New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin, 61029-61030 [E9-28019]
Download as PDF
<![CDATA[
61029
Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Rules and Regulations
Dated: November 16, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–28009 Filed 11–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Melengestrol; Monensin;
Tylosin
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 new animal
drug application (NADA) filed by
Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA
provides for use of the same dose levels
approved for single-ingredient Type C
medicated feeds containing
melengestrol acetate, monensin, or
tylosin phosphate for heifers fed in
confinement for slaughter in three-way,
combination drug Type C medicated
feeds containing melengestrol acetate,
monensin, and tylosin phosphate.
Melengestrol acetate in mg/head/
day
*
erowe on DSK5CLS3C1PROD with RULES
Combination in mg/head/day
*
(xi) 0.25 to 0.5 ......
DATES: This rule is effective November
23, 2009.
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed a supplement to NADA 138–870
for use of MGA (melengestrol acetate),
RUMENSIN (monensin, USP), and
TYLAN (tylosin phosphate) singleingredient Type A medicated articles to
make three-way, combination drug Type
C medicated feeds for heifers fed in
confinement for slaughter. The
supplemental NADA provides for use of
the same dose levels approved for single
ingredient Type C medicated feeds
containing melengestrol acetate,
monensin, or tylosin phosphate in the
three-way, combination drug Type C
medicated feeds. The supplemental
application is approved as of October
19, 2009, and the regulations are
amended in 21 CFR 558.342 to reflect
the approval.
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
*
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:
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
2. In § 558.342, add paragraph
(e)(1)(xi) to read as follows:
■
§ 558.342
*
Melengestrol.
*
*
(e) * * *
(1) * * *
Indications for use
*
Monensin 50 to 480, plus tylosin 60 to
90.
9 a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33 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.
*
*
Limitations
*
Heifers fed in confinement
for slaughter: As in paragraph (e)(1)(i) of this section; for the prevention
and control of coccidiosis
due to Eimeria bovis and
E. zuernii; and for reduction of incidence of liver
abscesses caused by
Fusobacterium
necrophorum and
Arcanobacterium
pyogenes.
*
Feed continuously as sole ration (liquid or dry) at a rate of 0.5 to 2.0
lb/head/day to provide 0.25 to 0.5
mg/head/day melengestrol acetate; 0.14 to 0.42 mg monensin/lb
body weight/day, depending on
the severity of the coccidiosis
challenge, up to 480 mg/head/day;
and 60 to 90 mg/head/day tylosin.
The melengestrol acetate portion
of this Type C medicated feed
must be mixed into a complete
feed containing 10 to 40 g/ton
monensin and 8 to 10 g/ton tylosin
in the amount of complete feed
consumed by an animal per day.
Monensin and tylosin phosphate provided by No. 000986 in
§ 510.600(c) of this chapter.
VerDate Nov<24>2008
15:09 Nov 20, 2009
Jkt 220001
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
E:\FR\FM\23NOR1.SGM
23NOR1
Sponsor
*
000009
61030
*
*
Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Rules and Regulations
*
*
*
Dated: November 17, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–28019 Filed 11–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Parts 538 and 560
Sudanese Sanctions Regulations;
Iranian Transactions Regulations
erowe on DSK5CLS3C1PROD with RULES
AGENCY: Office of Foreign Assets
Control, Treasury.
ACTION: Interim final rule with request
for comments.
SUMMARY: The Department of the
Treasury’s Office of Foreign Assets
Control (‘‘OFAC’’) is adopting an
interim final rule which makes
technical changes to certain sections of
the Sudanese Sanctions Regulations and
the Iranian Transactions Regulations, 31
CFR parts 538 and 560, respectively,
relating to the Trade Sanctions Reform
and Export Enhancement Act of 2000, as
amended (‘‘TSRA’’). The preamble to
this interim final rule clarifies OFAC’s
policy with respect to the process for
issuing one-year licenses to export
agricultural commodities, medicine, and
medical devices to Sudan and Iran
pursuant to section 906 of TSRA.
DATES: The interim final rule is effective
November 23, 2009. Written comments
may be submitted on or before January
22, 2010.
