52910 Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices 

Description: This descriptive study 

aims to provide insight into the models 

that have been used to centralize 

services; organizations’ history of and 

impetus for centralizing services; the 

benefits, challenges, and costs of 

centralizing services from the 

perspectives of staff and clients; and 

how organizations have coordinated 

their centralized services virtually. This 

project will include site visits to three 

centralized community resource centers 

(CCRCs). The proposed information 

collection activities include interviews 

with staff, including leadership and 

administrative staff, frontline staff, 

finance staff, and IT/data staff, and 

focus groups with clients. The research 

team will also conduct observations of 

program activities. 

Respondents: Respondents will 

include leadership and administrative 

staff at the CCRC, staff who manage 

finances at the CCRC, staff who manage 

data and/or technology at the CCRC, 

staff who provide services directly to 

clients at the CCRC, and clients who 

have accessed services at the CCRC. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Interview guide for administrative/leadership staff .......................................... 18 1 1.25 23 

Interview guide for frontline staff ..................................................................... 48 1 1.25 60 

Interview guide for finance staff ...................................................................... 9 1 1 9 

Interview guide for IT/data staff ....................................................................... 9 1 1 9 

Focus group guide for clients .......................................................................... 30 1 1.5 45 

Estimated Total Annual Burden 

Hours: 146. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Authorized by the Social 

Security Act 1110 [42 U.S.C. 1310], 

appropriated by the Continuing 

Appropriations Act of 2019. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–20556 Filed 9–22–21; 8:45 am] 

BILLING CODE 4184–07–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB #0970–0391] 

Proposed Information Collection 

Activity; National Survey of Early Care 

and Education COVID–19 Follow-Up 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), plans to request from 

the Office of Management and Budget 

(OMB) an extension to complete data 

collection for a two-wave COVID–19 

Follow-up data collection currently 

underway as part of the National Survey 

of Early Care and Education (NSECE). 

The objective of the NSECE COVID–19 

Follow-up is to document the nation’s 

current supply of early care and 

education services (that is, home-based 

providers, center-based providers, and 

the center-based provider workforce). 

There are no changes proposed. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: In the context of the 

COVID–19 pandemic, the NSECE 

COVID–19 Follow-up will deepen our 

understanding of the state of ECE 

supply and the ECE workforce following 

the initial period of crisis, including 

changes in supply or departures from 

and re-entries to the workforce. The 

NSECE COVID–19 Follow-up is 

collecting information from centerbased ECE providers to children birth 

through age 5 years, not yet in 

kindergarten, home-based ECE 

providers that serve children under age 

13, as well as the ECE workforce 

providing these services. The collection 

consists of three coordinated nationally 

representative surveys: 

1. A two-wave survey of individuals 

who provided paid care for children 

under the age of 13 in a residential 

setting as of 2019 and participated in 

the 2019 NSECE (Home-based Provider 

Interview), 

2. a two-wave survey of providers of 

care to children ages 0 through 5 years 

of age (not yet in kindergarten) in a nonresidential setting (Center-based 

Provider Interview) as of 2019 and that 

participated in the 2019 NSECE, and 

3. a two-wave survey conducted with 

individuals employed in center-based 


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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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