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 

WReier-Aviles on DSKGBLS3C1PROD with RULES

26648 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

adds claims for persistent effectiveness 

against various species of external and 

internal parasites that were approved for 

the pioneer product with 3 years of 

marketing exclusivity (69 FR 501, 

January 6, 2004). The supplemental 

ANADA is approved as of March 26, 

2010, and 21 CFR 524.1193 is amended 

to reflect the approval. 

In addition, FDA has noticed the 

regulations do not accurately reflect 

approved indications for generic 

products. At this time, the regulations 

are being revised to reflect which 

generic products have approved labeling 

for the durations of persistent 

effectiveness approved for the pioneer 

product. FDA is also adding a parasite 

species that was inadvertently omitted 

in the previously cited January 6, 2004, 

final rule. These actions are being taken 

to improve the accuracy of the 

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. 

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 524 

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 524 is amended as follows: 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 2. In § 524.1193, revise paragraphs (b) 

and (e)(2) to read as follows: 

§ 524.1193 Ivermectin topical solution. 

* * * * * 

(b) Sponsors. See sponsors in 

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

paragraph (e) of this section. 

(1) Nos. 050604, 055529, 058829 for 

use as in paragraphs (e)(1), (e)(2)(i), 

(e)(2)(iii), and (e)(3) of this section. 

(2) Nos. 054925, 059130, 061623, and 

066916 for use as in paragraphs (e)(1), 

(e)(2)(i), (e)(2)(ii), and (e)(3) of this 

section. 

* * * * * 

(e) * * * 

(2) Indications for use—(i) It is used 

for the treatment and control of: 

Gastrointestinal roundworms (adults 

and fourth-stage larvae) Ostertagia 

ostertagi (including inhibited stage), 

Haemonchus placei, Trichostrongylus 

axei, T. colubriformis, Cooperia 

oncophora, C. punctata, C. surnabada, 

Oesophagostomum radiatum; (adults) 

Strongyloides papillosus, Trichuris spp.; 

lungworms (adults and fourth-stage 

larvae) Dictyocaulus viviparus; cattle 

grubs (parasitic stages) Hypoderma 

bovis, H. lineatum; mites Sarcoptes 

scabiei var. bovis; lice Linognathus 

vituli, Haematopinus eurysternus, 

Damalinia bovis, Solenoptes capillatus; 

and horn flies Haematobia irritans. 

(ii) It controls infections and prevents 

reinfection with O. ostertagi, O. 

radiatum, H. placei, T. axei, C. 

punctata, and C. oncophora for 14 days 

after treatment. 

(iii) It controls infections and prevents 

reinfection with O. radiatum and D. 

viviparus for 28 days after treatment, C. 

punctata and T. axei for 21 days after 

treatment, O. ostertagi, H. placei, C. 

oncophora, and C. surnabada for 14 

days after treatment, and D. bovis for 56 

days after treatment. 

* * * * * 

Dated: May 6, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–11244 Filed 5–11–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0285] 

RIN 1625–AA00 

Safety Zones; May Fireworks Displays 

Within the Captain of the Port Puget 

Sound Area of Responsibility (AOR) 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The U.S Coast Guard is 

establishing two safety zones on the 

waters of Puget Sound, WA for two 

fireworks displays. This action is 

necessary to provide for the safety of life 

on navigable waters during the 

fireworks displays. Entry into, transit 

through, mooring, or anchoring within 

these zones is prohibited unless 

authorized by the Captain of the Port, 

Puget Sound or Designated 

Representative. 

DATES: This rule is effective from 12:01 

a.m. May 14, 2010 through 11:59 p.m. 

May 23, 2010 unless canceled sooner by 

the Captain of the Port. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2010– 

0285 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0285 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ They 

are also available for inspection or 

copying at 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. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or e-mail Ensign Rebecca E. 

McCann, Waterways Management, 

Sector Seattle, Coast Guard; telephone 

206–217–6088, email 

SectorSeattleWWM@uscg.mil. If you 

have questions on viewing the docket, 

call Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because it is 

contrary to public interest to delay the 

effective date of this rule. Delaying the 

effective date by first publishing an 

NPRM would be contrary to the safety 

zone’s intended objectives since 

WReier-Aviles on DSKGBLS3C1PROD with RULES