Agency Information Collection Request; 30-Day Public Comment Request, 62432-62433 [2022-22319]
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62432
Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
21 CFR section; activity
Total ..............................................................................
1 There
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total
hours
........................
........................
........................
...............................
929,140
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total
hours
111.75; petition for exemption from 100 percent identity testing
1
1
1
8
8
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. We
base our estimates for the recordkeeping
and reporting burdens on our
experience with the recordkeeping and
petition activities.
Dated: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22303 Filed 10–13–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0945–New]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection:
Nondiscrimination in Health Programs
and Activities.
Type of Collection: New.
OMB No.: 0990–XXXX or 0990–
NEW—Office for Civil Rights.
Abstract: This Information Collection
Request is for a new collection of
information as proposed in the
Department of Health and Human
Services (HHS) Office for Civil Rights
(OCR) Notice of Proposed Rulemaking
(NPRM) entitled Nondiscrimination in
Health Programs and Activities (RIN:
0945–AA17). The purpose of this
information collection is to ensure
covered entities (any health program or
activity, any part of which is receiving
federal financial assistance from the
Department and any health program or
activity conducted by the Department or
Title I entity) adhere to the statutory
requirements under Section 1557. The
proposed information collection helps
covered entities demonstrate
compliance with federal civil rights
laws and their awareness of their
obligations under those laws and
respective HHS implementing
regulations.
Comments on the ICR must be
received on or before November 14,
2022.
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.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041. When submitting
comments or requesting information,
please include the document identifier
0945–New–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
DATES:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
jspears on DSK121TN23PROD with NOTICES
Type of respondent
Number
responses per
respondent
Average
burden per
response
(in hours)
Total
burden hours
Recipients & State-based Exchanges with 15 or more employees ................
Recipients & State-based Exchanges .............................................................
41,250
275,002
1
1
10
1.75
412,500
481,254
Total ..........................................................................................................
316,252
........................
........................
893,754
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Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–22319 Filed 10–13–22; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Establishment of the Medicare Drug
Rebate and Negotiations Group Within
the Center for Medicare (CM)
Centers for Medicare &
Medicaid Services, HHS.
SUMMARY: Establish the Medicare Drug
Rebate and Negotiations Group within
the Center for Medicare (CM) to
implement the Drug Price Negotiation
Program and the Inflation Rebate
Program in Medicare Part B and Part D
as authorized under the Inflation
Reduction Act of 2022. CMS is
responsible for implementing these new
programs.
DATES: This reorganization was
approved by the Secretary of Health and
Human Services and takes effect
October 8, 2022.
SUPPLEMENTARY INFORMATION: Statement
of Organization, Functions, and
Delegations of Authority 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. 75, No. 56, pp.
14176–14178, dated March 24, 2010;
Vol. 76, No. 203, pp. 65197–65199,
dated October 20, 2011; Vol. 78, No. 86,
p. 26051, dated May 3, 2013; Vol. 79,
No. 2, pp. 397–398, dated January 3,
2014; and Vol. 84, No. 32, p. 4470, dated
February 15, 2019) is amended to reflect
the establishment of the Medicare Drug
Rebate and Negotiations Group within
the Center for Medicare (CM) to
implement the Drug Price Negotiation
Program and the Inflation Rebate
Program in Medicare Part B and Part D
as authorized under the Inflation
Reduction Act of 2022. CMS is
responsible for implementing these new
programs.
Title I, Subtitle B, Part 1, sections
11001–11004, of the Inflation Reduction
Act of 2022 (IRA) Public Law 117–169
enacted on August 16, 2022, establishes
a new Drug Price Negotiation Program
under Medicare Part B and Medicare
Part D to lower prices for certain highspend single source drugs. Title I,
Subtitle B, sections 11101 and 11102 of
the IRA also enacts a new program to
establish Inflation Rebates in Medicare
Part B and Medicare Part D. CMS is
jspears on DSK121TN23PROD with NOTICES
AGENCY:
VerDate Sep<11>2014
17:22 Oct 13, 2022
Jkt 259001
responsible for implementing these new
programs.
