Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol, 21041-21042 [E8-8346]
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Federal Register / Vol. 73, No. 76 / Friday, April 18, 2008 / Rules and Regulations
revising the ‘‘License Exceptions’’
section, to read as follows:
8D001 ‘‘Software’’ Specially Designed or
Modified for the ‘‘Development’’,
‘‘Production’’ or ‘‘Use’’ of Equipment or
Materials Controlled by 8A (Except 8A018 or
8A992), 8B or 8C.
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License Exceptions
CIV: N/A
TSR: Yes, except for exports or reexports
to destinations outside of Austria, Belgium,
Canada, Denmark, Finland, France, Germany,
Greece, Ireland, Italy, Japan, Luxembourg, the
Netherlands, Portugal, Spain, Sweden, or the
United Kingdom of ‘‘software’’ specially
designed for the ‘‘development’’ or
‘‘production’’ of equipment controlled by
8A001.b, 8A001.d, or 8A002.o.3.b.
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41. In Supplement No. 1 to part 774
(the Commerce Control List), Category
8—Marine, Export Control Classification
Number (ECCN) 8E001 is amended by
revising the ‘‘License Exceptions’’
section, to read as follows:
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9A004 Space Launch Vehicles and
‘‘Spacecraft’’.
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List of Items Controlled
Unit: Number
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43. In Supplement No. 1 to part 774
(the Commerce Control List), Category
9—Propulsion Systems, Space Vehicles
and Related Equipment, Export Control
Classification Number (ECCN) 9B009 is
amended by revising the ‘‘Unit’’
paragraph in the List of Items Controlled
section, to read as follows:
cprice-sewell on PROD1PC71 with RULES
I
VerDate Aug<31>2005
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Dated: April 11, 2008.
Matthew S. Borman,
Acting Assistant Secretary for Export
Administration.
[FR Doc. E8–8302 Filed 4–17–08; 8:45 am]
BILLING CODE 3510–33–P
15:26 Apr 17, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Food and Drug Administration,
HHS.
42. In Supplement No. 1 to part 774
(the Commerce Control List), Category
9—Propulsion Systems, Space Vehicles
and Related Equipment, Export Control
Classification Number (ECCN) 9A004 is
amended by revising the ‘‘Unit’’
paragraph in the List of Items Controlled
section, to read as follows:
*
*
ACTION:
I
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AGENCY:
License Exceptions
CIV: N/A
TSR: Yes, except for exports or reexports
to destinations outside of Austria, Belgium,
Canada, Denmark, Finland, France, Germany,
Greece, Ireland, Italy, Japan, Luxembourg, the
Netherlands, Portugal, Spain, Sweden, or the
United Kingdom of ‘‘technology’’ for items
controlled by 8A001.b, 8A001.d or
8A002.o.3.b.
*
*
List of Items Controlled
Unit: Number
Implantation or Injectable Dosage
Form New Animal Drugs; Florfenicol
8E001 ‘‘Technology’’ According to the
General Technology Note for the
‘‘Development’’ or ‘‘Production’’ of
Equipment or Materials Controlled by 8A
(Except 8A018 or 8A992), 8B or 8C.
*
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9B009 Tooling Specially Designed for
Producing Turbine Engine Powder
Metallurgy Rotor Components Capable of
Operating at Stress Levels of 60% of
Ultimate Tensile Strength (UTS) or More and
Metal Temperatures of 873 K (600 ≥C) or
More.
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 ScheringPlough Animal Health Corp. The NADA
provides for use of florfenicol injectable
solution for the treatment of bovine
respiratory disease.
DATES: This rule is effective April 18,
2008.
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.
ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit, NJ 07901, filed NADA
141–265 for veterinary prescription use
of NUFLOR GOLD (florfenicol)
Injectable Solution by subcutaneous
injection in beef and non-lactating dairy
cattle for the treatment of bovine
respiratory disease. The NADA is
approved as of March 21, 2008, and the
regulations are amended in 21 CFR
522.955 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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
21041
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(a)(1) 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.
