Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol, 9243-9244 [E7-3620]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii),
summaries of safety and effectiveness
data and information submitted to
support approval of these applications
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(i)), this
original approval of NADA 141–262
qualifies for 5 years of marketing
exclusivity beginning January 29, 2007.
Under section 512(c)(2)(F)(ii) of the
act, this original approval of NADA
141–263 qualifies for 3 years of
marketing exclusivity beginning January
29, 2007.
The agency has determined under 21
CFR 25.33(d)(1) that these actions are of
a type that do not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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 and
522
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 and 522 are amended as
follows:
I
kilogram (/kg) body weight once daily
for up to 5 consecutive days. For the
prevention of vomiting due to motion
sickness, administer a minimum of 8.0
mg/kg body weight once daily for up to
2 consecutive days.
(2) 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
3. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
4. Section 522.1315 is added to read
as follows:
I
§ 522.1315
Maropitant.
(a) Specifications. Each milliliter of
solution contains 10 milligrams (mg)
maropitant as maropitant citrate.
(b) Sponsor. See No. 000069 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer 1.0 mg per
kilogram body weight by subcutaneous
injection once daily for up to 5
consecutive days.
(2) Indications for use. For the
prevention and treatment of acute
vomiting.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: February 16, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–3402 Filed 2–28–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
21 CFR Part 522
1. The authority citation for 21 CFR
part 520 continues to read as follows:
Implantation or Injectable Dosage
Form New Animal Drugs; Trenbolone
and Estradiol
I
Authority: 21 U.S.C. 360b.
AGENCY:
rwilkins on PROD1PC63 with RULES
§ 520.1315
ACTION:
Maropitant.
(a) Specifications. Each tablet
contains 16, 24, 60, or 160 milligrams
(mg) maropitant as maropitant citrate.
(b) Sponsor. See No. 000069 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Indications for use and amount. For the
prevention of acute vomiting,
administer a minimum of 2.0 mg per
VerDate Aug<31>2005
15:44 Feb 28, 2007
Jkt 211001
Food and Drug Administration,
HHS.
2. Section 520.1315 is added to read
as follows:
I
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Ivy Laboratories, Division of Ivy
Animal Health, Inc. The supplemental
ANADA provides for the addition of
tylosin tartrate to an approved
subcutaneous implant containing
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
9243
trenbolone and estradiol used for
increased rate of weight gain and
improved feed efficiency in steers and
heifers fed in confinement for slaughter.
DATES: This rule is effective March 1,
2007.
Eric
S. Dubbin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0232, email: eric.dubbin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy
Laboratories, Div. of Ivy Animal Health,
Inc., 8857 Bond St., Overland Park, KS
66214, filed a supplement to ANADA
200–346 for COMPONENT TE–200 with
TYLAN (trenbolone acetate and
estradiol with tylosin tartrate), a
subcutaneous implant used for
increased rate of weight gain and
improved feed efficiency in steers and
heifers fed in confinement for slaughter.
The supplemental ANADA provides for
the addition of a pellet containing 29
milligrams (mg) tylosin tartrate to the
approved COMPONENT TE–200
implant for steers and heifers fed in
confinement for slaughter. The
supplemental application is approved as
of January 26, 2007, and the regulations
are amended in 21 CFR 522.2477 to
reflect the approval. The basis of
approval is discussed in the freedom of
information summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(iii)),
this approval qualifies for 3 years of
marketing exclusivity beginning January
26, 2007.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\01MRR1.SGM
01MRR1
9244
Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations
List of Subjects in 21 CFR Part 522
Animal drugs.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
2. In § 522.2477, add paragraph
(d)(2)(i)(F) to read as follows:
I
Trenbolone acetate and
*
*
*
*
*
(d) * * *
(2) * * *
(i) * * *
(F) 200 mg trenbolone acetate and 20
mg estradiol (one implant consisting of
11 pellets, each of 10 pellets containing
20 mg trenbolone acetate and 2 mg
estradiol, and 1 pellet containing 29 mg
tylosin tartrate) per implant dose.
*
*
*
*
*
Dated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–3620 Filed 2–28–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Monensin
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
rwilkins on PROD1PC63 with RULES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Elanco Animal Health. The
supplemental NADA provides for minor
revisions to labeling of monensin Type
A medicated articles for chickens. FDA
is also amending the regulations to
simplify the organization of special
labeling requirements for formulations
(Type A medicated articles, Type B and
Type C medicated feeds) containing
VerDate Aug<31>2005
15:44 Feb 28, 2007
Jkt 211001
DATES:
This rule is effective March 1,
2007.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
FOR FURTHER INFORMATION CONTACT:
Joan
2. In § 558.355, revise paragraphs (a),
(b)(1), (b)(4), (b)(6), (d)(4), (d)(5), and
(d)(8); and add paragraphs (d)(9)(iv)
through (d)(9)(vi), and (d)(10)(iv)
through (d)(10)(vi) to read as follows:
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
I
Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 38–878 that
provides for use of COBAN 60 and
COBAN 90 (monensin, USP) Type A
medicated articles in feed of chickens.
