Agency Information Collection Activities: Proposed Collection: Public Comment Request; Health Resources and Services Administration Uniform Data System, 92692-92694 [2024-27394]
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Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices
Industry and Food and Drug
Administration Staff’’ to the Office of
Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Mahlet Zinah, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4452, Silver Spring,
MD 20993–0002, 240–402–2623.
SUPPLEMENTARY INFORMATION:
I. Background
Non-spinal, non-resorbable bone
plates, screws, and washers are implants
intended for bone fixation. These are
class II medical devices for which the
safety and effectiveness are wellestablished. This guidance provides
recommendations for the content and
organization of premarket notification
(510(k)) submissions including the
information FDA recommends industry
include in a 510(k) submission for these
device types (e.g., non-clinical testing,
sterility, reprocessing, biocompatibility).
This guidance is intended to facilitate
consistency in information provided in
submissions by addressing common
deficiencies related to device
description and performance testing and
by identifying applicable cross-cutting
guidances and consensus standards.
A notice of availability of the draft
guidance appeared in the Federal
Register of March 29, 2023 (88 FR
18549). FDA considered comments
received and revised the guidance as
appropriate in response to the
comments, including clarification
regarding recommended language for
indications for use statements as well as
additional considerations for predicate
device comparisons when leveraging
information from previously cleared
devices.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Non-Spinal Bone
Plates, Screws, and Washers—Premarket
Notification (510(k)) Submissions.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following table have
been approved by OMB:
OMB control
No.
21 CFR part; guidance; or FDA form
Topic
807, subpart E ............................................................................
812 ..............................................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
800, 801, 809, and 830 ..............................................................
Premarket notification .................................................................
Investigational Device Exemption ..............................................
Q-submissions and Early Payor Feedback Request Programs
for Medical Devices.
Medical Device Labeling Regulations; Unique Device Identification.
Current Good Manufacturing Practice (CGMP); Quality System
(QS) Regulation.
Protection of Human Subjects and Institutional Review Boards
820 ..............................................................................................
50, 56 ..........................................................................................
Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–27114 Filed 11–21–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Health Resources
and Services Administration Uniform
Data System
BILLING CODE 4164–01–P
ddrumheller on DSK120RN23PROD with NOTICES1
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Non-Spinal Bone
Plates, Screws, and Washers—Premarket
Notification (510(k)) Submissions;
Guidance for Industry and Food and
Drug Administration Staff’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number GUI00019023 and
complete title to identify the guidance
you are requesting.
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
SUMMARY:
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0910–0120
0910–0078
0910–0756
0910–0485
0910–0073
0910–0130
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 January 21, 2025.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14NWH04, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Health Resources and Services
Administration (HRSA) Uniform Data
System (UDS), OMB No. 0915–0193—
Revision.
Abstract: The Health Center Program,
administered by HRSA, is authorized
under section 330 of the Public Health
Service (PHS) Act (42 U.S.C. 254b).
Health centers are community-based
and patient-directed organizations that
deliver affordable, accessible, quality,
and cost-effective primary health care
services to patients regardless of their
ability to pay. Nearly 1,400 health
centers operate approximately 15,500
service delivery sites that provide
primary health care to more than 31
million people in every U.S. state, the
District of Columbia, Puerto Rico, the
U.S. Virgin Islands, and the Pacific
Basin.
HRSA uses the UDS for annual
reporting of program-specific data by
Health Center Program awardees (those
funded under section 330 of the PHS
Act), Health Center Program look-alikes
(entities meeting requirements of, but
not funded under, section 330 of the
PHS Act), and Nurse Education,
Practice, Quality and Retention
(NEPQR) and Advanced Nursing
Education (ANE) Program awardees
(specifically those funded under the
practice priority areas of sections 831(b)
and 811 of the PHS Act).
Some NEPQR and ANE Program
awardees establish and expand nursing
practice arrangements in
noninstitutional settings to demonstrate
methods to improve access to primary
health care in medically underserved
communities. Nursing grantees
implementing nursing practice
arrangements have historically used the
same data collection system as the
Health Center Program.
