Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0906-xxxx-NEW, 54363-54364 [2018-23547]
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Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
issued a letter to Swedish Match North
America Inc. that denied the MRTPAs,
in part, and outlined deficiencies in the
remaining portions of the MRTPAs that
the applicant could address by
submitting an amendment to the
applications. FDA recently received an
amendment to Swedish Match North
America Inc.’s MRTPAs and is making
the amendment available (except for
matters in the amendment that are trade
secrets or otherwise confidential
commercial information) for public
comment. FDA is reopening the period
for public comment so that the public
has the opportunity to review and
comment on the amendment.
FDA is required by section 911(e) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 387k(e)) to
make an MRTPA available to the public
(except for matters in the application
that are trade secrets or otherwise
confidential commercial information)
and to request comments by interested
persons on the information contained in
the application and on the label,
labeling, and advertising accompanying
the application. The determination of
whether an order is appropriate under
section 911 of the FD&C Act is based on
the scientific information submitted by
the applicant as well as the scientific
evidence and other information that is
made available to the Agency, including
through public comments.
FDA has posted the application
amendment for public comment, which
has been redacted in accordance with
applicable laws. FDA intends to
establish a closing date for the comment
period that is at least 30 days after the
final documents from the application
are made available for public comment
and will announce the closing date at
least 30 days in advance. FDA will
notify the public about the availability
of additional application documents, if
any, and the closing date for the
comment period via the Agency’s web
page for the MRTPA (see section II) and
by other means of public
communication, such as by email to
individuals who have signed up to
receive email alerts. FDA does not
intend to issue additional notices in the
Federal Register regarding amendments
or the comment period for these
MRTPAs. To receive email alerts, visit
FDA’s email subscription service
management website (https://go.fda.gov/
subscriptionmanagement), provide an
email address, scroll down to the
‘‘Tobacco’’ heading, select ‘‘Modified
Risk Tobacco Product Application
Updates’’, and click ‘‘Submit’’. To
encourage public participation
consistent with section 911(e) of the
FD&C Act, FDA is making the redacted
VerDate Sep<11>2014
17:48 Oct 26, 2018
Jkt 247001
MRTPAs that are the subject of this
notice available electronically (see
section II).
II. Electronic Access
Persons with access to the internet
may obtain the documents at either
https://www.fda.gov/TobaccoProducts/
Labeling/MarketingandAdvertising/
ucm533454.htm or https://
www.regulations.gov.
Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23524 Filed 10–26–18; 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 Client-Level Data Reporting
System, OMB No. 0906–xxxx–NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with 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 November 28,
2018.
SUMMARY:
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:
Client-Level Data Reporting System.
OMB No. 0906–xxxx–NEW.
Abstract: The Ryan White HIV/AIDS
Program’s (RWHAP) client-level data
ADDRESSES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
54363
reporting system, entitled the RWHAP
Services Report or the Ryan White
Services Report (RSR), is designed to
collect information from grant
recipients, as well as their
subrecipients, funded under Parts A, B,
C, and D of the RWHAP statute. The
RWHAP, authorized under Title XXVI
of the Public Health Service Act, as
amended by the Ryan White HIV/AIDS
Treatment Extension Act of 2009, is
administered by HRSA HIV/AIDS
Bureau (HAB). The HRSA RWHAP
funds and coordinates with cities,
states, and local clinics/communitybased organizations to deliver efficient
and effective HIV care, treatment, and
support to low-income people living
with HIV (PLWH).
Need and Proposed Use of the
Information: The RWHAP statute
requires HRSA to monitor the
administration of grant funds, allocation
of funding, service utilization, and
client demographic and HIV health
outcome data (e.g., viral suppression).
The RSR collects data on the
characteristics of RWHAP-funded
recipients, subrecipients, and the
patients or clients served. The RSR
system consists of two online data
forms: the Recipient Report and the
Service Provider Report; and the Client
Report, which is a data file containing
the client-level data elements. Data are
submitted annually. The RWHAP
statute specifies the importance of
recipient accountability and linking
performance to budget. The RSR is used
to ensure recipient compliance with the
statute, including evaluating the
effectiveness of programs, monitoring
recipient and subrecipient performance,
and informing annual reports to
Congress. Information collected through
the RSR is critical for HRSA, state/local
grant recipients, and individual service
providers to understand existing HIVrelated service delivery systems and the
clients served. Information in the RSR is
used to assess trends in service
utilization and HIV health outcomes for
clients served. Data from the RSR is
analyzed to identify disparities and gaps
within the service delivery systems. The
60-day notice published on November
27, 2017 (Vol. 82, No. 226).
