Oncologic Drugs Advisory Committee; Notice of Meeting, 15886-15887 [E7-6171]

Download as PDF 15886 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices Corporate Blvd., Rockville, MD 20850, 301–594–2186, ext. 152. 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 Web site 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 October 1, 2006, through December 31, 2006. 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 OCTOBER 1, 2006, THROUGH DECEMBER 31, 2006. PMA No./Docket No. Applicant Trade Name Approval Date P040027/2006M–0411 W.L. Gore & Associates GORE VIATORR TIPS December 6, 2004 P040023/2006M–0512 DePuy Orthopedics, Inc. DURALOC OPTION CERAMIC HIP SYSTEM May 3, 2005 P030047/2006M–0412 Cordis Corp. CORDIS PRECISE NITINOL STENT September 22, 2006 P050038/2006M–0396 Medafor, Inc. ARISTA AH ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED September 26, 2006 P970053(S9)/2006M–0460 Nidek, Inc. NIDEK EC–5000 EXCIMER LASER October 11, 2006 P050022/2006M–0456 Siemens Medical Solutions USA, Inc. SYNGO LUNG COMPUTER ASSISTED DETECTION (CAD) SYSTEM October 18, 2006 P050025/2006M–0459 Endotex Interventional Systems, Inc. ENDOTEX NEXSTENT CAROTID STENT & DELIVERY SYSTERM; AND ENDOTEX NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTERM October 27, 2006 P020012/2006M–0455 Artes Medical USA, Inc. ARTEFILL October 27, 2006 P040050/2006M–0457 Uroplasty, Inc. MACROPLASTIQUE IMPLANTS October 30, 2006 P050031/2006M–0473 Paragon Vision Sciences PARAGON Z CRT November 16, 2006 P020056/2006M–0490 Allergan INAMED SILICONE-FILLED BREAST IMPLANTS November 17, 2006 P030053/2006M–0492 Mentor Corp. MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS November 17, 2006 P060010/2006M–0529 AbbeyMoor Medical, Inc. THE SPANNER TEMPORARY PROSTATIC STENT December 14, 2006 P040025/2006M–0530 Olympic Medical OLYMPIC COOL-CAP December 20, 2006 P050033/2006M–0531 Anika Therapeutics, Inc. COSMETIC TISSUE AUGMENTATION PRODUCT December 20, 2006 II. Electronic Access ycherry on PROD1PC64 with NOTICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Dated: March 22, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–6166 Filed 4–2–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. VerDate Aug<31>2005 18:30 Apr 02, 2007 Jkt 211001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\03APN1.SGM 03APN1 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices ycherry on PROD1PC64 with NOTICES 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: Oncologic 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 May 9, 2007, from 8 a.m. to 4 p.m. and May 10, 2007, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, 8727 Colesville Rd., Silver Spring, MD, 301–589–5200. Contact Person: Johanna Clifford, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301–827– 6761, FAX: 301–827–6776, e-mail: johanna.clifford@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. Agenda: On May 9, 2007, the committee will do the following: (1) Discuss new drug application (NDA) 022–092, proposed trade name JUNOVAN (mifamurtide), IDM Pharma, Inc., proposed indication for the treatment of newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy; and (2) discuss NDA 022–062, proposed trade name ORBEC (beclomethasone dipropionate), DOR BioPharma, Inc., proposed indication for the treatment of graft versus host disease (GvHD) involving the gastrointestinal tract in conjunction with an induction course of high-dose prednisone or prednisolone. On May 10, 2007, the committee will discuss updated information on risks of erythropoeisis-stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.) for use in the treatment of anemia due to cancer chemotherapy. FDA intends to make background material available to the public no later than 1 business day 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 VerDate Aug<31>2005 18:30 Apr 02, 2007 Jkt 211001 the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 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 25, 2007. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. on May 9 and from 10:45 a.m. to 11:45 a.m. on May 10. 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 April 19, 2007. 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 18, 2007. 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 Johanna Clifford at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 28, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–6171 Filed 4–2–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 15887 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N–0573] Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending to May 3, 2007, the comment period for the notice of availability that appeared in the Federal Register of January 3, 2007 (72 FR 136). In the notice, FDA requested comments on the draft risk assessment, the proposed risk management plan, and the draft guidance for industry on animal cloning. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written and electronic comments by May 3, 2007. ADDRESSES: Submit written comments on the draft risk assessment, proposed risk management plan, or draft guidance for industry to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–453–6842, email: clones@cvm.fda.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 3, 2007 (72 FR 136), FDA published a notice of availability with a 90-day comment period to request comments on a draft risk assessment to evaluate the health effects to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA also announced the availability for public comment of a proposed risk management plan for animal clones and their progeny and a draft guidance for industry describing FDA’s E:\FR\FM\03APN1.SGM 03APN1

Agencies

[Federal Register Volume 72, Number 63 (Tuesday, April 3, 2007)]
[Notices]
[Pages 15886-15887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6171]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

[[Page 15887]]


ACTION:  Notice.

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    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: Oncologic 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 May 9, 2007, from 8 a.m. 
to 4 p.m. and May 10, 2007, from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, 8727 Colesville Rd., 
Silver Spring, MD, 301-589-5200.
    Contact Person: Johanna Clifford, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 
301-827-6761, FAX: 301-827-6776, e-mail: johanna.clifford@fda.hhs.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512542. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On May 9, 2007, the committee will do the following: (1) 
Discuss new drug application (NDA) 022-092, proposed trade name JUNOVAN 
(mifamurtide), IDM Pharma, Inc., proposed indication for the treatment 
of newly diagnosed resectable high grade osteosarcoma following 
surgical resection in combination with multiple agent chemotherapy; and 
(2) discuss NDA 022-062, proposed trade name ORBEC (beclomethasone 
dipropionate), DOR BioPharma, Inc., proposed indication for the 
treatment of graft versus host disease (GvHD) involving the 
gastrointestinal tract in conjunction with an induction course of high-
dose prednisone or prednisolone. On May 10, 2007, the committee will 
discuss updated information on risks of erythropoeisis-stimulating 
agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, 
Inc.) for use in the treatment of anemia due to cancer chemotherapy.
    FDA intends to make background material available to the public no 
later than 1 business day 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 2007 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 25, 2007. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. on 
May 9 and from 10:45 a.m. to 11:45 a.m. on May 10. 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 April 19, 2007. 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 18, 2007.
    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 Johanna Clifford at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-6171 Filed 4-2-07; 8:45 am]
BILLING CODE 4160-01-S

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