Need and Proposed Use of the
Information: HRSA requires the
collection of information through UDS
to monitor and evaluate the
performance of health centers under
section 330 and select NEPQR and ANE
recipients under sections 831(b) and
811. These data aid in program
compliance, guide quality improvement
initiatives, and inform federal health
policy decisions. HRSA also leverages
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19:28 Nov 21, 2024
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92693
UDS data to assess the impact of health
centers and NEPQR and ANE recipients
on patient health outcomes and to
allocate funding and resources
effectively across the Health Center
Program. To keep this instrument
relevant and responsive to the health
center program’s needs and the evolving
healthcare landscape, periodic updates
are essential. HRSA plans to make the
following updates for the performance
year 2025 UDS data collection:
encompass assessments representing
standardized tools used for the
evaluation of cognition and mental
status of older adults. The addition of a
measure to capture screening of ADRD
will be valuable in understanding the
level of need and resources required to
continue to support the growing aging
population served by the Health Center
Program and will foster early detection
for those at risk for ADRD.
Table 6A (Selected Diagnoses and
Services Rendered) Additions
• Tobacco Use Cessation
Pharmacotherapies: A new measure is
being added to line 26c2 to identify the
number of visits where patients received
tobacco cessation pharmacotherapies as
an intervention and the number of
patients who received this
pharmacologic treatment. While the
Preventive Care and Screening: Tobacco
Use: Screening and Cessation
Intervention electronic-specified
clinical quality measures (CMS138v12)
(Table 6B, Line 14a) that is currently
reported in the UDS assesses for
cessation, it lacks the capacity to
disaggregate and report a distinct
percentage for patients receiving
counseling or recommendation to
cessation pharmacotherapies. Adding a
line for reporting of tobacco use
cessation pharmacotherapies will
promote greater understanding of the
breadth of tobacco cessation
interventions provided at health centers,
specifically allowing HRSA to see
differences in tobacco use cessation
approaches.
• Medications for Opioid Use
Disorder (MOUD): A new measure for
MOUD services will be reported on line
26c3 for the number of visits where
MOUD was administered and the
number of patients who received this
medication-based intervention. This
new measure will enhance the existing
MOUD related measures that health
centers currently report on in Appendix
E: Other Data Elements (e.g., number of
providers who treat opioid use disorder
with MOUD). The inclusion of this
measure is critical for supporting public
health efforts to address the ongoing
opioid epidemic. Greater understanding
of the use of MOUD in health centers is
necessary both to understand existing
services and identify remaining
healthcare gaps.
• Alzheimer’s Disease and Related
Dementias (ADRD) Screening: A new
measure is being added to line 26f to
capture the number of visits where
patients received ADRD screenings and
the number of patients who received the
screenings. This measure will
Table 6B (Quality of Care Measures)
Addition
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• Initiation and Engagement of
Substance Use Disorder Treatment: A
new measure with two distinct rates is
being added to Lines 23a and b to
capture the initiation and engagement of
substance use disorder treatment, in
alignment with electronic-specified
clinical quality measure CMS137v13.
This measure will report on the
percentage of patients 13 years and
older with a new substance use disorder
episode who received treatment,
including (a) those who initiated
treatment within 14 days and (b) those
who engaged in ongoing treatment
within 34 days. By incorporating this
measure, HRSA strengthens its
alignment with national performance
standards and gains greater insight into
how effectively health centers are
initiating and engaging patients in
substance use disorder treatment.
Table 6B (Quality of Care Measures)
and Table 7 (Health Outcomes and
Disparities)
Updates
• Tables 6B and 7 collect UDS
clinical quality measures,1 and where
applicable, clinical quality measures
will be updated in alignment with
specifications of the issued performance
year 2025 electronic-specified clinical
quality measures. These specifications
were released by the Centers for
Medicare and Medicaid Services (CMS)
on May 2, 2024, for use by eligible
providers.2 Clinical performance
measure alignment across national
programs promotes data
standardization, quality, and
transparency, and decreases reporting
burden for providers and organizations
participating in multiple federal
programs.
1 https://www.cms.gov/medicare/quality/
measures.
2 https://ecqi.healthit.gov/now-available-updatedecqm-specifications-and-implementation-resources2025-performance/reporting-period.
