1508 Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 

1Section 6101 of the Consolidated 

Appropriations Act, 2023, Public Law 117–328, 

recently amended Section 511 of the Social Security 

Act, as added by the Patient Protection and 

Affordable Care Act, Public Law 111–148, section 

2951, and extended appropriated funding through 

FY 2027. 

2 42 U.S.C. 711(d)(3)(C)(i). 

3The current HHS criteria for evidence-based 

models can be found at: https://

homvee.acf.hhs.gov/about-us/hhs-criteria. 

4HRSA, HHS. ‘‘Statutory Requirements and 

Process Standardization: Maternal, Infant, and Early 

Childhood Home Visiting (MIECHV) Program 

Model Eligibility Review.’’ Federal Register 86, no. 

184 (September 27, 2021): 53329. https://

www.federalregister.gov/d/2021-20853. 

5HomVEE lists home visiting models that meet 

HHS criteria for evidence of effectiveness at: 

https://homvee.acf.hhs.gov/HRSA-Models-EligibleMIECHV-Grantees. 

facts supporting the unfavorable factors 

outweigh those supporting the favorable 

factor, and therefore warrant imposition 

of a five-year period of debarment.’’ 

III. Findings and Order 

Therefore, the OSI Director, under 

section 306(b)(1) of the FD&C Act and 

authority delegated to him by the 

Commissioner of Food and Drugs, finds 

that Jiao has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance and 

is subject to debarment, as set forth in 

section 306(b)(3)(C) of the FD&C Act. 

FDA has considered the applicable 

factors listed in section 306(c)(3) of the 

FD&C Act and determined that a 

debarment period of 5 years is 

appropriate. 

As a result of the foregoing finding, 

Jiao is debarred for a period of 5 years 

from importing or offering for import 

any drug into the United States, 

effective January 8, 2025. Pursuant to 

section 301(cc) of the FD&C Act, the 

importing or offering for import into the 

United States of any drug by, with the 

assistance of, or at the direction of Jiao, 

is a prohibited act. 

Dated: December 31, 2024. 

George M. Warren, 

Director, Office of Scientific Integrity. 

[FR Doc. 2025–00126 Filed 1–7–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Maternal, 

Infant, and Early Childhood Home 

Visiting Program Model Eligibility 

Review Survey 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice with request for 

comment. 

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. 

Specifically, HRSA is inviting public 

comment on its proposed survey to 

identify evidence-based service delivery 

models that funding recipients may use 

to provide services under HRSA’s 

MIECHV Program. 

DATES: Comments on this ICR should be 

received no later than March 10, 2025. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14NWH04, 5600 Fishers 

Lane, Rockville, Maryland, 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 Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Maternal, Infant, and Early Childhood 

Home Visiting (MIECHV) Program 

Model Eligibility Review Survey, OMB 

No. 0915–xxxx—New 

Abstract: HRSA, through its Maternal 

and Child Health Bureau, oversees the 

MIECHV Program in partnership with 

the Administration for Children and 

Families (ACF) within HHS. The 

MIECHV Program supports voluntary, 

evidence-based home visiting services 

during pregnancy and to families with 

young children up to kindergarten entry 

living in at-risk communities. The 

MIECHV Program was last reauthorized 

in December 2022.1 One key program 

requirement is that programs deliver 

services using models that meet HHS 

criteria for evidence of effectiveness.2

HRSA and ACF define such service 

delivery models as ‘‘evidence-based.’’ 

ACF administers the Home Visiting 

Evidence of Effectiveness (HomVEE) 

review process to identify early 

childhood home visiting models that 

demonstrate evidence of effectiveness.3

However, not all evidence-based service 

delivery models approved through the 

HomVEE process meet MIECHV 

statutory requirements as enacted in the 

last reauthorization of the program in 

2022 such that they may be used to 

carry out the MIECHV Program in 

fidelity to applicable program 

requirements. 

HRSA previously issued a Request for 

Information notice and request for 

comment regarding its proposal to 

standardize criteria for assessing model 

eligibility to be implemented using 

MIECHV Program funds in 2021.4 This 

ICR reflects new MIECHV statutory 

provisions that were added in December 

2022 and thus replaces that 2021 notice. 

