Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability, 69653-69655 [2021-26454]

Download as PDF Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices 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 Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Hobart Rogers, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Rm 3114, Silver Spring, MD 20903–0002, 301– 796–2213. SUPPLEMENTARY INFORMATION: jspears on DSK121TN23PROD with NOTICES1 I. Background FDA is announcing the availability of a draft guidance for sponsorinvestigators entitled ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or LifeThreatening Diseases: Clinical Recommendations.’’ FDA is publishing this draft guidance to provide sponsorinvestigators (hereafter referred to as sponsors) who are interested in developing individualized ASO drug products for a rapidly progressive SDLT genetic disease (caused by a unique genetic variant or variants), with clinical recommendations for submission of INDs. These recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment of clinical response to treatment. This draft guidance describes clinical considerations and, when applicable, important information to include in IND submissions for such ASO drug products for a small number of participants (typically one to two) with SDTL diseases. In general, ASO drug products referred to in this draft guidance belong to a well-characterized chemical class and for which there is considerable nonclinical and clinical experience that is publicly available or to which the sponsor has a right of reference. The draft guidance discusses considerations and information to VerDate Sep<11>2014 16:53 Dec 07, 2021 Jkt 256001 submit in an IND regarding: (1) Confirmation of the participant’s genetic diagnosis and genetic variant(s) targeted by the ASO drug product, (2) the requirements and procedures for informed consent of the participant, (3) appropriate and safe dosing and administration procedures that are detailed and supported by relevant nonclinical evidence, (4) the nature and schedule of the specific safety assessments (adverse events and laboratory testing) to be conducted, and (5) methods for continuous clinical monitoring (e.g., via clinical outcome assessments, pharmacodynamic biomarkers) of the participant to evaluate and document their clinical response(s) and to allow for an informed benefit-risk determination. This draft guidance is expected to facilitate the preparation of adequate and complete IND submissions for investigational ASO drug products for participants with SDLT diseases targeted by the specified ASO drug product. This draft guidance represents one guidance in a series of guidances that FDA intends to publish to advise and help sponsors planning to use individualized ASO drug products for SDLT diseases caused by unique genetic variant(s) and for whom there are no alternative therapies available to treat their disease. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.’’ 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 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014. The collections of information in 21 CFR parts 50 and 56 for obtaining informed consent for prospective patients have been PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 69653 approved under OMB control number 0910–0130. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: December 1, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–26453 Filed 12–7–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–1139] Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.’’ This draft guidance provides FDA’s recommendations on the chemistry, manufacturing, and controls (CMC) information needed to support an investigational new drug application (IND) submitted by a sponsor-investigator developing an individualized antisense oligonucleotide (ASO) drug product for a severely debilitating or life-threatening (SDLT) disease caused by a unique genetic variant affecting a small number of individuals (typically one or two). DATES: Submit either electronic or written comments on the draft guidance by February 7, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. SUMMARY: E:\FR\FM\08DEN1.SGM 08DEN1 69654 Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices You may submit comments on any guidance at any time as follows: ADDRESSES: jspears on DSK121TN23PROD 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. • 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– 2021–D–1139 for ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or LifeThreatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.’’ 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 VerDate Sep<11>2014 16:53 Dec 07, 2021 Jkt 256001 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. 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 draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Carla R. Lankford, Center for Drug Evaluation and Research (HFD–123), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6656, Silver Spring, MD 20993–0002, 301–796–5203. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.’’ The purpose of this draft guidance is to provide FDA’s current thinking on the recommended CMC data and information to support an IND submitted by a sponsor-investigator developing an ASO drug product for a small number of individuals (typically one or two) with an SDLT disease. This draft guidance also explains FDA’s recommendations around compliance with current good manufacturing practice, including the applicability of 21 CFR part 211, to support investigational use of an ASO drug product in a small number of individuals with an SDLT disease. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.’’ 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 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. The collections of information in 21 CFR 211 for manufacture of drug product is approved under OMB control number 0910–0139. The collections of information for oversight of clinical investigations and safety reporting have been approved under OMB control number 0910–0733. E:\FR\FM\08DEN1.SGM 08DEN1 69655 Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: December 1, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–26454 Filed 12–7–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Environmental Information and Documentation, OMB No. 0915–0324, Extension Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the SUMMARY: Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than February 7, 2022. ADDRESSES: Submit your comments to paperwork@hrsa.gov or by mail to the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Samantha Miller, the acting HRSA Information Collection Clearance Officer at (301) 443–9094. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information collection request title for reference. Information Collection Request Title: Environmental Information and Documentation (EID), OMB No. 0915– 0324, Extension. Abstract: HRSA is requesting approval of an extension for the EID checklist which consists of information that the agency is required to obtain to comply with the National Environmental Policy Act of 1969 (NEPA). NEPA establishes the federal government’s national policy for protection of the environment. HRSA has developed the EID for applicants of funding that would potentially impact the environment and to ensure that their decision-making processes are consistent with NEPA. Need and Proposed Use of the Information: Applicants must provide information and assurance of compliance with NEPA on the EID checklist. This information is reviewed in the Pre-Award stage (and/or prior to the implementation of the project). The information is reviewed in the PostAward stage for project changes and the information is reviewed before the implementation of the project changes. Likely Respondents: HRSA applicants applying for federal loan guarantees, federal construction grants, and cooperative agreements. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents jspears on DSK121TN23PROD with NOTICES1 Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours NEPA EID Checklist ............................................................ 1,500 1 1,500 1 1,500 Total .............................................................................. 1,500 ........................ 1,500 ........................ 1,500 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. BILLING CODE 4165–15–P 16:53 Dec 07, 2021 Jkt 256001 ACTION: Notice. In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. SUMMARY: Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No. 0906–0044, Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. AGENCY: [FR Doc. 2021–26560 Filed 12–7–21; 8:45 am] VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Comments on this ICR should be received no later than February 7, 2022. DATES: E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 86, Number 233 (Wednesday, December 8, 2021)]
[Notices]
[Pages 69653-69655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26454]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1139]