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92694
Federal Register / Vol. 89, No. 226 / Friday, November 22, 2024 / Notices
UDS+ Test Submissions for Health
Centers
• Beginning with the 2024 UDS,
health centers will be able to submit deidentified, patient-level data in
fulfillment of data elements on Tables:
Æ Table PBZC (Patients by ZIP Code)
Æ Table 3A (Patients by Age and Sex
Assigned at Birth)
Æ Table 3B (Demographic
Characteristics)
Æ Table 4 (Selected Characteristics)
Æ Table 6A (Selected Diagnoses and
Services Rendered)
Æ Table 6B (Quality of Care Measures)
Æ Table 7 (Health Outcomes and
Disparities
UDS+ Patient-Level Reporting
leverages a shift in processes by which
health centers will submit their annual
UDS reports while maintaining historic
UDS measures. Health Centers are
encouraged to submit data through
UDS+.
UDS+ is currently in the testing phase
and data submission supports system
capacity building and progress towards
full implementation. The technical test
will inform next steps for scaling this
innovation. High-quality accessible data
are critical to strategically meeting the
unique needs of health center patients
and identifying training and technical
assistance opportunities for clinical
process improvement. The growth in
health information technology coupled
with the near universal adoption of
electronic health records across health
centers has transformed patient care
delivery and underscored the need for
secure and rapid exchange of health
data between disparate systems. Fast
Healthcare Interoperability Resources®
is a Health Level Seven International®
standard for exchanging health care
information electronically.3 The health
care community is adopting this next
generation exchange framework to
advance interoperability.4 Leveraging
Fast Healthcare Interoperability
Resources® to collect patient-level data
through the UDS+ system will support
improved data granularity, allowing for
the development of robust HRSAsupported patient care programs and
improved equitable access to HRSAsupported high-quality, cost-effective
primary care services. This electronic
reporting mechanism will reduce
reliance on manual data entry to
populate the annual UDS report, in turn
yielding a reduction in reporting effort
burden, and will greatly increase the
analytical value of UDS data for
Estimated
number of
respondents
Form name
informing policy and program decisionmaking.
Likely Respondents: Respondents will
include Health Center Program award
recipients and Health Center Program
look-alikes carrying out programs under
section 330 of the PHS Act and NEPQR
and ANE award recipients funded under
the practice priority areas of section
831(b) and 811 of the PHS Act.
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.
Total Estimated Annualized Burden
Hours:
Estimated
number of
responses per
respondent
Average
burden per
response
(in hours)
Estimated total
burden hours
Universal Report ..............................................................................................
Grant Report ....................................................................................................
UDS+ Test Submissions ..................................................................................
* 1,538
** 420
1,507
1.00
1.22
1.25
238
22
10
366,044
11,273
18,838
Total ..........................................................................................................
3,465
........................
270
396,155
* Consists of 1,363 health center program awardees, 133 Health Center Look-alikes, and 42 NEPQR and ANE respondents.
** Health Centers submitted one or more grant reports in 2023: 339 (1 report), 70 (2 reports), 11 (3 reports).
ddrumheller on DSK120RN23PROD with NOTICES1
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.
BILLING CODE 4165–15–P
3 https://ecqi.healthit.gov/fhir.
19:28 Nov 21, 2024
Indian Health Service
Notice of Purchased/Referred Care
Delivery Area Redesignation for the
Pokagon Band of Potawatomi Indians
of Michigan and Indiana
Indian Health Service,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
Notice is hereby given that
the Indian Health Service (IHS) has
decided to expand the geographic
boundaries of the Purchased/Referred
Care Delivery Area (PRCDA) for the
Pokagon Band of Potawatomi Indians of
SUMMARY:
[FR Doc. 2024–27394 Filed 11–21–24; 8:45 am]
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Michigan and Indiana (‘‘Pokagon
Band’’) to include the counties of
Kalamazoo, Kent, and Ottawa in the
State of Michigan. The final PRCDA for
the Pokagon Band now includes the
Michigan counties of Allegan, Berrien,
Cass, Kalamazoo, Kent, Ottawa, and Van
Buren, and the Indiana counties of
Elkhart, Kosciusko, La Porte, Marshall,
St. Joseph, and Starke. The sole purpose
of this expansion is to authorize
additional Pokagon Band members and
beneficiaries to receive Purchased/
Referred Care (PRC) services.
DATES: This expansion is effective as of
the date of publication of this notice.
ADDRESSES: This notice can be found at
https://www.federalregister.gov. Written
requests for information should be
delivered to: CAPT John Rael, Director,
4 https://ecqi.healthit.gov/fhir.
