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 

http://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 

Persons with access to the Internet 

may obtain the documents at http:// 

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. 


ycherry on PROD1PC64 with NOTICES
Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices 15887 

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 

the meeting. Background material is 

available at http://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 

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 http:// 

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 


ycherry on PROD1PC64 with NOTICES