Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Bureau of Primary Health Care Uniform Data System, OMB No. 0915-0193-Revision, 68175-68178 [2019-26876]
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Federal Register / Vol. 84, No. 240 / Friday, December 13, 2019 / Notices
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests
for single copies of the draft guidance to
the Office of Communication, Outreach
and Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002; Division
of Drug Information, Center for Drug
Evaluation and Research (CDER), Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The draft guidance may
also be obtained by mail by calling
CBER at 1–800–835–4709 or 240–402–
8010. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Gregory Reaman, Oncology Center of
Excellence, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2202, Silver Spring,
MD 20993–0002, 301–796–0785; or
Stephen Ripley, Center for Biologics
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘FDARA Implementation Guidance for
Pediatric Studies of Molecularly
Targeted Oncology Drugs: Amendments
to Sec. 505B of the FD&C Act.’’ This
draft guidance addresses early planning
for pediatric evaluation of certain
molecularly targeted oncology drugs
(including biological products) for
which original NDAs and BLAs are
expected to be submitted to FDA on or
after August 18, 2020, in accordance
with the provisions of section 505B of
the FD&C Act. Section 505B of the
FD&C Act (21 U.S.C. 355c) (also referred
to as the Pediatric Research Equity Act
or PREA (Pub. L. 108–155)), was
amended by FDARA.
The amendments provide a new
mechanism to expedite the evaluation of
certain novel drugs with the potential to
address an unmet medical need of
pediatric patients with cancer.
Specifically, FDARA amended the
requirement for pediatric investigations
of certain new targeted cancer drugs to
be based on molecular mechanism of
action rather than clinical indication.
For original NDAs and BLAs submitted
on or after August 18, 2020, if the
application is for a new active
ingredient, and the drug or biological
product that is the subject of the
application is intended for treatment of
an adult cancer and directed at a
molecular target FDA determines to be
substantially relevant to the growth or
progression of a pediatric cancer,
reports of molecularly targeted pediatric
cancer investigations must be submitted
with the marketing application, unless
the required investigations are waived
or deferred (section 505B(a)(1)(B) of the
FD&C Act).
This draft guidance provides
recommendations on regulatory
considerations related to the
amendments to section 505B of the
FD&C Act, including information on
molecular targets, factors FDA intends
to consider in the determination of
whether a molecular target is
substantially relevant to the growth or
progression of a pediatric cancer, the
molecular target lists, content of the
initial pediatric study plan and
description of recommended studies,
additional considerations for rare
cancers, and considerations for planned
waivers and deferrals. In addition, the
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draft guidance includes information
regarding global implications and
international collaboration.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘FDARA Implementation Guidance
for Pediatric Studies of Molecularly
Targeted Oncology Drugs.’’ 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. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 312 have
been approved under OMB control
numbers 0910–0014. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: December 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26877 Filed 12–12–19; 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; Bureau of Primary Health
Care Uniform Data System, OMB No.
0915–0193—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
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ACTION:
Federal Register / Vol. 84, No. 240 / Friday, December 13, 2019 / Notices
Notice.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this Notice has
closed.
DATES: Comments on this ICR should be
received no later than January 13, 2020.
ADDRESSES: Submit your comments,
including the ICR title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Bureau of Primary Health Care (BPHC)
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, most recently
amended by section 50901(b) of the
Bipartisan Budget Act of 2018, Public
Law 115–123. 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 12,000 service delivery
sites that provide primary health care to
more than 27 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
Uniform Data System (UDS) for annual
reporting by certain HRSA award
recipients, including Health Center
Program awardees (those funded under
section 330 of the PHS Act), Health
Center Program look-alikes, and Nurse
Education, Practice, Quality and
Retention Program awardees
(specifically those funded under the
practice priority areas of section 831(b)
of the PHS Act).
