Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 19226-19227 [E9-9592]

Download as PDF 19226 Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices ensure that appropriate steps will be taken in a timely manner. CDER and CBER have determined and the guidance recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the center may quickly and efficiently respond to the request: (1) A brief but comprehensive statement of each issue to be resolved, including a description of the issue, the nature of the issue (i.e., scientific, procedural, or both), possible solutions based on information in the administrative file, whether informal dispute resolution was sought prior to the formal appeal, whether advisory committee review is sought, and the expected outcome; (2) a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last agency official that attempted to formally resolve the matter; (3) a list of documents in the administrative file, or additional copies of such documents, that are deemed necessary for resolution of the issue(s); and (4) a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information that the agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute, (2) brief statements describing the history of the matter, and (3) the documents previously submitted to FDA under an OMB approved collection of information. Based on FDA’s experience with dispute resolution, the agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance will be minimal. Description of Respondents: A sponsor, applicant, or manufacturer of a drug or biological product regulated by the agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act who requests formal resolution of a scientific or procedural dispute. Burden Estimate: Provided in table 1 of this document is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately 13 sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately 1 respondent submits requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 22 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with this guidance, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the agency. Based on experience, FDA estimates that approximately 8 hours on average would be needed per response. Therefore, FDA estimates that 184 hours will be spent per year by respondents requesting formal dispute resolution under the guidance. In the Federal Register of November 3, 2008 (73 FR 65385), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1 Requests for Formal Dispute Resolution No. of Respondents No. of Responses per Respondent Total Annual Responses Hours Per Response Total Hours CDER 13 1.7 22 8 176 CBER 1 1 1 8 8 Total 1 There 184 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 21, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–9632 Filed 4–27–09; 8:45 am] ACTION: 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. BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration erowe on PROD1PC64 with NOTICES [Docket No. FDA–2009–N–0664] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. VerDate Nov<24>2008 15:33 Apr 27, 2009 Jkt 217001 Notice. 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 on May 14, 2009, from 8 a.m. to approximately 6 p.m. and on May 15, 2009, from 8 a.m. to approximately 1 pm. Location: Hilton Hotel, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Gail Dapolito or Danielle Cubbage, Food and Drug Administration, PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 1401 Rockville Pike (HFM–71), Rockville, MD, 301–827–0314, or FDA Advisory Committee Information Line, 1–800–741– 8138 (301–443–0572 in the Washington, DC area), code 3014512389. 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 May 14 in the morning, in open session, the Committee will discuss the potential for Chlamydia trachomatis and Neisseria gonorrhea transmission by human cells, tissues, and cellular and tissue-based E:\FR\FM\28APN1.SGM 28APN1 erowe on PROD1PC64 with NOTICES Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices products (HCT/Ps) that are recovered from the reproductive system or gestational tissues (e.g., amnionic membrane and placenta, cells recovered from menstrual blood, foreskin, placental/umbilical cord blood derived cell products), or other sources. In the afternoon, in open session, the Committee will discuss animal models for porcine xenotransplantation products intended to treat Type 1 diabetes or acute liver failure. On May 15, in open session, the Committee will: (1) Receive an update on Guidance documents from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research and the Center for Veterinary Medicine and (2) discuss clinical issues related to the FDA draft guidance ‘‘Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage.’’ 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 2009 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 May 7, 2009. Oral presentations from the public will be scheduled on May 14 between approximately 11 a.m. and 11:20 a.m. and between approximately 2 p.m. and 2:20 p.m. and on May 15 between approximately 10 a.m. and 10:20 a.m. 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 May 6, 2009. 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 May 7, 2009. 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 https://www.fda.gov/oc/ VerDate Nov<24>2008 15:33 Apr 27, 2009 Jkt 217001 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: April 17, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–9592 Filed 4–27–09; 8:45 am] 19227 Dated: April 21, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–9691 Filed 4–27–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Neurological Disorders and Stroke; Notice of Meeting 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 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: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Loan Repayment Program. Date: April 30, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Joann McConnell, PhD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/Neuroscience Center, 6001 Executive Blvd., Suite 3208, Msc 9529, Bethesda, MD 20892–9529, (301) 496–5324, mcconnej@ninds.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (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) PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Neurological Disorders and Stroke Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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: National Advisory Neurological Disorders and Stroke Council; Training, Career Development, and Special Programs Subcommittee. Date: May 27, 2009. Open: 8 p.m. to 9:30 p.m. Agenda: To discuss the training plan of the institute. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Closed: 9:30 p.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Stephen J. Korn, PhD, Training and Special Programs Officer, National Institute of Neurological Disorders and Stroke, National Institutes of Health, 6001 Executive Blvd., Suite 2154, MSC 9527, Bethesda, MD 20892–9527, (301) 496–4188. Information is also available on the Institute’s/Center’s home page: www.ninds.nih.gov, where an agenda and E:\FR\FM\28APN1.SGM 28APN1

Agencies

[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19226-19227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


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). The meeting will 
be open 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 on May 14, 2009, from 8 
a.m. to approximately 6 p.m. and on May 15, 2009, from 8 a.m. to 
approximately 1 pm.
    Location: Hilton Hotel, Grand Ballroom, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Gail Dapolito or Danielle Cubbage, Food and Drug 
Administration, 1401 Rockville Pike (HFM-71), Rockville, MD, 301-
827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), code 3014512389. 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 May 14 in the morning, in open session, the Committee 
will discuss the potential for Chlamydia trachomatis and Neisseria 
gonorrhea transmission by human cells, tissues, and cellular and 
tissue-based

[[Page 19227]]

products (HCT/Ps) that are recovered from the reproductive system or 
gestational tissues (e.g., amnionic membrane and placenta, cells 
recovered from menstrual blood, foreskin, placental/umbilical cord 
blood derived cell products), or other sources. In the afternoon, in 
open session, the Committee will discuss animal models for porcine 
xenotransplantation products intended to treat Type 1 diabetes or 
acute liver failure. On May 15, in open session, the Committee will: 
(1) Receive an update on Guidance documents from the Office of 
Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation 
and Research and the Center for Veterinary Medicine and (2) discuss 
clinical issues related to the FDA draft guidance ``Preparation of 
IDEs and INDs for Products Intended to Repair or Replace Knee 
Cartilage.''
    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 2009 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 
May 7, 2009. Oral presentations from the public will be scheduled on 
May 14 between approximately 11 a.m. and 11:20 a.m. and between 
approximately 2 p.m. and 2:20 p.m. and on May 15 between 
approximately 10 a.m. and 10:20 a.m. 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 May 6, 2009. 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 May 7, 2009.
    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 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: April 17, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-9592 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S

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