22812 Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 

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. 

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 BURDEN1

Section of the act/ 

FDA Form Number 

Number of 

Respondents 

Annual Frequency 

of Responses 

Total Annual 

Responses2

Hours per 

Response Total Hours 

512j/3488 40 0.4 16 .08 1.3 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Electronic 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0600] 

Guidance for Industry on Tobacco 

Health Document Submission; 

Availability; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of April 20, 2010 (75 FR 

20606). The notice announced the 

availability of a guidance entitled 

‘‘Tobacco Health Document 


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