Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Parts A and B Unobligated Balances and Rebate Addendum Tables, OMB No. 0906-xxxx-NEW, 63663-63664 [2019-24911]
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Federal Register / Vol. 84, No. 222 / Monday, November 18, 2019 / Notices
Authority for the
Nonprescription Drugs Advisory
Committee will expire on August 27,
2021, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, 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, email: NDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3, FDA is announcing
the renewal of the Nonprescription
Drugs Advisory Committee (the
Committee). The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of over-the-counter
(nonprescription) human drug products,
or any other FDA-regulated product, for
use in the treatment of a broad spectrum
of human symptoms and diseases and
advises the Commissioner either on the
promulgation of monographs
establishing conditions under which
these drugs are generally recognized as
safe and effective and not misbranded or
on the approval of new drug
applications for such drugs. The
Committee serves as a forum for the
exchange of views regarding the
prescription and nonprescription status,
including switches from one status to
another, of these various drug products
and combinations thereof. The
Committee may also conduct peer
review of agency sponsored intramural
and extramural scientific biomedical
programs in support of FDA’s mission
and regulatory responsibilities.
Pursuant to its charter, the Committee
consists of a core of 10 voting members,
including the Chair. Members and the
Chair are selected by the Commissioner
or designee from among authorities
knowledgeable in the fields of internal
medicine, family practice, clinical
toxicology, clinical pharmacology,
pharmacy, dentistry, and related
specialties. Members are invited to serve
for overlapping terms of up to 4 years.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The core of voting members
may include one technically qualified
DATES:
VerDate Sep<11>2014
17:41 Nov 15, 2019
Jkt 250001
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
nonprescription-drugs-advisorycommittee/nonprescription-drugsadvisory-committee-charter or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24917 Filed 11–15–19; 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; Ryan White HIV/AIDS
Program Parts A and B Unobligated
Balances and Rebate Addendum
Tables, OMB No. 0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
DATES: Comments on this ICR should be
received no later than December 18,
2019.
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
63663
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
paperwork@hrsa.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 Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Ryan White HIV/AIDS Program Parts A
and B Unobligated Balances and Rebate
Addendum Tables, OMB No. 0906–
xxxx—NEW.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states,
territories, and local clinics/communitybased organizations to deliver efficient
and effective HIV care, treatment, and
support to low-income people
diagnosed with HIV. Nearly two-thirds
of RWHAP clients (patients) live at or
below 100 percent of the federal poverty
level and approximately three-quarters
of RWHAP clients are racial and ethnic
minorities. Since 1990, the RWHAP has
developed a comprehensive system of
HIV service providers who deliver high
quality direct health care and support
services to over half a million people
diagnosed with HIV—more than 50
percent of all people diagnosed with
HIV in the United States.
Grant recipients funded under Parts
A, B, C, and D of the RWHAP (codified
under Title XXVI of the Public Health
Service Act) are required to report
financial data to HRSA at the beginning
(Allocations Report) and at the end of
each grant budget period (Expenditures
Report) using the HRSA Electronic
Handbooks (EHBs).i HRSA RWHAP
Parts A and B collect unobligated
balances (UOB) of federal funds and
rebate addendum information by
subprogram from their grant recipients.
Parts A and B use the UOB and rebate
addendum financial information to
determine formula funding as directed
by the RWHAP statute. These data were
collected when grant recipients
submitted their annual Federal
Financial Report (FFR SF–425) in hard
copy only, and were submitted to the
individual HHS Operating Divisions.
HRSA added UOB and rebate
addendum tables after the FFR SF–425,
using a suggested format through the
HRSA EHBs. This financial information
is collected in the same location to
ADDRESSES:
i The Allocations Report and the Expenditures
Report were approved by OMB under the 0915–
0318 control number.
E:\FR\FM\18NON1.SGM
18NON1
63664
Federal Register / Vol. 84, No. 222 / Monday, November 18, 2019 / Notices
streamline the process for the grant
recipients. The UOB and rebate
addendum data tables will be collected
in the HRSA EHBs below the FFR SF–
425 control number and the Paperwork
Burden Statement.
A 60-day notice was published in the
Federal Register on July 19, 2019, vol.
84, No. 139; pp. 34903–04. There were
no public comments.
Need and Proposed Use of the
Information: RWHAP Part A and Part B
recipients currently complete the UOB
and rebate addendum tables in a nonelectronic form and upload them as
attachments as a part of their FFR SF–
425 submission. This new process will
decrease administrative burden,
increase transparency, and improve the
quality of data submitted to HRSA.
These UOB and rebate addendum tables
are essential for allowing HRSA to
ensure that RWHAP recipients are
meeting the goal of accountability to
Congress, clients, advocacy groups, and
the general public. Information
provided in the UOB and rebate
addendum tables is critical for HRSA,
states and territories, local clinics, and
individual providers to evaluate the
effectiveness of these programs.
Likely Respondents: HRSA RWHAP
Parts A and B Recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Part A UOB Table ................................................................
Part B UOB Table ................................................................
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–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; Chart Abstraction of Ryan
White HIV/AIDS Program Recipient
Data, OMB No. 0906–xxxx—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
DATES: Comments on this ICR should be
received no later than December 18,
2019.
SUMMARY:
17:41 Nov 15, 2019
Jkt 250001
Frm 00060
Fmt 4703
Total burden
hours
1
1
52
59
0.5
0.5
26.0
29.5
111
........................
111
........................
55.5
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 Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Chart Abstraction of Ryan White HIV/
AIDS Program Recipient Data, OMB No.
