Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision, 1103-1105 [2024-00210]
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1103
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
CDER
Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section
VIII) ...................................................................................
Breakthrough Therapy Designation Requests (EPSC Section VI) ..............................................................................
Fast Track Designation Requests (EPSC Section V) .........
Accelerated Approval Designation (EPSC Section VII) ......
Premeeting Packages (21 CFR 312.82) .............................
81
1.53
124
30
3,720
71
235
26
163
1.08
1.18
1.27
1.01
77
277
33
165
70
60
100
100
5,390
16,620
3,300
16,500
CDER Subtotal .............................................................
........................
........................
676
........................
45,530
8
1
8
30
240
CBER
Priority Review Designation Request (EPSC Section VIII)
Breakthrough Therapy Designation Request (EPSC Section VI) ..............................................................................
Fast Track Designation Requests (EPSC Section VII) .......
RMAT Designation Requests (Regenerative Medicine
Therapies for Serious Conditions Guidance (RMAT)
Section III) ........................................................................
Guidance p 6) ......................................................................
Premeeting Packages (RMAT Section V) ...........................
15
64
1.1
1.2
17
77
70
60
1,190
4,620
33
146
1.1
1.9
36
277
60
100
2,160
27,700
CBER Subtotal ..............................................................
Total .......................................................................
........................
........................
........................
........................
415
1,091
........................
........................
35,910
81,440
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FY 2022 receipts, we
estimate that for Center for Drug
Evaluation and Research (CDER)
products, 81 respondents will submit
124 requests for priority review
designation annually, and we assume 30
hours are needed to prepare such a
request. We estimate 71 respondents
will submit 77 requests for breakthrough
designation annually, and we assume 70
hours are needed to prepare such a
request. We estimate that 235
respondents will submit 277 requests
for fast-track designation requests
annually, and we assume 60 hours are
required to prepare such a request. We
estimate 26 respondents will submit 33
accelerated approval designation
requests annually and we assume 100
hours are required to prepare such a
request. Finally, CDER received 165 premeeting package submissions from 163
respondents. We assume 100 hours are
needed to prepare a pre-meeting
package.
Similarly, also based on FY 2022
receipts, we estimate that for CBER
products, 8 applicants will submit 8
requests for priority review designation
annually, and we assume 30 hours are
required to prepare such a request. We
estimate 15 respondents will submit 17
requests for breakthrough designation
annually, and we assume 70 hours are
needed to prepare such a request. We
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estimate that 64 respondents will
submit 78 requests for fast-track
designation annually, and we assume 60
hours is required to prepare such a
request. We also estimate 33
respondents will submit 35 requests for
RMAT designation annually and assume
that 60 hours are needed to prepare each
RMAT designation request. Finally,
CBER received 283 pre-meeting package
submissions from 146 respondents. We
assume 100 hours are needed to prepare
a pre-meeting package.
Based on a review of the information
collection since our last request for
OMB approval, we have increased our
burden estimate by 143 responses and
10,350 hours to reflect actual
submissions we have received. We
attribute these changes to increased
interest in the expedited programs, new
expedited programs, and an increase in
the number of submissions we received
over the last few years.
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–00217 Filed 1–8–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Bureau of
Health Workforce Performance Data
Collection, OMB No. 0915–0061—
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
(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 8, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
SUMMARY:
E:\FR\FM\09JAN1.SGM
09JAN1
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1104
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Bureau of Health Workforce
Performance Data Collection, OMB No.
0915–0061—Revision.
Abstract: Over 50 Bureau of Health
Workforce (BHW) programs award
grants to health professions schools and
training programs across the United
States to develop, expand, and enhance
training, and to strengthen the
distribution of the health workforce.
These programs are governed by titles
III, VII, and VIII of the Public Health
Service Act. Performance information is
collected in the HRSA Performance
Report for Grants and Cooperative
Agreements. Data collection activities
consisting of an annual progress report
and an annual performance report
satisfy statutory and programmatic
requirements for performance
measurement and evaluation (including
specific title III, VII and VIII
requirements), as well as Government
Performance and Results Act of 1993,
the Government Performance and
Results Act Modernization Act of 2010,
and the Foundations for Evidence-Based
Policymaking Act of 2018 requirements.
