New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin, 15884-15885 [E8-6063]
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15884
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
Authority: 21 U.S.C. 331, 333, 337, 351,
352, 355, 360, 360c, 360f, 360i, 360j, 371; 42
U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554,
555, 556, 557.
2. In § 17.2, revise the introductory
text to read as follows:
I
§ 17.2
Maximum penalty amounts.
The following table shows maximum
civil monetary penalties associated with
the statutory provisions authorizing
civil monetary penalties under the act or
the Public Health Service Act:
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Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6082 Filed 3–25–08; 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; Bacitracin Methylene
Disalicylate and Nicarbazin
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 new animal drug
application (NADA) filed by Alpharma,
Inc. The NADA provides for use of
approved, single-ingredient Type A
medicated articles containing bacitracin
methylene disalicylate and nicarbazin to
formulate two-way combination drug
Type C medicated feeds for broiler
chickens.
DATES: This rule is effective March 26,
2008.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116, email: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma,
Inc., 440 Rt. 22, Bridgewater, NJ 08807,
filed NADA 141–279 that provides for
use of BMD (bacitracin methylene
disalicylate) and NICARB (nicarbazin)
Type A medicated articles to formulate
two-way combination drug Type C
medicated feeds for broiler chickens.
The NADA is approved as of February
21, 2008, and the regulations are
amended in 21 CFR 558.366 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.
Combination in
grams per ton
Nicarbazin in grams per ton
113.5 (0.0125 pct)
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*
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VerDate Aug<31>2005
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16:40 Mar 25, 2008
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. In the table in paragraph (d) of
§ 558.366, alphabetically add new
entries for ‘‘Bacitracin methylene
disalicylate 4 to 50’’ and ‘‘Bacitracin
methylene disalicylate 50’’ to read as
follows:
I
§ 558.366
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Fmt 4700
Sponsor
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046573
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Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a
treatment for outbreaks of coccidiosis;
do not use in flushing mashes; do not
feed to laying hens; withdraw 4 days
before slaughter.
*
Sfmt 4700
*
Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a
treatment for outbreaks of coccidiosis;
do not use in flushing mashes; do not
feed to laying hens; withdraw 4 days
before slaughter.
*
*
*
*
Broiler chickens; aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; as an aid in the prevention of
necrotic enteritis caused or complicated by Clostridium spp. or other
organisms susceptible to bacitracin.
PO 00000
Nicarbazin.
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(d) * * *
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Jkt 214001
Animal drugs, Animal feeds.
I 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:
Limitations
Broiler chickens; aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight
gain and improved feed efficiency.
Bacitracin methylene disalicylate
50.
*
List of Subjects in 21 CFR Part 558
Indications for use
Bacitracin methylene disalicylate 4
to 50.
*
The agency has determined under 21
CFR 25.33(a)(2) 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.
E:\FR\FM\26MRR1.SGM
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26MRR1
046573
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Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
Dated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–6063 Filed 3–25–08; 8:45 am]
Regulatory Analysis and Notices
DEPARTMENT OF STATE
[Public Notice: 6147]
Amendment to the International Traffic
in Arms Regulations: North Atlantic
Treaty Organization (NATO)
Department of State.
Final rule.
AGENCY:
SUMMARY: The Department of State is
amending the International Traffic in
Arms Regulations (ITAR), to clarify
United States policy to allow for
reexports or retransfers of U.S.-origin
components incorporated into a foreign
defense article to the North Atlantic
Treaty Organization (NATO), and its
agencies, as well as to NATO member
governments.
Effective Date: This rule is
effective March 26, 2008.
ADDRESSES: Interested parties may
submit comments at any time by any of
the following methods:
• E-mail:
DDTCResponseTeam@state.gov with an
appropriate subject line.
• Mail: Department of State,
Directorate of Defense Trade Controls,
Office of Defense Trade Controls Policy,
ATTN: Regulatory Change, ITAR Part
123, SA–1, 12th Floor, Washington, DC
20522–0112.
Persons with access to the Internet
may also view this notice by going to
the regulations.gov Web site at https://
regulations.gov/index.cfm.
FOR FURTHER INFORMATION CONTACT:
Director Ann Ganzer, Office of Defense
Trade Controls Policy, Department of
State, Telephone (202) 663–2792 or Fax
(202) 261–8199; E-mail
DDTCResponseTeam@state.gov. ATTN:
Regulatory Change, Part 123.
SUPPLEMENTARY INFORMATION: To clarify
the current regulation, it is necessary to
explicitly provide that NATO and its
agencies, in addition to the government
of a NATO country, or the governments
of Australia or Japan, are authorized
without the prior written approval of
the Directorate of Defense Trade
Controls, upon meeting certain
conditions, to reexport or retransfer
U.S.-origin components incorporated
into a foreign defense article.
sroberts on PROD1PC70 with RULES
DATES:
16:40 Mar 25, 2008
PART 123—LICENSES FOR THE
EXPORT OF DEFENSE ARTICLES
Regulatory Flexibility Act
Since this amendment involves a
foreign affairs function of the United
States, it does not require analysis under
the Regulatory Flexibility Act.
22 CFR Part 123
VerDate Aug<31>2005
I
Administrative Procedure Act
This amendment involves a foreign
affairs function of the United States and,
therefore, is not subject to the
procedures required by 5 U.S.C. 553 and
554.
BILLING CODE 4160–01–S
ACTION:
Jkt 214001
15885
Unfunded Mandates Reform Act of 1995
This amendment does not involve a
mandate that will result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
in any year, and it will not significantly
or uniquely affect small governments.
Therefore, no actions were deemed
necessary under the provisions of the
Unfunded Mandates Reform Act of
1995.
