[Federal Register Volume 68, Number 152 (Thursday, August 7, 2003)]
[Notices]
[Pages 47076-47077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20059]


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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