You are on page 1of 3

Federal Register / Vol. 70, No.

165 / Friday, August 26, 2005 / Rules and Regulations 50181

National Environmental Policy Act (d) Applications and other documents Final rule; technical
ACTION:
This rule will not significantly affect should be addressed to: Director, United amendment.
the quality of the human environment. States Patent and Trademark Office,
Therefore, an environmental assessment P.O. Box 16471, Arlington, VA 22215– SUMMARY: The Food and Drug
or Environmental Impact Statement is 1471 Attn: FQA Administration (FDA) is amending the
not required to be prepared under the Dated: August 10, 2005. animal drug regulations by removing
National Environmental Policy Act of Jon W. Dudas, those portions that reflect approval of 16
1969. Under Secretary of Commerce for Intellectual new animal drug applications (NADAs)
Property and Director of the United States and 1 abbreviated NADA (ANADA)
List of Subjects in 15 CFR Part 280, Patent and Trademark Office. because they are no longer
Subpart D William Jeffrey, manufactured or marketed. In a notice
Application for Insignia. Director, National Institute of Standards and published elsewhere in this issue of the
Technology. Federal Register, FDA is withdrawing
■ For the reasons set forth in the
[FR Doc. 05–17020 Filed 8–25–05; 8:45 am] approval of these NADAs.
preamble, the National Institute of
Standards and Technology and the BILLING CODE 3510–16–P DATES: This rule is effective September
United States Patent and Trademark 6, 2005.
Office amend 15 CFR Part 280, Subpart
FOR FURTHER INFORMATION CONTACT:
D, as follows: DEPARTMENT OF HEALTH AND
Pamela K. Esposito, Center for
HUMAN SERVICES
PART 280—[AMENDED] Veterinary Medicine (HFV–212), Food
Food and Drug Administration and Drug Administration, 7519 Standish
■ 1. The authority citation for Part 280 Pl., Rockville, MD 20855, 301–827–
continues to read: 21 CFR Parts 510, 520, 522, 524, and 7818, e-mail: pesposit@cvm.fda.gov.
Authority: 15 U.S.C. 5401 et seq. 529 SUPPLEMENTARY INFORMATION: The
■ 2. Section 280.310 is amended by following sponsors have requested that
Animal Drugs, Feeds, and Related
revising paragraph (d) to read as FDA withdraw approval of the 16
Products; Withdrawal of Approval of
follows: NADAs and 1 ANADA listed in table 1
New Animal Drug Applications
of this document because the products
§ 280.310 Application for insignia. AGENCY: Food and Drug Administration, are no longer manufactured or
* * * * * HHS. marketed:

TABLE 1.
21 CFR Section Affected (Sponsor Drug La-
Sponsor NADA Number, Product (Drug) beler Code)

Abbott Laboratories, North Chicago, IL 60064 NADA 99–568, FURANACE Caps 529.1526 (000074)
(nifurpirinol)

Biocraft Laboratories, Inc., 92 Route 46, Elm- NADA 140–889, DERM–OTIC Ointment (neo- 524.1600a (000332)
wood Park, NJ 07407 mycin sulfate; nystatin; thiostrepton;
triamcinolone acetonide)

First Priority, Inc., 1585 Todd Farm Dr., NADA 48–646, THERAZONE Injection 522.1720 (058829)
Elgin, IL 60123 (phenylbutazone)

Happy Jack, Inc., Snow Hill, NC 28580 NADA 121–556, Selenium Sulfide Suspension 524.2101 (023851)
(selenium disulfide)
NADA 121–723, Nitrofurazone Dressing 524.1580b (023851)
NADA 125–137, FILARICIDE Capsules 520.622d (023851)
(diethylcarbamazine citrate)

IMPAX Laboratories, Inc., 30831 Huntwood NADA 92–151, N-Butyl Chloride Canine 520.260 (000115)
Ave., Hayward, CA 94544 Worming Caps
NADA 65–065, Tetracycline HCl Caps 520.2345a (000115)
NADA 138–900, Dichlorophene/Toluene 520.580 (000115)

Jorgensen Laboratories, Inc., 1450 North NADA 10–481, SUREJETS (salicylic acid) 529.2090 (048087)
Van Buren Ave., Loveland, CO 80538

Pliva d.d., Ulica grada Vukovara 49, 10000 ANADA 200–232, GEOMYCIN 200 Injection 522.1660a (011722)
Zagreb, Croatia (oxytetracycline)

