27956 Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Rules and Regulations 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

FDA has determined under 21 CFR 

25.33 that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

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. 

List of Subjects in 21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 520 

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 520 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. Section 510.600 is amended in the 

table in paragraph (c)(1) by 

alphabetically adding a new entry for 

‘‘Superior Equine Pharmaceuticals, 

Inc.’’ and in the table in paragraph (c)(2) 

by numerically adding a new entry for 

‘‘027053’’ 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 

* * * * * 

Superior Equine Pharmaceuticals, Inc., 

Pleasant Grove, UT 

84062 027053 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

027053 Superior Equine Pharmaceuticals, Inc., 

Pleasant Grove, UT 

84062. 

* * * * * 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 4. Revise § 520.1720e, to read as 

follows: 

§ 520.1720e Phenylbutazone powder. 

(a) Specifications—(1) Each 1.15 

grams (g) of powder contains 1 g 

phenylbutazone. 

(2) Each 10 g of powder contains 1 g 

phenylbutazone. 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter. 

(1) No. 027053 for use of product 

described in paragraph (a)(1) of this 

section. 

(2) No. 057699 for use of product 

described in paragraph (a)(2) of this 

section. 

(c) Conditions of use in horses—(1) 

Amount. Administer 1 to 2 g (1 to 2 

level scoops, using the scoop provided) 

per 500 pounds of body weight on a 

small amount of palatable feed, not 

exceed 4 g per animal daily. 

(2) Indications for use. For the relief 

of inflammatory conditions associated 

with the musculosketetal system. 

(3) Limitations. Do not use in horses 

intended for human consumption. 

Federal law prohibits the extralabel use 

of this product in female cattle 20 

months of age or older. Federal law 

restricts this drug to use by or on the 

order of a licensed veterinarian. 

Dated: May 7, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–9559 Filed 5–17–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; Butorphanol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an abbreviated new animal 

drug application (ANADA) filed by IVX 

Animal Health, Inc. The ANADA 

provides for veterinary prescription use 

of butorphanol tartrate injectable 

solution in cats for the relief of pain. 

DATES: This rule is effective May 18, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: IVX 

Animal Health, Inc., 3915 South 48th 

Street Ter., St. Joseph, MO 64503, filed 

ANADA 200–408 that provides for 

veterinary prescription use of 

Butorphanol Tartrate Injection (2mg/ 

mL) in cats for the relief of pain. IVX 

Animal Health, Inc.’s Butorphanol 

Tartrate Injection (2mg/mL) is approved 

as a generic copy of Fort Dodge Animal 

Health, a Div. of Wyeth’s 

TORBUGESIC–SA (butorphanol tartrate, 

USP), approved under NADA 141–047. 

The ANADA is approved as of April 20, 

2007, and the regulations are amended 

in 21 CFR 522.246 to reflect the 

approval and a current format. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

FDA has determined under 21 CFR 

25.33(a)(1) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 


cprice-sewell on PRODPC61 with RULES
Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Rules and Regulations 27957 

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. 

List of Subjects in 21 CFR Part 522 

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 part 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. Revise § 522.246 to read as follows: 

§ 522.246 Butorphanol. 

(a) Specifications. Each milliliter of 

solution contains butorphanol (as 

butorphanol tartrate) in the following 

amounts: 

(1) 0.5 milligrams (mg); 

(2) 2 mg; or 

(3) 10 mg 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter as follows: 

(1) No. 000856 for use of the product 

described in paragraph (a)(1) as in 

paragraph (d)(1) of this section; for use 

of the product described in paragraph 

(a)(2) as in paragraph (d)(2) of this 

section; and for use of the product 

described in paragraph (a)(3) as in 

paragraph (d)(3) of this section. 

(2) No. 059130 for use of the product 

described in paragraph (a)(2) as in 

paragraph (d)(2) of this section. 

(3) Nos. 057926 and 059130 for use of 

the product described in paragraph 

(a)(3) as in paragraph (d)(3) of this 

section. 

(c) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

(d) Conditions of use—(1) Dogs—(i) 

Amount. Administer 0.025 mg per 

pound of body weight by subcutaneous 

injection at intervals of 6 to 12 hours, 

as required. If necessary, increase dose 

to a maximum of 0.05 mg per pound of 

body weight. Treatment should not 

normally be required for longer than 7 

days. 

