New Animal Drugs for Use in Animal Feeds; Melengestrol, 2566-2567 [05-761]
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Federal Register / Vol. 70, No. 10 / Friday, January 14, 2005 / Rules and Regulations
comment.’’ 5 U.S.C. 601(2). Since the
rules are not being effected pursuant to
section 553(b), they are not ‘‘rules’’ as
defined in the RFA, and the analysis
and certification process certified in that
statute do not apply.
C. The Paperwork Reduction Act
The Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501, et seq., which
imposes certain requirements on federal
agencies, including the Commission, in
connection with their conducting or
sponsoring any collection of
information as defined by the PRA, does
not apply to these rule amendments
because these rule amendments do not
contain information collection
requirements as defined by the PRA.
D. Cost-Benefit Analysis
Section 15 of the Act, as amended by
section 119 of the CFMA, requires the
Commission, before issuing a new
regulation under the Act, to consider the
costs and benefits of its action. The
Commission understands that, by its
terms, section 15 does not require the
Commission to quantify the costs and
benefits of a new regulation or to
determine whether the benefits of the
proposed regulation outweigh its costs.
Section 15 further specifies that costs
and benefits shall be evaluated in light
of five broad areas of market and public
concern: (1) Protection of market
participants and the public; (2)
efficiency, competitiveness, and
financial integrity of futures markets; (3)
price discovery; (4) sound risk
management practices; and (5) other
public interest considerations.
Accordingly, the Commission could in
its discretion give greater weight to any
one of the five enumerated areas of
concern and could in its discretion
determine that, notwithstanding its
costs, a particular rule was necessary or
appropriate to protect the public interest
or to effectuate any of the provisions or
to accomplish any of the purposes of the
Act.
The Commission has considered the
costs and benefits of this rule package
in light of the specific areas of concern
identified in section 15, at the time that
the Commission delegated these
responsibilities to the Division and the
National Futures Association.
List of Subjects in 17 CFR Part 140
Authority delegations (Government
agencies), Organization and functions
(Government agencies).
VerDate jul<14>2003
13:05 Jan 13, 2005
Jkt 205001
PART 140—ORGANIZATION,
FUNCTIONS, AND PROCEDURES OF
THE COMMISSION
Accordingly, 17 CFR part 140 is
corrected by making the following
technical amendments:
I 1. The authority citation for part 140
continues to read as follows:
I
Authority: 7 U.S.C. 2, 12a.
§ 140.93
[Corrected]
2. In § 140.93:
a. Remove the words ‘‘Trading and
Markets’’ in the title and add, in their
place, ‘‘Clearing and Intermediary
Oversight.’’
I b. Remove paragraph (a)(2);
I c. Redesignate paragraphs (a)(3) and
(a)(4) as paragraphs (a)(2) and (a)(3),
respectively;
I d. Redesignate paragraph (a)(5) as
paragraph (a)(4) and correct
‘‘§ 4.5(c)(2)(v)’’ in newly redesignated
paragraph (a)(4) to read ‘‘§ 4.5(c)(2)(ii)’’;
and
I e. Redesignate paragraph (a)(6) as
paragraph (a)(5).
*
*
*
*
*
I
I
Issued in Washington, DC, on January 11,
2005 by the Commission.
Jean A. Webb,
Secretary of the Commission.
[FR Doc. 05–817 Filed 1–14–05; 8:45 am]
BILLING CODE 8351–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Melengestrol
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 an abbreviated new animal
drug application (ANADA) filed by Ivy
Laboratories, Division of Ivy Animal
Health, Inc. The ANADA provides for
use of a melengestrol acetate liquid
Type A medicated article to make Type
C medicated feeds for heifers fed in
confinement for slaughter and for
heifers intended for breeding.
DATES: This rule is effective January 14,
2005.
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary
Medicine (HFV–104), Food and Drug
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301–827–8549, email: lonnie.luther@fda.gov.
SUPPLEMENTARY INFORMATION: Ivy
Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland
Park, KS 66214, filed ANADA 200–343
for use of HEIFERMAX 500
(melengestrol acetate) Liquid Premix, a
liquid Type A medicated article used to
make dry and liquid Type C medicated
feeds for heifers fed in confinement for
slaughter and for heifers intended for
breeding. Ivy Laboratories’ HEIFERMAX
500 Liquid Premix is approved as a
generic copy of Pharmacia and Upjohn
Co.’s MGA 500 (melengestrol acetate)
Liquid Premix, approved under NADA
39–402. The application is approved as
of December 3, 2004, and the
regulations are amended in 21 CFR
558.342 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.
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.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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
part 558 is amended as follows:
I
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.
2. Section 558.342 is amended by
revising paragraph (b) and in the table in
I
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Federal Register / Vol. 70, No. 10 / Friday, January 14, 2005 / Rules and Regulations
paragraphs (e)(1)(i) and (e)(1)(ii) in the
‘‘Sponsor’’ column by adding in
numerical sequence ‘‘021641’’ to read as
follows:
§ 558.342
Melengestrol.
*
*
*
*
*
(b) Approvals. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
(1) No. 000009 for use of products
described in paragraph (a) of this
section.
