New Animal Drugs For Use in Animal Feeds; Ractopamine, 70776-70777 [E7-24145]
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Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Rules and Regulations
Oxytetracycline amount
Indications for use
Limitations
Sponsor
(ii) 10 mg/lb of body
weight daily
Sheep: For treatment of bacterial enteritis
caused by E. coli and bacterial pneumonia
caused by P. multocida susceptible to oxytetracycline.
Feed continuously for 7 to 14 d; withdraw 5 d before slaughter.
066104,
048164
(iii) 200 mg/colony
Honey bees: For control of American foulbrood
caused by Paenibacillus larvae and European
foulbrood caused by Streptococcus pluton susceptible to oxytetracycline.
Remove at least 6 weeks prior to main honey
flow.
066104,
048164
(iv) 250 mg/kilogram of
fish/day (11.35 g/100 lb
of fish/day)
Pacific salmon: For marking of skeletal tissue.
For salmon not over 30 g body weight; administer as sole ration for 4 consecutive days; fish
not to be liberated for at least 7 d following the
last administration of medicated feed.
066104
(v) 2.5 to 3.75 g/100 lb of
fish/day
1. Salmonids: For control of ulcer disease
caused by Hemophilus piscium, furunculosis
caused by Aeromonas salmonicida, bacterial
hemorrhagic septicemia caused by A.
liquefaciens, and pseudomonas disease.
2. Catfish: For control of bacterial hemorrhagic
septicemia caused by A. liquefaciens and
pseudomonas disease.
Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated
feed; do not administer when water temperature is below 9 °C (48.2 °F).
Administer in mixed ration for 10 d; do not liberate fish or slaughter fish for food for 21 d following the last administration of medicated
feed; do not administer when water temperature is below 16.7 °C (62 °F).
066104
Lobsters: For control of gaffkemia caused by
Aerococcus viridans.
Administer as sole ration for 5 consecutive days;
withdraw medicated feed 30 d before harvesting lobsters.
066104
(vi) 1 g/lb of medicated
feed
(6) Oxytetracycline may be used in
accordance with the provisions of this
section in the combinations as follows:
(i) Carbadox as in § 558.115.
(ii) Lasalocid as in § 558.311.
(iii) Melengestrol acetate as in
§ 558.342.
(iv) Robenidine hydrochloride as in
§ 558.515.
(v) Salinomycin as in § 558.550.
Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–24146 Filed 12–12–07; 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; Ractopamine
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 new animal
drug application (NADA) filed by
Elanco Animal Health. The
supplemental NADA provides for an
rwilkins on PROD1PC63 with RULES
SUMMARY:
VerDate Aug<31>2005
16:31 Dec 12, 2007
Jkt 214001
increased level of monensin in threeway combination Type C medicated
feeds containing ractopamine,
melengestrol, and monensin for heifers
fed in confinement for slaughter.
DATES: This rule is effective December
13, 2007.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–234 that
provides for use of OPTAFLEXX
(ractopamine hydrochloride), MGA
(melengestrol acetate), and RUMENSIN
(monensin USP) Type A medicated
articles to make dry and liquid threeway combination Type C medicated
feeds used for increased rate of weight
gain, improved feed efficiency, and
increased carcass leanness; for
prevention and control of coccidiosis
due to Eimeria bovis and E. zuernii; and
for suppression of estrus (heat) in
heifers fed in confinement for slaughter
during the last 28 to 42 days on feed.
The supplemental NADA provides for
an increased level of monensin. The
supplemental NADA is approved as of
November 20, 2007, and the regulations
in 21 CFR 558.500 are amended to
reflect the approval.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
066104
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 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 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
E:\FR\FM\13DER1.SGM
13DER1
70777
Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Rules and Regulations
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
Ractopamine grams/
ton
*
*
(xii) 9.8 to 24.6
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Part 127
[Public Notice: 6024]
Voluntary Disclosures
Department of State.
