27734 Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 

is approved as a generic copy of Merial, 

Ltd.’s IVOMEC Plus Injection for Cattle, 

approved under NADA 140–833. The 

ANADA is approved as of April 23, 

2007, and the regulations are amended 

in 21 CFR 522.1193 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(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. 

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. Amend § 522.1193 as follows: 

a. Revise the section heading and 

paragraphs (a) and (b); 

b. Redesignate paragraph (d) as 

paragraph (e); 

c. Add new paragraph (d); and 

d. Revise newly redesignated 

paragraph (e). 

The revisions, redesignation, and 

addition read as follows: 

§ 522.1193 Ivermectin and clorsulon. 

(a) Specifications. Each milliliter (mL) 

of solution contains 10 milligrams (mg) 

(1 percent) ivermectin and 100 mg (10 

percent) clorsulon. 

(b) Sponsors. See Nos. 050604 and 

055529 in § 510.600(c) of this chapter 

for use as in paragraph (e) of this 

section. 

* * * * * 

(d) Special considerations. See 

§ 500.25 of this chapter. 

(e) Conditions of use in cattle—(1) 

Amount. Administer 1 mL (10 mg 

ivermectin and 100 mg clorsulon) per 50 

kilograms (110 pounds) by 

subcutaneous injection. 

(2) 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); liver flukes (adults only) 

(Fasciola hepatica); grubs (parasitic 

stages) (Hypoderma bovis, H. lineatum); 

lice (Linognathus vituli, Haematopinus 

eurysternus, Solenopotes capillatus); 

mites (Psoroptes ovis (syn. P. communis 

var. bovis), Sarcoptes scabiei var. bovis); 

and for control of infections of D. 

viviparus and O. radiatum for 28 days 

afer treatment; O. ostertagi, T. axei, and 

C. punctata for 21 days after treatment; 

and H. placei and C. oncophora for 14 

days after treatment. 

(3) Limitations. For subcutaneous use 

only. Not for intravenous or 

intramuscular use. Do not treat cattle 

within 49 days of slaughter. Because a 

withdrawal time in milk has not been 

established, do not use in female dairy 

cattle of breeding age. Do not use in 

other animal species because severe 

adverse reactions, including fatalities in 

dogs, may result. A withdrawal period 

has not been established for this product 

in preruminating calves. Do not use in 

calves to be processed for veal. 

Dated: May 7, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–9517 Filed 5–16–07; 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; 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 

Norbrook Laboratories, Ltd. The 

ANADA provides for use of a one 

percent ivermectin solution by 

subcutaneous injection in cattle, swine, 

reindeer, and American bison for the 

treatment and control of various internal 

and external parasites. 

DATES: This rule is effective May 17, 

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: Norbrook 

Laboratories, Ltd., Station Works, 

Newry BT35 6JP, Northern Ireland, filed 

supplemental ANADA 200–437 that 

provides for use of NOROMECTIN 

(ivermectin) Injection for Cattle and 

Swine by subcutaneous injection in 

cattle, swine, reindeer, and American 

bison for the treatment and control of 

various internal and external parasites. 

Norbrook Laboratories, Ltd.’s 

NOROMECTIN Injection for Cattle and 

Swine 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 April 20, 2007, and the 

regulations are amended in 21 CFR 

522.1192 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. 

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. 


cprice-sewell on PROD1PC71 with RULES
Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 27735 

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 § 522.1192 to read as 

follows: 

§ 522.1192 Ivermectin. 

(a) Specifications—(1) Each milliliter 

(mL) of solution contains 20 milligrams 

(mg) ivermectin. 

(2) Each mL of solution contains 10 

mg ivermectin. 

(3) Each mL of solution contains 2.7 

mg ivermectin. 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (e) of this section. 

(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)(i), (e)(2)(ii)(A), 

(e)(2)(ii)(C), (e)(2)(iii), (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. 059130 and 055529 for use of 

the product described in paragraph 

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

(e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(B), 

(e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this 

section. 

(c) Related tolerances. See § 556.344 

of this chapter. 

(d) Special considerations—(1) See 

§ 500.25 of this chapter. 

(2) Labeling shall bear the following 

precaution: ‘‘This product should not be 

used in other animal species as severe 

adverse reactions, including fatalities in 

dogs, may result.’’