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 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:
I
Authority: 21 U.S.C. 360b.
I
2. Revise § 522.955 to read as follows:
§ 522.955
Florfenicol.
(a) Specifications. Each milliliter (mL)
of solution contains:
(1) 300 milligrams (mg) florfenicol in
the inactive vehicles 2-pyrrolidone and
triacetin.
(2) 300 mg florfenicol in the inactive
vehicle n-methyl-2-pyrrolidone.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter for use of
product described in paragraph (a)(1) as
in paragraph (d)(1)(i) and for use of
product described in paragraph (a)(2) as
in paragraph (d)(1)(ii).
(c) Related tolerance. See § 556.283 of
this chapter.
(d) Conditions of use—(1) Cattle—(i)
300 mg/mL florfenicol in 2-pyrrolidone
and triacetin (inactive vehicles).
(A) Amount. 40 mg/kilogram (kg)
body weight as a single subcutaneous
injection.
E:\FR\FM\18APR1.SGM
18APR1
21042
Federal Register / Vol. 73, No. 76 / Friday, April 18, 2008 / Rules and Regulations
cprice-sewell on PROD1PC71 with RULES
(B) Indications for use. For treatment
of bovine respiratory disease (BRD)
associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni in beef and nonlactating dairy cattle.
(C) Limitations. Do not slaughter
within 44 days of last treatment. Do not
use in female dairy cattle 20 months of
age or older. Use may cause milk
residues. A withdrawal period has not
been established in preruminating
calves. Do not use in calves to be
processed for veal. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(ii) 300 mg/mL florfenicol in nmethyl-2-pyrrolidone (inactive vehicle).
(A)(1) Amount. 20 mg/kg of body
weight as an intramuscular injection. A
second dose should be administered 48
hours later. Alternatively, 40 mg/kg of
body weight as a single subcutaneous
injection may be used.
(2) Indications for use. For treatment
of BRD associated with Mannheimia
(Pasteurella) haemolytica, P. multocida,
and Haemophilus somnus. For
treatment of bovine interdigital
phlegmon (foot rot, acute interdigital
necrobacillosis, infectious
pododermatitis) associated with
Fusobacterium necrophorum and
Bacteroides melaninogenicus.
(B)(1) Amount. 40 mg/kg of body
weight as a single subcutaneous
injection.
(2) Indications for use. For control of
respiratory disease in cattle at high risk
of developing BRD associated with
Mannheimia (Pasteurella) haemolytica,
P. multocida, and Haemophilus
somnus.
(C) Limitations. Do not slaughter
within 28 days of last intramuscular
treatment or within 38 days of
subcutaneous treatment. Do not use in
female dairy cattle 20 months of age or
older. Use may cause milk residues. A
withdrawal period has not been
established in preruminating calves. Do
not use in calves to be processed for
veal. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
(2) [Reserved]
Dated: April 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–8346 Filed 4–17–08; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:26 Apr 17, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Insulin
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
Intervet, Inc. The supplemental NADA
provides for the veterinary prescription
use of an injectable suspension of
porcine insulin zinc for the reduction of
hyperglycemia and hyperglycemiaassociated clinical signs in cats with
diabetes mellitus.
DATES: This rule is effective April 18,
2008.
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: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed a supplement
to NADA 141–236 providing for the
veterinary prescription use of
VETSULIN (porcine insulin zinc)
Suspension for the reduction of
hyperglycemia and hyperglycemiaassociated clinical signs in cats with
diabetes mellitus. The application also
provides for a lower initial dosage of
insulin for dogs. The supplemental
NADA is approved as of March 24,
2008, and the regulations are amended
in 21 CFR 522.1160 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(d)(1) 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
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
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
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval. The three years of
marketing exclusivity applies only to
the indication for use in cats for which
this supplement is approved.
