Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 50181 

National Environmental Policy Act 

This rule will not significantly affect 

the quality of the human environment. 

Therefore, an environmental assessment 

or Environmental Impact Statement is 

not required to be prepared under the 

National Environmental Policy Act of 

1969. 

List of Subjects in 15 CFR Part 280, 

Subpart D 

Application for Insignia. 

■ For the reasons set forth in the 

preamble, the National Institute of 

Standards and Technology and the 

United States Patent and Trademark 

Office amend 15 CFR Part 280, Subpart 

D, as follows: 

PART 280—[AMENDED] 

■ 1. The authority citation for Part 280 

continues to read: 

Authority: 15 U.S.C. 5401 et seq. 

■ 2. Section 280.310 is amended by 

revising paragraph (d) to read as 

follows: 

§ 280.310 Application for insignia. 

* * * * * 

(d) Applications and other documents 

should be addressed to: Director, United 

States Patent and Trademark Office, 

P.O. Box 16471, Arlington, VA 22215– 

1471 Attn: FQA 

Dated: August 10, 2005. 

Jon W. Dudas, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

William Jeffrey, 

Director, National Institute of Standards and 

Technology. 

[FR Doc. 05–17020 Filed 8–25–05; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, 524, and 

529 

Animal Drugs, Feeds, and Related 

Products; Withdrawal of Approval of 

New Animal Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations by removing 

those portions that reflect approval of 16 

new animal drug applications (NADAs) 

and 1 abbreviated NADA (ANADA) 

because they are no longer 

manufactured or marketed. In a notice 

published elsewhere in this issue of the 

Federal Register, FDA is withdrawing 

approval of these NADAs. 

DATES: This rule is effective September 

6, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Pamela K. Esposito, Center for 

Veterinary Medicine (HFV–212), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 301–827– 

7818, e-mail: pesposit@cvm.fda.gov. 

SUPPLEMENTARY INFORMATION: The 

following sponsors have requested that 

FDA withdraw approval of the 16 

NADAs and 1 ANADA listed in table 1 

of this document because the products 

are no longer manufactured or 

marketed: 

TABLE 1. 

Sponsor NADA Number, Product (Drug) 21 CFR Section Affected (Sponsor Drug Labeler Code) 

Abbott Laboratories, North Chicago, IL 60064 NADA 99–568, FURANACE Caps 

(nifurpirinol) 

529.1526 (000074) 

Biocraft Laboratories, Inc., 92 Route 46, Elmwood Park, NJ 07407 NADA 140–889, DERM–OTIC Ointment (neomycin sulfate; nystatin; thiostrepton; 

triamcinolone acetonide) 

524.1600a (000332) 

First Priority, Inc., 1585 Todd Farm Dr., 

Elgin, IL 60123 

NADA 48–646, THERAZONE Injection 

(phenylbutazone) 

522.1720 (058829) 

Happy Jack, Inc., Snow Hill, NC 28580 NADA 121–556, Selenium Sulfide Suspension 

(selenium disulfide) 

524.2101 (023851) 

NADA 121–723, Nitrofurazone Dressing 524.1580b (023851) 

NADA 125–137, FILARICIDE Capsules 

(diethylcarbamazine citrate) 

520.622d (023851) 

IMPAX Laboratories, Inc., 30831 Huntwood 

Ave., Hayward, CA 94544 

NADA 92–151, N-Butyl Chloride Canine 

Worming Caps 

520.260 (000115) 

NADA 65–065, Tetracycline HCl Caps 520.2345a (000115) 

NADA 138–900, Dichlorophene/Toluene 520.580 (000115) 

Jorgensen Laboratories, Inc., 1450 North 

Van Buren Ave., Loveland, CO 80538 

NADA 10–481, SUREJETS (salicylic acid) 529.2090 (048087) 

Pliva d.d., Ulica grada Vukovara 49, 10000 

Zagreb, Croatia 

ANADA 200–232, GEOMYCIN 200 Injection 

(oxytetracycline) 

