Oral Dosage Form New Animal Drugs; Tylosin, 69438-69439 [05-22752]
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Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Rules and Regulations
III. Conclusion
Based on all data relevant to vitamin
D3 reviewed by the agency, FDA
concludes that there is a reasonable
certainty that no harm will result from
the use of vitamin D3 as a nutrient
supplement in cheese and cheese
products, excluding cottage cheese,
ricotta cheese, and hard grating cheeses,
such as Parmesan and Romano as
defined in §§ 133.165 and 133.183,
respectively, and those defined by the
standard of identity in § 133.148, at
levels up to 81 IU/30 g of cheese. Thus,
vitamin D3 is safe for the proposed use
and the agency concludes that the food
additive regulations should be amended
as set forth in this document. To ensure
that only food grade vitamin D3 is used
in food, the additive must meet the
specifications set forth in § 172.380.
In accordance with § 171.1(h) (21 CFR
171.1(h)), the petition and the
documents that FDA considered and
relied upon in reaching its decision to
approve the petition are available for
inspection at the Center for Food Safety
and Applied Nutrition by appointment
with the information contact person (see
FOR FURTHER INFORMATION CONTACT). As
provided in § 171.1(h), the agency will
delete from the documents any
materials that are not available for
public disclosure before making the
documents available for inspection.
IV. Environmental Effects
The agency has previously considered
the environmental effects of this rule as
announced in the notice of filing for
FAP 4A4758. No new information or
comments have been received that
would affect the agency’s previous
determination that there is no
significant impact on the human
environment and that an environmental
impact statement is not required.
V. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
VI. Objections
Any person who will be adversely
affected by this regulation may file with
the Division of Dockets Management
(see ADDRESSES) written or electronic
objections. Each objection shall be
separately numbered, and each
numbered objection shall specify with
particularity the provisions of the
regulation to which objection is made
and the grounds for the objection. Each
numbered objection on which a hearing
is requested shall specifically so state.
Failure to request a hearing for any
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14:56 Nov 15, 2005
Jkt 208001
particular objection shall constitute a
waiver of the right to a hearing on that
objection. Each numbered objection for
which a hearing is requested shall
include a detailed description and
analysis of the specific factual
information intended to be presented in
support of the objection in the event
that a hearing is held. Failure to include
such a description and analysis for any
particular objection shall constitute a
waiver of the right to a hearing on the
objection. For written objections, three
copies of all documents shall be
submitted and shall be identified with
the docket number found in brackets in
the heading of this document. Any
objections received in response to the
regulation may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VII. Reference
The following reference has been
placed on display at the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Memorandum from Folmer, Division of
Petition Review, Chemistry Review Group, to
Kidwell, Division of Petition Review,
February 2, 2005.
List of Subjects in 21 CFR Part 172
Food additives, Reporting and
recordkeeping requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 172 is
amended as follows:
PART 172—FOOD ADDITIVES
PERMITTED FOR DIRECT ADDITION
TO FOOD FOR HUMAN
CONSUMPTION
1. The authority citation for 21 CFR
part 172 continues to read as follows:
I
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
2. Section 172.380 is amended by
adding paragraph (c)(5) to read as
follows:
I
§ 172.380
Vitamin D3.
*
*
*
*
*
(c) * * *
(5) At levels not to exceed 81 IU per
30 grams in cheese and cheese products
as defined under § 170.3(n)(5) of this
chapter, excluding cottage cheese,
ricotta cheese, and hard grating cheeses
such as Parmesan and Romano as
defined in §§ 133.165 and 133.183 of
this chapter, and those defined by
standard of identity in § 133.148 of this
chapter.
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Dated: November 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–22670 Filed 11–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Tylosin
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
Elanco Animal Health. The
supplemental NADA provides for use of
tylosin soluble powder in honey bees
for the control of American foulbrood
(Paenibacillus larvae).
DATES: This rule is effective November
16, 2005.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 13 076 that
provides for the use of TYLAN (tylosin
tartrate) Soluble in honey bees for the
control of American foulbrood
(Paenibacillus larvae). The approval of
this supplemental NADA relied on
publicly available safety and
effectiveness data contained in Public
Master File (PMF) 5783 which were
compiled under National Research
Support Project 7 (NRSP 7), a national
agricultural research program for
obtaining clearances for use of new
drugs in minor animal species and for
special uses. The supplemental NADA
is approved as of October 17, 2005, and
the regulations in 21 CFR 520.2640 are
amended to reflect the approval. The
basis of approval is discussed in the
freedom of information summary.
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
E:\FR\FM\16NOR1.SGM
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Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Rules and Regulations
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 carefully considered
the potential environmental impact of
this action and has concluded that the
action will not have a significant impact
on the human environment and that an
environmental impact statement is not
required. FDA’s finding of no significant
impact and the evidence supporting that
finding, contained in an environmental
assessment, may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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:
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 520.2640, revise paragraph (e)
introductory text, and add paragraph
(e)(4) to read as follows:
I
§ 520.2640
Tylosin.
*
*
*
*
*
(e) Conditions of use—
*
*
*
*
*
(4) Honey bees—(i) Amount. Mix 200
milligrams tylosin in 20 grams
confectioners’/powdered sugar. Use
immediately. Apply (dust) this mixture
over the top bars of the brood chamber
once weekly for 3 weeks.
(ii) Indications for use. For the control
of American foulbrood (Paenibacillus
larvae).
(iii) Limitations. The drug should be
fed early in the spring or fall and
consumed by the bees before the main
honey flow begins, to avoid
contamination of production honey.
Complete treatments at least 4 weeks
before main honey flow.
