Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 54155 

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, 2010, through 

June 30, 2010. 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, 

2010, THROUGH JUNE 30, 2010 

PMA No. Docket No. Applicant TRADE NAME Approval Date 

P090018 

FDA–2010–M–0244 

Envoy Medical Corp. ESTEEM TOTALLY IMPLANTABLE HEARING 

SYSTEM 

March 17, 2010 

P080029 

FDA–2010–M–0220 

Interventional Therapies, 

LLC 

QUICK CLOSE VASCULAR SUTURING SYSTEM April 8, 2010 

P090022 

FDA–2010–M–0219 

Lenstec, Inc. SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) April 12, 2010 

P080032 

FDA–2010–0242 

Asthmatix, Inc. ALAIR BRONCHIAL THERMOPLASTY April 27, 2010 

P090007 

FDA–2010–M–0261 

Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND 

ELECSYS PRECICONTROL ANTI-HCV FOR 

USE ON THE COBAS E411 IMMUNOASSAY 

ANALYZER 

April 29, 2010 

P090008 

FDA–2010–M–0262 

Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND 

ELECSYS PRECICONTROL ANTI-HCV FOR 

USE ON THE COBAS E601 IMMUNOASSAY 

ANALYZER 

April 29, 2010 

P090009 

FDA–2010–M–0264 

Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND 

ELECSYS PRECICONTROL ANTI-HCV FOR 

USE ON THE MODULAR ANALYTICS E170 

ANALYZER 

April 29, 2010 

P050027 

FDA–2010–M–0294 

Karl Storz endoscopy— 

America, Inc. 

PHOTODYNAMIC DIAGNOSTIC D-LIGHT C May 28, 2010 

P060029 

FDA–2010–M–0285 

Ethicon, Inc. OMNEX SURGICAL SEALANT June 3, 2010 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

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

Dated: August 31, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–22085 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; 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. 


srobinson on DSKHWCL6B1PROD with NOTICES
54156 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Review of T32 

Applications on Clinical and Developmental 

Pharmacology. 

Date: September 29, 2010. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

PhD, Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Blvd., Room 5B01, Bethesda, MD 20892, 

301–435–6680, skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos.93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: August 30, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22087 Filed 9–2–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 on 

Aging Initial Review Group, Neuroscience of 

Aging Review Committee. 

Date: October 4–5, 2010. 

Time: 4 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20892. 

Contact Person: William Cruce, PhD, 

Scientific Review Administrator, National 

Institute On Aging, Scientific Review Office, 

Gateway Building 2C–212, 7201 Wisconsin 

Ave., Bethesda, MD 20814, 301–402–7704, 

crucew@nia.nih.gov. 

Name of Committee: National Institute on 

Aging Initial Review Group, Clinical Aging 

Review Committee. 

Date: October 7–8, 2010. 

Time: 7 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20892. 

Contact Person: Alicja L. Markowska, PhD, 

DSC, National Institute On Aging, National 

Institutes of Health, Gateway Building 2C212, 

7201 Wisconsin Avenue, Bethesda, MD 

20892, 301–496–9666, 

markowsa@nia.nih.gov. 

Name of Committee: National Institute on 

Aging Initial Review Group, Biological Aging 

Review Committee. 

Date: October 7, 2010. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Suite 2C212, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Bita Nakhai, PhD., 

Scientific Review Officer, Scientific Review 

Branch, National Institute On Aging, 

Gateway Bldg., 2C212, 7201 Wisconsin 

Avenue, Bethesda, MD 20814, 301–402– 

7701, nakhaib@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: August 27, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22089 Filed 9–2–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Language and 

Communication Study Section, October 

4, 2010, 8 a.m. to October 5, 2010, 5 

p.m., Ritz Carlton Hotel, 1150 22nd 

Street, NW., Washington, DC 20037 

which was published in the Federal 

Register on August 25, 2010, 75 FR 

52357. 

The meeting will be one day only 

October 4, 2010. The meeting time and 

location remain the same. The meeting 

is closed to the public. 

Dated: August 26, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22090 Filed 9–2–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Oncology 2— 

Translational Clinical Integrated Review 

Group, Basic Mechanisms of Cancer 

Therapeutics Study Section. 

Date: October 4–5, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marina del Rey Hotel, 13534 Bali 

Way, Marina del Rey, CA 90292. 

Contact Person: Lambratu Rahman, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

MSC 7804, Bethesda, MD 20892, 301–451– 

3493, rahmanl@csr.nih.gov. 

Name of Committee: Infectious Diseases 

and Microbiology Integrated Review Group, 

Clinical Research and Field Studies of 

Infectious Diseases Study Section. 

Date: October 7–8, 2010. 

Time: 8:30 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Churchill Hotel, 1914 

Connecticut Avenue, NW., Washington, DC 

20009. 

Contact Person: Soheyla Saadi, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3211, 

MSC 7808, Bethesda, MD 20892, 301–435– 

0903, saadisoh@csr.nih.gov. 

Name of Committee: Oncology 2— 

Translational Clinical Integrated Review 

Group, Clinical Oncology Study Section. 

Date: October 11–12, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Long Beach and Executive 

Meeting Center, 701 West Ocean Boulevard, 

Long Beach, CA 90831. 

Contact Person: Malaya Chatterjee, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6192, 

MSC 7804, Bethesda, MD 20892, 301–451– 

0131, chatterm@csr.nih.gov. 


srobinson on DSKHWCL6B1PROD with NOTICES