73862 Federal Register / Vol. 88, No. 207 / Friday, October 27, 2023 / Notices 

associated outpatient costs and charges, 

but that have not yet registered in 

OPAIS, to continue to use 340B drugs 

for patients of the covered entity 

pending registration of the facility in 

OPAIS during the next 340B Program 

quarterly registration period (January 1– 

16). If a facility is not registered during 

January 1–16 quarterly registration 

period, the hospital covered entity may 

be subject to audit and compliance 

action. 

2. HRSA will continue to allow offsite, outpatient facilities that are not yet 

listed as a reimbursable facility on the 

hospital’s most recently filed Medicare 

Cost Report with associated outpatient 

costs and charges to continue to use 

340B drugs for patients of the covered 

entity if the following conditions are 

met: 

a. The off-site, outpatient facility was 

opened and began using 340B drugs 

prior to the publication date of this 

Notice; and 

b. The hospital that is the covered 

entity and the parent organization for 

the off-site, outpatient facility provides 

HRSA, via email to 340Bcompliance@

hrsa.gov within 90 days of publication 

date of this Notice, with the following 

information consistent with 340B 

registration requirements: 

• The name of the off-site, outpatient 

facility; 

• The date the site will be listed on 

the hospital’s Medicare Cost Report (this 

must be the next filed Medicare Cost 

Report) with associated outpatient costs 

and charges; and 

• The date the covered entity will 

register the site in OPAIS. 

If a covered entity does not provide 

this information within 90-days of 

publication of this Notice, any off-site, 

outpatient facility that is not listed on 

the most recently filed Medicare Cost 

Report with associated outpatient costs 

and charges will have to cease 

purchasing 340B drugs for use at those 

facilities and will be subject to audit 

and compliance action. Consistent with 

longstanding 340B Program 

requirements, covered entities that 

provide this information within 90 days 

of publication must subsequently 

register in OPAIS at the soonest possible 

opportunity (and no later than the dates 

listed in the information provided to 

HRSA), and recertify in OPAIS annually 

with the most recently filed Medicare 

Cost Report with associated outpatient 

costs and charges. 

3. Hospital covered entities using 

340B drugs at off-site, outpatient 

facilities that are not listed on the most 

recently filed Medicare Cost Report with 

associated outpatient cost and charges, 

are not in OPAIS, and do not meet 

categories 1 or 2 above are out of 

compliance and must stop using 340B 

drugs at these unregistered sites as soon 

as practically possible, but no later than 

90 days after the publication of this 

Federal Register Notice. After the 90-day 

grace period, non-compliant covered 

entities may be subject to audit and 

compliance action. HRSA is allowing 

for a 90-day grace period for affected 

hospitals to come into compliance and 

does not believe that any undue burden 

would be caused by reverting back to its 

original program guidelines, which have 

been in place since 1994. 

II. Other Deadlines 

Deadlines for 340B Program 

requirements other than those listed 

above are not affected by this Notice. All 

other registrations and change requests 

are not affected by this Notice and will 

be processed as they are received. 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–23702 Filed 10–26–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Information Technology 

Advisory Committee Schedule of 

Meetings 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), HHS. 

ACTION: Notice of meetings. 

SUMMARY: The Health Information 

Technology Advisory Committee 

(HITAC) was established in accordance 

with the 21st Century Cures Act and the 

Federal Advisory Committee Act. The 

HITAC, among other things, identifies 

priorities for standards adoption and 

makes recommendations to the National 

Coordinator for Health Information 

Technology (National Coordinator). The 

HITAC will hold public meetings for the 

remainder of 2023 and throughout 2024. 

See list of public meetings below. 

FOR FURTHER INFORMATION CONTACT: 

Michael Berry, Designated Federal 

Officer, at Michael.Berry@hhs.gov, (202) 

701–0795. 

SUPPLEMENTARY INFORMATION: Section 

4003(e) of the 21st Century Cures Act 

(Pub. L. 114–255) establishes the Health 

Information Technology Advisory 

Committee (referred to as the ‘‘HITAC’’). 

The HITAC will be governed by the 

provisions of the Federal Advisory 

Committee Act (FACA) (Pub. L. 92– 

463), as amended, (5 U.S.C. app.), which 

sets forth standards for the formation 

and use of federal advisory committees. 

Composition: The HITAC is 

comprised of at least 25 members, of 

which: 

• No fewer than 2 members are 

advocates for patients or consumers of 

health information technology; 

• 3 members are appointed by the 

HHS Secretary 

Æ 1 of whom shall be appointed to 

represent the Department of Health and 

Human Services and 

Æ 1 of whom shall be a public health 

official; 

• 2 members are appointed by the 

majority leader of the Senate; 

• 2 members are appointed by the 

minority leader of the Senate; 

• 2 members are appointed by the 

Speaker of the House of Representatives; 

• 2 members are appointed by the 

minority leader of the House of 

Representatives; 

• Other members are appointed by 

the Comptroller General of the United 

States. 

