Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 97627 

teleconference and/or video conference 

meeting will be available at the location 

of the advisory committee meeting and 

at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The online presentation of 

materials will include slide 

presentations with audio and video 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committees. All electronic 

and written submissions to the Docket 

(see ADDRESSES) on or before January 22, 

2025, will be provided to the 

Committees. Oral presentations from the 

public will be scheduled between 

approximately between 1 p.m. and 2 

p.m. Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, whether they would like to 

present online or in-person, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 13, 2025. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. Similarly, room 

for interested persons to participate inperson may be limited. If the number of 

registrants requesting to speak in-person 

during the open public hearing is 

greater than can be reasonably 

accommodated in the venue for the inperson portion of the advisory 

committee meeting, FDA may conduct a 

lottery to determine the speakers who 

will be invited to participate in-person. 

The contact person will notify 

interested persons regarding their 

request to speak by January 14, 2025. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jessica Seo 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform in conjunction with 

the physical meeting room (see 

location). This waiver is in the interest 

of allowing greater transparency and 

opportunities for public participation, 

in addition to convenience for advisory 

committee members, speakers, and 

guest speakers. The conditions for 

issuance of a waiver under 21 CFR 10.19 

are met. 

Dated: December 2, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28811 Filed 12–6–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; HRSA Ryan White HIV/AIDS 

Program Part F Regional AIDS 

Education and Training Center 

Program Activities 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than January 8, 2025. 

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 Review—Open for 

Public Comments,’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

HRSA Ryan White HIV/AIDS Program 

Part F Regional AIDS Education and 

Training Center Program Activities, 

OMB No. 0906–xxxx—New. 

Abstract: The Ryan White HIV/AIDS 

Program’s (RWHAP) AIDS Education 

and Training Center (AETC) Program, 

authorized under title XXVI of the 

Public Health Service Act, supports a 

network of regional centers that conduct 

targeted, multi-disciplinary education 

and training programs for health care 

providers treating people with HIV. The 

RWHAP Regional AETC Program’s 

purpose is to increase the number of 

health care providers who are 

effectively educated and equipped to 

counsel, diagnose, treat, and medically 

manage people with HIV. The RWHAP 

Regional AETC Program recipients are 

required to report data on the training 

activities and trainees to HRSA once a 

year. HRSA is requesting the approval of 

new AETC data collection forms to 

accurately capture data relating to 

Regional AETC activities, participants, 

and site information for both Practice 

Transformation (PT) and 

Interprofessional Education (IPE) sites 

as well as involvement in the HIV care 

and treatment workforce (1-year postparticipation), knowledge gained 

through participating in an activity, and 

satisfaction with the activity. The 

RWHAP Regional AETC Program 

recipients will gather data on the 

training activities they conduct using 

six data collection instruments. The 

Individual Participant Record is 

completed at least once every reporting 

period by participants actively engaging 

in Regional AETC activities. This form 

includes Regional AETC participant 

demographic, workplace, and clientsserved data for the participant’s 


ddrumheller on DSK120RN23PROD with NOTICES1
97628 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 

respective provider sites. The Regional 

AETC recipient completes the Training 

Activity Record form at the end of each 

Regional AETC activity that takes place 

during the reporting period. This form 

describes the activity in hours, 

modality, and topic(s). The PT Site 

Characteristics/Outcomes form collects 

site characteristics information for PT 

recipient sites only, such as clinic 

activities and procedures and aggregate 

counts of clients. PT sites provide 

clinical services and differ from IPE 

sites that support students, thus 

necessitating a different form. The IPE 

Site Characteristics/Outcomes form 

collects site characteristics information 

for IPE recipient sites only. The 

Participant Post-Activity Immediate 

Survey collects information from 

participants immediately after an 

activity, specifically, their satisfaction 

and potential increased knowledge due 

to participating in said activity. The IPE 

Long-Term form collects 1-year postparticipation information from 

participant students who engaged in an 

IPE program to assess involvement in 

the field of HIV care and treatment. 

A 60-day notice published in the 

Federal Register on July 19, 2024, 89 FR 

58744–45. The 60-day FRN publication 

elicited 15 public comments, including 

feedback from eight currently funded 

AETC regional recipients. The public 

comments offered input to clarify the 

definitions of the terminology used on 

the forms; requested additions and 

revisions to response options and 

categories; provided feedback to update 

demographic questions; requested more 

review to identify which professions 

should be included or removed from the 

forms; asked for clarity on the training 

track and the process for selecting a 

track; and suggested that there be a 

balance of questions on both HIV 

treatment and prevention. 

