27802 Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments 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) 

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 or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: June 8, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–13684 Filed 6–10–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0572] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Implementation of 

the Animal Generic Drug User Fee Act 

of 2008; User Fee Cover Sheet Form 

FDA 3728 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by July 13, 

2009. 

ADDRESSES: 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: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0632. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Implementation of the Animal Generic 

Drug User Fee Act of 2008; User Fee 

Cover Sheet Form FDA 3728—21 U.S.C. 

379j-21 (OMB Control Number 0910– 

0632)—Extension 

This collection of information is 

currently approved under the 

emergency processing provisions of the 

PRA for 180 days. FDA is now seeking 

a 3-year clearance. 

Section 741 of the act (21 U.S.C. 379j21), establishes three different kinds of 

user fees: (1) Fees for certain types of 

abbreviated applications for generic new 

animal drugs, (2) annual fees for certain 

generic new animal drug products, and 

(3) annual fees for certain sponsors of 

abbreviated applications for generic new 

animal drugs and/or investigational 

submissions for generic new animal 

drugs. Because the submission of user 

fees concurrently with applications is 

required, the review of an application 

cannot begin until the fee is submitted. 

Form FDA 3728, the Animal Generic 

Drug User Fee Cover Sheet, is designed 

to provide the minimum necessary 

information in order to do the following: 

(1) Determine whether a fee is required 

for review of an application, (2) 

determine the amount of fee required, 

and (3) account for and track user fees. 

In the Federal Register of March 11, 

2009 (74 FR 10596), 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 U.S.C. 

379j-21 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 

Form FDA 

3728 20 2 40 .08 3.2 

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

Respondents to this collection of 

information are generic animal drug 

applicants. Based on FDA’s database 

system, there are an estimated 20 

sponsors of new animal drugs 

potentially subject to the Animal 

Generic Drug User Fee Act of 2008. 

Dated: June 3, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13716 Filed 6–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Performance Progress Report. 

OMB No.: 0970–0334. 


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