Need and Proposed Use of the
Information: HRSA collects UDS data
annually to ensure compliance with
legislative and regulatory requirements,
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improve clinical and operational
performance, and report overall program
accomplishments. HRSA aligns several
clinical measures reported in UDS with
the Centers for Medicare & Medicaid
Services’ (CMS) electronic specified
clinical quality measures (eCQM). These
data help to identify trends over time,
enabling HRSA to establish or expand
targeted programs and to identify
effective services and interventions that
will improve the health of medically
underserved communities. HRSA
analyzes UDS data with other national
health-related data sets to compare the
Health Center Program patient
populations and the overall U.S.
population.
HRSA received comments on the
BPHC UDS Federal Register notice
published on July 26, 2019, vol. 84, No.
144; pp. 36108. We have taken the
commenter’s suggestions into
consideration and have made
appropriate adjustments to the draft
instruments. The 2020 UDS data
collection will be updated in the
following ways:
• Retiring CMS126 Use of
Appropriate Medications for Asthma:
The CMS eCQM is no longer being
updated when new asthma medications
are approved for use. This measure was
also retired from the Healthcare
Effectiveness Data and Information Set,
is no longer endorsed by the NQF, and
there is currently no comparable eCQM
for asthma. Thus, no replacement
measure is planned at this time.
• Retaining CMS277v0—Dental
Sealants for Children Between 6–9
years: Based upon public feedback,
HRSA has decided to retain the dental
sealant measure for 2020 UDS reporting.
HRSA has also decided to not add the
fluoride varnish measure for 2020 UDS.
• Adding CMS159v8 Depression
Remission at Twelve Months: The
addition of the CMS depression
remission measure at 12 months
provides complementary mental health
outcome data on how well health
centers help patients reach remission.
Improvement in the symptoms of
depression and an ongoing assessment
of the current treatment plan are crucial
to the reduction of symptoms and
psychosocial well-being of patients. The
addition of CMS159v8 further supports
HRSA’s commitment to HHS’ strategic
objective to ‘‘Reduce the impact of
mental and substance use disorders
through prevention, early intervention,
treatment, and recovery support.’’
• Revising the HIV linkage to care
measure: The HIV linkage to care
measure captures the percentage of
patients whose first ever HIV diagnosis
was made by health center staff between
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October 1 of the prior year and
September 30 of the measurement year
and who were seen for follow-up
treatment within 90 days of that firstever diagnosis. This measure will be
modified to change the follow-up
treatment from 90 days to 30 days
aligning with Centers for Disease
Control and Prevention’s guidance.1
• Adding CMS349v2 HIV Screening:
The addition of the CMS HIV screening
measure will enable HRSA to better
identify priority geographic locations,
assist high risk groups among health
center patients, and more effectively
deploy interventions and resources in
support of the ‘‘Ending the HIV
Epidemic’’ Initiative.
• Adding Prescription for PreExposure Prophylaxis International
Classification of Diseases (ICD) 10
Codes and Current Procedural
Terminology codes: The addition of the
Prescription for Pre-Exposure
Prophylaxis ICD–10 and Current
Procedural Terminology codes will
allow for the collection of this HIV
prescription prevention data in health
centers and further supports the
‘‘Ending the HIV Epidemic’’ Initiative’s
goal of reducing new HIV infections.
• Refraining from including
additional diabetes measures: Based
upon public feedback, HRSA will not be
adding CMS131v8 Diabetes Eye Exam,
CMS123v7 Diabetes Foot Exam, or
CMS134v8 Diabetes Medial Attention to
Nephropathy to the 2020 UDS.
• Adding CMS125v8 Breast Cancer
Screening: There is substantial
geographic and demographic variation
in breast cancer death rates, suggesting
that there are social and non-economic
obstacles that affect breast cancer
screening.2 Preventive screening
through timely access to mammograms
can lead to early detection, better
treatment prognosis, and potential to
reduce health disparities.3
• Adding a Prescription Drug
Monitoring Programs (PDMPs) Question
to Appendix D: Health Center Health
Information Technology Capabilities:
PDMPs are effective tools for reducing
prescription drug abuse and diversion.
Improving provider utilization and
access to real-time data has
demonstrated meaningful results in
1 https://www.cdc.gov/hiv/pdf/library/factsheets/
cdc-hiv-care-continuum.pdf.
