[Federal Register: February 26, 2004 (Volume 69, Number 38)]
[Notices]               
[Page 8980-8981]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe04-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0077]

 
Agency Emergency Processing Under Office of Management and Budget 
Review; Animal Drug User Fee Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[Page 8981]]

 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). FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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 Section of the act as amended by      No. of     Annual Frequency per  Total Annual    Hours per
               ADUFA                 Respondents        Response          Responses     Response     Total Hours
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740(a)(1) FDA Form 3546 (cover               69   1 time for each                69             1            69
 sheet).                                           application.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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.

    Dated: February 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4309 Filed 2-23-04; 4:07 pm]

BILLING CODE 4160-01-S