[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Rules and Regulations]
[Pages 10165-10168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4560]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules
and Regulations
[[Page 10165]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 524, and 526
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 18 new animal drug
applications (NADAs) and 1 abbreviated new animal drug application
(ANADA) from Fort Dodge Animal Health, Division of Wyeth, a wholly
owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica,
Inc. (Boehringer). In addition, FDA is amending the animal drug
regulations to reflect a change of sponsor for 15 NADAs from Fort Dodge
Animal Health, Division of Wyeth Holdings Corp., a wholly owned
subsidiary of Pfizer, Inc., to Boehringer.
DATES: This rule is effective March 5, 2010.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York,
NY 10017 (Pfizer) has informed FDA that it has transferred ownership
of, and all rights and interest in, the following 18 approved NADAs and
1 approved ANADA to Boehringer Ingelheim Vetmedica, Inc., 2621 North
Belt Highway, St. Joseph, MO 64506-2002 (Boehringer): NADA 15-030, 32-
702, 34-879, 45-290, 55-021, 55-022, 55-030, 55-048, 55-054, 55 058,
97-222, 108-114, 119-688, 140-684, 140-806, 140-854, 141-096, and 141-
274; and ANADA 200-088. In addition, Fort Dodge Animal Health, Division
of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following 15 approved NADAs to Boehringer: NADA 6-084,
8-774, 12-198, 13-624, 33-127, 33-318, 33-319, 33-373, 40-181, 46-146,
65-269, 99-388, 122-271, 122-272, and 141-108. Accordingly, the agency
is amending the regulations in 21 CFR parts 520, 522, 524, and 526 to
reflect the transfer of ownership. In addition, several sections are
being revised to reflect the current format.
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 Parts 520, 522, 524, and 526
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 520,
522, 524, and 526 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Revise Sec. 520.23 to read as follows:
Sec. 520.23 Acepromazine.
(a) Specifications. Each tablet contains 5, 10, or 25 milligrams
(mg) acepromazine maleate.
(b) Sponsors. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 0.25 to 1.0 mg per
pound (/lb) body weight orally.
(ii) Indications for use. As an aid in tranquilization and as a
preanesthetic agent.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. 0.5 to 1.0 mg/lb body weight orally.
(ii) Indications for use. As a tranquilizer.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
3. Revise Sec. 520.314 to read as follows:
Sec. 520.314 Cefadroxil.
(a) Specifications.--(1) Each tablet contains 50, 100, or 200
milligrams (mg) or 1 gram of cefadroxil.
(2) Each milliliter of suspension constituted from powder contains
50 mg of cefadroxil.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs.
Administer 10 mg per pound (/lb) body weight twice daily orally.
(ii) Cats. Administer 10 mg/lb body weight once daily orally.
(2) Indications for use--(i) Dogs. For the treatment of skin and
soft tissue infections including cellulitis, pyoderma, dermatitis,
wound infections, and abscesses due to susceptible strains of
Staphylococcus aureus. For the treatment of genitourinary tract
infections (cystitis) due to susceptible strains of Escherichia coli,
Proteus mirabilis, and S. aureus.
(ii) Cats. For the treatment of skin and soft tissue infections
including abscesses, wound infections, cellulitis, and dermatitis
caused by susceptible strains of Pasteurella multocida, S. aureus,
Staphylococcus epidermidis, and Streptococcus spp.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.315 [Removed]
0
4. Remove Sec. 520.315.
0
5. In Sec. 520.645, in paragraph (b), remove ``000856'' and in its
place add ``000010''; and revise paragraphs (d)(1)(i)and (d)(1)(iii) to
read as follows:
Sec. 520.645 Difloxacin.
* * * * *
(d) * * *
(1) * * *
(i) Amount. Administer 5 to 10 mg per kilogram (2.3 to 4.6 mg per
pound) of body weight orally once a day for 2 to 3 days beyond
cessation of clinical signs of disease up to a maximum of 30 days.
* * * * *
[[Page 10166]]
(iii) Limitations. Federal law prohibits the extra-label use of
this drug in food-producing animals. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
* * * * *
0
6. In Sec. 520.870, in paragraph (b), remove ``053501'' and in its
place add ``No. 000010''; revise paragraphs (d)(1)(i)and (d)(1)(iii to
read as follows:
Sec. 520.870 Etodolac.
