Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 11815-11816 [2016-04984]
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Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices 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 Wednesday, April 20, 2016,
from 8 a.m. to 6 p.m.
Location: Hilton Washington, DC/
North, Salons A, B, C, and D, 620 Perry
Pkwy., Gaithersburg, MD 20877. The
hotel telephone number is 301–977–
8900.
Contact Person: S.J. Anderson, Center
for Devices and Radiological Health,
Food and Drug Administration, Bldg.
66, rm. 1643, 10903 New Hampshire
Ave., Silver Spring, MD 20993, email:
Sara.Anderson@fda.hhs.gov, 301 796–
7047, 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.
Agenda: The Committee will discuss,
make recommendations, and vote on the
premarket approval application for the
Cartiva Synthetic Cartilage Implant
(SCI), sponsored by Cartiva, Inc. The
Cartiva Synthetic Cartilage Implant
(SCI) is an organic polymer-based
biomaterial to mimic biologic cartilage.
The device is to be indicated for
treatment of degenerative and posttraumatic arthritis in the first
metatarsophalangeal joint in the
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presence of good bone stock along with
the following clinical conditions: hallux
valgus or hallux limitus, hallux rigidus,
and an unstable or painful
metatarsophalangeal joint.
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 April 13, 2016. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 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 April 5,
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 April 6, 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 AnnMarie
Williams at 301–796–5966 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
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11815
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 29, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–04927 Filed 3–4–16; 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
ACTION:
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
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.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at (301)
443–1984.
DATES: Deadline: Comments on this ICR
should be received no later than April
6, 2016.
ADDRESSES: Submit your comments to
the desk officer for HRSA, either by
email to OIRA_submission@
omb.eop.gov or by fax to 202–395–5806.
Please direct all correspondence to the
‘‘attention of the desk officer for HRSA.’’
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Center Controlled Networks
(OMB No. 0915–0360) Extension.
Abstract: One goal of the Health
Resources and Services Administration
(HRSA) is to ensure that all Health
Center Program grantees effectively
implement health information
technology (HIT) systems that enable all
providers to adopt and implement HIT,
including Electronic Health Records
(EHRs); to become meaningful users of
EHRs and use HIT systems to increase
access to care, improve quality of care,
and reduce the costs of care delivered.
SUMMARY:
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11816
Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
The Health Center Controlled Network
(HCCN) Program serves as a major
component of HRSA’s HIT initiative to
support these goals. The HCCN model
focuses on the integration of certain
functions and the sharing of skills,
resources, and data to improve health
center operations and care provision,
and generating efficiencies and
economies of scale. Through this grant,
HCCNs will provide support for the
adoption and implementation of HIT,
including meaningful use of EHRs, to
improve the quality of care provided by
existing Health Center Program grantees
(i.e., Section 330 funded health centers)
by engaging in the following program
components:
• Adoption and Implementation:
Assist participating health centers with
effectively adopting and implementing
certified EHR technology.
• Meaningful Use: Support
participating health centers in meeting
Meaningful Use requirements and
accessing incentive payments under the
Medicare and Medicaid Electronic
Health Records Incentive Programs.
• Quality Improvement (QI): Advance
participating health centers’ QI
initiatives to improve clinical and
operational quality, including their
obtaining of Patient Centered Medical
Home (PCMH) recognition.
HRSA collects and evaluates network
outcome measures. HRSA requires that
HCCNs report such measures to HRSA
in annual work plan updates as part of
their annual, non-competing
continuation progress reports through
an electronic reporting system. The
work plan includes information on
grantees’ plans and progress on the
following:
• Adoption and Implementation of
HIT (including EHR);
• Attainment of Meaningful Use
Requirements; and
• Improvement of quality measures
(e.g., Healthy People 2020 clinical
quality measures, PCMH recognition
status, etc.).
The annual, non-competing
continuation progress reports describe
each grantee’s progress in achieving key
activity goals such as quality
improvement, data access and exchange,
efficiency and effectiveness of network
services, and the ability to track and
monitor patient outcomes, as well as
emerging needs, challenges and barriers
encountered customer satisfaction, and
Responses
per
respondent
Number of
respondents
Form name
plans to meet goals for the next year.
