Notice2022-03915
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising From the COVID-19 Pandemic; Guidance for Industry; Availability
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Published
February 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 37 (Thursday, February 24, 2022)</title>
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[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10373-10375]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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\
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\1\ See ``Rapid Response by Laboratory Animal Research
Institutions During the COVID-19 Pandemic: Lessons Learned:
Proceedings of a Workshop--in Brief''; available at <a href="https://www.nap.edu/catalog/26189/rapid-response-by-laboratory-animal-research-institutions-during-the-covid-19-pandemic-lessons-learned">https://www.nap.edu/catalog/26189/rapid-response-by-laboratory-animal-research-institutions-during-the-covid-19-pandemic-lessons-learned</a>.
\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.
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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.
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\3\ See <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx</a>.
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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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
https://
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www.fda.gov/regulatory-information/search-fda-guidance-documents,
<a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders">https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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</html>Indexed from Federal Register on February 24, 2022.
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