Agency Emergency Processing Under Office of Management and Budget Review; Animal Drug User Fee 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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information, Animal Drug User Fee Cover Sheet (cover sheet), will be used to assure that each animal drug user fee payment and each animal drug application for which payment is made is appropriately linked to the payment that is made. FDA is requesting this emergency processing under the PRA to implement new statutory requirements of the Animal Drug User Fee Act (ADUFA) (section 740(a)(1) of the Federal Food Drug and Cosmetic Act (the act). ADUFA requires FDA to collect fees from each person who submits certain new animal drug applications or supplements on or after September 1, 2003, and FDA may not accept applications for review if all fees have not been paid (section 740(e) of the act).

DATES:

Fax written comments on the collection of information provisions by March 10, 2004. FDA is requesting approval of this emergency processing by March 15, 2004.

ADDRESSES:

OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974, or electronically mail comments to: Fumie_Yokota@omb.eop.gov. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:

FDA has requested 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). This information is needed immediately so that the agency can use the cover sheet to collect information from entities submitting animal drug applications. That information is needed to assure that the application fee payments are correctly associated with the payer of the fee and with the application for which payment is made.

ADUFA was signed into law on November 18, 2003 (Public Law 108-130) and the appropriation act enabling FDA to collect the newly authorized fees was signed into law on January 23, 2004 (Public Law 108-199). ADUFA requires FDA to collect animal drug application fees from each person who submits certain animal drug applications or supplements on or after September 1, 2003 (section 740(a)(1)(A) of the act). The use of normal clearance procedures would result in the prevention or disruption of this collection of information and the delay of fees that must be collected immediately to fund animal drug review activities in the current fiscal year. Therefore, FDA has requested approval of this emergency processing for this proposed collection of information by March 15, 2004.

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.

Animal Drug User Fee Cover Sheet; FDA Form 3546

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. Under the new statutory provisions (section 740(e) of the act, as amended by ADUFA), animal drug applications and supplemental animal drug applications for which the required fee has not been paid are considered incomplete and are not to be accepted for review by the agency. 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 (Form FDA 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 the payment that is made. The form, when completed electronically, will result in the generation of a unique payment identification number used in tracking the payment. FDA will use he information collected to initiate administrative screening of new animal drug applications and supplements to determine if payment has been received. Inability to collect this information would delay the review process, and would also delay receipt of revenue that is to be used to fund the review of animal drug applications during the current fiscal year. FDA is requesting this emergency processing under the PRA to implement these new statutory requirements of ADUFA (section 740(a)(1) and (e) of the act).

Respondents to this collection of information are new animal drug applicants or manufacturers. Based on FDA's data base system, there are an estimated 140 manufacturers of products or sponsors of new animal drugs potentially subject to ADUFA. However, not all manufacturers or sponsors will have any submissions in a given year and some may have multiple submissions. The total number of annual responses is based on the number of submissions received by FDA in fiscal year 2003. The Center for Veterinary Medicine (CVM) estimates 69 annual responses that include the following: 28 new animal drug premarket approval applications and 41 supplements. The estimated hours per response are based on past FDA experience with the various submissions, and range from 30 minutes to 1 hour. The hours per response are based on the average of these estimates.