Advisory Council on Alzheimer's Research, Care, and Services; Meeting, 24619-24620 [2023-08469]
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Federal Register / Vol. 88, No. 77 / Friday, April 21, 2023 / Notices
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 N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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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–10302 Collection Requirements
for Compendia for Determination of
Medically-accepted Indications for
Off-label Uses of Drugs and
Biologicals in an Anti-cancer
Chemotherapeutic Regimen
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
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: 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
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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: April 17, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–08401 Filed 4–20–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council provides advice on
how to prevent or reduce the burden of
Alzheimer’s disease and related
dementias (ADRD) on people with the
disease and their caregivers. During the
SUMMARY:
PO 00000
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24619
meeting on May 8, 2023, the Advisory
Council will hear presentations about
the drug approval and coverage decision
processes. A panel will also present on
progress and challenges in translating
research into clinical impact. Federal
agencies will provide updates on
activities during the last quarter.
DATES: The meeting will be held on May
8th from 9:30 p.m. to 4:30 p.m. EST.
ADDRESSES: The meeting will be a
hybrid of in-person and virtual. The
meeting will be held in Room 305A of
the Hubert H. Humphrey Building, 200
Independence Avenue SW, Washington,
DC 20201. It will also stream live at
www.hhs.gov/live.
Comments: Time is allocated on the
agenda to hear public comments from
4:00 p.m. to 4:30 p.m. The time for oral
comments will be limited to two (2)
minutes per individual. In order to
provide a public comment, please
register by emailing your name to
napa@hhs.gov by Thursday, May 4th.
Registered commenters will receive both
a dial-in number and a link to join the
meeting virtually; individuals will have
the choice to either join virtually via the
link, or to call in only by using the dialin number. Note: There may be a 30–45
second delay in the livestream video
presentation of the conference. For this
reason, if you have pre-registered to
submit a public comment, it is
important to connect to the meeting by
3:45 p.m. to ensure that you do not miss
your name and allotted time when
called. You will not be admitted into the
meeting before 3:45 p.m. If you miss
your name and allotted time to speak,
you may not be able to make your
public comment. Should you have
questions during the session email
napa@hhs.gov and someone will
respond to your message as quickly as
possible.
In order to ensure accuracy, please
submit a written copy of oral comments
for the record by emailing napa@
hhs.gov by Tuesday, May 9, 2023. These
comments will be shared on the website
and reflected in the meeting minutes.
In lieu of oral comments, formal
written comments may be submitted for
the record by Tuesday, May 9, 2023 to
Helen Lamont, Ph.D., OASPE, 200
Independence Avenue SW, Room 424E,
Washington, DC 20201. Comments may
also be sent to napa@hhs.gov. Those
submitting written comments should
identify themselves and any relevant
organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 202–260–6075,
helen.lamont@hhs.gov. Note: The
meeting will be available to the public
live at www.hhs.gov/live. Note: Seating
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Federal Register / Vol. 88, No. 77 / Friday, April 21, 2023 / Notices
is very limited and will be limited to 10
members of the public. Those wishing
to attend the meeting must send an
email to napa@hhs.gov and put ‘‘May 8
Meeting Attendance’’ in the subject line
so that their names may be put on a list
of expected attendees and forwarded to
the security officers at the Department
of Health and Human Services. Any
interested member of the public who is
a non-U.S. citizen should include this
information at the time of registration to
ensure that the appropriate security
procedure to gain entry to the building
is carried out. Although the meeting is
open to the public, procedures
governing security and the entrance to
Federal buildings may change without
notice. If you wish to make a public
comment, you must note that within
your email.
Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. app. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: clinical
care, dementia risk reduction, social
determinants of health.
Procedure and Agenda: The meeting
will be webcast at www.hhs.gov/live and
video recordings will be added to the
National Alzheimer’s Project Act
website when available, after the
meeting.
Authority: 42 U.S.C. 11225; section
2(e)(3) of the National Alzheimer’s
Project Act. The panel is governed by
provisions of Public Law 92–463, as
amended (5 U.S.C. appendix 2), which
sets forth standards for the formation
and use of advisory committees.
SUPPLEMENTARY INFORMATION:
Dated: April 6, 2023.
Miranda Lynch-Smith,
Senior Official Performing the Duties of the
Assistant Secretary for Planning and
Evaluation Deputy Assistant Secretary for
Human Services Policy.
[FR Doc. 2023–08469 Filed 4–20–23; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0001]
Agency Information Collection
Request; 60-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.
DATES: Comments on the ICR must be
received on or before June 20, 2023.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0001–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
SUMMARY:
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: Application for
waiver of the two-year foreign residence
requirement of the Exchange Visitor
Program.
Type of Collection: Reinstatement
without change.
OMB No.: 0990–0001.
Abstract: The Department of Health
and Human Services, Office of Global
Health Affairs program deals with both
research and clinical care waivers.
Applicant institutions apply to this
Department to request a waiver on
behalf of research scientists or foreign
medical graduates to work as clinicians
in HHS designated health shortage areas
doing primary care in medical facilities.