HRSA is issuing this ICR to propose a 

survey to identify service delivery 

models that meet both HHS criteria for 

evidence of effectiveness, as determined 

by HomVEE review, and applicable 

MIECHV statutory requirements, and 

therefore may be used by eligible 

entities to provide home visiting 

services through the MIECHV Program. 

This will be accomplished by validating 

whether evidence-based models, as 

determined by HomVEE, align with the 

MIECHV Program’s statutory 

requirements, as further discussed in 

this notice. This process will ensure that 

models used by funding recipients (and 

their local implementing agencies) to 

deliver MIECHV Program services 

effectively support programs in meeting 

core components of the MIECHV 

Program, including those added during 

the program’s 2022 reauthorization. 

Following approval of this ICR 

request, HRSA will assess all models 

that meet HHS criteria for evidence of 

effectiveness, as determined by the 

HomVEE review, to determine their 

MIECHV eligibility by requesting 

information from home visiting model 

developers through a standardized 

survey. As of November 20, 2024, 

HomVEE lists 24 models that meet HHS 

criteria for evidence of effectiveness.5

Upon receiving the survey from HRSA, 

model developers will have 30 days to 

provide requested information on model 

characteristics, resources, and 

processes. A panel of HRSA reviewers 

will assess the survey responses against 

the MIECHV statutory requirements. 

Any of the 24 evidence-based models 

that also meet these criteria will be 

considered eligible for MIECHV 

Program implementation and remain 

eligible for implementation after the end 

of the current performance period. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 1509 

6 42 U.S.C. 711(d)(3)(A)(i)(I). 

7 42 U.S.C. 711(d)(3)(A)(i)(I). 

8 42 U.S.C. 711(d)(4)(B). 

9HRSA proposes to identify service delivery 

models that may be used by MIECHV funding 

recipients because they comply with statutory 

requirements applicable to service delivery models 

and support MIECHV statutory program 

requirements. Such models, in addition to meeting 

the service delivery model requirements in 

subsections 711(d)(3)(A)(i) and 711(d)(4)(B), must 

also support program requirements, including those 

in subsections 711(d)(3)(C) and 711(e). 

10 42 U.S.C. 711(d)(3)(C)(ii). 

11 42 U.S.C. 711(d)(3)(C)(iii). 

12 42 U.S.C. 711(d)(3)(C)(iv). 

13 42 U.S.C. 711(d)(3)(C)(v). 

14 42 U.S.C. 711(d)(3)(C)(vi). 

15 42 U.S.C. 711(e)(7)(A). 

16HRSA proposes to identify service delivery 

models that may be used by MIECHV funding 

recipients because they comply with statutory 

requirements applicable to service delivery models 

and support MIECHV statutory program 

requirements. 

17 42 U.S.C. 711(d)(3)(B). 

18 42 U.S.C. 711(d)(3)(C)(vii), 711(e)(10)(C). 

Models that do not meet these criteria 

will not be eligible to be used by eligible 

entities (and their local implementing 

agencies) to carry out the MIECHV 

Program and may continue to be used 

only through the currently applicable 

period of performance. HRSA will work 

with eligible entities regarding any 

changes in model approval that may 

affect their program implementation 

because certain models will no longer 

be available for use; however, eligible 

entities will be expected to propose 

projects using models approved for 

MIECHV Program implementation 

under future funding awards. Model 

developers may submit a written request 

for reconsideration of HRSA’s decision 

within 15 days of receiving a negative 

determination and should provide any 

available supporting information for 

their request. HRSA will have 45 days 

after the receipt of the request to 

reassess the model. 

After HRSA completes the initial 

review, all eligible models may be 

reassessed against the statutory 

requirements through the routine, 

periodic HomVEE review process for 

models that have already met HHS 

criteria for evidence of effectiveness. 

HRSA and ACF will continue to 

collaborate in future years to assess 

home visiting models against MIECHV 

statutory requirements. 

HRSA seeks public comment on the 

proposed methodology HRSA proposes 

to use to identify service delivery 

models that meet MIECHV statutory 

requirements, including how the 

proposed changes will affect interested 

parties such as eligible entities, model 

developers, and eligible families 

receiving MIECHV services. 

