS for recognition in the SRP–RMT. This program will not E:\FR\FM\20OCN1.SGM 20OCN1 Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices apply to: (1) statutory and regulatory standards that are legally binding, such as certain provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the Public Health Service Act (42 U.S.C. 6A); (2) standards developed by Standards Development Organizations that do not follow consensus mechanisms; or (3) electronic data exchange standards for submissions to CBER. In the Federal Register of Thursday, June 16, 2022 (87 FR 36327), FDA announced the availability of the draft guidance of the same title dated June 2022. FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes minor edits to improve clarity and the addition of information regarding information collection provisions under the Paperwork Reduction Act of 1995. The guidance announced in this notice finalizes the draft guidance dated June 2022. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). The collections of information have been approved under OMB control number 0910–0338. ddrumheller on DSK120RN23PROD with NOTICES1 III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: October 17, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–23156 Filed 10–19–23; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:20 Oct 19, 2023 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1137] Development and Licensure of Vaccines To Prevent COVID–19; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ‘‘Development and Licensure of Vaccines to Prevent COVID–19.’’ This guidance revises the guidance of the same name, which was announced in the Federal Register on August 3, 2020. FDA is issuing this guidance to assist the Agency and sponsors in the clinical development and licensure of vaccines for the prevention of COVID–19. Additionally, this guidance provides an overview of key considerations to satisfy regulatory requirements set forth in the investigational new drug application (IND) regulations and in the licensing regulations for chemistry, manufacturing, and controls (CMC), and nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation of COVID–19 preventive vaccines. FDA is also announcing the withdrawal of an FDA guidance document related to COVID–19. DATES: The announcement of the guidance is published in the Federal Register on October 20, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 72489 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– 2020–D–1137 for ‘‘Development and Licensure of Vaccines to Prevent COVID–19.’’ Received comments 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 E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72487-72489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0745]


Voluntary Consensus Standards Recognition Program for 
Regenerative Medicine Therapies; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

[[Page 72488]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Voluntary Consensus 
Standards Recognition Program for Regenerative Medicine Therapies; 
Guidance for Industry.'' The guidance document describes a standards 
recognition program for regenerative medicine therapies (SRP-RMT) at 
FDA's Center for Biologics Evaluation and Research (CBER) designed to 
identify Voluntary Consensus Standards (VCS) that might be used in the 
preparation and evaluation of submissions for Regenerative Medicine 
Therapy (RMT) products regulated by CBER when such standards are 
appropriate. The use of recognized VCS can assist stakeholders in more 
efficiently meeting regulatory requirements and increasing regulatory 
predictability for RMT products. This program is modeled after the 
formal standards and conformity assessment program (S-CAP) for medical 
devices where the term ``recognize'' refers to FDA's formal 
identification of a standard after the determination that the standard 
is appropriate to meet relevant requirements as defined by law. CBER 
encourages the use of appropriate standards in the development of CBER-
regulated products. The guidance announced in this notice finalizes the 
draft guidance of the same title dated June 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on October 20, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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. 
[insert docket number FDA-2022-D-0745] for ``Voluntary Consensus 
Standards Recognition Program for Regenerative Medicine Therapies.'' 
Received comments 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Voluntary Consensus Standards Recognition Program for Regenerative 
Medicine Therapies; Guidance for Industry.'' The guidance describes a 
program at FDA's CBER for recognition of VCS relevant to RMT products 
regulated in CBER. The SRP-RMT is designed to identify and recognize 
VCS to facilitate the development and assessment of RMT products. The 
voluntary use of recognized VCS can assist stakeholders in more 
efficiently meeting regulatory requirements and increasing regulatory 
predictability for RMT products. The program parallels the S-CAP for 
medical devices.
    The guidance describes the purpose of the program, how the SRP-RMT 
is expected to facilitate RMT development, and describes how the Office 
of Therapeutic Products in CBER generally intends to evaluate VCS for 
recognition in the SRP-RMT. This program will not

[[Page 72489]]

apply to: (1) statutory and regulatory standards that are legally 
binding, such as certain provisions of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) and the Public Health Service Act 
(42 U.S.C. 6A); (2) standards developed by Standards Development 
Organizations that do not follow consensus mechanisms; or (3) 
electronic data exchange standards for submissions to CBER.
    In the Federal Register of Thursday, June 16, 2022 (87 FR 36327), 
FDA announced the availability of the draft guidance of the same title 
dated June 2022. FDA received a few comments on the draft guidance and 
those comments were considered as the guidance was finalized. A summary 
of changes includes minor edits to improve clarity and the addition of 
information regarding information collection provisions under the 
Paperwork Reduction Act of 1995. The guidance announced in this notice 
finalizes the draft guidance dated June 2022.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Voluntary Consensus Standards Recognition 
Program for Regenerative Medicine Therapies.'' It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information have been approved under OMB control number 
0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: October 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23156 Filed 10-19-23; 8:45 am]
BILLING CODE 4164-01-P
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