2 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC4540479/.
3 https://www.thecommunityguide.org/findings/
cancer-screening-reducing-structural-barriersclients-breast-cancer.
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Federal Register / Vol. 84, No. 240 / Friday, December 13, 2019 / Notices
reducing over-prescribing of
medication.4
• Revising the Social Determinants of
Health Question in Appendix D: Health
Center Health Information Technology
Capabilities: There is strong evidence
that social and economic factors
influence an individual’s health.5
Several health care systems are
exploring how to collect information on
the social determinants of health
(SDOH). The inclusion of these
questions into Appendix D allows
HRSA to see how health centers are
approaching this challenge and how
many of their vulnerable patients are
experiencing social and economic risks
associated with poor health. For health
centers that are using a standardized
screener, there is one additional
question asking for the total number of
patients that screen positive for food
insecurity, housing insecurity, financial
strain, and lack of transportation/access
to public transportation.
• Adding ICD–10 Codes to Capture
Human Trafficking and Intimate Partner
Violence: HRSA is aware that human
trafficking 6 and intimate partner
violence 7 are part of the SDOH that can
affect a wide range of health and quality
of life outcomes. Addressing SDOH is a
HRSA objective to improve the health
and well-being of health center patients
and the broader community in which
they reside.
• Utilizing the Uniform Data System
Test Cooperative (UTC): As part of
HRSA’s efforts to modernize the UDS
HRSA is establishing the UTC as an
enduring testing and piloting capability.
The UTC consists of three main
components: (1) A steering committee,
(2) a coordinating entity, and (3) health
center test participants. Through this
cooperative, HRSA will be able to pilot
test innovative information technology
and software, streamlining of clinical
quality measures, and alternative data
collection methodologies to reduce
reporting burden and improve data
quality and integrity.
The total number of estimated
respondents changed from 2,075 to
2,134. The reason for the increase in the
number of respondents for the UDS
Report from 1,471 to 1,503 is because
this number was previously based on
2018 UDS data that HRSA had available
in July 2019. Since then, HRSA has been
able to update the respondents that we
anticipate for 2019 UDS reporting due to
the incremental increase of awardees in
the Health Center Program. The increase
in the number of Grant Reports for
Vulnerable Populations from 504 to 531
is due to an increase in a subset of
awardees who receive Migrant Health
Center, Health Care for the Homeless,
and Health Centers for Residents of
Public Housing funding.
The average burden hours per
response changed from 223 to 238 as a
result of comments received on the 60day Federal Register Notice and
additional consultation with external
stakeholders. These stakeholders stated
that the inclusion of additional clinical
quality measures in the UDS would
slightly increase the reporting burden.
While these measures are already
included in most electronic health
records, there is some additional work
that health centers will need to do in
order to incorporate the measures into
their workflows and their annual
reporting. In addition to these changes,
the names of the forms Universal Report
and Grant Report were updated to
provide greater specificity.
Likely Respondents: Likely
respondents will include Health Center
Program award recipients, Health Center
Program look-alikes, and Nurse
Education, Practice, Quality and
Retention Program awardees funded
under the practice priority areas of
section 831(b) of the PHS Act.
Burden Statement: Burden includes
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 use technology and systems for the
purpose of: Collecting, validating, and
verifying information, processing and
maintaining information, disclosing and
providing information. It also accounts
for time to train personnel, respond to
a collection of information, search data
sources, complete and review the
collection of information, and transmit
or otherwise disclose the information. It
will also include testing information
necessary to support the UTC. No more
than three tests would be conducted
each calendar year and no more than
one hundred health centers would
participate in one test. Participation is
voluntary and will not affect health
centers’ funding status. This sample size
is sufficient to conduct a pilot test and
determine if proposed innovations
should be scaled across the Health
Center Program.
The total annual burden hours
estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Uniform Data System (UDS) Report ...................................
Grant Report for Vulnerable Populations ............................
UTC Tests ............................................................................
1,503
531
100
1
1
3
1,503
531
300
238
30
80
357,714
15,930
24,000
Total ..............................................................................
