52912 Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices 

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 Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed 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: 

Lynne Boxer, Center for Veterinary 

Medicine (HFV–114), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0611, 

Lynne.Boxer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (GFI) #253 

entitled ‘‘Good Manufacturing Practices 

for Animal Cells, Tissues, and Cell- and 

Tissue-Based Products.’’ CVM is issuing 

this guidance to provide establishments 

that manufacture ACTPs with 

recommendations for meeting CGMP 

requirements. All new animal drugs, 

including ACTPs, are required to be 

manufactured in accordance with 

CGMPS to ensure that such drugs meet 

the requirements of the FD&C Act as to 

safety and have the identity, strength, 

quality, and purity characteristics that 

they purport to or are represented to 

possess. The CGMP requirements for 

new animal drugs are found in Title 21 

parts 210 and 211 of the Code of Federal 

Regulations (parts 210 and 211 (21 CFR 

parts 210 and 211)). The CGMP 

regulations in parts 210 and 211 are 

broad in scope, and we recognize that 

these regulations do not specifically or 

fully address all aspects of the 

manufacture of ACTPs, including early 

stages of the manufacturing process. 

This guidance provides our 

recommendations for complying with 

section 501(a)(2)(B) of the FD&C Act (21 

U.S.C. 351(a)(2)(B)) for those aspects of 

manufacturing specific to ACTPs. 

ACTPs that meet the definition of a 

new animal drug are subject to the same 

statutory and regulatory requirements 

found under the FD&C Act and Title 21 

of the CFR. Sponsors are responsible for 

ensuring that their products are 

manufactured in accordance with 

Federal law, including parts 210 and 

211 and section 501(a)(2)(B) of the 

FD&C Act. New animal drugs not 

manufactured in conformity with 

CGMPs are adulterated under the 

relevant provisions of the FD&C Act. 

This guidance specifically addresses 

the methods, facilities, and controls 

used for manufacturing ACTPs, 

including steps in recovery, processing, 

storage, labeling, packaging, and 

distribution. We refer to our 

recommendations for meeting CGMPs in 

the manufacture of ACTPs as ACTP 

CGMPs. These ACTP CGMPs should be 

applied to consistently produce quality 

and to ensure that ACTPs are not 

contaminated and do not become 

contaminated during manufacturing. 

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 good manufacturing 

practices 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/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

http://inside.fda.gov:9003/Policy

Procedures/GuidanceRegulations/ 

FederalRegister/default.htm, or https://

www.regulations.gov. 

Dated: September 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20514 Filed 9–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0401] 

Donor Eligibility for Animal Cells, 

Tissues, and Cell- and Tissue-Based 

Products; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency or we) 

is announcing the availability of a draft 

guidance for industry #254 entitled 

‘‘Donor Eligibility for Animal Cells, 

Tissues, and Cell- and Tissue-Based 

Products.’’ FDA’s Center for Veterinary 

Medicine (CVM) is issuing this guidance 


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Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices 52913 

for sponsors, firms, individuals, and 

establishments that participate in the 

manufacture of, or perform any aspect 

of, the donor eligibility determination 

for animal cells, tissues, and cell- and 

tissue-based products (ACTPs), which 

meet the definition of new animal drugs 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). Donor 

eligibility is a critical component of 

current good manufacturing practices 

(CGMPs) when manufacturing ACTPs. A 

donor should be considered eligible to 

donate ACTPs only if screening of the 

donor shows that the donor is free from 

risk factors for, and clinical evidence of, 

infection with relevant disease agents 

and diseases, and the donor (and 

product/source material) test results for 

relevant disease agents are negative or 

nonreactive. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 22, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

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–0401 for ‘‘Donor Eligibility for 

Animal Cells, Tissues, and Cell- and 

Tissue-Based Products.’’ 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 Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed 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: 

Lynne Boxer, Center for Veterinary 

Medicine (HFV–114), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0611, 

Lynne.Boxer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (GFI) #254 

entitled ‘‘Donor Eligibility for Animal 

Cells, Tissues, and Cell- and TissueBased Products.’’ This draft guidance is 

for sponsors, firms, individuals, and 

establishments that participate in the 

manufacture of, or perform any aspect 

of, the donor eligibility determination 

for ACTPs, which meet the definition of 

new animal drugs under section 201(v) 

of the FD&C Act (21 U.S.C. 321(v)). 

ACTPs that are intended for use in the 

diagnosis, cure, mitigation, treatment, or 

prevention of disease or are intended to 

affect the structure or function of the 

animal generally meet the definition of 

a new animal drug. All new animal 

drugs, including ACTPs, are required to 

be manufactured in accordance with 

CGMPs to ensure that such drugs meet 

the requirements of the FD&C Act as to 

safety, and have the identity, strength, 

quality, and purity characteristics that 

they purport to or are represented to 

possess. Advances in the field of 

veterinary regenerative medicine have 

resulted in increasing research into 

veterinary applications for ACTPs, and 

many of these products are intended for 

use as new animal drugs. 

Donor eligibility is a critical 

component of CGMPs when 

manufacturing ACTPs. Selecting 

appropriate donors is critical to product 

quality and compliance with ACTP 

CGMPs. Establishments performing any 

function related to donor eligibility 

should comply with the ACTP CGMPs 

related to that function. A donor should 

be considered eligible to donate ACTPs 

only if screening of the donor shows 

that the donor is free from risk factors 

for, and clinical evidence of, infection 

with relevant disease agents and 


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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. 


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