Food and Drug Administration, HHS.
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the burden hours required for the Animal Generic Drug User Fee Cover Sheet, Form FDA 3728 and the timeframe requirement under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (21 U.S.C. 379j-21) for implementing the new user fee cover sheet Form FDA 3728.
Fax written comments on the collection of information by November 10, 2008.
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 firstname.lastname@example.org. All comments should be identified with the OMB control number 0910-NEW and “Implementation of the Animal Generic Drug User Fee Act of 2008 (21 U.S.C. 379j-21(a)); User Fee Cover Sheet Form 3728; Emergency Request.” Also include the FDA docket number found in brackets in the heading of this document.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
FDA is requesting emergency processing of this proposed collection of information under section 3507(j) of the PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The Federal Food, Drug, and Cosmetic Act (the act), as amended by AGDUFA authorizes FDA to collect user fees: (1) For certain abbreviated applications for a generic new animal drug, (2) on certain generic new animal drug products, and (3) on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs.
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); Emergency Request
Section 741 of the 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. 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:
|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|
|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 new animal drug applicants. Based on FDA's data base system, there are an estimated 20 sponsors of new animal drugs potentially subject to AGDUFA. The Start Printed Page 65385annual reporting burden estimates in table 1 of this document are based on FDA's previous experience.Start Signature
Dated: October 29, 2008.
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26162 Filed 10-31-08; 8:45 am]
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