8436 Federal Register / Vol. 89, No. 26 / Wednesday, February 7, 2024 / Notices 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: New collection of information; 

Title of Information Collection: Prior 

Authorization Process and 

Requirements for Certain Hospital 

Outpatient Department (OPD) Services; 

Use: Section 1833(t)(2)(F) of the Act 

authorizes CMS to develop a method for 

controlling unnecessary increases in the 

volume of covered OPD services. CMS 

believes the increases in volume 

associated with certain covered OPD 

services are unnecessary because the 

data show that the volume of utilization 

of these OPD service categories far 

exceeds what would be expected in 

light of the average rate-of-increase in 

the number of Medicare beneficiaries. 

Therefore, CMS is using the authority 

under section 1833(t)(2)(F) of the Act to 

require prior authorization for certain 

covered OPD services as a condition of 

Medicare payment. The reviews 

conducted under the program help to 

reduce unnecessary utilization and 

payments for these services. 

The information required for the prior 

authorization request includes all 

documentation necessary to show that 

the service meets applicable Medicare 

coverage, coding, and payment rules. 

Trained clinical reviewers at the 

Medicare Administrative Contractors 

(MACs) receive and review the 

information required for this collection. 

Review of that documentation is used to 

determine if the requested services are 

medically necessary and meet Medicare 

requirements to help reduce 

unnecessary increases for these services. 

Form Number: CMS–10711 (OMB 

Control Number: 0938–1368); 

Frequency: Occasionally; Affected 

Public: Business or other for-profits; 

Number of Respondents: 11,469; 

Number of Responses: 564,010; Annual 

Hours: 316,412. (For policy questions 

regarding this collection contact Yuliya 

Cook at Yuliya.Cook@cms.hhs.gov) 

2. Title of Information Collection: 

Pharmacy Benefit Manager 

Transparency for Qualified Health 

Plans; Type of Information Collection 

Request: Revision of a currently 

approved collection; Use: 

Implementation of section 1150A of the 

Social Security Act, as added by section 

6005 of the Patient Protection and 

Affordable Care Act (ACA), requires, 

among other entities, Qualified Health 

Plans (QHPs) and pharmacy benefit 

managers (PBMs) that serve QHP issuers 

to report information on prescription 

drug benefits to the U.S. Department of 

Health and Human Services (HHS). 

PBMs are third-party administrators of 

prescription programs for a variety of 

types of health plans, including QHPs. 

CMS finalized regulations for this 

reporting at 45 CFR 156.295 and 184.50. 

Under these requirements a QHP 

issuer is required to report issuer and 

plan level prescription drug data to 

CMS only when the QHP issuer does 

not contract with a PBM to administer 

the prescription drug benefit for their 

QHPs. Section 1150A(a)(1) of the Social 

Security Act authorizes CMS to collect 

the same prescription drug and rebate 

information from Prescription Drug Plan 

sponsors of a prescription drug plan and 

Medicare Advantage organizations 

offering a Medicare Advantage 

Prescription Drug Plan under part D of 

title XVIII. Since 2012, CMS has 

collected these data from Part D 

sponsors as part of the Medicare Part D 

Direct and Indirect Remuneration (DIR) 

reporting requirement, and detailed 

drug information for each National Drug 

Code (NDC) from the Prescription Drug 

Event (PDE) data that plans are required 

to submit. 

CMS is requesting to renew this 

collection of information in connection 

with submission from QHP issuers that 

do not contract with a PBM and PBMs 

(hereinafter referred to as ‘‘submitters’’). 

