Risk Communications Advisory Committee; Notice of Meeting, 11797-11798 [2014-04523]
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Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
submissions may be made to the contact
person on or before March 7, 2014. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. on March 14, 2014.
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 February 27, 2014. 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
March 3, 2014.
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 physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov or 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
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: February 25, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–04522 Filed 2–28–14; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Risk Communications Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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: Risk
Communications 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 May 5 and 6, 2014, from 9 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Entrance for the public
meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Contact Person: Luis G. Bravo, Risk
Communication Staff, Office of
Planning, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3274, Silver Spring,
MD 20993–0002, 240–402–5274, email
Luis.Bravo@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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
11797
information line to learn about possible
modifications before coming to the
meeting.
If you are unable to join us in person,
we encourage you to watch the free Web
cast. Visit the Risk Communication
Advisory Committee Web site at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
RiskCommunicationAdvisory
Committee/default.htm. The link will
become active shortly before the open
session begins at 9 a.m.
Agenda: On May 5 and 6, 2014, the
committee will meet to discuss methods
for identifying the impact and
increasing the reach of communications
on topics of interest to consumers. The
discussion will also address how FDA
can evaluate whether its Consumer
Updates (https://www.fda.gov/
ForConsumers/ConsumerUpdates/
default.htm) are reaching the targeted
population, and whether they are
increasing awareness and understanding
of the key risk messages. The discussion
will also assess whether the
communications are having the
intended impact on knowledge,
behaviors and/or outcomes.
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 28, 2014. 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 18,
2014. 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
E:\FR\FM\03MRN1.SGM
03MRN1
11798
Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
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 21, 2014.
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 physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Luis G. Bravo
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/Advisory
Committees/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).
Dated: February 24, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–04523 Filed 2–28–14; 8:45 am]
BILLING CODE 4160–01–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, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
Secretary of the HHS) of the OPTN as
a condition of participation in Medicare
and Medicaid for the hospital. Section
1138 contains a similar provision for the
organ procurement organizations
(OPOs) and makes membership in the
OPTN and compliance with its
operating rules and requirements (that
have been approved by the Secretary),
including those relating to data
collection, mandatory for all transplant
hospitals and OPOs. These applications
are developed to prompt submission of
all the information required to make
such membership approval decisions. In
addition, hospitals wishing to obtain
designation for particular (e.g., organ
specific) transplant programs must
submit applications to the OPTN.
Likely Respondents: Parties seeking
initial OPTN membership approval and
then maintenance of the existing OPTN
approval. Applicants will include: every
hospital seeking to perform organ
transplants; every non-profit
organization seeking to become an organ
procurement organization; and every
medical laboratory seeking to become a
histocompatibility laboratory. In
addition, there are other OPTN
membership categories for organizations
and individuals who want to participate
in the organ transplant system and they
too are required to fill out an
appropriate application.
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.
(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:
Organ Procurement and Transplantation
Network (OPTN) Application Form
OMB No.: 0915–0184 ¥ Revision
Abstract: This is a request for OMB
approval for revisions of the application
documents used to collect information
for determining if the interested party is
compliant with membership and
transplant program requirements
contained in the Final Rule Governing
the Operation of the Organ Procurement
and Transplantation Network (OPTN),
‘‘the OPTN final rule’’.
Need and Proposed Use of the
Information: Membership in the OPTN
is determined by submission of
application materials to the OPTN (not
to HRSA) demonstrating that the
applicant meets all required criteria for
membership and transplant program
requirements and will agree to comply
with all applicable provisions of the
National Organ Transplant Act, as
amended, 42 U.S.C. 273, et seq. Section
1138 of the Social Security Act, as
amended, 42 U.S.C. 1320b-8 (section
1138) requires that hospitals in which
transplants are performed be members
of, and abide by, the rules and
requirements (as approved by the
mstockstill on DSK4VPTVN1PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
A
B
B
B
B
B
Number of
responses
per
respondent
8
94
73
56
43
50
1
2
2
2
2
2
New Transplant Member/Program Application—General .............
Kidney (KI) Designated Program Application ................................
Liver (LI) Designated Program Application ....................................
Pancreas (PA) Designated Program Application ..........................
Heart (HR) Designated Program Application ................................
Lung (LU) Designated Program Application ..................................
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19:40 Feb 28, 2014
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Frm 00049
Fmt 4703
Sfmt 4703
Total
responses
E:\FR\FM\03MRN1.SGM
8
188
146
112
86
100
03MRN1
Average
burden per
response
(in hours)
8
4
4
4
4
4
Total burden
hours
64
752
584
448
344
400
Agencies
[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11797-11798]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04523]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Risk Communications Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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: Risk Communications 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 May 5 and 6, 2014, from
9 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Entrance for the public meeting participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Luis G. Bravo, Risk Communication Staff, Office of
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, rm. 3274, Silver Spring, MD 20993-0002, 240-402-5274, email
Luis.Bravo@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.
If you are unable to join us in person, we encourage you to watch
the free Web cast. Visit the Risk Communication Advisory Committee Web
site at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/default.htm. The link will become active shortly before the open
session begins at 9 a.m.
Agenda: On May 5 and 6, 2014, the committee will meet to discuss
methods for identifying the impact and increasing the reach of
communications on topics of interest to consumers. The discussion will
also address how FDA can evaluate whether its Consumer Updates (https://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm) are reaching the
targeted population, and whether they are increasing awareness and
understanding of the key risk messages. The discussion will also assess
whether the communications are having the intended impact on knowledge,
behaviors and/or outcomes.
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 28, 2014. 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 18, 2014. 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
[[Page 11798]]
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 21, 2014.
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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Luis G. Bravo 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).
Dated: February 24, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-04523 Filed 2-28-14; 8:45 am]
BILLING CODE 4160-01-P