2012-17369. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Form FDA 3728, Animal Generic Drug User Fee Act 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 August 16, 2012.

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: [phone], or emailed to [e-mail]. 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 II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 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.

Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet—21 U.S.C. 379j-21 (OMB Control Number 0910-0632)—Extension

Section 741 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-21) 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 (21 U.S.C. 379j-21(a)). Because the submission of user fees concurrent with applications is required, the review of an application cannot begin until the fee is submitted. Form FDA 3728 is the Animal Generic Drug User Fee Act (AGDUFA) Cover Sheet, which is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees.

In the Federal Register of October 5, 2011 (76 FR 61709), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

FDA Form Number	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
3728	20	2	40	.08 (5 min.)	3.2
1 There 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 AGDUFA.

Dated: July 12, 2012.

Leslie Kux,

Assistant Commissioner for Policy.