522.1660a (011722) 

Purina Mills, Inc., P.O. Box 66812, St. Louis, 

MO 63166–6812 

NADA 65–113 AUREO Sulfa Soluble Powder 

(chlortetracycline/sulfamethazine) 

N/A (017800) 

Roche Vitamins, Inc., 45 Waterview Blvd., 

Parsippany, NJ 07054–1298 

NADA 140–848, VETEEZE Injection 

(diazepam) 

522.575 (063238) 

Teva Pharmaceuticals USA, 650 Cathill Rd., 

Sellersville, PA 18960 

NADA 131–806, Furosemide Tablets 520.1010 (000093) 

50182 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 

TABLE 1.—Continued 

Sponsor NADA Number, Product (Drug) 21 CFR Section Affected (Sponsor Drug Labeler Code) 

Virbac AH, Inc., 3200 Meacham Blvd., Ft. 

Worth, TX 76137 

NADA 10–886, Purina Liquid Wormer (piperazine citrate) N/A (051311) 

Wyeth Laboratories, Division American Home 

Products Corp., P.O. Box 8299, Philadelphia, PA 19101 

NADA 10–782, SPARINE Injection 

(promazine) 

522.1962 (000008) 

NADA 55–008, BICILLIN Fortified (penicillin G 

benzathine and penicillin G procaine) 

522.1696a (000008) 

Following the withdrawal of approval 

of these NADAs, Biocraft Laboratories, 

Inc., IMPAX Laboratories, Inc., 

Jorgensen Laboratories, Inc., Pliva d.d., 

and Teva Pharmaceuticals USA are no 

longer sponsors of an approved 

application. Therefore, we are removing 

entries for these five sponsors from 21 

CFR 510.600(c). 

As provided below, the animal drug 

regulations are amended to reflect the 

withdrawal of approvals and a current 

format. In addition, FDA has noticed 

that the regulations do not reflect 

approved NADA 065–063 for 

Tetracycline Capsules sponsored by Eon 

Labs Manufacturing, Inc. At this time, 

the regulations in 21 CFR 520.2345a are 

amended to reflect this approved 

product. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Parts 520, 522, 524, and 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, 520, 522, 524, 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. 

§ 510.600 [Amended] 

■ 2. Section 510.600 is amended in the 

table in paragraph (c)(1) by removing 

the entries for ‘‘Biocraft Laboratories, 

Inc.’’, ‘‘IMPAX Laboratories, Inc.’’, 

‘‘Jorgensen Laboratories, Inc.’’, ‘‘Pliva 

d.d.’’, and ‘‘Teva Pharmaceuticals 

USA’’; and in the table in paragraph 

(c)(2) by removing the entries for 

‘‘000093’’, ‘‘000115’’, ‘‘000332’’, 

‘‘011722’’, and ‘‘045087’’. 

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. 

§ 520.260 [Amended] 

■ 4. Section 520.260 is amended in 

paragraph (b)(2) by removing ‘‘000115 

or’’; and by removing paragraph (c). 

§ 520.580 [Amended] 

■ 5. Section 520.580 is amended in 

paragraph (b)(1) by removing ‘‘, 

000115’’. 

■ 6. Section 520.622d is revised to read 

as follows: 

§ 520.622d Diethylcarbamazine citrate 

capsules. 

(a) Specifications. Each capsule 

contains 12.5, 50, 200, or 400 milligrams 

(mg) diethylcarbamazine citrate. 

(b) Sponsor. See No. 011014 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount/indications for use. 3 mg per 

pound (/lb) body weight daily for 

prevention of heartworm disease 

(Dirofilaria immitis); 25 to 50 mg/lb 

body weight in a single dose as an aid 

in the treatment of ascarid infections 

(Toxocara canis and Toxascaris 

leonina). 

(2) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

§ 520.1010 [Amended] 

■ 7. Section 520.1010 is amended by 

removing paragraph (b)(2); and by 

redesignating paragraphs (b)(3) and 

(b)(4) as paragraphs (b)(2) and (b)(3), 

respectively. 

