Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Teaching Health Center Graduate Medical Education Program Reconciliation Tool, OMB No. 0915-0342-Revision, 76204-76205 [2022-27033]
Download as PDF
<![CDATA[
76204
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity; 21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average time
per response
(in hours)
Total hours
Preparation of DHCP letters; § 200.5 ..................................
6
1.3
8
100
800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have identified 24 DHCP letters
that 18 distinct sponsors submitted to
FDA during the 3-year period (2019 to
2021). Based on our Document
Archiving, Reporting, and Regulatory
Tracking System, we estimate eight
DHCP letters will be submitted annually
from six application holders. Based on
our experience, we assume that each
letter will require 100 hours to prepare
and disseminate as recommended in the
guidance. Our estimate reflects a
downward adjustment by five responses
and 500 hours annually. We attribute
this decrease to the effectiveness of the
guidance and the decreased number of
DHCP letters submitted for FDA review.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27012 Filed 12–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; The Teaching Health Center
Graduate Medical Education Program
Reconciliation Tool, OMB No. 0915–
0342—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 13,
2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
The Teaching Health Center Graduate
Medical Education (THCGME) Program
Reconciliation Tool OMB No. 0915–
0342— Revision
Abstract: The THCGME program,
authorized by Section 340H of the
Public Health Service Act, was
established by Section 5508 of Public
Law 111–148. The Consolidated
Appropriations Act, 2021 (Pub. L. 116–
260) and the American Rescue Plan Act
of 2021 (Pub. L. 117–2) provide
continued funding for the THCGME
Program.
The THCGME program awards
payment for both direct and indirect
expenses to support training for primary
care residents in community-based
ambulatory patient care settings. Direct
expense payments are designed to
compensate eligible teaching health
centers for those expenses directly
associated with sponsoring resident
training programs, while indirect
expense payments are intended to
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
compensate for the additional costs
relating to teaching residents in such
programs.
HRSA collects information from
THCGME program award recipients
using an OMB-approved reconciliation
tool. HRSA seeks to extend its approved
information collection and is increasing
the total estimated annual burden hours
associated with the collection, due to an
increase in the number of program
award recipients from 58 to 83.
Need and Proposed Use of the
Information: THCGME program
payments are prospective payments,
and the statute provides for a
reconciliation process, through which
overpayments may be recouped and
underpayments may be adjusted at the
end of the fiscal year. This data
collection instrument will gather
information relating to the number of
resident full-time equivalents in
Teaching Health Center training
programs in order to reconcile payments
for both direct and indirect expenses.
Likely Respondents: The likely
respondents to the THCGME
Reconciliation Tool are THCGME
program award recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
E:\FR\FM\13DEN1.SGM
13DEN1
76205
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
THCGME Reconciliation Tool ..............................................
83
1
83
2
166
Total ..............................................................................
83
1
83
2
166
HRSA specifically requests comments
on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–27033 Filed 12–12–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Information Technology
Advisory Committee 2023 Schedule of
Meetings
Office of the National
Coordinator for Health Information
Technology (ONC), HHS.
ACTION: Notice of meetings.
AGENCY:
The Health Information
Technology Advisory Committee
(HITAC) was established in accordance
with the 21st Century Cures Act and the
Federal Advisory Committee Act. The
HITAC, among other things, identifies
priorities for standards adoption and
makes recommendations to the National
Coordinator for Health Information
Technology (National Coordinator). The
HITAC will hold public meetings
throughout 2023. See list of public
meetings below.
FOR FURTHER INFORMATION CONTACT:
Michael Berry, Designated Federal
Officer, at Michael.Berry@hhs.gov, (202)
701–0795.
SUPPLEMENTARY INFORMATION: Section
4003(e) of the 21st Century Cures Act
(Pub. L. 114–255) establishes the Health
Information Technology Advisory
Committee (referred to as the ‘‘HITAC’’).
The HITAC will be governed by the
provisions of the Federal Advisory
Committee Act (FACA) (Pub. L. 92–
463), as amended, (5 U.S.C. app.), which
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
sets forth standards for the formation
and use of federal advisory committees.
