3224 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

appears to have no conflict of interest 

that would preclude membership. 

We are requesting that all curricula 

vitae include the following: 

• List of areas of expertise 

• Title and current position 

• Professional affiliation 

• Home and business address 

• Telephone numbers (Please specify if 

the number is for: home, office, or cell 

phone) 

• Email address (Please specify if the 

email address is for work/personal) 

In the nomination letter, we are 

requesting that nominees specify 

whether they are applying for a patient 

advocate position, an at-large standing 

position, or as an industry 

representative. Potential candidates will 

be asked to provide detailed information 

concerning such matters as financial 

holdings, consultancies, and research 

grants or contracts in order to permit 

evaluation of possible sources of 

financial conflict of interest. Department 

policy prohibits multiple committee 

memberships. A federal advisory 

committee member may not serve on 

more than one committee within an 

agency at the same time. 

Members may be invited to serve for 

overlapping 2-year terms. A member 

may continue to serve after the 

expiration of the member’s term until a 

successor is named. Any interested 

person may nominate one or more 

qualified persons. Self-nominations are 

also accepted. Individuals interested in 

the representative positions are 

encouraged to include a letter of support 

from the organization or interest group 

they would represent. 

III. Collection of Information 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Chief Medical Officer and 

Director of the Center for Clinical 

Standards and Quality for the Centers 

for Medicare & Medicaid Services 

(CMS), Dora Hughes, having reviewed 

and approved this document, authorizes 

Chyana Woodyard, who is the Federal 

Register Liaison, to electronically sign 

this document for purposes of 

publication in the Federal Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2025–00391 Filed 1–13–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Tribal Maternal, Infant, and 

Early Childhood Home Visiting 

(MIECHV) Program Community Needs 

and Readiness Assessment Guidance 

and Implementation Plan Guidance 

(Office of Management and Budget#: 

0970–0611) 

AGENCY: Office of Early Childhood 

Development, 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), Office of 

Early Childhood Development (ECD) is 

requesting revisions to the Tribal 

Maternal, Infant, and Early Childhood 

Home Visiting Program Community 

Needs and Readiness Assessment 

Guidance and Implementation Plan 

Guidance (Office of Management and 

Budget (OMB) #: 0970–0611; expiration 

June 30, 2026) and a 3-year extension of 

approval. 

DATES: Comments due March 17, 2025. 

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 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: Section 511(e)(8)(A) of 

title V of the Social Security Act 

requires that grantees under the Tribal 

MIECHV program, in the first year of 

their grants, submit an implementation 

plan on how they will meet the 

requirements of the program. Section 

511(h)(2)(A) further states that the 

requirements for the MIECHV grants to 

Tribes, Tribal organizations, and urban 

Indian organizations are to be 

consistent, to the greatest extent 

practicable, with the requirements for 

grantees under the MIECHV program for 

states and jurisdictions. 

ACF ECD, in collaboration with the 

Health Resources and Services 

Administration’s Maternal and Child 

Health Bureau, awarded grants for the 

Tribal MIECHV Program (Tribal Home 

Visiting) to support cooperative 

agreements to conduct community 

needs assessments; plan for and 

implement high-quality, culturally 

relevant, evidence-based home visiting 

programs in at-risk Tribal communities; 

establish, measure, and report on 

progress toward meeting performance 

measures in six legislatively mandated 

benchmark areas; and conduct rigorous 

evaluation activities to build the 

knowledge base on home visiting among 

Native populations. 

During the first grant year, Tribal 

Home Visiting grantees must comply 

with the requirement to conduct a 

Community Needs and Readiness 

Assessment (CNRA) and submit an 

implementation plan that should feature 

planned activities to be carried out 

under the program in years 2–5 of their 

cooperative agreements. To assist 

grantees with meeting these 

requirements, ACF created a CNRA and 

implementation guidance for grantees to 

use when writing their plans. The 

CNRA Guidance and Implementation 

Plan Guidance (IPG) specifies that 

grantees must provide a plan to address 

the following areas: 

• CNRA 

• Program Design 

• Program Blueprint 

• Plan for Data Collection, Management, 

and Performance Measurement 

• Fidelity Monitoring and Quality 

Assurance 

The previous guidance included 

information about the CNRA and the 

implementation plan for grant 

recipients. This extension request 

updates the guidance by separating the 

CNRA Guidance from the IPG. This 

separation allows the CNRA Guidance 

to function as an independent 

document, enhancing clarity and 

usability instead of being incorporated 

within the IPG. 

Additionally, significant 

modifications have been made to the 

guidance compared to earlier versions, 

with a primary focus on reducing the 

burden on grant recipients. These 

changes include eliminating redundant 

sections that overlap with other 

reporting requirements, reducing the 

number of guiding questions, and 

allowing for shorter responses. 

Respondents: Tribal Home Visiting 

Managers (information collection does 

not include direct interaction with 

individuals or families that receive the 

services). 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3225 

ANNUAL BURDEN ESTIMATES

Instrument 

Total number 

of 

respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

Implementation Plan Guidance for Development and Implementation Grantees ..................................................... 27 1 450 12,150 4,050 

DIG Community Needs and Readiness Assessment .......... 27 1 450 12,150 4,050 

Totals: ........................................................................... ........................ ........................ ........................ 24,300 8,100 

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: Title V of the Social 

Security Act, sections 511(e)(8)(A) & 

511(h)(2)(A) 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2025–00556 Filed 1–13–25; 8:45 am] 

BILLING CODE 4184–77–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5890] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Drug User 

Fee Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with our generic 

drug user fee program. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 17, 2025. 

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 

March 17, 2025. 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– 

2024–N–5890 for ‘‘Generic Drug User 

Fee Program.’’ 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 

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 


khammond on DSK9W7S144PROD with NOTICES