Final rule.
AGENCY:
rwilkins on PROD1PC63 with RULES
SUMMARY: The Department of State is
amending the Voluntary Disclosure
provisions of the International Traffic in
Arms Regulations (ITAR) by imposing a
60-calendar day deadline after the
initial notification to submit a full
disclosure, in order to ensure timely
submissions; and by clarifying what
identifying information should be
provided, as well as who should sign
the voluntary disclosure in cases of a
major violation, a systemic pattern of
violations, or in the absence of an
effective compliance program, in order
to improve the government’s ability to
assess and respond to the national
security and foreign policy
consequences of any export violation.
These amendments will provide
integrity to the voluntary disclosure
process, but involve only minor changes
VerDate Aug<31>2005
16:31 Dec 12, 2007
Jkt 214001
*
*
Monensin 10 to 30, plus
melengestrol acetate to provide 0.25 to 0.5 mg/head/day
Heifers fed in confinement for
slaughter: As in paragraph
(e)(2)(vi) of this section; for prevention and control of coccidiosis
due to Eimeria bovis and E.
zuernii; and for suppression of
estrus (heat).
Frm 00015
Fmt 4700
Sfmt 4700
*
*
*
Sponsor
*
As in paragraph (e)(2)(vi) of
this section; see
§§ 558.342(d) and
558.355(d) of this chapter.
Melengestrol acetate as
provided by No. 000009 in
§ 510.600(c) of this chapter.
*
to the current voluntary disclosure
process.
EFFECTIVE DATE: This rule is effective
December 13, 2007.
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
Compliance, ATTN: Regulatory Change,
12th Floor, SA–1, Washington, DC
20522–0112.
• Fax: 202–261–8695.
• Hand Delivery or Courier (regular
work hours only:) Department of State,
Directorate of Defense Trade Controls,
Office of Defense Trade Controls
Compliance, ATTENTION: Regulatory
Change, SA–1, 12th Floor, 2401 E Street,
NW., Washington, DC 20037.
Persons with access to the Internet
may also view this notice by going to
the regulations.gov Web site at: https://
www.regulations.gov/index.cfm.
FOR FURTHER INFORMATION CONTACT:
Glenn Smith, Office of Defense Trade
Controls Compliance, Department of
State, 12th Floor, SA–1, Washington DC
20522–0112; Telephone 202–736–9230
or FAX 202–261–8695; e-mail:
DDTCResponseTeam@state.gov. ATTN:
Regulatory Change.
SUPPLEMENTARY INFORMATION: Section
127.12(c)(1)(i) imposes a 60-calendar
day deadline after the initial notification
PO 00000
Ractopamine.
*
*
(e) * * *
(2) * * *
Limitations
Heifers fed in confinement for
slaughter: As in paragraph
(e)(2)(vi) of this section; for prevention and control of coccidiosis
due to Eimeria bovis and E.
zuernii; and for suppression of
estrus (heat).
*
Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–24145 Filed 12–12–07; 8:45 am]
ACTION:
*
Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/lb
of body weight, depending on
severity of coccidiosis challenge, up to 480 mg/head/day,
plus melengestrol acetate to
provide 0.25 to 0.5 mg/head/
day
*
Indications for use
*
*
§ 558.500
2. In § 558.500, in the table in
paragraph (e)(2), revise paragraph
(e)(2)(viii) and add paragraph (e)(2)(xii)
to read as follows:
Combination grams/ton
*
(viii) 9.8 to 24.6
Authority: 21 U.S.C. 360b, 371.
I
*
As in paragraph (e)(2)(vi) of
this section; see
§§ 558.342(d) and
558.355(d) of this chapter.
Melengestrol acetate as
provided by No. 021641 in
§ 510.600(c) of this chapter.
