Agency Information Collection Request; 30-Day Public Comment Request, 56075-56076 [2022-19757]
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
determinations: (1) A determination by
the Secretary of Homeland Security that
there is a domestic emergency, or a
significant potential for a domestic
emergency, involving a heightened risk
of attack with a, chemical, biological,
radiological, or nuclear (‘‘CBRN’’) agent
or agents; (2) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act [1] sufficient to affect national
security or the health and security of
United States citizens living abroad; (3)
a determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces, including personnel operating
under the authority of title 10 or title 50,
of attack with (i) a biological, chemical,
radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause,
or are otherwise associated with, an
imminently life-threatening and specific
risk to United States military forces; or
(4) a determination by the Secretary that
there is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad, and
that involves a CBRN agent or agents, or
a disease or condition that may be
attributable to such agent or agents.[2]
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the Commissioner of Food and
Drugs may issue an EUA if the criteria
for issuance of an authorization under
section 564 of the FD&C Act are met.
The ASPR requested that the
Secretary issue the declaration to allow
the Department to take measures based
on information currently available about
monkeypox virus. The determination of
a public health emergency or a
significant potential for a public health
emergency, and the declaration that
circumstances exist justifying
emergency use of in vitro diagnostics for
detection and/or diagnosis of infection
with the monkeypox virus, including in
vitro diagnostics that detect and/or
diagnose infection with non-variola
Orthopoxvirus by the Secretary of HHS,
as described below, enable the
Commissioner of Food and Drugs to
issue EUAs for in vitro diagnostics for
detection and/or diagnosis of infection
with the monkeypox virus, including in
vitro diagnostics that detect and/or
diagnose infection with non-variola
Orthopoxvirus for emergency use under
section 564 of the FD&C Act.
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56075
II. Determination by the Secretary of
Health and Human Services
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
On August 9, 2022, pursuant to
section 564 of the FD&C Act, I
determined that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of United States citizens living
abroad that involves monkeypox virus.
[Document Identifier: OS–0990–New]
III. Declaration of the Secretary of
Health and Human Services
On September 7, 2022, on the basis of
my August 9, 2022 determination that
there is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad and
that involves monkeypox virus, I
declared that circumstances exist
justifying authorizations of emergency
use of in vitro diagnostics for detection
and/or diagnosis of infection with the
monkeypox virus, including in vitro
diagnostics that detect and/or diagnose
infection with non-variola
Orthopoxvirus, pursuant to section 564
of the FD&C Act, subject to the terms of
any authorization issued under that
section.
Notice of the EUAs issued by the
Commissioner of Food and Drugs
pursuant to this determination and
declaration will be provided promptly
in the Federal Register as required
under section 564 of the FD&C Act.
Xavier Becerra,
Secretary, U.S. Department of Health and
Human Services.
Footnotes
1. 42 U.S.C. 247d–6b.
2. As amended by the Pandemic and AllHazards Preparedness Reauthorization
Act, Public Law 113–5, the Secretary
may make a determination of a public
health emergency, or a significant
potential for a public health emergency,
under section 564 of the FD&C Act. The
Secretary is no longer required to make
a determination of a public health
emergency in accordance with section
319 of the PHS Act, 42 U.S.C. 247d to
support a determination or declaration
made under section 564 of the FD&C Act.
[FR Doc. 2022–19752 Filed 9–12–22; 8:45 am]
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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.
DATES: Comments on the ICR must be
received on or before October 13, 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
0990-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: Evaluation of
the Extension of the Certified
Community Behavioral Health Clinic
(CCBHC) Demonstration Program.
Type of Collection: New.
OMB No.: 0990–NEW—Office of the
Assistant Secretary for Planning and
Evaluation.
Abstract: The Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) at the U.S. Department of Health
and Human Services (HHS) is
requesting Office of Management and
Budget (OMB) approval for new data
collection activities to support its
SUMMARY:
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56076
Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
evaluation of the extension of the
Certified Community Behavioral Health
Clinic (CCBHC) demonstration program.
Section 223 of the Protecting Access
to Medicare Act (Pub. L. 113–93;
PAMA) authorized the CCBHC
demonstration to allow states to test a
new strategy for delivering and
reimbursing a comprehensive array of
services provided in community
behavioral health clinics. The
demonstration aims to improve the
availability, quality, and outcomes of
outpatient services provided in these
clinics by establishing a standard
definition for CCBHCs and develops a
new Medicaid prospective payment
system (PPS) in each state that accounts
for the total cost of providing nine types
of services to all people who seek care.
The PPS in each state is designed to
provide CCBHCs with the financial
support and stability necessary to
the federal and state costs of a full range
of mental health services (including
inpatient, emergency, and ambulatory
services). The ability of ASPE to provide
this information to Congress requires a
rigorously designed and independent
evaluation of the CCBHC demonstration.
The information collected under this
submission will help ASPE address
research questions for the evaluation
and inform required reports to Congress.
ASPE is requesting approval of this
information collection for a three-year
period. Information will be collected
from individuals (CCBHC clients),
businesses (CCBHC staff) and from state
governments.