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.
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 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:
I
Authority: 21 U.S.C. 360b.
2. In § 522.1160, revise paragraphs (a)
and (c) to read as follows:
I
§ 522.1160
Insulin.
(a) Specifications. Each milliliter of
porcine insulin zinc suspension
contains 40 international units (IU) of
insulin.
*
*
*
*
*
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer an initial oncedaily dose of 0.5 IU per kilogram of
body weight by subcutaneous injection
concurrently with or right after a meal.
Adjust this once-daily dose at
appropriate intervals based on clinical
signs, urinalysis results, and glucose
curve values until adequate glycemic
control has been attained. Twice-daily
therapy should be initiated if the
duration of insulin action is determined
to be inadequate. If twice-daily
treatment is initiated, the two doses
should be 25 percent less than the once
daily dose required to attain an
acceptable nadir.
(ii) Indications for use. For the
reduction of hyperglycemia and
hyperglycemia-associated clinical signs
in dogs with diabetes mellitus.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. Administer an
initial dose of 1 to 2 IU by subcutaneous
E:\FR\FM\18APR1.SGM
18APR1
]]>Agencies
[Federal Register Volume 73, Number 76 (Friday, April 18, 2008)]
[Rules and Regulations]
[Pages 21041-21042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8346]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Florfenicol
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 Schering-Plough Animal Health Corp. The NADA provides
for use of florfenicol injectable solution for the treatment of bovine
respiratory disease.
DATES: This rule is effective April 18, 2008.
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: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, filed NADA 141-265 for veterinary
prescription use of NUFLOR GOLD (florfenicol) Injectable Solution by
subcutaneous injection in beef and non-lactating dairy cattle for the
treatment of bovine respiratory disease. The NADA is approved as of
March 21, 2008, and the regulations are amended in 21 CFR 522.955 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(a)(1) 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. Revise Sec. 522.955 to read as follows:
Sec. 522.955 Florfenicol.
(a) Specifications. Each milliliter (mL) of solution contains:
(1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin.
(2) 300 mg florfenicol in the inactive vehicle n-methyl-2-
pyrrolidone.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter for
use of product described in paragraph (a)(1) as in paragraph (d)(1)(i)
and for use of product described in paragraph (a)(2) as in paragraph
(d)(1)(ii).
(c) Related tolerance. See Sec. 556.283 of this chapter.
(d) Conditions of use--(1) Cattle--(i) 300 mg/mL florfenicol in 2-
pyrrolidone and triacetin (inactive vehicles).
(A) Amount. 40 mg/kilogram (kg) body weight as a single
subcutaneous injection.
[[Page 21042]]
(B) Indications for use. For treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni in beef and non-lactating dairy
cattle.
(C) Limitations. Do not slaughter within 44 days of last treatment.
Do not use in female dairy cattle 20 months of age or older. Use may
cause milk residues. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(ii) 300 mg/mL florfenicol in n-methyl-2-pyrrolidone (inactive
vehicle).
(A)(1) Amount. 20 mg/kg of body weight as an intramuscular
injection. A second dose should be administered 48 hours later.
Alternatively, 40 mg/kg of body weight as a single subcutaneous
injection may be used.
(2) Indications for use. For treatment of BRD associated with
Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus
somnus. For treatment of bovine interdigital phlegmon (foot rot, acute
interdigital necrobacillosis, infectious pododermatitis) associated
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
(B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous
injection.
(2) Indications for use. For control of respiratory disease in
cattle at high risk of developing BRD associated with Mannheimia
(Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.
(C) Limitations. Do not slaughter within 28 days of last
intramuscular treatment or within 38 days of subcutaneous treatment. Do
not use in female dairy cattle 20 months of age or older. Use may cause
milk residues. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
Dated: April 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8346 Filed 4-17-08; 8:45 am]
BILLING CODE 4160-01-S