MIECHV Program Statutory 

Requirements for Home Visiting Models: 

The MIECHV Program’s authorizing 

statute mandates that funding recipients 

implementing the program use a service 

delivery model that meets specific 

statutory requirements. Models must 

‘‘conform to a clear consistent home 

[visiting] model that has been in 

existence for at least 3 years and is 

research-based, grounded in relevant 

empirically-based knowledge, linked to 

program determined outcomes, [and is] 

associated with a national organization 

or institution of higher education that 

has comprehensive home visitation 

program standards that ensure highquality service delivery and continuous 

program quality improvement.’’ 6 Under 

the statute, the model must also have 

demonstrated significant sustained 

positive outcomes in statutory 

benchmark areas and participant 

outcomes when evaluated using welldesigned and rigorous randomized 

controlled research designs, and the 

evaluation results have been published 

in a peer-reviewed journal; or quasiexperimental research designs.7 The 

2022 reauthorization also added a new 

requirement that the ‘‘standards for 

training requirements applicable to 

virtual service delivery under a home 

visiting model shall be equivalent to 

those that apply to in-person service 

delivery under the model.’’ 8

To ensure programs comply with 

MIECHV statutory requirements,9

service delivery models also must 

support the delivery of home visiting 

services through the employment of 

well-trained and competent staff 10 that 

receive ongoing high-quality 

supervision,11 support programs’ strong 

organizational capacity to implement 

home visiting activities 12 and ability to 

establish appropriate linkages and 

referral networks to other community 

resources and supports for participating 

families,13 monitor the fidelity of 

program implementation to ensure 

services are delivered in fidelity to the 

specified model,14 and ensure voluntary 

participation in the program.15 The 

2022 reauthorization also requires 

MIECHV programs 16 to implement 

service delivery home visiting models 

that provide or support targeted, 

intensive home visiting services for 

high-risk populations 17 and support the 

delivery of home visiting services 

through at least one in-person home 

visit for each participating family during 

each 12-month period of enrollment.18

Need and Proposed Use of the 

Information: Section 711 establishes 

statutory requirements for the MIECHV 

Program. Information gained from this 

information collection will inform 

determinations of which service 

delivery models are eligible to be 

implemented in the MIECHV Program. 

Likely Respondents: Organizations 

that develop, support implementation 

of, and implement early childhood 

home visiting models that meet HHS 

criteria for evidence of effectiveness, as 

determined by HomVEE review. 

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. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

MIECHV Program Model Eligibility Review Survey ............. 24 1 24 3 72 

Total .............................................................................. 24 ........................ 24 ........................ 72 


lotter on DSK11XQN23PROD with NOTICES1
1510 Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 

HRSA specifically requests comments 

on: (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2025–00129 Filed 1–7–25; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Center for Indigenous Innovation and 

Health Equity Tribal Advisory 

Committee; Solicitation of 

Nominations for Delegates 

AGENCY: Office of Minority Health, 

Office of the Secretary, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

Office of Minority Health (OMH) hereby 

gives notice that OMH is accepting 

nominations of candidates to serve as 

primary and alternate delegates for the 

Center for Indigenous Innovation and 

Health Equity Tribal Advisory 

Committee (CIIHE TAC). 

DATES: Tribal leaders are encouraged to 

submit their nomination letters for 

CIIHE TAC delegates by January 17, 

2024, at the address listed below. OMH 

will continue to receive nominations 

until all CIIHE TAC primary and 

alternate delegate positions are filled. 

ADDRESSES: All nominations should be 

emailed to minorityhealth@hhs.gov. 

Please use the subject line ‘‘CIIHE TAC 

Nomination.’’ 

FOR FURTHER INFORMATION CONTACT: For 

information and guidance about the 

nomination process for CIIHE TAC 

delegates, please contact Rochelle 

Rollins, Senior Policy Advisor, at 

Rochelle.Rollins@hhs.gov. Sample 

CIIHE TAC nomination letters are 

available on the OMH website: https:// 

minorityhealth.hhs.gov/ciihe-tribaladvisory-committee-tac. 

SUPPLEMENTARY INFORMATION: 

Authorized under Section 1707 of the 

Public Health Service Act, 42 U.S.C. 

