New Animal Drugs for Use in Animal Feeds; Chlortetracycline, 9334 [2010-4205]
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Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Rules and Regulations
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:
■
Authority: 21 U.S.C. 360b.
2. In § 522.2471, revise paragraphs
(e)(1)(i), (e)(1)(ii), and (e)(1)(iii) to read
as follows:
■
§ 522.2471
Tilmicosin.
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(e) * * *
(1) * * *
(i) Amount. 10 to 20 milligrams per
kilograms (mg/kg) of body weight as a
single subcutaneous injection.
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni. For the control of
respiratory disease in cattle at high risk
of developing BRD associated with M.
haemolytica.
(iii) Limitations. Do not use in female
dairy cattle 20 months of age or older.
Use of this antibiotic in this class of
cattle may cause milk residues. Do not
slaughter within 42 days of last
treatment.
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Dated: February 16, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–4206 Filed 3–1–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
WReier-Aviles on DSKGBLS3C1PROD with RULES
Food and Drug Administration
[Docket No. FDA–2010–N–0002]
Food and Drug Administration,
HHS.
14:52 Mar 01, 2010
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 ADM
Alliance Nutrition, Inc. The
supplemental NADA provides for use of
a higher concentration chlortetracycline
Type A medicated article for the
manufacture of medicated feeds for
livestock and poultry.
DATES: This rule is effective March 2,
2010.
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.
ADM
Alliance Nutrition, Inc., 1000 North
30th St., Quincy, IL 62305–3115, filed a
supplement to NADA 48–480 that
provides for the use of CHLORATET 50
(chlortetracycline), a Type A medicated
article containing 50 grams of
chlortetracycline per pound, for the
manufacture of medicated feeds for
livestock and poultry. The supplement
provides for use of Type A medicated
articles containing 90 or 100 grams of
chlortetracycline per pound. The
supplemental NADA is approved as of
January 7, 2010, and the regulations are
amended in 21 CFR 558.128 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.
FDA 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.
Jkt 220001
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 § 558.128, revise paragraph (b)(2)
to read as follows:
■
§ 558.128
Chlortetracycline.
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*
(b) * * *
(2) No. 012286: 50, 90, or 100 grams
per pound of Type A medicated article.
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Dated: February 16, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–4205 Filed 3–1–10; 8:45 am]
BILLING CODE 4160–01–S
SUPPLEMENTARY INFORMATION:
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:
■
New Animal Drugs for Use in Animal
Feeds; Chlortetracycline
VerDate Nov<24>2008
Final rule.
List of Subject in 21 CFR Part 558
21 CFR Part 558
AGENCY:
ACTION:
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
29 CFR Part 2520
RIN 1210–AB21
Multiemployer Pension Plan
Information Made Available on
Request
AGENCY: Employee Benefits Security
Administration, Labor.
ACTION: Final rule.
SUMMARY: This document contains a
final rule implementing section 101(k)
of the Employee Retirement Income
Security Act of 1974, as amended by the
Pension Protection Act of 2006. Section
101(k) requires the administrator of a
multiemployer plan to provide copies of
certain actuarial and financial
documents about the plan to
participants, beneficiaries, employee
representatives and contributing
employers upon request. The final rule
affects plan administrators, participants
and beneficiaries and contributing
employers of multiemployer plans.
DATES: This final rule is effective on
April 1, 2010.
FOR FURTHER INFORMATION CONTACT: June
Solonsky or Stephanie L. Ward, Office
of Regulations and Interpretations,
Employee Benefits Security
Administration, (202) 693–8500. This is
not a toll-free number.
SUPPLEMENTARY INFORMATION:
A. Background
Section 101(k) of the Employee
Retirement Income Security Act
E:\FR\FM\02MRR1.SGM
02MRR1
]]>Agencies
[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Rules and Regulations]
[Page 9334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4205]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2010-N-0002]
New Animal Drugs for Use in Animal Feeds; Chlortetracycline
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 ADM Alliance Nutrition, Inc. The
supplemental NADA provides for use of a higher concentration
chlortetracycline Type A medicated article for the manufacture of
medicated feeds for livestock and poultry.
DATES: This rule is effective March 2, 2010.
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: ADM Alliance Nutrition, Inc., 1000 North
30th St., Quincy, IL 62305-3115, filed a supplement to NADA 48-480 that
provides for the use of CHLORATET 50 (chlortetracycline), a Type A
medicated article containing 50 grams of chlortetracycline per pound,
for the manufacture of medicated feeds for livestock and poultry. The
supplement provides for use of Type A medicated articles containing 90
or 100 grams of chlortetracycline per pound. The supplemental NADA is
approved as of January 7, 2010, and the regulations are amended in 21
CFR 558.128 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.
FDA 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 Subject 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. 558.128, revise paragraph (b)(2) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(b) * * *
(2) No. 012286: 50, 90, or 100 grams per pound of Type A medicated
article.
* * * * *
Dated: February 16, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-4205 Filed 3-1-10; 8:45 am]
BILLING CODE 4160-01-S
