51288 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

571.1(c) moderate category 1 1 1 3,000 3,000 

571.1(c) complex category 1 1 1 10,000 10,000 

571.6 amendment of petition 2 2 4 1,300 5,200 

Total Hours 18,200 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA derived the annual reporting 

burden estimate for the different 

categories as follows: 

Section 571.1(c)—moderate category: 

For food additive petition without 

complex chemistry, manufacturing, 

efficacy, or safety issues, the estimated 

time requirement per petition is 

approximately 3,000 hours. An average 

of 1 (one) petitions of this type is 

received on an annual basis, resulting in 

a burden of 3,000 hours. 

Section 571.1(c)—complex category: 

For a food additive petition with 

complex chemistry, manufacturing, 

efficacy, and/or safety issues, the 

estimated time requirement per petition 

is approximately 10,000 hours. An 

average of 1 (one) petition of this type 

is received on an annual basis, resulting 

in a burden of 10,000 hours. 

Section 571.6: For a food additive 

petition amendment, the estimated time 

requirement per petition is 

approximately 1,300 hours. An average 

of 4 (four) petitions of this type is 

received on an annual basis, resulting in 

a burden of 5,200 hours. 

Thus, the estimated total annual 

burden for this information collection is 

18,200 hours. 

Dated: September 29, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24047 Filed 10–05–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Establishment 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2), the Director, National 

Institutes of Health (NIH), announces 

the establishment of the Interagency 

Breast Cancer and Environmental 

Research Coordinating Committee 

(Committee). 

The Committee shall coordinate all 

efforts within the Department of Health 

and Human Services to share and 

coordinate information on existing 

research activities, and make 

recommendations to the Secretary 

DHHS, the National Institutes of Health 

and other Federal agencies regarding 

how to improve existing research 

programs. 

The Committee’s primary mission is 

to facilitate the efficient and effective 

exchange of information on breast 

cancer research activities among the 

member agencies, and to coordinate 

solicitation of proposals for 

collaborative, multidisciplinary 

research, including proposals to 

evaluate environmental and genomic 

factors that may be related to the 

etiology of breast cancer. 

Duration of this committee is two 

years from the date the Charter is filed. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. E9–23974 Filed 10–5–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–M–0033, FDA– 

2009–M–0016, FDA–2009–M–0034, FDA– 

2009–M–0049, FDA–2009–M–0071, FDA– 

2009–M–0127, FDA–2009–M–0128, FDA– 

2009–M–0135, FDA–2009–M–0159] 

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 (HFZ–402), 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 51289 

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 January 1, 2009, through 

March 31, 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 JANUARY 1, 

2009, THROUGH MARCH 31, 2009 

PMA No. 

Docket No. Applicant Trade Name Approval Date 

P060030 

FDA–2009–M–0033 

Roche Molecular Systems, Inc. Cobas ampliprep/cobas taqman HFC 

test 

October 30, 2008 

P950009 (S8) 

FDA–2009–M–0016 

BD Diagnostics BD focal point gs imaging system December 3, 2008 

P080010 

FDA–2009–M–0034 

Advanced Medical Optics, Inc. Tecnis multifocal foldable posterior 

chamber intraocular lens 

January 16, 2009 

P080021 

FDA–2009–M–0049 

Advanced Vision Science, Inc. xact foldable hydrophobic acrylic UV 

light absorbing posterior chamber IOL 

February 2, 2009 

P030031 (S11) 

FDA–2009–M–0071 

Biosense Webster, Inc. Navistar & Celsius thermo cool catheters February 6, 2009 

P070014 

FDA–2009–M–0127 

Bard Peripheral Vascular, Inc. lifestent flexstar & flexstar XL vascular 

stent system 

February 13, 2009 

P940015 (S12) 

FDA–2009–M–0128 

Genzyme Corp. Synvisc-One February 26, 2009 

P070005 

FDA–2009–M–0135 

Synthemed Corp. Repel-cv bioresorbable adhesion barrier March 6, 2009 

P080002 

FDA–2009–M–0159 

The Female Health Co. FC2 female condom March 10, 2009 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

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

Dated: September 24, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–23962 Filed 10–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; 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. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel; Review of P01 applications 

on Interdisciplinary Research on Oral 

Manifestations of HIV/AIDS in Vulnerable 

Populations. 

Date: November 12, 2009. 

Time: 9 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Victor Henriquez, PhD, 

Scientific Review Officer, DEA/SRB/NIDCR, 

6701 Democracy Blvd., Room 668, Bethesda, 

MD 20892–4878, 301–451–2405, 

henriquv@nidcr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: September 29, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23997 Filed 10–5–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Pediatric 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: Pediatric 

Advisory Committee. 


jlentini on DSKJ8SOYB1PROD with NOTICES