69 FR 38 pgs. 8980-8981 - Agency Emergency Processing Under Office of Management and BudgetReview; Animal Drug User Fee Cover Sheet
Type: NOTICEVolume: 69Number: 38Pages: 8980 - 8981
Docket number: [Docket No. 2004N-0077]
FR document: [FR Doc. 04-4309 Filed 2-23-04; 4:07 pm]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMANSERVICES
Food and Drug Administration
[Docket No. 2004N-0077]
Agency Emergency Processing Under Office of Management and BudgetReview; Animal Drug User Fee Cover Sheet
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing that a proposed collection of information has been submitted tothe Office of Management and Budget (OMB) for emergency processing underthe Paperwork Reduction Act of 1995 (the PRA). The proposed collection ofinformation, Animal Drug User Fee Cover Sheet (cover sheet), will be usedto assure that each animal drug user fee payment and each animal drugapplication for which payment is made is appropriately linked to thepayment that is made. FDA is requesting this emergency processing under thePRA 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 (theact). ADUFA requires FDA to collect fees from each person who submitscertain new animal drug applications or supplements on or after September1, 2003, and FDA may not accept applications for review if all fees havenot been paid (section 740(e) of the act).
DATES:
Fax written comments on the collection ofinformation provisions by March 10, 2004. FDA is requesting approval ofthis 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 notbeing accepted. To ensure that comments on the information collection arereceived, OMB recommends that written comments be faxed to the Office ofInformation and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officerfor FDA, FAX: 202-395-6974, or electronically mail commentsto: Fumie_Yokota@omb.eop.gov . All comments should beidentified with the docket number found in brackets in the heading of thisdocument.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management Programs (HFA-250), Food andDrug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1472.
SUPPLEMENTARY INFORMATION:
FDA has requested emergency processing of this proposed collection ofinformation under section 3507(j) of the PRA (44 U.S.C. 3507(j) and 5 CFR1320.13). This information is needed immediately so that the agency can usethe cover sheet to collect information from entities submitting animal drugapplications. That information is needed to assure that the applicationfee payments are correctly associated with the payer of the fee and withthe application for which payment is made.
ADUFA was signed into law on November 18, 2003 (Public Law108-130) and the appropriation act enabling FDA to collect the newlyauthorized fees was signed into law on January 23, 2004 (Public Law108-199). ADUFA requires FDA to collect animal drug application feesfrom each person who submits certain animal drug applications orsupplements on or after September 1, 2003 (section 740(a)(1)(A) of theact). The use of normal clearance procedures would result in the preventionor disruption of this collection of information and the delay of fees thatmust be collected immediately to fund animal drug review activities in thecurrent fiscal year. Therefore, FDA has requested approval of thisemergency processing for this proposed collection of information by March15, 2004.
FDA invites comments on these topics: (1) Whether the proposedcollection of information is necessary for the proper performance of FDA'sfunctions, including whether the information will have practical utility;(2) the accuracy of FDA's estimate of the burden of the proposed collectionof information, including the validity of the methodology and assumptionsused; (3) ways to enhance the quality, utility, and clarity of theinformation to be collected; and (4) ways to minimize the burden of thecollection of information on respondents, including through the use ofautomated collection techniques, when appropriate, and other forms ofinformation 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 userfees. Because the submission of user fees concurrently with applicationsand supplements is required, review of an application cannot begin untilthe fee is submitted. Under the new statutory provisions (section 740(e)of the act, as amended by ADUFA), animal drug applications and supplementalanimal drug applications for which the required fee has not been paid areconsidered incomplete and are not to be accepted for review by the agency.The types of fees that require a cover sheet are certain animal drugapplication fees and certain supplemental animal drug application fees.The cover sheet (Form FDA 3546) is designed to provide the minimumnecessary information to determine whether a fee is required for the reviewof an application or supplement, to determine the amount of the feerequired, and to assure that each animal drug user fee payment and eachanimal drug application for which payment is made is appropriately linkedto the payment that is made. The form, when completed electronically, willresult in the generation of a unique payment identification number used intracking the payment. FDA will use he information collected to initiateadministrative screening of new animal drug applications and supplements todetermine if payment has been received. Inability to collect thisinformation would delay the review process, and would also delay receipt ofrevenue that is to be used to fund the review of animal drug applicationsduring the current fiscal year. FDA is requesting this emergencyprocessing under the PRA to implement these new statutory requirements ofADUFA (section 740(a)(1) and (e) of the act).
FDA estimates the burden of this collection of information as follows:
| Section of the act as amended by ADUFA | No. 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 maintenancecosts associated with this collection of information. | |||||
Respondents to this collection of information are new animal drugapplicants or manufacturers. Based on FDA's data base system, there are anestimated 140 manufacturers of products or sponsors of new animal drugspotentially subject to ADUFA. However, not all manufacturers or sponsorswill have any submissions in a given year and some may have multiplesubmissions. The total number of annual responses is based on the number ofsubmissions received by FDA in fiscal year 2003. The Center for VeterinaryMedicine (CVM) estimates 69 annual responses that include the following:28 new animal drug premarket approval applications and 41 supplements. Theestimated hours per response are based on past FDA experience with thevarious submissions, and range from 30 minutes to 1 hour. The hours perresponse are based on the average of these estimates.
Dated: February 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4309 Filed 2-23-04; 4:07 pm]
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