ADDRESSES: You may submit comments
by any of the following methods:
Federal eRulemaking Portal: https://
www.regulations.gov.
Follow the instructions for submitting
comments.
Fax: Attn: Request for Comments
(Trade Sanctions Reform and Export
Enhancement Act) (202) 622–1657
Mail: Attn: Request for Comments
(Trade Sanctions Reform and Export
Enhancement Act): Office of Foreign
Assets Control, Department of the
Treasury, 1500 Pennsylvania Avenue,
NW., Washington, DC 20220.
Instructions: All submissions received
must include the agency name and the
Federal Register Doc. number that
appears at the end of this document.
Comments received will be made
available to the public via
regulations.gov or upon request, without
change and including any personal
information provided.
VerDate Nov<24>2008
15:09 Nov 20, 2009
Jkt 220001
FOR FURTHER INFORMATION CONTACT:
Assistant Director for Compliance,
Outreach and Implementation, tel.: 202/
622–2490, Assistant Director for
Licensing, tel.: 202/622–2480, Assistant
Director for Policy, tel.: 202/622–4855,
Office of Foreign Assets Control, or
Chief Counsel (Foreign Assets Control),
tel.: 202/622–2410, Office of the General
Counsel, Department of the Treasury
(not toll free numbers).
SUPPLEMENTARY INFORMATION:
Electronic and Facsimile Availability
This document and additional
information concerning OFAC are
available from OFAC’s Web site
(https://www.treas.gov/ofac). Certain
general information pertaining to
OFAC’s sanctions programs is also
available via facsimile through a 24hour fax-on-demand service, tel.: 202/
622–0077.
Procedural Requirements
Because the amendment of 31 CFR
parts 538 and 560 involves a foreign
affairs function, the provisions of
Executive Order 12866 and the
Administrative Procedure Act (5 U.S.C.
553), requiring notice of proposed
rulemaking, opportunity for public
participation, and delay in effective
date, are inapplicable. Because no
notice of proposed rulemaking is
required for this rule, the Regulatory
Flexibility Act (5 U.S.C. 601–612) does
not apply.
Although a prior notice of proposed
rulemaking is not required, OFAC is
soliciting comments on this interim
final rule in order to consider how it
might make improvements to these
sections of the Sudanese Sanctions
Regulations and the Iranian
Transactions Regulations, 31 CFR parts
538 and 560, respectively. Comments
must be submitted in writing. The
addresses and deadline for submitting
comments appear near the beginning of
this notice. OFAC will not accept
comments accompanied by a request
that all or part of the submission be
treated confidentially because of its
business proprietary nature or for any
other reason. All comments received by
the deadline will be a matter of public
record and will be made available to the
public via regulations.gov.
Background
The Office of Foreign Assets Control
(‘‘OFAC’’) today is adopting an interim
final rule which makes technical
changes to certain sections of the
Sudanese Sanctions Regulations, 31
CFR part 538 (the ‘‘SSR’’), and the
Iranian Transactions Regulations, 31
CFR part 560 (the ‘‘ITR’’), relating to the
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
Trade Sanctions Reform and Export
Enhancement Act of 2000, as amended
(22 U.S.C. 7201 et seq.) (‘‘TSRA’’). This
interim final rule and accompanying
preamble serve to clarify OFAC’s policy
with respect to the process for issuing
one-year licenses to export agricultural
commodities, medicine, and medical
devices to Sudan and Iran, and the
considerations relevant to such
licensing decisions.
TSRA provides that, with certain
exceptions, the President may not
impose a unilateral agricultural sanction
or unilateral medical sanction against a
foreign country or foreign entity unless,
at least 60 days before imposing such a
sanction, the President submits a report
to Congress describing the proposed
sanction and the reasons for it and
Congress enacts a joint resolution
approving the report. Section 906 of
TSRA, however, requires that the export
of agricultural commodities, medicine,
and medical devices to Cuba, or to the
government of a country that has been
determined by the Secretary of State,
pursuant to, inter alia, section 6(j) of the
Export Administration Act of 1979 (50
U.S.C. App. 2405(j)), to have repeatedly
provided support for acts of
international terrorism, or to any entity
in such a country, shall only be made
pursuant to one-year licenses issued by
the United States Government. Section
906 also requires that procedures shall
be in place to deny licenses for exports
to any entity within such country that
promotes international terrorism.
