Pediatric Ethics Subcommittee; Notice of Meeting, 67525-67526 [E8-27118]

Download as PDF 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 http:// 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 http:// 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 http://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 http://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 http://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 http:// 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 http://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]


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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 http://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 http://
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 
http://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 http://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