Agency Information Collection Activities: Proposed Collection; Comment Request, 12844-12845 [2024-03348]
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12844
Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices
one member shall be a specialist in the
rural aspects of one or more of the
professions or fields listed below. In
addition, the Secretary designates, as ex
officio members, representatives from
other Federal agencies, principally
agencies that conduct or support health
care research, as well as Federal officials
the Secretary may consider appropriate.
42 U.S.C. 299c(c)(3).
Seven current members’ terms will
expire in November 2024. To fill these
positions, we are seeking individuals
who: (1) are distinguished in the
conduct of research, demonstration
projects, and evaluations with respect to
health care; (2) are distinguished in the
fields of health care quality research or
health care improvement; (3) are
distinguished in the practice of
medicine; (4) are distinguished in other
health professions; (5) represent the
private health care sector (including
health plans, providers, and purchasers)
or are distinguished as administrators of
health care delivery systems; (6) are
distinguished in the fields of health care
economics, information systems, law,
ethics, business, or public policy; and
(7) represent the interests of patients
and consumers of health care, 42 U.S.C.
299c(c)(2). Individuals are particularly
sought with experience and success in
these activities. AHRQ will accept
nominations to serve on the Council in
a representative capacity.
The Council meets in the Washington,
DC, metropolitan area, generally in
Rockville, Maryland, approximately
three times a year to provide broad
guidance to the Secretary and AHRQ’s
Director on the direction of and
programs undertaken by AHRQ.
Seven individuals will be selected by
the Secretary to serve on the Council
beginning with the meeting in the
spring of 2024. Members generally serve
3-year terms. Appointments are
staggered to permit an orderly rotation
of membership.
Interested persons may nominate one
or more qualified persons for
membership on the Council. Selfnominations are accepted. Nominations
shall include: (1) a copy of the
nominee’s resume or curriculum vitae;
and (2) a statement that the nominee is
willing to serve as a member of the
Council. Selected candidates will be
asked to provide detailed information
concerning their financial interests,
consultant positions and research grants
and contracts, to permit evaluation of
possible sources of conflict of interest.
Please note that once a candidate is
nominated, AHRQ may consider that
nomination for future positions on the
Council.
VerDate Sep<11>2014
16:54 Feb 16, 2024
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The Department seeks a broad
geographic representation. In addition,
AHRQ conducts and supports research
concerning priority populations, which
include: Inner city; rural; low income;
minority; women; children; elderly; and
those with special health care needs,
including those who have disabilities,
need chronic care, or need end-of-life
health care. See 42 U.S.C. 299(c). AHRQ
also includes in its definition of priority
populations those groups identified in
section 2(a) of Executive Order 13985 as
members of underserved communities:
Black, Latino, and Indigenous and
Native American persons, Asian
Americans and Pacific Islanders and
other persons of color; members of
religious minorities; lesbian, gay,
bisexual, transgender, and queer
(LGBTQ+) persons; persons with
disabilities; persons who live in rural
areas; and persons otherwise adversely
affected by persistent poverty or
inequality. Nominations of persons with
expertise in health care for these
priority populations are encouraged.
Dated: February 14, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–03401 Filed 2–16–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10110]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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
April 22, 2024.
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.
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:
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
Contents
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
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
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–10110 Manufacturer Submission
of Average Sales Price (ASP) Data for
Medicare Part B Drugs and Biologicals
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
AGENCY:
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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
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 currently approved
collection; Title of Information
Collection: Manufacturer Submission of
Average Sales Price (ASP) Data for
Medicare Part B Drugs and Biologicals;
Use: Section 1847A of the Act requires
that the Medicare Part B payment
amounts for covered drugs and
biologicals not paid on a cost or
prospective payment basis be based
upon manufacturers’ average sales price
data submitted quarterly to the Centers
for Medicare & Medicaid Services
(CMS). The reporting requirements are
specified in 42 CFR part 414 subpart J.
CMS, specifically, the Division of
Data Analysis and Market-based Pricing
(DDAMBP) will utilize the ASP data
(ASP and number of units sold as
specific in section 1847A of the Act) to
determine the Medicare Part B drug
payment amounts for CY 2005 and
beyond. The manufacturers submit their
ASP data for all of their National Drug
Codes (NDC) for Part B drugs. DDAMBP
compiles the data, analyzes the data and
runs the data through software to
calculate the volume-weighted ASP for
all of the NDCs that are grouped within
a given HCPCS code. The formula to
calculate the volume-weighted ASP is
the Sum (ASP * units) for all NDCs/Sum
(units * bill units per pkg) for all NDCs.
