[Federal Register: October 14, 2004 (Volume 69, Number 198)]
[Page 61024-61025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0185]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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 review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, 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 3547 (OMB Control Number 
    Under section 740 of the Federal Food, Drug, and Cosmetic Act (the 
act), as amended by the Animal Drug User Fee Act (ADUFA) (21 U.S.C. 
379j-12), FDA has the authority to assess and collect 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, 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 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 the 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. Respondents to 
this collection of information are new animal drug applicants or 
    In the Federal Register of May 3, 2004 (69 FR 24168), FDA published 
a 60-day notice requesting comment on the collection of information. In 
response to that notice, no comments were received regarding the 
collection of information.
    FDA estimates the burden of this collection of information as 

[[Page 61025]]

                                 Table 1.--Estimated Annual Reporting Burden\1\
Section of the Act        No. of          Frequency      Total Annual          Hours per
   as Amended by        Respondents          per           Responses           Response           Total Hours
       ADUFA                              Response
740(a)(1) FDA Form                 69   1 time for                   69                   1                  69
 3547 (Cover                             each
 Sheet)                                  application
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Based on FDA's database 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 the fiscal year 2003. FDA's Center for 
Veterinary Medicine, 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 

    Dated: October 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-23105 Filed 10-13-04; 8:45 am]