New Animal Drugs for Use in Animal Feeds; Lasalocid; Roxarsone, 34236-34237 [E9-16733]
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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.
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(c) * * *
(1) * * *
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Firm name and address
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Cephazone Pharma, LLC,
250 East Bonita Ave.,
Pomona, CA 91767
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Drug labeler
code
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068330
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(2) * * *
Drug labeler
code
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068330
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Firm name and address
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Cephazone Pharma, LLC,
250 East Bonita Ave.,
Pomona, CA 91767
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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.
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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.
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*
*
*
*
(4) See Nos. 059130 and 061623 for
use as in paragraphs (e)(1) and (e)(2) of
this section.
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*
*
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*
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
34237
Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations
In addition, FDA is amending
§ 558.530 to remove an incorrect human
food safety warning and to revise an
animal safety limitation for use of
roxarsone in chicken and turkey feeds.
The food safety warning restricting use
of roxarsone in poultry producing eggs
for human consumption was codified in
error during a change from text to table
format in 2005 (70 FR 41958; July 21,
2005). The animal safety warning is
revised to reflect recommendations of
the National Academy of SciencesNational Research Council (NAS-NRC)
Drug Efficacy Study in 1970 (35 FR
14273; September 10, 1970), following
their evaluation of the product. NASNRC’s recommended warning was
restated, but not codified, at the time of
Drug Efficacy Study Implementation’s
finalization of NADA 7–891 for a
roxarsone Type A medicated article in
1981 (46 FR 52330; October 27, 1981).
The revised warning for medicated feed
use agrees with the warning that is
codified for roxarsone oral dosage forms
in 21 CFR part 520.
Lasalocid sodium activity
in grams per ton
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.
Combination in
grams per ton
(xv) 68 (0.0075 pct) to
113 (0.0125 pct).
*
*
§ 558.530
3. Amend § 558.530 as follows:
a. In the table in paragraph (d)(1)(i),
in the ‘‘Limitations’’ column, remove
the phrase ‘‘do not feed to chickens
producing eggs for human
consumption;’’ and remove the phrase
‘‘may result in leg weakness’’ and in its
place add the phrase ‘‘may result in
weakness or paralysis of the legs’’ and
b. In the table in paragraph (d)(2)(i),
in the ‘‘Limitations’’ column, remove
the phrase ‘‘do not feed to turkeys
producing eggs for human
consumption;’’ and remove the phrase
‘‘may result in leg weakness’’ and in its
place add the phrase ‘‘may result in
weakness or paralysis of the legs’’.
srobinson on DSKHWCL6B1PROD with RULES
Dated: July 9, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–16733 Filed 7–14–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
15:15 Jul 14, 2009
Jkt 217001
Authority: 21 U.S.C. 360b, 371.
2. In § 558.311, in the table in
paragraph (e)(1)(xv), alphabetically add
a new entry for ‘‘Roxarsone 22.7 to
45.4’’ to read as follows:
■
§ 558.311
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Lasalocid.
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(e) * * *
(1) * * *
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■
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
*
Limitations
*
Sponsor
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Growing turkeys: For prevention of
coccidiosis caused by E.
meleagrimitis, E. gallopavonis, and E.
adenoeides, increased rate of weight
gain, improved feed efficiency, and
improved pigmentation.
*
[Amended]
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
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*
Roxarsone 22.7 to
45.4
*
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:
■
Indications for use
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List of Subjects in 21 CFR Part 558
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Feed continuously as the sole ration.
Roxarsone provided by No. 046573 in
§ 510.600(c) in this chapter.
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046573
*
Effective August 1, 2009.
PENSION BENEFIT GUARANTY
CORPORATION
DATES:
29 CFR Part 4022
Catherine B. Klion, Manager, Regulatory
and Policy Division, Legislative and
Regulatory Department, Pension Benefit
Guaranty Corporation, 1200 K Street,
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll-free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions
for Valuing and Paying Benefits
AGENCY: Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
SUMMARY: Pension Benefit Guaranty
Corporation’s regulation on Benefits
Payable in Terminated Single-Employer
Plans prescribes interest assumptions
for valuing and paying certain benefits
under terminating singleπemployer
plans. This final rule amends the benefit
payments regulation to adopt interest
assumptions for plans with valuation
dates in August 2009. Interest
assumptions are also published on
PBGC’s Web site (https://www.pbgc.gov).
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
FOR FURTHER INFORMATION CONTACT:
PBGC’s
regulations prescribe actuarial
assumptions—including interest
assumptions—for valuing and paying
plan benefits of terminating singleemployer plans covered by title IV of
the Employee Retirement Income
Security Act of 1974. The interest
assumptions are intended to reflect
current conditions in the financial and
annuity markets.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15JYR1.SGM
15JYR1
]]>Agencies
[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Rules and Regulations]
[Pages 34236-34237]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16733]
-----------------------------------------------------------------------
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 Sec. 558.530 (21
CFR 558.530) to reflect the approval.
[[Page 34237]]
In addition, FDA is amending Sec. 558.530 to remove an incorrect
human food safety warning and to revise an animal safety limitation for
use of roxarsone in chicken and turkey feeds. The food safety warning
restricting use of roxarsone in poultry producing eggs for human
consumption was codified in error during a change from text to table
format in 2005 (70 FR 41958; July 21, 2005). The animal safety warning
is revised to reflect recommendations of the National Academy of
Sciences-National Research Council (NAS-NRC) Drug Efficacy Study in
1970 (35 FR 14273; September 10, 1970), following their evaluation of
the product. NAS-NRC's recommended warning was restated, but not
codified, at the time of Drug Efficacy Study Implementation's
finalization of NADA 7-891 for a roxarsone Type A medicated article in
1981 (46 FR 52330; October 27, 1981). The revised warning for medicated
feed use agrees with the warning that is codified for roxarsone oral
dosage forms in 21 CFR part 520.
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 558
Animal drugs, Animal feeds.
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 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In Sec. 558.311, in the table in paragraph (e)(1)(xv),
alphabetically add a new entry for ``Roxarsone 22.7 to 45.4'' to read
as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(1) * * *
------------------------------------------------------------------------
Lasalocid
sodium Combination
activity in in grams per Indications for Limitations Sponsor
grams per ton use
ton
------------------------------------------------------------------------
(xv) 68 * * * * * *
(0.0075
pct) to
113
(0.0125
pct).
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Roxarsone Growing Feed 046573
22.7 to 45.4 turkeys: For continuously
prevention of as the sole
coccidiosis ration.
caused by E. Roxarsone
meleagrimitis, provided by
E. No. 046573 in
gallopavonis, Sec.
and E. 510.600(c) in
adenoeides, this chapter.
increased rate
of weight
gain, improved
feed
efficiency,
and improved
pigmentation.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Sec. 558.530 [Amended]
0
3. Amend Sec. 558.530 as follows:
a. In the table in paragraph (d)(1)(i), in the ``Limitations''
column, remove the phrase ``do not feed to chickens producing eggs for
human consumption;'' and remove the phrase ``may result in leg
weakness'' and in its place add the phrase ``may result in weakness or
paralysis of the legs'' and
b. In the table in paragraph (d)(2)(i), in the ``Limitations''
column, remove the phrase ``do not feed to turkeys producing eggs for
human consumption;'' and remove the phrase ``may result in leg
weakness'' and in its place add the phrase ``may result in weakness or
paralysis of the legs''.
Dated: July 9, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-16733 Filed 7-14-09; 8:45 am]
BILLING CODE 4160-01-S
