65202 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency 

per Record 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

510(k) reviews 15 14 210 10 2,100

Totals 2,100

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

The burdens are explained as follows:

I. Reporting

A. Requests for Accreditation

Under the agency’s third-party review 

pilot program, the agency received 37 

applications for recognition as thirdparty reviewers, of which the agency 

recognized 7. In the past 3 years, the 

agency has averaged receipt of 15 

applications for recognition of thirdparty review accredited persons. The 

agency has accredited 15 of the 

applicants to conduct third-party 

reviews.

B. 510(k) Reviews Conducted by 

Accredited Third Parties

In the 18 months under the thirdparty review pilot program, FDA 

received 22 submissions of 510(k)s that 

requested and were eligible for review 

by third parties. The agency has 

experienced that the number of 510(k)s 

submitted annually for third-party 

review since the last OMB approval in 

2001 is approximately 210 annually, 

which is 14 annual reviews per each of 

the estimated 15 accredited reviewers.

II. Recordkeeping

Third-party reviewers are required to 

keep records of their review of each 

submission. The agency anticipates 

approximately 140 annual submissions 

of 510(k)s for third-party review.

Dated: November 3, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24994 Filed 11–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Advisory Committees; Filing of Annual 

Reports

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing, as 

required by the Federal Advisory 

Committee Act, that the agency has filed 

with the Library of Congress the annual 

reports of those FDA advisory 

committees that held closed meetings 

during fiscal year 2004.

ADDRESSES: Copies are available from 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20857, 301–827–

6860.

FOR FURTHER INFORMATION CONTACT:

Theresa L. Green, Committee 

Management Officer, Advisory 

Committee Oversight and Management 

Staff (HF–4), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1220.

SUPPLEMENTARY INFORMATION: Under 

section 13 of the Federal Advisory 

Committee Act (5 U.S.C. app. 2) and 21 

CFR 14.60(c), FDA has filed with the 

Library of Congress the annual reports 

for the following FDA advisory 

committees through September 30, 

2004:

Center for Biologics Evaluation and 

Research

Biological Response Modifiers 

Advisory Committee

Blood Products Advisory Committee

Vaccines and Related Biological 

Products Advisory Committee

Center for Drug Evaluation and Research

Anti-Infective Drugs Advisory 

Committee

Anesthetic and Life Support Drugs 

Advisory Committee

Dermatologic and Ophthalmic Drugs 

Advisory Committee

Nonprescription Drugs Advisory 

Committee

Center for Devices and Radiological 

Health

Medical Devices Advisory Committee 

(consisting of reports for the Dental 

Products Panel; Orthopaedic and 

Rehabilitation Devices Panel; 

Ophthalmic Devices Panel; Radiological 

Devices Panel)

Annual reports are available for 

public inspections between 9 a.m. and 

4 p.m., Monday through Friday at the 

following locations:

1. The Library of Congress, Madison 

Bldg., Newspaper and Current 

Periodical Reading Room, 101 

Independence Ave. SE., rm. 133, 

Washington, DC; and

2. The Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852.

Dated: November 3, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–24996 Filed 11–9–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0468]

Draft Guidance for Industry on 

Development of Target Animal Safety 

and Effectiveness Data to Support 

Approval of Non-Steroidal AntiInflammatory Drugs for Use in 

Animals; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance for 

industry (#123) entitled ‘‘Development 

of Target Animal Safety and 

Effectiveness Data to Support Approval 

of Non-Steroidal Anti-Inflammatory 

Drugs (NSAIDS) for Use in Animals.’’

This draft guidance is intended to 

provide specific advice regarding the 

development of target animal safety and 

effectiveness data to support approval of 

veterinary NSAIDs, specifically 

cyclooxygenase (COX) inhibitors.

DATES: Submit written or electronic 

comments on agency guidances by 

January 24, 2005 to ensure their 

adequate consideration in preparation of 

the final document. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document to the Communications Staff 

(HFV–12), Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests.

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Notices 65203

Submit written comments on the draft 

guidance document 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. 

Comments should be identified with the 

full title of the draft guidance document 

and the docket number found in the 

heading of this document. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document.

FOR FURTHER INFORMATION CONTACT:

Linda Wilmot, Center for Veterinary 

Medicine (HFV–114), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0135, email: lwilmot@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance document 

provides information on approaches to 

the development of target animal safety 

and effectiveness data to support 

approval of veterinary NSAIDs—

specifically, NSAIDs that reduce the 

production of prostaglandins by 

inhibiting the COX pathway. NSAIDs 

that inhibit lipooxygenase, or both 

lipooxygenase and COX, or act as 

cytokine antagonists. The Center for 

Veterinary Medicine (CVM) may 

recommend alternative product 

development strategies to complete its 

evaluation.

II. Significance of Guidance

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance represents 

the agency’s current thinking on the 

development of target animal safety and 

effectiveness data to support approval of 

non-steroidal anti-inflammatory drugs 

for use in animals. The document does 

not create or confer any rights for or on 

any person and will not operate to bind 

FDA or the public. Alternative methods 

may be used as long as they satisfy the 

requirements of the applicable statutes 

and regulations.

III. Paperwork Reduction Act of 1995

The collection of information 

requirements are approved by the Office 

of Management and Budget (OMB) 

under OMB control number 0910–0032.

IV. Comments

This draft guidance document is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit written or electronic comments 

to the Division of Dockets Management 

(see ADDRESSES) regarding this draft 

guidance document. Two paper copies 

of any mailed comments are to be 

submitted, 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. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

V. Electronic Access

Electronic comments may be 

submitted on the Internet at http://

www.fda.gov/dockets/ecomments. Once 

on this site, select [Docket No. 2004D–

0468] ‘‘Guidance for Industry on 

Development of Target Animal Safety 

and Effectiveness Data to Support 

Approval of Non-Steroidal AntiInflammatory Drugs (NSAIDS) for use in 

Animals’’ and follow the directions. 

Copies of this draft guidance may be 

obtained on the Internet from the CVM 

home page at http://www.fda.gov/cvm.

Dated: November 2, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24995 Filed 11–9–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 Cancer 

Institute Special Emphasis Panel, EDRN: 

Biomarkers Reference Laboratories 

(EDRN:BRL). 

Date: December 9, 2004. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6130 

Executive Blvd., Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Timothy C. Meeker, MD, 

Scientific Review Administrator, Special 

Referral and Resources Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Boulevard, Room 

8088, Rockville, MD 20852 (301) 594–1279.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower, 93.399, 

Cancer Control, National Institutes of Health, 

HHS)

Dated: November 2, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–25016 Filed 11–9–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Research 

Resources; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 Center for 

Research Resources Special Emphasis Panel, 

Scientific and Technical Review Board. 

Date: November 10, 2004. 

Time: 10 a.m. to Adjournment. 

Agenda: To review and evaluate grant 

applications. 

Place: Office of Review, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Barbara J. Nelson, PhD, 

Office of Review, National Center for 

Research Resources, NIH, 6701 Democracy 

Blvd., Room 1080, 1 Democracy Plaza, 

Bethesda, MD 20892, (301) 435–0806. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.