This new ICR is being developed to
replace the existing ICR (OMB control
number 0915–0323), for which HRSA
has collected RSR data since 2009. As
more recipients fully fund services
using other RWHAP-related funding
streams, such as pharmacy rebate
dollars, HRSA HAB receives less
information on RWHAP eligible clients,
which reduces HRSA HAB’s ability to
measure the investment and impact of
all RWHAP-related expenditures at state
E:\FR\FM\29OCN1.SGM
29OCN1
54364
Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
and local levels. Revisions in this new
package will account for the funding
decisions made by recipients and will
now include reporting of eligible clients
who receive HRSA RWHAP allowable
services using RWHAP-related funding
(e.g., program income and pharmacy
rebates) starting with the 2019 RSR,
submitted in March 2020. The proposed
change may require recipients to collect
additional data, either on clients or
outcome measures. To decrease burden
in collecting these additional data,
HRSA HAB proposes a phased approach
to allow time for recipients to expand
their systems to collect the data. HRSA
HAB expects that some recipients
already receive this information from
subrecipients for monitoring purposes.
However, with respect to those
subrecipients who are not collecting
these data, such subrecipients would be
required to collect additional client
level information.
In an effort to increase HRSA HAB’s
ability to understand coverage areas for
RWHAP provider sites and the
population that provider sites serve, this
new ICR will ask recipients to provide
zip codes for RWHAP clients receiving
outpatient ambulatory health services,
in addition to asking them to list the
number of unduplicated clients residing
in each zip code.
Additional modifications will be
made to several variables within the
client report to reduce burden, improve
data quality, and align data collection
efforts with Policy Clarification Notice
Ryan White HIV/AIDS Program
Services: Eligible Individuals and
Allowable Uses of Funds (PCN 16–02).
These modifications will include the
removal of 14 variables in the Client,
Service Provider, and Recipient Reports.
HRSA will continue to collect and
report the client-level data elements
supplied by the existing ICR through
2019. In 2019, HRSA will discontinue
use of the existing ICR and will collect
and report on the data elements defined
in the new ICR. While there will be no
overlap in the data collected and
reported between the existing and new
ICR, HRSA is submitting this new ICR
in tandem with the existing ICR to allow
recipients the ability to make
modifications to their RSR systems
between the two reporting periods. This
will allow recipients to continue
collecting and reporting on both the old
and new variables without interruption.
Likely Respondents: RWHAP Part A,
Part B, Part C, and Part D recipients and
their subrecipients.
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 (1) review instructions; (2)
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; (3) train
personnel and respond to a collection of
information; (4) search data sources; (5)
complete and review the collection of
information; and (6) 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
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Form name
RWHAP Parts A, B, C, and D Grant
recipients.
Recipient Report ..
475
1
475
11
5,225
Service Provider
Report.
Client Report .......
2,079
1
2,079
13
27,027
1,607
1
1,607
113
181,591
..............................
4,161
........................
4,161
........................
213,843
Total ............................................
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before December 28,
2018.
[FR Doc. 2018–23547 Filed 10–26–18; 8:45 am]
BILLING CODE 4165–15–P
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0302–60D
and project title for reference, to
Sherrette.funn@hhs.gov, or call the
Reports Clearance Officer at 202–795–
7714.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0302]
Agency Information Collection
Request. 60-Day Public Comment
Request
amozie on DSK3GDR082PROD with NOTICES1
Total
responses
Type of respondents
AGENCY:
ACTION:
Office of the Secretary, HHS.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
SUMMARY:
VerDate Sep<11>2014
17:48 Oct 26, 2018
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
SUPPLEMENTARY INFORMATION:
Notice.
Jkt 247001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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.
Title of the Collection: Medical
Reserve Corps Unit Profile and Reports.
Type of Collection: Revision.
OMB No. 0990–0302.
Abstract: Medical Reserve Corps
Units are currently located in 889
communities across the United States
and represent a resource of 188,229
volunteers. In order to continue to
support MRC units detailed information
about the MRC units, including unit
demographics, contact information
(regular and emergency), volunteer
numbers and information about unit
activities is needed by the MRC
E:\FR\FM\29OCN1.SGM
29OCN1
]]>Agencies
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54363-54364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23547]
-----------------------------------------------------------------------
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 Client-Level Data Reporting System, OMB No. 0906-xxxx-NEW
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with 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 November
28, 2018.
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: Client-Level Data Reporting
System.
OMB No. 0906-xxxx-NEW.