Small Business Regulatory Enforcement
Fairness Act of 1996
This amendment has been found not
to be a major rule within the meaning
of the Small Business Regulatory
Enforcement Fairness Act of 1996.
Executive Orders 12372 and 13132
This amendment will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with Executive Order 13132,
it is determined that this amendment
does not have sufficient federalism
implications to require consultations or
warrant the preparation of a federalism
summary impact statement. The
regulations implementing Executive
Order 12372 regarding
intergovernmental consultation on
federal programs and activities do not
apply to this amendment.
Executive Order 12866
This amendment is exempt from
review under Executive Order 12866,
but has been reviewed internally by the
Department of State to ensure
consistency with the purposes thereof.
Paperwork Reduction Act
This rule does not impose any new
reporting or recordkeeping requirements
subject to the Paperwork Reduction Act,
44 U.S.C. Chapter 35.
List of Subjects in 22 CFR Part 123
Arms and munitions, Exports.
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Fmt 4700
Sfmt 4700
Accordingly, for the reasons set forth
above, Title 22, Chapter I, Subchapter
M, part 123 is amended as follows:
1. The authority citation for part 123
continues to read as follows:
I
Authority: Secs. 2, 38, and 71, Pub. L. 90–
629, 90 Stat. 744 (22 U.S.C. 2752, 2778,
2797); 22 U.S.C. 2753; E.O. 11958, 42 FR
4311; 3 CFR, 1977 Comp., p. 79; 22 U.S.C.
2651a; 22 U.S.C. 2776; Pub. L. 105–261, 112
Stat. 1920; Sec. 1205(a), Pub. L. 107–228.
2. Section 123.9 is amended by
revising paragraph (e) introductory text
to read as follows:
I
§ 123.9 Country of ultimate destination
and approval of reexports or retransfers.
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(e) Reexports or retransfers of U.S.origin components incorporated into a
foreign defense article to NATO, NATO
agencies, a government of a NATO
country, or the governments of Australia
or Japan, are authorized without the
prior written approval of the Directorate
of Defense Trade Controls, provided:
*
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Dated: March 10, 2008.
John C. Rood,
Acting Under Secretary for Arms Control and
International Security, Department of State.
[FR Doc. E8–6019 Filed 3–25–08; 8:45 am]
BILLING CODE 4710–25–P
DEPARTMENT OF THE INTERIOR
Minerals Management Service
30 CFR Parts 203, 206, 210, 216, 218,
and 227
[Docket No. MMS–2008–MRM–0021]
RIN 1010–AD20
Reporting Amendments
Minerals Management Service
(MMS), Interior.
ACTION: Final rule.
AGENCY:
SUMMARY: The MMS is amending
existing regulations for reporting
production and royalties on oil, gas,
coal and other solid minerals, and
geothermal resources produced from
Federal and Indian leases in order to
align the regulations with current MMS
business practices. These amendments
reflect changes that were implemented
as a result of major reengineering of
MMS financial systems and other legal
requirements.
DATES: Effective Date: April 25, 2008.
E:\FR\FM\26MRR1.SGM
26MRR1
]]>Agencies
[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Rules and Regulations]
[Pages 15884-15885]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6063]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene
Disalicylate and Nicarbazin
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 new animal drug application
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved,
single-ingredient Type A medicated articles containing bacitracin
methylene disalicylate and nicarbazin to formulate two-way combination
drug Type C medicated feeds for broiler chickens.
DATES: This rule is effective March 26, 2008.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rt. 22, Bridgewater, NJ
08807, filed NADA 141-279 that provides for use of BMD (bacitracin
methylene disalicylate) and NICARB (nicarbazin) Type A medicated
articles to formulate two-way combination drug Type C medicated feeds
for broiler chickens. The NADA is approved as of February 21, 2008, and
the regulations are amended in 21 CFR 558.366 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(a)(2) 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 the table in paragraph (d) of Sec. 558.366, alphabetically add
new entries for ``Bacitracin methylene disalicylate 4 to 50'' and
``Bacitracin methylene disalicylate 50'' to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(d) * * *
------------------------------------------------------------------------
Nicarbazin Combination
in grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
113.5 * * * * * *
(0.0125
pct)
------------------------------------------------------------------------
Bacitracin Broiler Feed 046573
methylene chickens; aid continuously
disalicylate in preventing as sole
4 to 50. outbreaks of ration from
cecal time chicks
(Eimeria are placed on
tenella) and litter until
intestinal past the time
(E. when
acervulina, coccidiosis
E. maxima, E. is ordinarily
necatrix, and a hazard; do
E. brunetti) not use as a
coccidiosis; treatment for
for increased outbreaks of
rate of coccidiosis;
weight gain do not use in
and improved flushing
feed mashes; do
efficiency. not feed to
laying hens;
withdraw 4
days before
slaughter.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Bacitracin Broiler Feed 046573
methylene chickens; aid continuously
disalicylate in preventing as sole
50. outbreaks of ration from
cecal time chicks
(Eimeria are placed on
tenella) and litter until
intestinal past the time
(E. when
acervulina, coccidiosis
E. maxima, E. is ordinarily
necatrix, and a hazard; do
E. brunetti) not use as a
coccidiosis; treatment for
as an aid in outbreaks of
the coccidiosis;
prevention of do not use in
necrotic flushing
enteritis mashes; do
caused or not feed to
complicated laying hens;
by withdraw 4
Clostridium days before
spp. or other slaughter.
organisms
susceptible
to
bacitracin.
------------------------------------------------------------------------
* * * * * * *
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[[Page 15885]]
Dated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6063 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S