Purina Mills, Inc., P.O. Box 66812, St. Louis, NADA 65–113 AUREO Sulfa Soluble Powder N/A (017800)
MO 63166–6812 (chlortetracycline/sulfamethazine)

Roche Vitamins, Inc., 45 Waterview Blvd., NADA 140–848, VETEEZE Injection 522.575 (063238)
Parsippany, NJ 07054–1298 (diazepam)

Teva Pharmaceuticals USA, 650 Cathill Rd., NADA 131–806, Furosemide Tablets 520.1010 (000093)
Sellersville, PA 18960

VerDate Aug<18>2005 16:11 Aug 25, 2005 Jkt 205001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1
50182 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations

TABLE 1.—Continued
21 CFR Section Affected (Sponsor Drug La-
Sponsor NADA Number, Product (Drug) beler Code)

Virbac AH, Inc., 3200 Meacham Blvd., Ft. NADA 10–886, Purina Liquid Wormer (piper- N/A (051311)
Worth, TX 76137 azine citrate)

Wyeth Laboratories, Division American Home NADA 10–782, SPARINE Injection 522.1962 (000008)
Products Corp., P.O. Box 8299, Philadel- (promazine)
phia, PA 19101
NADA 55–008, BICILLIN Fortified (penicillin G 522.1696a (000008)
benzathine and penicillin G procaine)

Following the withdrawal of approval the entries for ‘‘Biocraft Laboratories, ■ 8. Section 520.2345a is revised to read
of these NADAs, Biocraft Laboratories, Inc.’’, ‘‘IMPAX Laboratories, Inc.’’, as follows
Inc., IMPAX Laboratories, Inc., ‘‘Jorgensen Laboratories, Inc.’’, ‘‘Pliva
Jorgensen Laboratories, Inc., Pliva d.d., d.d.’’, and ‘‘Teva Pharmaceuticals § 520.2345a Tetracycline hydrochloride
capsules.
and Teva Pharmaceuticals USA are no USA’’; and in the table in paragraph
longer sponsors of an approved (c)(2) by removing the entries for (a) Specifications. Each capsule
application. Therefore, we are removing ‘‘000093’’, ‘‘000115’’, ‘‘000332’’, contains 50, 100, 125, 250, or 500
entries for these five sponsors from 21 ‘‘011722’’, and ‘‘045087’’. milligrams (mg) tetracycline
CFR 510.600(c). hydrochloride.
As provided below, the animal drug PART 520—ORAL DOSAGE FORM
regulations are amended to reflect the NEW ANIMAL DRUGS (b) Sponsor. See sponsors in
withdrawal of approvals and a current § 510.600(c) of this chapter for use as in
format. In addition, FDA has noticed ■ 3. The authority citation for 21 CFR paragraph (c) of this section:
that the regulations do not reflect part 520 continues to read as follows: (1) No. 000009: 250 mg per capsule.
Authority: 21 U.S.C. 360b. (2) No. 000069: 125, 250, or 500 mg
approved NADA 065–063 for
per capsule.
Tetracycline Capsules sponsored by Eon
§ 520.260 [Amended] (3) No. 000185: 50, 100, 250, or 500
Labs Manufacturing, Inc. At this time,
■ 4. Section 520.260 is amended in mg per capsule.
the regulations in 21 CFR 520.2345a are
paragraph (b)(2) by removing ‘‘000115 (c) Conditions of use in dogs—(1)
amended to reflect this approved
or’’; and by removing paragraph (c). Amount. 25 mg per pound of body