2,134
........................
2,334
........................
397,644
Maria G. Button,
Director, Executive Secretariat.
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4 https://www.pdmpassist.org/content/
prescription-drug-monitoring-frequently-askedquestions-faq.
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5 https://www.countyhealthrankings.org/explorehealth-rankings/measures-data-sources/countyhealth-rankings-model/health-factors/social-andeconomic-factors.
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6 https://www.acf.hhs.gov/otip/about/what-ishuman-trafficking.
7 https://www.hrsa.gov/sites/default/files/hrsa/
HRSA-strategy-intimate-partner-violence.pdf.
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Federal Register / Vol. 84, No. 240 / Friday, December 13, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Opportunity to Co-Sponsor Office of
Disease Prevention and Health
Promotion Healthy Aging Summit and
Regional Workshops
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Office of Disease
Prevention and Health Promotion
(ODPHP) announces the opportunity for
non-Federal public and private sector
organizations and entities to co-sponsor
the 2020 Healthy Aging Regional
Workshops (Workshops) and/or the
2021 Healthy Aging Summit (HAS).
Opportunity A: 2020 Healthy Aging
Regional Workshop co-sponsorship will
involve executing a single or series of
financially self-sustaining (no federal
funds will be provided to the cosponsor) meetings or workshops to
convene healthy-aging stakeholders to
support regional action planning and
dissemination of information on healthy
aging, aging in place, and age-friendly
public health systems.
Opportunity B: 2021 Healthy Aging
Summit co-sponsorship will involve
executing a single financially selfsustaining (no federal funds will be
provided to the co-sponsor) conference
and related activities focused on health
promotion and disease prevention
research across the lifespan. This
Summit will identify critical research
needs and highlight the latest science of
creating livable communities and
improving healthy aging.
This co-sponsorship opportunity is
not a grant or contract award program
and each partner will be responsible for
financially supporting its own activities.
Potential co-sponsors must have
demonstrated interest in and experience
with coordinating healthy aging-focused
activities, be capable of managing the
day-to-day operations associated with
the proposed activities, and be willing
to participate substantively in the
execution of the co-sponsored activity.
DATES: To receive consideration,
proposals for co-sponsoring Healthy
Aging Regional Workshops and/or the
2021 Healthy Aging Summit must be
received via email or postmarked mail
at the addresses listed below, by 5:00
p.m. EST on January 17, 2020. Proposals
will meet the deadline if they are either
(1) received on or before the deadline
date; or (2) postmarked on or before the
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deadline date. Private metered
postmarks will not be accepted as proof
of timely mailing. Hand-delivered
proposals must be received by 5:00 p.m.
EST on January 17, 2020. Proposals that
are received after the deadline will not
be considered.
ADDRESSES: Expressions of interest for
healthy-aging co-sponsorships should
be submitted via email to HP2030@
hhs.gov with the subject line ‘‘Cosponsorship Opportunity for Healthy
Aging’’ or by mail to Ayanna Johnson,
Office of Disease Prevention and Health
Promotion, 1101 Wootton Parkway,
Suite 420, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ayanna Johnson, Office of Disease
Prevention and Health Promotion,
Office of the Assistant Secretary for
Health, 1101 Wootton Parkway, Suite
420, Rockville, MD 20852; Telephone:
(240) 453–8280; Email: HP2030@
hhs.gov.
SUPPLEMENTARY INFORMATION:
Background
ODPHP is a program office within the
Office of the Assistant Secretary for
Health (OASH), Office of the Secretary
of the U.S. Department of Health and
Human Services (HHS). ODPHP was
established by Congress in 1976 with a
mission to provide leadership for
disease prevention and health
promotion efforts for all Americans. To
promote the health of the country,
ODPHP sets national health goals and
supports programs, services, and
educational activities. ODPHP leads
Healthy People 2020/2030, Dietary
Guidelines for Americans, Physical
Activity Guidelines for Americans,
National Clinical Care Commission,
National Youth Sports Strategy,
President’s Council on Sports, Fitness
and Nutrition, and healthfinder.gov.
