53270 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

part 801 have been approved under 

OMB control number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 2, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24964 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–M–0299, FDA– 

2009–M–0300, FDA–2009–M–0182, FDA– 

2009–M–0244, FDA–2009–M–0243, FDA– 

2009–M–0255] 

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. 

ADDRESSES: 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 

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: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993, 301–796–6570. 

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 

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 April 1, 2009, through 

June 30, 2009. 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 APRIL 1, 

2009, THROUGH JUNE 30, 2009. 

PMA No./Docket No. Applicant TRADE NAME Approval Date 

P080014 

FDA–2009–M–0299 

Third Wave Technologies, Inc. CERVISTA HPV HR March 12, 2009 

P080015 

FDA–2009–M–0300 

Third Wave Technologies, Inc. CERVISTA HPV 16/18 March 12, 2009 

P080006 

FDA–2009–M–0182 

Medtronic Inc. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD April 7, 2009 

P080023 

FDA–2009–M–0244 

Abbott Laboratories ARCHITECT CORE REAGENT KIT, ARCHITECT 

CORE CALIBRATOR AND ARCHITECT CORE 

CONTROLS 

April 10, 2009 

P060023 

FDA–2009–M–0243 

Medtronic Sofamor Danek BRYAN CERVICAL DISC May 12, 2009 

P060008 (S8) 

FDA–2009–M–0255 

Boston Scientific Co. TAXUS LIBERTE ATOM PACLITAXEL–ELUTING 

CORONARY STENT SYSTEM 

May 21, 2009 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53271 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: October 2, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24967 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

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 meetings. 

The meetings 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 

General Medical Sciences Special Emphasis 

Panel; NIGMS Knowledgebase Resource 

Review. 

Date: November 9, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Brian R. Pike, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18, Bethesda, MD 

20892, 301–594–3907, pikbr@mail.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Minority Biomedical Research Score. 

Date: November 16–17, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Palomar Hotel, 2121 P Street, NW., 

Washington, DC 20037. 

Contact Person: Lisa Dunbar, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN12, Bethesda, MD 

20892, 301–594–2849, dunbarl@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: October 7, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–24704 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

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 meetings. 

The meetings 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 

General Medical Sciences; Special Emphasis 

Panel Minority Biomedical Research Score. 

Date: November 9, 2009. 

Time: 1 p.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892. (Telephone 

Conference Call). 

Contact Person: Margaret J. Weidman, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3ANI8B, Bethesda, MD 

20892, 301–594–3663, 

weidmanma@nigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences; Special Emphasis 

Panel ZGM1 BRT–X (TR). 

Date: November 13, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Hotel, One Bethesda 

Metro Center, Bethesda, MD 20814. 

Contact Person: John J. Laffan, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN18J, Bethesda, 

MD 20892, 301–594–2773. 

Name of Committee: National Institute of 

General Medical Sciences; Special Emphasis 

Panel Minority Biomedical Research Score. 

Date: November 16, 2009. 

Time: 1 p.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892. (Telephone 

Conference Call). 

Contact Person: Margaret J. Weidman, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18B, Bethesda, MD 

20892, 301–594–3663, 

weidmanma@nigms.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: October 7, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–24708 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

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 meetings. 

The meetings 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 

General Medical Sciences Initial Review 

Group; Biomedical Research and Research 

Training Review Subcommittee B. 

Date: November 9, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 


jlentini on DSKJ8SOYB1PROD with NOTICES