The instructions request a copy of Form
G–28 from applicant institutions
represented by legal counsel outside of
the applying institution. United States
Department of Justice Form G–28
ascertains that legal counsel represents
both the applicant organization and the
exchange visitor.
Need and Proposed Use of the
Information: Required as part of the
application process to collect basic
information such as name, address,
family status, sponsor and current visa
information.
Likely Respondents: Research
scientists and research facilities.
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ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
(hours)
Forms
(if necessary)
Respondents
(If necessary)
Application Waiver/Supplemental A Research ............
Application Waiver/Supplemental B Clinical Care ......
HHS 426 ................
HHS 426 ................
45
35
1
1
10
10
450
350
Total ......................................................................
................................
........................
........................
........................
800
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–08404 Filed 4–20–23; 8:45 am]
National Institutes of Health
BILLING CODE 4150–38–P
Center for Scientific Review: Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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Total burden
hours
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 grant applications and
the discussions could disclose
confidential trade secrets or commercial
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[Federal Register Volume 88, Number 77 (Friday, April 21, 2023)]
[Notices]
[Pages 24619-24620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08469]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Council on Alzheimer's Research, Care, and Services;
Meeting
AGENCY: Assistant Secretary for Planning and Evaluation, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the public meeting of the Advisory
Council on Alzheimer's Research, Care, and Services (Advisory Council).
The Advisory Council provides advice on how to prevent or reduce the
burden of Alzheimer's disease and related dementias (ADRD) on people
with the disease and their caregivers. During the meeting on May 8,
2023, the Advisory Council will hear presentations about the drug
approval and coverage decision processes. A panel will also present on
progress and challenges in translating research into clinical impact.
Federal agencies will provide updates on activities during the last
quarter.
DATES: The meeting will be held on May 8th from 9:30 p.m. to 4:30 p.m.
EST.
ADDRESSES: The meeting will be a hybrid of in-person and virtual. The
meeting will be held in Room 305A of the Hubert H. Humphrey Building,
200 Independence Avenue SW, Washington, DC 20201. It will also stream
live at www.hhs.gov/live.
Comments: Time is allocated on the agenda to hear public comments
from 4:00 p.m. to 4:30 p.m. The time for oral comments will be limited
to two (2) minutes per individual. In order to provide a public
comment, please register by emailing your name to [email protected] by
Thursday, May 4th. Registered commenters will receive both a dial-in
number and a link to join the meeting virtually; individuals will have
the choice to either join virtually via the link, or to call in only by
using the dial-in number. Note: There may be a 30-45 second delay in
the livestream video presentation of the conference. For this reason,
if you have pre-registered to submit a public comment, it is important
to connect to the meeting by 3:45 p.m. to ensure that you do not miss
your name and allotted time when called. You will not be admitted into
the meeting before 3:45 p.m. If you miss your name and allotted time to
speak, you may not be able to make your public comment. Should you have
questions during the session email [email protected] and someone will
respond to your message as quickly as possible.
In order to ensure accuracy, please submit a written copy of oral
comments for the record by emailing [email protected] by Tuesday, May 9,
2023. These comments will be shared on the website and reflected in the
meeting minutes.
In lieu of oral comments, formal written comments may be submitted
for the record by Tuesday, May 9, 2023 to Helen Lamont, Ph.D., OASPE,
200 Independence Avenue SW, Room 424E, Washington, DC 20201. Comments
may also be sent to [email protected]. Those submitting written comments
should identify themselves and any relevant organizational
affiliations.
FOR FURTHER INFORMATION CONTACT: Helen Lamont, 202-260-6075,
[email protected]. Note: The meeting will be available to the public
live at www.hhs.gov/live. Note: Seating
[[Page 24620]]
is very limited and will be limited to 10 members of the public. Those
wishing to attend the meeting must send an email to [email protected] and
put ``May 8 Meeting Attendance'' in the subject line so that their
names may be put on a list of expected attendees and forwarded to the
security officers at the Department of Health and Human Services. Any
interested member of the public who is a non-U.S. citizen should
include this information at the time of registration to ensure that the
appropriate security procedure to gain entry to the building is carried
out. Although the meeting is open to the public, procedures governing
security and the entrance to Federal buildings may change without
notice. If you wish to make a public comment, you must note that within
your email.
SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
Federal Advisory Committee Act (5 U.S.C. app. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: clinical care, dementia risk reduction,
social determinants of health.
Procedure and Agenda: The meeting will be webcast at www.hhs.gov/live and video recordings will be added to the National Alzheimer's
Project Act website when available, after the meeting.
Authority: 42 U.S.C. 11225; section 2(e)(3) of the National
Alzheimer's Project Act. The panel is governed by provisions of Public
Law 92-463, as amended (5 U.S.C. appendix 2), which sets forth
standards for the formation and use of advisory committees.
Dated: April 6, 2023.
Miranda Lynch-Smith,
Senior Official Performing the Duties of the Assistant Secretary for
Planning and Evaluation Deputy Assistant Secretary for Human Services
Policy.
[FR Doc. 2023-08469 Filed 4-20-23; 8:45 am]
BILLING CODE 4150-05-P
