10596 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0572] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the Animal Generic Drug User Fee 

Cover Sheet Form FDA 3728 that further 

implements certain provisions of the 

Animal Generic Drug User Fee Act of 

2008 (AGDUFA). 

DATES: Submit written or electronic 

comments on the collection of 

information by May 11, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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 of 1995 for 90 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: (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. 

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 data base 

system, there are an estimated 20 

sponsors of new animal drugs 

potentially subject to AGDUFA. 

Dated: March 4, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5107 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0462] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CERENIA INJECTABLE 

SOLUTION 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CERENIA INJECTABLE SOLUTION and 

is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

animal drug product. 


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