Pediatric Ethics Subcommittee; Notice of Meeting, 67525-67526 [E8-27118]
Download as PDF
<![CDATA[
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 221 / Friday, November 14, 2008 / Notices
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 December 2, 2008.
Oral presentations from the public will
be scheduled between approximately 4
p.m. and 5 p.m. on December 9, 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
November 24, 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 November 25, 2008.
Electronic comments should be
submitted to https://
www.regulations.gov. Select Docket No.
FDA–2008–N–0578 entitled ‘‘G–CSF
Stimulated Bone Marrow IRB Referral’’
and follow the prompts to submit your
statement. Written comments should be
submitted to Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Please
submit comments by 4:30 p.m. on
December 2, 2008. Received comments
may be viewed at https://
www.regulations.gov, or may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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 Carlos Pena
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.
VerDate Aug<31>2005
16:29 Nov 13, 2008
Jkt 217001
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–27117 Filed 11–13–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0578]
Pediatric Ethics Subcommittee; 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: Pediatric Ethics
Subcommittee of the Pediatric Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Pediatric
Advisory Committee on FDA, and
certain Department of Health and
Human Services (DHHS) regulatory
issues.
Date and Time: The meeting will be
held on Tuesday, December 9, 2008,
from 9 a.m. to 3 p.m.
Location: The Legacy Hotel & Meeting
Centre, 1775 Rockville Pike, Rockville,
MD 20852.
˜
Contact Person: Carlos Pena, Office of
Science and Health Coordination, Office
of the Commissioner (HF–33), Food and
Drug Administration, 5600 Fishers Lane
(for express delivery, rm. 14B–08),
Rockville, MD 20857, 301–827–3340, or
˜
by e-mail: carlos.pena@fda.hhs.gov or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
8732310001. 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 December 9, 2008, the
Pediatric Ethics Subcommittee
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
67525
(subcommittee) of the Pediatric
Advisory Committee will meet to
discuss a referral by an Institutional
Review Board (IRB) of a clinical
investigation that involves both an FDA
regulated product and research
involving children as subjects that is
conducted or supported by DHHS. The
clinical investigation is entitled
‘‘Children’s Oncology Group Protocol
ASCT0631: A Phase III Randomized
Trial of Granulocyte Colony Stimulating
Factor (G–CSF) Stimulated Bone
Marrow vs. Conventional Bone Marrow
as a Stem Cell Source in Matched
Sibling Donor Transplantation.’’
Because the clinical investigation would
be regulated by FDA, and conducted or
supported by the DHHS, both FDA and
the Office for Human Research
Protections, DHHS, will participate in
the meeting.
After presentation of an overview of
the IRB referral process, background
information on the use of G–CSF
stimulated bone marrow in stem cell
transplantation, an overview of the
protocol and the referring IRB’s
deliberations on the protocol, and a
summary of public comments received
concerning whether the protocol should
proceed, the subcommittee will discuss
the proposed protocol and develop a
recommendation regarding whether the
protocol should proceed. The
subcommittee’s recommendation will
then be presented to the FDA Pediatric
Advisory Committee on December 9,
2008; the announcement of the
December 9, 2008, Pediatric Advisory
Committee meeting can be found
elsewhere in this issue of the Federal
Register.
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 subcommittee. Written
submissions may be made to the contact
person on or before December 2, 2008.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on December 9, 2008.
Those desiring to make formal oral
presentations should notify the contact
E:\FR\FM\14NON1.SGM
14NON1
67526
Federal Register / Vol. 73, No. 221 / Friday, November 14, 2008 / Notices
jlentini on PROD1PC65 with NOTICES
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 24, 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 November 25, 2008.
Electronic comments should be
submited to https://www.regulations.gov.
Select Docket No. FDA–2008–N–0578
entitled ‘‘G–CSF Stimulated Bone
Marrow IRB Referral’’ and follow the
prompts to submit your statement.
Written comments should be submitted
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Please
submit comments by 4:30 p.m. on
December 2, 2008. Received comments
may be viewed at https://
www.regulations.govor may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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 Carlos Pena
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: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–27118 Filed 11–13–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
To request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: The Nursing
Scholarship Program (NSP):
Extension—(OMB No. 0915–0301)
The Nursing Scholarship Program
(NSP) or ‘‘Nursing Scholarship’’ is a
competitive Federal program which
awards scholarships to individuals for
attendance at schools of nursing. The
program is administered by the Bureau
of Clinician Recruitment and Service
Number of
respondents
Type of report
Application ............................................................................
In-school monitoring .............................................................
VerDate Aug<31>2005
16:29 Nov 13, 2008
Jkt 217001
PO 00000
Frm 00059
Responses
per
respondent
4,000
500
Fmt 4703
Sfmt 4703
(BCRS) in HRSA. The scholarship
consists of payment of tuition, fees,
other reasonable educational costs, and
a monthly support stipend. In return,
the students agree to provide a
minimum of 2 years of full-time clinical
service (or an equivalent part-time
commitment, as approved by the NSP)
at a health care facility with a critical
shortage of nurses as defined by the
program.