(e) Conditions of use—(1) Horses—(i) 

Amount. 200 micrograms per kilogram 

(μg/kg) of body weight by intramuscular 

injection. 

(ii) Indications for use. For the 

treatment and control of large strongyles 

(adult) (Strongylus vulgaris, S. 

edentatus, Triodontophorus spp.), small 

strongyles (adult and fourth stage 

larvae) (Cyathostomum spp., 

Cylicocyclus spp., Cylicostephanus 

spp.), pinworms (adult and fourth-stage 

larvae) (Oxyuris equi), large 

roundworms (adult) (Parascaris 

equorum), hairworms (adult) 

(Trichostrongylus axei), large mouth 

stomach worms (adult) (Habronema 

muscae), neck threadworms 

(microfilariae) (Onchocerca spp.), and 

stomach bots (Gastrophilus spp.). 

(iii) Limitations. Not for use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

(2) Cattle—(i) Amount. 200 μg/kg of 

body weight by subcutaneous injection. 

(ii) Indications for use—(A) For the 

treatment and control of gastrointestinal 

nematodes (adults and fourth-stage 

larvae) (Haemonchus placei, Ostertagia 

ostertagi (including inhibited larvae), O. 

lyrata, T. 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). 

(B) For control of infections of D. 

viviparus for 28 days after treatment, 

and O. ostertagi for 21 days after 

treatment, and H. placei, T. axei, C. 

punctata, C. oncophora, and O. 

radiatum for 14 days after treatment. 

(C) 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. 

(iii) Limitations. Do not treat cattle 

within 35 days of slaughter. Because a 

withdrawal time in milk has not been 

established, do not use in female dairy 

cattle of breeding age. A withdrawal 

period has not been established for this 

product in pre-ruminating calves. Do 

not use in calves to be processed for 

veal. 

(3) Swine—(i) Amount. 300 μg/kg of 

body weight by subcutaneous injection. 

(ii) Indications for use. For the 

treatment and control of gastrointestinal 

roundworms (adults and fourth-stage 

larvae) (large roundworm, Ascaris 

suum; red stomach worm, 

Hyostrongylus rubidus; nodular worm, 

Oesophagostomum spp.; threadworm, 

Strongyloides ransomi (adults only)); 

somatic roundworm larvae 

(threadworm, S. ransomi (somatic 

larvae)); lungworms (Metastrongylus 

spp. (adults only)); lice (H. suis); and 

mites (S. scabiei var. suis). 

(iii) Limitations. Do not treat swine 

within 18 days of slaughter. 

(4) American bison—(i) Amount. 200 

μg/kg of body weight by subcutaneous 

injection. 

(ii) Indications for use. For the 

treatment and control of grubs (H. 

bovis). 

(iii) Limitations. Do not slaughter 

within 56 days of last treatment. 

(5) Reindeer—(i) Amount. 200 μg/kg 

of body weight by subcutaneous 

injection. 

(ii) Indications for use. For the 

treatment and control of warbles 

(Oedemagena tarandi). 

(iii) Limitations. Do not treat reindeer 

within 56 days of slaughter. 

(6) Ranch-raised foxes—(i) Amount. 

200 μg/kg of body weight by 

subcutaneous injection. Repeat in 3 

weeks. 

(ii) Indications for use. For treatment 

and control of ear mites (Otodectes 

cynotis). 

Dated: May 7, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–9515 Filed 5–16–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[CGD13–07–013] 

RIN 1625–AA00 

Special local regulation: ULHRA 

Hydroplane Races, Howard Amon 

Park, Richland, WA 

AGENCY: Coast Guard, DHS. 

ACTION: Special local regulation 

temporary final rule. 

SUMMARY: The Coast Guard is 

undertaking two actions with regard to 

the above captioned regulation. The first 

is to withdraw the temporary final rule 

previously published on April 23, 2007 

because it erroneously described the 

race area. The second is to correct the 

previous error by establishing a 

temporary special local regulation for 

the ULHRA National Series Hydroplane 

Race to be held on the waters of the 

Columbia River in the vicinity of 

Howard Amon Park, Richland, WA. 

These special local regulations limit the 

movement of non-participating vessels 

in the regulated race area. This 


cprice-sewell on PROD1PC71 with RULES