[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65532-65533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0435]


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 extending OMB approval on the 
existing reporting requirements for the information collection activity 
entitled ``How to Use E-mail to Submit a Notice of Intent to Slaughter 
For Human Food Purposes.''

DATES: Submit written or electronic comments on the collection of 
information by January 8, 2007.

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, 5630 Fishers Lane, rm. 1061, 
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, Jr., Office of the 
Chief Information Officer (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 extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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; (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,'' Section 512j, Federal 
Food, Drug, and Cosmetic Act; (OMB Control Number 0910-0450)--Extension

    Section 512(j) of the Federal Food, Drug, and Cosmetic Act (the 
act), gives FDA the authority to set conditions under which animals 
treated with investigational new animal drugs may be marketed for food 
use. Under this authority, the Center for Veterinary Medicine (CVM), 
issues to a new animal drug sponsor (sponsors) a slaughter 
authorization letter that sets the terms under which investigational 
animals may be slaughtered. The United States Department of Agriculture 
(USDA), also monitors the slaughter of animals treated with 
investigational new animal drugs under the authority of the Meat 
Inspection Act (21 U.S.C. 601-95). Sponsors must submit slaughter 
notices each time investigational animals are presented for slaughter, 
unless this requirement is waived by an authorization letter ((21 CFR 
511.1(b)(5)), (9 CFR 309.17)). These notifications assist CVM and USDA 
in monitoring the safety of the food supply. Slaughter notices were 
previously submitted to CVM and USDA on paper. (OMB No. 0910-0450). 
CVM's guidance on ``How to Use E-Mail to Submit a Notice of Intent to 
Slaughter for Human Food Purposes'' provides sponsors with the option 
to submit a slaughter notice as an e-mail attachment to CVM and USDA by 
the internet.
    The electronic submission of slaughter notices is part of CVM's 
ongoing initiative to provide a method for paperless submissions.
    The likely respondents are new animal drug sponsors.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                       Form No.                            Respondents         per Response         Responses\2\         Response         Total Hours
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FDA Form 3488                                                 25                   .08                  2               0.41                .82
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 65533]]

 
\2\Electronic submissions received between July 1, 2005 and June 30, 2006.

    The number of respondents in table 1 of this document is the number 
of sponsors registered to make electronic submissions (25). The number 
of total annual responses are based on a review of the actual number of 
submissions made between July 1, 2005, and June 30, 2006. 2 x hours per 
response (.41) = .82 total hours.
    Submitting a slaughter notice electronically represents an 
alternative to submitting a notice of intent to slaughter 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 21 CFR 511.1 (OMB No. 0910-0450). The estimates in Table 
1 of this document reflect the burden associated with putting the same 
information on FDA Form 3488 and resulted from previous 
discussions with sponsors about the time necessary to complete this 
form.

    Dated: November 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18896 Filed 11-7-06; 8:45 am]
BILLING CODE 4160-01-S