The percentage of the population age
65 or older in the United States is
growing. It is estimated that by 2050,
20.9% of the population will be over age
65, compared to 13.7% in 2012. This
group is living and working longer,
redefining later life, and enriching our
communities and society in new and
vital ways. Improvements in the
delivery of preventive services and care
coordination, and a greater
understanding of the social,
environmental and emotional factors
that influence health in the later years
of life could help reduce health care
costs and improve quality of life for
older Americans.
Preparing regional public health and
aging services leaders, to ensure that our
public health system is equipped to
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support the unique health needs of
older Americans, is of utmost
importance. To further address the
health needs of Americans as they age,
ODPHP organized Healthy Aging
Summits in 2015 and 2018. The
Summits provided an opportunity to
share the state-of-the-science in healthy
aging, identify knowledge gaps, promote
prevention and support livable
communities for aging in place.
Following the Summits, one-day
national workshops convened state
aging directors and state health officers
to develop state-level priorities and
action plans to promote healthy aging.
The 2018 workshop expanded convened
both state and local public health
leaders to explore issues affecting older
adults.
Building on the Healthy People
model, ODPHP projects use a socialdeterminants-of-health (SDOH)
framework to strengthen public health.
The framework calls for looking at
upstream conditions that impact health.
The SDOH framework was adapted to
each of the Summits through the
conference tracks which included:
Maximizing Quality of Life, Social and
Community Context, Health and Health
Care, and Neighborhood and Built
Environment.
Requirements of the Co-Sponsorship
Consistent with ODPHP’s mission and
the applicable statutory authority, Title
XVII of the Public Health Service Act,
the Healthy Aging Regional Workshops
and Healthy Aging Summit aim to
support the dissemination of relevant
information and convene experts to
share best practices for disease
prevention and health promotion. The
Workshops convene over 1 day, and
typically have 50 attendees. The
Summit convenes over 3 days, and
typically has 600 attendees.
ODPHP is seeking organizations
capable of managing the development
and execution of healthy aging researchsharing conferences or workshops and
programming. Co-sponsors will assist
with workshop and/or summit and
agenda development, coordination,
financial management, and meeting
logistics in conjunction with ODPHP
staff.
Approved proposals will require a cosponsorship agreement signed by both
the co-sponsor and ODPHP that outlines
the terms and parameters of the
agreement. The co-sponsorship will be
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]]>Agencies
[Federal Register Volume 84, Number 240 (Friday, December 13, 2019)]
[Notices]
[Pages 68175-68178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26876]
-----------------------------------------------------------------------
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; Bureau of Primary Health
Care Uniform Data System, OMB No. 0915-0193--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
[[Page 68176]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the 30
day comment period for this Notice has closed.
DATES: Comments on this ICR should be received no later than January
13, 2020.
ADDRESSES: Submit your comments, including the ICR title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at [email protected] or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Bureau of Primary Health Care
(BPHC) 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,
most recently amended by section 50901(b) of the Bipartisan Budget Act
of 2018, Public Law 115-123. 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 12,000 service delivery sites that provide primary health
care to more than 27 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 Uniform Data System (UDS) for annual reporting by
certain HRSA award recipients, including Health Center Program awardees
(those funded under section 330 of the PHS Act), Health Center Program
look-alikes, and Nurse Education, Practice, Quality and Retention
Program awardees (specifically those funded under the practice priority
areas of section 831(b) of the PHS Act).
Need and Proposed Use of the Information: HRSA collects UDS data
annually to ensure compliance with legislative and regulatory
requirements, improve clinical and operational performance, and report
overall program accomplishments. HRSA aligns several clinical measures
reported in UDS with the Centers for Medicare & Medicaid Services'
(CMS) electronic specified clinical quality measures (eCQM). These data
help to identify trends over time, enabling HRSA to establish or expand
targeted programs and to identify effective services and interventions
that will improve the health of medically underserved communities. HRSA
analyzes UDS data with other national health-related data sets to
compare the Health Center Program patient populations and the overall
U.S. population.
