Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 71922-71923 [E7-24629]

Download as PDF 71922 Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2007M–0285, 2007M–0286, 2007M–0287, 2007M–0288, 2007M–0289, 2007M–0298, 2007M–0303, 2007M–0344] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this ADDRESSES: document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Samie Allen, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4013. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the agency now posts this information on the Internet on FDA’s home page at https://www.fda.gov. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from July 1, 2007, through September 30, 2007. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the approval date. TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2007, THROUGH SEPTEMBER 30, 2007 PMA No./Docket No. Applicant Trade Name Approval Date P040044(S1)/2007M–0285 Access Closure, Inc. MYNX VASCULAR CLOSURE DEVICE May 16, 2007 P050016/2007M–0286 Corin, USA CORMET HIP RESURFACING SYSTEM July 3, 2007 P050039/2007M–0287 Exactech, Inc. NOVATION CERAMIC ARTICULATION HIP SYSTEM July 5, 2007 P930016(S25)/2007M–0288 VISX, Inc. STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM July 11, 2007 P060018/2007M–0289 Medtronic Sofamor Danek, Inc. PRESTIGE CERVICAL DISC SYSTEM July 16, 2007 P060002/2007M–0298 C.R. Bard, Inc. FLAIR ENDOVASCULAR STENT GRAFT July 23, 2007 P050024/2007M–0303 Cryocor, Inc. CRYOCOR CRYOABLATION SYSTEM August 1, 2007 P050043/2007M–0344 Morris Innovative Research, Inc. FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE 5, 6, & 8 FRENCH August 20, 2007 II. Electronic Access DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on PROD1PC66 with NOTICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Food and Drug Administration Dated: December 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–24620 Filed 12–18–07; 8:45 am] [Docket No. 2007N–0471] BILLING CODE 4160–01–S HHS. VerDate Aug<31>2005 21:40 Dec 18, 2007 Jkt 214001 Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: PO 00000 Food and Drug Administration, Frm 00052 Fmt 4703 Sfmt 4703 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. E:\FR\FM\19DEN1.SGM 19DEN1 mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 243 / Wednesday, December 19, 2007 / Notices 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 April 10, 2008, from 9 a.m. to approximately 6 p.m. and on April 11, 2008, from 8 a.m. to approximately 12 noon. Addresses: Electronic comments should be submitted to https:// www.fda.gov/dockets/ecomments. Select ‘‘2007N–0471—Scientific Considerations for Safety Testing for Cellular Therapy Products Derived From Human Embryonic Stem Cell’’ and follow 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, by close of business on March 26, 2008. All comments received will be posted without change, including any personal information provided. Comments received on or before March 26, 2008, will be provided to the committee before or at the meeting. Location: Hilton DC North/ Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 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 April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. On April 11, 2008, the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) FDA’s Somatic Cell Therapy Letter; and (3) VerDate Aug<31>2005 21:40 Dec 18, 2007 Jkt 214001 recently released FDA guidance documents. 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 April 3, 2008. Oral presentations from the public will be scheduled on April 10, 2008, between approximately 1:45 p.m. and 2:15 p.m. and on April 11, 2008, between approximately 10:15 a.m. and 10:45 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 March 26, 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 March 27, 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 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. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 71923 Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–24629 Filed 12–18–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs 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: Psychopharmacologic Drugs 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 February 6, 2008, from 8 a.m. to 5 p.m. Location: Crowne Plaza Silver Spring, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD. The hotel phone number is 301–587–4791. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, e-mail: diemkieu.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512544. 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: The committee will discuss new drug application (NDA) 22–173, ZYPREXA ADHERA (olanzapine pamoate depot) long acting E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 72, Number 243 (Wednesday, December 19, 2007)]
[Notices]
[Pages 71922-71923]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24629]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0471]


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.

[[Page 71923]]

    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 April 10, 2008, from 9 
a.m. to approximately 6 p.m. and on April 11, 2008, from 8 a.m. to 
approximately 12 noon.
    Addresses: Electronic comments should be submitted to https://
www.fda.gov/dockets/ecomments. Select ``2007N-0471--Scientific 
Considerations for Safety Testing for Cellular Therapy Products Derived 
From Human Embryonic Stem Cell'' and follow 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, by close of business on 
March 26, 2008. All comments received will be posted without change, 
including any personal information provided. Comments received on or 
before March 26, 2008, will be provided to the committee before or at 
the meeting.
    Location: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry 
Pkwy., Gaithersburg, MD.
    Contact Person: Gail Dapolito or Danielle Cubbage, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 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 April 10, 2008, the committee will meet to discuss 
scientific considerations for safety testing for cellular therapy 
products derived from human embryonic stem cells. On April 11, 2008, 
the committee will meet to discuss updates on the following topics: (1) 
Research management related to the September 29, 2005, review of 
research programs of the Office of Cellular, Tissue and Gene Therapies, 
Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell 
Therapy Letter; and (3) recently released FDA guidance documents.
    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 
April 3, 2008. Oral presentations from the public will be scheduled on 
April 10, 2008, between approximately 1:45 p.m. and 2:15 p.m. and on 
April 11, 2008, between approximately 10:15 a.m. and 10:45 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 March 26, 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 March 27, 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 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: December 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-24629 Filed 12-18-07; 8:45 am]
BILLING CODE 4160-01-S

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