[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Page 22812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10084]
[[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 [email protected]. 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
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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]
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