The performance measures were last
revised in 2022 to ensure they
addressed programmatic changes, met
evolving program management needs,
and responded to emerging workforce
concerns. As these changes were
successful, BHW will continue with its
current performance management
strategy and make additional changes
that reduce burden, simplify reporting,
reflect new Department of Health and
Human Services and HRSA priorities,
and enable longitudinal analysis of
VerDate Sep<11>2014
16:38 Jan 08, 2024
Jkt 262001
program performance. Specifically, an
Excel upload feature was implemented
for all programs to reduce burden.
Questions on partnerships were revised
and standardized across forms to
understand the type and purposes of
partnerships associated with grant
funding. Employment-related questions
were standardized across programs and
forms to provide consistent outcomes on
employment location, type of
employment, and hiring organization.
New questions were added for programs
using apprenticeships. Specifically,
questions were added to measure
additional employment outcomes
including role at the employment site
and vulnerable populations served and
to measure program satisfaction and
types of competencies graduates were
ready to perform.
A 60-day notice published in the
Federal Register on October 19, 2023,
88 FR 72086–87. There was one public
comment. The commenter was
complementary of BHW’s efforts to
consolidate performance data into one
collection and raised questions related
to collaborating with other departments
on the data collection, defining
apprenticeships, and making
individual-level data publicly available.
Specifically, the commenter asked how
HRSA collaborates on data collection
with agencies outside of the Department
of Health and Human services. Our
response to the commenter explained
the data collected via this OMB package
are performance metrics specific to
HRSA grant programs and the data are
used to meet obligations for
performance budgeting. This is in
alignment with the Government’s
authorization to collect data to meet
reporting requirements. The commenter
also asked how HRSA defines
apprenticeships and how it aligns with
definitions from other agencies. HRSA
responded that it uses the Department of
Labor’s definition of apprentices and
that it included questions from the
Department of Labor’s Employment and
Training Administration instrument to
reduce reporting burden and made data
comparable across the agencies. Lastly,
the commenter requested that HRSA
make more individual-level data
available, but statute prohibits HRSA
from doing so (see 42 U.S.C. 292 et seq.).
There was a follow-up comment from
the same commenter regarding HRSA
working with external researchers to
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analyze data on workforce program
participants. HRSA’s response was that
HRSA does not work with external
researchers to analyze data collected on
workforce programs. Aggregated data is
publicly available to external
researchers via HRSA’s data warehouse.
Need and Proposed Use of the
Information: The purpose of the
proposed data collection is to continue
analysis and reporting of grantee
training activities and education,
identify details about the practice
locations where trainees work (or plan
to work) after program completion, and
report outcomes of funded initiatives.
Data collected from these grant
programs will also provide a description
of the program activities of
approximately 1,828 reporting grantees
to inform policymakers on the barriers,
opportunities, and outcomes involved
in health care workforce development.
The proposed measures focus on four
key outcomes:
(1) increasing the workforce supply of
well-educated practitioners in needed
professions,
(2) increasing the number of
practitioners that practice in
underserved and rural areas,
(3) enhancing the quality of
education, and
(4) supporting educational
infrastructure to increase the capacity to
train more health professionals in high
demand areas.
Likely Respondents: Respondents are
awardees of BHW health professions
grant programs.
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\09JAN1.SGM
09JAN1
1105
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Direct Financial Support Program .......................................
Infrastructure Program .........................................................
Multipurpose or Hybrid Program ..........................................
619
219
1,044
1
1
1
619
219
1,044
2.7
4.8
3.1
1,671.3
1,051.2
3,236.4
Total ..............................................................................
1,882
........................
1,882
........................
5,958.9
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. 2024–00210 Filed 1–8–24; 8:45 am]
BILLING CODE 4165–15–P
registration, https://www.hrsa.gov/
advisory-committees/heritabledisorders/, by the deadline of
12 p.m. ET on Friday, January 26, 2024.
