[Federal Register: May 3, 2004 (Volume 69, Number 85)]
[Notices]
[Page 24168-24169]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my04-92]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
0910-0539)--Extension
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
follows:
Table 1.--Estimated Annual Reporting\1\
------------------------------------------------------------------------
Section
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
Sheet)
------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-S