Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 3227 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden 

per 

response 

Total hours 

Submission of Generic Drug User Fee Cover Sheet .......... 500 7.616 3,808 0.5 

(30 minutes) 

1,904 

Submission of Controlled Correspondence as Discussed 

in Agency Topic-Specific Guidance Documents .............. 400 12.5 5000 5 25,000 

Total .............................................................................. ........................ ........................ 8,808 ........................ 26,904 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated is based on available 

Agency data. Our burden estimate 

reflects an overall increase attributable 

to the inclusion of controlled 

correspondence and new generic drug 

product CPA requests. 

Dated: January 7, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00564 Filed 1–13–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Physician-Focused Payment Model 

Technical Advisory Committee; 

Meetings 

ACTION: Notice of meetings. 

SUMMARY: This notice announces the 

2025 meetings of the Physician-Focused 

Payment Model Technical Advisory 

Committee (PTAC). These meetings 

include deliberation and voting on 

proposals for physician-focused 

payment models (PFPMs) submitted by 

individuals and stakeholder entities and 

may include discussions on topics 

related to current or previously 

submitted PFPMs. All meetings are 

open to the public. 

DATES: The 2025 PTAC meetings will 

occur on the following dates: 

D Monday–Tuesday, March 3–4, 2025, 

from 9 a.m. to 5 p.m. ET 

D Tuesday–Wednesday, June 3–4, 2025, 

from 9 a.m. to 5 p.m. ET 

D Monday–Tuesday, September 8–9, 

2025, from 9 a.m. to 5 p.m. ET 

D Tuesday–Wednesday, December 9–10, 

2025, from 9 a.m. to 5 p.m. ET 

Please note that times are subject to 

change. If the times change, the ASPE 

PTAC website will be updated (https:// 

aspe.hhs.gov/ptac-physician-focusedpayment-model-technical-advisorycommittee) and registrants will be 

notified directly via email. 

ADDRESSES: All PTAC meetings will be 

held virtually and/or in the Great Hall 

of the Hubert H. Humphrey Building, 

200 Independence Avenue SW, 

Washington, DC, 20201. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Shats, Designated Federal Officer at 

Lisa.Shats@hhs.gov (202) 875–0938. 

SUPPLEMENTARY INFORMATION: 

Agenda and Comments. PTAC will 

hear presentations on proposed PFPMs 

that have been submitted by individuals 

and stakeholder entities and/or 

discussion on topics related to current 

or previously submitted PFPMs. 

Regarding proposed PFPMs, following 

each presentation, PTAC will deliberate 

on the proposed PFPM. If PTAC 

completes its deliberation, PTAC will 

vote on the extent to which the 

proposed PFPM meets criteria 

established by the Secretary of Health 

and Human Services and on an overall 

recommendation to the Secretary (if 

applicable). Time will be allocated for 

public comments. The agenda and other 

documents will be posted on the PTAC 

section of the ASPE website, https://

aspe.hhs.gov/ptac-physician-focusedpayment-model-technical-advisorycommittee, prior to the meeting. The 

agenda is subject to change. If the 

agenda does change, registrants will be 

notified directly via email, the website 

will be updated, and notification will be 

sent out through the PTAC email 

listserv (https://list.nih.gov/cgi-bin/ 

wa.exe?A0=PTAC to subscribe). 

Meeting Attendance. These meetings 

are open to the public and may be 

hosted in-person or virtually. We intend 

that in-person meetings will be held in 

the Great Hall of the Hubert H. 

Humphrey Building. The public may 

attend in person, when feasible, 

virtually, or view the meeting via 

livestream at www.hhs.gov/live. 

Information about how to access the 

meeting virtually or via livestream will 

be sent to registrants prior to the 

meeting; and a telephone number will 

be sent to registrants participating via 

the dial-in only option prior to the 

meeting. Space may be limited, and 

registration is preferred. When 

registration opens, a link to the 

registration page will be available at 

https://aspe.hhs.gov/collaborationscommittees-advisory-groups/ptac/ptacmeetings prior to the meeting. 

Registrants will receive a confirmation 

email shortly after completing the 

registration process. 

Special Accommodations. If sign 

language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact 

PTAC@hhs.gov, no later than two weeks 

prior to the scheduled meeting. 

Authority. 42 U.S.C. 1395(ee); section 

101(e)(1) of the Medicare Access and 

CHIP Reauthorization Act of 2015; 

section 51003(b) of the Bipartisan 

Budget Act of 2018. 

PTAC is governed by provisions of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C app.), which sets 

forth standards for the formation and 

use of federal advisory committees. 

Dated: January 3, 2025. 

Tisamarie B. Sherry, 

Deputy Assistant Secretary for Behavioral 

Health, Disability and Aging Policy, 

Performing the Delegable Duties of the 

Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2025–00612 Filed 1–13–25; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 


khammond on DSK9W7S144PROD with NOTICES
3228 Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Special Emphasis 

Panel; Multicenter Clinical Trials; Leveraging 

Network (U01). 

Date: March 7, 2025. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, 6710 B Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Vera A. Cherkasova, Ph.D., 

Scientific Review Branch, Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development, NIH, 6710B 

Rockledge Drive, Room 2137B, Bethesda, MD 

20892, (240) 478–4580, vera.cherkasova@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: January 8, 2025. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2025–00597 Filed 1–13–25; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Special Emphasis 

Panel; the Road to Prevention of Stillbirth— 

Data Coordinating Center (UM2) Companion. 

Date: March 28, 2025. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, 6710 B Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Luis E. Dettin, Ph.D., 

Scientific Review Branch, Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development, NIH 6710B, 

Rockledge Drive, Rm. 2131B, Bethesda, MD 

20892, (301) 827–8231, luis_dettin@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: January 8, 2025. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2025–00605 Filed 1–13–25; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Special Emphasis 

Panel; the Road to Prevention of Stillbirth— 

Clinical Research Center (UG1). 

Date: March 24, 2025. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, 6710 B Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting: 

Contact Person: Luis E. Dettin, Ph.D., 

Scientific Review Branch, Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development, NIH 6710B, 

Rockledge Drive, Rm. 2131B Bethesda, MD 

20892, (301) 827–8231, luis_dettin@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: January 8, 2025. 

Lauren A. Fleck, 

Program Analyst,Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2025–00607 Filed 1–13–25; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Initial Review 

Group, Population Sciences Study Section. 

Date: March 6, 2025. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, 6710 B Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Christiane M. Robbins, 

Scientific Review Branch, Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development, NIH, 6710B 

Rockledge Drive, Rm 2121B, Bethesda, MD 

20817, 301–451–4989, crobbins@

mail.nih.gov. 


khammond on DSK9W7S144PROD with NOTICES