(2) No. 021641 for use of product
described in paragraph (a)(2) of this
section.
*
*
*
*
*
Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–761 Filed 1–13–05; 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; Decoquinate
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 two supplemental new
animal drug applications (NADAs) filed
by Alpharma Inc. The supplemental
NADAs provide for the use of singleingredient decoquinate and
Decoquinate in
grams/ton
Combination in
grams/ton
*
Indications for use
*
(ii) 12.9 to 90.8
VerDate jul<14>2003
chlortetracycline Type A medicated
articles to make two-way Type B and
Type C medicated feeds for cattle at a
broader range of concentrations.
DATES: This rule is effective January 14,
2005.
FOR FURTHER INFORMATION CONTACT:
Janis R. Messenheimer, Center for
Veterinary Medicine (HFV–135), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301–827–
7578, e-mail:
janis.messenheimer@fda.gov.
SUPPLEMENTARY INFORMATION: Alpharma
Inc., One Executive Drive, P.O. Box
1399, Fort Lee, NJ 07024, filed a
supplement to NADA 141–147 for use of
DECCOX (decoquinate) and
CHLORMAX (chlortetracycline) Type A
medicated articles to make two-way
Type B and Type C medicated feeds for
cattle at the broader range of
concentrations. Alpharma Inc. also filed
a supplement to NADA 141–185 for use
of DECCOX and AUREOMYCIN
(chlortetracycline) Type A medicated
articles for the same revised conditions
of use. The supplemental applications
are approved as of December 16, 2004,
and the regulations are amended in 21
CFR 558.195 to reflect the approval. The
basis of approval is discussed in the
freedom of information summaries.
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.
*
Chlortetracycline
500 to 4,000.
13:05 Jan 13, 2005
Jkt 205001
*
Frm 00007
Fmt 4700
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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
part 558 is amended as follows:
I
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.
2. Section 558.195 is amended by
redesignating paragraphs (e)(2)(ii),
(e)(2)(iii), and (e)(2)(iv) as paragraphs
(e)(2)(vi), (e)(2)(iv), and (e)(2)(iii)
respectively; and by adding new
paragraphs (e)(2)(ii) and (e)(2)(vii) to
read as follows:
I
§ 558.195
Decoquinate.
*
*
*
(e) * * *
*
*
*
(2) Cattle.
*
*
*
*
Limitations
Calves, beef, and nonlactating
dairy cattle: As in paragraph
(e)(2)(i) of this section; for treatment of bacterial enteritis
caused by Escherichia coli; and
for treatment of bacterial pneumonia caused by Pasteurella
multocida organisms susceptible to chlortetracycline.
PO 00000
The agency has determined under 21
CFR 25.33(a)(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 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.
*
Sponsor
*
Feed Type C feed to provide 22.7 mg decoquinate
and 1 gram chlortetracycline per 100 lb body
weight per day for not more than 5 days. When
consumed, feed 22.7 mg decoquinate per 100 lb
body weight/day for a total of 28 days to prevent
coccidiosis. Withdraw 24 hours prior to slaughter
when manufactured from CTC (chlortetracycline)
Type A medicated articles under NADA 141–
147. Zero withdrawal time when manufactured
from AUREOMYCIN (chlortetracycline) Type A
medicated articles under NADA 141–185. A
withdrawal period has not been established for
this product in preruminating calves. Do not use
in calves to be processed for veal. Do not feed
to animals producing milk for food. Chlortetracycline as provided by No. 046573 in
§ 510.600(c) of this chapter.
Sfmt 4700
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14JAR1
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046573
]]>Agencies
[Federal Register Volume 70, Number 10 (Friday, January 14, 2005)]
[Rules and Regulations]
[Pages 2566-2567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-761]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Melengestrol
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 an abbreviated new animal drug
application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal
Health, Inc. The ANADA provides for use of a melengestrol acetate
liquid Type A medicated article to make Type C medicated feeds for
heifers fed in confinement for slaughter and for heifers intended for
breeding.
DATES: This rule is effective January 14, 2005.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
lonnie.luther@fda.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-
343 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix, a
liquid Type A medicated article used to make dry and liquid Type C
medicated feeds for heifers fed in confinement for slaughter and for
heifers intended for breeding. Ivy Laboratories' HEIFERMAX 500 Liquid
Premix is approved as a generic copy of Pharmacia and Upjohn Co.'s MGA
500 (melengestrol acetate) Liquid Premix, approved under NADA 39-402.
The application is approved as of December 3, 2004, and the regulations
are amended in 21 CFR 558.342 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.
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.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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 part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. Section 558.342 is amended by revising paragraph (b) and in the
table in
[[Page 2567]]
paragraphs (e)(1)(i) and (e)(1)(ii) in the ``Sponsor'' column by adding
in numerical sequence ``021641'' to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
(1) No. 000009 for use of products described in paragraph (a) of
this section.
(2) No. 021641 for use of product described in paragraph (a)(2) of
this section.
* * * * *
Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-761 Filed 1-13-05; 8:45 am]
BILLING CODE 4160-01-S
