Agency Information Collection Activities: Proposed Collection: Public Comment Request, 42506-42507 [2015-17552]
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 15, 2015, from 8:30
a.m. to 2:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
For those unable to attend in person,
the meeting will also be webcast and
will be available at the following link
https://collaboration.fda.gov/
cbervrbpac0915/.
Contact Person: Sujata Vijh or Denise
Royster, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6128, Silver Spring,
MD 20993–0002, 240–402–7107 or 240–
402–8158, or FDA Advisory Committee
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AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On September 15, 2015, from
8:30 a.m. to 2:30 p.m., the committee
will meet in open session to discuss and
make recommendations on the safety
and immunogenicity of Seasonal
Trivalent Influenza Vaccine, Surface
Antigen, Inactivated, Adjuvanted with
MF59 (FLUAD) manufactured by
Novartis.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
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20:59 Jul 16, 2015
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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. Written
submissions may be made to the contact
person on or before September 8, 2015.
Oral presentations from the public will
be scheduled between approximately
12:15 p.m. to 1:15 p.m. on September
15, 2015. Those individuals interested
in making formal oral presentations
should notify the contact person and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on
or before August 31, 2015. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by September 1, 2015.
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FDA welcomes the attendance of the
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require special accommodations due to
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least 7 days in advance of the meeting.
FDA is committed to the orderly
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AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17559 Filed 7–16–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (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 Information
Collection Request must be received no
later than September 15, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, Parklawn
Building, 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 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:
Bureau of Health Workforce (BHW)
Uniform Data System (UDS).
OMB No. 0915–XXXX—NEW.
Abstract: The UDS is the Bureau of
Primary Health Care’s (BPHC’s) annual
reporting system for HRSA-supported
health centers. The UDS is a program
performance reporting system that
tracks a variety of information,
including patient demographics,
services provided, staffing, clinical
indicators, utilization rates, costs, and
revenues. BHW proposes that HRSA
Nurse Managed Health Clinic (NMHC)
grantees and Interprofessional
Collaborative Practice (IPCP) program
cooperative agreement awardees also
submit data into the UDS.
SUMMARY:
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
This request is to expand the UDS
data reporting resource to the BHW
NMHC grantees and IPCP program
cooperative agreement awardees.
Calendar year data would be submitted
annually to enable BHW to track clinical
practice and patient outcome data. The
data collection is limited to NMHC and
IPCP grantees and cooperative
agreement awardees because of the
similarities these care models share
with health centers; therefore, the use of
the pre-existing infrastructure will
enable HRSA to populate the data set
with additional sources, making the
resource more robust.
Need and Proposed Use of the
Information: HRSA collects UDS data
which are used to ensure compliance
with legislative and regulatory
requirements, improve grantee and
cooperative agreement awardee
performance and operations, and report
overall program accomplishments. BHW
Interprofessional Collaborative Practice
(IPCP) program cooperative agreement
awardees.
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 Information
Collection Request are summarized in
the table below.
proposes to collect core data elements
that include patient demographics,
healthcare services, clinical indicators
and outcomes, provider utilization, and
costs. BHW will use the patient and
provider-level data to determine the
impact of healthcare services on patient
outcomes. The data will also enable
BHW to establish or expand targeted
programs and identify effective services
and interventions to improve the health
of underserved communities and
vulnerable populations. In addition, the
UDS data are useful to BHW grantees
and cooperative agreement awardees for
performance and operations
improvement, patient forecasts,
identification of trends/patterns,
implication of access barriers, and cost
analysis to support long-term
sustainability.
Likely Respondents: The respondents
will be HRSA BHW Nurse Managed
Health Clinic (NMHC) grantees and
Number of
respondents
Total estimated annualized hours: Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Universal Report ..................................................................
Grant Report ........................................................................
81
81
1
1
81
81
170
22
13,770
1,782
Total ..............................................................................
162
........................
........................
........................
15,552
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
or other forms of information
technology to minimize the information
collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–17552 Filed 7–16–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK5SPTVN1PROD with NOTICES
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.
