Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin, 1274-1275 [2010-209]
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Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Rules and Regulations
tenth month following their receipt are
countable as resources at that time.
(c) Exception: For any payments
described in paragraph (a) of this
section received before March 2, 2004,
we will exclude for the month following
the month of receipt the unspent
portion of any such payment.
8. Amend § 416.1236 by revising
paragraph (a)(24) and adding a new
paragraph (a)(25) to read as follows:
■
she makes to dispose of them, the
resources will be counted at their
current market value and the individual
will be ineligible due to excess
resources. We will use the original
estimate of current market value unless
the individual submits evidence
establishing a lower value (e.g., an
estimate from a disinterested
knowledgeable source).
[FR Doc. 2010–241 Filed 1–8–10; 8:45 am]
BILLING CODE 4191–02–P
§ 416.1236 Exclusions from resources;
provided by other statutes.
(a) * * *
(24) Assistance provided for flood
mitigation activities under section 1324
of the National Flood Insurance Act of
1968, pursuant to section 1 of Public
Law 109–64 (119 Stat. 1997, 42 U.S.C.
4031).
(25) Payments made to individuals
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000, pursuant to
section 1, app. [Div. C. Title XXXVI
section 3646] of Public Law 106–398
(114 Stat. 1654A–510, 42 U.S.C. 7385e).
*
*
*
*
*
■ 9. Revise § 416.1240 to read as
follows:
cprice-sewell on DSK2BSOYB1PROD with RULES
§ 416.1240
Disposition of Resources.
(a) Where the resources of an
individual (and spouse, if any) are
determined to exceed the limitations
prescribed in § 416.1205, such
individual (and spouse, if any) shall not
be eligible for payment except under the
conditions provided in this section.
Payment will be made to an individual
(and spouse, if any) if the individual
agrees in writing to:
(1) Dispose of, at current market
value, the nonliquid resources (as
defined in § 416.1201(c)) in excess of
the limitations prescribed in § 416.1205
within the time period specified in
§ 416.1242; and
(2) Repay any overpayments (as
defined in § 416.1244) with the
proceeds of such disposition.
(b) Payment made for the period
during which the resources are being
disposed of will be conditioned upon
the disposition of those resources as
prescribed in paragraphs (a)(1) and
(a)(2) of this section. Any payments so
made are (at the time of disposition)
considered overpayments to the extent
they would not have been paid had the
disposition occurred at the beginning of
the period for which such payments
were made.
(c) If an individual fails to dispose of
the resources as prescribed in
paragraphs (a)(1) and (a)(2) of this
section, regardless of the efforts he or
VerDate Nov<24>2008
18:55 Jan 08, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Hyaluronate
Sodium
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FDA 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 522
Animal drugs.
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 522 is amended as follows:
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
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 Anika
Therapeutics, Inc. The supplemental
NADA provides for a revised human
food safety warning for use of
hyaluronate sodium injectable solution
in horses.
DATES: This rule is effective January 11,
2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Anika
Therapeutics, Inc., 236 W. Cummings
Park, Woburn, MA 01801, filed a
supplement to NADA 122–578 that
provides for the veterinary prescription
use of HYVISC (hyaluronate sodium)
Sterile Injection in horses. The
supplemental NADA provides for a
revised human food safety warning on
product labeling. The supplemental
NADA is approved as of December 11,
2009, and the regulations are amended
in 21 CFR 522.1145 to reflect the
approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
Authority: 21 U.S.C. 360b.
SUMMARY:
PO 00000
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§ 522.1145
[Amended]
2. In paragraph (f)(3)(iii) of § 522.1145,
remove the third sentence and in its
place add ‘‘Do not use in horses
intended for human consumption.’’
■
Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–207 Filed 1–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Florfenicol
and Flunixin
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 original new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for veterinary
prescription use of a combination
injectable solution containing
E:\FR\FM\11JAR1.SGM
11JAR1
Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Rules and Regulations
cprice-sewell on DSK2BSOYB1PROD with RULES
florfenicol and flunixin meglumine in
cattle.
DATES: This rule is effective January 11,
2010.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., 56 Livingston Ave., Roseland, NJ
07068, filed NADA 141–299 that
provides for use RESFLOR GOLD
(florfenicol and flunixin meglumine), a
combination injectable solution, for
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni, and control of BRDassociated pyrexia in beef and nonlactating dairy cattle. The NADA is
approved as of November 23, 2009, and
the regulations in 21 CFR part 522 are
amended by adding § 522.956 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.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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 522
Animal drugs.
