26646 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

contact for correspondence between the 

FAA and the certificate holder and the 

name and mailing address of the 

certificate holder’s agent for service. 

(2) Other business names under 

which the certificate holder may 

operate. 

(3) Reference to the economic 

authority issued by the Department of 

Transportation, if required. 

(4) Type of aircraft, registration 

markings, and serial number of each 

aircraft authorized for use. 

(i) Subject to the approval of the 

Administrator with regard to form and 

content, the certificate holder may 

incorporate by reference the items listed 

in paragraph (b)(4) of this section into 

the certificate holder’s operations 

specifications by maintaining a current 

listing of those items and by referring to 

the specific list in the applicable 

paragraph of the operations 

specifications. 

(ii) The certificate holder may not 

conduct any operation using any aircraft 

not listed. 

(5) Kinds of operations authorized. 

(6) Authorization and limitations for 

routes and areas of operations. 

(7) Special airport authorizations and 

limitations. 

(8) Time limitations, or standards for 

determining time limitations, for 

overhauling, inspecting, and checking 

airframes, engines, propellers, 

appliances, and emergency equipment. 

(9) Authorization for the method of 

controlling weight and balance of 

aircraft. 

(10) Aircraft wet lease information 

required by § 119.53(c). 

(11) Any authorization or requirement 

to conduct supplemental operations as 

provided by § 119.21(a)(3). 

(12) Any authorized deviation or 

exemption from any requirement of this 

chapter. 

(13) An authorization permitting, or a 

prohibition against, accepting, handling, 

and transporting materials regulated as 

hazardous materials in transport under 

49 CFR parts 171 through 180. 

(14) Any other item the Administrator 

determines is necessary. 

* * * * * 

Issued in Washington, DC on May 7, 2010. 

Pamela Hamilton-Powell, 

Director, Office of Rulemaking, Aviation 

Safety. 

[FR Doc. 2010–11266 Filed 5–11–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2010–N–0002] 

Oral Dosage Form New Animal Drugs; 

Orbifloxacin Suspension 

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 a new animal drug 

application (NADA) filed by Intervet, 

Inc. The NADA provides for the 

veterinary prescription use of an oral 

suspension containing orbifloxacin for 

the treatment of various bacterial 

infections in dogs and cats. 

DATES: This rule is effective May 12, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Intervet, 

Inc., 56 Livingston Ave., Roseland, NJ 

07068, filed NADA 141–305 that 

provides for veterinary prescription use 

of ORBAX (orbifloxacin) Oral 

Suspension for the treatment of various 

bacterial infections in dogs and cats. 

The NADA is approved as of March 25, 

2010, and the regulations are amended 

in 21 CFR part 520 by adding new 

§ 520.1618 to reflect the approval. 

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. 

Under section 512(c)(2)(F)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(ii)), this 

approval qualifies for 3 years of 

marketing exclusivity beginning on the 

date of approval. 

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 520 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

§ 520.1616 [Amended] 

■ 2. Revise the section heading of 

§ 520.1616 to read ‘‘Orbifloxacin 

tablets.’’. 

■ 3. Add § 520.1618 to read as follows: 

§ 520.1618 Orbifloxacin suspension. 

(a) Specifications. Each milliliter of 

suspension contains 30 milligrams (mg) 

orbifloxacin. 

(b) Sponsor. See No. 000061 in 

510.600(c) of this chapter. 

(c) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

Federal law prohibits the extralabel use 

of this drug in food-producing animals. 

(d) Conditions of use—(1) Dogs—(i) 

Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ 

kg) of body weight once daily. 

(ii) Indications for use. For the 

treatment of urinary tract infections 

(cystitis) in dogs caused by susceptible 

strains of Staphylococcus 

pseudintermedius, Proteus mirabilis, 

Escherichia coli, and Enterococcus 

faecalis and skin and soft tissue 

infections (wounds and abscesses) in 

dogs caused by susceptible strains of 

Staphylococcus pseudintermedius, 

Staphylococcus aureus, coagulasepositive staphylococci, Pasteurella 

multocida, Proteus mirabilis, 

Pseudomonas spp., Klebsiella 

pneumoniae, E. coli, Enterobacter spp., 

Citrobacter spp., E. faecalis, b-hemolytic 

streptococci (Group G), and 

Streptococcus equisimilis. 

