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:

Federal Register / Vol. 69, No. 198 / Thursday, October 14, 2004 / Notices 61025

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Act as Amended by 

ADUFA 

No. of

Respondents

Annual Frequency 

per

Response

Total Annual

Responses

Hours per

Response Total Hours 

740(a)(1) FDA Form 3547 (Cover 

Sheet)

69 1 time for each application69 1 69

1 There 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 140 

manufacturers of products or sponsors 

of new animal drugs potentially subject 

to ADUFA. However, not all 

manufacturers or sponsors will have any 

submissions in a given year and some 

may have multiple submissions. The 

total number of annual responses is 

based on the number of submissions 

received by FDA in the fiscal year 2003. 

FDA’s Center for Veterinary Medicine, 

estimates 69 annual responses that 

include the following: 28 new animal 

drug premarket approval applications 

and 41 supplements. The estimated 

hours per response are based on past 

FDA experience with the various 

submissions and range from 30 minutes 

to 1 hour. The hours per response are 

based on the average of these estimates.

Dated: October 4, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–23105 Filed 10–13–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c) (2) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13), the Health 

Resources and Services Administration 

(HRSA) will publish periodic 

summaries of proposed projects being 

developed for submission to the Office 

of Management and Budget (OMB) 

under the Paperwork Reduction Act of 

1995. To request more information on 

the proposed project or to obtain a copy 

of the data collection plans, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

of other forms of information 

technology. 

Proposed Project: Survey of Safety Net 

Providers for the Healthy Communities 

Access Program National Evaluation—

New 

A survey of 800 safety net providers 

will be performed to provide essential 

information not otherwise available for 

the national evaluation of the Healthy 

Communities Access Program (Sect. 

340, Pub. L. 107–251, Oct. 26, 2002). A 

preliminary review indicates that this 

sample of providers provides an 

adequate representation of provider 

types of most interest. The survey 

results will be considered along with 

information from other quantitative and 

qualitative data sources (including 

national, State and local data and 

information from grantee consortia 

leaders and clients) in order to develop 

a Report to Congress in September 2005 

and a program evaluation report by 

September 2006. The survey will collect 

data for key evaluation goals including 

coordination and integration of safety 

net services, capacity and access issues, 

health care delivery, quality of care, cost 

savings, sustainability, and provider and 

patient satisfaction. 

The survey of the provider 

institution’s administrator will be multimodal using mail, telephone, and 

internet modes of data collection. Mail 

or internet responses will be requested, 

with telephone follow-up or survey 

administration. The key types of 

providers to be surveyed are those 

specified in the law as required 

consortia members (i.e., federally 

qualified health centers, hospitals, 

public health departments, and 

providers serving the medically 

uninsured and underserved). Two 

hundred providers of each type will be 

surveyed. The burden estimate is as 

follows:

Form Number of

respondents 

Responses per 

respondent Total reponses Hours perresponse 

Total burden 

hours 

Survey .............................................................. 800 1 800 .33 264 

Send comments to Susan G. Queen, 

Ph.D., HRSA Reports Clearance Officer, 

Room 14–33, Parklawn Building, 5600 

Fishers Lane, Rockville, Maryland 

20857. Written comments should be 

received with 60 days of this notice.

Dated: October 8, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–23109 Filed 10–13–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Availability of Funds Announced in the 

HRSA Preview

AGENCY: Health Resources and Services 

Administration, HHS.