Instructions on how to access the
meeting via webcast will be provided
upon registration. If you are a nonUnited States citizen who would like to
attend the January meeting in-person,
please contact ACHDNC@hrsa.gov by
January 11, 2024.
Kim
Morrison, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
Room, Rockville, Maryland 20857; 301–
822–4978; or ACHDNC@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
ACHDNC
provides advice and recommendations
to the Secretary of Health and Human
Services (Secretary) on the development
of newborn screening activities,
technologies, policies, guidelines, and
programs for effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders. ACHDNC reviews
and reports regularly on newborn and
childhood screening practices,
recommends improvements in the
national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening on
the Recommended Uniform Screening
Panel (RUSP), following adoption by the
Secretary, are evidence-informed
preventive health services provided for
in the comprehensive guidelines
supported by HRSA pursuant to section
2713 of the Public Health Service Act
(42 U.S.C. 300gg–13). Under this
provision, non-grandfathered group
health plans and health insurance
issuers offering non-grandfathered
group or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is one
year from the Secretary’s adoption of the
condition for screening.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with section
1111(g) of the Public Health Service Act,
and the Federal Advisory Committee
Act, this notice announces that the
Advisory Committee on Heritable
Disorders in Newborns and Children
(ACHDNC or Committee) has scheduled
a public meeting. Information about the
ACHDNC and the agenda for this
meeting can be found on the ACHDNC
website at https://www.hrsa.gov/
advisory-committees/heritabledisorders/.
DATES: Monday, January 29, 2024, from
10 a.m. to 5 p.m. Eastern Time (ET) and
Tuesday, January 30, 2024, from 10 a.m.
to 3 p.m. ET.
ADDRESSES: This meeting will be held in
person with webcast options. While this
meeting is open to the public, advance
registration is required. Please visit the
ACHDNC website for information on
SUMMARY:
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Total
responses
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During the January 29–30, 2024,
meeting, ACHDNC will hear from
experts in the fields of public health,
medicine, heritable disorders, rare
disorders, and newborn screening.
Agenda items include the following
topics:
(1) A possible presentation on
qualitative research that focuses on
family perspectives;
(2) Updates from Committee ad hoc
topic groups. Potential topics include:
the nomination process and revisions to
the decision matrix;
(3) An update on the evidence review
of Duchenne muscular dystrophy
nomination; and
(4) Presentation of the final evidencebased review report on the Krabbe
disease condition nomination for
possible inclusion on the RUSP.
Following this report presentation, the
ACHDNC expects to vote on the second
meeting day, on January 30, 2024,
whether to recommend to the Secretary
adding Krabbe disease to the RUSP
(with potential implications under
section 2713 of the Public Health
Service Act, as noted above).
The agenda for this meeting includes
a potential vote to recommend a
nominated condition (Krabbe disease)
be added by the Secretary to the RUSP.
Agenda items are subject to change as
priorities dictate. Information about the
ACHDNC, including a roster of members
and past meeting summaries, is also
available on the ACHDNC website.
Members of the public also will have
the opportunity to provide comments on
any or all of the above agenda items.
Public participants may request to
provide general oral comments and may
submit written statements in advance of
the scheduled meeting. Oral comments
will be honored in the order they are
requested and may be limited as time
allows. Subject to change: members of
the public registered to submit oral
public comments on Krabbe disease are
tentatively scheduled to provide their
statements on Tuesday, January 30,
2024. Members of the public registered
to provide oral public comments on all
other newborn screening related topics
are tentatively scheduled to provide
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1103-1105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00210]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Bureau of
Health Workforce Performance Data Collection, OMB No. 0915-0061--
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
8, 2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent
[[Page 1104]]
within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting
``Currently under Review--Open for Public Comments'' or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Joella Roland, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Bureau of Health Workforce
Performance Data Collection, OMB No. 0915-0061--Revision.
Abstract: Over 50 Bureau of Health Workforce (BHW) programs award
grants to health professions schools and training programs across the
United States to develop, expand, and enhance training, and to
strengthen the distribution of the health workforce. These programs are
governed by titles III, VII, and VIII of the Public Health Service Act.
