[Federal Register: January 8, 2004 (Volume 69, Number 5)]
[Notices]
[Page 1300-1301]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja04-29]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D-1314]
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 Intent to Slaughter for
Human Food Purposes
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 Intent
to Slaughter for Human Food Purposes--(OMB Control Number 0910-0450)--
Extension
Section 512(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(j)) gives FDA the authority to issue regulations setting
out the conditions for marketing animals treated with investigational
new animal drugs for food use. Under this authority, FDA's regulations
at Sec. 511.1(b)(4) (21 CFR 511.1(b)(4)), provide that sponsors must
obtain authorization to slaughter these animals for food. The Center
for Veterinary Medicine (CVM) may grant such authorization to a sponsor
under Sec. 511.1(b)(5). If CVM authorizes the slaughter of
investigational animals for food use, CVM issues a slaughter
authorization letter to new animal drug sponsors which sets the terms
under which such animals treated with investigational new animal drugs
may be slaughtered. The authorization letter states that sponsors must
submit slaughter notices each time such animals are to be slaughtered
unless CVM waives this notice in the authorization letter. Currently,
slaughter notices are submitted to CVM on paper. This guidance will
give sponsors the option to submit a slaughter notice electronically as
an e-mail attachment. The electronic submission of slaughter notices is
part of CVM's ongoing initiative to provide a method for paperless
submissions. The likely respondents to this collection of information
are new animal drug sponsors who have conducted clinical studies under
Sec. 511.1(b).
In the Federal Register of August 7, 2003 (68 FR 47076), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
[[Page 1301]]
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
No. of Frequency Total Hours per Total
Form No. Respondents per Annual Response Hours
Respondent Responses
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FDA Form 12 7 84 0.40 33.6
3488
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
Submitting a slaughter notice electronically represents a new
medium for submission of information currently submitted on paper. The
reporting burden for compilation and submission of this information on
paper is included in OMB clearance of the information collection
provisions of Sec. 511.1 (OMB control number 0910-0117). The estimates
in table 1 of this document reflect the burden associated with putting
the same information on FDA Form No. 3488 and resulted from discussions
with sponsors about the time necessary to complete this form.
Dated: December 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-349 Filed 1-7-04; 8:45 am]
BILLING CODE 4160-01-S