Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Notices 65201

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section 

No. of

Recordkeepers

Annual Frequency

of Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours 

226.42 115 260 29,000 0.75 22,425

226.58 115 260 29,000 1.75 52,325

226.80 115 260 29,000 0.75 22,425

226.102 115 260 24,000 1.75 52,325

226.110 115 260 29,000 0.25 7,475

226.115 115 10 1,150 0.5 575

Total 157,550

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

The estimate of the time required for 

record preparation and maintenance is 

based on agency communications with 

industry. Other information needed to 

calculate the total burden hours (i.e., 

manufacturing sites, number of type A 

medicated articles being manufactured, 

etc.) are derived from agency records 

and experience.

Dated: November 3, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24993 Filed 11–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0332]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Third-Party Review Under the Food 

and Drug Administration 

Modernization Act

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the 

collection of information by December 

10, 2004.

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance.

Medical Devices; Third-Party Review 

Under the Food and Drug 

Administration Modernization Act—

(OMB Control Number 0910–0375)—

Extension 

Section 210 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) established section 523 

of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360m), directing 

FDA to accredit persons in the private 

sector to review certain premarket 

applications and notifications. 

Participation in this third-party review 

program by accredited persons is 

entirely voluntary. A third party 

wishing to participate will submit a 

request for accreditation to FDA. 

Accredited third-party reviewers have 

the ability to review a manufacturer’s 

510(k) submission for selected devices. 

After reviewing a submission, the 

reviewer will forward a copy of the 

510(k) submission, along with the 

reviewer’s documented review and 

recommendation to FDA. Third-party 

reviews should maintain records of their 

510(k) reviews and a copy of the 510(k) 

for a reasonable period of time, usually 

a period of 3 years. This information 

collection will allow FDA to continue to 

implement the accredited person review 

program established by FDAMA and 

improve the efficiency of 510(k) review 

for low to moderate risk devices.

Respondents to this information 

collection are businesses or other forprofit organizations.

In the Federal Register of August 10, 

2004 (69 FR 48508), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency per 

Record Total Annual Records Hours per Recordkeeper Total Hours 

Requests for accreditation 15 1 15 24 360

510(k) reviews conducted by 

accredited third parties 15 14 210 40 8,400

Totals 8,760

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

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.