Document ID: FDA-2010-D-0035-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on How to Submit a Notice of Intent to Slaughter for Human Food Purposes, etc.
Posted Date: 2010-04-30T04:00Z

[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Notices]               
[Page 22812]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap10-90]                         

[[Page 22812]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0035]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on How to Submit a Notice of Intent to Slaughter for Human Food 
Purposes in Electronic Format to the Center for Veterinary Medicine

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 June 1, 
2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0450. 
Also include the FDA docket number found in brackets in the heading of 
this document

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 Submit a Notice of Intent to Slaughter 
for Human Food Purposes in Electronic Format to The Center for 
Veterinary Medicine--(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, FDA's Center for Veterinary Medicine (CVM) 
issues to a new animal drug sponsor (sponsor) a slaughter authorization 
letter that sets the terms under which animals treated with 
investigational new animal drugs may be slaughtered. The U.S. 
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 animals treated with investigational 
new animal drugs are presented for slaughter, unless this requirement 
is waived by an authorization letter (21 CFR 511.1(b)(5) and 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 in paper format. CVM's guidance on ``How to Submit a 
Notice of Intent to Slaughter for Human Food Purposes in Electronic 
Format to the Center for Veterinary Medicine'' provides sponsors with 
the option of submitting a slaughter notice to CVM and USDA via the 
Internet as an e-mail attachment. The electronic submission of 
slaughter notices is part of CVM's ongoing initiative to provide a 
method for paperless submission. The likely respondents are new animal 
drug sponsors.
    In the Federal Register of February 5, 2010 (75 FR 6034), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  Section of the
  act/  FDA Form       Number of       Annual Frequency     Total Annual        Hours per         Total Hours
      Number          Respondents        of Responses       Responses\2\         Response
----------------------------------------------------------------------------------------------------------------
512j/3488                         40                0.4                 16                .08                1.3
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Electronic submissions received between January 1, 2008, and December 31, 2008.

    The number of respondents in table 1 of this document is the number 
of sponsors registered to make electronic submissions (40). The number 
of total annual responses are based on a review of the actual number of 
submissions made between January 1, 2008, and December 31, 2008. 
Sixteen total annual responses times .08 hours per response = 1.3 total 
hours.
    Submitting a slaughter notice electronically represents an 
alternative to submitting a notice on paper of intent to slaughter. The 
reporting burden for compilation and submission on paper of this 
information is included in OMB clearance of the information collection 
provisions of 21 CFR 511.1 (OMB number 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: April 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10084 Filed 4-29-10; 8:45 am]
BILLING CODE 4160-01-S