The total annual burden hours
estimated for this information collection
request are summarized in the table
below.
deliver these required services. The
demonstration also aims to incentivize
quality through quality bonus payments
to clinics and requires CCBHCs to report
quality measures and costs.
Need and Proposed Use of the
Information: PAMA mandates that HHS
submit reports to Congress about the
Section 223 demonstration that assess
(1) access to community-based mental
health services under Medicaid in the
area or areas of a state targeted by a
demonstration program as compared to
other areas of the state, (2) the quality
and scope of services provided by
certified community behavioral health
clinics as compared to communitybased mental health services provided
in states not participating in a
demonstration program and in areas of
a demonstration state that are not
participating in the demonstration, and
(3) the impact of the demonstration on
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Average
burden
per response
(in hours)
Total
burden hours
State official interviews ....................................................................................
CCBHC leadership interviews .........................................................................
CCBHC client focus groups .............................................................................
CCBHC survey ................................................................................................
27
10
14
50
1
1
1
1
1
1
1
3
27
10
14
150
Total ..........................................................................................................
101
........................
........................
201
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–19757 Filed 9–12–22; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental and
Craniofacial Research; Notice of
Closed Meetings
jspears on DSK121TN23PROD with NOTICES
Number
responses per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; DSR Member Conflict.
Date: October 14, 2022.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Aiwu Cheng, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
National Institute of Dental and Craniofacial
Research, National Institutes of Health, 6701
Democracy Blvd., Bethesda, MD 20892,
Aiwu.cheng@nih.gov.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Clinical Studies.
Date: October 27, 2022.
Time: 9 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Yun Mei, MD, Scientific
Review Officer, Scientific Review Branch,
National Institute of Dental and Craniofacial
PO 00000
Frm 00089
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Research, National Institutes of Health, 6701
Democracy Boulevard, Suite #670, Bethesda,
MD 20892, (301) 827–4639, yun.mei@
nih.gov.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; In Utero Treatments of
Congenital Dental and Craniofacial Disorders
Using Precision Medicine Approaches.
Date: October 28, 2022.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Aiwu Cheng, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
National Institute of Dental and Craniofacial
Research, National Institutes of Health, 6701
Democracy Blvd., Bethesda, MD 20892,
Aiwu.cheng@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS.)
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]]>Agencies
[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56075-56076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19757]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-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 October 13,
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 0990-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: Evaluation of the Extension of the
Certified Community Behavioral Health Clinic (CCBHC) Demonstration
Program.
Type of Collection: New.
OMB No.: 0990-NEW--Office of the Assistant Secretary for Planning
and Evaluation.
Abstract: The Office of the Assistant Secretary for Planning and
Evaluation (ASPE) at the U.S. Department of Health and Human Services
(HHS) is requesting Office of Management and Budget (OMB) approval for
new data collection activities to support its
[[Page 56076]]
evaluation of the extension of the Certified Community Behavioral
Health Clinic (CCBHC) demonstration program.
Section 223 of the Protecting Access to Medicare Act (Pub. L. 113-
93; PAMA) authorized the CCBHC demonstration to allow states to test a
new strategy for delivering and reimbursing a comprehensive array of
services provided in community behavioral health clinics. The
demonstration aims to improve the availability, quality, and outcomes
of outpatient services provided in these clinics by establishing a
standard definition for CCBHCs and develops a new Medicaid prospective
payment system (PPS) in each state that accounts for the total cost of
providing nine types of services to all people who seek care. The PPS
in each state is designed to provide CCBHCs with the financial support
and stability necessary to deliver these required services. The
demonstration also aims to incentivize quality through quality bonus
payments to clinics and requires CCBHCs to report quality measures and
costs.
Need and Proposed Use of the Information: PAMA mandates that HHS
submit reports to Congress about the Section 223 demonstration that
assess (1) access to community-based mental health services under
Medicaid in the area or areas of a state targeted by a demonstration
program as compared to other areas of the state, (2) the quality and
scope of services provided by certified community behavioral health
clinics as compared to community-based mental health services provided
in states not participating in a demonstration program and in areas of
a demonstration state that are not participating in the demonstration,
and (3) the impact of the demonstration on the federal and state costs
of a full range of mental health services (including inpatient,
emergency, and ambulatory services). The ability of ASPE to provide
this information to Congress requires a rigorously designed and
independent evaluation of the CCBHC demonstration. The information
collected under this submission will help ASPE address research
questions for the evaluation and inform required reports to Congress.
ASPE is requesting approval of this information collection for a three-
year period. Information will be collected from individuals (CCBHC
clients), businesses (CCBHC staff) and from state governments.
The total annual burden hours estimated for this information
collection request are summarized in the table below.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Type of respondent respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
State official interviews....................... 27 1 1 27
CCBHC leadership interviews..................... 10 1 1 10
CCBHC client focus groups....................... 14 1 1 14
CCBHC survey.................................... 50 1 3 150
---------------------------------------------------------------
Total....................................... 101 .............. .............. 201
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2022-19757 Filed 9-12-22; 8:45 am]
BILLING CODE 4150-05-P
