9766 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations 

or 505(j)(2)(A)(vii)(IV) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(b)(2)(A)(iv) or 

355(j)(2)(A)(vii)(IV)). The Division of 

Drug Information Resources no longer 

exists. The agency contact for this 

information is now the Orange Book 

Staff, Office of Generic Drugs. 

In § 314.53(f), FDA is updating the 

agency unit to which notifications of 

requests for correction of patent 

information should be directed. The 

Drug Information Services Branch no 

longer exists. These notifications should 

now be sent to the Office of Generic 

Drugs Document Room, attention the 

Orange Book Staff. 

In § 314.107(e), FDA is updating the 

listing of agency units to which a 

505(b)(2) applicant must send 

notification of entry of an order or 

judgment in a court action. Instead of 

the appropriate division in the Office of 

Drug Evaluation I and Office of Drug 

Evaluation II, these notifications should 

now be sent to the appropriate division 

in the Office of New Drugs. 

In § 314.107(f)(2)(iv), FDA is updating 

the agency recipient of a 505(b)(2) 

applicant’s required notification that a 

legal action has been filed within 45 

days of receipt of a notice of paragraph 

IV certification (submitted under section 

505(b)(2)(A)(iv) of the act) from the 

appropriate division in the Center for 

Drug Evaluation and Research to the 

appropriate division in the Office of 

New Drugs. 

In § 314.125(b)(16), FDA is correcting 

a cross-reference to the agency’s 

regulations on institutional review 

boards (21 CFR part 56) by replacing 

‘‘part 58’’ with ‘‘part 56.’’ 

Publication of this document 

constitutes final action under the 

Administrative Procedure Act (5 U.S.C. 

553). FDA has determined that notice 

and public comment are unnecessary 

because the amendments to the 

regulations provide only technical 

changes to correct an inaccurate citation 

and to update agency contacts, and are 

nonsubstantive. 

List of Subjects in 21 CFR Part 314 

Administrative practice and 

procedure, Confidential business 

information, Drugs, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 314 is 

amended as follows: 

PART 314—APPLICATIONS FOR FDA 

APPROVAL TO MARKET A NEW DRUG 

■ 1. The authority citation for 21 CFR 

part 314 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

§ 314.52 [Amended] 

■ 2. Section 314.52 is amended in 

paragraph (a)(2) by removing ‘‘Division 

of Drug Information Resources (HFD– 

80), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘Orange Book Staff, Office of 

Generic Drugs, at the address identified 

on FDA’s Web site (http://www.fda.gov/ 

cder/ogd)’’. 

§ 314.53 [Amended] 

■ 3. Section 314.53 is amended in 

paragraph (f) by removing ‘‘Drug 

Information Services Branch (HFD–84), 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘Office of Generic Drugs, OGD 

Document Room, Attention: Orange 

Book Staff, at the address identified on 

FDA’s Web site (http://www.fda.gov/ 

cder/ogd)’’. 

§ 314.95 [Amended] 

■ 4. Section 314.95 is amended in 

paragraph (a)(2) by removing ‘‘Division 

of Drug Information Resources (HFD– 

80), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘Orange Book Staff, Office of 

Generic Drugs, at the address identified 

on FDA’s Web site (http://www.fda.gov/ 

cder/ogd)’’. 

§ 314.107 [Amended] 

■ 5. Section 314.107 is amended in 

paragraph (e) by removing ‘‘Office of 

Drug Evaluation I (HFD–100) or Office 

of Drug Evaluation II (HFD–500), 

whichever is applicable,’’ and by adding 

in its place ‘‘Office of New Drugs’’ and 

in paragraph (f)(2)(iv) by removing 

‘‘Center for Drug Evaluation and 

Research’’ and by adding in its place 

‘‘Office of New Drugs’’. 

§ 314.125 [Amended] 

■ 6. Section 314.125 is amended in 

paragraph (b)(16) by removing ‘‘part 58’’ 

and by adding in its place ‘‘part 56’’. 

Dated: February 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy. 

[FR Doc. E9–4813 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 529 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Change of 

Sponsor; Methoxyflurane 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for a new animal drug 

application (NADA) from ScheringPlough Animal Health, Inc., to Medical 

Developments International, Ltd. 

DATES: This rule is effective March 6, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 556 Morris 

Ave., Summit, NJ 07901, has informed 

FDA that it has transferred ownership 

of, and all rights and interest in, NADA 

14–485 for ANAFANE (methoxyflurane) 

Volatile Liquid for Inhalation 

Anesthesia to Medical Developments 

International, Ltd., P.O. Box 21, 

Sandown Village, 3171 VIC Australia. 