(ii) Indications for use. For the relief 

of chronic nonproductive cough 

associated with tracheo-bronchitis, 

tracheitis, tonsillitis, laryngitis, and 

pharyngitis associated with 

inflammatory conditions of the upper 

respiratory tract. 

(2) Cats—(i) Amount. Administer 0.2 

mg per pound of body weight by 

subcutaneous injection. Dose may be 

repeated up to 4 times per day. Do not 

treat for more than 2 days. 

(ii) Indications for use. For the relief 

of pain in cats caused by major or minor 

trauma, or pain associated with surgical 

procedures. 

(3) Horses—(i) Amount. Administer 

0.05 mg per pound of body weight by 

intravenous injection. Dose may be 

repeated within 3 to 4 hours. Treatment 

should not exceed 48 hours. 

(ii) Indications for use. For the relief 

of pain associated with colic and 

postpartum pain in adult horses and 

yearlings. 

(iii) Limitations. Do not use in horses 

intended for human consumption. 

Dated: May 3, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–9557 Filed 5–17–07; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[MD201–3117; FRL–8313–2] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Maryland; Update to Materials 

Incorporated by Reference 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; Notice of 

administrative change. 

SUMMARY: EPA is updating the materials 

submitted by Maryland that are 

incorporated by reference (IBR) into the 

State implementation plan (SIP). The 

regulations affected by this update have 

been previously submitted by the 

Maryland Department of the 

Environment (MDE) and approved by 

EPA. This update affects the SIP 

materials that are available for public 

inspection at the National Archives and 

Records Administration (NARA), the 

Air and Radiation Docket and 

Information Center located at EPA 

Headquarters in Washington, DC, and 

the Regional Office. 

EFFECTIVE DATE: This action is effective 

May 18, 2007. 

ADDRESSES: SIP materials which are 

incorporated by reference into 40 CFR 

part 52 are available for inspection at 

the following locations: Air Protection 

Division, U.S. Environmental Protection 

Agency, Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103; the 

Air and Radiation Docket and 

Information Center, EPA Headquarters 

Library, Room Number 3334, EPA West 

Building, 1301 Constitution Ave., NW., 

Washington, DC 20460, and the 

National Archives and Records 

Administration. If you wish to obtain 

materials from a docket in the EPA 

Headquarters Library, please call the 

Office of Air and Radiation (OAR) 

Docket/Telephone number: (202) 566–

1742; or the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/

federal_register/

code_of_federal_regulations/

ibr_locations.html. 

FOR FURTHER INFORMATION CONTACT: 

Harold A. Frankford, (215) 814–2108 or 

by e-mail at frankford.harold@epa.gov. 

SUPPLEMENTARY INFORMATION: The SIP is 

a living document which the State 

revises as necessary to address the 

unique air pollution problems. 

Therefore, EPA from time to time must 

take action on SIP revisions containing 

new and/or revised regulations to make 

them part of the SIP. On May 22, 1997 

(62 FR 27968), EPA revised the 

procedures for incorporating by 

reference Federally-approved SIPs, as a 

result of consultations between EPA and 

the Office of the Federal Register (OFR). 

The description of the revised SIP 

document, IBR procedures and 

‘‘Identification of plan’’ format are 

discussed in further detail in the May 

22, 1997 Federal Register document. On 

November 29, 2004 (69 FR 69304), EPA 

published a document in the Federal 

Register beginning the new IBR 

procedure for Maryland. On February 2, 

2006 (72 FR 5607), EPA published an 

update to the IBR material for Maryland. 

In this document, EPA is doing the 

following: 

1. Announcing the update to the IBR 

material as of March 15, 2007. 

2. Making corrections to the following 

entries listed in the paragraph 

52.1070(c) chart, as described below: 

a. COMAR 26.11.01.04—revising the 

text in the ‘‘Additional explanation/ 

citation at 40 CFR § 52.1100’’ column by 

adding the SIP effective date. 

b. COMAR 26.11.09.01—revising the 

text in the ‘‘Additional explanation/ 

citation at 40 CFR § 52.1100’’ column by 

correcting the COMAR citation. 

c. Technical Memorandum (TM) 91–

01—This entry is revised to reflect 

EPA’s approval of revisions to this TM 


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