Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin, 58872-58873 [E8-23832]
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Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations
dwashington3 on PRODPC61 with RULES
of bovine foot rot (interdigital
necrobacillosis).
DATES: This rule is effective October 8,
2008.
FOR FURTHER INFORMATION CONTACT:
Donald A. Prater, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed a supplement to NADA 141–209
for EXCEDE (ceftiofur crystalline free
acid) Sterile Suspension. The
supplemental NADA provides for
veterinarian prescription use of ceftiofur
crystalline free acid injectable
suspension for the treatment of bovine
foot rot (interdigital necrobacillosis) in
beef, non-lactating dairy, and lactating
dairy cattle. The application is approved
as of August 15, 2008, and the
regulations are amended in 21 CFR
522.313a 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),
summaries of the safety and
effectiveness data and information
submitted to support approval of these
applications 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)(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. The 3 years of
marketing exclusivity apply only to the
bovine foot rot indication for which this
supplement is approved.
The agency has determined under 21
CFR 25.33(d)(5) 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
VerDate Aug<31>2005
14:27 Oct 07, 2008
Jkt 217001
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:
■
Authority: 21 U.S.C. 360b.
2. In § 522.313a, amend paragraph
(e)(2)(ii) by adding a third sentence to
read as follows:
■
§ 522.313a
Ceftiofur crystalline free acid.
*
*
*
*
*
(e) * * *
(2) * * *
(ii) * * * For the treatment of bovine
foot rot (interdigital necrobacillosis)
associated with Fusobacterium
necrophorum and Porphyromonas levii
in beef, non-lactating dairy, and
lactating dairy cattle.
*
*
*
*
*
Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–23830 Filed 10–7–08; 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–2008–N–0039]
Implantation or Injectable Dosage
Form New Animal Drugs;
Tulathromycin
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 Pfizer,
Inc. The supplemental NADA provides
for veterinarian prescription use of
tulathromycin injectable solution for the
treatment of bovine foot rot (interdigital
necrobacillosis) in beef and nonlactating dairy cattle.
DATES: This rule is effective October 8,
2008.
FOR FURTHER INFORMATION CONTACT:
Donald A. Prater, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov.
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
Pfizer,
Inc., 235 East 42d St., New York, NY
10017, filed a supplement to NADA
141–244 for DRAXXIN (tulathromycin)
Injectable Solution. The supplemental
NADA provides for treatment of bovine
foot rot (interdigital necrobacillosis)
associated with Fusobacterium
necrophorum and Porphyromonas levii
in beef and non-lactating dairy cattle.
The application is approved as of
August 28, 2008, and the regulations are
amended in 21 CFR 522.2630 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)(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. The 3 years of
marketing exclusivity apply only to the
bovine foot rot indication for which this
supplement is approved.
The agency has determined under 21
CFR 25.33(d)(5) 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.
SUPPLEMENTARY INFORMATION:
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:
■
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. In § 522.2630, revise paragraph
(d)(1)(ii) to read as follows:
■
E:\FR\FM\08OCR1.SGM
08OCR1
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations
§ 522.2630
Tulathromycin.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis. For the control of respiratory
disease in cattle at high risk of
developing BRD associated with M.
haemolytica, P. multocida, H. somni,
and M. bovis. For the treatment of
infectious bovine keratoconjunctivitis
(IBK) associated with Moraxella bovis.
For the treatment of bovine foot rot
(interdigital necrobacillosis) associated
with Fusobacterium necrophorum and
Porphyromonas levii.
*
*
*
*
*
Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–23832 Filed 10–7–08; 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–2008–N–0039]
New Animal Drugs for Use in Animal
Feeds; Fenbendazole
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 use of a fenbendazole free
choice, liquid Type C medicated feed in
dairy and beef cattle for the removal and
control of various internal parasites.
DATES: This rule is effective October 8,
2008.
FOR FURTHER INFORMATION CONTACT:
Donald A. Prater, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed a supplement
to NADA 131–675 for SAFE-GUARD
(fenbendazole) 20% Type A medicated
article. The supplemental NADA
provides for manufacture of a
fenbendazole free choice, liquid Type C
medicated feed for use in dairy and beef
cattle for the removal and control of
various internal parasites. The
supplemental NADA is approved as of
September 5, 2008, and the regulations
are amended in 21 CFR 558.258 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)(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. The 3 years of
exclusivity apply only to the use of
fenbendazole liquid Type C medicated
feed for the removal and control of
lungworms (Dictyocaulus viviparus),
one of the parasite species for which the
supplement is approved.
FDA has determined under 21 CFR
25.33(a) 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 § 558.258, in the table in
paragraph (e)(1), in the ‘‘Indications for
use’’ column, remove ‘‘round worms’’
and in its place add ‘‘roundworms’’; and
revise paragraph (e)(3) to read as
follows:
■
§ 558.258
*
Indications for use
Dairy and beef cattle: For the removal and control of: Lungworms
(Dictyocaulus viviparus); Stomach
worms: barberpole worms
(Haemonchus contortus), brown
stomach worms (Ostertagia
ostertagi), small stomach worms
(Trichostrongylus axei); Intestinal
worms: hookworms (Bunostomum
phlebotomum), thread-necked intestinal worms (Nematodirus
helvetianus), small intestinal
worms (Cooperia oncophora and
C. punctata); Bankrupt worms
(Trichostrongylus colubriformis);
and Nodular worms
(Oesophagostomum radiatum).
Feed as the sole ration or as a
top dress for one day. Retreatment may be needed after 4 to 6
weeks. Cattle must not be slaughtered within 13 days following last
treatment. For dairy cattle the milk
discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in
calves to be processed for veal.
*
Limitations
(i) 5 mg/kg body weight (2.27 mg/
lb)
dwashington3 on PRODPC61 with RULES
Fenbendazole.
*
*
(e) * * *
(3) Cattle.
Amount fenbendazole
14:27 Oct 07, 2008
Jkt 217001
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
E:\FR\FM\08OCR1.SGM
*
Sponsor
057926
(ii) [Reserved]
VerDate Aug<31>2005
58873
08OCR1
]]>Agencies
[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Rules and Regulations]
[Pages 58872-58873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2008-N-0039]
Implantation or Injectable Dosage Form New Animal Drugs;
Tulathromycin
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 Pfizer, Inc. The supplemental NADA provides
for veterinarian prescription use of tulathromycin injectable solution
for the treatment of bovine foot rot (interdigital necrobacillosis) in
beef and non-lactating dairy cattle.
DATES: This rule is effective October 8, 2008.
FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail:
donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed a supplement to NADA 141-244 for DRAXXIN (tulathromycin)
Injectable Solution. The supplemental NADA provides for treatment of
bovine foot rot (interdigital necrobacillosis) associated with
Fusobacterium necrophorum and Porphyromonas levii in beef and non-
lactating dairy cattle. The application is approved as of August 28,
2008, and the regulations are amended in 21 CFR 522.2630 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)(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. The 3 years of marketing exclusivity apply only to the bovine
foot rot indication for which this supplement is approved.
The agency has determined under 21 CFR 25.33(d)(5) 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. In Sec. 522.2630, revise paragraph (d)(1)(ii) to read as follows:
[[Page 58873]]
Sec. 522.2630 Tulathromycin.
* * * * *
(d) * * *
(1) * * *
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis. For the control of
respiratory disease in cattle at high risk of developing BRD associated
with M. haemolytica, P. multocida, H. somni, and M. bovis. For the
treatment of infectious bovine keratoconjunctivitis (IBK) associated
with Moraxella bovis. For the treatment of bovine foot rot
(interdigital necrobacillosis) associated with Fusobacterium
necrophorum and Porphyromonas levii.
* * * * *
Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-23832 Filed 10-7-08; 8:45 am]
BILLING CODE 4160-01-S
