Agency Information Collection Activities: Submission for OMB Review; Comment Request, 42722-42723 [2023-14176]
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Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Notices
Notice and request for
comments.
ACTION:
As part of its continuing effort
to reduce paperwork burdens, and as
required by the Paperwork Reduction
Act (PRA) of 1995, the Federal
Communications Commission (FCC or
the Commission) invites the general
public and other Federal agencies to
take this opportunity to comment on the
following information collection.
Comments are requested concerning:
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
the accuracy of the Commission’s
burden estimate; ways to enhance the
quality, utility, and clarity of the
information collected; ways to minimize
the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology; and ways to
further reduce the information
collection burden on small business
concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a
collection of information unless it
displays a currently valid control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
PRA that does not display a valid Office
of Management and Budget (OMB)
control number.
DATES: Written PRA comments should
be submitted on or before September 1,
2023. If you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all PRA comments to
Nicole Ongele, FCC, via email PRA@
fcc.gov and to nicole.ongele@fcc.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information about the
information collection, contact Nicole
Ongele, (202) 418–2991.
SUPPLEMENTARY INFORMATION:
OMB Control Number: 3060–0057.
Title: Application for Equipment
Authorization, FCC Form 731.
Form Number: FCC Form 731.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit.
Number of Respondents and
Responses: 11,305 respondents; 24,873
responses.
Estimated Time per Response: 0.1–40
hours.
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SUMMARY:
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Frequency of Response: On occasion
and other ongoing reporting
requirements.
Obligation to Respond: Required to
obtain or retain benefits. Statutory
authority for this information collection
is contained in 47 U.S.C. 154(i), 301,
302a, 303, 309(j), 312, 316, and the
Secure Equipment Act of 2021, Public
Law 117–55, 135 Stat. 423.
Total Annual Burden: 206,863 hours.
Total Annual Cost: $50,155,140.
Needs and Uses: The Commission
will submit this information collection
to the Office of Management and Budget
(OMB) after this 60-day comment period
to obtain the three-year clearance. The
information will be used by the
Commission to fulfill its statutory
mandate under the Secure Equipment
Act of 2021, Public Law 117–55, 135
Stat. 423 (2021) to implement
prohibitions in its equipment
authorization program that will protect
the nation’s telecommunications
systems from equipment that has been
determined to pose an unacceptable risk
to national security or the safety of U.S.
persons.
Federal Communications Commission.
Marlene Dortch,
Secretary, Office of the Secretary.
[FR Doc. 2023–14012 Filed 6–30–23; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10847]
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
SUMMARY:
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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 August 2, 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: New collection (Request for a
new OMB control number); Title of
Information Collection: Negotiation Data
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Notices
Elements under Sections 11001 and
11002 of the Inflation Reduction Act;
Use: Under the authority in sections
11001 and 11002 of the Inflation
Reduction Act of 2022 (Pub. L. 117–
169), the Centers for Medicare &
Medicaid Services (CMS) is
implementing the Medicare Drug Price
Negotiation Program (the ‘‘Negotiation
Program’’), codified in sections 1191
through 1198 of the Social Security Act
(‘‘the Act’’). The Act establishes the
Negotiation Program to negotiate
maximum fair prices (‘‘MFPs’’), defined
at 1191(c)(3) of the Act, for certain high
expenditure, single source selected
drugs covered under Medicare Part B
and Part D. For the first year of the
Negotiation Program, the Secretary of
Health and Human Services (the
‘‘Secretary’’) will select 10 Part D high
expenditure, single source drugs for
negotiation.
The statute requires that CMS
consider certain data from Primary
Manufacturers as part of the negotiation
process. These data include the data
required to calculate non-FAMP for
selected drugs for the purpose of
establishing a ceiling price, as outlined
in section 1193(a)(4)(A), and the
negotiation factors outlined in section
1194(e)(1) for the purpose of
formulating offers and counteroffers
process pursuant to section
1193(a)(4)(B). Some of these data are
held by the Primary Manufacturer and
are not currently available to CMS. Data
described in section 1194(e)(1) and
1193(a)(4) must be submitted by the
Primary Manufacturer.
Section 1194(e)(2) requires CMS to
consider certain data on alternative
treatments to the selected drug. Because
the statute does not specify where these
data come from, CMS will allow for
optional submission from Primary
Manufacturers and the public. CMS will
additionally review existing literature,
conduct internal analyses, and consult
subject matter and clinical experts on
the factors listed in 1194(e)(2) to ensure
consideration of such factors.
Manufacturers may optionally submit
this information as part of their
Negotiation Data Elements Information
Collection Request Form. The public
may optionally submit evidence about
alternative treatments. Form Number:
CMS–10847 (OMB control number:
0938–NEW); Frequency: Occasionally;
Affected Public: Individuals and
Households, Private Sector (Business or
other for-profits and Not-for-profit
institutions); Number of Respondents:
3,300; Total Annual Responses: 3,000;
Total Annual Hours: 17,000. (For policy
questions regarding this collection
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contact Lara Strawbridge at 410–786–
6880.)
