[Federal Register: October 14, 2004 (Volume 69, Number 198)]
[Notices]
[Page 61024-61025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc04-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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
0910-0539)--Extension
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
manufacturers.
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
follows:
[[Page 61025]]
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
Section of the Act No. of Frequency Total Annual Hours per
as Amended by Respondents per Responses Response Total Hours
ADUFA Response
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740(a)(1) FDA Form 69 1 time for 69 1 69
3547 (Cover each
Sheet) application
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\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 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
estimates.
Dated: October 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-23105 Filed 10-13-04; 8:45 am]
BILLING CODE 4160-01-S