(2) Cats—(i) Amount. 3.4 mg/lb (7.5 

mg/kg) of body weight once daily. 

(ii) Indications for use. For the 

treatment of skin infections (wounds 

and abscesses) in cats caused by 

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Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 26647 

susceptible strains of S. aureus, E. coli, 

and P. multocida. 

Dated: May 6, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–11245 Filed 5–11–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Ivermectin 

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 

Sparhawk Laboratories, Inc. The 

ANADA provides for use of an 

ivermectin injectable solution in cattle 

and swine for treatment and control of 

various internal and external parasites. 

DATES: This rule is effective May 12, 

2010. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Sparhawk 

Laboratories, Inc., 12340 Santa Fe Trail 

Dr., Lenexa, KS 66215, filed ANADA 

200–429 for the use of Ivermectin 

Injection in cattle and swine for 

treatment and control of various internal 

and external parasites. Sparhawk 

Laboratories, Inc.’s, Ivermectin Injection 

is approved as a generic copy of Merial 

Ltd.’s IVOMEC Injection for Cattle and 

Swine, approved under NADA 128–409. 

The ANADA is approved as of March 

26, 2010, and the regulations in 21 CFR 

522.1192 are amended to reflect the 

approval. 

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. 

The agency 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 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. In § 522.1192, revise paragraphs 

(b)(1), (b)(2), and (e)(2)(ii) to read as 

follows: 

§ 522.1192. Ivermectin 

* * * * * 

(b)* * * 

(1) No. 050604 for use of the product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(1) of this 

section; the product described in 

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

paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) 

of this section; and the product 

described in paragraph (a)(3) of this 

section as in paragraphs (e)(3) and (e)(6) 

of this section. 

(2) Nos. 055529, 058005, and 059130 

for use of the product described in 

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

paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) 

of this section. 

* * * * * 

(e) * * * 

(2) * * * 

(ii) Indications for use. For the 

treatment and control of gastrointestinal 

nematodes (adults and fourth-stage 

larvae) (Haemonchus placei, Ostertagia 

ostertagi (including inhibited larvae), O. 

lyrata, Trichostrongylus axei, T. 

colubriformis, Cooperia oncophora, C. 

punctata, C. pectinata, 

Oesophagostomum radiatum, 

Nematodirus helvetianus (adults only), 

N. spathiger (adults only), Bunostomum 

phlebotomum); lungworms (adults and 

fourth-stage larvae) (Dictyocaulus 

viviparus); grubs (parasitic stages) 

(Hypoderma bovis, H. lineatum); 

sucking lice (Linognathus vituli, 

Haematopinus eurysternus, Solenopotes 

capillatus); mites (scabies) (Psoroptes 

ovis (syn. P. communis var. bovis), 

Sarcoptes scabiei var. bovis). For control 

of infections and to protect from 

reinfection with D. viviparus and O. 

radiatum for 28 days after treatment; O. 

ostertagi, T. axei, and C. punctata for 21 

days after treatment; H. placei and C. 

oncophora for 14 days after treatment. 

* * * * * 

Dated: May 7, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–11282 Filed 5–11–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 524 

[Docket No. FDA–2010–N–0002] 

Ophthalmic and Topical Dosage Form 

New Animal Drugs; Ivermectin Topical 

Solution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule, technical 

amendment. 

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 First 

Priority, Inc. The supplemental ANADA 

adds claims for persistent effectiveness 

against various species of external and 

internal parasites when cattle are treated 

with a topical solution of ivermectin. 

DATES: This rule is effective May 12, 

2010. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: First 

Priority, Inc., 1590 Todd Farm Dr., 

Elgin, IL 60123, filed a supplement to 

ANADA 200–340 for PRIVERMECTIN 

(ivermectin), a topical solution used on 

cattle to control infestations of certain 

species of external and internal 

parasites. The supplemental ANADA 

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