Agency Information Collection Activities: Proposed Collection; Comment Request, 50157-50158 [2023-16281]
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50157
Federal Register / Vol. 88, No. 146 / Tuesday, August 1, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Employees and Representatives ..........
Health Hazard Evaluation Request
Form.
Health Hazard Evaluation Request
Form.
Health Hazard Evaluation specific
interview example.
Health Hazard Evaluation specific
questionnaire example.
HHE specific informed consent form ...
Contact information post card ..............
First Followback Survey .......................
Employers .............................................
Employees ............................................
Employees ............................................
Employees ............................................
Employees ............................................
Employees and Representatives; Employers—Year 1 (on-site evaluation).
Employees and Representatives; Employers—Year 1 (on-site evaluation).
Employees and Representatives; Employers—Year 2 (on-site evaluation).
Employees and Representatives; Employers—Year 1 (without on-site
evaluation).
Employees and Representatives; Employers—Year 2 (without on-site
evaluation).
Total ...............................................
35
75
1
12/60
15
1,470
1
15/60
368
2,100
1
30/60
1,050
60
1,225
140
1
1
1
30/60
5/60
10/60
30
102
23
Second Followback Survey ..................
140
1
20/60
47
Third Followback Survey ......................
140
1
15/60
35
First Followback Survey .......................
94
1
10/60
16
Second Followback Survey ..................
94
1
15/60
24
...............................................................
........................
........................
....................
1,745
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10241]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
18:34 Jul 31, 2023
Jkt 259001
Total
burden
(in hours)
12/60
BILLING CODE 4163–18–P
VerDate Sep<11>2014
Average
burden per
response
(in hours)
1
[FR Doc. 2023–16221 Filed 7–31–23; 8:45 am]
SUMMARY:
Number of
responses per
respondent
175
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
lotter on DSK11XQN23PROD with NOTICES1
Number of
respondents
Type of respondents
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
October 2, 2023.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10241 Survey of Retail Prices
Under the PRA (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires Federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
E:\FR\FM\01AUN1.SGM
01AUN1
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]
[Pages 50157-50158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16281]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10241]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), Federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by October 2, 2023.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10241 Survey of Retail Prices
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. The term
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of
[[Page 50158]]
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
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.)
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