Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising From the COVID-19 Pandemic; Guidance for Industry; Availability, 10373-10375 [2022-03915]

Download as PDF Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices should allow you to enter the webinar directly. If Zoom asks for a passcode, please use the passcode f7DLM=, which is case-sensitive. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the meeting recording will also be available on the internet at https://www.fda.gov/ drugs/news-events-human-drugs/publicmeeting-final-assessment-programenhanced-review-transparency-andcommunication-biosimilar. Dated: February 18, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–03926 Filed 2–23–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–1311] Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising From the COVID– 19 Pandemic; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ‘‘Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID–19 Pandemic.’’ The COVID–19 pandemic has resulted in a significant reduction in the supply of nonhuman primates (NHPs) available for conducting toxicology studies for new pharmaceuticals. This has the potential to significantly delay the development of new medications for the treatment of diseases currently without effective treatment options. This guidance provides FDA’s recommendations to industry to help mitigate the NHP supply issue by reducing the demand for NHPs during the COVID–19 pandemic. Given the public health emergency presented by COVID–19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency’s good guidance practices. jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:29 Feb 23, 2022 Jkt 256001 The announcement of the guidance is published in the Federal Register on February 24, 2022. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: 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–1311 for ‘‘Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID–19 Pandemic.’’ 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 10373 • 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. 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 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; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, 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 that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. E:\FR\FM\24FEN1.SGM 24FEN1 10374 Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices FOR FURTHER INFORMATION CONTACT: Ronald Wange, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3342, Silver Spring, MD 20993–0002, 301– 796–1304; or Stephen Ripley, 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 jspears on DSK121TN23PROD with NOTICES1 FDA is announcing the availability of a final guidance for industry entitled ‘‘Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID–19 Pandemic.’’ The COVID–19 pandemic has caused a marked reduction in the supply of NHPs available for conducting nonclinical toxicity assessments. Before the pandemic, China was the largest supplier of NHPs used in pharmaceutical development, accounting for 60 percent of NHPs imported to the United States.1 Early in the pandemic, China implemented a ban on the trade of wild animals—including NHPs—in an effort to potentially curb the spread of SARS–CoV–2. This ban remains in effect. In conjunction with this reduction in supply, there has been a substantial increase in the demand for NHPs for the testing of experimental COVID–19 treatments and vaccines.2 This reduction in supply and prioritization for COVID–19-related studies have severely restricted the availability of NHPs for other pharmaceutical development programs, resulting in a disruption in supply that has the potential to significantly delay the development of new medications for the treatment of diseases currently without effective treatment options. While the disruption affects the NHP supply generally, there is a particularly acute shortage of sexually mature NHPs that are often the only pharmacologically relevant species with which to assess developmental and 1 See ‘‘Rapid Response by Laboratory Animal Research Institutions During the COVID–19 Pandemic: Lessons Learned: Proceedings of a Workshop—in Brief’’; available at https:// www.nap.edu/catalog/26189/rapid-response-bylaboratory-animal-research-institutions-during-thecovid-19-pandemic-lessons-learned. 2 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We encourage sponsors to consult with us if they wish to use a nonanimal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method is adequate to meet the regulatory need. VerDate Sep<11>2014 16:46 Feb 23, 2022 Jkt 256001 reproductive toxicity endpoints for biotherapeutic proteins (biological products). This guidance provides recommendations regarding the use of NHPs in development programs for small molecule drugs as well as for biological products, covering both general toxicity studies and developmental and reproductive toxicity (DART) studies. The guidance provides FDA’s recommendations for sponsors to use alternative nonrodent species, whenever possible, in general toxicology studies and, in general, to not use NHPs for DART assessment of small molecule drugs. For DART studies of biological products, the guidance provides FDA’s recommendation that sponsors fully utilize non-NHP approaches to assess DART. These approaches include, when scientifically appropriate, the use of a weight-ofevidence approach to risk assessment, the use of species-specific surrogate proteins in rodents, and the use of rodents genetically modified to (1) respond to the clinical candidate or (2) evaluate the effects of altered activity of the target of the biological product. In instances with no scientifically appropriate alternatives to the NHP, the sponsor may be able to reduce the number of NHPs used per study by reducing the number of treatment groups in the study. The guidance also addresses the potential for delaying the conduct of DART studies to the postmarketing setting. Taken together, these recommendations are expected to help mitigate the constrained supply of NHPs until such time as the NHP supply recovers sufficiently from the effect of the COVID–19 pandemic. In light of the public health emergency related to COVID–19 declared by the Secretary of Health and Human Services (HHS), pursuant to section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)), FDA has determined that prior public participation for this guidance is not feasible or appropriate and is issuing this guidance without prior public comment (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practice statute and regulation. This guidance is intended to remain in effect for the duration of the public health emergency related to COVID–19 declared by the Secretary of HHS, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 including any renewals.3 However, the recommendations and processes described in the guidance are expected to help mitigate the COVID–19 pandemic-related NHP supply constraints affecting pharmaceutical development that are expected to persist beyond the termination of the COVID– 19 public health emergency (e.g., time required to rebuild breeding stocks and for NHPs to reach sexual maturity) and reflect the Agency’s current thinking on this issue. Therefore, within 60 days following the termination of the public health emergency, FDA intends to revise and replace this guidance with any appropriate changes based on comments received on this guidance and the Agency’s experience with implementation. 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 ‘‘Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID–19 Pandemic.’’ 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 part 314 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; and the collections of information in 21 CFR part 601 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/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// 3 See https://www.phe.gov/emergency/news/ healthactions/phe/Pages/default.aspx. E:\FR\FM\24FEN1.SGM 24FEN1 Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices www.fda.gov/regulatory-information/ search-fda-guidance-documents, https://www.fda.gov/emergencypreparedness-and-response/ coronavirus-disease-2019-covid-19/ covid-19-related-guidance-documentsindustry-fda-staff-and-otherstakeholders, or https:// www.regulations.gov. Bethesda, MD 20892, 301–496–6455, rneumann@cc.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Dated: February 16, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–03915 Filed 2–23–22; 8:45 am] Dated: February 18, 2022. Patricia B. Hansberger, Supervisory Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4164–01–P [FR Doc. 2022–03946 Filed 2–23–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Clinical Center; Notice of Closed Meeting jspears on DSK121TN23PROD with NOTICES1 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors of the NIH Clinical Center. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the CLINICAL CENTER, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors of the NIH Clinical Center. Date: March 28, 2022. Time: 10:00 a.m. to 4:45 p.m. Agenda: To review and evaluate department of Perioperative Medicine Pain and Palliative Care Service and Interviews. Place: Clinical Center, National Institutes of Health, 10 Center Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ronald Neumann, MD, Senior Investigation, Clinical Center, National Institutes of Health, 10 Center Drive, Bethesda, MD 20892, 301–496–6455, rneumann@cc.nih.gov. Name of Committee: Board of Scientific Counselors of the NIH Clinical Center. Date: March 29, 2022. Time: 10:30 a.m. to 12:30 p.m. Agenda: To review and evaluate department of Perioperative Medicine Pain and Palliative Care Service and Interviews. Place: Clinical Center, National Institutes of Health, 10 Center Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ronald Neumann, MD, Senior Investigation, Clinical Center, National Institutes of Health, 10 Center Drive, VerDate Sep<11>2014 16:46 Feb 23, 2022 Jkt 256001 National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Career Development (Ks) and Conference support (R13) Review. Date: March 17, 2022. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting). Contact Person: Songtao Liu, MD, Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Blvd., Suite 920, Bethesda, MD 20892, (301) 827–3025, songtao.liu@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, HHS) PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 10375 Dated: February 17, 2022. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–03888 Filed 2–23–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2022–0002; Internal Agency Docket No. FEMA–B–2216] Changes in Flood Hazard Determinations Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. AGENCY: This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The currently effective community number is shown in the table below and must be used for all new policies and renewals. DATES: These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities. From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period. ADDRESSES: The affected communities are listed in the table below. Revised SUMMARY: E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10373-10375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1311]