The work required to implement and
administer these new programs will be
novel and differ significantly from the
Medicare functions that CMS performs
today. Given the unique nature of this
new work, there is not an existing
operating component, group, office or
division in CMS or CM that performs
these actions. Moreover, the scope and
complexity of these new programs, and
the deadlines for implementation,
require that a new, dedicated
organization be established to ensure
that CMS is able to implement these
programs successfully and on time. In
order to implement and operate these
new programs, CMS is creating a new
group—the Medicare Drug Rebate and
Negotiations Group—within CM.
Part F, Section FC. 10 (Organization)
is revised as follows:
Center for Medicare, Medicare Drug
Rebate and Negotiations Group
Part F, Section FC. 20 (Functions) for
the new organization is as follows:
Medicare Drug Rebate and Negotiations
Group
With regard to the Drug Price
Negotiation Program, each year, the new
group will negotiate drug prices with
pharmaceutical manufacturers for
certain Part B and Part D drugs. This
will require identifying negotiationeligible drugs, entering into agreements
with manufacturers, collecting extensive
data from manufacturers and other
sources, calculating ceiling and
maximum fair prices, negotiating prices
with manufacturers, re-negotiating
prices as necessary and publishing the
results of the negotiation. Under the
Inflation Rebate Program, manufacturers
of certain drugs will be required to pay
a penalty or ‘‘rebate’’ if the price of their
drug increases faster than the rate of
inflation. For this program, the new
group will need to identify the universe
of rebatable drugs under Part B and Part
D; determine which drugs had price
increases in excess of inflation; and
compute, invoice, and collect rebates
owed by manufacturers.
To carry out these functions, the
major tasks of the new group will
include:
• Developing policy, including
identifying and vetting policy options
and preparing policy memoranda,
rulemaking and technical guidance;
• Briefing policy officials in CMS,
U.S. Department of Health and Human
Services (HHS), and Executive Office of
the President (EOP);
• Establishing operational processes
to collect data from manufacturers and
other sources;
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62433
• Conducting pharmacoeconomic
analyses and assessments of selected
drugs;
• Establishing operational processes
to negotiate and re-negotiate drug prices
and conducting those negotiations with
manufacturers;
• Establishing operational processes
to calculate and invoice rebates;
• Developing contractual agreements
with manufacturers necessary to
effectuate both programs;
• Monitoring manufacturer
compliance with programmatic rules;
• Procuring and managing contractors
to support these functions;
• Conducting stakeholder outreach
and educational materials; and
• Responding to inquiries from
Congress, the press, and other external
stakeholders.
Authority: 44 U.S.C. 3101.
Dated: October 7, 2022.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2022–22296 Filed 10–12–22; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Blueprint MedTech (BPMT)
Biocompatibility, Sterilization, and Animal
Studies.
Date: November 15, 2022.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Scientific Review
E:\FR\FM\14OCN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62432-62433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22319]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0945-New]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before November 14,
2022.
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.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041. When submitting comments or requesting information,
please include the document identifier 0945-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Nondiscrimination in Health Programs and
Activities.
Type of Collection: New.
OMB No.: 0990-XXXX or 0990-NEW--Office for Civil Rights.
Abstract: This Information Collection Request is for a new
collection of information as proposed in the Department of Health and
Human Services (HHS) Office for Civil Rights (OCR) Notice of Proposed
Rulemaking (NPRM) entitled Nondiscrimination in Health Programs and
Activities (RIN: 0945-AA17). The purpose of this information collection
is to ensure covered entities (any health program or activity, any part
of which is receiving federal financial assistance from the Department
and any health program or activity conducted by the Department or Title
I entity) adhere to the statutory requirements under Section 1557. The
proposed information collection helps covered entities demonstrate
compliance with federal civil rights laws and their awareness of their
obligations under those laws and respective HHS implementing
regulations.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Recipients & State-based Exchanges with 15 or 41,250 1 10 412,500
more employees.................................
Recipients & State-based Exchanges.............. 275,002 1 1.75 481,254
---------------------------------------------------------------
Total....................................... 316,252 .............. .............. 893,754
----------------------------------------------------------------------------------------------------------------
[[Page 62433]]
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2022-22319 Filed 10-13-22; 8:45 am]
BILLING CODE 4153-01-P
