Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications, 50181-50183 [05-16995]
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Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations
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:
(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
DATES:
This rule is effective September
6, 2005.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
1. The authority citation for Part 280
continues to read:
21 CFR Parts 510, 520, 522, 524, and
529
Authority: 15 U.S.C. 5401 et seq.
2. Section 280.310 is amended by
revising paragraph (d) to read as
follows:
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
New Animal Drug Applications
§ 280.310
Application for insignia.
AGENCY:
*
*
HHS.
■
*
*
*
Final rule; technical
amendment.
ACTION:
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.
PART 280—[AMENDED]
■
50181
Food and Drug Administration,
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.
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:
SUPPLEMENTARY INFORMATION:
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)
NADA 121–723, Nitrofurazone Dressing
NADA 125–137, FILARICIDE Capsules
(diethylcarbamazine citrate)
524.2101 (023851)
NADA 92–151, N-Butyl Chloride Canine
Worming Caps
NADA 65–065, Tetracycline HCl Caps
NADA 138–900, Dichlorophene/Toluene
520.260 (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)
IMPAX Laboratories, Inc., 30831 Huntwood
Ave., Hayward, CA 94544
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524.1580b (023851)
520.622d (023851)
520.2345a (000115)
520.580 (000115)
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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)
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’’.
■
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
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:
■
21 CFR Part 510
§ 520.622d
capsules.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
(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).
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
■
VerDate Aug<18>2005
16:11 Aug 25, 2005
Jkt 205001
Diethylcarbamazine citrate
(2) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.1010
[Amended]
Fmt 4700
Tetracycline hydrochloride
(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,’’.
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.
Frm 00034
§ 520.2345a
capsules.
■
■
PO 00000
8. Section 520.2345a is revised to read
as follows
Sfmt 4700
§ 522.1720
[Amended]
13. Section 522.1720 is amended in
paragraph (b)(1) by removing ‘‘,
058829’’.
■
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Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations
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.
(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.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
(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.
15. The authority citation for 21 CFR
part 524 continues to read as follows:
PART 529—OTHER DOSAGE FORM
NEW ANIMAL DRUGS
■
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.
VerDate Aug<18>2005
16:11 Aug 25, 2005
19. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Jkt 205001
Authority: 21 U.S.C. 360b.
§ 529.1526
■
§ 529.2090
■
[Removed]
20. Section 529.1526 is removed.
[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
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50183
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 for International
Development (USAID).
ACTION: Final rule.
AGENCY:
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.
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[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Rules and Regulations]
[Pages 50181-50183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16995]
=======================================================================
-----------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
21 CFR Section Affected (Sponsor
Sponsor NADA Number, Product (Drug) Drug Labeler Code)
----------------------------------------------------------------------------------------------------------------
Abbott Laboratories, North Chicago, NADA 99-568, FURANACE Caps 529.1526 (000074)
IL 60064 (nifurpirinol)
----------------------------------------------------------------------------------------------------------------
Biocraft Laboratories, Inc., 92 NADA 140-889, DERM-OTIC Ointment 524.1600a (000332)
Route 46, Elmwood Park, NJ 07407 (neomycin sulfate; nystatin;
thiostrepton; triamcinolone
acetonide)
----------------------------------------------------------------------------------------------------------------
First Priority, Inc., 1585 Todd NADA 48-646, THERAZONE Injection 522.1720 (058829)
Farm Dr., Elgin, IL 60123 (phenylbutazone)
----------------------------------------------------------------------------------------------------------------
Happy Jack, Inc., Snow Hill, NC NADA 121-556, Selenium Sulfide 524.2101 (023851)
28580 Suspension (selenium disulfide)
NADA 121-723, Nitrofurazone Dressing 524.1580b (023851)
NADA 125-137, FILARICIDE Capsules 520.622d (023851)
(diethylcarbamazine citrate)
----------------------------------------------------------------------------------------------------------------
IMPAX Laboratories, Inc., 30831 NADA 92-151, N-Butyl Chloride Canine 520.260 (000115)
Huntwood 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 NADA 10-481, SUREJETS (salicylic 529.2090 (048087)
North Van Buren Ave., Loveland, CO acid)
80538
----------------------------------------------------------------------------------------------------------------
Pliva d.d., Ulica grada Vukovara ANADA 200-232, GEOMYCIN 200 Injection 522.1660a (011722)
49, 10000 Zagreb, Croatia (oxytetracycline)
----------------------------------------------------------------------------------------------------------------
Purina Mills, Inc., P.O. Box 66812, NADA 65-113 AUREO Sulfa Soluble N/A (017800)
St. Louis, MO 63166-6812 Powder (chlortetracycline/
sulfamethazine)
----------------------------------------------------------------------------------------------------------------
Roche Vitamins, Inc., 45 Waterview NADA 140-848, VETEEZE Injection 522.575 (063238)
Blvd., Parsippany, NJ 07054-1298 (diazepam)
----------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals USA, 650 NADA 131-806, Furosemide Tablets 520.1010 (000093)
Cathill Rd., Sellersville, PA
18960
----------------------------------------------------------------------------------------------------------------
[[Page 50182]]
Virbac AH, Inc., 3200 Meacham NADA 10-886, Purina Liquid Wormer N/A (051311)
Blvd., Ft. Worth, TX 76137 (piperazine citrate)
----------------------------------------------------------------------------------------------------------------
Wyeth Laboratories, Division NADA 10-782, SPARINE Injection 522.1962 (000008)
American Home Products Corp., P.O. (promazine)
Box 8299, Philadelphia, PA 19101
NADA 55-008, BICILLIN Fortified 522.1696a (000008)
(penicillin G benzathine and
penicillin G procaine)
----------------------------------------------------------------------------------------------------------------
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.
0
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
0
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.
Sec. 510.600 [Amended]
0
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
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.260 [Amended]
0
4. Section 520.260 is amended in paragraph (b)(2) by removing ``000115
or''; and by removing paragraph (c).
Sec. 520.580 [Amended]
0
5. Section 520.580 is amended in paragraph (b)(1) by removing ``,
000115''.
0
6. Section 520.622d is revised to read as follows:
Sec. 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 Sec. 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.
Sec. 520.1010 [Amended]
0
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.
0
8. Section 520.2345a is revised to read as follows
Sec. 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 Sec. 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
0
9. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.575 [Removed]
0
10. Section 522.575 is removed.
Sec. 522.1660a [Amended]
0
11. Section 522.1660a is amended in paragraph (b) by removing ``,
011722''.
Sec. 522.1696a [Amended]
0
12. Section 522.1696a is amended in paragraph (b)(1) by removing
``000008,''.
Sec. 522.1720 [Amended]
0
13. Section 522.1720 is amended in paragraph (b)(1) by removing ``,
058829''.
[[Page 50183]]
0
14. Section 522.1962 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 522.1962 Promazine hydrochloride.
* * * * *
(b) Sponsors. See sponsors in Sec. 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
0
15. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
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:
Sec. 524.1580b Nitrofurazone ointment.
* * * * *
(b) Sponsors. See sponsors in Sec. 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.
Sec. 524.1600a [Amended]
0
17. Section 524.1600a is amended in paragraph (b) by removing ``,
000332''.
0
18. Section 524.2101 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 524.2101 Selenium disulfide suspension.
* * * * *
(b) Sponsors. See Nos. 000061, 017135, and 050604 in Sec.
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
0
19. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1526 [Removed]
0
20. Section 529.1526 is removed.
Sec. 529.2090 [Removed]
0
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
