Agency Information Collection Activities: Submission for OMB Review; Comment Request, 49178-49179 [2024-12774]
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49178
Federal Register / Vol. 89, No. 113 / Tuesday, June 11, 2024 / Notices
To prepare the proposed expansion
area for development, some existing
utilities and PCA infrastructure will
need to be accommodated in a new way,
either within the LPOE via easements or
moved off site to the west or south on
PCA-owned land. Project changes have
triggered the reconfiguration of some of
the existing PCA operations on PCA
lands and will require relocation of
some infrastructure associated with
PCA, the MD&W Railway, and
OfficeMax. Relocation of utilities and
infrastructure may be conducted by
either GSA or PCA, depending on final
acquisition negotiations. Actions taken
by PCA are considered as connected
actions to the Proposed Action.
Alternative 1 also considers the
implementation of renewable energy
technologies within the expanded and
modernized LPOE. These technologies
were not considered in the 2011 Final
EIS but have since been proposed for
inclusion in future site plans.
Renewable technologies that may be
incorporated into the facility design
include solar and geothermal
technologies, depending on the final
design.
GSA is currently undergoing formal
consultation with the State Historic
Preservation Officer (SHPO) and
consulting parties to follow
coordination procedures as required
under Section 106 of the National
Historic Preservation Act. GSA intends
on implementing and complying with
all mitigation measures resulting from
section 106 consultation as detailed in
the ROD.
William Renner,
Director, Facilities Management and Services
Programs Division, Great Lakes Region 5, U.S.
General Services Administration.
[FR Doc. 2024–12700 Filed 6–10–24; 8:45 am]
BILLING CODE 6820–CF–P
Comments on the collection(s) of
information must be received by the
OMB desk officer by July 11, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
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.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
[Document Identifiers: CMS–381 and CMS–
R–38]
khammond on DSKJM1Z7X2PROD with NOTICES
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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.
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
SUMMARY:
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William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to publish a 30-day notice in the
PO 00000
Frm 00034
Fmt 4703
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Federal Register concerning each
proposed collection of 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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Identification of
Extension Units of Medicare Approved
Outpatient Physical Therapy/Outpatient
Speech Pathology (OPT/OSP) Providers
and Supporting Regulations; Use: Form
CMS–381 was developed to ensure that
each OPT/OSP extension location at
which OPT/OSP providers furnish
services, must be reported by the
providers to the State Survey Agencies
(SAs). Form CMS–381 is completed
when: (1) new OPT/OSP providers enter
the Medicare program; (2) when existing
OPT/OPS providers delete or add a
service, or close or add an extension
location; or, (3) when existing OPT/OSP
providers are recertified by the State
Survey Agency every 6 years.
In 2022, CMS transitioned some of the
certification processes to the Center for
Program Integrity (CPI) and the
Medicare Administrative Contractor
(MAC). Prior to the transition, the CMS
Survey Operations Group was involved
in the processing of the extension
location requests. As a result of the new
processing instructions, CMS is now
reconciling the Form CMS–381 with
updates to the instructions.
Additionally, CMS has revised the Form
CMS–381 to incorporate the initial
enrollment of OPT/OSPs which was
previously completed on the Form
CMS–1856 (0938–0065). CMS has
combined the forms into one form in
order to further align with the
transitioned processes and streamline
the requests from the provider
community. This change will decrease
the burden on both the provider
community as well as CMS.
Furthermore, this change will also allow
for OPTs who wish to initially enroll in
the Medicare program to submit an
extension location request with the
initial enrollment. The State Survey
Agency or Accrediting Organization (for
those OPTs requesting deemed status)
will survey the extension location
during the initial survey to verify
compliance with the Medicare
conditions. Form Number: CMS–381
(OMB control number: 0938–0273);
Frequency: Occasionally; Affected
Public: Private Sector; Business or other
for-profit and not-for-profit institutions;
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Federal Register / Vol. 89, No. 113 / Tuesday, June 11, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Number of Respondents: 506; Total
Annual Responses: 506; Total Annual
Hours: 253. (For policy questions
regarding this collection contact
Caecilia Andrews at 410–786–2190.)
2. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Conditions for
Certification for Rural Health Clinics
and Conditions for Coverage for
Federally Qualified Health Centers in 42
CFR 491; Use: The Conditions for
Medicare Certification (CfCs) for Rural
Health Clinics (RHCs) are based on
criteria prescribed in law and designed
to ensure that each RHC has properly
trained staff to provide appropriate care
and to assure a safe physical
environment for patients. The
information collection requirements
described herein are needed to
implement the Medicare and Medicaid
CfCs for a total of 5,349 RHCs. These
requirements are similar in intent to
standards developed by industry
organizations such as the Joint
Commission on Accreditation of
Hospitals, and the National League of
Nursing/American Public Association,
and merely reflect accepted standards of
management and care to which rural
health clinics must adhere.
