New Animal Drugs; Ceftiofur Sodium, 34235-34236 [E9-16734]
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Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations
between other countries, if that person
has reached his or her 60th birthday
unless there is another pilot in the flight
deck crew who has not yet attained 60
years of age.
(e) No pilot may:
(1) Serve as a pilot in operations
under this part if that person has
reached his or her 65th birthday.
(2) Serve as a pilot in command in
operations under this part between the
United States and another country, or in
operations between other countries, if
that person has reached his or her 60th
birthday unless there is another pilot in
the flight deck crew who has not yet
attained 60 years of age.
■ 8. Amend § 121.411 by revising
paragraph (e) to read as follows:
§ 121.411 Qualifications: Check airmen
(airplane) and check airmen (simulator).
*
*
*
*
*
(e) Check airmen who have reached
their 65th birthday or who do not hold
an appropriate medical certificate may
function as check airmen, but may not
serve as pilot flightcrew members in
operations under this part.
*
*
*
*
*
9. Amend § 121.412 by revising
paragraph (e) to read as follows:
§ 121.412 Qualifications: Flight instructors
(airplane) and flight instructors (simulator).
*
*
*
*
*
(e) Flight instructors who have
reached their 65th birthday or who do
not hold an appropriate medical
certificate may function as flight
instructors, but may not serve as pilot
flightcrew members in operations under
this part.
*
*
*
*
*
■ 10. Amend § 121.440 by adding
paragraphs (d), (e), and (f) to read as
follows:
srobinson on DSKHWCL6B1PROD with RULES
§ 121.440
Line checks.
* * *
(d) No certificate holder may use the
services of any person as a pilot in
operations under this part unless the
certificate holder evaluates every 6
months the performance, through a line
check, of each pilot of the certificate
holder who has attained 60 years of age.
Notwithstanding the foregoing, a
certificate holder is not required to
conduct for a 6-month period a line
check under this paragraph of a pilot
serving as a second-in-command if the
pilot has undergone a regularly
scheduled simulator evaluation during
that period.
(e) No pilot who has attained 60 years
of age may serve as a pilot in operations
under this part unless the certificate
holder has evaluated the pilot’s
VerDate Nov<24>2008
15:15 Jul 14, 2009
Jkt 217001
performance every 6 months, through a
line check. Notwithstanding the
foregoing, a certificate holder is not
required to conduct for a 6-month
period a line check under this paragraph
of a pilot serving as a second-incommand if the pilot has undergone a
regularly scheduled simulator
evaluation during that period.
(f) The training program provisions of
§ 121.401(b) do not apply to pilots who
have attained 60 years of age and serve
in operations under this part.
Issued in Washington, DC, on July 8, 2009.
J. Randolph Babbitt,
Administrator.
[FR Doc. E9–16777 Filed 7–14–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Ceftiofur Sodium
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 abbreviated new
animal drug application (ANADA) filed
by Cephazone Pharma, LLC. The
ANADA provides for the use of ceftiofur
sodium powder for injection as a
solution in dogs, horses, cattle, swine,
day old chickens, turkey poults, sheep,
and goats as therapy for various
bacterial infections.
DATES: This rule is effective July 15,
2009.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Cephazone Pharma, LLC, 250 East
Bonita Ave., Pomona, CA 91767, filed
ANADA 200–420 that provides for use
of Ceftiofur Sodium Sterile Powder, as
an injectable solution, in dogs, horses,
cattle, swine, day-old chickens, turkey
poults, sheep, and goats as therapy for
various bacterial infections. Cephazone
Pharma, LLC’s Ceftiofur Sodium Sterile
Powder is approved as a generic copy of
NAXCEL (ceftiofur sodium) Sterile
Powder for Injection, sponsored by
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
34235
Pharmacia & Upjohn Co., a Division of
Pfizer, Inc., under NADA 140–338. The
ANADA is approved as of May 27, 2009,
and the regulations are amended in 21
CFR 522.313c to reflect the approval.
In addition, Cephazone Pharma, LLC,
has not been previously listed in the
animal drug regulations as a sponsor of
an approved application. Accordingly,
21 CFR 510.600(c) is being amended to
add entries for this firm.
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.
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
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
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 parts 510 and 522 are amended as
follows:
■
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add an
entry for ‘‘Cephazone Pharma, LLC’’;
and in the table in paragraph (c)(2)
numerically add an entry for ‘‘068330’’
to read as follows:
■
E:\FR\FM\15JYR1.SGM
15JYR1
34236
Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Cephazone Pharma, LLC,
250 East Bonita Ave.,
Pomona, CA 91767
*
*
*
Drug labeler
code
*
*
068330
*
*
(2) * * *
Drug labeler
code
*
*
068330
*
*
Firm name and address
*
*
*
Cephazone Pharma, LLC,
250 East Bonita Ave.,
Pomona, CA 91767
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 522.313c, revise paragraph (b)
to read as follows:
■
§ 522.313c
Ceftiofur sodium
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*
*
*
*
(b) Sponsors. See Nos. 000009 and
068330 in § 510.600(c) of this chapter.