000986
*
021641
to submit a full disclosure. A party may
request an extension to the 60-calendar
day deadline, and, in certain cases, the
Department may require the requester to
provide a written certification that the
full disclosure in accordance with
§ 127.12(c)(2) will be submitted within
a specified time period. Failure to
submit a full disclosure may result in a
decision by the Directorate of Defense
Trade Controls not to consider the
initial notification as a mitigating factor
in determining the appropriate
disposition of the violation.
Section 127.12(c)(2)(iii) is amended to
provide additional details and examples
of identifying information to be
included in a voluntary disclosure.
Section 127.12(c)(2)(vi) is amended to
clarify that corrective actions and
compliance initiatives implemented
must be directly in response to the
violation in the voluntary disclosure,
and designed to deter that particular
violation from occurring again.
Further, Section 127.12(e) is amended
to provide that, in cases of a major
violation, a systemic pattern of
violations, or the absence of an effective
compliance program, DDTC may require
that the written certification be signed
by a senior officer.
The Directorate of Defense Trade
Controls’ website at § 127.12(g) is
updated.
E:\FR\FM\13DER1.SGM
13DER1
]]>Agencies
[Federal Register Volume 72, Number 239 (Thursday, December 13, 2007)]
[Rules and Regulations]
[Pages 70776-70777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24145]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; Ractopamine
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 Elanco Animal Health. The supplemental NADA
provides for an increased level of monensin in three-way combination
Type C medicated feeds containing ractopamine, melengestrol, and
monensin for heifers fed in confinement for slaughter.
DATES: This rule is effective December 13, 2007.
FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 141-234 that provides for use of OPTAFLEXX
(ractopamine hydrochloride), MGA (melengestrol acetate), and RUMENSIN
(monensin USP) Type A medicated articles to make dry and liquid three-
way combination Type C medicated feeds used for increased rate of
weight gain, improved feed efficiency, and increased carcass leanness;
for prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii; and for suppression of estrus (heat) in heifers fed in
confinement for slaughter during the last 28 to 42 days on feed. The
supplemental NADA provides for an increased level of monensin. The
supplemental NADA is approved as of November 20, 2007, and the
regulations in 21 CFR 558.500 are amended 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 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 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:
[[Page 70777]]
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. 558.500, in the table in paragraph (e)(2), revise paragraph
(e)(2)(viii) and add paragraph (e)(2)(xii) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
------------------------------------------------------------------------
Ractopamine Combination Indications
grams/ton grams/ton for use Limitations Sponsor
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(viii) 9.8 to Monensin 10 to Heifers fed in As in 000986
24.6 40 to provide confinement paragraph
0.14 to 0.42 for (e)(2)(vi)
mg monensin/ slaughter: As of this
lb of body in paragraph section; see
weight, (e)(2)(vi) of Sec. Sec.
depending on this section; 558.342(d)
severity of for and
coccidiosis prevention 558.355(d)
challenge, up and control of this
to 480 mg/ of chapter.
head/day, coccidiosis Melengestrol
plus due to acetate as
melengestrol Eimeria bovis provided by
acetate to and E. No. 000009
provide 0.25 zuernii; and in Sec.
to 0.5 mg/ for 510.600(c)
head/day suppression of this
of estrus chapter.
(heat).
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(xii) 9.8 to Monensin 10 to Heifers fed in As in 021641
24.6 30, plus confinement paragraph
melengestrol for (e)(2)(vi)
acetate to slaughter: As of this
provide 0.25 in paragraph section; see
to 0.5 mg/ (e)(2)(vi) of Sec. Sec.
head/day this section; 558.342(d)
for and
prevention 558.355(d)
and control of this
of chapter.
coccidiosis Melengestrol
due to acetate as
Eimeria bovis provided by
and E. No. 021641
zuernii; and in Sec.
for 510.600(c)
suppression of this
of estrus chapter.
(heat).
------------------------------------------------------------------------
Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24145 Filed 12-12-07; 8:45 am]
BILLING CODE 4160-01-S