HRSA’s HIV/AIDS Bureau conducted 

a thorough review of all the feedback 

provided by the public during the 60- 

day publication period. HRSA will 

incorporate much of the public feedback 

into the new forms, including through 

the addition of new proposed questions, 

removal of current incompatible 

questions, correcting spelling and 

grammar, providing definitions and 

instructions for clarity, incorporating 

skip logic to streamline question 

response options/categories, updating 

the form format, and the change of the 

form title from Interprofessional 

Education Site Characteristics/ 

Outcomes Form to the Interprofessional 

Education Health Profession Program 

Characteristics/Outcomes Form. Other 

suggestions may be further reviewed in 

future OMB packages or non-substantive 

change memos. 

Need and Proposed Use of the 

Information: HRSA uses the data 

collected when conducting RWHAP 

AETC programmatic assessments to 

determine future program needs. These 

data allow HRSA to identify where gaps 

exist in training HIV professionals as 

well as to measure whether training 

activities are meeting the goals of the 

National HIV/AIDS Strategy and the 

RWHAP statute. 

Likely Respondents: RWHAP Regional 

AETC participants complete the 

Individual Participant Record at least 

once a reporting period. Regional AETC 

recipients complete a Training Activity 

Record for each training activity they 

conduct during the reporting period. All 

Regional AETC participants will take 

the Participant Post-Activity Survey 

immediately after any attended activity. 

The IPE Long-Term form will only be 

completed by participants who engaged 

in an IPE program, 1-year postparticipation in the program. Finally, PT 

recipients will complete the PT Site 

Characteristics/Outcomes form at least 

once per reporting period, and IPE 

recipients will complete the IPE Site 

Characteristics/Outcomes form at least 

once per reporting period. 

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 use 

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 

Individual Participant Record ............................................... 59,576 1 59,576 0.27 16,085.52 

Training Activity Record ....................................................... 12,226 1 12,226 0.21 2,567.46 

PT, Site Characteristics and Outcomes .............................. 128 1 128 0.31 39.68 

IPE, Site Characteristics and Outcomes ............................. 86 1 86 0.09 7.74 

Participant Post-Activity Immediate Survey ......................... 59,576 3 178,728 0.06 10,723.68 

IPE, Long-Term .................................................................... 4,403 1 4,403 0.07 308.21 

Combined Data Set ............................................................. 8 1 8 64.00 512.00 

Total .............................................................................. 136,003 ........................ 255,155 ........................ 30,244.29 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 97629 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–28803 Filed 12–6–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Availability of Draft Health 

Center Program Scope Policy Manual 

Guidance 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Request for public comment. 

SUMMARY: HRSA requests public 

comments on the Draft Health Center 

Program Scope of Project Manual (draft 

Scope Policy Manual). The draft Scope 

Policy Manual provides updated policy 

guidance on what constitutes the Health 

Center Program scope of project under 

the Public Health Service Act (PHS Act). 

DATES: Submit comments no later than 

February 7, 2025. 

ADDRESSES: Electronic comments 

should be submitted through the HRSA 

Bureau of Primary Health Care Contact 

Form (https://hrsa.my.site.com/support/ 

s/), by selecting ‘‘Comment on Draft 

Policy’’ under the ‘‘Policy’’ section. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Joseph, Office of Policy and 

Program Development Director, Bureau 

of Primary Health Care, HRSA, at 

jjoseph@hrsa.gov and 301–594–4300. 

SUPPLEMENTARY INFORMATION: The draft 

Scope Policy Manual (https://

bphc.hrsa.gov/sites/default/files/bphc/ 

compliance/draft-health-centerprogram-scope-project-manual) updates 

Health Center Program scope of project 

policy guidance for all health centers 

that apply for and receive federal award 

(https://bphc.hrsa.gov/compliance/ 

compliance-manual/glossary#federalaward) funds under the Health Center 

Program subrecipient organization 

(sections 1861(aa)(4)(A)(ii) and 

1905(l)(2)(B)(ii) of the Social Security 

Act; https://bphc.hrsa.gov/compliance/ 

compliance-manual/ 

glossary#subrecipient), and Health 

Center Program look-alikes (sections 

1861(aa)(4)(B) and 1905(l)(2)(B) of the 

Social Security Act; (https://

bphc.hrsa.gov/compliance/compliancemanual/glossary#look-alike). 