0906–xxxx—New.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states, and local
clinics/community-based organizations
to deliver efficient and effective HIV
care, treatment, and support to lowincome people with HIV. Nearly twothirds of clients (patients) live at or
below 100 percent of the Federal
poverty level and approximately threequarters of RWHAP clients are racial
and ethnic minorities. Since 1990, the
RWHAP has developed a
comprehensive system of HIV service
providers who deliver high quality
direct health care and support services
to over half a million people with HIV—
more than 50 percent of all people with
diagnosed HIV in the United States.
HRSA is required to assess the quality
of care provided by RWHAP grant
PO 00000
Average
burden per
response
(in hours)
Total
responses
52
59
ADDRESSES:
[FR Doc. 2019–24911 Filed 11–15–19; 8:45 am]
VerDate Sep<11>2014
Number of
responses per
respondent
Sfmt 4703
recipients. HHS guidelines (e.g.,
Guidelines for the Use of Antiretroviral
Agents in Adults and Adolescents
Living with HIV; Guidelines for the
Prevention and Treatment of
Opportunistic Infections in HIVInfected Adults and Adolescents; and
Sexually Transmitted Diseases
Treatment Guidelines, 2015) and U.S.
Preventative Services Task Force
(USPSTF) guidelines serve as the basis
for assessing the quality of care within
the RWHAP. The purpose of the Chart
Abstraction of RWHAP Data study is to
assess the extent to which the care
provided with funding from the
RWHAP is meeting the HHS and
USPSTF guidelines. The study will
collect data from RWHAP service
providers via a provider screening
phone interview, a provider pre-site
visit interview, and medical records
data abstraction. The data will reflect
the full range of HIV outpatient
ambulatory health services, primary
care, and screening and treatment for
hepatitis, sexually transmitted
infections (STIs), and opioid use
disorder provided by service providers
and allow HRSA to assess the extent to
which care provided by RWHAP service
providers meets the HHS and USPSTF
guidelines.
A 60-day notice was published in the
Federal Register on May 10, 2019, vol.
84, No. 91; pp. 20638–20639. There
were no public comments.
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63663-63664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24911]
-----------------------------------------------------------------------
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; Ryan White HIV/AIDS
Program Parts A and B Unobligated Balances and Rebate Addendum Tables,
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 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.
DATES: Comments on this ICR should be received no later than December
18, 2019.
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 Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Ryan White HIV/AIDS Program
Parts A and B Unobligated Balances and Rebate Addendum Tables, OMB No.
0906-xxxx--NEW.
Abstract: HRSA's Ryan White HIV/AIDS Program (RWHAP) funds and
coordinates with cities, states, territories, and local clinics/
community-based organizations to deliver efficient and effective HIV
care, treatment, and support to low-income people diagnosed with HIV.
Nearly two-thirds of RWHAP clients (patients) live at or below 100
percent of the federal poverty level and approximately three-quarters
of RWHAP clients are racial and ethnic minorities. Since 1990, the
RWHAP has developed a comprehensive system of HIV service providers who
deliver high quality direct health care and support services to over
half a million people diagnosed with HIV--more than 50 percent of all
people diagnosed with HIV in the United States.
Grant recipients funded under Parts A, B, C, and D of the RWHAP
(codified under Title XXVI of the Public Health Service Act) are
required to report financial data to HRSA at the beginning (Allocations
Report) and at the end of each grant budget period (Expenditures
Report) using the HRSA Electronic Handbooks (EHBs).\i\ HRSA RWHAP Parts
A and B collect unobligated balances (UOB) of federal funds and rebate
addendum information by subprogram from their grant recipients. Parts A
and B use the UOB and rebate addendum financial information to
determine formula funding as directed by the RWHAP statute. These data
were collected when grant recipients submitted their annual Federal
Financial Report (FFR SF-425) in hard copy only, and were submitted to
the individual HHS Operating Divisions. HRSA added UOB and rebate
addendum tables after the FFR SF-425, using a suggested format through
the HRSA EHBs. This financial information is collected in the same
location to
[[Page 63664]]
streamline the process for the grant recipients. The UOB and rebate
addendum data tables will be collected in the HRSA EHBs below the FFR
SF-425 control number and the Paperwork Burden Statement.
---------------------------------------------------------------------------
\i\ The Allocations Report and the Expenditures Report were
approved by OMB under the 0915-0318 control number.
---------------------------------------------------------------------------
A 60-day notice was published in the Federal Register on July 19,
2019, vol. 84, No. 139; pp. 34903-04. There were no public comments.
Need and Proposed Use of the Information: RWHAP Part A and Part B
recipients currently complete the UOB and rebate addendum tables in a
non-electronic form and upload them as attachments as a part of their
FFR SF-425 submission. This new process will decrease administrative
burden, increase transparency, and improve the quality of data
submitted to HRSA. These UOB and rebate addendum tables are essential
for allowing HRSA to ensure that RWHAP recipients are meeting the goal
of accountability to Congress, clients, advocacy groups, and the
general public. Information provided in the UOB and rebate addendum
tables is critical for HRSA, states and territories, local clinics, and
individual providers to evaluate the effectiveness of these programs.
Likely Respondents: HRSA RWHAP Parts A and B Recipients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Part A UOB Table................ 52 1 52 0.5 26.0
Part B UOB Table................ 59 1 59 0.5 29.5
-------------------------------------------------------------------------------
111 .............. 111 .............. 55.5
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-24911 Filed 11-15-19; 8:45 am]
BILLING CODE 4165-15-P
