Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 15726-15727 [2013-05582]

Download as PDF 15726 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Notices public regarding the burden estimate, below, or any other aspect of the ICR. Comments on the ICR must be received on or before May 13, 2013. DATES: Submit your comments to Information.CollectionClearance@ hhs.gov or by calling (202) 690–6162. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@ hhs.gov or (202) 690–6162. When submitting comments or requesting information, please include the document identifier HHS–OS–19060– 60D for reference. SUPPLEMENTARY INFORMATION: women forty years and over. Evaluation of the initiative will address the following questions: (1) Does a healthy weight intervention based on the individual and the social environment improve health and reduce weight of older lesbian and bisexual women; and, (2) If the intervention does improve health and/or reduce weight, what attributes of the intervention contributed to this success? Information will be gathered and analyzed in an effort to identify and understand the effects of this healthy weight intervention and to inform the applicability of the intervention to other sites across the United States. The project is scheduled for one year. Information Collection Request Title: Living Healthier, Living Longer Program Evaluation. Abstract: The Department of Health and Human Services (HHS), the Office of Women’s Health, (OWH) Coordinating Committee on Lesbian, Gay, Bi-sexual and Transgender (LGBT) Issues has prioritized the collection of health data on LGBT populations. In response, OWH funded an initiative to ‘‘identify and test effective and innovative ways of reducing obesity in lesbian and bisexual women’’ (HHS, 2012). This initiative will include nutritional and physical activity counseling and activities, and will be implemented in New York City. It will be tailored to bisexual and lesbian TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Average burden per response (in hours) Number of responses per respondent Number of respondents Form name Total burden hours Baseline Survey ............................................................................................... Study Completion Survey ................................................................................ Pedometer Profile ............................................................................................ Health Screen (physical measurement) .......................................................... Health History Questionnaire ........................................................................... Intervention Experience Study Mid-Point) ....................................................... Intervention Experience ( Study Completion) .................................................. 40 40 40 40 40 40 40 1 1 1 3 1 1 1 15/60 15/60 2/60 10/60 12/60 1 1 10 10 1 20 8 40 hours 40 hours Total .......................................................................................................... ........................ ........................ ........................ 129 hours OS specifically requests comments on (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Keith A. Tucker, Information Collection Clearance Officer. [FR Doc. 2013–05609 Filed 3–11–13; 8:45 am] BILLING CODE 4150–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Mar<15>2010 17:21 Mar 11, 2013 Jkt 229001 This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies 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 by teleconference on April 17, 2013, from 1:30 p.m. to 5 p.m. Location: Rockwall II Building, 5515 Security Lane, Conference Room 1033, Rockville, MD 20852. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Contact Person: Gail Dapolito (301– 827–1289) or Rosanna Harvey (301– 827–1297), Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 http://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: On April 17, 2013, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Chemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. 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 E:\FR\FM\12MRN1.SGM 12MRN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Notices available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On April 17, 2013, from 1:30 p.m. to from approximately 4 p.m., the meeting is open to the public. 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 10, 2013. Oral presentations from the public will be scheduled between approximately 3 p.m. and 4 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 2, 2013. 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 3, 2013. Closed Committee Deliberations: On April 17, 2013, from 4 p.m. to 5 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. 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 Gail Dapolito 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/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. VerDate Mar<15>2010 17:21 Mar 11, 2013 Jkt 229001 Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 5, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–05582 Filed 3–11–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting 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 meeting. The meeting 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 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel Member Conflict: Computational Biophysics. Date: April 4, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Mike Radtke, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301–435– 1728, radtkem@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: March 7, 2013. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–05682 Filed 3–11–13; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 15727 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting 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 meeting. The meeting 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 materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Loan Repayment Program Review. Date: April 30, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: JoAnn McConnell, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS, NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892– 9529, 301–496–5324, McConnej@ninds.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: March 7, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–05687 Filed 3–11–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting 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 meeting. E:\FR\FM\12MRN1.SGM 12MRN1

Agencies

[Federal Register Volume 78, Number 48 (Tuesday, March 12, 2013)]
[Notices]
[Pages 15726-15727]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Cellular, Tissue and Gene Therapies 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Cellular, Tissue and Gene Therapies 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 by teleconference on April 
17, 2013, from 1:30 p.m. to 5 p.m.
    Location: Rockwall II Building, 5515 Security Lane, Conference Room 
1033, Rockville, MD 20852. The public is welcome to attend the meeting 
at the specified location where a speakerphone will be provided. Public 
participation in the meeting is limited to the use of the speakerphone 
in the conference room.
    Contact Person: Gail Dapolito (301-827-1289) or Rosanna Harvey 
(301-827-1297), Food and Drug Administration, 1401 Rockville Pike (HFM-
71), Rockville, MD 20852, 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 http://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: On April 17, 2013, the committee will meet by 
teleconference. In open session, the committee will hear updates of 
research programs in the Laboratory of Chemistry, Division of 
Therapeutic Proteins, Office of Biotechnology Products, Center for Drug 
Evaluation and Research, FDA.
    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

[[Page 15727]]

available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On April 17, 2013, from 1:30 p.m. to from approximately 
4 p.m., the meeting is open to the public. 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 10, 2013. Oral presentations from the 
public will be scheduled between approximately 3 p.m. and 4 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 2, 2013. 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 3, 2013.
    Closed Committee Deliberations: On April 17, 2013, from 4 p.m. to 5 
p.m., the meeting will be closed to permit discussion where disclosure 
would constitute a clearly unwarranted invasion of personal privacy (5 
U.S.C. 552b(c)(6)). The committee will discuss reports of intramural 
research programs and make recommendations regarding personnel staffing 
decisions.
    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 Gail Dapolito 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/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: March 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05582 Filed 3-11-13; 8:45 am]
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