product.
weight per day in divided doses every
This rule does not meet the definition § 520.580 [Amended] 6 hours.
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
■ 5. Section 520.580 is amended in (2) Indications for use. For treatment
it is a rule of ‘‘particular applicability.’’
paragraph (b)(1) by removing ‘‘, of infections caused by organisms
Therefore, it is not subject to the
000115’’. sensitive to tetracycline hydrochloride,
congressional review requirements in 5
■ 6. Section 520.622d is revised to read
such as bacterial gastroenteritis due to
U.S.C. 801–808.
as follows: E. coli and urinary tract infections due
List of Subjects to Staphylococcus spp. and E. coli.
§ 520.622d Diethylcarbamazine citrate (3)Limitations. Federal law restricts
21 CFR Part 510 capsules. this drug to use by or on the order of
Administrative practice and (a) Specifications. Each capsule a licensed veterinarian.
procedure, Animal drugs, Labeling, contains 12.5, 50, 200, or 400 milligrams
Reporting and recordkeeping (mg) diethylcarbamazine citrate. PART 522—IMPLANTATION OR
requirements. (b) Sponsor. See No. 011014 in INJECTABLE DOSAGE FORM NEW
§ 510.600(c) of this chapter. ANIMAL DRUGS
21 CFR Parts 520, 522, 524, and 529
(c) Conditions of use in dogs—(1)
Animal drugs. Amount/indications for use. 3 mg per ■ 9. The authority citation for 21 CFR
■ Therefore, under the Federal Food, pound (/lb) body weight daily for part 522 continues to read as follows:
Drug, and Cosmetic Act and under prevention of heartworm disease Authority: 21 U.S.C. 360b.
authority delegated to the Commissioner (Dirofilaria immitis); 25 to 50 mg/lb
§ 522.575 [Removed]
of Food and Drugs and redelegated to body weight in a single dose as an aid
the Center for Veterinary Medicine, 21 in the treatment of ascarid infections ■ 10. Section 522.575 is removed.
CFR parts 510, 520, 522, 524, and 529 (Toxocara canis and Toxascaris
§ 522.1660a [Amended]
are amended as follows: leonina).
■ 11. Section 522.1660a is amended in
PART 510—NEW ANIMAL DRUGS (2) Limitations. Federal law restricts paragraph (b) by removing ‘‘, 011722’’.
this drug to use by or on the order of
■ 1. The authority citation for 21 CFR a licensed veterinarian. § 522.1696a [Amended]
part 510 continues to read as follows: ■ 12. Section 522.1696a is amended in
§ 520.1010 [Amended] paragraph (b)(1) by removing ‘‘000008,’’.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e. ■ 7. Section 520.1010 is amended by
removing paragraph (b)(2); and by § 522.1720 [Amended]
§ 510.600 [Amended] redesignating paragraphs (b)(3) and ■ 13. Section 522.1720 is amended in
■ 2. Section 510.600 is amended in the (b)(4) as paragraphs (b)(2) and (b)(3), paragraph (b)(1) by removing ‘‘,
table in paragraph (c)(1) by removing respectively. 058829’’.