Members serve for one-, two-, or 

three-year terms. All members may be 

reappointed for a subsequent three-year 

term. Each member is limited to two 

three-year terms, not to exceed six years 

of service. Members serve without pay 

but will be provided per-diem and 

travel costs for committee services, if 

warranted. 

Recommendations: The HITAC 

recommendations to the National 

Coordinator are publicly available at 

https://www.healthit.gov/topic/federaladvisory-committees/recommendationsnational-coordinator-health-it. 

Public Meetings: All HITAC meetings 

will be virtual. Please note that some 

HITAC meetings may also have an inperson meeting option. For web 

conference instructions and the most 

up-to-date information, including inperson meeting location (if applicable), 

please visit the HITAC calendar on the 

ONC website, www.healthit.gov/topic/ 

federal-advisory-committees/hitaccalendar. 

The schedule of remaining meetings 

to be held in 2023 and throughout 2024 

is as follows: 

• November 9, 2023, from 

approximately 9:30 a.m. to 4:00 p.m./ 

Eastern Time (virtual and in-person 

meeting options, address: Hubert H. 

Humphrey Federal Building, 200 

Independence Ave SW, Washington, 

DC 20201) 

• January 18, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• February 8, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• March 7, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• April 11, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 207 / Friday, October 27, 2023 / Notices 73863 

• May 16, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• June 13, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• July 11, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• August 15, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• September 12, 2024, from 

approximately 10:00 a.m. to 3:00 

p.m./Eastern Time 

• October 17, 2024, from approximately 

10:00 a.m. to 3:00 p.m./Eastern Time 

• November 7, 2024, from 

approximately 10:00 a.m. to 3:00 

p.m./Eastern Time 

All meetings are open to the public. 

Additional meetings may be scheduled 

as needed. 

Contact Person for Meetings: Michael 

Berry, Michael.Berry@hhs.gov. A notice 

in the Federal Register about last 

minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Please email Michael 

Berry for the most current information 

about meetings. 

Agenda: As outlined in the 21st 

Century Cures Act, the HITAC will 

develop and submit recommendations 

to the National Coordinator on the 

topics of interoperability, privacy and 

security, patient access, and use of 

technologies that support public health. 

In addition, the committee will also 

address any administrative matters and 

hear periodic reports from ONC. ONC 

intends to make background material 

available to the public no later than 24 

hours prior to the meeting start time. If 

ONC is unable to post the background 

material on its website prior to the 

meeting, the material will be made 

publicly available on ONC’s website 

after the meeting, at www.healthit.gov/ 

hitac. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person prior to the meeting date. An 

oral public comment period will be 

scheduled at each meeting. Time 

allotted for each commenter will be 

limited to three minutes. If the number 

of speakers requesting to comment is 

greater than can be reasonably 

accommodated during the scheduled 

public comment period, ONC will take 

written comments after the meeting. 

ONC welcomes the attendance of the 

public at its HITAC meetings. If you 

require special accommodations due to 

a disability, please contact Michael 

Berry at least seven (7) days in advance 

of the meeting. 

Notice of these meetings are given 

under the Federal Advisory Committee 

Act (Pub. L. 92–463, 5 U.S.C., app. 2). 

Dated: October 16, 2023. 

Michael Berry, 

Designated Federal Officer, Office of the 

National Coordinator for Health Information 

Technology. 

[FR Doc. 2023–23762 Filed 10–26–23; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Diversity Training Grants. 

Date: December 1, 2023. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge I, 6705 Rockledge Drive, Bethesda, 

MD 20892 (Virtual Meeting). 

Contact Person: Sun Saret, Ph.D., Scientific 

Review Officer, Office of Scientific Review/ 

DERA, National Heart, Lung, and Blood 

Institute, National Institutes of Health, 6705 

Rockledge Drive, Room 208–S, Bethesda, MD 

20892, (301) 435–0270, sun.saret@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: October 23, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–23751 Filed 10–26–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Minority Health 

and Health Disparities; Notice of 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council on Minority Health and Health 

Disparities. 

The meeting will be held as a virtual 

meeting and is open to the public as 

indicated below. Individuals who plan 

to view the virtual meeting and need 

special assistance or other reasonable 

accommodations to view the meeting, 

should notify the Contact Person listed 

below in advance of the meeting. The 

open session will be videocast and can 

be accessed from the NIH Videocast at 

the following link: http://

videocast.nih.gov/. 

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: National Advisory 

Council on Minority Health and Health 

Disparities. 

Date: February 1, 2024. 

Closed: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6707 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Name of Committee: National Advisory 

Council on Minority Health and Health 

Disparities. 

Date: February 2, 2024. 

Open: 11:00 a.m. to 5:00 p.m. 

Agenda: Opening Remarks, Administrative 

Matters, Director’s Report, Presentations, and 

Other Business of the Council. 

Place: National Institutes of Health, 6707 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Paul Cotton, Ph.D., RDN, 

Director, Office of Extramural Research 

Activities, National Institute on Minority 

Health and Health Disparities, National 

Institutes of Health, 6707 Democracy 

Boulevard, Suite 800, Bethesda, MD 20892, 

301–402–1366, paul.cotton@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 


ddrumheller on DSK120RN23PROD with NOTICES1