Amendments to General Regulations of the Food and Drug Administration; Confirmation of Effective Date, 12563 [2011-5147]
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Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations
not have a significant economic impact.
Therefore the FAA preliminarily
certifies that this rule will not have a
significant economic impact on a
substantial number of small entities.
The FAA solicits comments regarding
this determination on this supplemental
regulatory flexibility analysis. Please
provide detailed economic analysis to
support the position of higher cost. The
FAA also invites comments regarding
other small entity concerns with respect
to the final rule.
Nan Shellabarger,
Director, Office of Aviation Policy and Plans.
[FR Doc. 2011–5257 Filed 3–7–11; 8:45 am]
BILLING CODE P
day period ending February 14, 2011.
FDA stated that the effective date of the
direct final rule would be on April 14,
2011, 60 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
Authority: Therefore, under the Federal
Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of
Food and Drugs, 21 CFR parts 1, 14, and 17
are amended. Accordingly, the amendments
issued thereby are effective.
Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5147 Filed 3–7–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 1, 14, and 17
Food and Drug Administration
[Docket No. FDA–2010–N–0560]
21 CFR Part 520
RIN 0910–AG55
Amendments to General Regulations
of the Food and Drug Administration;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
[Docket No. FDA–2011–N–0003]
Oral Dosage Form New Animal Drugs;
Spinosad and Milbemycin Oxime
AGENCY:
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of April 14, 2011, for the
final rule that appeared in the Federal
Register of November 30, 2010 (75 FR
73951). The direct final rule amends
certain general regulations of FDA to
include tobacco products, where
appropriate, in light of FDA’s authority
to regulate these products under the
Family Smoking Prevention and
Tobacco Control Act, by revising the
Agency’s regulations to require tobacco
products to be subject to the same
general requirements that apply to other
FDA-regulated products. This document
confirms the effective date of the direct
final rule.
DATES: Effective date confirmed: April
14, 2011.
FOR FURTHER INFORMATION CONTACT:
Gerie A. Voss, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
rm. 204G, Rockville, MD 20850, 1–877–
CTP–1373.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 30, 2010
(75 FR 73951), FDA solicited comments
concerning the direct final rule for a 75SUMMARY:
emcdonald on DSK2BSOYB1PROD with RULES
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
18:59 Mar 07, 2011
Jkt 223001
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Elanco
Animal Health. The NADA provides for
veterinary prescription use of chewable
tablets containing spinosad and
milbemycin oxime in dogs for the
treatment and prevention of flea
infestations and for the prevention and
control of various internal parasites.
DATES: This rule is effective March 8,
2011.
FOR FURTHER INFORMATION CONTACT:
Angela Clarke, Center for Veterinary
Medicine (HFV–112), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8318, email: angela.clarke@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed NADA
141–321 that provides for veterinary
prescription use of TRIFEXIS (spinosad
and milbemycin oxime) Chewable
Tablets in dogs for the treatment and
prevention of flea infestations and for
the prevention and control of various
internal parasites. The NADA is
SUMMARY:
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
12563
approved as of January 4, 2011, and the
regulations in part 520 (21 CFR part
520) are amended by adding § 520.2134
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.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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 Subjects in 21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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. Add § 520.2134 to read as follows:
§ 520.2134
Spinosad and milbemycin.
(a) Specifications. Each chewable
tablet contains 140 milligrams (mg)
spinosad and 2.3 mg milbemycin oxime,
270 mg spinosad and 4.5 mg
milbemycin oxime, 560 mg spinosad
and 9.3 mg milbemycin oxime, 810 mg
spinosad and 13.5 mg milbemycin
oxime, or 1,620 mg spinosad and 27 mg
milbemycin oxime.
(b) Sponsor. See No. 000986 in
§ 510.600 of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer once a month at a
E:\FR\FM\08MRR1.SGM
08MRR1
]]>Agencies
[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Rules and Regulations]
[Page 12563]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5147]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 14, and 17
[Docket No. FDA-2010-N-0560]
RIN 0910-AG55
Amendments to General Regulations of the Food and Drug
Administration; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of April 14, 2011, for the final rule that appeared in
the Federal Register of November 30, 2010 (75 FR 73951). The direct
final rule amends certain general regulations of FDA to include tobacco
products, where appropriate, in light of FDA's authority to regulate
these products under the Family Smoking Prevention and Tobacco Control
Act, by revising the Agency's regulations to require tobacco products
to be subject to the same general requirements that apply to other FDA-
regulated products. This document confirms the effective date of the
direct final rule.
DATES: Effective date confirmed: April 14, 2011.
FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd., rm. 204G,
Rockville, MD 20850, 1-877-CTP-1373.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 30, 2010
(75 FR 73951), FDA solicited comments concerning the direct final rule
for a 75-day period ending February 14, 2011. FDA stated that the
effective date of the direct final rule would be on April 14, 2011, 60
days after the end of the comment period, unless any significant
adverse comment was submitted to FDA during the comment period. FDA did
not receive any significant adverse comments.
Authority: Therefore, under the Federal Food, Drug, and
Cosmetic Act and under authority delegated to the Commissioner of
Food and Drugs, 21 CFR parts 1, 14, and 17 are amended. Accordingly,
the amendments issued thereby are effective.
Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5147 Filed 3-7-11; 8:45 am]
BILLING CODE 4160-01-P
