Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Assessing Care and Health Outcomes Among Ryan White HIV/AIDS Program (RWHAP) Clients Who Do Not Receive RWHAP-Funded Outpatient Ambulatory Health Services (OAHS), OMB No. 0906-xxxx-New, 13934-13936 [2019-06767]
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13934
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
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FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
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committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: During the morning session,
the committee will discuss new drug
application (NDA) 211810 for
pexidartinib capsule, submitted by
Daiichi Sankyo, Inc. The proposed
indication (use) for this product is for
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the treatment of adult patients with
symptomatic tenosynovial giant cell
tumor, also referred to as giant cell
tumor of the tendon sheath or
pigmented villonodular synovitis,
which is associated with severe
morbidity or functional limitations, and
which is not amenable to improvement
with surgery.
During the afternoon session, the
committee will discuss NDA 212166 for
quizartinib tablets, submitted by Daiichi
Sankyo, Inc. The proposed indication
(use) for this product is for the treatment
of adults with relapsed or refractory
acute myeloid leukemia, which is
FLT3–ITD positive, as detected by an
FDA-approved test.
FDA intends to make background
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than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
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location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
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April 30, 2019, will be provided to the
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For press inquiries, please contact the
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–06896 Filed 4–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Assessing
Care and Health Outcomes Among
Ryan White HIV/AIDS Program
(RWHAP) Clients Who Do Not Receive
RWHAP-Funded Outpatient
Ambulatory Health Services (OAHS),
OMB No. 0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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 June 7, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
SUMMARY:
E:\FR\FM\08APN1.SGM
08APN1
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Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Assessing Care and Health Outcomes
Among Ryan White HIV/AIDS Program
Clients Who Do Not Receive RWHAPFunded Outpatient Ambulatory Health
Services, OMB No. 0906–xxxx–New.
Abstract: RWHAP is administered by
HRSA’s HIV/ADS Bureau. RWHAP
funds and coordinates with cities,
states, and local clinics and communitybased organizations to deliver HIV care,
treatment, and support to low-income
people living with HIV (PLWH). Nearly
two-thirds of RWHAP clients live at or
below 100 percent of the federal poverty
level and about three-quarters are racial
or ethnic minorities. Since 1990, the
RWHAP has developed a
comprehensive system of nearly 2,000
safety net provider organizations that
deliver high quality health care and
support services to more than 500,000
PLWH, more than 50 percent of all
diagnosed PLWH in the United States.
Recipients and subrecipients funded to
provide direct services must submit
client-level data annually to HRSA as
part of their RWHAP Services Report
(RSR). The RSR (0906–0039) contains a
single record for each RWHAP-eligible
client who received a service during the
calendar year. Providers report
demographic and service use data for all
their clients. However, they report
clinical data (including lab results) only
for those who received RWHAP-funded
OAHS.
HRSA is embarking on a 24-month
study called Assessing Care and Health
Outcomes Among RWHAP Clients Who
Do Not Receive RWHAP-Funded OAHS.
The purpose of the study is to learn
about the quality of care and health
outcomes among the one-third of clients
for whom HRSA does not collect
clinical information—that is, for the
164,000 clients who do not receive
directly funded OAHS under the
RWHAP. HRSA will use the findings to
(1) assess HIV care and health outcomes
among its non-OAHS clients, (2)
determine if and where these clients
receive OAHS, (3) identify any unmet
HIV care and treatment needs faced by
this population, and (4) develop
strategies to better coordinate services
between RWHAP-funded and
nonfunded providers. To meet these
objectives, HRSA proposes to conduct
30 site visits. Each site visit will include
one RWHAP-funded provider that is not
directly funded to deliver OAHS and, if
necessary for accessing the medical
records of their non-OAHS clients, up to
two non-RWHAP medical providers.
During each site visit, HRSA will collect
qualitative and quantitative information
via (1) semistructured interviews with
program managers, clinicians, and
frontline service providers, as well as
with non-OAHS clients and (2) medical
chart reviews for clients who do not
receive directly funded OAHS under the
RWHAP.
