Risk Communication Advisory Committee; Notice of Meeting, 43942-43943 [E8-17304]
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jlentini on PROD1PC65 with NOTICES
43942
Federal Register / Vol. 73, No. 146 / Tuesday, July 29, 2008 / Notices
April 29 to 30, 2008, workshop on
hemoglobin based oxygen carriers; (2)
July 10 to 11, 2008, blood establishment
computer software conference; (3) the
development of an automated Biologics
License Application submission system;
and (4) Draft Guidance for Industry: Requalification Method for Re-entry of
Blood Donors Deferred Because of
Reactive Test Results for Antibody to
Hepatitis B Core Antigen (Anti-HBc).
Following these updates, the Committee
will discuss options for blood donor
screening and re-entry for malaria. 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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee 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 2, 2008.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. and 11:30 a.m. and between
approximately 4 p.m. and 4:30 p.m. on
September 10, 2008, and between
approximately 9:15 a.m. and 9:45 a.m.
and between approximately 1:30 p.m.
and 2 p.m. on September 11, 2008.
Those desiring to make 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
22, 2008. 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 August 25, 2008.
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
VerDate Aug<31>2005
16:12 Jul 28, 2008
Jkt 214001
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 Donald W.
Jehn or Pearline K. Muckelvene 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/oc/advisory/
default.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: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–17359 Filed 7–28–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Risk Communication 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. All attendees should bring some
form of government-issued photo
identification, such as a driver’s license.
Name of Committee: Risk
Communication Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
effective risk communication.
Date and Time: The meeting will be
held on August 14, 2008, from 8 a.m. to
5 p.m. and August 15, 2008, from 8 a.m.
to 2 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Lee L. Zwanziger,
Office of the Commissioner, Office of
Policy, Planning and Preparedness,
Office of Planning (HFP–60), Food and
Drug Administration, 5600 Fishers Lane
(for express delivery: rm 15–22),
Rockville, MD 20857, 301–827–2895,
FAX: 301–827–3285, Food and Drug
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Administration, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
8732112560. Please call the Information
Line for up-to-date information on this
meeting. 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 and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On August 14 and 15, 2008,
the committee will meet for
presentations and discussion of the
scientific basis for translating principles
of risk communication into practice in
situations of emerging and uncertain
risk.
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 or
will be available at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the
appropriate advisory committee 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 August 11, 2008.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on August 14th and
10:30 to 11:30 on August 15th. Those
desiring to make formal oral
presentations should notify the contact
person and should 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 7, 2008. 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
E:\FR\FM\29JYN1.SGM
29JYN1
43943
Federal Register / Vol. 73, No. 146 / Tuesday, July 29, 2008 / Notices
notify interested persons regarding their
request to speak by August 8, 2008.
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 Lee L.
Zwanziger 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/oc/advisory/
default.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: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–17304 Filed 7–28–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Sickle Cell Disease
Treatment Demonstration Program
(SCDTDP), Health Resources and
Services Administration (HRSA): NEW
In 2004 Congress enacted and the
President signed into law Public Law
108–357, the American Jobs Creation
Act of 2004. Section 712 of Public Law
108–357 authorized a demonstration
program for the prevention and
treatment of Sickle Cell Disease. The
legislation was enacted to (1) create an
optional medical assistance program for
individuals with Sickle Cell Diseases for
treatment and education, genetic
counseling and other services to prevent
mortality and decrease morbidity from
Sickle Cell Disease, and (2) create a
demonstration program, the SCDTDP,
under HRSA. The SCDTDP provides
grants to federally-qualified and
nonprofit health care providers to
establish geographically distributed
regional networks that will work with
comprehensive Sickle Cell Disease
centers and community-based support
organizations to provide coordinated,
comprehensive, culturally competent,
Number of
respondents
Form name
Sickle Cell Disease
clients or caregivers.
Sickle Cell Disease
clients or caregivers.
Sickle Cell Disease
clients or caregivers.
Parents of Sickle Cell
Disease clients.
Sickle Cell Disease
clients age 18 and
younger.
Sickle Cell Disease
clients or caregivers.
Utilization Questionnaire (predemonstration).
Utilization Questionnaire (post
demonstration).
SF–36 Health Survey for adults
over 18 years of age.
PedsQL for parents .....................
Total ....................
jlentini on PROD1PC65 with NOTICES
Type of respondent
Total
responses
Hours per
response
Total burden
hours
400
1
400
.75
300
400
1
400
.50
200
280
2
560
.25
140
120
2
240
.25
60
PedsQL for children and adolescents.
100
2
200
.25
50
The Medical Home Family Index
(Health Care Satisfaction).
400
2
800
.25
200
......................................................
500
........................
2,600
........................
950
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
VerDate Aug<31>2005
Responses
per
respondent
and family-centered care to families
with Sickle Cell Disease. In fiscal year
2006, HRSA awarded four, 4-year grants
to the Illinois Sickle Cell Association
Network, Alabama Network for Sickle
Cell Care, Access, Prevention, and
Education, Carolina Partnership for
Sickle Cell Treatment Continuum of
Care, and the Cincinnati Sickle Cell
Network.
Under the authorizing legislation, a
National Coordinating Center (NCC) was
established to (1) collect, coordinate,
monitor, and distribute data, best
practices and findings regarding the
activities of the demonstration program,
(2) identify a model protocol for eligible
entities with respect to the prevention
and treatment of Sickle Cell Disease, (3)
identify educational materials regarding
the prevention and treatment of Sickle
Cell Disease, and (4) prepare a final
report on the efficacy of the
demonstration program based on
evaluation findings.
As part of the evaluation, pre and post
utilization and satisfaction data and
quality of life assessments will be
collected from the demonstration clients
during various phases of their
participation. These data will be
collected through medical record
abstractions and self-report using hard
copy questionnaires and submitted to
the NCC for processing and analysis.
The total burden estimate per
participant is shown below:
16:12 Jul 28, 2008
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the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 73, Number 146 (Tuesday, July 29, 2008)]
[Notices]
[Pages 43942-43943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17304]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Risk Communication 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. All attendees should bring some form of
government-issued photo identification, such as a driver's license.
Name of Committee: Risk Communication Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on effective risk communication.
Date and Time: The meeting will be held on August 14, 2008, from 8
a.m. to 5 p.m. and August 15, 2008, from 8 a.m. to 2 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Lee L. Zwanziger, Office of the Commissioner,
Office of Policy, Planning and Preparedness, Office of Planning (HFP-
60), Food and Drug Administration, 5600 Fishers Lane (for express
delivery: rm 15-22), Rockville, MD 20857, 301-827-2895, FAX: 301-827-
3285, Food and Drug Administration, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 8732112560. Please call the Information Line for up-to-date
information on this meeting. 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
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On August 14 and 15, 2008, the committee will meet for
presentations and discussion of the scientific basis for translating
principles of risk communication into practice in situations of
emerging and uncertain risk.
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 or
will be available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm,
click on the year 2008 and scroll down to the appropriate advisory
committee 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
August 11, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on August 14\th\ and 10:30 to
11:30 on August 15\th\. Those desiring to make formal oral
presentations should notify the contact person and should 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 7, 2008. 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
[[Page 43943]]
notify interested persons regarding their request to speak by August 8,
2008.
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 Lee L. Zwanziger 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/oc/advisory/
default.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: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17304 Filed 7-28-08; 8:45 am]
BILLING CODE 4160-01-S
