Federal Register / Vol. 69, No. 198 / Thursday, October 14, 2004 / Notices 61023

information gathered since this 

collection was last reviewed in 2001, 

the agency has experienced that nine 

European manufacturers have not 

received any third-party requests for 

review annually. The agency estimates, 

based on dialog with EU officials and 

actual experience, nine firms will be 

designated to act as EU CABs.

2. Quality System Reports

Under this program, EU CABs will be 

able to perform third-party evaluations 

of the quality systems established by 

manufacturers of European products 

produced for export to the United 

States. EU CABs would be required to 

submit to FDA reports of their 

evaluations. Based upon information 

gathered during the negotiation of the 

U.S./E.C. MRA and actual experience 

since the collection was last approved 

by OMB in 2001, the agency anticipates 

that European manufacturers will 

request third-party audits for 

approximately 36 medical device 

products annually. The agency 

estimates that 9 EU CABs will perform 

these evaluations.

II. Recordkeeping

Third-party reviewers are required to 

keep records of their review of each 

submission. The agency anticipates 

approximately 210 annual submissions 

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

As stated previously, firms designated 

as EU CABs will be able to perform 

third-party evaluations of quality 

systems and premarket submissions for 

certain products produced for export to 

the United States. Such review will be 

conducted consistent with FDA’s 

regulatory requirements, and FDA will 

require the reviewers to keep, in their 

records, a copy of the report that they 

submit to FDA for each review. The 

agency anticipates that 45 premarket 

reports and 36 quality system reports 

will be generated and required to be 

maintained by EU CABs annually. The 

agency further estimates that each 

reviewer will require no more than 10 

hours (2 hours per recordkeeping per 

report) for each to maintain such 

records annually.

Dated: October 4, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–23103 Filed 10–13–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0186]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Animal Drug User 

Fees and Fee Waivers and Reductions

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that the 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 

(the PRA).

DATES: Fax written comments on the 

collection of information by November 

15, 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:

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

4B–41, Rockville, MD 20857, 301–827–

1472.

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.

Animal Drug User Fees and Fee 

Waivers and Reductions (OMB Control 

Number 0910–0540)—Extension

Enacted on November 18, 2003, the 

Animal Drug User Fee Act (ADUFA), 

(Public Law 108–130) amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) and requires FDA to assess and 

collect user fees for certain applications, 

products, establishments, and sponsors. 

It also requires the agency to grant a 

waiver from, or a reduction of those fees 

in certain circumstances. Thus, to 

implement this statutory provision of 

ADUFA, FDA developed a guidance 

entitled ‘‘Guidance for Industry: Animal 

Drug User Fees and Fee Waivers and 

Reductions.’’ This document provides 

guidance on the types of fees FDA is 

authorized to collect under ADUFA, and 

how to request waivers and reductions 

from FDA’s animal drug user fees. 

Further, this guidance also describes the 

types of fees and fee waivers and 

reductions; what information FDA 

recommends be submitted in support of 

a request for a fee waiver or reduction; 

how to submit such a request; and 

FDA’s process for reviewing requests. 

Respondents to this collection of 

information are new animal drug 

sponsors. Requests for waivers or 

reductions may be submitted by a 

person paying any of the animal drug 

user fees assessed—application fees, 

product fees, establishment fees, or 

sponsor fees.

In the Federal Register of May 3, 2004 

(69 FR 24169), FDA published a 60-day 

notice requesting comment on the 

collection of information. In response to 

that notice, no comments were received 

regarding the collection of information.

FDA estimates the burden for this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Act

Types of Waiver or Reduction Requests

No. of

Respondents Annual Frequency 

per Response 

Total Annual

Responses

Hours per

Response Total Hours 

740(d)(1)(A) 

Significant barrier to innovation 5 1 time for each 

application

5 2 10

740(d)(1)(B) 

Fees exceed cost 1 ‘‘ 122

740(d)(1)(C) 

Free choice feeds 5 ‘‘ 5 2 10

61024 Federal Register / Vol. 69, No. 198 / Thursday, October 14, 2004 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

Section of the Act

Types of Waiver or Reduction Requests

No. of

Respondents Annual Frequency 

per Response 

Total Annual

Responses

Hours per

Response Total Hours 

740(d)(1)(D) 

Minor use or minor species 10 ‘‘ 10 2 20

740(d)(1)(E) 

Small business 2 ‘‘ 224

Request for reconsideration of a decision 5 ‘‘ 5 2 10

Request for review—(user fee appeal 

officer) 2 ‘‘ 224

Total 60

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

Based on FDA’s database system, 

there are an estimated 250 sponsors of 

products subject to ADUFA. However, 

not all sponsors will have any 

submissions in a given year and some 

may have multiple submissions. The 

total number of waiver requests is based 

on the number of submissions types 

received by FDA in fiscal year 2003. The 

Center for Veterinary Medicine 

estimates 30 waiver requests that 

include the following: 5 significant 

barriers to innovation, 1 fee exceed cost, 

5 free choice feeds, 10 minor use or 

minor species, 2 small business waiver 

requests, 5 requests for reconsideration 

of a decision, and 2 requests for user fee 

appeal officers. The estimated hours per 

response are based on past FDA 

experience with the various waiver 

requests in the Center for Drug 

Evaluation and Research. The hours per 

response are based on the average of 

these estimates.

Dated: October 8, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–23104 Filed 10–13–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0185]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Animal Drug User 

Fee Cover Sheet

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 November 

15, 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:

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

4B–41, Rockville, MD 20857, 301–827–

1472.

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:

Animal Drug User Fee Cover Sheet; 

FDA Form 3547 (OMB Control Number 

0910–0539)—Extension

Under section 740 of the Federal 

Food, Drug, and Cosmetic Act (the act), 

as amended by the Animal Drug User 

Fee Act (ADUFA) (21 U.S.C. 379j–12), 

FDA has the authority to assess and 

collect certain animal drug user fees. 

Because the submission of user fees 

concurrently with applications and 

supplements is required, review of an 

application cannot begin until the fee is 

submitted. Under the new statutory 

provisions (section 740(e) of the act, as 

amended by ADUFA), animal drug 

applications and supplemental animal 

drug applications for which the required 

fee has not been paid are considered 

incomplete and are not to be accepted 

for review by the agency. The types of 

fees that require a cover sheet are 

certain animal drug application fees and 

certain supplemental animal drug 

application fees. The cover sheet, FDA 

Form 3546, is designed to provide the 

minimum necessary information to 

determine whether a fee is required for 

the review of an application or 

supplement, to determine the amount of 

the fee required, and to assure that each 

animal drug user fee payment and each 

animal drug application for which 

payment is made, is appropriately 

linked to the payment that is made. The 

form, when completed electronically, 

will result in the generation of a unique 

payment identification number used in 

tracking the payment. FDA will use the 

information collected, to initiate 

administrative screening of new animal 

drug applications and supplements to 

determine if payment has been received. 

Inability to collect this information 

would delay the review process and 

would also delay receipt of revenue that 

is to be used to fund the review of 

animal drug applications during the 

current fiscal year. Respondents to this 

collection of information are new 

animal drug applicants or 

manufacturers.

In the Federal Register of May 3, 2004 

(69 FR 24168), FDA published a 60-day 

notice requesting comment on the 

collection of information. In response to 

that notice, no comments were received 

regarding the collection of information.

FDA estimates the burden of this 

collection of information as follows: