Oral Dosage Form New Animal Drugs; Tiamulin, 54492 [2010-22277]
Download as PDF
<![CDATA[
54492
Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
congressional review requirements in 5
U.S.C. 801–808.
Food and Drug Administration
List of Subjects in 21 CFR Part 520
21 CFR Part 520
■
[Docket No. FDA–2010–N–0002]
Oral Dosage Form New Animal Drugs;
Tiamulin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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 use of
an increased strength of tiamulin
concentrate solution in the drinking
water of swine for the treatment of
certain bacterial respiratory and enteric
diseases.
DATES: This rule is effective September
8, 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.
SUMMARY:
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 administered in drinking
water for the treatment of certain
bacterial respiratory and enteric
diseases in swine. The supplemental
NADA provides for use of a 12.5 percent
tiamulin concentrate solution. The
supplemental NADA is approved as of
June 14, 2010, 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 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
mstockstill on DSKH9S0YB1PROD with RULES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
17:27 Sep 07, 2010
Jkt 220001
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 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, revise paragraphs (a)
and (b) to read as follows:
■
§ 520.2455
Tiamulin.
(a) Specifications. (1) Each gram of
soluble powder contains 450 milligrams
(mg) tiamulin hydrogen fumarate.
(2) Each milliliter (mL) of solution
contains 125 mg (12.5 percent) tiamulin
hydrogen fumarate.
(3) Each mL of solution contains 123
mg (12.3 percent) tiamulin hydrogen
fumarate.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 058198 for products described
in paragraphs (a)(1) and (a)(2) of this
section.
(2) No. 059130 for products described
in paragraphs (a)(1) and (a)(3) of this
section.
*
*
*
*
*
Dated: September 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–22277 Filed 9–7–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
animal drug regulations to codify the
conditions of use of an approved new
animal drug application (NADA) for
gentamicin sulfate and betamethasone
acetate ophthalmic solution. This action
is being taken to comply with the
Federal Food, Drug, and Cosmetic Act
and to improve the accuracy of the
regulations.
This rule is effective September
8, 2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337,
email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has
noticed that the approved conditions of
use for GENTOCIN DURAFILM
(gentamicin sulfate and betamethasone
acetate) Ophthalmic Solution,
sponsored by Intervet, Inc., 56
Livingston Ave., Roseland, NJ 07068
under NADA 34–267 are not codified.
When this NADA was approved in
1967, codification of approved
conditions of use for NADAs was not
required. Accordingly, the regulations
are amended in 21 CFR part 524 by
adding § 524.1044i to reflect the
approval. This action is being taken to
comply with section 512(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(i)) and to improve the
accuracy of the regulations.
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.
DATES:
List of Subjects in 21 CFR Part 524
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 524 is amended as follows:
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
[Docket No. FDA–2010–N–0002]
Ophthalmic and Topical Dosage Form
New Animal Drugs; Gentamicin and
Betamethasone Ophthalmic Solution
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
1. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 524.1044i to read as follows:
§ 524.1044i Gentamicin and
betamethasone ophthalmic solution.
(a) Specifications. Each milliliter (mL)
of solution contains gentamicin sulfate
equivalent to 3 milligrams (mg) of
gentamicin base and 1 mg
E:\FR\FM\08SER1.SGM
08SER1
]]>Agencies
[Federal Register Volume 75, Number 173 (Wednesday, September 8, 2010)]
[Rules and Regulations]
[Page 54492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22277]
[[Page 54492]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2010-N-0002]
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 use of an increased strength of tiamulin
concentrate solution in the drinking water of swine for the treatment
of certain bacterial respiratory and enteric diseases.
DATES: This rule is effective September 8, 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: 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 administered in
drinking water for the treatment of certain bacterial respiratory and
enteric diseases in swine. The supplemental NADA provides for use of a
12.5 percent tiamulin concentrate solution. The supplemental NADA is
approved as of June 14, 2010, 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 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, revise paragraphs (a) and (b) to read as follows:
Sec. 520.2455 Tiamulin.
(a) Specifications. (1) Each gram of soluble powder contains 450
milligrams (mg) tiamulin hydrogen fumarate.
(2) Each milliliter (mL) of solution contains 125 mg (12.5 percent)
tiamulin hydrogen fumarate.
(3) Each mL of solution contains 123 mg (12.3 percent) tiamulin
hydrogen fumarate.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (d) of this section.
(1) No. 058198 for products described in paragraphs (a)(1) and
(a)(2) of this section.
(2) No. 059130 for products described in paragraphs (a)(1) and
(a)(3) of this section.
* * * * *
Dated: September 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22277 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S