Nursing scholarship recipients must
be willing and are required to fulfill
their NSP service commitment at a
health care facility with a critical
shortage of nurses in the United States,
the District of Columbia, the
Commonwealth of Puerto Rico, the
Territory of Guam, the Commonwealth
of the Northern Marianas, the U.S.
Virgin Islands, the Territory of America
Samoa, the Republic of Palau, the
Republic of the Marshall Islands, or the
Federated States of Micronesia.
Students who are uncertain of their
commitment to provide nursing in a
health care facility with a critical
shortage of nurses in the United States
and its Territories are advised not to
participate in this program.
The NSP needs to collect data to
determine an applicant’s eligibility for
the program, to monitor a participant’s
continued enrollment in a school of
nursing, to monitor the participant’s
compliance with the NSP service
obligation, and to obtain data on its
program to ensure compliance with
legislative mandates and prepare annual
reports to Congress. The following
information will be collected: (1) From
the applicants and/or the schools,
general applicant and nursing school
data such as full name, location, tuition/
fees, and enrollment status; (2) from the
schools, on an annual basis, data
concerning tuition/fees and student
enrollment status; and (3) from the
participants and their health care
facilities with a critical shortage of
nurses, on a biannual basis, data
concerning the participant’s
employment status, work schedule and
leave usage. The BCRS enters the cost
information into its computerized data
system, along with the projected amount
for the monthly stipend, to determine
the amount of each scholarship award.
The estimated annual burden is as
follows:
Total
responses
1
1
E:\FR\FM\14NON1.SGM
4,000
500
14NON1
Hours
per
response
Total
burden
hours
2
2
8,000
1,000
]]>Agencies
[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Notices]
[Pages 67525-67526]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27118]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0578]
Pediatric Ethics Subcommittee; 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: Pediatric Ethics Subcommittee of the Pediatric
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Pediatric Advisory Committee on FDA, and certain
Department of Health and Human Services (DHHS) regulatory issues.
Date and Time: The meeting will be held on Tuesday, December 9,
2008, from 9 a.m. to 3 p.m.
Location: The Legacy Hotel & Meeting Centre, 1775 Rockville Pike,
Rockville, MD 20852.
Contact Person: Carlos Pe[ntilde]a, Office of Science and Health
Coordination, Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08),
Rockville, MD 20857, 301-827-3340, or by e-mail:
carlos.pe[ntilde]a@fda.hhs.gov or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
8732310001. 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 December 9, 2008, the Pediatric Ethics Subcommittee
(subcommittee) of the Pediatric Advisory Committee will meet to discuss
a referral by an Institutional Review Board (IRB) of a clinical
investigation that involves both an FDA regulated product and research
involving children as subjects that is conducted or supported by DHHS.
The clinical investigation is entitled ``Children's Oncology Group
Protocol ASCT0631: A Phase III Randomized Trial of Granulocyte Colony
Stimulating Factor (G-CSF) Stimulated Bone Marrow vs. Conventional Bone
Marrow as a Stem Cell Source in Matched Sibling Donor
Transplantation.'' Because the clinical investigation would be
regulated by FDA, and conducted or supported by the DHHS, both FDA and
the Office for Human Research Protections, DHHS, will participate in
the meeting.
After presentation of an overview of the IRB referral process,
background information on the use of G-CSF stimulated bone marrow in
stem cell transplantation, an overview of the protocol and the
referring IRB's deliberations on the protocol, and a summary of public
comments received concerning whether the protocol should proceed, the
subcommittee will discuss the proposed protocol and develop a
recommendation regarding whether the protocol should proceed. The
subcommittee's recommendation will then be presented to the FDA
Pediatric Advisory Committee on December 9, 2008; the announcement of
the December 9, 2008, Pediatric Advisory Committee meeting can be found
elsewhere in this issue of the Federal Register.
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 subcommittee.
Written submissions may be made to the contact person on or before
December 2, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on December 9, 2008. Those
desiring to make formal oral presentations should notify the contact
[[Page 67526]]
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 24, 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 November 25, 2008.
Electronic comments should be submited to https://
www.regulations.gov. Select Docket No. FDA-2008-N-0578 entitled ``G-CSF
Stimulated Bone Marrow IRB Referral'' and follow the prompts to submit
your statement. Written comments should be submitted to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Please submit comments by
4:30 p.m. on December 2, 2008. Received comments may be viewed at
https://www.regulations.govor may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
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 Carlos Pe[ntilde]a
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: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-27118 Filed 11-13-08; 8:45 am]
BILLING CODE 4160-01-S
