15584 Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices 

obtained NPIs to review their NPPES 

records to ensure that the information 

they furnished when applying for their 

NPIs is up-to-date and accurate. 

B. Impact on FOIA-Releasable NPPES 

Data 

The NPPES Data Dissemination notice 

identified both the provider location 

address and provider gender code as 

NPPES data elements that must be 

released under FOIA. The changes to 

these data elements described in section 

II. of this notice do not affect HHS’s 

assessment of their releasability under 

FOIA and the data elements will 

continue to be made available to the 

public through the NPI registry and the 

NPI downloadable files. 

III. Collection of Information 

Requirements 

This document imposes new 

information for collection and 

recordkeeping requirements. It makes 

reference to an existing information 

collection request that will be revised as 

a result of the revised data elements 

discussed in this notice. Specifically, 

we will submit a non-substantive 

change request to OMB for review and 

approval of the data element revisions 

associated with the information 

collection request currently approved 

under 0938–0931. 

Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on February 

27, 2024. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–04517 Filed 3–1–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Head Start REACH: 

Strengthening Outreach, Recruitment, 

and Engagement Approaches With 

Families—Mixed Methods Study (New 

Collection) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, U.S. Department 

of Health and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF) within the 

U.S. Department of Health and Human 

Services (HHS) is proposing to collect 

data on different approaches that Head 

Start programs use to recruit, select, and 

enroll families, and the ways in which 

such practices reflect programs’ 

community contexts. We are not 

attempting to recruit a nationally 

representative sample. Instead, the 

study will aim to obtain a variety of 

eligibility, recruitment, selection, 

enrollment, and attendance (ERSEA) 

practices and experiences to explore 

how these practices and experiences 

intersect with different adversities, 

demographic characteristics, and 

community contexts. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing OPREinfo

collection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: Building on information 

collected previously through case 

studies (OMB #0970–0580), the Head 

Start REACH: Strengthening Outreach, 

Recruitment, and Engagement 

Approaches with Families Project is 

proposing to conduct a mixed-methods 

study to expand understanding of (1) 

how Head Start programs implement 

recruitment, selection, and enrollment 

practices; and (2) the ways in which 

practices reflect programs’ community 

contexts. The mixed-methods study 

would achieve several goals including 

(1) providing in-depth contextual 

information about recruitment, 

selection, and enrollment practices and 

experiences; (2) identifying promising 

recruitment, selection, and enrollment 

practices and experiences; and (3) 

informing training and technical 

assistance regarding recruitment, 

selection, and enrollment challenges 

and needs. We will aim to collect 

information from 60 Head Start and 

Early Head Start programs in 15 

geographic areas in states, from Head 

Start regions I–X, located in census 

tracts where the rate of deep poverty is 

high. 

We will collect information about the 

characteristics of families in Head Start 

programs and their communities; 

programs’ enrollment numbers and 

goals; programs’ use and perceived 

effectiveness of and challenges with 

recruitment, selection, and enrollment 

practices; promising recruitment, 

selection, and enrollment practices for 

potential future replication; families’ 

reasons for choosing Head Start and 

experiences with and perceptions of 

recruitment, selection, and enrollment 

practices; and how community partner 

staff support recruitment, selection, and 

enrollment of families into Head Start. 

The findings are intended to help Head 

Start programs understand how to 

support the needs of families facing 

adversities. We will disseminate 

findings in a report, research brief, and 

presentations or briefings. 

Respondents: Head Start program 

directors (one per program), ERSEA lead 

staff (one per program), Head Start 

parents/caregivers (up to 10 per 

program), and staff from community 

organizations with which Head Start 

programs partner for ERSEA activities 

(four in each geographic area). 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Average 

burden per 

response 

(in hours) 

Total/annual 

burden 

(in hours) 

Program director survey (Instrument 1) .......................................................... 60 1 0.17 10.2 

ERSEA lead staff survey (Instrument 2) ......................................................... 60 1 0.75 45 

Onsite coordination a ........................................................................................ 60 1 1.5 90 

Head Start parent/caregiver survey (Instrument 3) ......................................... 600 1 0.5 300 

Community partner survey (Instrument 4) ....................................................... 60 1 0.25 15 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices 15585 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Average 

burden per 

response 

(in hours) 

Total/annual 

burden 

(in hours) 

ERSEA lead staff focus group guide (Instrument 5) ....................................... 24 1 1.5 36 

Estimated Total Annual Burden Hours ..................................................... ............................ ............................ .................... 496.2 

aThere is no instrument associated with this activity. We will ask each program director to nominate a staff person who will help coordinate 

data collection activities. This line accounts for the time of the onsite coordinator. 

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: Head Start Act Section 640 

[42 U.S.C. 9835]. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–04520 Filed 3–1–24; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–E–2460] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SOTYKTU 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for SOTYKTU and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by May 3, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

September 3, 2024. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

May 3, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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– 

2023–E–2460 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; SOTYKTU.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 


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