Abstract: The Ryan White HIV/AIDS Program's (RWHAP) client-level
data reporting system, entitled the RWHAP Services Report or the Ryan
White Services Report (RSR), is designed to collect information from
grant recipients, as well as their subrecipients, funded under Parts A,
B, C, and D of the RWHAP statute. The RWHAP, authorized under Title
XXVI of the Public Health Service Act, as amended by the Ryan White
HIV/AIDS Treatment Extension Act of 2009, is administered by HRSA HIV/
AIDS Bureau (HAB). The HRSA RWHAP funds and coordinates with cities,
states, and local clinics/community-based organizations to deliver
efficient and effective HIV care, treatment, and support to low-income
people living with HIV (PLWH).
Need and Proposed Use of the Information: The RWHAP statute
requires HRSA to monitor the administration of grant funds, allocation
of funding, service utilization, and client demographic and HIV health
outcome data (e.g., viral suppression). The RSR collects data on the
characteristics of RWHAP-funded recipients, subrecipients, and the
patients or clients served. The RSR system consists of two online data
forms: the Recipient Report and the Service Provider Report; and the
Client Report, which is a data file containing the client-level data
elements. Data are submitted annually. The RWHAP statute specifies the
importance of recipient accountability and linking performance to
budget. The RSR is used to ensure recipient compliance with the
statute, including evaluating the effectiveness of programs, monitoring
recipient and subrecipient performance, and informing annual reports to
Congress. Information collected through the RSR is critical for HRSA,
state/local grant recipients, and individual service providers to
understand existing HIV-related service delivery systems and the
clients served. Information in the RSR is used to assess trends in
service utilization and HIV health outcomes for clients served. Data
from the RSR is analyzed to identify disparities and gaps within the
service delivery systems. The 60-day notice published on November 27,
2017 (Vol. 82, No. 226).
This new ICR is being developed to replace the existing ICR (OMB
control number 0915-0323), for which HRSA has collected RSR data since
2009. As more recipients fully fund services using other RWHAP-related
funding streams, such as pharmacy rebate dollars, HRSA HAB receives
less information on RWHAP eligible clients, which reduces HRSA HAB's
ability to measure the investment and impact of all RWHAP-related
expenditures at state
[[Page 54364]]
and local levels. Revisions in this new package will account for the
funding decisions made by recipients and will now include reporting of
eligible clients who receive HRSA RWHAP allowable services using RWHAP-
related funding (e.g., program income and pharmacy rebates) starting
with the 2019 RSR, submitted in March 2020. The proposed change may
require recipients to collect additional data, either on clients or
outcome measures. To decrease burden in collecting these additional
data, HRSA HAB proposes a phased approach to allow time for recipients
to expand their systems to collect the data. HRSA HAB expects that some
recipients already receive this information from subrecipients for
monitoring purposes. However, with respect to those subrecipients who
are not collecting these data, such subrecipients would be required to
collect additional client level information.
In an effort to increase HRSA HAB's ability to understand coverage
areas for RWHAP provider sites and the population that provider sites
serve, this new ICR will ask recipients to provide zip codes for RWHAP
clients receiving outpatient ambulatory health services, in addition to
asking them to list the number of unduplicated clients residing in each
zip code.
Additional modifications will be made to several variables within
the client report to reduce burden, improve data quality, and align
data collection efforts with Policy Clarification Notice Ryan White
HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of
Funds (PCN 16-02). These modifications will include the removal of 14
variables in the Client, Service Provider, and Recipient Reports. HRSA
will continue to collect and report the client-level data elements
supplied by the existing ICR through 2019. In 2019, HRSA will
discontinue use of the existing ICR and will collect and report on the
data elements defined in the new ICR. While there will be no overlap in
the data collected and reported between the existing and new ICR, HRSA
is submitting this new ICR in tandem with the existing ICR to allow
recipients the ability to make modifications to their RSR systems
between the two reporting periods. This will allow recipients to
continue collecting and reporting on both the old and new variables
without interruption.
Likely Respondents: RWHAP Part A, Part B, Part C, and Part D
recipients and their subrecipients.
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 (1) review
instructions; (2) 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; (3) train personnel and respond to a collection
of information; (4) search data sources; (5) complete and review the
collection of information; and (6) 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
Type of respondents Form name respondents responses per responses response (in hours
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
RWHAP Parts A, B, C, and D Grant Recipient Report............ 475 1 475 11 5,225
recipients.
Service Provider Report..... 2,079 1 2,079 13 27,027
Client Report............... 1,607 1 1,607 113 181,591
-------------------------------------------------------------------------------
Total................................. ............................ 4,161 .............. 4,161 .............. 213,843
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-23547 Filed 10-26-18; 8:45 am]
BILLING CODE 4165-15-P