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]]>Agencies
[Federal Register Volume 89, Number 226 (Friday, November 22, 2024)]
[Notices]
[Pages 92692-92694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27394]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Health Resources and Services Administration
Uniform Data System
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 January
21, 2025.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
[[Page 92693]]
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Health Resources and Services
Administration (HRSA) Uniform Data System (UDS), OMB No. 0915-0193--
Revision.
Abstract: The Health Center Program, administered by HRSA, is
authorized under section 330 of the Public Health Service (PHS) Act (42
U.S.C. 254b). Health centers are community-based and patient-directed
organizations that deliver affordable, accessible, quality, and cost-
effective primary health care services to patients regardless of their
ability to pay. Nearly 1,400 health centers operate approximately
15,500 service delivery sites that provide primary health care to more
than 31 million people in every U.S. state, the District of Columbia,
Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.
HRSA uses the UDS for annual reporting of program-specific data by
Health Center Program awardees (those funded under section 330 of the
PHS Act), Health Center Program look-alikes (entities meeting
requirements of, but not funded under, section 330 of the PHS Act), and
Nurse Education, Practice, Quality and Retention (NEPQR) and Advanced
Nursing Education (ANE) Program awardees (specifically those funded
under the practice priority areas of sections 831(b) and 811 of the PHS
Act).
Some NEPQR and ANE Program awardees establish and expand nursing
practice arrangements in noninstitutional settings to demonstrate
methods to improve access to primary health care in medically
underserved communities. Nursing grantees implementing nursing practice
arrangements have historically used the same data collection system as
the Health Center Program.
Need and Proposed Use of the Information: HRSA requires the
collection of information through UDS to monitor and evaluate the
performance of health centers under section 330 and select NEPQR and
ANE recipients under sections 831(b) and 811. These data aid in program
compliance, guide quality improvement initiatives, and inform federal
health policy decisions. HRSA also leverages UDS data to assess the
impact of health centers and NEPQR and ANE recipients on patient health
outcomes and to allocate funding and resources effectively across the
Health Center Program. To keep this instrument relevant and responsive
to the health center program's needs and the evolving healthcare
landscape, periodic updates are essential. HRSA plans to make the
following updates for the performance year 2025 UDS data collection:
Table 6A (Selected Diagnoses and Services Rendered) Additions
Tobacco Use Cessation Pharmacotherapies: A new measure is
being added to line 26c2 to identify the number of visits where
patients received tobacco cessation pharmacotherapies as an
intervention and the number of patients who received this pharmacologic
treatment. While the Preventive Care and Screening: Tobacco Use:
Screening and Cessation Intervention electronic-specified clinical
quality measures (CMS138v12) (Table 6B, Line 14a) that is currently
reported in the UDS assesses for cessation, it lacks the capacity to
disaggregate and report a distinct percentage for patients receiving
counseling or recommendation to cessation pharmacotherapies. Adding a
line for reporting of tobacco use cessation pharmacotherapies will
promote greater understanding of the breadth of tobacco cessation
interventions provided at health centers, specifically allowing HRSA to
see differences in tobacco use cessation approaches.
Medications for Opioid Use Disorder (MOUD): A new measure
for MOUD services will be reported on line 26c3 for the number of
visits where MOUD was administered and the number of patients who
received this medication-based intervention. This new measure will
enhance the existing MOUD related measures that health centers
currently report on in Appendix E: Other Data Elements (e.g., number of
providers who treat opioid use disorder with MOUD). The inclusion of
this measure is critical for supporting public health efforts to
address the ongoing opioid epidemic. Greater understanding of the use
of MOUD in health centers is necessary both to understand existing
services and identify remaining healthcare gaps.
Alzheimer's Disease and Related Dementias (ADRD)
Screening: A new measure is being added to line 26f to capture the
number of visits where patients received ADRD screenings and the number
of patients who received the screenings. This measure will encompass
assessments representing standardized tools used for the evaluation of
cognition and mental status of older adults. The addition of a measure
to capture screening of ADRD will be valuable in understanding the
level of need and resources required to continue to support the growing
aging population served by the Health Center Program and will foster
early detection for those at risk for ADRD.