VerDate Aug<18>2005 16:11 Aug 25, 2005 Jkt 205001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 50183

■ 14. Section 522.1962 is amended by (2) See No. 017135 for use on dogs AGENCY FOR INTERNATIONAL
revising paragraphs (b) and (c) to read and horses. DEVELOPMENT
as follows: (c) [Reserved]
(d) Conditions of use—(1) Amount. 22 CFR Part 226
§ 522.1962 Promazine hydrochloride. Apply directly on the lesion with a
[Aid Reg 226]
* * * * * spatula or first place on a piece of gauze.
(b) Sponsors. See sponsors in The preparation should remain on the RIN 0412–AA55
§ 510.600(c) of this chapter for use as in lesion for at least 24 hours. Use of a
paragraph (c) of this section: bandage is optional. Administration of Assistance Awards
(1) No. 000856 for use as in (2) Indications for use. For prevention to U.S. Non-Governmental
paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), or treatment of surface bacterial Organizations; Marking Requirements
(c)(1)(iii), and (c)(2) of this section. infections of wounds, burns, and AGENCY: Agency for International
(2) No. 061623 for use as in cutaneous ulcers of dogs, cats, or horses. Development (USAID).
paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (3) Limitations. For use only on dogs,
cats, and horses (not for food use). In ACTION: Final rule.
(c)(1)(iii) of this section.
(c) Conditions of use—(1)Horses—(i) case of deep or puncture wounds or SUMMARY: This final rule implements
Amount—(A) 0.2 to 0.5 milligrams per serious burns, use only as recommended the statutory requirement that all USAID
pounds (mg/lb) body weight by veterinarian. If redness, irritation, or programs be marked appropriately
intramuscularly or intravenously every swelling persists or increases, overseas as ‘‘American Aid.’’ It does so
4 to 6 hours. discontinue use; consult veterinarian. by adding a USAID regulation that
(B) 0.2 to 0.5 mg/lb body weight requires recipients of USAID funded
§ 524.1600a [Amended]
intravenously as required. grants and cooperative agreements and
(ii) Indications for use—(A) For use as ■ 17. Section 524.1600a is amended in other assistance awards—with certain
a tranquilizer, preanesthetic, or for paragraph (b) by removing ‘‘, 000332’’. Presumptive Exceptions and subject to a
minor operative procedures in ■ 18. Section 524.2101 is amended by waiver if warranted by specific
conjunction with local anesthesia; and revising paragraphs (b) and (c) to read conditions in the cooperating country—
as adjunctive therapy for tetanus. as follows: to mark programs, projects, activities,
(B) For use as a tranquilizer and public communications, and
preanesthetic. § 524.2101 Selenium disulfide suspension.
commodities with the USAID Standard
* * * * *
(b) Sponsors. See Nos. 000061, Graphic Identity (USAID Identity,
(iii) Limitations. Not for use in horses defined below.
intended for food. Federal law restricts 017135, and 050604 in § 510.600(c) of
this chapter. EFFECTIVE DATES: January 2, 2006.
this drug to use by or on the order of
a licensed veterinarian. (c) Conditions of use on dogs—(1) FOR FURTHER INFORMATION CONTACT: John
(2) Dogs and cats—(i) Amount. 1 to 2 Indications for use. For use as a Niemeyer (or designee), Assistant
mg/lb body weight intramuscularly or cleansing shampoo and as an agent for General Counsel, Office of the General
intravenously every 4 to 6 hours. removing skin debris associated with Counsel, USAID, Rm. 6.06.95, 1300
(ii) Indications for use. For use as a dry eczema, seborrhea, and nonspecific Pennsylvania Ave., NW., Washington,
tranquilizer, preanesthetic, for minor dermatoses. DC 20523; telephone: (202) 712–4776
operative procedures in conjunction (2) Amount. One to 2 ounces per (this is not a toll-free number).
with local anesthesia, as adjunctive application. SUPPLEMENTARY INFORMATION: On
therapy for tetanus, and as an antiemetic December 20, 2004, USAID published in
(3) Limitations. Use carefully around the Federal Register (69 FR 75885–
prior to worming; or to prevent motion
scrotum and eyes, covering scrotum 75887) a proposed rule to implement
sickness in dogs.
(iii) Limitations. Federal law restricts with petrolatum. Allow the shampoo to fully Section 641 of the Foreign
this drug to use by or on the order of remain for 5 to 15 minutes before Assistance Act of 1961, as amended.
a licensed veterinarian. thorough rinsing. Repeat treatment once The Agency provided a forty five (45)-
or twice a week. If conditions persist or day public comment period on the
PART 524—OPHTHALMIC AND if rash or irritation develops, proposed rule, which ended on
TOPICAL DOSAGE FORM NEW discontinue use and consult a February 3, 2005. The Agency also
ANIMAL DRUGS veterinarian. offered the public the opportunity to
PART 529—OTHER DOSAGE FORM submit comments by surface mail, e-
■ 15. The authority citation for 21 CFR mail or fax.
part 524 continues to read as follows: NEW ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
I. Background
■ 19. The authority citation for 21 CFR
■ 16. Section 524.1580b is amended by part 529 continues to read as follows: The marking of foreign aid as
redesignating paragraph (c) as paragraph assistance from the U.S. Government
Authority: 21 U.S.C. 360b.
(d); by reserving new paragraph (c); and was first required during the Marshall
by revising paragraph (b) and newly § 529.1526 [Removed] Plan when Congress became concerned
redesignated paragraph (d) to read as about poorly marked U.S. foreign aid
■ 20. Section 529.1526 is removed.
follows: donations to European countries.
§ 529.2090 [Removed] USAID’s framework legislation, the
§ 524.1580b Nitrofurazone ointment. Foreign Assistance Act of 1961, as
■ 21. Section 529.2090 is removed.
* * * * * amended, section 641, requires that all
(b) Sponsors. See sponsors in Dated: June 30, 2005. programs under the Foreign Assistance
§ 510.600(c) of this chapter. Stephen F. Sundlof, Act, including assistance awards, be
(1) See Nos. 000010, 000069, 050749, Director, Center for Veterinary Medicine. identified appropriately overseas as
051259, 058005, and 061623 for use on [FR Doc. 05–16995 Filed 8–25–05; 8:45 am] ‘‘American Aid.’’ While USAID has
dogs, cats, or horses. BILLING CODE 4160–01–S required its contractors to mark U.S.

VerDate Aug<18>2005 16:11 Aug 25, 2005 Jkt 205001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1