Performance information is collected in the HRSA Performance Report for
Grants and Cooperative Agreements. Data collection activities
consisting of an annual progress report and an annual performance
report satisfy statutory and programmatic requirements for performance
measurement and evaluation (including specific title III, VII and VIII
requirements), as well as Government Performance and Results Act of
1993, the Government Performance and Results Act Modernization Act of
2010, and the Foundations for Evidence-Based Policymaking Act of 2018
requirements. The performance measures were last revised in 2022 to
ensure they addressed programmatic changes, met evolving program
management needs, and responded to emerging workforce concerns. As
these changes were successful, BHW will continue with its current
performance management strategy and make additional changes that reduce
burden, simplify reporting, reflect new Department of Health and Human
Services and HRSA priorities, and enable longitudinal analysis of
program performance. Specifically, an Excel upload feature was
implemented for all programs to reduce burden. Questions on
partnerships were revised and standardized across forms to understand
the type and purposes of partnerships associated with grant funding.
Employment-related questions were standardized across programs and
forms to provide consistent outcomes on employment location, type of
employment, and hiring organization. New questions were added for
programs using apprenticeships. Specifically, questions were added to
measure additional employment outcomes including role at the employment
site and vulnerable populations served and to measure program
satisfaction and types of competencies graduates were ready to perform.
A 60-day notice published in the Federal Register on October 19,
2023, 88 FR 72086-87. There was one public comment. The commenter was
complementary of BHW's efforts to consolidate performance data into one
collection and raised questions related to collaborating with other
departments on the data collection, defining apprenticeships, and
making individual-level data publicly available. Specifically, the
commenter asked how HRSA collaborates on data collection with agencies
outside of the Department of Health and Human services. Our response to
the commenter explained the data collected via this OMB package are
performance metrics specific to HRSA grant programs and the data are
used to meet obligations for performance budgeting. This is in
alignment with the Government's authorization to collect data to meet
reporting requirements. The commenter also asked how HRSA defines
apprenticeships and how it aligns with definitions from other agencies.
HRSA responded that it uses the Department of Labor's definition of
apprentices and that it included questions from the Department of
Labor's Employment and Training Administration instrument to reduce
reporting burden and made data comparable across the agencies. Lastly,
the commenter requested that HRSA make more individual-level data
available, but statute prohibits HRSA from doing so (see 42 U.S.C. 292
et seq.). There was a follow-up comment from the same commenter
regarding HRSA working with external researchers to analyze data on
workforce program participants. HRSA's response was that HRSA does not
work with external researchers to analyze data collected on workforce
programs. Aggregated data is publicly available to external researchers
via HRSA's data warehouse.
Need and Proposed Use of the Information: The purpose of the
proposed data collection is to continue analysis and reporting of
grantee training activities and education, identify details about the
practice locations where trainees work (or plan to work) after program
completion, and report outcomes of funded initiatives. Data collected
from these grant programs will also provide a description of the
program activities of approximately 1,828 reporting grantees to inform
policymakers on the barriers, opportunities, and outcomes involved in
health care workforce development. The proposed measures focus on four
key outcomes:
(1) increasing the workforce supply of well-educated practitioners
in needed professions,
(2) increasing the number of practitioners that practice in
underserved and rural areas,
(3) enhancing the quality of education, and
(4) supporting educational infrastructure to increase the capacity
to train more health professionals in high demand areas.
Likely Respondents: Respondents are awardees of BHW health
professions grant programs.
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 1105]]
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
----------------------------------------------------------------------------------------------------------------
Direct Financial Support Program 619 1 619 2.7 1,671.3
Infrastructure Program.......... 219 1 219 4.8 1,051.2
Multipurpose or Hybrid Program.. 1,044 1 1,044 3.1 3,236.4
-------------------------------------------------------------------------------
Total....................... 1,882 .............. 1,882 .............. 5,958.9
----------------------------------------------------------------------------------------------------------------
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. 2024-00210 Filed 1-8-24; 8:45 am]
BILLING CODE 4165-15-P
