Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid, 58871-58872 [E8-23830]
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58871
Rules and Regulations
Federal Register
Vol. 73, No. 196
Wednesday, October 8, 2008
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
[Docket No. FAA–2008–0024; Airspace
Docket No. 08–AGL–4]
Amendment of Class E Airspace; Black
River Falls, WI
Federal Aviation
Administration (FAA), DOT.
ACTION: Direct final rule; confirmation of
effective date.
AGENCY:
This action confirms the
effective date of the direct final rule that
amended Class E airspace at Black River
Falls, WI, published in the Federal
Register August 6, 2008 (73 FR 45606)
Docket No. FAA–2008–0024.
DATES: Effective Date: 0901 UTC
October 8, 2008. The Director of the
Federal Register approves this
incorporation by reference action under
Title 1, Code of Federal Regulations,
part 51, subject to the annual revision of
FAA Order 7400.9 and publication of
conforming amendments.
FOR FURTHER INFORMATION CONTACT:
Scott Enander, Central Service Center,
System Support Group, Federal
Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort
Worth, TX 76193–0530; telephone (817)
222–5582.
SUPPLEMENTARY INFORMATION:
dwashington3 on PRODPC61 with RULES
SUMMARY:
History
The FAA published a direct final rule
with request for comments in the
Federal Register August 6, 2008 (73 FR
45606), Docket No. FAA–2008–0024.
This rule amended Class E airspace at
Black River Falls Area Airport, Black
River Falls, WI. The FAA uses the direct
final rule procedure for noncontroversial rules where the FAA
believes that there will be no adverse
public comment. This direct final rule
14:27 Oct 07, 2008
Jkt 217001
History
BILLING CODE 4910–13–P
The FAA published a direct final rule
with request for comments in the
Federal Register August 6, 2008 (73 FR
45607), Docket No. FAA–2008–0003.
This rule established Class E airspace at
Muldrow Army Heliport, Lexington,
OK. The FAA uses the direct final rule
procedure for non-controversial rules
where the FAA believes that there will
be no adverse public comment. This
direct final rule advised the public that
no adverse comments were anticipated,
and that unless a written adverse
comment, or a written notice of intent
to submit an adverse comment, was
received within the comment period,
the regulation would become effective
on September 25, 2008. No adverse
comments were received; thus, this
notice confirms that the direct final rule
became effective on this date.
DEPARTMENT OF TRANSPORTATION
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
*
14 CFR Part 71
VerDate Aug<31>2005
advised the public that no adverse
comments were anticipated, and that
unless a written adverse comment, or a
written notice of intent to submit an
adverse comment, was received within
the comment period, the regulation
would become effective on September
25, 2008. No adverse comments were
received; thus, this notice confirms that
the direct final rule became effective on
this date.
*
*
*
*
Issued in Fort Worth, TX, on September 25,
2008.
Donald R. Smith,
Manager, Operations Support Group, ATO
Central Service Center.
[FR Doc. E8–23770 Filed 10–7–08; 8:45 am]
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2008–0003; Airspace
Docket No. 08–ASW–1]
Establishment of Class E Airspace;
Lexington, OK
Federal Aviation
Administration (FAA), DOT.
ACTION: Direct final rule; confirmation of
effective date.
*
*
*
*
*
Issued in Fort Worth, TX, on September 25,
2008.
Donald R. Smith,
Manager, Operations Support Group, ATO
Central Service Center.
[FR Doc. E8–23777 Filed 10–7–08; 8:45 am]
BILLING CODE 4910–13–P
AGENCY:
SUMMARY: This action confirms the
effective date of the direct final rule that
established Class E airspace at Muldrow
Army Heliport, Lexington, OK,
published in the Federal Register
August 6, 2008 (73 FR 45607) Docket
No. FAA–2008–0003.
DATES: Effective Dates: 0901 UTC
October 8, 2008. The Director of the
Federal Register approves this
incorporation by reference action under
Title 1, Code of Federal Regulations,
part 51, subject to the annual revision of
FAA Order 7400.9 and publication of
conforming amendments.
FOR FURTHER INFORMATION: Scott
Enander, Central Service Center, System
Support Group, Federal Aviation
Administration, Southwest Region, 2601
Meacham Blvd., Fort Worth, TX 76193–
0530; telephone (817) 222–5582.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
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; Ceftiofur
Crystalline Free Acid
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
Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA
provides for veterinarian prescription
use of ceftiofur crystalline free acid
injectable suspension for the treatment
E:\FR\FM\08OCR1.SGM
08OCR1
58872
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
]]>Agencies
[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Rules and Regulations]
[Pages 58871-58872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23830]
=======================================================================
-----------------------------------------------------------------------
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;
Ceftiofur Crystalline Free Acid
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 Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA provides for veterinarian
prescription use of ceftiofur crystalline free acid injectable
suspension for the treatment
[[Page 58872]]
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, e-mail:
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.
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. 522.313a, amend paragraph (e)(2)(ii) by adding a third
sentence to read as follows:
Sec. 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