Dated: June 29, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–14176 Filed 6–30–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1800–N]
Inflation Reduction Act (IRA) Revised
Program Guidance
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
the availability of CMS’ revised
guidance for the Medicare Drug Price
Negotiation Program for the
implementation of the Inflation
Reduction Act. CMS will be releasing
additional Inflation Reduction Actrelated guidance; all can be viewed on
the dedicated Inflation Reduction Act
section of the CMS website.
ADDRESSES: Inquiries related to the
revised guidance should be sent to
IRARebateandNegotiation@cms.hhs.gov
with the relevant subject line,
‘‘Medicare Drug Price Negotiation
Program Guidance.’’
SUPPLEMENTARY INFORMATION: The
Inflation Reduction Act was signed into
law on August 16, 2022. Sections 11001
and 11002 of the Inflation Reduction
Act (IRA) (Pub. L. 117–169), signed into
law on August 16, 2022, established the
Medicare Drug Price Negotiation
Program (hereafter the ‘‘Negotiation
Program’’) to negotiate Maximum Fair
Prices (MFPs) for certain high
expenditure, single source drugs and
biological products. The requirements
for this program are described in
sections 1191 through 1198 of the Social
Security Act (hereafter ‘‘the Act’’) as
added by sections 11001 and 11002 of
the Inflation Reduction Act.
To obtain copies of the revised
guidance and the responses to
comments from the initial guidance, as
well as other Inflation Reduction Actrelated documents, please access the
CMS Inflation Reduction Act website by
copying and pasting the following web
address into your web browser: https://
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42723
www.cms.gov/inflation-reduction-actand-medicare. If interested in receiving
CMS Inflation Reduction Act updates by
email, individuals may sign up for CMS
Inflation Reduction Act’s email updates
at https://www.cms.gov/About-CMS/
Agency-Information/Aboutwebsite/
EmailUpdates.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Evell J. Barco Holland, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: June 28, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–14097 Filed 6–30–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2440]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cardiovascular and Renal
Drugs Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on
September 13, 2023, from 9 a.m. to 4
p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
DATES:
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]]>Agencies
[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Notices]
[Pages 42722-42723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14176]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10847]
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 August 2, 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: New collection (Request
for a new OMB control number); Title of Information Collection:
Negotiation Data
[[Page 42723]]
Elements under Sections 11001 and 11002 of the Inflation Reduction Act;
Use: Under the authority in sections 11001 and 11002 of the Inflation
Reduction Act of 2022 (Pub. L. 117-169), the Centers for Medicare &
Medicaid Services (CMS) is implementing the Medicare Drug Price
Negotiation Program (the ``Negotiation Program''), codified in sections
1191 through 1198 of the Social Security Act (``the Act''). The Act
establishes the Negotiation Program to negotiate maximum fair prices
(``MFPs''), defined at 1191(c)(3) of the Act, for certain high
expenditure, single source selected drugs covered under Medicare Part B
and Part D. For the first year of the Negotiation Program, the
Secretary of Health and Human Services (the ``Secretary'') will select
10 Part D high expenditure, single source drugs for negotiation.
The statute requires that CMS consider certain data from Primary
Manufacturers as part of the negotiation process. These data include
the data required to calculate non-FAMP for selected drugs for the
purpose of establishing a ceiling price, as outlined in section
1193(a)(4)(A), and the negotiation factors outlined in section
1194(e)(1) for the purpose of formulating offers and counteroffers
process pursuant to section 1193(a)(4)(B). Some of these data are held
by the Primary Manufacturer and are not currently available to CMS.
Data described in section 1194(e)(1) and 1193(a)(4) must be submitted
by the Primary Manufacturer.
Section 1194(e)(2) requires CMS to consider certain data on
alternative treatments to the selected drug. Because the statute does
not specify where these data come from, CMS will allow for optional
submission from Primary Manufacturers and the public. CMS will
additionally review existing literature, conduct internal analyses, and
consult subject matter and clinical experts on the factors listed in
1194(e)(2) to ensure consideration of such factors. Manufacturers may
optionally submit this information as part of their Negotiation Data
Elements Information Collection Request Form. The public may optionally
submit evidence about alternative treatments. Form Number: CMS-10847
(OMB control number: 0938-NEW); Frequency: Occasionally; Affected
Public: Individuals and Households, Private Sector (Business or other
for-profits and Not-for-profit institutions); Number of Respondents:
3,300; Total Annual Responses: 3,000; Total Annual Hours: 17,000. (For
policy questions regarding this collection contact Lara Strawbridge at
410-786-6880.)
Dated: June 29, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-14176 Filed 6-30-23; 8:45 am]
BILLING CODE 4120-01-P