AGENCY:
ACTION:
Notice.
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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 August 17, 2015.
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 Access to Emergency Devices
Grant Program OMB No. 0915–xxxx—
NEW.
SUMMARY:
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Abstract: This program is authorized
by the Public Health Improvement Act
Title IV—Cardiac Arrest Survival Act of
2000, Subtitle B—Rural Access to
Emergency Devices, Section 413, (42
U.S.C. 254c (Note) and the Consolidated
and Further Continuing Appropriations
Act (Pub. L. 113–235). The purpose of
this grant program is to: (1) Purchase
automated external defibrillators (AEDs)
that have been approved, or cleared for
marketing, by the Food and Drug
Administration; (2) provide defibrillator
and basic life support training in AED
usage through the American Heart
Association, the American Red Cross, or
other nationally recognized training
courses; and (3) place the AEDs in rural
communities with local organizations.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the program and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act (GPRA) of 1993 (Pub. L.
103–62). These measures cover the
principal topic areas of interest to the
Federal Office of Rural Health Policy,
including: (a) The number of counties
served by the program; (b) the number
of AEDs purchased and placed and the
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]]>Agencies
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42506-42507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17552]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (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 Information Collection Request must be received
no later than September 15, 2015.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10C-03, Parklawn
Building, 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 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: Bureau of Health Workforce
(BHW) Uniform Data System (UDS).
OMB No. 0915-XXXX--NEW.
Abstract: The UDS is the Bureau of Primary Health Care's (BPHC's)
annual reporting system for HRSA-supported health centers. The UDS is a
program performance reporting system that tracks a variety of
information, including patient demographics, services provided,
staffing, clinical indicators, utilization rates, costs, and revenues.
BHW proposes that HRSA Nurse Managed Health Clinic (NMHC) grantees and
Interprofessional Collaborative Practice (IPCP) program cooperative
agreement awardees also submit data into the UDS.
[[Page 42507]]
This request is to expand the UDS data reporting resource to the
BHW NMHC grantees and IPCP program cooperative agreement awardees.
Calendar year data would be submitted annually to enable BHW to track
clinical practice and patient outcome data. The data collection is
limited to NMHC and IPCP grantees and cooperative agreement awardees
because of the similarities these care models share with health
centers; therefore, the use of the pre-existing infrastructure will
enable HRSA to populate the data set with additional sources, making
the resource more robust.
Need and Proposed Use of the Information: HRSA collects UDS data
which are used to ensure compliance with legislative and regulatory
requirements, improve grantee and cooperative agreement awardee
performance and operations, and report overall program accomplishments.
BHW proposes to collect core data elements that include patient
demographics, healthcare services, clinical indicators and outcomes,
provider utilization, and costs. BHW will use the patient and provider-
level data to determine the impact of healthcare services on patient
outcomes. The data will also enable BHW to establish or expand targeted
programs and identify effective services and interventions to improve
the health of underserved communities and vulnerable populations. In
addition, the UDS data are useful to BHW grantees and cooperative
agreement awardees for performance and operations improvement, patient
forecasts, identification of trends/patterns, implication of access
barriers, and cost analysis to support long-term sustainability.
Likely Respondents: The respondents will be HRSA BHW Nurse Managed
Health Clinic (NMHC) grantees and Interprofessional Collaborative
Practice (IPCP) program cooperative agreement awardees.
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 Information Collection Request are summarized in the table below.
----------------------------------------------------------------------------------------------------------------
Average
Total estimated annualized Number of Number of Total burden per Total burden
hours: Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Universal Report................ 81 1 81 170 13,770
Grant Report.................... 81 1 81 22 1,782
-------------------------------------------------------------------------------
Total....................... 162 .............. .............. .............. 15,552
----------------------------------------------------------------------------------------------------------------
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 or other forms of information technology to
minimize the information collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-17552 Filed 7-16-15; 8:45 am]
BILLING CODE 4165-15-P