The supplement provides for minor
revisions to labeling. The supplemental
NADA is approved as of February 7,
2007, and the regulations in 21 CFR
558.355 are amended to reflect the
approval.
In addition, FDA is taking this
opportunity to amend the regulations to
simplify the organization of special
labeling requirements for formulations
(Type A medicated articles, Type B and
Type C medicated feeds) containing
monensin for poultry and game birds.
Similar restructuring was done recently
for monensin formulations used in
ruminants (71 FR 66231, November 14,
2006). This action is being taken to
improve the clarity of the regulations.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
FDA has determined under 21 CFR
25.33(a)(1) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
§ 558.355
SUPPLEMENTARY INFORMATION:
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
§ 522.2477
estradiol.
monensin for poultry and game birds.
This action is being taken to improve
the clarity of the regulations.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
I
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
Monensin.
(a) Specifications. Type A medicated
articles containing monensin, USP.
(b) * * *
(1) To No. 000986: 36.3 (for export
only), 44, 45, 60, or 90.7 grams per
pound for use as in paragraphs (f)(1)(i)
and (f)(4) of this section.
*
*
*
*
*
(4) To No. 000986: 45, 60, or 90.7
grams per pound for use as in paragraph
(f)(2) of this section.
*
*
*
*
*
(6) To No. 000986: 45, 60, or 90.7
grams per pound for use as in paragraph
(f)(5) of this section.
*
*
*
*
*
(d) * * *
(4) Liquid Type B feeds shall bear an
expiration date of 8 weeks after its date
of manufacture.
(5) All Type A medicated articles
containing monensin shall bear the
following warning statement: When
mixing and handling monensin Type A
medicated articles, use protective
clothing, impervious gloves, and a dust
mask. Operators should wash
thoroughly with soap and water after
handling. If accidental eye contact
occurs, immediately rinse thoroughly
with water.
*
*
*
*
*
(8) Type A medicated articles
containing monensin intended for use
in chickens, turkeys, and quail shall
bear the following statements:
(i) Do not allow horses, other equines,
mature turkeys, or guinea fowl access to
feed containing monensin. Ingestion of
monensin by horses and guinea fowl has
been fatal.
(ii) Must be thoroughly mixed in feeds
before use.
(iii) Do not feed undiluted.
(iv) Do not feed to laying chickens.
(v) Do not feed to chickens over 16
weeks of age.
(vi) For replacement chickens
intended for use as cage layers only.
(vii) Some strains of turkey coccidia
may be monensin tolerant or resistant.
Monensin may interfere with
development of immunity to turkey
coccidiosis.
E:\FR\FM\01MRR1.SGM
01MRR1
]]>Agencies
[Federal Register Volume 72, Number 40 (Thursday, March 1, 2007)]
[Rules and Regulations]
[Pages 9243-9244]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3620]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Trenbolone and Estradiol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Ivy Laboratories, Division of
Ivy Animal Health, Inc. The supplemental ANADA provides for the
addition of tylosin tartrate to an approved subcutaneous implant
containing trenbolone and estradiol used for increased rate of weight
gain and improved feed efficiency in steers and heifers fed in
confinement for slaughter.
DATES: This rule is effective March 1, 2007.
FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0232, e-mail: eric.dubbin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health,
Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to
ANADA 200-346 for COMPONENT TE-200 with TYLAN (trenbolone acetate and
estradiol with tylosin tartrate), a subcutaneous implant used for
increased rate of weight gain and improved feed efficiency in steers
and heifers fed in confinement for slaughter. The supplemental ANADA
provides for the addition of a pellet containing 29 milligrams (mg)
tylosin tartrate to the approved COMPONENT TE-200 implant for steers
and heifers fed in confinement for slaughter. The supplemental
application is approved as of January 26, 2007, and the regulations are
amended in 21 CFR 522.2477 to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval
qualifies for 3 years of marketing exclusivity beginning January 26,
2007.
The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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.
[[Page 9244]]
List of Subjects in 21 CFR Part 522
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.2477, add paragraph (d)(2)(i)(F) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(d) * * *
(2) * * *
(i) * * *
(F) 200 mg trenbolone acetate and 20 mg estradiol (one implant
consisting of 11 pellets, each of 10 pellets containing 20 mg
trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg
tylosin tartrate) per implant dose.
* * * * *
Dated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E7-3620 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S