Nonclinical Considerations for Mitigating Nonhuman Primate Supply 
Constraints Arising From the COVID-19 Pandemic; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Nonclinical Considerations for Mitigating Nonhuman Primate Supply 
Constraints Arising from the COVID-19 Pandemic.'' The COVID-19 pandemic 
has resulted in a significant reduction in the supply of nonhuman 
primates (NHPs) available for conducting toxicology studies for new 
pharmaceuticals. This has the potential to significantly delay the 
development of new medications for the treatment of diseases currently 
without effective treatment options. This guidance provides FDA's 
recommendations to industry to help mitigate the NHP supply issue by 
reducing the demand for NHPs during the COVID-19 pandemic. Given the 
public health emergency presented by COVID-19, this guidance document 
is being implemented without prior public comment because FDA has 
determined that prior public participation is not feasible or 
appropriate, but it remains subject to comment in accordance with the 
Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on February 24, 2022.

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. 
FDA-2021-D-1311 for ``Nonclinical Considerations for Mitigating 
Nonhuman Primate Supply Constraints Arising from the COVID-19 
Pandemic.'' 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 
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; or the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, 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 that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

[[Page 10374]]


FOR FURTHER INFORMATION CONTACT: Ronald Wange, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3342, Silver Spring, MD 20993-0002, 301-
796-1304; or Stephen Ripley, 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 final guidance for industry 
entitled ``Nonclinical Considerations for Mitigating Nonhuman Primate 
Supply Constraints Arising from the COVID-19 Pandemic.''
    The COVID-19 pandemic has caused a marked reduction in the supply 
of NHPs available for conducting nonclinical toxicity assessments. 
Before the pandemic, China was the largest supplier of NHPs used in 
pharmaceutical development, accounting for 60 percent of NHPs imported 
to the United States.\1\ Early in the pandemic, China implemented a ban 
on the trade of wild animals--including NHPs--in an effort to 
potentially curb the spread of SARS-CoV-2. This ban remains in effect. 
In conjunction with this reduction in supply, there has been a 
substantial increase in the demand for NHPs for the testing of 
experimental COVID-19 treatments and vaccines.\2\
---------------------------------------------------------------------------

