Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 18919-18920 [2014-07508]
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Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
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fda.hhs.gov to receive an electronic
copy of the document or send a fax
request to 301–847–8149 to receive a
hard copy. Please use the document
number 1804 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This 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–
3520). The collections of information in
21 CFR part 807, subpart E, have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 814, subpart
B, have been approved under OMB
control number 0910–0231; and the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
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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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(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 within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request 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:
SUMMARY:
Information Collection Request Title:
Rural Health Network Development
Planning Performance Improvement
and Measurement System Database
OMB No. 0915–xxxx—NEW
Abstract: The purpose of the Rural
Health Network Development Planning
(Network Planning) program, authorized
by Section 330A(f) of the Public Health
Service Act, 42 U.S.C. 254c(f), as
amended by section 201, Public Law
107–251 of the Health Care Safety Net
Amendments of 2002, is to assist in the
development of an integrated healthcare
network, if the network participants do
not have a history of collaborative
efforts. The Network Planning program
helps to promote the planning and
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18919
development of health care networks in
order to: (i) Achieve efficiencies; (ii)
expand access to, coordinate, and
improve the quality of essential health
care services; and (iii) strengthen the
rural health care system as a whole.
This program brings together key parts
of a rural health care delivery system,
particularly those entities that may not
have collaborated in the past under a
formal relationship, to work together to
establish and improve local capacity
and coordination of care. This grant
program supports 1 year of planning
with the primary goal of helping
networks create a foundation for their
infrastructure and focusing member
efforts to address important regional or
local community health needs.
Need and Proposed Use of the
Information: Performance measures
were developed to provide routine data
for the program and to enable HRSA to
aggregate program data. These measures
cover the principal topic areas of
interest to the Office of Rural Health
Policy, including: (a) Network
infrastructure; (b) network
collaboration; (c) sustainability; and (d)
network assessment. Several measures
will be used for this program.
Summary of Prior Comments and
Agency Response
A 60-day Federal Register Notice was
published in the Federal Register on
December 5, 2013, Vol. 78, No. 234; pp.
73200–01. There were no comments.
Likely Respondents: The respondents
would be Rural Health Network
Development Planning grant 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 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.
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18920
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices
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
Rural Health Network Development Planning Program
Performance Improvement and Measurement System
Measures ..........................................................................
21
1
21
1
21
Total ..............................................................................
21
1
21
1
21
Dated: March 27, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–07508 Filed 4–3–14; 8:45 am]
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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(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 May 5, 2014.
ADDRESSES: Submit your comments,
including the Information Collection
Request 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:
Client-Level Data Reporting System,
OMB No. 0915–0323—Revision.
Abstract: The Ryan White HIV/AIDS
Program’s client-level data reporting
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SUMMARY:
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system, entitled the Ryan White HIV/
AIDS Program Services Report or the
Ryan White Services Report (RSR), was
created in 2009 by the Health Resources
and Services Administration (HRSA). It
is designed to collect information from
grantees as well as their subcontracted
service providers, funded under Parts A,
B, C, D, and F Minority AIDS Initiative
of Title XXVI of the Public Health
Service Act, as amended by the Ryan
White HIV/AIDS Treatment Extension
Act of 2009 (Ryan White HIV/AIDS
Program). The Ryan White HIV/AIDS
Program provides entities funded by the
program with flexibility to respond
effectively to the changing HIV
epidemic, with an emphasis on
providing life-saving and life-extending
services for people living with HIV
across this country, as well as targeting
resources to areas that have the greatest
needs.
Need and Proposed Use of the
Information: All parts of the Ryan White
HIV/AIDS Program specify HRSA’s
responsibilities in administering grant
funds, allocating funds, evaluating
programs for the populations served,
and improving quality of care. Accurate
records of the providers receiving Ryan
White HIV/AIDS Program funding, the
clients served, and services provided
continue to be critical issues for the
implementation of the legislation and
are necessary for HRSA to fulfill its
responsibilities.
The RSR provides data on the
characteristics of Ryan White HIV/AIDS
Program-funded grantees, their
contracted service providers, and the
clients served with program funds. The
RSR is intended to support clinical
quality management, performance
measurement, service delivery, and
client monitoring at the systems and
client levels. The reporting systems
consist of two online data forms, the
Grantee Report and the Service Provider
Report, as well as a data file containing
the client-level data elements. Data are
submitted annually.
