New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin, 60721 [2011-25220]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Rules and Regulations
application process. The employer is
expected to continue to pay at least the
prevailing wage as promised in the
employer’s labor certification (ETA
Form 9142) for any work performed
before November 30, 2011. However,
employers who received a supplemental
H–2B prevailing wage determination
must pay at least that wage to any H–
2B worker and any U.S. worker
recruited in connection with the labor
certification for work performed on or
after November 30, 2011.
Signed at Washington, DC, this 27th of
September 2011.
Jane Oates,
Assistant Secretary for Employment and
Training.
Nancy J. Leppink,
Deputy Administrator, Wage and Hour
Division.
[FR Doc. 2011–25302 Filed 9–28–11; 11:15 am]
BILLING CODE 4510–FP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2011–N–0003]
New Animal Drugs for Use in Animal
Feeds; Melengestrol; Monensin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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 use of increased
dose levels of melengestrol acetate and
monensin in two-way, combination
drug Type C medicated feeds for heifers
fed in confinement for slaughter.
DATES: This rule is effective September
30, 2011.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy
Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland
Park, KS 66214, filed a supplement to
ANADA 200–422 for use of
HEIFERMAX 500 (melengestrol acetate)
and RUMENSIN (monensin, USP)
single-ingredient Type A medicated
wreier-aviles on DSK7SPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
14:18 Sep 29, 2011
Jkt 223001
articles to make two-way, combination
drug Type C medicated feeds for heifers
fed in confinement for slaughter. The
supplemental ANADA provides for use
of increased dose levels of melengestrol
acetate and monensin. The
supplemental application is approved as
of July 1, 2011, and the regulations in
21 CFR 558.342 are amended to reflect
the approval and minor revisions.
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.
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, in the table in
paragraph (e)(1), remove and reserve
paragraphs (e)(1)(v) and (e)(1)(vi); in
paragraph (e)(1)(x), in the ‘‘Sponsor’’
column, add ‘‘021641’’; and revise
paragraph (d)(2) to read as follows:
■
§ 558.342
Melengestrol.
*
*
*
*
*
(d) * * *
(2) A physically stable melengestrol
acetate liquid Type B or C feed will not
be subject to the requirements for
mixing directions prescribed in
paragraph (d)(1) of this section provided
it has a pH of 4.0 to 8.0 and contains
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
60721
a suspending agent(s) sufficient to
maintain a viscosity of not less than 300
centipoises per second for 3 months.
*
*
*
*
*
Dated: September 20, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2011–25220 Filed 9–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1 and 602
[TD 9551]
RIN 1545–BF94
Deduction for Qualified Film and
Television Production Costs
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
AGENCY:
This document contains final
regulations relating to deductions for
the costs of producing qualified film
and television productions. These final
regulations reflect changes to the law
made by the American Jobs Creation Act
of 2004 and the Gulf Opportunity Zone
Act of 2005, and affect persons that
produce film and television productions
within the United States.
DATES: Effective Date: These regulations
are effective on September 29, 2011.
Applicability Dates: For dates of
applicability, see § 1.181–6.
FOR FURTHER INFORMATION CONTACT:
Bernard P. Harvey, (202) 622–4930 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Paperwork Reduction Act
The collection of information
contained in these final regulations has
been reviewed and approved by the
Office of Management and Budget in
accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)) under control number 1545–
2059. The collection of information in
these final regulations is in §§ 1.181–1,
1.181–2, and 1.181–3. This information
is required to enable the IRS to verify
that a taxpayer is entitled to the
deduction.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid control
number.
Books and records relating to a
collection of information must be
E:\FR\FM\30SER1.SGM
30SER1
]]>Agencies
[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Rules and Regulations]
[Page 60721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25220]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2011-N-0003]
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin
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 use of
increased dose levels of melengestrol acetate and monensin in two-way,
combination drug Type C medicated feeds for heifers fed in confinement
for slaughter.
DATES: This rule is effective September 30, 2011.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a
supplement to ANADA 200-422 for use of HEIFERMAX 500 (melengestrol
acetate) and RUMENSIN (monensin, USP) single-ingredient Type A
medicated articles to make two-way, combination drug Type C medicated
feeds for heifers fed in confinement for slaughter. The supplemental
ANADA provides for use of increased dose levels of melengestrol acetate
and monensin. The supplemental application is approved as of July 1,
2011, and the regulations in 21 CFR 558.342 are amended to reflect the
approval and minor revisions.
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.
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, in the table in paragraph (e)(1), remove and
reserve paragraphs (e)(1)(v) and (e)(1)(vi); in paragraph (e)(1)(x), in
the ``Sponsor'' column, add ``021641''; and revise paragraph (d)(2) to
read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(d) * * *
(2) A physically stable melengestrol acetate liquid Type B or C
feed will not be subject to the requirements for mixing directions
prescribed in paragraph (d)(1) of this section provided it has a pH of
4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a
viscosity of not less than 300 centipoises per second for 3 months.
* * * * *
Dated: September 20, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-25220 Filed 9-29-11; 8:45 am]
BILLING CODE 4160-01-P