Need and Proposed Use of the
Information: The interviews with
provider staff and clients will provide
qualitative information on HIV-related
medical service use, process, and health
outcomes; barriers to care; unmet needs;
provider referral relationships; and
opportunities to improve care and
outcomes among clients who do not
receive directly funded OAHS under the
RWHAP. The medical chart reviews will
provide quantitative information on
medical visits, prescription
medications, and clinical outcomes for
a representative sample of non-OAHS
clients. HRSA will use the data to
estimate three main outcomes for the
study population: (1) Retention in care,
(2) initiation of antiretroviral therapy,
and (3) viral suppression. This
information will supplement data
available from the RSR on OAHS clients
and enable HRSA for the first time to
measure the quality of care and health
outcomes for its entire client
population, an important step toward
ending the HIV epidemic in the United
States.
Likely Respondents: HRSA plans to
conduct individual interviews with two
groups of informants: (1) Program
managers, case managers or other
frontline service providers, and medical
directors or clinicians; and (2) RWHAP
clients. HRSA also plans to review and
abstract key data elements from nonOAHS client medical records from
providers.
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
Number of
respondents
Form name
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Program manager ................................................................
Case manager .....................................................................
Medical director ....................................................................
Client ....................................................................................
Chart abstraction ..................................................................
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
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Number of
responses per
respondent
Frm 00074
Fmt 4703
Average
burden per
response
(in hours)
Total burden
hours
30
30
40
120
30
1
1
1
1
50
30
30
40
120
1,500
1.00
1.00
1.00
0.50
0.08
30
30
40
60
120
250
........................
1,720
........................
280
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
PO 00000
Total
responses
Sfmt 4703
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
E:\FR\FM\08APN1.SGM
08APN1
13936
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
or other forms of information
technology to minimize the information
collection burden.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–06767 Filed 4–5–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: EvidenceBased Telehealth Network Program
Measures, OMB No. 0906–xxxx–New
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 June 7, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
SUMMARY:
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Evidence-Based Telehealth Network
Program Measures, OMB No. 0906–
xxxx–New
Abstract: This ICR is for a new
approval of measures for HRSA’s
Federal Office of Rural Health Policy’s
Office of Advancement of Telehealth
programs. Specifically, grants
administered in accordance with the
following legislative statutes (i) Section
330I(d)(1) of the Public Health Service
Act (42 U.S.C. 254c14(d)(1)), as
amended and (ii) Section 711(b) of the
Social Security Act (42 U.S.C. 912(b)),
as amended. The purpose of these
programs are to provide grants that
demonstrate how telehealth programs
and networks can improve access to
quality health care services in rural,
frontier, and underserved communities.
These grants will work to: (a) expand
access to, coordinate, and improve the
quality of health care services; (b)
improve and expand the training of
health care providers; and (c) expand
and improve the quality of health
information available to health care
providers, patients and their families for
decision-making. In addition, these
grants will help HRSA assess the
effectiveness of evidence based
practices with the use of telehealth for
patients, providers, and payers.
Need and Proposed Use of the
Information: The measures will enable
HRSA to capture awardee-level and
aggregate data that illustrate the impact
and scope of federal funding along with
assessing these efforts. The measures
cover the principal topic areas of
interest to HRSA including: (a)
population demographics, (b) access to
health care, (c) cost savings and costeffectiveness, and (d) clinical outcomes.
Likely Respondents: The respondents
will be award recipients of the Evidence
Based Telehealth Network Program and
Telehealth Network Grant Program.
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
Number of
respondents
Form name
Number of
responses per
respondent
(annually)
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Evidence-Based Telehealth Network Program Report ........
Telehealth Performance Measurement Report ...................
Telehealth Evidence Collection Report ...............................
50
50
36
12
1
12
600
50
432
31.0
5.0
37.5
18,600
250
16,200
Total ..............................................................................
50*
........................
1,082
........................
35,050
jbell on DSK30RV082PROD with NOTICES
* There are 50 unique respondents. All respondents will be responding to the first two forms and a subset will be responding to the third form.
