Agency Information Collection Activities: Submission for OMB Review; Comment Request, 41631-41632 [2023-13656]
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41631
Federal Register / Vol. 88, No. 122 / Tuesday, June 27, 2023 / Notices
funded 33 state and local public health
programs (funded SLHD). These
recipients were selected through a
competitive objective review process
and are managed as CDC cooperative
agreements. Awards are for five years
and are renewed through an Annual
Performance Report (APR)/Continuation
Application. The Tracking Program
collects data from recipients about their
activities and progress for the purposes
of program evaluation and monitoring
(hereafter referenced as program data).
Environmental public health tracking
is the ongoing collection, integration,
analysis, and dissemination of health,
exposure, and hazard data (hereinafter
referenced as Tracking Network data) to
inform public health actions that protect
the population from harm resulting from
exposure to environmental
contaminants. The Tracking Network
provides data from existing health,
exposure, and hazard surveillance
systems and supports ongoing efforts
within the public health and
environmental sectors to improve data
collection, accessibility, and
dissemination as well as analytic and
response capacity. Data that were
previously collected for different
purposes and stored in separate state
and local systems are now available in
a nationally standardized format
allowing programs to begin bridging the
gap between health and the
environment.
CDC is requesting approval for an
increase of seven additional annual
respondents from the 30 approved
under the previous ICR and five-year
NOFO (No. CDC–RFA–EH17–1702). In
spring of 2022, under the new five-year
NOFO (No. CDC–RFA–EH22–2202), the
CDC’s Tracking Program funded 33 state
and local public health programs
(funded SLHD). CDC is now requesting
approval for up to 37 annual
respondents. This number reflects the
current 33 SLHD respondents plus four
to allow for future funding of new SLHD
or to collect voluntary responses from
unfunded SLHD.
Data from recipients or other SLHD
are submitted annually following
standardized procedures. Tracking
network data submitted annually by
recipients and other SLHD to the
Tracking Program include seven
datasets and the metadata form,
specifically (1) birth defects prevalence,
(2) childhood blood lead levels, (3)
drinking water monitoring, (4)
emergency department visits, (5)
hospitalizations, (6) radon testing, (7)
biomonitoring, and (8) metadata. The
Tracking Program will begin using
Research Electronic Data Capture
(REDCap) for its Electronic Data Capture
System (EDCS) needs, which is an easyto-use, free software tool that is useful
for programmatic deliverable
management and data capture. Using an
EDCS significantly reduces the burden
by optimizing the data capture method
to eliminate the need for personnel to
complete manual data cleaning and
organization before using data for
analysis and evaluation upon
submission.
Based on the above changes, CDC
requests OMB approval for an estimated
14,384 annualized burden hours. There
is no cost to respondents other than
their time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Form name
State and Local Health Department ...............
Birth defects prevalence ................................
Childhood blood lead levels ...........................
Drinking water monitoring ..............................
Emergency department visits .........................
Hospitalizations ..............................................
Radon testing .................................................
Biomonitoring .................................................
Metadata records ...........................................
Work Plan Template ......................................
Program Accomplishments and Public Health
Actions Report.
Performance Measures Report ......................
PHA Impact Follow Up Form .........................
Communications plan .....................................
Web Stats Template ......................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
Number of
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[FR Doc. 2023–13569 Filed 6–26–23; 8:45 am]
[Document Identifier: CMS–10302]
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Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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Number of
responses per
respondent
Average
burden
per
response
(in hrs.)
30
37
37
37
37
25
25
37
37
37
1
1
1
1
1
1
1
2
1
2
40
40
50
40
40
50
40
20
21
20
37
37
37
37
1
2
1
2
20
0.25
2
1
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
SUMMARY:
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41632
Federal Register / Vol. 88, No. 122 / Tuesday, June 27, 2023 / Notices
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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by July 27, 2023.
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:
FOR FURTHER INFORMATION CONTACT:
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
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: Extension of a currently
approved collection; Title of
Information Collection: Collection
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SUPPLEMENTARY INFORMATION:
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Requirements for Compendia for
Determination of Medically-accepted
Indications for Off-label Uses of Drugs
and Biologicals in an Anti-cancer
Chemotherapeutic Regimen; Use:
Section 182(b) of the Medicare
Improvement of Patients and Providers
Act (MIPPA) amended section
1861(t)(2)(B) of the Social Security Act
(42 U.S.C. 1395x(t)(2)(B)) by adding at
the end the following new sentence: ‘On
and after January 1, 2010, no compendia
may be included on the list of
compendia under this subparagraph
unless the compendia has a publicly
transparent process for evaluating
therapies and for identifying potential
conflicts of interest.’ We believe that the
implementation of this statutory
provision that compendia have a
‘‘publicly transparent process for
evaluating therapies and for identifying
potential conflicts of interests’’ is best
accomplished by amending 42 CFR
414.930 to include the MIPPA
requirements and by defining the key
components of publicly transparent
processes for evaluating therapies and
for identifying potential conflicts of
interests.
All currently listed compendia will be
required to comply with these
provisions, as of January 1, 2010, to
remain on the list of recognized
compendia. In addition, any
compendium that is the subject of a
future request for inclusion on the list
of recognized compendia will be
required to comply with these
provisions. No compendium can be on
the list if it does not fully meet the
standard described in section
1861(t)(2)(B) of the Act, as revised by
section 182(b) of the MIPPA. Form
Number: CMS–10302 (OMB control
number: 0938–1078); Frequency:
Annually; Affected Public: Business and
other for-profits and Not-for-profit
institutions; Number of Respondents:
845; Total Annual Responses: 900; Total
Annual Hours: 5,135. (For policy
questions regarding this collection
contact Sarah Fulton at 410–786–2749.)
Dated: June 22, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–13656 Filed 6–26–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10638]
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
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
August 28, 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: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
SUMMARY:
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Agencies
[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41631-41632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10302]
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
[[Page 41632]]
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 27, 2023.
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: Extension of a currently
approved collection; Title of Information Collection: Collection
Requirements for Compendia for Determination of Medically-accepted
Indications for Off-label Uses of Drugs and Biologicals in an Anti-
cancer Chemotherapeutic Regimen; Use: Section 182(b) of the Medicare
Improvement of Patients and Providers Act (MIPPA) amended section
1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by
adding at the end the following new sentence: `On and after January 1,
2010, no compendia may be included on the list of compendia under this
subparagraph unless the compendia has a publicly transparent process
for evaluating therapies and for identifying potential conflicts of
interest.' We believe that the implementation of this statutory
provision that compendia have a ``publicly transparent process for
evaluating therapies and for identifying potential conflicts of
interests'' is best accomplished by amending 42 CFR 414.930 to include
the MIPPA requirements and by defining the key components of publicly
transparent processes for evaluating therapies and for identifying
potential conflicts of interests.
All currently listed compendia will be required to comply with
these provisions, as of January 1, 2010, to remain on the list of
recognized compendia. In addition, any compendium that is the subject
of a future request for inclusion on the list of recognized compendia
will be required to comply with these provisions. No compendium can be
on the list if it does not fully meet the standard described in section
1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA.
Form Number: CMS-10302 (OMB control number: 0938-1078); Frequency:
Annually; Affected Public: Business and other for-profits and Not-for-
profit institutions; Number of Respondents: 845; Total Annual
Responses: 900; Total Annual Hours: 5,135. (For policy questions
regarding this collection contact Sarah Fulton at 410-786-2749.)
Dated: June 22, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-13656 Filed 6-26-23; 8:45 am]
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