Oral Dosage Form New Animal Drugs; Tiamulin, 7180 [E9-3131]
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7180
Federal Register / Vol. 74, No. 29 / Friday, February 13, 2009 / Rules and Regulations
Dated: February 9, 2009.
William F. Hagy III,
Acting Deputy Under Secretary, Rural
Development.
[FR Doc. E9–3092 Filed 2–12–09; 8:45 am]
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.
BILLING CODE 3410–XY–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
List of Subjects in 21 CFR Part 520
[Docket No. FDA–2009–N–0665]
Animal drugs.
Oral Dosage Form New Animal Drugs;
Tiamulin
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PRODPC61 with RULES
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
Novartis Animal Health US, Inc. The
supplemental NADA provides for
removal of a 250-pound weight
restriction and the addition of a
reproductive caution statement to
labeling of tiamulin concentrate
solution used in drinking water for the
treatment of certain bacterial respiratory
and enteric diseases in swine.
DATES: This rule is effective February
13, 2009.
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: Novartis
Animal Health US, Inc., 3200 Northline
Ave., suite 300, Greensboro, NC 27408,
filed a supplement to NADA 140–916
for DENAGARD (tiamulin) Liquid
Concentrate used for the treatment of
certain bacterial respiratory and enteric
diseases in swine. The supplemental
NADA provides for removal of a 250pound weight restriction and the
addition of a reproductive caution
statement to labeling. The supplemental
NADA is approved as of January 27,
2009, and 21 CFR 520.2455 is amended
to reflect the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(d)(1) that this action is of a
VerDate Nov<24>2008
13:38 Feb 12, 2009
Jkt 217001
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 520 is amended as follows:
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 520.2455, remove paragraph
(d), redesignate paragraph (e) as
paragraph (d), and revise newly
redesignated paragraph (d)(2) to read as
follows:
■
§ 520.2455
Tiamulin.
*
*
*
*
*
(d) * * *
(2) Limitations. Use as only source of
drinking water. Prepare fresh medicated
water daily. Withdraw medication 3
days before slaughter following
treatment at 3.5 mg/lb and 7 days before
slaughter following treatment at 10.5
mg/lb of body weight. Swine being
treated with tiamulin should not have
access to feeds containing polyether
ionophores (e.g., lasalocid, monensin,
narasin, salinomycin, or semduramycin)
as adverse reactions may occur. The
effects of tiamulin on swine
reproductive performance, pregnancy,
and lactation have not been determined.
Dated: February 10, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–3131 Filed 2–12–09; 8:45 am]
BILLING CODE 4160–01–S
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PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Part 4022
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 single-employer
plans. This final rule amends the benefit
payments regulation to adopt interest
assumptions for plans with valuation
dates in March 2009. Interest
assumptions are also published on
PBGC’s Web site (https://www.pbgc.gov).
DATES: Effective March 1, 2009.
FOR FURTHER INFORMATION CONTACT:
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.)
SUPPLEMENTARY INFORMATION: 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.
These interest assumptions are found
in two PBGC regulations: The regulation
on Benefits Payable in Terminated
Single-Employer Plans (29 CFR part
4022) and the regulation on Allocation
of Assets in Single-Employer Plans (29
CFR Part 4044). Assumptions under the
asset allocation regulation are updated
quarterly; assumptions under the benefit
payments regulation are updated
monthly. This final rule updates only
the assumptions under the benefit
payments regulation.
Two sets of interest assumptions are
prescribed under the benefit payments
regulation: (1) A set for PBGC to use to
determine whether a benefit is payable
as a lump sum and to determine lumpsum amounts to be paid by PBGC (found
in Appendix B to Part 4022), and (2) a
set for private-sector pension
practitioners to refer to if they wish to
E:\FR\FM\13FER1.SGM
13FER1
]]>Agencies
[Federal Register Volume 74, Number 29 (Friday, February 13, 2009)]
[Rules and Regulations]
[Page 7180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3131]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2009-N-0665]
Oral Dosage Form New Animal Drugs; Tiamulin
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 Novartis Animal Health US, Inc. The
supplemental NADA provides for removal of a 250-pound weight
restriction and the addition of a reproductive caution statement to
labeling of tiamulin concentrate solution used in drinking water for
the treatment of certain bacterial respiratory and enteric diseases in
swine.
DATES: This rule is effective February 13, 2009.
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: Novartis Animal Health US, Inc., 3200
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to
NADA 140-916 for DENAGARD (tiamulin) Liquid Concentrate used for the
treatment of certain bacterial respiratory and enteric diseases in
swine. The supplemental NADA provides for removal of a 250-pound weight
restriction and the addition of a reproductive caution statement to
labeling. The supplemental NADA is approved as of January 27, 2009, and
21 CFR 520.2455 is amended to reflect the approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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 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 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.2455, remove paragraph (d), redesignate paragraph (e)
as paragraph (d), and revise newly redesignated paragraph (d)(2) to
read as follows:
Sec. 520.2455 Tiamulin.
* * * * *
(d) * * *
(2) Limitations. Use as only source of drinking water. Prepare
fresh medicated water daily. Withdraw medication 3 days before
slaughter following treatment at 3.5 mg/lb and 7 days before slaughter
following treatment at 10.5 mg/lb of body weight. Swine being treated
with tiamulin should not have access to feeds containing polyether
ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or
semduramycin) as adverse reactions may occur. The effects of tiamulin
on swine reproductive performance, pregnancy, and lactation have not
been determined.
Dated: February 10, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-3131 Filed 2-12-09; 8:45 am]
BILLING CODE 4160-01-S