The statute specifies the importance
of grantee accountability and linking
performance to budget. The RSR is used
to ensure compliance with the
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requirements of the statute, to evaluate
the progress of programs, to monitor
grantee and provider performance, and
to meet reporting responsibilities to the
Department, Congress, and OMB.
In addition to meeting the goal of
accountability to Congress, clients,
advocacy groups, and the general
public, information collected through
the RSR is critical for HRSA, state and
local grantees, and individual providers
to assess the status of existing HIV
related service delivery systems,
investigate trends in service utilization,
and identify areas of greatest need.
On April 11, 2012, a memo from the
Secretary of the Department of Health
and Human Services (HHS) directed
HRSA, along with other Health and
Human Services Operating Divisions
(OpDivs) to work together to: (1)
Identify seven common core HIV/AIDS
indicators; (2) develop implementation
plans to deploy these indicators; and (3)
streamline data collection; and reduce
reporting by at least 20 to 25 percent. In
November 2012, the HIV/AIDS
Indicators Implementation Group
(HAIIG) comprised of representatives
from HHS OpDivs, the Department of
Housing and Urban Development, the
Veterans’ Health Administration, and
community partners successfully
identified the required common core
HIV/AIDS indicators.
Revisions to the RSR are required to
support implementation of the core
indicators, streamline data collection,
and reduce reporting burden. Nine data
elements will be deleted from the RSR
and 22 variables will be modified to
reduce reporting burden. Two new data
elements will be added to the RSR: (1)
Date of client’s confidential
confirmatory HIV test with a positive
result in the reporting period; and (2)
date of client’s first outpatient
ambulatory medical care visit after
positive HIV test. These data elements
are required to deploy the Linkage to
HIV Medical Care core indicator.
Another data element, Sex at Birth,
defined to the biological sex assigned to
the client at birth, will be added to align
with variables collected by other HHS
OpDivs.
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]]>Agencies
[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Pages 18919-18920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07508]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(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 within 30 days of this
notice.
ADDRESSES: Submit your comments, including the Information Collection
Request 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: Rural Health Network Development
Planning Performance Improvement and Measurement System Database
OMB No. 0915-xxxx--NEW
Abstract: The purpose of the Rural Health Network Development
Planning (Network Planning) program, authorized by Section 330A(f) of
the Public Health Service Act, 42 U.S.C. 254c(f), as amended by section
201, Public Law 107-251 of the Health Care Safety Net Amendments of
2002, is to assist in the development of an integrated healthcare
network, if the network participants do not have a history of
collaborative efforts. The Network Planning program helps to promote
the planning and development of health care networks in order to: (i)
Achieve efficiencies; (ii) expand access to, coordinate, and improve
the quality of essential health care services; and (iii) strengthen the
rural health care system as a whole. This program brings together key
parts of a rural health care delivery system, particularly those
entities that may not have collaborated in the past under a formal
relationship, to work together to establish and improve local capacity
and coordination of care. This grant program supports 1 year of
planning with the primary goal of helping networks create a foundation
for their infrastructure and focusing member efforts to address
important regional or local community health needs.
Need and Proposed Use of the Information: Performance measures were
developed to provide routine data for the program and to enable HRSA to
aggregate program data. These measures cover the principal topic areas
of interest to the Office of Rural Health Policy, including: (a)
Network infrastructure; (b) network collaboration; (c) sustainability;
and (d) network assessment. Several measures will be used for this
program.
Summary of Prior Comments and Agency Response
A 60-day Federal Register Notice was published in the Federal
Register on December 5, 2013, Vol. 78, No. 234; pp. 73200-01. There
were no comments.
Likely Respondents: The respondents would be Rural Health Network
Development Planning grant 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 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.
[[Page 18920]]
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
----------------------------------------------------------------------------------------------------------------
Rural Health Network Development 21 1 21 1 21
Planning Program Performance
Improvement and Measurement
System Measures................
-------------------------------------------------------------------------------
Total....................... 21 1 21 1 21
----------------------------------------------------------------------------------------------------------------
Dated: March 27, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-07508 Filed 4-3-14; 8:45 am]
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