■ 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 522 is amended as follows:
VerDate Nov<24>2008
15:08 Jan 08, 2010
Jkt 220001
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 522.956 to read as follows:
§ 522.956
Florfenicol and flunixin.
(a) Specifications. Each milliliter (mL)
of solution contains 300 milligrams (mg)
florfenicol and 16.5 mg flunixin (27.37
mg flunixin meglumine).
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(c) Tolerances. See §§ 556.283 and
556.286 of this chapter.
(d) Conditions for use in cattle—(1)
Amount. 40 mg florfenicol/kg body
weight (BW) and 2.2 mg flunixin/kg BW
(equivalent to 2 mL/15 kg BW or 6 mL/
100 lbs) once, by subcutaneous
injection.
(2) Indications for use. For treatment
of bovine respiratory disease (BRD)
associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni, and control of BRDassociated pyrexia in beef and nonlactating dairy cattle.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Animals
intended for human consumption must
not be slaughtered within 38 days of
treatment. Do not use in female dairy
cattle 20 months of age or older. Use of
florfenicol in this class of cattle may
cause milk residues. A withdrawal
period has not been established in
preruminating calves. Do not use in
calves to be processed for veal.
Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–209 Filed 1–8–10; 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; 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
PO 00000
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Fmt 4700
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1275
approval of a supplemental new animal
drug application (NADA) filed by
Elanco Animal Health, A Division of Eli
Lilly & Co. The supplemental NADA
provides for administering ractopamine
hydrochloride Type C medicated feeds
as a top dress to cattle fed in
confinement for slaughter.
DATES: This rule is effective January 11,
2010.
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: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–221 that
provides for use of OPTAFLEXX 45
(ractopamine hydrochloride) Type A
medicated articles to formulate Type B
and Type C medicated feeds
administered to cattle fed in
confinement for slaughter for increased
rate of weight gain and improved feed
efficiency during the last 28 to 42 days
on feed. The supplement provides for
feeding ractopamine hydrochloride
Type C medicated feed as a top dress.
The supplemental NADA is approved as
of December 11, 2009, 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 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.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval.
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\11JAR1.SGM
11JAR1
]]>Agencies
[Federal Register Volume 75, Number 6 (Monday, January 11, 2010)]
[Rules and Regulations]
[Pages 1274-1275]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2009-N-0665]
Implantation or Injectable Dosage Form New Animal Drugs;
Florfenicol and Flunixin
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 original new animal drug
application (NADA) filed by Intervet, Inc. The NADA provides for
veterinary prescription use of a combination injectable solution
containing
[[Page 1275]]
florfenicol and flunixin meglumine in cattle.
DATES: This rule is effective January 11, 2010.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068, filed NADA 141-299 that provides for use RESFLOR
GOLD (florfenicol and flunixin meglumine), a combination injectable
solution, for treatment of bovine respiratory disease (BRD) associated
with Mannheimia haemolytica, Pasteurella multocida, and Histophilus
somni, and control of BRD-associated pyrexia in beef and non-lactating
dairy cattle. The NADA is approved as of November 23, 2009, and the
regulations in 21 CFR part 522 are amended by adding Sec. 522.956 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.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
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 522
Animal drugs.
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Add Sec. 522.956 to read as follows:
Sec. 522.956 Florfenicol and flunixin.
(a) Specifications. Each milliliter (mL) of solution contains 300
milligrams (mg) florfenicol and 16.5 mg flunixin (27.37 mg flunixin
meglumine).
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(c) Tolerances. See Sec. Sec. 556.283 and 556.286 of this chapter.
(d) Conditions for use in cattle--(1) Amount. 40 mg florfenicol/kg
body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW
or 6 mL/100 lbs) once, by subcutaneous injection.
(2) Indications for use. For treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni, and control of BRD-associated pyrexia
in beef and non-lactating dairy cattle.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Animals intended for human
consumption must not be slaughtered within 38 days of treatment. Do not
use in female dairy cattle 20 months of age or older. Use of
florfenicol in this class of cattle may cause milk residues. A
withdrawal period has not been established in preruminating calves. Do
not use in calves to be processed for veal.
Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-209 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S