Table 6B (Quality of Care Measures) Addition
Initiation and Engagement of Substance Use Disorder
Treatment: A new measure with two distinct rates is being added to
Lines 23a and b to capture the initiation and engagement of substance
use disorder treatment, in alignment with electronic-specified clinical
quality measure CMS137v13. This measure will report on the percentage
of patients 13 years and older with a new substance use disorder
episode who received treatment, including (a) those who initiated
treatment within 14 days and (b) those who engaged in ongoing treatment
within 34 days. By incorporating this measure, HRSA strengthens its
alignment with national performance standards and gains greater insight
into how effectively health centers are initiating and engaging
patients in substance use disorder treatment.
Table 6B (Quality of Care Measures) and Table 7 (Health Outcomes and
Disparities)
Updates
Tables 6B and 7 collect UDS clinical quality measures,\1\
and where applicable, clinical quality measures will be updated in
alignment with specifications of the issued performance year 2025
electronic-specified clinical quality measures. These specifications
were released by the Centers for Medicare and Medicaid Services (CMS)
on May 2, 2024, for use by eligible providers.\2\ Clinical performance
measure alignment across national programs promotes data
standardization, quality, and transparency, and decreases reporting
burden for providers and organizations participating in multiple
federal programs.
---------------------------------------------------------------------------
\1\ https://www.cms.gov/medicare/quality/measures.
\2\ https://ecqi.healthit.gov/now-available-updated-ecqm-specifications-and-implementation-resources-2025-performance/reporting-period.
---------------------------------------------------------------------------
[[Page 92694]]
UDS+ Test Submissions for Health Centers
Beginning with the 2024 UDS, health centers will be able
to submit de-identified, patient-level data in fulfillment of data
elements on Tables:
[cir] Table PBZC (Patients by ZIP Code)
[cir] Table 3A (Patients by Age and Sex Assigned at Birth)
[cir] Table 3B (Demographic Characteristics)
[cir] Table 4 (Selected Characteristics)
[cir] Table 6A (Selected Diagnoses and Services Rendered)
[cir] Table 6B (Quality of Care Measures)
[cir] Table 7 (Health Outcomes and Disparities
UDS+ Patient-Level Reporting leverages a shift in processes by
which health centers will submit their annual UDS reports while
maintaining historic UDS measures. Health Centers are encouraged to
submit data through UDS+.
UDS+ is currently in the testing phase and data submission supports
system capacity building and progress towards full implementation. The
technical test will inform next steps for scaling this innovation.
High-quality accessible data are critical to strategically meeting the
unique needs of health center patients and identifying training and
technical assistance opportunities for clinical process improvement.
The growth in health information technology coupled with the near
universal adoption of electronic health records across health centers
has transformed patient care delivery and underscored the need for
secure and rapid exchange of health data between disparate systems.
Fast Healthcare Interoperability Resources[supreg] is a Health Level
Seven International[supreg] standard for exchanging health care
information electronically.\3\ The health care community is adopting
this next generation exchange framework to advance interoperability.\4\
Leveraging Fast Healthcare Interoperability Resources[supreg] to
collect patient-level data through the UDS+ system will support
improved data granularity, allowing for the development of robust HRSA-
supported patient care programs and improved equitable access to HRSA-
supported high-quality, cost-effective primary care services. This
electronic reporting mechanism will reduce reliance on manual data
entry to populate the annual UDS report, in turn yielding a reduction
in reporting effort burden, and will greatly increase the analytical
value of UDS data for informing policy and program decision-making.
---------------------------------------------------------------------------
\3\ https://ecqi.healthit.gov/fhir.
\4\ https://ecqi.healthit.gov/fhir.
---------------------------------------------------------------------------
Likely Respondents: Respondents will include Health Center Program
award recipients and Health Center Program look-alikes carrying out
programs under section 330 of the PHS Act and NEPQR and ANE award
recipients funded under the practice priority areas of section 831(b)
and 811 of the PHS Act.
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.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated
Form name number of responses per per response total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Universal Report................................ * 1,538 1.00 238 366,044
Grant Report.................................... ** 420 1.22 22 11,273
UDS+ Test Submissions........................... 1,507 1.25 10 18,838
---------------------------------------------------------------
Total....................................... 3,465 .............. 270 396,155
----------------------------------------------------------------------------------------------------------------
* Consists of 1,363 health center program awardees, 133 Health Center Look-alikes, and 42 NEPQR and ANE
respondents.
** Health Centers submitted one or more grant reports in 2023: 339 (1 report), 70 (2 reports), 11 (3 reports).
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. 2024-27394 Filed 11-21-24; 8:45 am]
BILLING CODE 4165-15-P
