[Federal Register: August 7, 2003 (Volume 68, Number 152)]
[Notices]
[Page 47076-47077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au03-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0330]
Agency Information Collection Activities; Proposed Collection;
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 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
electronically submitting notices of intent to slaughter for human food
purposes.
DATES: Submit written or electronic comments on the collection of
information by October 6, 2003.
ADDRESSES: Submit electronic comments on the collection of information
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, rm. 1061, 5630 Fishers Lane,
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 renewal 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 listed in
this document.
With respect to the proposed collection of information, FDA invites
comments on: (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;
[[Page 47077]]
(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.
Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent
to Slaughter for Human Food Purposes--21 CFR Part 511 (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).
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual
Form No. No. of Respondents per Respondent Responses Hours per Response Total Hours
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FDA Form 3488 12 7 84 0.40 33.6
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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: July 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20059 Filed 8-6-03; 8:45 am]
BILLING CODE 4160-01-S