300u–6, as amended, the mission of 

OMH is to improve the health of racial 

and ethnic minority and American 

Indian and Alaska Native (AI/AN) 

populations through the development of 

health policies and programs that help 

eliminate health disparities. OMH 

awards and other activities are intended 

to support the identification of effective 

policies, programs, and practices that 

improve health outcomes and to 

promote the sustainability and 

dissemination of these approaches. 

Through the Joint Explanatory 

Statement (JES) accompanying the 2021 

Consolidated Appropriations Act, 

Congress directed OMH to create the 

CIIHE to advance Indigenous solutions 

that ultimately address health 

disparities in AI/AN and Native 

Hawaiian and Pacific Islander 

populations. Congress identified four 

CIIHE priority areas: research, 

education, service, and policy 

development. The JES accompanying 

the subsequent annual appropriations 

acts has included language for OMH to 

continue funding the CIIHE. 

OMH established the CIIHE TAC to 

provide Tribal leaders a venue to 

exchange views, share information, and 

provide feedback to OMH on the 

development of activities addressing the 

four CIIHE priority areas. The CIIHE 

TAC shall support, but not supplant, 

government-to-government consultation 

activities that OMH undertakes. 

TAC Membership: The CIIHE TAC 

will consist of 16 delegate positions: one 

from each of the 12 geographic areas 

served by the Indian Health Service 

(IHS) and four National At-Large 

Member positions. 

Alaska Area 

Albuquerque Area 

Bemidji Area 

Billings Area 

California Area 

Great Plains Area 

Nashville Area 

Navajo Area 

Oklahoma Area 

Phoenix Area 

Portland Area 

Tucson Area 

National At-Large Members (4) 

The CIIHE TAC charter establishes a 

two (2) year term length for each 

delegate. There are vacancies for all IHS 

areas, except the Navajo and Tucson 

Areas, due to the ending of the CIIHE 

TAC members’ 2-year terms. 

Eligibility: The CIIHE TAC delegates 

must be: (1) Elected Tribal officials from 

a federally recognized Tribe acting in 

their official capacity as elected officials 

of their Tribe, with authority to act on 

behalf of the Tribe; or (2) individuals 

designated by an elected Tribal official. 

Designees must have the authority to act 

on behalf of the Tribal official and the 

Tribe and be qualified to represent the 

views of the AI/AN Tribes in the area 

from which they are nominated. No 

delegate of the CIIHE TAC may be an 

employee of the federal government. 

Nomination Procedures: CIIHE TAC 

candidates must be nominated by an 

elected Tribal leader. The nomination 

letter must be on Tribal letterhead and 

signed by an elected Tribal leader, and 

must include the following information: 

• Name of the nominee 

• Nominee’s official title 

• Name of the nominee’s tribe 

• Date of nominee’s election to official 

Tribal position and term length 

• Nominee’s contact information 

(mailing address, phone, and email) 

• Nominee’s expertise that is relevant to 

the CIIHE TAC 

• Name of Tribal leader submitting the 

nomination 

• Official title of Tribal leader 

submitting the nomination 

• Contact information for Tribal leader 

submitting the nomination and/or the 

administrative office for the Tribal 

government 

Sample CIIHE TAC nomination letters 

are available on the OMH website: 

https://minorityhealth.hhs.gov/ciihetribal-advisory-committee-tac. 

Selection Process: OMH is responsible 

for selecting and finalizing CIIHE TAC 

delegates. 

Eligible nominees will be considered 

in the following priority order: 

1. Tribal President/Chairperson/ 

Governor 

2. Tribal Vice-President/ViceChairperson/Lt. Governor 

3. Elected or Appointed Tribal Official 

4. Designated Tribal Official with 

authority to act on behalf of the 

Tribal Leader 

In the event there are multiple 

nominations for a given IHS area, OMH 

will determine the delegates based on a 

review of the submitted nomination 

materials. 

Nominees will be notified of the 

status of delegate selection in February 

2024. 

Dated: December 16, 2024. 

Capt. Tarsha Cavanaugh, 

Principal Deputy Director, Office of Minority 

Health. 

[FR Doc. 2025–00210 Filed 1–7–25; 8:45 am] 

BILLING CODE 4150–29–P 


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