Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 10373 

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. 

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. 


jspears on DSK121TN23PROD with NOTICES1
10374 Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 

1See ‘‘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. 

2FDA 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. 

3See https://www.phe.gov/emergency/news/ 

healthactions/phe/Pages/default.aspx. 

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

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-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, 

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:// 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 10375 

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. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; 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 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, 

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 18, 2022. 

Patricia B. Hansberger, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2022–03946 Filed 2–23–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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) 

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 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: Notice. 

SUMMARY: 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 


jspears on DSK121TN23PROD with NOTICES1