Federally Qualified Health Centers
(FQHCs) are also subject to Conditions
for Certification to participate in the
Medicare and Medicaid programs.
These health and safety standards are
the foundation for improving quality
and protecting the health and safety of
Medicare and Medicaid beneficiaries.
The information collection requirements
described herein affect approximately
11,252 FQHCs. The current information
collection requirements at 42 CFR
491.9(b) and 491.11 are applicable to
both RHCs and FQHCs. Form Number:
CMS–R–38 (OMB control number:
0938–0334); Frequency: Recordkeeping
and Reporting—Annually; Affected
Public: Business or other for-profits;
Number of Respondents: 17,663; Total
Annual Responses: 17,663; Total
Annual Hours: 104,245. (For policy
questions regarding this collection
contact Claudia Molinar at 410–786–
8445.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–12774 Filed 6–10–24; 8:45 am]
BILLING CODE 4120–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2332]
Emerging Drug Safety Technology
Meetings; Program Announcement
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Center for Drug
Evaluation and Research (CDER) within
the Food and Drug Administration (FDA
or we) is announcing a meeting
program, the Emerging Drug Safety
Technology Meeting (EDSTM) program.
These meetings will be administered by
staff in the newly established CDER
Emerging Drug Safety Technology
Program (EDSTP). EDSTMs provide
applicants with an approved application
and/or other relevant parties supporting
industry’s pharmacovigilance (PV)
activities (e.g., academia, contract
research organizations (CROs),
pharmacovigilance vendors, software
developers) who meet the eligibility and
selection criteria for participation with
an opportunity to meet with CDER staff
to discuss their research, development,
and use of Artificial Intelligence (AI)
and other emerging technologies in PV.
The goals of the meeting program in its
initial phase are to facilitate mutual
learning and discussion of the
pharmaceutical industry’s application of
these technologies to PV, including
efforts to validate and verify relevant
models. While the EDSTP is specifically
focused on the use of AI in PV for
postmarket activities, it is part of
CDER’s multifaceted approach to
enhance mutual learning of where and
how specific innovations, such as AI,
can best be used across the drug product
life cycle.
DATES: Applicants and other relevant
parties may submit meeting requests
under the program beginning June 11,
2024.
SUMMARY:
For additional information
about the EDSTM program, please refer
to FDA’s web page at https://
www.fda.gov/drugs/science-andresearch-drugs/cder-emerging-drugsafety-technology-program-edstp.
FOR FURTHER INFORMATION CONTACT:
Ricardo Hernandez, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993–0002, 240–402–9526, or
email AIMLforDrugDevelopment@
fda.hhs.gov with the subject line
‘‘EDSTM—General Inquiry’’.
ADDRESSES:
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49179
SUPPLEMENTARY INFORMATION:
I. Background
The pharmaceutical industry is
expanding its use of AI and other
emerging technology across the drug
product life cycle. FDA is interested in
accelerating its understanding of the
research, development, and use of AI
and other emerging technology in the
area of pharmacovigilance, including
their performance characteristics. The
EDSTM is a means by which applicants
and other relevant parties who meet the
eligibility and selection criteria for
participation, can meet with CDER to
share information about their use of AI
and other emerging technology, and its
potential application in PV, including
efforts to validate and verify relevant
models.
The goal of the EDSTM is to facilitate
mutual learning and discussion on the
opportunities and challenges with using
such technologies in PV. If selected for
a meeting, application holders and/or
other relevant parties will meet with
CDER staff to discuss their research,
development, and/or use of AI and other
emerging technologies in PV. FDA plans
to leverage these learnings to help
inform potential regulatory and policy
approaches, within the use of emerging
technology in PV. The EDSTM program
is not an avenue to seek regulatory
advice on compliance with
pharmacovigilance regulations. Rather,
we expect that the information gained
during this program will help CDER
consider providing regulatory advice on
specific technologies to facilitate their
adoption when appropriate. The
discussions and background
information submitted through the
EDSTMs are nonbinding on both FDA
and EDSTM requesters.
