Federal Register / Vol. 73, No. 160 / Monday, August 18, 2008 / Rules and Regulations 48127 

Issued in Washington, DC, on August 13, 

2008. 

Pamela Hamilton, 

Director, Office of Rulemaking. 

[FR Doc. E8–19039 Filed 8–15–08; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 530 

[Docket No. FDA–2008–N–0326] 

New Animal Drugs; Cephalosporin 

Drugs; Extralabel Animal Drug Use; 

Order of Prohibition; Extension of 

Comment Period; Delay of Effective 

Date of Final Rule 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Extension of comment period; 

delay of effective date of final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

November 1, 2008, the comment period 

for the order of prohibition. FDA is also 

delaying the effective date of this final 

rule to November 30, 2008. In the final 

rule, FDA requested comments on the 

document. The agency is taking this 

action in response to requests for an 

extension to allow additional time to 

submit comments. 

DATES: The effective date of the rule 

amending 21 CFR 530.41 published at 

73 FR 38110, July 3, 2008 is delayed 

until November 30, 2008. Submit 

written and electronic comments by 

November 1, 2008. 

ADDRESSES: You may submit comments, 

identified by [Docket No. FDA–2008–N–

0326], by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Neal 

Bataller, Center for Veterinary Medicine 

(HFV–230), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD, 20855, 240–276–9200, email: neal.bataller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 3, 2008 

(73 FR 38110), FDA published an order 

prohibiting the extralabel use of 

cephalosporin antimicrobial drugs in 

food-producing animals, with a 60-day 

comment period and a 90-day effective 

date for the final rule. 

The agency has received requests for 

a 60-day extension of the comment 

period for the order of prohibition. The 

requests conveyed concern that the 

current 60-day comment period does 

not allow sufficient time to examine the 

available evidence, consider the impact 

of the ruling, and provide constructive 

comment. 

FDA has considered the requests and 

is extending the comment period for the 

order for 60 days, until November 1, 

2008. Accordingly, FDA is also delaying 

the effective date of the final rule 60 

days, until November 30, 2008. The 

agency believes that a 60-day extension 

allows adequate time for interested 

persons to submit comments without 

significantly delaying implementation 

of the final rule. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: July 31, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–18967 Filed 8–15–08; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2008–0051–200805(a); 

FRL–8705–3] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Tennessee; Approval of Revisions to 

the Nashville/Davidson County Portion 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to approve a revision to the State 

Implementation Plan (SIP) submitted by 

the State of Tennessee on October 19, 

2007. The revision affects the Nashville/ 

Davidson County portion of the 

Tennessee SIP. Specifically, the revision 

pertains to the Metropolitan Public 

Health Department, Pollution Control 

Division’s Regulation Number 8, 

‘‘Inspection and Maintenance of LightDuty Motor Vehicles.’’ The revision is 

part of Nashville/Davidson County’s 

strategy to meet the requirements of 

EPA’s 1997 8-hour ozone standard. 

Regulation Number 8 is amended by 

reducing the vehicle emission 

inspection fee to $9.00 and updating the 

definitions section. This revision is 

considered by the Tennessee 

Department of Environment and 

Conservation (TDEC), to be at least as 

stringent as the State of Tennessee’s 


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