[Federal Register: May 3, 2004 (Volume 69, Number 85)]
[Page 24168-24169]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0185]

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements for 
the animal drug user fee cover sheet.

DATES: Submit written or electronic comments on the collection of 
information by July 2, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on the 

collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    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.

Animal Drug User Fee Cover Sheet; FDA Form 3547 (OMB Control Number 

    Under section 740 of 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.

[[Page 24169]]

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 manufacturers.
    FDA estimates the burden of this collection of information as 

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

    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 fiscal year 2003. FDA's Center for 
Veterinary Medicine estimates 69 annual responses that include 28 new 
animal drug premarket approval applications and 41 supplements. The 
estimated hours per responses 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.

    Dated: April 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9889 Filed 4-30-04; 8:45 am]