Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 76363-76364 [2016-26402]
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Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency sponsored
intramural and extramural scientific
research programs. The meeting will be
open to the public.
DATES: The meeting will be held on
November 15, 2016, from 8:30 a.m. until
5 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, Section C), Silver Spring,
MD 20993. For those unable to attend in
person, the meeting will also be Web
cast. The link for the Web cast is
available at https://
collaboration.fda.gov/sbm1116/.
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 FURTHER INFORMATION CONTACT:
Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver Spring,
MD 20993, 301–796–4769,
rakesh.raghuwanshi@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/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.
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Agenda: The Science Board will hear
about: (1) The Center for Biologics
Evaluation and Research’s strategic
goals for regulatory science; (2) a
progress update on FDA’s Opioid
Action Plan and the Bovine Heparin
Initiative; (3) a response from the Office
of Scientific Professional Development
to the Science Board’s report on the
Commissioner’s Fellowship Program; (4)
a report from the Scientific Engagements
Subcommittee; (5) and a report from the
Food Emergency Response Network
Cooperative Agreement Program
Evaluation Subcommittee.
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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
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 November 8, 2016.
Oral presentations from the public will
be scheduled between approximately 4
p.m. and 5 p.m. 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
November 2, 2016. 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 November 4, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Rakesh
Raghuwanshi at least 7 days in advance
of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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76363
Dated: October 28, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–26491 Filed 11–1–16; 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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) 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 2,
2016.
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:
Telehealth Outcome Measures OMB No.
0915–0311—Revision.
Abstract: To help carry out its
mission, the Office for the Advancement
of Telehealth (OAT) created a set of
performance measures that grantees use
to evaluate the effectiveness of their
services programs and monitor their
progress through the use of performance
reporting data.
Need and Proposed Use of the
Information: As required by the
Government Performance and Results
Act of 1993, all federal agencies must
develop strategic plans describing their
overall goal and objectives. HRSA’s
SUMMARY:
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76364
Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
Federal Office of Rural Health Policy
(FORHP), OAT, has worked with its
grantees to develop performance
measures to be used to evaluate and
monitor the progress of the grantees.
Grantee goals are as follows: To improve
access to needed services, reduce rural
practitioner isolation, improve health
system productivity and efficiency, and
improve patient outcomes. In each of
these categories, specific indicators
were designed and are reported through
a performance monitoring Web site.
These measures cover the principal
topic areas of interest to FORHP. The
data are used for program improvement
and grantees use the data for
performance tracking and improvement.
Revisions include minor additions to
the OAT Performance Improvement
Measurement System (PIMS) to capture
minimal data on access to care,
population demographics, insurance
status, quality improvement and clinical
measures.
Likely Respondents: Telehealth
Network Grantees.
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
Average
burden per
response
(in hours)
Total
responses
Total
burden
hours
PIMS ....................................................................................
200
2
400
7
2,800
Total ..............................................................................
200
........................
400
........................
2,800
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–26402 Filed 11–1–16; 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; Ryan White HIV/
AIDS Program Core Medical Services
Waiver Application Requirements
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 (Section 3506(c)(2)(A) 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 January 3, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
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SUMMARY:
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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 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:
Ryan White HIV/AIDS Program Core
Medical Services Waiver Application
Requirements.
OMB No. 0915–0307—Extension.
Abstract: Title XXVI of the Public
Health Service (PHS) Act, as amended
by the Ryan White HIV/AIDS Treatment
Extension Act of 2009 (Ryan White HIV/
AIDS Program), Part A section 2604(c),
Part B section 2612(b), and Part C
section 2651(c), requires that grantees
expend 75 percent of Parts A, B, and C
funds on core medical services,
including antiretroviral drugs for
individuals with HIV, identified and
eligible under the legislation. For
grantees under Parts A, B, and C to be
exempted from the 75 percent core
medical services requirement, they must
request and receive a waiver from
HRSA, as required in the Act.
On October 25, 2013, HRSA
published revised standards for core
medical services waiver requests in the
Federal Register (78 FR 63990). These
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revised standards allow grant recipients
flexibility to adjust resource allocation
based on the current situation in their
local environment. These standards
ensure that grant recipients receiving
waivers demonstrate the availability of
core medical services, including
antiretroviral drugs, for persons with
HIV served under Title XXVI of the PHS
Act. The core medical services waiver
uniform standard and waiver request
process will apply to Ryan White HIV/
AIDS Program Grant Awards under
Parts A, B, and C of Title XXVI of the
PHS Act. Core medical services waivers
will be effective for a 1-year period that
is consistent with the grant recipient
award period. Grant recipients may
submit a waiver request before the
annual grant application, with the
application, or up to 4 months after the
grant recipient award has been made.
Need and Proposed Use of the
Information: HRSA uses the
documentation submitted in core
medical services waiver requests to
determine if the applicant/grant
recipient meets the statutory
requirements for waiver eligibility
including: (1) No waiting lists for AIDS
Drug Assistance Program services; and
(2) evidence of core medical services
availability within the grant recipient’s
jurisdiction, state, or service area to all
individuals with HIV identified and
eligible under Title XXVI of the PHS
Act. See sections 2604(c)(2), 2612(b)(2),
and 2651(c)(2) of the PHS Act.
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]]>Agencies
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76363-76364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26402]
-----------------------------------------------------------------------
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 (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) 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
2, 2016.
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: Telehealth Outcome Measures
OMB No. 0915-0311--Revision.
Abstract: To help carry out its mission, the Office for the
Advancement of Telehealth (OAT) created a set of performance measures
that grantees use to evaluate the effectiveness of their services
programs and monitor their progress through the use of performance
reporting data.
Need and Proposed Use of the Information: As required by the
Government Performance and Results Act of 1993, all federal agencies
must develop strategic plans describing their overall goal and
objectives. HRSA's
[[Page 76364]]
Federal Office of Rural Health Policy (FORHP), OAT, has worked with its
grantees to develop performance measures to be used to evaluate and
monitor the progress of the grantees. Grantee goals are as follows: To
improve access to needed services, reduce rural practitioner isolation,
improve health system productivity and efficiency, and improve patient
outcomes. In each of these categories, specific indicators were
designed and are reported through a performance monitoring Web site.
These measures cover the principal topic areas of interest to FORHP.
The data are used for program improvement and grantees use the data for
performance tracking and improvement. Revisions include minor additions
to the OAT Performance Improvement Measurement System (PIMS) to capture
minimal data on access to care, population demographics, insurance
status, quality improvement and clinical measures.
Likely Respondents: Telehealth Network Grantees.
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)
----------------------------------------------------------------------------------------------------------------
PIMS............................ 200 2 400 7 2,800
-------------------------------------------------------------------------------
Total....................... 200 .............. 400 .............. 2,800
----------------------------------------------------------------------------------------------------------------
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-26402 Filed 11-1-16; 8:45 am]
BILLING CODE 4165-15-P
