[Federal Register Volume 75, Number 24 (Friday, February 5, 2010)]
[Notices]
[Pages 6034-6035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2461]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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.

-----------------------------------------------------------------------

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 
the information collection on how to submit a notice of intent to 
slaughter for human food purposes in electronic format to the Center 
for Veterinary Medicine (CVM).

DATES: Submit written or electronic comments on the collection of 
information by April 6, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 Submit a Notice of Intent to Slaughter 
for Human Food Purposes in Electronic Format to the Center for 
Veterinary Medicine--Section 512(j) of the 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) (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, 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 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. 601-695). 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) 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 for 
submitting 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             No. of.         Annual Frequency       Total Annual        Hours per
         Section of the act/FDA Form              Respondents         per Response          Responses          Responses         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
512(j)/3488                                                            40                   0.4              16\2\                .08                1.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

[[Page 6035]]

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 Control 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: January 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2461 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S