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17:45 Apr 05, 2019
Jkt 247001
PO 00000
Frm 00075
Fmt 4703
Sfmt 9990
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13934-13936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06767]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Assessing
Care and Health Outcomes Among Ryan White HIV/AIDS Program (RWHAP)
Clients Who Do Not Receive RWHAP-Funded Outpatient Ambulatory Health
Services (OAHS), OMB No. 0906-xxxx-New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
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 June 7,
2019.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance
[[Page 13935]]
Officer, Room 14N39, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Assessing Care and Health
Outcomes Among Ryan White HIV/AIDS Program Clients Who Do Not Receive
RWHAP-Funded Outpatient Ambulatory Health Services, OMB No. 0906-xxxx-
New.
Abstract: RWHAP is administered by HRSA's HIV/ADS Bureau. RWHAP
funds and coordinates with cities, states, and local clinics and
community-based organizations to deliver HIV care, treatment, and
support to low-income people living with HIV (PLWH). Nearly two-thirds
of RWHAP clients live at or below 100 percent of the federal poverty
level and about three-quarters are racial or ethnic minorities. Since
1990, the RWHAP has developed a comprehensive system of nearly 2,000
safety net provider organizations that deliver high quality health care
and support services to more than 500,000 PLWH, more than 50 percent of
all diagnosed PLWH in the United States. Recipients and subrecipients
funded to provide direct services must submit client-level data
annually to HRSA as part of their RWHAP Services Report (RSR). The RSR
(0906-0039) contains a single record for each RWHAP-eligible client who
received a service during the calendar year. Providers report
demographic and service use data for all their clients. However, they
report clinical data (including lab results) only for those who
received RWHAP-funded OAHS.
HRSA is embarking on a 24-month study called Assessing Care and
Health Outcomes Among RWHAP Clients Who Do Not Receive RWHAP-Funded
OAHS. The purpose of the study is to learn about the quality of care
and health outcomes among the one-third of clients for whom HRSA does
not collect clinical information--that is, for the 164,000 clients who
do not receive directly funded OAHS under the RWHAP. HRSA will use the
findings to (1) assess HIV care and health outcomes among its non-OAHS
clients, (2) determine if and where these clients receive OAHS, (3)
identify any unmet HIV care and treatment needs faced by this
population, and (4) develop strategies to better coordinate services
between RWHAP-funded and nonfunded providers. To meet these objectives,
HRSA proposes to conduct 30 site visits. Each site visit will include
one RWHAP-funded provider that is not directly funded to deliver OAHS
and, if necessary for accessing the medical records of their non-OAHS
clients, up to two non-RWHAP medical providers. During each site visit,
HRSA will collect qualitative and quantitative information via (1)
semistructured interviews with program managers, clinicians, and
frontline service providers, as well as with non-OAHS clients and (2)
medical chart reviews for clients who do not receive directly funded
OAHS under the RWHAP.
Need and Proposed Use of the Information: The interviews with
provider staff and clients will provide qualitative information on HIV-
related medical service use, process, and health outcomes; barriers to
care; unmet needs; provider referral relationships; and opportunities
to improve care and outcomes among clients who do not receive directly
funded OAHS under the RWHAP. The medical chart reviews will provide
quantitative information on medical visits, prescription medications,
and clinical outcomes for a representative sample of non-OAHS clients.
HRSA will use the data to estimate three main outcomes for the study
population: (1) Retention in care, (2) initiation of antiretroviral
therapy, and (3) viral suppression. This information will supplement
data available from the RSR on OAHS clients and enable HRSA for the
first time to measure the quality of care and health outcomes for its
entire client population, an important step toward ending the HIV
epidemic in the United States.
Likely Respondents: HRSA plans to conduct individual interviews
with two groups of informants: (1) Program managers, case managers or
other frontline service providers, and medical directors or clinicians;
and (2) RWHAP clients. HRSA also plans to review and abstract key data
elements from non-OAHS client medical records from providers.
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Program manager................. 30 1 30 1.00 30
Case manager.................... 30 1 30 1.00 30
Medical director................ 40 1 40 1.00 40
Client.......................... 120 1 120 0.50 60
Chart abstraction............... 30 50 1,500 0.08 120
-------------------------------------------------------------------------------
250 .............. 1,720 .............. 280
----------------------------------------------------------------------------------------------------------------
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
[[Page 13936]]
or other forms of information technology to minimize the information
collection burden.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-06767 Filed 4-5-19; 8:45 am]
BILLING CODE 4165-15-P