HRSA received comments on the BPHC UDS Federal Register notice
published on July 26, 2019, vol. 84, No. 144; pp. 36108. We have taken
the commenter's suggestions into consideration and have made
appropriate adjustments to the draft instruments. The 2020 UDS data
collection will be updated in the following ways:
Retiring CMS126 Use of Appropriate Medications for Asthma:
The CMS eCQM is no longer being updated when new asthma medications are
approved for use. This measure was also retired from the Healthcare
Effectiveness Data and Information Set, is no longer endorsed by the
NQF, and there is currently no comparable eCQM for asthma. Thus, no
replacement measure is planned at this time.
Retaining CMS277v0--Dental Sealants for Children Between
6-9 years: Based upon public feedback, HRSA has decided to retain the
dental sealant measure for 2020 UDS reporting. HRSA has also decided to
not add the fluoride varnish measure for 2020 UDS.
Adding CMS159v8 Depression Remission at Twelve Months: The
addition of the CMS depression remission measure at 12 months provides
complementary mental health outcome data on how well health centers
help patients reach remission. Improvement in the symptoms of
depression and an ongoing assessment of the current treatment plan are
crucial to the reduction of symptoms and psychosocial well-being of
patients. The addition of CMS159v8 further supports HRSA's commitment
to HHS' strategic objective to ``Reduce the impact of mental and
substance use disorders through prevention, early intervention,
treatment, and recovery support.''
Revising the HIV linkage to care measure: The HIV linkage
to care measure captures the percentage of patients whose first ever
HIV diagnosis was made by health center staff between October 1 of the
prior year and September 30 of the measurement year and who were seen
for follow-up treatment within 90 days of that first-ever diagnosis.
This measure will be modified to change the follow-up treatment from 90
days to 30 days aligning with Centers for Disease Control and
Prevention's guidance.\1\
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\1\ https://www.cdc.gov/hiv/pdf/library/factsheets/cdc-hiv-care-continuum.pdf.
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Adding CMS349v2 HIV Screening: The addition of the CMS HIV
screening measure will enable HRSA to better identify priority
geographic locations, assist high risk groups among health center
patients, and more effectively deploy interventions and resources in
support of the ``Ending the HIV Epidemic'' Initiative.
Adding Prescription for Pre-Exposure Prophylaxis
International Classification of Diseases (ICD) 10 Codes and Current
Procedural Terminology codes: The addition of the Prescription for Pre-
Exposure Prophylaxis ICD-10 and Current Procedural Terminology codes
will allow for the collection of this HIV prescription prevention data
in health centers and further supports the ``Ending the HIV Epidemic''
Initiative's goal of reducing new HIV infections.
Refraining from including additional diabetes measures:
Based upon public feedback, HRSA will not be adding CMS131v8 Diabetes
Eye Exam, CMS123v7 Diabetes Foot Exam, or CMS134v8 Diabetes Medial
Attention to Nephropathy to the 2020 UDS.
Adding CMS125v8 Breast Cancer Screening: There is
substantial geographic and demographic variation in breast cancer death
rates, suggesting that there are social and non-economic obstacles that
affect breast cancer screening.\2\ Preventive screening through timely
access to mammograms can lead to early detection, better treatment
prognosis, and potential to reduce health disparities.\3\
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\2\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4540479/.
\3\ https://www.thecommunityguide.org/findings/cancer-screening-reducing-structural-barriers-clients-breast-cancer.
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Adding a Prescription Drug Monitoring Programs (PDMPs)
Question to Appendix D: Health Center Health Information Technology
Capabilities: PDMPs are effective tools for reducing prescription drug
abuse and diversion. Improving provider utilization and access to real-
time data has demonstrated meaningful results in
[[Page 68177]]
reducing over-prescribing of medication.\4\
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\4\ https://www.pdmpassist.org/content/prescription-drug-monitoring-frequently-asked-questions-faq.