* * * * *
(d) * * *
(1) * * *
(i) Amount. Administer 10 to 15 mg per kilogram (4.5 to 6.8 mg per
pound) of body weight per day orally.
* * * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *
0
7. Revise Sec. 520.1130 to read as follows:
Sec. 520.1130 Hetacillin.
(a) Specifications.--(1) Each capsule or tablet contains hetacillin
potassium equivalent to 50, 100, or 200 milligrams (mg) of ampicillin.
(2) Each milliliter of suspension contains hetacillin potassium
equivalent to 50 mg of ampicillin.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs.
Administer 5 mg per pound (/lb) of body weight orally, twice daily. In
severe infections, administer 5 mg/lb three times daily, or up to 10
mg/lb twice daily. For stubborn urinary tract infections, administer up
to 20 mg/lb twice daily.
(ii) Cats. Administer 50 mg twice daily.
(2) Indications for use. For the treatment of respiratory tract
infections, urinary tract infections, gastrointestinal infections, skin
infections, soft tissue infections, and postsurgical infections
associated with strains of organisms susceptible to hetacillin
potassium.
(3) Limitations. Federal law restricts this drug to use only by or
on the order of a licensed veterinarian.
Sec. 520.1130a [Removed]
0
8. Remove Sec. 520.1130a.
Sec. 520.1130b [Removed]
0
9. Remove Sec. 520.1130b.
Sec. 520.1130c [Removed]
0
10. Remove Sec. 520.1130c.
Sec. 520.1630 [Amended]
0
11. In paragraph (b) of Sec. 520.1630, remove ``000856'' and in its
place add ``No. 000010''.
0
12. Revise Sec. 520.2200 to read as follows:
Sec. 520.2200 Sulfachlorpyridazine.
(a) Specifications.--(1) Sodium sulfachlorpyridazine powder.
(2) Each bolus contains 2 grams sulfachlorpyridazine.
(3) Each tablet contains 250 milligrams (mg) sulfachlorpyridazine.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.630 of this chapter.
(d) Conditions of use. It is used as follows:
(1) Calves--(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine
powder per pound (/lb) of body weight per day in milk or milk replacer,
or in a bolus, in divided doses twice daily for 1 to 5 days.
(ii) Indications for use. For the treatment of diarrhea caused or
complicated by Escherichia coli (colibacillosis).
(iii) Limitations. Treated ruminating calves must not be
slaughtered for food during treatment or for 7 days after the last
treatment. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
(2) Swine--(i) Amount. Administer 20 to 35 mg/lb body weight per
day, in divided doses twice daily for 1 to 5 days:
(A) In drinking water or
(B) For individual treatment, in an oral suspension containing 50
mg per milliliter.
(ii) Indications for use. For the treatment of diarrhea caused or
complicated by E. coli (colibacillosis).
(iii) Limitations. Treated swine must not be slaughtered for food
during treatment or for 4 days after the last treatment.
(3) Dogs--(i) Amount. Administer tablets orally at 500 mg per 10 to
15 lb of body weight daily, in two or three divided doses.
(ii) Indications for use. As an aid in the treatment of infectious
tracheobronchitis and infections caused by E. coli, and in the
treatment of infections caused by other Gram-positive and Gram-negative
organisms that are susceptible to sulfonamide therapy.
(iii) Limitations. Federal law restricts this drug to use only by
or on the order of a licensed veterinarian.
Sec. 520.2200a [Removed]
0
13. Remove Sec. 520.2200a.
Sec. 520.2200b [Removed]
0
14. Remove Sec. 520.2200b.
Sec. 520.2200c [Removed]
0
15. Remove Sec. 520.2200c.
Sec. 520.2260a [Amended]
0
16. In paragraph (a)(1) of Sec. 520.2260a, remove ``053501'' and in
its place add ``000010''.
Sec. 520.2261a [Amended]
0
17. In Sec. 520.2261a, in the first sentence of paragraph (a), remove
``053501'' and in its place add ``000010''; and remove paragraph (d).