EDSTMs may be requested by
applicants with at least one approved
application regulated by CDER,
including new drug applications,
abbreviated new drug applications, or
biologics license applications, and/or by
other relevant parties supporting
industry’s PV activities (e.g., academia,
CROs/PV vendors, software developers)
who develop, leverage, or intend to
leverage AI or other emerging
technology that can be used to satisfy
the postmarketing reporting
requirements in 21 CFR 314.80, 314.98,
and 600.80. Eligible parties, such as an
applicant or an applicant’s PV vendor,
may request meetings separately or in
partnership. Requests may be submitted
on a rolling basis and will be reviewed
quarterly each calendar year. Please
refer to the EDSTM program web page
for details on submission deadlines for
quarterly review. CDER will select up to
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]]>Agencies
[Federal Register Volume 89, Number 113 (Tuesday, June 11, 2024)]
[Notices]
[Pages 49178-49179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12774]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-381 and CMS-R-38]
Agency Information Collection Activities: Submission for OMB
Review; 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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by July 11, 2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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 Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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 (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of 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 that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Identification of
Extension Units of Medicare Approved Outpatient Physical Therapy/
Outpatient Speech Pathology (OPT/OSP) Providers and Supporting
Regulations; Use: Form CMS-381 was developed to ensure that each OPT/
OSP extension location at which OPT/OSP providers furnish services,
must be reported by the providers to the State Survey Agencies (SAs).
Form CMS-381 is completed when: (1) new OPT/OSP providers enter the
Medicare program; (2) when existing OPT/OPS providers delete or add a
service, or close or add an extension location; or, (3) when existing
OPT/OSP providers are recertified by the State Survey Agency every 6
years.
In 2022, CMS transitioned some of the certification processes to
the Center for Program Integrity (CPI) and the Medicare Administrative
Contractor (MAC). Prior to the transition, the CMS Survey Operations
Group was involved in the processing of the extension location
requests. As a result of the new processing instructions, CMS is now
reconciling the Form CMS-381 with updates to the instructions.
Additionally, CMS has revised the Form CMS-381 to incorporate the
initial enrollment of OPT/OSPs which was previously completed on the
Form CMS-1856 (0938-0065). CMS has combined the forms into one form in
order to further align with the transitioned processes and streamline
the requests from the provider community. This change will decrease the
burden on both the provider community as well as CMS. Furthermore, this
change will also allow for OPTs who wish to initially enroll in the
Medicare program to submit an extension location request with the
initial enrollment. The State Survey Agency or Accrediting Organization
(for those OPTs requesting deemed status) will survey the extension
location during the initial survey to verify compliance with the
Medicare conditions. Form Number: CMS-381 (OMB control number: 0938-
0273); Frequency: Occasionally; Affected Public: Private Sector;
Business or other for-profit and not-for-profit institutions;
[[Page 49179]]
Number of Respondents: 506; Total Annual Responses: 506; Total Annual
Hours: 253. (For policy questions regarding this collection contact
Caecilia Andrews at 410-786-2190.)
2. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Conditions for Certification for Rural Health Clinics and Conditions
for Coverage for Federally Qualified Health Centers in 42 CFR 491; Use:
The Conditions for Medicare Certification (CfCs) for Rural Health
Clinics (RHCs) are based on criteria prescribed in law and designed to
ensure that each RHC has properly trained staff to provide appropriate
care and to assure a safe physical environment for patients. The
information collection requirements described herein are needed to
implement the Medicare and Medicaid CfCs for a total of 5,349 RHCs.
These requirements are similar in intent to standards developed by
industry organizations such as the Joint Commission on Accreditation of
Hospitals, and the National League of Nursing/American Public
Association, and merely reflect accepted standards of management and
care to which rural health clinics must adhere.
Federally Qualified Health Centers (FQHCs) are also subject to
Conditions for Certification to participate in the Medicare and
Medicaid programs. These health and safety standards are the foundation
for improving quality and protecting the health and safety of Medicare
and Medicaid beneficiaries. The information collection requirements
described herein affect approximately 11,252 FQHCs. The current
information collection requirements at 42 CFR 491.9(b) and 491.11 are
applicable to both RHCs and FQHCs. Form Number: CMS-R-38 (OMB control
number: 0938-0334); Frequency: Recordkeeping and Reporting--Annually;
Affected Public: Business or other for-profits; Number of Respondents:
17,663; Total Annual Responses: 17,663; Total Annual Hours: 104,245.
(For policy questions regarding this collection contact Claudia Molinar
at 410-786-8445.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-12774 Filed 6-10-24; 8:45 am]
BILLING CODE 4120-01-P