Effective July 26, 2001, OFAC
promulgated amendments to the SSR
and the ITR to implement section 906 of
TSRA. See 66 FR 36683 (July 12, 2001)
(the ‘‘2001 interim rule’’). The preamble
to the 2001 interim rule described an
expedited process for the issuance of the
one-year license required by section 906
for all exports and reexports of
agricultural commodities, medicine, and
medical devices to Sudan or Iran.
OFAC published the 2001 interim
rule describing the expedited licensing
process in July 2001. As OFAC has
stated publicly, circumstances
developed almost immediately after
publication of the 2001 interim rule that
seriously limited OFAC’s ability to
process applications as expeditiously as
had been hoped. See Clarification of
Policy With Respect to the Process for
Issuing One-Year Licenses to Export
Agricultural Commodities, Medicine,
and Medical Devices to Sudan and Iran,
72 FR 12980 (March 20, 2007). To begin
with, the terrorist attacks of September
11, 2001, magnified concerns about
international terrorism and proliferation
of weapons of mass destruction. These
concerns prompted greater scrutiny on
E:\FR\FM\23NOR1.SGM
23NOR1
]]>Agencies
[Federal Register Volume 74, Number 224 (Monday, November 23, 2009)]
[Rules and Regulations]
[Pages 61029-61030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28019]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin;
Tylosin
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 new animal drug
application (NADA) filed by Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA provides for use of the same dose
levels approved for single-ingredient Type C medicated feeds containing
melengestrol acetate, monensin, or tylosin phosphate for heifers fed in
confinement for slaughter in three-way, combination drug Type C
medicated feeds containing melengestrol acetate, monensin, and tylosin
phosphate.
DATES: This rule is effective November 23, 2009.
FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail:
suzanne.sechen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement
to NADA 138-870 for use of MGA (melengestrol acetate), RUMENSIN
(monensin, USP), and TYLAN (tylosin phosphate) single-ingredient Type A
medicated articles to make three-way, combination drug Type C medicated
feeds for heifers fed in confinement for slaughter. The supplemental
NADA provides for use of the same dose levels approved for single
ingredient Type C medicated feeds containing melengestrol acetate,
monensin, or tylosin phosphate in the three-way, combination drug Type
C medicated feeds. The supplemental application is approved as of
October 19, 2009, and the regulations are amended in 21 CFR 558.342 to
reflect the approval.
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 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. In Sec. 558.342, add paragraph (e)(1)(xi) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/head/ Combination in mg/head/
day day Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(xi) 0.25 to 0.5............... Monensin 50 to 480, Heifers fed in Feed continuously as 000009
plus tylosin 60 to 90. confinement for sole ration (liquid or
slaughter: As in dry) at a rate of 0.5
paragraph to 2.0 lb/head/day to
(e)(1)(i) of this provide 0.25 to 0.5 mg/
section; for the head/day melengestrol
prevention and acetate; 0.14 to 0.42
control of mg monensin/lb body
coccidiosis due to weight/day, depending
Eimeria bovis and on the severity of the
E. zuernii; and coccidiosis challenge,
for reduction of up to 480 mg/head/day;
incidence of liver and 60 to 90 mg/head/
abscesses caused day tylosin. The
by Fusobacterium melengestrol acetate
necrophorum and portion of this Type C
Arcanobacterium medicated feed must be
pyogenes. mixed into a complete
feed containing 10 to
40 g/ton monensin and
8 to 10 g/ton tylosin
in the amount of
complete feed consumed
by an animal per day.
.......................
Monensin and tylosin
phosphate provided by
No. 000986 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
[[Page 61030]]
* * * * *
Dated: November 17, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-28019 Filed 11-20-09; 8:45 am]
BILLING CODE 4160-01-S