The information required from 

submitters and the process of 

submission has changed since the 

previous collection was approved in 

2021. The submitters are now required 

to complete a web form that reports the 

allocation methodology that is selected 

by the submitters to allocate data, where 

necessary. Submitters are required to 

maintain internal documentation of the 

allocation methodologies chosen, as 

CMS may need to follow up with the 

submitters to better understand the 

methodology. The burden estimates for 

the collection of information included 

in this package reflect the time and 

effort for submitters to provide 

prescription drug benefit information to 

CMS using the Health Information 

Oversight System (HIOS) module. Form 

Number: CMS–10725 (OMB control 

number: 0938–1394); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other For-Profits; 

Number of Respondents: 278; Number 

of Responses: 278; Total Annual Hours: 

1,285. (For questions regarding this 

collection, contact LeAnn Brodhead at 

(301) 492–4493.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–02444 Filed 2–6–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

cooperative agreement applications, the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Clinical Trial 

Implementation Cooperative Agreement (U01 

Clinical Trial Required); NIAID SBIR Phase II 

Clinical Trial Implementation Cooperative 

Agreement (U44 Clinical Trial Required); 

Clinical Trial Planning Grants (R34 Clinical 

Trials) 

Date: February 29, 2024. 

Time: 9:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane Rockville, MD 

20892 (Video Assisted Meeting). 

Contact Person: Annie Walker-Abbey, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, MSC 9834, 

Rockville, MD 20852, 240–627–3390, 

aabbey@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 26 / Wednesday, February 7, 2024 / Notices 8437 

Dated: February 1, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–02434 Filed 2–6–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

cooperative agreement applications, the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID SBIR Phase II 

Clinical Trial Implementation Cooperative 

Agreement (U44 Clinical Trial Required); 

NIAID Clinical Trial Planning Grants (R34 

Clinical Trial Not Allowed); NIAID Clinical 

Trial Implementation Cooperative 

Agreement. 

Date: February 29, 2024. 

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

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3E70A, 

Rockville, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Soheyla Saadi, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3E70A, Rockville, MD 

20852, (240) 669–5178, saadisoh@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 1, 2024. 

Lauren A. Fleck, 

Program Analyst,Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–02436 Filed 2–6–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Neural Oxidative Metabolism 

and Death Study Section. 

Date: February 28–29, 2024. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza National Airport, 1480 

Crystal Drive, Arlington, VA 22202. 

Contact Person: Christine Jean DiDonato, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1014J, 

Bethesda, MD 20892, (301) 435–1042, 

didonatocj@csr.nih.gov. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Biobehavioral Regulation, Learning 

and Ethology Study Section. 

Date: February 28–29, 2024. 

Time: 9:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Hybrid Meeting). 

Contact Person: Sara Louise Hargrave, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 3170, 

Bethesda, MD 20892, (301) 443–7193, 

hargravesl@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Research on Current Topics in Alzheimer’s 

Disease and its Related Dementias. 

Date: February 28–29, 2024. 

Time: 9:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Bernard Rajeev Srambical 

Wilfred, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Bethesda, MD 20892, (301) 480–6813, 

bernard.srambicalwilfred@nih.gov. 

Name of Committee: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group; Integrative Myocardial Physiology/ 

Pathophysiology A Study Section. 

Date: February 28–29, 2024. 

Time: 9:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Abdelouahab Aitouche, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4222, 

MSC 7814, Bethesda, MD 20892, 301–435– 

2365, aitouchea@csr.nih.gov. 

Name of Committee: Infectious Diseases 

and Immunology B, Integrated Review 

Group; Transplantation, Tolerance, and 

Tumor Immunology Study Section. 

Date: February 28–29, 2024. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Carmen Angeles UfretVincenty, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Bethesda, MD 20892, (301) 594–0912, 

carmen.ufret-vincenty@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Neurotechnology and Eye Diseases. 

Date: February 28, 2024. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Barbara Susanne Mallon, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 480–8992. mallonb@

mail.nih.gov. 

Name of Committee: Biology of 

Development and Aging Integrated Review 

Group; Mechanisms of Cancer Therapeutics, 

C Study Section. 

Date: February 29–March 1, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Gloria Huei-Ting Su, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–496–0465, gloria.su@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Topics in Biophysics and 

Biochemistry. 

Date: February 29–March 1, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


khammond on DSKJM1Z7X2PROD with NOTICES