Grantees submit their work plan
updates and annual, non-competing
continuation progress reports each fiscal
year of the grant; the submission and
subsequent HRSA approval of each
report triggers the budget period
renewal and release of each subsequent
year of funding.
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.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Work Plan Update ..............................................................
Annual Progress Report ....................................................
43
43
1
1
43
43
10.9
44.5
468.7
1913.5
Total ............................................................................
86
..........................
........................
........................
2382.2
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–04984 Filed 3–4–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK3SPTVN1PROD with NOTICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
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18:37 Mar 04, 2016
Jkt 238001
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Bioreactors for Reparative Medicine (STTR).
Date: March 24, 2016.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7180, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Tony L Creazzo, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892–7924, 301–435–
0725, creazzotl@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Bioreactors for Reparative Medicine (SBIR).
Date: March 24, 2016.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7180, Bethesda, MD
20892, (Telephone Conference Call).
PO 00000
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Contact Person: Tony L Creazzo, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892–7924, 301–435–
0725, creazzotl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: March 1, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–04915 Filed 3–4–16; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11815-11816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04984]
-----------------------------------------------------------------------
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
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and
Services Administration (HRSA) will submit an Information Collection
Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests
submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443-1984.
DATES: Deadline: Comments on this ICR should be received no later than
April 6, 2016.
ADDRESSES: Submit your comments to the desk officer for HRSA, either by
email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. Please
direct all correspondence to the ``attention of the desk officer for
HRSA.''
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Health Center Controlled
Networks (OMB No. 0915-0360) Extension.
Abstract: One goal of the Health Resources and Services
Administration (HRSA) is to ensure that all Health Center Program
grantees effectively implement health information technology (HIT)
systems that enable all providers to adopt and implement HIT, including
Electronic Health Records (EHRs); to become meaningful users of EHRs
and use HIT systems to increase access to care, improve quality of
care, and reduce the costs of care delivered.
[[Page 11816]]
The Health Center Controlled Network (HCCN) Program serves as a major
component of HRSA's HIT initiative to support these goals. The HCCN
model focuses on the integration of certain functions and the sharing
of skills, resources, and data to improve health center operations and
care provision, and generating efficiencies and economies of scale.
Through this grant, HCCNs will provide support for the adoption and
implementation of HIT, including meaningful use of EHRs, to improve the
quality of care provided by existing Health Center Program grantees
(i.e., Section 330 funded health centers) by engaging in the following
program components:
Adoption and Implementation: Assist participating health
centers with effectively adopting and implementing certified EHR
technology.
Meaningful Use: Support participating health centers in
meeting Meaningful Use requirements and accessing incentive payments
under the Medicare and Medicaid Electronic Health Records Incentive
Programs.
Quality Improvement (QI): Advance participating health
centers' QI initiatives to improve clinical and operational quality,
including their obtaining of Patient Centered Medical Home (PCMH)
recognition.
HRSA collects and evaluates network outcome measures. HRSA requires
that HCCNs report such measures to HRSA in annual work plan updates as
part of their annual, non-competing continuation progress reports
through an electronic reporting system. The work plan includes
information on grantees' plans and progress on the following:
Adoption and Implementation of HIT (including EHR);
Attainment of Meaningful Use Requirements; and
Improvement of quality measures (e.g., Healthy People 2020
clinical quality measures, PCMH recognition status, etc.).
The annual, non-competing continuation progress reports describe
each grantee's progress in achieving key activity goals such as quality
improvement, data access and exchange, efficiency and effectiveness of
network services, and the ability to track and monitor patient
outcomes, as well as emerging needs, challenges and barriers
encountered customer satisfaction, and plans to meet goals for the next
year. Grantees submit their work plan updates and annual, non-competing
continuation progress reports each fiscal year of the grant; the
submission and subsequent HRSA approval of each report triggers the
budget period renewal and release of each subsequent year of funding.
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.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form name respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Work Plan Update............... 43 1 43 10.9 468.7
Annual Progress Report......... 43 1 43 44.5 1913.5
--------------------------------------------------------------------------------
Total...................... 86 ............... .............. .............. 2382.2
----------------------------------------------------------------------------------------------------------------
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-04984 Filed 3-4-16; 8:45 am]
BILLING CODE 4165-15-P