    \1\ See ``Rapid Response by Laboratory Animal Research 
Institutions During the COVID-19 Pandemic: Lessons Learned: 
Proceedings of a Workshop--in Brief''; available at https://www.nap.edu/catalog/26189/rapid-response-by-laboratory-animal-research-institutions-during-the-covid-19-pandemic-lessons-learned.
    \2\ FDA supports the principles of the 3Rs, to reduce, refine, 
and replace animal use in testing when feasible. We encourage 
sponsors to consult with us if they wish to use a nonanimal testing 
method they believe is suitable, adequate, validated, and feasible. 
We will consider if such an alternative method is adequate to meet 
the regulatory need.
---------------------------------------------------------------------------

    This reduction in supply and prioritization for COVID-19-related 
studies have severely restricted the availability of NHPs for other 
pharmaceutical development programs, resulting in a disruption in 
supply that has the potential to significantly delay the development of 
new medications for the treatment of diseases currently without 
effective treatment options. While the disruption affects the NHP 
supply generally, there is a particularly acute shortage of sexually 
mature NHPs that are often the only pharmacologically relevant species 
with which to assess developmental and reproductive toxicity endpoints 
for biotherapeutic proteins (biological products).
    This guidance provides recommendations regarding the use of NHPs in 
development programs for small molecule drugs as well as for biological 
products, covering both general toxicity studies and developmental and 
reproductive toxicity (DART) studies. The guidance provides FDA's 
recommendations for sponsors to use alternative nonrodent species, 
whenever possible, in general toxicology studies and, in general, to 
not use NHPs for DART assessment of small molecule drugs. For DART 
studies of biological products, the guidance provides FDA's 
recommendation that sponsors fully utilize non-NHP approaches to assess 
DART. These approaches include, when scientifically appropriate, the 
use of a weight-of-evidence approach to risk assessment, the use of 
species-specific surrogate proteins in rodents, and the use of rodents 
genetically modified to (1) respond to the clinical candidate or (2) 
evaluate the effects of altered activity of the target of the 
biological product. In instances with no scientifically appropriate 
alternatives to the NHP, the sponsor may be able to reduce the number 
of NHPs used per study by reducing the number of treatment groups in 
the study. The guidance also addresses the potential for delaying the 
conduct of DART studies to the postmarketing setting. Taken together, 
these recommendations are expected to help mitigate the constrained 
supply of NHPs until such time as the NHP supply recovers sufficiently 
from the effect of the COVID-19 pandemic.
    In light of the public health emergency related to COVID-19 
declared by the Secretary of Health and Human Services (HHS), pursuant 
to section 319(a)(2) of the Public Health Service Act (42 U.S.C. 
247d(a)(2)), FDA has determined that prior public participation for 
this guidance is not feasible or appropriate and is issuing this 
guidance without prior public comment (see section 701(h)(1)(C)(i) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i) and 
21 CFR 10.115(g)(2)). This guidance document is being implemented 
immediately, but it remains subject to comment in accordance with the 
Agency's good guidance practice statute and regulation.
    This guidance is intended to remain in effect for the duration of 
the public health emergency related to COVID-19 declared by the 
Secretary of HHS, including any renewals.\3\ However, the 
recommendations and processes described in the guidance are expected to 
help mitigate the COVID-19 pandemic-related NHP supply constraints 
affecting pharmaceutical development that are expected to persist 
beyond the termination of the COVID-19 public health emergency (e.g., 
time required to rebuild breeding stocks and for NHPs to reach sexual 
maturity) and reflect the Agency's current thinking on this issue. 
Therefore, within 60 days following the termination of the public 
health emergency, FDA intends to revise and replace this guidance with 
any appropriate changes based on comments received on this guidance and 
the Agency's experience with implementation.
---------------------------------------------------------------------------

    \3\ See https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
---------------------------------------------------------------------------

    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 ``Nonclinical Considerations for Mitigating 
Nonhuman Primate Supply Constraints Arising from the COVID-19 
Pandemic.'' 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 part 314 have been approved under OMB control 
number 0910-0001; the collections of information in 21 CFR part 312 
have been approved under OMB control number 0910-0014; and the 
collections of information in 21 CFR part 601 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/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://

[[Page 10375]]

www.fda.gov/regulatory-information/search-fda-guidance-documents, 
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov.

    Dated: February 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03915 Filed 2-23-22; 8:45 am]
BILLING CODE 4164-01-P
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