Sec. 520.2261b [Amended]
0
18. In paragraph (b) of Sec. 520.2261b, remove ``053501'' and in its
place add ``000010''.
Sec. 520.2345d [Amended]
0
19. In paragraphs (b)(3), (d)(1)(iii), and (d)(2)(iii) of Sec.
520.2345d, remove ``053501'' and in its place add ``000010''.
Sec. 520.2481 [Removed]
0
20. Remove Sec. 520.2481.
Sec. 520.2482 [Removed]
0
21. Remove Sec. 520.2482.
0
22. Add Sec. 520.2483 to read as follows:
Sec. 520.2483 Triamcinolone.
(a) Specifications.--(1) Each tablet contains 0.5 milligram (mg) or
1.5 mg triamcinolone acetonide.
(2) Each 15 grams of powder contains 10 mg triamcinolone acetonide.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Special considerations. See Sec. 510.410 of this chapter.
(d) Conditions of use--(1) Dogs and cats. Use tablets described in
paragraph (a)(1) of this section as follows:
(i) Amount. Administer 0.05 mg per pound (/lb) of body weight daily
by mouth; up to 0.1 mg per pound (/lb) of body weight daily, if
response to the smaller dose is inadequate. Therapy may be initiated
with a single injection of triamcinolone acetonide suspension as in
Sec. 522.2483 of this chapter, in which case triamcinolone acetonide
tablets should be administered beginning 5 to 7 days after the
injection.
(ii) Indications for use. As an anti-inflammatory agent.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses. Use oral powder described in paragraph (a)(2) of this
section as follows:
[[Page 10167]]
(i) Amount. Administer 0.005 to 0.01 mg/lb of body weight twice
daily, sprinkled (top-dressed) on a small portion of feed. Therapy may
be initiated with a single injection of triamcinolone acetonide
suspension as in Sec. 522.2483 of this chapter, in which case
triamcinolone acetonide oral powder should be administered beginning 3
or 4 days after the injection.
(ii) Indications for use. As an anti-inflammatory agent.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Do not use in horses intended for
human consumption.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
23. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
24. Revise Sec. 522.23 to read as follows:
Sec. 522.23 Acepromazine.
(a) Specifications. Each milliliter of solution contains 10
milligrams (mg) acepromazine maleate.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) No. 000010 for use as in paragraphs (d) and (e) of this
section.
(2) No. 059130 for use as in paragraph (d) of this section.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(d) Conditions of use. It is used in dogs, cats, and horses as
follows:
(1) Amount. Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight;
Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100
lbs of body weight.
(2) Indications for use. As a tranquilizer.
(e) Conditions of use. It is used in dogs as follows:
(1) Amount. Dogs: 0.25 to 0.5 mg/lb of body weight.
(2) Indications for use. As an aid in tranquilization and as a
preanesthetic agent.
Sec. 522.90b [Amended]
0
25. In Sec. 522.90b, in the section heading, remove ``sterile''; and
in paragraph (b)(1), remove ``000856'' and in its place add ``No.
000010''.
Sec. 522.775 [Amended]
0
26. In paragraph (b) of Sec. 522.775, remove ``000856'' and in its
place add ``000010''.
Sec. 522.870 [Amended]
0
27. In paragraph (b) of Sec. 522.870, remove ``000856'' and in its
place add ``000010''.
Sec. 522.1145 [Amended]
0
28. In paragraph (c)(2) of Sec. 522.1145, remove ``000856'' and in its
place add ``No. 000010''.
Sec. 522.1222a [Amended]
0
29. In paragraph (b) of Sec. 522.1222a, remove ``000856,''.
0
30. Revise Sec. 522.2200 to read as follows:
Sec. 522.2200 Sulfachlorpyridazine.
(a) Specifications. Each milliliter of solution contains sodium
sulfachlorpyridazine equivalent to 200 milligrams (mg)
sulfachlorpyridazine.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.630 of this chapter.
(d) Conditions of use in calves. It is used as follows:
(1) Amount. Administer 30 to 45 mg per pound (/lb) of body weight
in divided doses by twice daily injection for 1 to 5 days.
(2) Indications for use. For the treatment of diarrhea caused or
complicated by Escherichia coli (colibacillosis).