*
*
*
*
*
Dated: July 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–16734 Filed 7–14–09; 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; Flunixin
AGENCY:
Food and Drug Administration,
srobinson on DSKHWCL6B1PROD with RULES
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original abbreviated new
animal drug application (ANADA) filed
by Norbrook Laboratories, Ltd. The
SUMMARY:
VerDate Nov<24>2008
15:15 Jul 14, 2009
Jkt 217001
ANADA provides for the use of flunixin
meglumine injectable solution in swine.
DATES: This rule is effective July 15,
2009.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
ANADA 200–476 that provides for use
of Flunixin Injection -S in swine for
various bacterial infections. Norbrook
Laboratories, Ltd.’s Flunixin Injection -S
is approved as a generic copy of
BANAMINE–S (flunixin meglumine)
injectable solution, sponsored by
Schering-Plough Animal Health Corp.
under NADA 101–479. The ANADA is
approved as of June 22, 2009, and the
regulations are amended in 21 CFR
522.970 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.
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:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
PO 00000
Authority: 21 U.S.C. 360b.
Frm 00028
Fmt 4700
Sfmt 4700
2. In § 522.970, revise paragraphs
(b)(1) and (b)(4) to read as follows:
■
§ 522.970
Flunixin.
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*
*
*
*
(b) * * *
(1) See Nos. 000061 and 055529 for
use as in paragraph (e) of this section.
*
*
*
*
*
(4) See Nos. 059130 and 061623 for
use as in paragraphs (e)(1) and (e)(2) of
this section.
*
*
*
*
*
Dated: July 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–16735 Filed 7–14–09; 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 for Use in Animal
Feeds; Lasalocid; Roxarsone
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
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 Alpharma
Inc. The NADA provides for use of
single-ingredient Type A medicated
articles containing lasalocid and
roxarsone to formulate two-way
combination drug Type C medicated
feeds for use in growing turkeys.
DATES: This rule is effective July 15,
2009.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116,
e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma
Inc., 440 Rte. 22, Bridgewater, NJ 08807,
filed NADA 141–293 that provides for
use of AVATEC (lasalocid sodium) and
3-NITRO (roxarsone) single-ingredient
Type A medicated articles to formulate
two-way combination drug Type C
medicated feeds for use in growing
turkeys. The NADA is approved as of
May 22, 2009, and the regulations are
amended in 21 CFR 558.311 and
§ 558.530 (21 CFR 558.530) to reflect the
approval.
E:\FR\FM\15JYR1.SGM
15JYR1
]]>Agencies
[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Rules and Regulations]
[Pages 34235-34236]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16734]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Ceftiofur Sodium
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 abbreviated new
animal drug application (ANADA) filed by Cephazone Pharma, LLC. The
ANADA provides for the use of ceftiofur sodium powder for injection as
a solution in dogs, horses, cattle, swine, day old chickens, turkey
poults, sheep, and goats as therapy for various bacterial infections.
DATES: This rule is effective July 15, 2009.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cephazone Pharma, LLC, 250 East Bonita Ave.,
Pomona, CA 91767, filed ANADA 200-420 that provides for use of
Ceftiofur Sodium Sterile Powder, as an injectable solution, in dogs,
horses, cattle, swine, day-old chickens, turkey poults, sheep, and
goats as therapy for various bacterial infections. Cephazone Pharma,
LLC's Ceftiofur Sodium Sterile Powder is approved as a generic copy of
NAXCEL (ceftiofur sodium) Sterile Powder for Injection, sponsored by
Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 140-338.
The ANADA is approved as of May 27, 2009, and the regulations are
amended in 21 CFR 522.313c to reflect the approval.
In addition, Cephazone Pharma, LLC, has not been previously listed
in the animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
firm.
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.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1) alphabetically
add an entry for ``Cephazone Pharma, LLC''; and in the table in
paragraph (c)(2) numerically add an entry for ``068330'' to read as
follows:
[[Page 34236]]
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Cephazone Pharma, LLC, 250 East Bonita Ave., 068330
Pomona, CA 91767
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
068330 Cephazone Pharma, LLC, 250 East Bonita
Ave., Pomona, CA 91767
* * * * *
------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 522.313c, revise paragraph (b) to read as follows:
Sec. 522.313c Ceftiofur sodium
* * * * *
(b) Sponsors. See Nos. 000009 and 068330 in Sec. 510.600(c) of
this chapter.
* * * * *
Dated: July 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-16734 Filed 7-14-09; 8:45 am]
BILLING CODE 4160-01-S