Investigational New Drug Application Submissions for 
Individualized Antisense Oligonucleotide Drug Products for Severely 
Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, 
and Controls Recommendations, Guidance for Sponsor-Investigators; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``IND 
Submissions for Individualized Antisense Oligonucleotide Drug Products 
for Severely Debilitating or Life-Threatening Diseases: Chemistry, 
Manufacturing, and Controls Recommendations.'' This draft guidance 
provides FDA's recommendations on the chemistry, manufacturing, and 
controls (CMC) information needed to support an investigational new 
drug application (IND) submitted by a sponsor-investigator developing 
an individualized antisense oligonucleotide (ASO) drug product for a 
severely debilitating or life-threatening (SDLT) disease caused by a 
unique genetic variant affecting a small number of individuals 
(typically one or two).

DATES: Submit either electronic or written comments on the draft 
guidance by February 7, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

[[Page 69654]]


ADDRESSES: You may submit comments on any guidance 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. 
FDA-2021-D-1139 for ``IND Submissions for Individualized Antisense 
Oligonucleotide Drug Products for Severely Debilitating or Life-
Threatening Diseases: Chemistry, Manufacturing, and Controls 
Recommendations.'' 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 draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Carla R. Lankford, Center for Drug 
Evaluation and Research (HFD-123), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 6656, Silver Spring, MD 20993-0002, 
301-796-5203.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``IND Submissions for Individualized Antisense Oligonucleotide 
Drug Products for Severely Debilitating or Life-Threatening Diseases: 
Chemistry, Manufacturing, and Controls Recommendations.'' The purpose 
of this draft guidance is to provide FDA's current thinking on the 
recommended CMC data and information to support an IND submitted by a 
sponsor-investigator developing an ASO drug product for a small number 
of individuals (typically one or two) with an SDLT disease. This draft 
guidance also explains FDA's recommendations around compliance with 
current good manufacturing practice, including the applicability of 21 
CFR part 211, to support investigational use of an ASO drug product in 
a small number of individuals with an SDLT disease.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``IND 
Submissions for Individualized Antisense Oligonucleotide Drug Products 
for Severely Debilitating or Life-Threatening Diseases: Chemistry, 
Manufacturing, and Controls Recommendations.'' 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR parts 312 and 314 have been approved under OMB 
control numbers 0910-0014 and 0910-0001, respectively. The collections 
of information in 21 CFR 211 for manufacture of drug product is 
approved under OMB control number 0910-0139. The collections of 
information for oversight of clinical investigations and safety 
reporting have been approved under OMB control number 0910-0733.

[[Page 69655]]

III. Electronic Access

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

    Dated: December 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26454 Filed 12-7-21; 8:45 am]
BILLING CODE 4164-01-P
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