Composition
The HITAC is comprised of at least 25
members, of which:
• No fewer than 2 members are
advocates for patients or consumers of
health information technology;
• 3 members are appointed by the
HHS Secretary
Æ 1 of whom shall be appointed to
represent the Department of Health and
Human Services and
Æ 1 of whom shall be a public health
official;
• 2 members are appointed by the
majority leader of the Senate;
• 2 members are appointed by the
minority leader of the Senate;
• 2 members are appointed by the
Speaker of the House of Representatives;
• 2 members are appointed by the
minority leader of the House of
Representatives; and
• Other members are appointed by
the Comptroller General of the United
States.
Members serve for one-, two-, or
three-year terms. All members may be
reappointed for a subsequent three-year
term. Each member is limited to two
three-year terms, not to exceed six years
of service. Members serve without pay,
but will be provided per-diem and
travel costs for committee services, if
warranted.
Recommendations
The HITAC recommendations to the
National Coordinator are publicly
available at https://www.healthit.gov/
topic/federal-advisory-committees/
recommendations-national-coordinatorhealth-it.
Public Meetings
The schedule of meetings to be held
in 2023 is as follows:
• January 19, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• February 8, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• March 9, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
• April 12, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• May 17, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• June 15, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• July 13, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• August 17, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• September 14, 2023, from
approximately 10:00 a.m. to 3:00
p.m./Eastern Time (virtual meeting)
• October 19, 2023, from approximately
10:00 a.m. to 3:00 p.m./Eastern Time
(virtual meeting)
• November 9, 2023, from
approximately 10:00 a.m. to 3:00
p.m./Eastern Time (virtual meeting)
All meetings are open to the public.
Additional meetings may be scheduled
as needed. For web conference
instructions and the most up-to-date
information, please visit the HITAC
calendar on the ONC website,
www.healthit.gov/topic/federaladvisory-committees/hitac-calendar.
Contact Person for Meetings: Michael
Berry, Michael.Berry@hhs.gov. A notice
in the Federal Register about last
minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Please email Michael
Berry for the most current information
about meetings.
Agenda: As outlined in the 21st
Century Cures Act, the HITAC will
develop and submit recommendations
to the National Coordinator on the
topics of interoperability, privacy and
security, patient access, and use of
technologies that support public health.
In addition, the committee will also
address any administrative matters and
hear periodic reports from ONC. ONC
intends to make background material
available to the public no later than 24
hours prior to the meeting start time. If
ONC is unable to post the background
material on its website prior to the
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76204-76205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27033]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; The Teaching Health Center
Graduate Medical Education Program Reconciliation Tool, OMB No. 0915-
0342--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than February
13, 2023.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Samantha Miller,
the HRSA Information Collection Clearance Officer at (301) 594-4394.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: The Teaching Health Center
Graduate Medical Education (THCGME) Program Reconciliation Tool OMB No.
0915-0342-- Revision
Abstract: The THCGME program, authorized by Section 340H of the
Public Health Service Act, was established by Section 5508 of Public
Law 111-148. The Consolidated Appropriations Act, 2021 (Pub. L. 116-
260) and the American Rescue Plan Act of 2021 (Pub. L. 117-2) provide
continued funding for the THCGME Program.
The THCGME program awards payment for both direct and indirect
expenses to support training for primary care residents in community-
based ambulatory patient care settings. Direct expense payments are
designed to compensate eligible teaching health centers for those
expenses directly associated with sponsoring resident training
programs, while indirect expense payments are intended to compensate
for the additional costs relating to teaching residents in such
programs.
HRSA collects information from THCGME program award recipients
using an OMB-approved reconciliation tool. HRSA seeks to extend its
approved information collection and is increasing the total estimated
annual burden hours associated with the collection, due to an increase
in the number of program award recipients from 58 to 83.
Need and Proposed Use of the Information: THCGME program payments
are prospective payments, and the statute provides for a reconciliation
process, through which overpayments may be recouped and underpayments
may be adjusted at the end of the fiscal year. This data collection
instrument will gather information relating to the number of resident
full-time equivalents in Teaching Health Center training programs in
order to reconcile payments for both direct and indirect expenses.
Likely Respondents: The likely respondents to the THCGME
Reconciliation Tool are THCGME program award recipients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
[[Page 76205]]
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
THCGME Reconciliation Tool...... 83 1 83 2 166
-------------------------------------------------------------------------------
Total....................... 83 1 83 2 166
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-27033 Filed 12-12-22; 8:45 am]
BILLING CODE 4165-15-P