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Revising the Social Determinants of Health Question in
Appendix D: Health Center Health Information Technology Capabilities:
There is strong evidence that social and economic factors influence an
individual's health.\5\ Several health care systems are exploring how
to collect information on the social determinants of health (SDOH). The
inclusion of these questions into Appendix D allows HRSA to see how
health centers are approaching this challenge and how many of their
vulnerable patients are experiencing social and economic risks
associated with poor health. For health centers that are using a
standardized screener, there is one additional question asking for the
total number of patients that screen positive for food insecurity,
housing insecurity, financial strain, and lack of transportation/access
to public transportation.
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\5\ https://www.countyhealthrankings.org/explore-health-rankings/measures-data-sources/county-health-rankings-model/health-factors/social-and-economic-factors.
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Adding ICD-10 Codes to Capture Human Trafficking and
Intimate Partner Violence: HRSA is aware that human trafficking \6\ and
intimate partner violence \7\ are part of the SDOH that can affect a
wide range of health and quality of life outcomes. Addressing SDOH is a
HRSA objective to improve the health and well-being of health center
patients and the broader community in which they reside.
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\6\ https://www.acf.hhs.gov/otip/about/what-is-human-trafficking.
\7\ https://www.hrsa.gov/sites/default/files/hrsa/HRSA-strategy-intimate-partner-violence.pdf.
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Utilizing the Uniform Data System Test Cooperative (UTC):
As part of HRSA's efforts to modernize the UDS HRSA is establishing the
UTC as an enduring testing and piloting capability. The UTC consists of
three main components: (1) A steering committee, (2) a coordinating
entity, and (3) health center test participants. Through this
cooperative, HRSA will be able to pilot test innovative information
technology and software, streamlining of clinical quality measures, and
alternative data collection methodologies to reduce reporting burden
and improve data quality and integrity.
The total number of estimated respondents changed from 2,075 to
2,134. The reason for the increase in the number of respondents for the
UDS Report from 1,471 to 1,503 is because this number was previously
based on 2018 UDS data that HRSA had available in July 2019. Since
then, HRSA has been able to update the respondents that we anticipate
for 2019 UDS reporting due to the incremental increase of awardees in
the Health Center Program. The increase in the number of Grant Reports
for Vulnerable Populations from 504 to 531 is due to an increase in a
subset of awardees who receive Migrant Health Center, Health Care for
the Homeless, and Health Centers for Residents of Public Housing
funding.
The average burden hours per response changed from 223 to 238 as a
result of comments received on the 60-day Federal Register Notice and
additional consultation with external stakeholders. These stakeholders
stated that the inclusion of additional clinical quality measures in
the UDS would slightly increase the reporting burden. While these
measures are already included in most electronic health records, there
is some additional work that health centers will need to do in order to
incorporate the measures into their workflows and their annual
reporting. In addition to these changes, the names of the forms
Universal Report and Grant Report were updated to provide greater
specificity.
Likely Respondents: Likely respondents will include Health Center
Program award recipients, Health Center Program look-alikes, and Nurse
Education, Practice, Quality and Retention Program awardees funded
under the practice priority areas of section 831(b) of the PHS Act.
Burden Statement: Burden includes 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 use technology and systems for the
purpose of: Collecting, validating, and verifying information,
processing and maintaining information, disclosing and providing
information. It also accounts for time to train personnel, respond to a
collection of information, search data sources, complete and review the
collection of information, and transmit or otherwise disclose the
information. It will also include testing information necessary to
support the UTC. No more than three tests would be conducted each
calendar year and no more than one hundred health centers would
participate in one test. Participation is voluntary and will not affect
health centers' funding status. This sample size is sufficient to
conduct a pilot test and determine if proposed innovations should be
scaled across the Health Center Program.
The total annual burden hours estimated for this Information
Collection Request are summarized in the table below.
Total Estimated Annualized Burden--Hours
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Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
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Uniform Data System (UDS) Report 1,503 1 1,503 238 357,714
Grant Report for Vulnerable 531 1 531 30 15,930
Populations....................
UTC Tests....................... 100 3 300 80 24,000
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Total....................... 2,134 .............. 2,334 .............. 397,644
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-26876 Filed 12-12-19; 8:45 am]
BILLING CODE 4165-15-P
