[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