DDAMBP provides ASP payment
amounts for several components within
CMS that utilize 1847(A) payment
methodologies to implement various
payment policies including, but not
limited to, ESRD, OPPS, OTP and
payment models. CMS will also use
reported ASP and units to calculate
inflation adjusted coinsurance and
rebates. The Department of Health and
Human Services’ Office of the Inspector
General also uses the ASP data in
conducting studies. Form Number:
CMS–10110 (OMB Control Number:
0938–0921); Frequency: Quarterly;
Affected Public: Private and Business or
other for-profits; Number of
Respondents: 500; Number of
Responses: 2,00; Total Annual Hours:
VerDate Sep<11>2014
16:54 Feb 16, 2024
Jkt 262001
26,000. (For policy questions regarding
this collection contact Felicia Brown at
(410) 786–9287 or Felicia.brown@
cms.hhs.gov).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–03348 Filed 2–16–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10466]
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
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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by March 21, 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
DATES:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
12845
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.
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: Patient
Protection and Affordable Care Act;
Exchange Functions: Eligibility for
Exemptions; Use: The data collection
and reporting requirements in ‘‘Patient
Protection and Affordable Care Act;
Exchange Functions: Eligibility for
Exemptions; Miscellaneous Minimum
Essential Coverage Provisions’’ (78 FR
39494 (July 1, 2013)), address Federal
requirements that states must meet with
regard to the Exchange minimum
function of performing eligibility
determinations and issuing certificates
of exemption from the shared
responsibility payment. In the final
regulation, CMS addresses standards
related to eligibility, including the
verification and eligibility
determination process, eligibility
redeterminations, options for states to
rely on HHS to make eligibility
determinations for certificates of
exemption, and reporting. CMS
developed four appendices of
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20FEN1
Agencies
[Federal Register Volume 89, Number 34 (Tuesday, February 20, 2024)]
[Notices]
[Pages 12844-12845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03348]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10110]
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 (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 April 22, 2024.
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-10110 Manufacturer Submission of Average Sales Price (ASP) Data for
Medicare Part B Drugs and Biologicals
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
[[Page 12845]]
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 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 currently
approved collection; Title of Information Collection: Manufacturer
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs
and Biologicals; Use: Section 1847A of the Act requires that the
Medicare Part B payment amounts for covered drugs and biologicals not
paid on a cost or prospective payment basis be based upon
manufacturers' average sales price data submitted quarterly to the
Centers for Medicare & Medicaid Services (CMS). The reporting
requirements are specified in 42 CFR part 414 subpart J.
CMS, specifically, the Division of Data Analysis and Market-based
Pricing (DDAMBP) will utilize the ASP data (ASP and number of units
sold as specific in section 1847A of the Act) to determine the Medicare
Part B drug payment amounts for CY 2005 and beyond. The manufacturers
submit their ASP data for all of their National Drug Codes (NDC) for
Part B drugs. DDAMBP compiles the data, analyzes the data and runs the
data through software to calculate the volume-weighted ASP for all of
the NDCs that are grouped within a given HCPCS code. The formula to
calculate the volume-weighted ASP is the Sum (ASP * units) for all
NDCs/Sum (units * bill units per pkg) for all NDCs. DDAMBP provides ASP
payment amounts for several components within CMS that utilize 1847(A)
payment methodologies to implement various payment policies including,
but not limited to, ESRD, OPPS, OTP and payment models. CMS will also
use reported ASP and units to calculate inflation adjusted coinsurance
and rebates. The Department of Health and Human Services' Office of the
Inspector General also uses the ASP data in conducting studies. Form
Number: CMS-10110 (OMB Control Number: 0938-0921); Frequency:
Quarterly; Affected Public: Private and Business or other for-profits;
Number of Respondents: 500; Number of Responses: 2,00; Total Annual
Hours: 26,000. (For policy questions regarding this collection contact
Felicia Brown at (410) 786-9287 or [email protected]).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-03348 Filed 2-16-24; 8:45 am]
BILLING CODE 4120-01-P