The draft Scope Policy Manual 

proposes new policy and clarifies 

existing policy in key areas. Through 

the draft Scope Policy Manual, HRSA 

updates the Health Center Program 

scope of project policy to consolidate 

scope of project-related policy into a 

single policy document to assist health 

centers in understanding scope of 

project, statutory language and the 

Health Center Program Compliance 

Manual (https://bphc.hrsa.gov/ 

compliance/compliance-manual). 

The draft Scope Policy Manual does 

not include scope of project processrelated instructions. Instructions for 

documenting and updating scope of 

project will continue to be available on 

the Health Center Program Scope of 

Project web page (https://bphc.hrsa.gov/ 

compliance/scope-project). 

HRSA proposes that the final Scope 

Policy Manual supersede the following 

previously issued scope of project 

Policy Information Notices (PINs): 

• PIN 2007–09: Service Area Overlap: 

Policy and Process 

• PIN 2008–01: Defining Scope of 

Project and Policy for Requesting 

Changes 

• PIN 2009–02: Specialty Services and 

Health Centers’ Scope of Project 

• PIN 2009–05: Policy for Special 

Populations-Only Grantees 

Requesting a Change in Scope to Add 

a New Target Population 

HRSA provides grants to eligible 

applicants under section 330 of the PHS 

Act (42 U.S.C. 254b) to support the 

delivery of preventive and primary care 

services to the nation’s underserved 

individuals and families. HRSA also 

designates eligible applicants as Health 

Center Program look-alikes. Look-alikes 

do not receive Health Center Program 

funding but must meet the Health 

Center Program statutory and regulatory 

requirements. Nearly 1,400 Health 

Center Program-funded health centers 

and more than 100 Health Center 

Program look-alike organizations 

operate more than 15,000 service 

delivery sites that provide care to more 

than 30.5 million patients in every U.S. 

state, the District of Columbia, Puerto 

Rico, the U.S. Virgin Islands, and the 

Pacific Basin. Note that for the purposes 

of this document, the term ‘‘health 

center’’ refers to entities that receive a 

federal award under section 330 of the 

PHS Act, as well as subrecipients and 

organizations designated as look-alikes, 

unless otherwise stated. 

Carole Johnson, 

Administrator. 

[FR Doc. 2024–28748 Filed 12–6–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Minority Health 

AGENCY: Office of Minority Health, 

Office of the Secretary, U.S. Department 

of Health and Human Services. 

ACTION: Notice of meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the Advisory Committee on 

Minority Health (ACMH) will hold a 

meeting conducted as a webcast on 

January 7, 2025. This virtual meeting 

will be open to the public. 

DATES: The virtual ACMH meeting will 

be held on January 7, 2025, from 2 p.m. 

to 3 p.m. EST. If the Committee 

completes its work before 3 p.m. EST, 

the meeting will adjourn early. 

Any individual who wishes to 

participate in the virtual meeting should 

register using the Zoom registration link 

provided below by 5 p.m. EST on 

January 3, 2025. 

ADDRESSES: The meeting will be held 

virtually and will be accessible by 

webcast. Instructions regarding webcast 

access and providing written public 

comments will be given after meeting 

registration occurs. 

Registration is required for the public 

to attend the meeting, provide comment, 

and/or distribute material(s) to ACMH 

members. Instructions regarding 

participating in the call and providing 

written or verbal public comments will 

be provided after meeting registration 

occurs. Information about the meeting 

will be posted on the HHS Office of 

Minority Health (OMH) website: 

www.minorityhealth.hhs.gov. 

Information about ACMH activities can 

be found on the OMH website under the 

heading About OMH, Committees and 

Working Groups. 

FOR FURTHER INFORMATION CONTACT: 

Violet Woo, Designated Federal Officer, 

Advisory Committee on Minority 

Health, OMH, HHS, Tower Building, 

1101 Wootton Parkway, Suite 100, 

Rockville, Maryland 20852. Phone: 240– 

453–6816; email: OMH-ACMH@hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with Public Law 105–392, 

the ACMH was established to provide 

advice to the Deputy Assistant Secretary 

for Minority Health on the development 

of goals and program activities related to 

OMH’s duties. 

The topic to be discussed during the 

virtual meeting will be finalizing 

recommendations on the 


ddrumheller on DSK120RN23PROD with NOTICES1