[Federal Register Volume 72, Number 32 (Friday, February 16, 2007)]
[Notices]
[Pages 7660-7661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0435]


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 a 
proposed collection of information 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 March 
19, 2007.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-6974.

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: 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,'' 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 (21 
U.S.C. 360b(j)) 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 USC 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 
via the Internet. The electronic submission of slaughter notices is 
part of CVM's ongoing initiative to provide a method for paperless 
submissions.
    In the Federal Register of November 8, 2006 (71 FR 65532), FDA 
published a 60-day notice soliciting comments on the information 
collection provisions of this collection. In response to this notice, 
no comments were received.
    The likely respondents for this collection of information 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 7661]]

 
\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 is 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: February 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2710 Filed 2-15-07; 8:45 am]
BILLING CODE 4160-01-S