Medical Developments International, 

Ltd., is not currently listed in the animal 

drug regulations as a sponsor of an 

approved application. In addition, FDA 

has noticed that this new animal drug 

has not been previously codified in 21 

CFR part 529. Accordingly, the 

regulations are amended in 21 CFR 

510.600(c) to add entries for Medical 

Developments International, Ltd., and in 

21 CFR part 529 to add this new animal 

drug. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

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Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations 9767 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 529 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510 and 529 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) alphabetically add an 

entry for ‘‘Medical Developments 

International, Ltd.’’; and in the table in 

paragraph (c)(2) numerically add an 

entry for ‘‘025245’’ to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Medical Developments 

International, Ltd.,P.O. 

Box 21, Sandown Village, 3171 VIC Australia 

025245 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

025245 ......... Medical Developments 

International, Ltd.,P.O. 

Box 21, Sandown Village, 3171 VIC Australia 

* * * * * 

* * * * * 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 529 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 4. Add § 529.1455 to read as follows: 

§ 529.1455 Methoxyflurane. 

(a) Specifications. Methoxyflurane 

liquid. 

(b) Sponsor. See No. 025245 in 

§ 510.600 of this chapter. 

(c) Conditions of use—(1) Amount. 

The amount of methoxyflurane used 

depends on the weight of the patient, 

the depth of anesthesia, and the type of 

equipment used. Anesthesia may be 

induced with methoxyflurane alone, or 

by the intravenous administration of a 

short-acting general anesthetic or by 

inhalation of another anesthetic agent. 

(2) Indications for use. For the 

induction and maintenance of general 

anesthesia. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: March 3, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–4758 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2009–0026] 

Drawbridge Operation Regulation; 

Park Street Drawbridge, Oakland Inner 

Harbor, Alameda, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Eleventh 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the Park 

Street drawbridge across the Oakland 

Inner Harbor, mile 5.2, at Alameda, CA. 

The deviation is necessary to allow 

seismic retrofitting of the bridge. This 

deviation allows single leaf operation of 

the double leaf, bascule style 

drawbridge, during the deviation 

period. 

DATES: This deviation is effective from 

12:01 a.m. on February 1, 2009 until 

11:59 p.m. on May 31, 2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of the docket USCG– 

2009–0026 and are available online at 

http://www.regulations.gov. They are 

also available for inspection or copying 

at two locations: the Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays, and the 

Commander (dpw), Eleventh Coast 

Guard District, Building 50–2, Coast 

Guard Island, Alameda, CA 94501– 

5100, between 8 a.m. and 4 p.m., 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: 

David H. Sulouff, Chief, Bridge Section, 

Eleventh Coast Guard District, 

telephone (510) 437–3516. If you have 

questions on viewing the docket, call 

Renee Wright, Program Manager, Docket 

Operations, telephone (202) 366–9826. 

SUPPLEMENTARY INFORMATION: The 

County of Alameda requested a 

temporary change to the operation of the 

Park Street drawbridge across the 

Oakland Inner Harbor, mile 5.2, at 

Alameda, CA. The Park Street 

drawbridge navigation span provides a 

horizontal clearance of 241 feet between 

pier fenders. During single leaf 

operation, horizontal clearance is 

reduced to approximately 100 feet. The 

drawbridge provides a vertical clearance 

of 15 feet above Mean High Water in the 

closed-to-navigation position and 

unlimited vertical clearance in the 

open-to-navigation position. As required 

by 33 CFR 117.181, the draw shall open 

on signal; except that, from 8 a.m. to 9 

a.m. and 4:30 p.m. to 6:30 p.m. Monday 

through Friday except Federal holidays, 

the draw need not be opened for the 

passage of vessels. However, the draw 

shall open during the above closed 

periods for vessels which must, for 

reasons of safety, move on a tide or 

slack water, if at least two hours notice 

is given. The waterway is navigated by 

commercial, recreational, emergency 

and law enforcement vessels. 

Between the hours of 7 a.m. and 9 

p.m. Monday through Thursday, and 

between the hours of 7 a.m. and 3:30 

p.m. on Friday, the drawspan will be 

operated, one leaf at a time, while the 

opposite leaf, counterweight and hinges 

are seismically retrofitted. The 

drawbridge will be operated in the 

normal double leaf operation mode at 

night and on weekends, when work is 

not actually being performed on the 

bridge. The starting and ending dates for 

the project are from 12:01 a.m. on 

February 1, 2009 until 11:59 p.m. on 

May 31, 2009. This temporary deviation 

has been coordinated with the waterway 

users. The largest tug and barge 

combination on the waterway will be 

able to continue navigating safely 

through the bridge. Recreational and 

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