New Animal Drugs; Change of Sponsor, 10165-10168 [2010-4560]
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10165
Rules and Regulations
Federal Register
Vol. 75, No. 43
Friday, March 5, 2010
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
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.
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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, email: david.newkirk@fda.hhs.gov.
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
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(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.
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
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Revise § 520.23 to read as follows:
§ 520.23
Acepromazine.
(a) Specifications. Each tablet
contains 5, 10, or 25 milligrams (mg)
acepromazine maleate.
(b) Sponsors. See No. 000010 in
§ 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.
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(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.
■ 3. Revise § 520.314 to read as follows:
§ 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
§ 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.
§ 520.315
[Removed]
4. Remove § 520.315.
■ 5. In § 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:
■
§ 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.
*
*
*
*
*
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(iii) Limitations. Federal law prohibits
the extra-label use of this drug in foodproducing animals. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
*
*
*
*
6. In § 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:
■
§ 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.
*
*
*
*
*
7. Revise § 520.1130 to read as
follows:
■
§ 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
§ 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.
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§ 520.1130a
■
§ 520.1130b
■
[Removed]
9. Remove § 520.1130b.
§ 520.1130c
■
[Removed]
8. Remove § 520.1130a.
[Removed]
10. Remove § 520.1130c.
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§ 520.1630
[Amended]
§ 520.2200a
11. In paragraph (b) of § 520.1630,
remove ‘‘000856’’ and in its place add
‘‘No. 000010’’.
■ 12. Revise § 520.2200 to read as
follows:
■
§ 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
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 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 Grampositive 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.
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§ 520.2200b
■
[Removed]
13. Remove § 520.2200a.
[Removed]
14. Remove § 520.2200b.
§ 520.2200c
[Removed]
15. Remove § 520.2200c.
§ 520.2260a
[Amended]
16. In paragraph (a)(1) of § 520.2260a,
remove ‘‘053501’’ and in its place add
‘‘000010’’.
■
§ 520.2261a
[Amended]
17. In § 520.2261a, in the first
sentence of paragraph (a), remove
‘‘053501’’ and in its place add ‘‘000010’’;
and remove paragraph (d).
■
§ 520.2261b
[Amended]
18. In paragraph (b) of § 520.2261b,
remove ‘‘053501’’ and in its place add
‘‘000010’’.
■
§ 520.2345d
[Amended]
19. In paragraphs (b)(3), (d)(1)(iii), and
(d)(2)(iii) of § 520.2345d, remove
‘‘053501’’ and in its place add ‘‘000010’’.
■
§ 520.2481
■
§ 520.2482
■
■
[Removed]
20. Remove § 520.2481.
[Removed]
21. Remove § 520.2482.
22. Add § 520.2483 to read as follows:
§ 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
§ 510.600(c) of this chapter.
(c) Special considerations. See
§ 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 § 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 antiinflammatory 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:
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(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 § 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 antiinflammatory 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
23. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
24. Revise § 522.23 to read as follows:
§ 522.23
Acepromazine.
(a) Specifications. Each milliliter of
solution contains 10 milligrams (mg)
acepromazine maleate.
(b) Sponsors. See sponsors in
§ 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.
§ 522.90b
[Amended]
25. In § 522.90b, in the section
heading, remove ‘‘sterile’’; and in
paragraph (b)(1), remove ‘‘000856’’ and
in its place add ‘‘No. 000010’’.
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■
§ 522.775
[Amended]
26. In paragraph (b) of § 522.775,
remove ‘‘000856’’ and in its place add
‘‘000010’’.
■
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§ 522.870
[Amended]
§ 522.2483
27. In paragraph (b) of § 522.870,
remove ‘‘000856’’ and in its place add
‘‘000010’’.
■
§ 522.1145
[Amended]
28. In paragraph (c)(2) of § 522.1145,
remove ‘‘000856’’ and in its place add
‘‘No. 000010’’.
■
§ 522.1222a
[Amended]
29. In paragraph (b) of § 522.1222a,
remove ‘‘000856,’’.
■ 30. Revise § 522.2200 to read as
follows:
■
§ 522.2200
Sulfachlorpyridazine.
(a) Specifications. Each milliliter of
solution contains sodium
sulfachlorpyridazine equivalent to 200
milligrams (mg) sulfachlorpyridazine.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 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.
■ 31. Amend § 522.2260 as follows:
■ a. Revise the section heading;
■ b. Revise paragraphs (a) and (b);
■ c. Remove paragraph (d);
■ d. Redesignate paragraph (e) as (d);
and
■ e. Revise newly redesignated
paragraph (d) introductory text and
paragraph (d)(1).
■ The revisions read as follows:
§ 522.2260
Sulfamethazine.
(a) Specifications. Each milliliter of
solution contains 250 milligrams
sulfamethazine sodium.
(b) Sponsor. See No. 000010 in
§ 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.
*
*
*
*
*
■ 32. Revise § 522.2483 to read as
follows:
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10167
Triamcinolone.
(a) Specifications. Each milliliter of
suspension contains 2 or 6 milligrams
(mg) triamcinolone acetonide.
(b) Sponsor. See No. 000010 in
§ 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.
§ 522.2662
[Amended]
33. In paragraph (b)(2) of § 522.2662,
remove ‘‘000856’’ and in its place add
‘‘000010’’.
