E7-22649. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546

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 December 20, 2007.

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 e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0539. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley Jr. Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 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 3546; 21 U.S.C. 379j-12; (OMB Control Number: 0910-0539)—Extension

Under Section 740 of the act, as amended by ADUFA (21 U.S.C. 379j-12), FDA has the authority to assess and collect for 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. 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 that payment. The form, when completed electronically, will result in the generation of a unique payment identification number used for 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.

In a Federal Register of June 15, 2007 (72 FR 33231), FDA published a 60-day notice soliciting public comment on the proposed collection of information provisions. In response to that notice, no comments were received.

Respondents to this collection of information are new animal drug sponsors applicants or manufacturers.

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

Table 1.—Estimated Annual Reporting Burden¹

21 U.S.C. 379j-12	Number of Respondents	Annual Frequency per Response	Total annual Responses	Hours per Response	Total Hours
740(a)(1) FDA Form 3546 (Cover Sheet)	69	1 time for each application	69	1	69
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: November 14, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.