■ 8. Section 520.2345a is revised to read 

as follows 

§ 520.2345a Tetracycline hydrochloride 

capsules. 

(a) Specifications. Each capsule 

contains 50, 100, 125, 250, or 500 

milligrams (mg) tetracycline 

hydrochloride. 

(b) Sponsor. See sponsors in 

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

paragraph (c) of this section: 

(1) No. 000009: 250 mg per capsule. 

(2) No. 000069: 125, 250, or 500 mg 

per capsule. 

(3) No. 000185: 50, 100, 250, or 500 

mg per capsule. 

(c) Conditions of use in dogs—(1) 

Amount. 25 mg per pound of body 

weight per day in divided doses every 

6 hours. 

(2) Indications for use. For treatment 

of infections caused by organisms 

sensitive to tetracycline hydrochloride, 

such as bacterial gastroenteritis due to 

E. coli and urinary tract infections due 

to Staphylococcus spp. and E. coli. 

(3)Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 9. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

§ 522.575 [Removed] 

■ 10. Section 522.575 is removed. 

§ 522.1660a [Amended] 

■ 11. Section 522.1660a is amended in 

paragraph (b) by removing ‘‘, 011722’’. 

§ 522.1696a [Amended] 

■ 12. Section 522.1696a is amended in 

paragraph (b)(1) by removing ‘‘000008,’’. 

§ 522.1720 [Amended] 

■ 13. Section 522.1720 is amended in 

paragraph (b)(1) by removing ‘‘, 

058829’’. 

Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 50183 

■ 14. Section 522.1962 is amended by 

revising paragraphs (b) and (c) to read 

as follows: 

§ 522.1962 Promazine hydrochloride. 

* * * * * 

(b) Sponsors. See sponsors in 

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

paragraph (c) of this section: 

(1) No. 000856 for use as in 

paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), 

(c)(1)(iii), and (c)(2) of this section. 

(2) No. 061623 for use as in 

paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and 

(c)(1)(iii) of this section. 

(c) Conditions of use—(1)Horses—(i) 

Amount—(A) 0.2 to 0.5 milligrams per 

pounds (mg/lb) body weight 

intramuscularly or intravenously every 

4 to 6 hours. 

(B) 0.2 to 0.5 mg/lb body weight 

intravenously as required. 

(ii) Indications for use—(A) For use as 

a tranquilizer, preanesthetic, or for 

minor operative procedures in 

conjunction with local anesthesia; and 

as adjunctive therapy for tetanus. 

(B) For use as a tranquilizer and 

preanesthetic. 

(iii) Limitations. Not for use in horses 

intended for food. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) Dogs and cats—(i) Amount. 1 to 2 

mg/lb body weight intramuscularly or 

intravenously every 4 to 6 hours. 

(ii) Indications for use. For use as a 

tranquilizer, preanesthetic, for minor 

operative procedures in conjunction 

with local anesthesia, as adjunctive 

therapy for tetanus, and as an antiemetic 

prior to worming; or to prevent motion 

sickness in dogs. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 15. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 16. Section 524.1580b is amended by 

redesignating paragraph (c) as paragraph 

(d); by reserving new paragraph (c); and 

by revising paragraph (b) and newly 

redesignated paragraph (d) to read as 

follows: 

§ 524.1580b Nitrofurazone ointment. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter. 

(1) See Nos. 000010, 000069, 050749, 

051259, 058005, and 061623 for use on 

dogs, cats, or horses. 

(2) See No. 017135 for use on dogs 

and horses. 

(c) [Reserved] 

(d) Conditions of use—(1) Amount. 

Apply directly on the lesion with a 

spatula or first place on a piece of gauze. 

The preparation should remain on the 

lesion for at least 24 hours. Use of a 

bandage is optional. 

(2) Indications for use. For prevention 

or treatment of surface bacterial 

infections of wounds, burns, and 

cutaneous ulcers of dogs, cats, or horses. 

