[Federal Register: January 8, 2004 (Volume 69, Number 5)]
[Notices]
[Page 1299-1300]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja04-27]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0328]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on How To Use E-Mail To Submit a Notice of Final Disposition of Animals
Not Intended for Immediate Slaughter
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below 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
February 9, 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,
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.
Guidance for Industry on How to Use E-Mail to Submit a Notice of Final
Disposition of Animals Not Intended for Immediate Slaughter--(OMB
Control Number 0910-0453)--Extension
The Center for Veterinary Medicine (CVM) monitors the final
disposition of food animals treated with investigational new animal
drugs in situations where the treated animals do not enter the human
food chain immediately at the completion of the investigational study.
CVM believes that monitoring of the final disposition of such food
animals is consistent with its responsibility to protect the public
health under the Federal Food, Drug, and Cosmetic Act. In addition, CVM
believes that acceptable standards of study conduct such as those set
out in 21 CFR 514.117 would include sponsors accounting for the
disposition of all animals treated with investigational new animal
drugs.
This guidance document describes the procedures that should be
followed by sponsors who wish to file a notice of disposition
electronically on FDA Form 3487. The information sponsors
should include on the form includes the sponsor's name and address, and
information about the investigational animals. The form has been
revised at the request of the sponsors to add a box that can be checked
if the submission amends a notice of disposition previously submitted
to CVM and to allow for consistency across forms. The likely
respondents to this collection of information are new animal drug
sponsors who have conducted clinical studies under 21 CFR 511.1(b).
In the Federal Register of August 7, 2003 (68 FR 47078), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 1300]]
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
FDA Form No. of Frequency Total Hours per Total
No. Respondents per Annual Response Hours
Respondent Responses
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3487 12 27 324 0.81 262
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
Dated: December 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-347 Filed 1-7-04; 8:45 am]
BILLING CODE 4160-01-S