Statement of Organization, Functions, and Delegations of Authority, 50158 [2023-16280]
Download as PDF
<![CDATA[
50158
Federal Register / Vol. 88, No. 146 / Tuesday, August 1, 2023 / Notices
information, including each proposed
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
lotter on DSK11XQN23PROD with NOTICES1
Dated: July 27, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–16281 Filed 7–31–23; 8:45 am]
BILLING CODE 4120–01–P
18:34 Jul 31, 2023
Centers for Medicare & Medicaid
Services
Statement of Organization, Functions,
and Delegations of Authority
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Survey of Retail
Prices; Use: This information collection
request provides for a survey of the
average acquisition costs of all covered
outpatient drugs purchased by retail
community pharmacies. CMS may
contract with a vendor to conduct
monthly surveys of retail prices for
covered outpatient drugs. Such prices
represent a nationwide average of
consumer purchase prices, net of
discounts and rebates. The contractor
shall provide notification when a drug
product becomes generally available
and that the contract includes such
terms and conditions as the Secretary
shall specify, including a requirement
that the vendor monitor the
marketplace. CMS has developed a
National Average Drug Acquisition Cost
(NADAC) for states to consider when
developing reimbursement
methodology. The NADAC is a pricing
benchmark that is based on the national
average costs that pharmacies pay to
acquire Medicaid covered outpatient
drugs. This pricing benchmark is based
on drug acquisition costs collected
directly from pharmacies through a
nationwide survey process. This survey
is conducted on a monthly basis to
ensure that the NADAC reference file
remains current and up-to-date. Form
Number: CMS–10241 (OMB control
number 0938–1041); Frequency:
Monthly; Affected Public: Private sector
(Business or other for-profits); Number
of Respondents: 72,000; Total Annual
Responses: 72,000; Total Annual Hours:
36,000. (For policy questions regarding
this collection contact: Robert Giles at
667–290–8626.)
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 259001
The Centers for Medicare and
Medicaid Services, Center for Medicare
and Medicaid Innovation (CMMI), has
modified its organizational structure.
DATES: These new organizational
structures were approved by the
Secretary of Health and Human Services
and took effect on July 27, 2023.
FOR FURTHER INFORMATION CONTACT: Joe
Kane at (410) 786–0655; 7500 Security
Blvd., Baltimore, MD.
SUPPLEMENTARY INFORMATION: Part F of
the Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services, Centers for Medicare &
Medicaid Services (CMS) (last amended
at Federal Register, Vol. 88, No. 107,
pp. 36586–36587, dated June 5, 2023) is
further amended to reflect the
establishment of the Division of Drug
Innovation within the Center for
Medicare and Medicaid Innovation
(CMMI). Part F, Section FC. 10
(Organization) is revised as follows:
Center for Medicare and Medicaid
Innovation (CMMI), Seamless Care
Models Group, Seamless Care Models
Group, Division of Health Plan
Innovations
SUMMARY:
Part F, Section FC. 20 (Functions) for
the new organization is as follows:
Centers for Medicare & Medicaid
Services
Office of the Administrator
Center for Medicare and Medicaid
Innovation
Seamless Care Models Group
Division of Drug Innovation
• Directs, designs and implements
models to test alternative approaches to
payment for drugs in Medicare Part B,
Part D, and Medicaid to optimize access
to high quality, affordable drugs.
• Seeks and develop opportunities to
include Part B and Part D drugs in
alternative payment models, including
accountable care models, and addresses
regulatory and operational issues that
arise when trying to develop a model
crossing different parts of the Medicare
program.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
• Builds relationships within CMS
and HHS, with States and Medicaid
agencies, and with both governmental
and non-governmental entities to
develop, implement, and operate
innovative Medicare Part B, Part D, and
Medicaid models.
• Meets with model participants and
other interested parties, including
relevant Government officials,
representatives from the pharmaceutical
industry, payers, providers, academia,
and consumer advocates regarding their
perspectives on innovative models,
research, and ideas for new models.
• Conducts formative research studies
to inform innovative payment models.
• Provides technical expertise to
various CMS and non-Governmental
entities on innovative Medicare Part B,
Part D, and Medicaid payment and
service delivery models to optimize
access to affordable drugs.
Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023–16280 Filed 7–31–23; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–1574]
Determination That Progesterone
Injection, USP, 50 Milligrams/Milliliter,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that Progesterone Injection,
USP, 50 milligrams/milliliter (mg/mL),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Iris
Masucci, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Silver Spring, MD
20993–0002, 301–796–3600,
Iris.Masucci@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
SUMMARY:
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Page 50158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16280]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare and Medicaid Services, Center for
Medicare and Medicaid Innovation (CMMI), has modified its
organizational structure.
DATES: These new organizational structures were approved by the
Secretary of Health and Human Services and took effect on July 27,
2023.
FOR FURTHER INFORMATION CONTACT: Joe Kane at (410) 786-0655; 7500
Security Blvd., Baltimore, MD.
SUPPLEMENTARY INFORMATION: Part F of the Statement of Organization,
Functions, and Delegations of Authority for the Department of Health
and Human Services, Centers for Medicare & Medicaid Services (CMS)
(last amended at Federal Register, Vol. 88, No. 107, pp. 36586-36587,
dated June 5, 2023) is further amended to reflect the establishment of
the Division of Drug Innovation within the Center for Medicare and
Medicaid Innovation (CMMI). Part F, Section FC. 10 (Organization) is
revised as follows:
Center for Medicare and Medicaid Innovation (CMMI), Seamless Care
Models Group, Seamless Care Models Group, Division of Health Plan
Innovations
Part F, Section FC. 20 (Functions) for the new organization is as
follows:
Centers for Medicare & Medicaid Services
Office of the Administrator
Center for Medicare and Medicaid Innovation
Seamless Care Models Group
Division of Drug Innovation
Directs, designs and implements models to test alternative
approaches to payment for drugs in Medicare Part B, Part D, and
Medicaid to optimize access to high quality, affordable drugs.
Seeks and develop opportunities to include Part B and Part
D drugs in alternative payment models, including accountable care
models, and addresses regulatory and operational issues that arise when
trying to develop a model crossing different parts of the Medicare
program.
Builds relationships within CMS and HHS, with States and
Medicaid agencies, and with both governmental and non-governmental
entities to develop, implement, and operate innovative Medicare Part B,
Part D, and Medicaid models.
Meets with model participants and other interested
parties, including relevant Government officials, representatives from
the pharmaceutical industry, payers, providers, academia, and consumer
advocates regarding their perspectives on innovative models, research,
and ideas for new models.
Conducts formative research studies to inform innovative
payment models.
Provides technical expertise to various CMS and non-
Governmental entities on innovative Medicare Part B, Part D, and
Medicaid payment and service delivery models to optimize access to
affordable drugs.
Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023-16280 Filed 7-31-23; 8:45 am]
BILLING CODE 4150-28-P
