National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 8436-8437 [2024-02434]
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8436
Federal Register / Vol. 89, No. 26 / Wednesday, February 7, 2024 / Notices
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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
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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
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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]
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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)
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Federal Register / Vol. 89, No. 26 / Wednesday, February 7, 2024 / Notices
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
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.
BILLING CODE 4140–01–P
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National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
BILLING CODE 4140–01–P
[FR Doc. 2024–02436 Filed 2–6–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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,
PO 00000
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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.
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Agencies
[Federal Register Volume 89, Number 26 (Wednesday, February 7, 2024)]
[Notices]
[Pages 8436-8437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02434]
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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, [email protected].
(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)
[[Page 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]
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