(3) Limitations. For use only on dogs, 

cats, and horses (not for food use). In 

case of deep or puncture wounds or 

serious burns, use only as recommended 

by veterinarian. If redness, irritation, or 

swelling persists or increases, 

discontinue use; consult veterinarian. 

§ 524.1600a [Amended] 

■ 17. Section 524.1600a is amended in 

paragraph (b) by removing ‘‘, 000332’’. 

■ 18. Section 524.2101 is amended by 

revising paragraphs (b) and (c) to read 

as follows: 

§ 524.2101 Selenium disulfide suspension. 

* * * * * 

(b) Sponsors. See Nos. 000061, 

017135, and 050604 in § 510.600(c) of 

this chapter. 

(c) Conditions of use on dogs—(1) 

Indications for use. For use as a 

cleansing shampoo and as an agent for 

removing skin debris associated with 

dry eczema, seborrhea, and nonspecific 

dermatoses. 

(2) Amount. One to 2 ounces per 

application. 

(3) Limitations. Use carefully around 

scrotum and eyes, covering scrotum 

with petrolatum. Allow the shampoo to 

remain for 5 to 15 minutes before 

thorough rinsing. Repeat treatment once 

or twice a week. If conditions persist or 

if rash or irritation develops, 

discontinue use and consult a 

veterinarian. 

PART 529—OTHER DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 19. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

§ 529.1526 [Removed] 

■ 20. Section 529.1526 is removed. 

§ 529.2090 [Removed] 

■ 21. Section 529.2090 is removed. 

Dated: June 30, 2005. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. 05–16995 Filed 8–25–05; 8:45 am] 

BILLING CODE 4160–01–S 

AGENCY FOR INTERNATIONAL 

DEVELOPMENT 

22 CFR Part 226 

[Aid Reg 226] 

RIN 0412–AA55 

Administration of Assistance Awards 

to U.S. Non-Governmental 

Organizations; Marking Requirements 

AGENCY: Agency for International 

Development (USAID). 

ACTION: Final rule. 

SUMMARY: This final rule implements 

the statutory requirement that all USAID 

programs be marked appropriately 

overseas as ‘‘American Aid.’’ It does so 

by adding a USAID regulation that 

requires recipients of USAID funded 

grants and cooperative agreements and 

other assistance awards—with certain 

Presumptive Exceptions and subject to a 

waiver if warranted by specific 

conditions in the cooperating country— 

to mark programs, projects, activities, 

public communications, and 

commodities with the USAID Standard 

Graphic Identity (USAID Identity, 

defined below. 

EFFECTIVE DATES: January 2, 2006. 

FOR FURTHER INFORMATION CONTACT: John 

Niemeyer (or designee), Assistant 

General Counsel, Office of the General 

Counsel, USAID, Rm. 6.06.95, 1300 

Pennsylvania Ave., NW., Washington, 

DC 20523; telephone: (202) 712–4776 

(this is not a toll-free number). 

SUPPLEMENTARY INFORMATION: On 

December 20, 2004, USAID published in 

the Federal Register (69 FR 75885– 

75887) a proposed rule to implement 

fully Section 641 of the Foreign 

Assistance Act of 1961, as amended. 

The Agency provided a forty five (45)- 

day public comment period on the 

proposed rule, which ended on 

February 3, 2005. The Agency also 

offered the public the opportunity to 

submit comments by surface mail, email or fax. 

I. Background 

The marking of foreign aid as 

assistance from the U.S. Government 

was first required during the Marshall 

Plan when Congress became concerned 

about poorly marked U.S. foreign aid 

donations to European countries. 

USAID’s framework legislation, the 

Foreign Assistance Act of 1961, as 

amended, section 641, requires that all 

programs under the Foreign Assistance 

Act, including assistance awards, be 

identified appropriately overseas as 

‘‘American Aid.’’ While USAID has 

required its contractors to mark U.S.