(3) Limitations. Treated calves must not be slaughtered for food
during treatment or for 5 days after the last treatment. A withdrawal
period has not been established for this product in preruminating
calves. Do not use in calves to be processed for veal.
0
31. Amend Sec. 522.2260 as follows:
0
a. Revise the section heading;
0
b. Revise paragraphs (a) and (b);
0
c. Remove paragraph (d);
0
d. Redesignate paragraph (e) as (d); and
0
e. Revise newly redesignated paragraph (d) introductory text and
paragraph (d)(1).
0
The revisions read as follows:
Sec. 522.2260 Sulfamethazine.
(a) Specifications. Each milliliter of solution contains 250
milligrams sulfamethazine sodium.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Conditions of use in cattle--(1) Amount. 20 milliliters for
each 50 pounds of body weight (100 milligrams per pound) initially; 20
milliliters per 100 pounds of body weight (50 milligrams per pound)
daily, thereafter.
* * * * *
0
32. Revise Sec. 522.2483 to read as follows:
Sec. 522.2483 Triamcinolone.
(a) Specifications. Each milliliter of suspension contains 2 or 6
milligrams (mg) triamcinolone acetonide.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs and cats--(i) Amount--(A)
Intramuscular or subcutaneous. For inflammatory, arthritic, or allergic
disorders, administer 0.05 to 0.1 mg per pound (/lb) of body weight as
a single injection. For dermatologic disorders, administer 0.1 mg per
pound (/lb) of body weight as a single injection. If symptoms recur,
the dose may be repeated, or oral corticosteroid therapy may be
instituted.
(B) Intralesional. Administer 1.2 to 1.8 mg, divided in several
injections around the lesion, spaced 0.5 to 2.5 centimeters apart,
depending on lesion size. At any one site, the dose injected should not
exceed 0.6 mg. and should be well into the cutis to prevent rupture of
the epidermis. When treating animals with multiple lesions, do not
exceed a total dose of 6 mg.
(C) Intra-articular and intrasynovial. Administer 1 to 3 mg as a
single injection, depending on the size of the joint and severity of
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial
results are inadequate or too transient, dosage may be increased, not
to exceed 3 mg.
(ii) Indications for use. For the treatment of inflammation and
related disorders, and the management and treatment of acute arthritis
and allergic and dermatologic disorders.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses--(i) Amount--(A) Intramuscular or subcutaneous.
Administer 0.01 to 0.02 mg/lb of body weight as a single injection.
Usual dose is 12 to 20 mg.
(B) Intra-articular and intrasynovial. Administer 6 to 18 mg as a
single injection, depending on the size of the joint and severity of
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial
results are inadequate or too transient, dosage may be increased, not
to exceed 18 mg.
(ii) Indications for use. For the treatment of inflammation and
related disorders.
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 522.2662 [Amended]
0
33. In paragraph (b)(2) of Sec. 522.2662, remove ``000856'' and in its
place add ``000010''.
[[Page 10168]]
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.2481 [Redesignated as Sec. 524.2483]
0
35. Redesignate Sec. 524.2481 as Sec. 524.2483.
Sec. 524.2483 [Amended]
0
36. In paragraph (b) of newly redesignated Sec. 524.2483, remove
``015914, 053501, and 054925'' and in its place add ``000010, 015914,
and 054925''.
PART 526--INTRAMAMMARY DOSAGE FORMS
0
37. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 526.363 [Amended]
0
38. In paragraph (b) of Sec. 526.363, remove ``000856'' and in its
place add ``000010''.
Sec. 526.365 [Amended]
0
39. In paragraph (b) of Sec. 526.365, remove ``000856'' and in its
place add ``000010''.
0
40. In Sec. 526.464a, revise the section heading and paragraph (c) to
read as follows:
Sec. 526.464a Cloxacillin benzathine.
* * * * *
(c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter for
use in dairy cows.
* * * * *
Sec. 526.1130 [Amended]
0
41. In Sec. 526.1130, in paragraph (b), remove ``000856'' and in its
place add ``000010''; and in paragraph (c)(3), remove the first
sentence.
Dated: February 26, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-4560 Filed 3-4-10; 8:45 am]
BILLING CODE 4160-01-S