52914 Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices 

diseases, and the donor (and product/ 

source material) test results for relevant 

disease agents are negative or 

nonreactive. To prevent transmission of 

disease when manufacturing ACTPs, it 

is necessary to determine that donors 

are healthy and free from relevant 

disease agents. Transmission of relevant 

disease agents by an ACTP may be the 

result of the presence of relevant disease 

agents in the donated cells/tissues 

(either within the cells/tissues, within 

other accompanying cells/tissues, or in 

the extracellular components of the 

product). 

The CGMP requirements for new 

animal drugs are found in Title 21 parts 

210 and 211 of the Code of Federal 

Regulations (21 CFR parts 210 and 211). 

These regulations are broad in scope, 

and FDA recognizes that they do not 

specifically or fully address some 

aspects of the manufacture of ACTPs, 

including donor eligibility 

determinations. This guidance offers 

FDA’s recommendations for 

determining that a donor is free from 

relevant disease agents and is an eligible 

source of cells, tissues, or both, used in 

the manufacture of allogeneic or 

xenogeneic ACTPs. We encourage 

sponsors and manufacturers of ACTPs 

to contact CVM early in the product 

development process to discuss 

considerations specific to approval of a 

new animal drug product. 

This level 1 draft guidance is being 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 The draft guidance, when 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 donor eligibility for 

animal cells, tissues, and cell- and 

tissue-based products. 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 514 have 

been approved under OMB control 

number 0910–0032. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20517 Filed 9–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

[OMB No. 0906–XXXX] 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: SHIP COVID– 

19 Testing and Mitigation Program 

Data Collection—New, Emergency 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: 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. 

DATES: Comments on this ICR should be 

received no later than October 4, 2021. 

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 HRSA 

Information Collection Clearance Officer 

at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

SHIP COVID–19 Testing and Mitigation 

Program Data Collection, OMB No. 

0906–XXXX—New, Emergency. 

Abstract: The American Rescue Plan 

Act of 2021 (Pub. L. 117–2) provided 

one-time funding for awards that will be 

carried out under Section 711 of the 

Social Security Act (42 U.S.C. 

912(b)(5)). The Small Rural Hospital 

Improvement Program (SHIP) is 

requesting approval of an emergency 

ICR. State grantees will improve health 

care in rural areas by using the funding 

to provide support to eligible rural 

hospitals to increase COVID–19 testing 

efforts, expand access to testing in rural 

communities, and expand the range of 

mitigation activities. 

Need and Proposed Use of the 

Information: The terms and conditions 

for this program specify that, ‘‘hospitals 

will be required to report on the number 

of tests provided and categories in 

which the funding is spent.’’ The data 

will allow HRSA to ensure SHIP 

COVID–19 recipients are meeting the 

terms and conditions of their funding, 

while providing HRSA with information 

on the effectiveness of funds distributed 

through this program. 

Likely Respondents: The respondents 

will be hospital staff and designated 

representatives. 

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. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices 52915 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of respondents Number of responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden hours 

SHIP COVID–19 Testing and 

Mitigation Data Reporting.

1,540: Number of unique organizations funded through the 

program.

6: Reported on a quarterly 

basis during the 18 month 

program or the end of the 

public health emergency 

(whichever is first).

9,240 .25 2,310: Total hours spent on responses for all funded organizations over a 2-year period. 

Total ................................... 1,540 ........................................ ................................................... 9,240 ........................ 2,310. 

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. 

[FR Doc. 2021–20601 Filed 9–22–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Minority Health 

and Health Disparities; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 on 

Minority Health and Health Disparities 

Special Emphasis Panel; Impact of Structural 

Racism and Discrimination on Minority 

Health and Health Disparities. 

Date: November 15–17, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Gateway Plaza, 7201 Wisconsin Avenue, 

Bethesda, MD 20817 (Virtual Meeting). 

Contact Person: Karen Nieves-Lugo, 

M.P.H., Ph.D., Scientific Review Officer, 

Office of Extramural Research Activities, 

National Institute on Minority Health and 

Health Disparities, National Institutes of 

Health, Gateway Building, 7201 Wisconsin 

Avenue, Bethesda, MD 20892, (301) 480– 

4727, karen.nieveslugo@nih.gov. 

Dated: September 17, 2021. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–20583 Filed 9–22–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; Exploratory Data Science 

Methods and Algorithm Development, EarlyStage Development of Data Science 

Technologies, and Enhancement or 

Sustainment of Data Science Tools for 

Infectious and Immune-Mediated Diseases 

(R21, U01, U24). 

Date: October 26–28, 2021. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Sandip Bhattacharyya, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20852, 240–292–0189, 

sandip.bhattacharyya@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: September 17, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–20585 Filed 9–22–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of 

meetings of the Board of Scientific 

Counselors, National Institute of 

Neurological Disorders and Stroke. 

The meetings will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

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 

NATIONAL INSTITUTE OF 

NEUROLOGICAL DISORDERS AND 

STROKE, 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, National Institute of 

Neurological Disorders and Stroke. 


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