Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices 52911 

child care programs working directly 

with children in classrooms (Centerbased Classroom Staff [Workforce] 

Interview) as of 2019 and who 

participated in the 2019 NSECE. 

Respondents: Home-based providers 

as of 2019 serving children under 13 

years (listed and unlisted paid)— 

regardless of their status serving 

children in 2020–2022, center-based 

child care providers as of 2019 serving 

children ages 0 through 5 years of age 

(not yet in kindergarten)—regardless of 

their status serving children in 2020– 

2022, and classroom-assigned 

instructional staff members working 

with children ages 0 through 5 years of 

age (not yet in kindergarten) in centerbased child care providers as of 2019, 

regardless of their employment status in 

2020–2022. 

Annual Burden Estimates: This 

request is for an extension through 

spring 2022. 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total burden 

(in hours) 

Home-based Provider Interview, Wave 2—In ECE during focal week ........... 2,025 1 0.35 709 

Home-based Provider Interview, Wave 2—Not in ECE during focal week .... 506 1 0.25 126 

Center-based Provider Interview, Wave 2 spring or fall; in ECE during focal 

week ............................................................................................................. 3,291 1 0.38 1,251 

Center-based Provider Interview, Wave 2 spring or fall; not in ECE during 

focal week .................................................................................................... 1,097 1 0.22 241 

Center-based Provider Fall 2021 Funding Receipt Supplement ..................... 1,255 1 0.20 251 

Center-based Provider Interview Wave 2 fall; Centers completing in Wave 2 

spring also .................................................................................................... 1,136 1 0.29 329

(Center-based) Workforce Interview—Wave 2; In ECE during Focal Week .. 1,775 1 0.37 657 

(Center-based) Workforce Interview—Wave 2; Not in ECE during Focal 

Week ............................................................................................................ 874 1 0.24 210 

Estimated Total Burden Hours: 3,774. 

Authority: Child Care and 

Development Block Grant (CCDBG) Act 

of 1990 as amended by the CCDBG Act 

of 2014 (Pub. L. 113–186). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–20573 Filed 9–22–21; 8:45 am] 

BILLING CODE 4184–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0399] 

Good Manufacturing Practices 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, Agency, or we) is 

announcing the availability of a draft 

guidance for industry #253 entitled 

‘‘Good Manufacturing Practices for 

Animal Cells, Tissues, and Cell- and 

Tissue-Based Products.’’ FDA’s Center 

for Veterinary Medicine (CVM) is 

issuing this guidance to provide 

establishments that manufacture animal 

cells, tissues, and cell- and tissue-based 

products (ACTPs) meeting the definition 

of new animal drugs with 

recommendations for meeting 

requirements for current good 

manufacturing practices (CGMPs). 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 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) as to safety, and have the 

identity, strength, quality, and purity 

characteristics, which they purport to or 

are represented to possess. This 

guidance also provides FDA’s 

recommendations for those aspects of 

manufacturing specific to ACTPs in 

accordance with existing CGMP 

regulations, as applicable, and with the 

FD&C Act. In this guidance, we 

specifically address the methods, 

facilities, and controls used for 

manufacturing ACTPs. 

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–0399 for ‘‘Good Manufacturing 

Practices for Animal Cells, Tissues, and 

Cell- and Tissue-Based Products.’’ 


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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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