■
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PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
DEPARTMENT OF JUSTICE
34. The authority citation for 21 CFR
part 524 continues to read as follows:
21 CFR Part 1313
Drug Enforcement Administration
■
[Docket No. DEA–295F]
Authority: 21 U.S.C. 360b.
§ 524.2481
RIN 1117–AB07
[Redesignated as § 524.2483]
Information on Foreign Chain of
Distribution for Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine
35. Redesignate § 524.2481 as
§ 524.2483.
■
§ 524.2483
[Amended]
36. In paragraph (b) of newly
redesignated § 524.2483, remove
‘‘015914, 053501, and 054925’’ and in its
place add ‘‘000010, 015914, and
054925’’.
■
PART 526—INTRAMAMMARY DOSAGE
FORMS
37. The authority citation for 21 CFR
part 526 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 526.363
[Amended]
38. In paragraph (b) of § 526.363,
remove ‘‘000856’’ and in its place add
‘‘000010’’.
■
§ 526.365
[Amended]
39. In paragraph (b) of § 526.365,
remove ‘‘000856’’ and in its place add
‘‘000010’’.
■
40. In § 526.464a, revise the section
heading and paragraph (c) to read as
follows:
■
§ 526.464a
Cloxacillin benzathine.
*
*
*
*
*
(c) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter for use in
dairy cows.
*
*
*
*
*
§ 526.1130
[Amended]
41. In § 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.
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BILLING CODE 4160–01–S
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AGENCY: Drug Enforcement
Administration (DEA), Justice.
ACTION: Final rule.
SUMMARY: The Drug Enforcement
Administration (DEA) is finalizing,
without change, the Notice of Proposed
Rulemaking published in the Federal
Register on March 31, 2008 (73 FR
16793). The Combat Methamphetamine
Epidemic Act of 2005 (CMEA) requires
DEA to collect from importers of
ephedrine, pseudoephedrine, and
phenylpropanolamine all information
known to the importer on the foreign
chain of distribution of the chemical
from the manufacturer to the importer.
This rule amends DEA regulations to
incorporate the requirement for this
information.
DATES: Effective Dates: This Final Rule
is effective May 4, 2010.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone (202)
307–7297.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
DEA implements the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, often referred to as the
Controlled Substances Act (CSA) and
the Controlled Substances Import and
Export Act (CSIEA) (21 U.S.C. 801–971),
as amended. DEA publishes the
implementing regulations for these
statutes in Title 21 of the Code of
Federal Regulations (CFR), parts 1300 to
1399. These regulations are designed to
ensure that there is a sufficient supply
of controlled substances for legitimate
medical, scientific, research, and
industrial purposes and to deter the
diversion of controlled substances to
illegal purposes. The CSA mandates that
DEA establish a closed system of control
for manufacturing, distributing, and
dispensing controlled substances. Any
person who manufactures, distributes,
dispenses, imports, exports, or conducts
research or chemical analysis with
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controlled substances must register with
DEA (unless exempt) and comply with
the applicable requirements for the
activity. The CSA as amended also
requires DEA to regulate the
manufacture, distribution, import, and
export of chemicals that may be used to
manufacture controlled substances
illegally. Listed chemicals that are
classified as List I chemicals are
important to the manufacture of
controlled substances. Those classified
as List II chemicals may be used to
manufacture controlled substances.
On March 9, 2006, the President
signed the Combat Methamphetamine
Epidemic Act of 2005 (CMEA), which is
Title VII of the USA PATRIOT
Improvement and Reauthorization Act
of 2005 (Pub. L. 109–177). The changes
made by this rule are needed to
implement the statutory provisions.
This Final Rule amends the language of
the regulations to be consistent with
that of the statute.
Import/Export Declaration
Requirements
Under existing DEA regulations (21
CFR part 1313), importers of listed
chemicals are required to provide DEA
with advance notification of imports
unless the importer has met the
requirements as a regular importer of
the listed chemical; for regular
importers, the notification must be filed
by the date of importation. In the
importation declaration (DEA Form
486), the importer must provide
information on the chemical (name, size
and weight of the container, number of
containers, total weight of chemical),
importation (date, foreign port of
shipment, United States port of entry)
and the foreign supplier (name, address,
contact information).
CMEA imposes several new
requirements on imports of listed
chemicals. CMEA amended 21 U.S.C.
971, ‘‘Notification, suspension of
shipment, and penalties with respect to
importation and exportation of listed
chemicals,’’ to require DEA to collect
information regarding persons to whom
the U.S. importer, exporter, broker, or
trader transfers the listed chemical,
actual quantities shipped, and the date
the shipment occurred. If the person to
whom the listed chemical is to be
transferred is not a regular customer of
the U.S. importer or exporter, then the
importer or exporter must notify DEA
no later than 15 days before the
transaction is to take place. Further, if
the person to whom the chemical is to
be transferred changes subsequent to
initial notification of DEA, or if the
amount of the chemical to be transferred
increases, the importer or exporter shall
E:\FR\FM\05MRR1.SGM
05MRR1
]]>Agencies
[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Rules and Regulations]
[Pages 10165-10168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4560]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
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:
david.newkirk@fda.hhs.gov.
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