VerDate Aug<31>2005
11:21 Nov 15, 2005
Jkt 208001
Dated: November 3, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–22752 Filed 11–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[CGD01–05–100]
Drawbridge Operation Regulations:
Connecticut River, CT
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, First Coast
Guard District, has issued a temporary
deviation from the drawbridge operation
regulations for the Amtrak Old
Saybrook-Old Lyme Bridge, mile 3.4,
across the Connecticut River,
Connecticut. This deviation from the
regulations allows the bridge to operate
on a fixed schedule for bridge openings
from November 21, 2005 through
December 22, 2005. This deviation is
necessary in order to facilitate necessary
scheduled bridge maintenance.
DATES: This deviation is effective from
November 21, 2005 through December
22, 2005.
FOR FURTHER INFORMATION CONTACT: Judy
Leung-Yee, Project Officer, First Coast
Guard District, at (212) 668–7195.
SUPPLEMENTARY INFORMATION: The Old
Saybrook-Old Lyme Bridge, at mile 3.4,
across the Connecticut River has a
vertical clearance in the closed position
of 19 feet at mean high water and 22 feet
at mean low water. The existing
drawbridge operating regulations are
listed at 33 CFR 117.205(b).
The owner of the bridge, National
Railroad Passenger Corporation
(Amtrak), requested a temporary
deviation from the drawbridge operating
regulations to facilitate scheduled
electrical bridge repairs. In order to
complete the above repairs the bridge
must open on a fixed bridge opening
schedule.
This deviation to the operating
regulations allows the Old SaybrookOld Lyme Bridge to operate from
November 21, 2005 through December
22, 2005, as follows:
From Monday through Friday, the
bridge shall open on signal at 8:15 a.m.,
12:15 p.m., and 2:15 p.m., daily. From
4 p.m. through 8 a.m. the bridge shall
open on signal after a four-hour advance
PO 00000
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Fmt 4700
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69439
notice is given by calling the number
posted at the bridge.
On Saturday and Sunday, the bridge
shall open on signal at 8 a.m., 10 a.m.,
1 p.m., and 4 p.m., daily. From 4 p.m.
through 8 a.m. the bridge shall open on
signal after a four-hour advance notice
is given by calling the number posted at
the bridge.
The bridge shall open on signal for
commercial vessels at any time after a
four-hour advance notice is given by
calling the number posted at the bridge.
In accordance with 33 CFR 117.35(c),
this work will be performed with all due
speed in order to return the bridge to
normal operation as soon as possible.
This deviation from the operating
regulations is authorized under 33 CFR
117.35.
Dated: November 4, 2005.
Gary Kassof,
Bridge Program Manager, First Coast Guard
District.
[FR Doc. 05–22647 Filed 11–15–05; 8:45 am]
BILLING CODE 4910–15–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[CGD08–05–052]
Drawbridge Operation Regulations;
Berwick Bay, Morgan City, LA
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, Eighth
Coast Guard District, has issued a
temporary deviation from the regulation
governing the operation of the
Burlington Northern Railway Vertical
Lift Span Railroad Bridge across
Berwick Bay, mile 17.5 [Gulf
Intracoastal Waterway (Morgan City to
Port Allen Alternate Route), mile 0.4], at
Morgan City, St. Mary Parish, Louisiana.
This deviation provides for two (2) fourhour bridge closures to conduct
scheduled maintenance to the railroad
on the drawbridge.
DATES: This deviation is effective from
8 a.m. on Tuesday, November 29, 2005
until noon on Wednesday, November
30, 2005.
ADDRESSES: Materials referred to in this
document are available for inspection or
copying at the office of the Eighth Coast
Guard District, Bridge Administration
Branch, Hale Boggs Federal Building,
room 1313, 500 Poydras Street, New
Orleans, Louisiana 70130–3310 between
E:\FR\FM\16NOR1.SGM
16NOR1
]]>Agencies
[Federal Register Volume 70, Number 220 (Wednesday, November 16, 2005)]
[Rules and Regulations]
[Pages 69438-69439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22752]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Tylosin
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 Elanco Animal Health. The supplemental NADA
provides for use of tylosin soluble powder in honey bees for the
control of American foulbrood (Paenibacillus larvae).
DATES: This rule is effective November 16, 2005.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 13 076 that provides for the use of TYLAN (tylosin
tartrate) Soluble in honey bees for the control of American foulbrood
(Paenibacillus larvae). The approval of this supplemental NADA relied
on publicly available safety and effectiveness data contained in Public
Master File (PMF) 5783 which were compiled under National Research
Support Project 7 (NRSP 7), a national agricultural research program
for obtaining clearances for use of new drugs in minor animal species
and for special uses. The supplemental NADA is approved as of October
17, 2005, and the regulations in 21 CFR 520.2640 are amended to reflect
the approval. The basis of approval is discussed in the freedom of
information summary.
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
[[Page 69439]]
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 carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
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 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
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. 520.2640, revise paragraph (e) introductory text, and add
paragraph (e)(4) to read as follows:
Sec. 520.2640 Tylosin.
* * * * *
(e) Conditions of use--
* * * * *
(4) Honey bees--(i) Amount. Mix 200 milligrams tylosin in 20 grams
confectioners'/powdered sugar. Use immediately. Apply (dust) this
mixture over the top bars of the brood chamber once weekly for 3 weeks.
(ii) Indications for use. For the control of American foulbrood
(Paenibacillus larvae).
(iii) Limitations. The drug should be fed early in the spring or
fall and consumed by the bees before the main honey flow begins, to
avoid contamination of production honey. Complete treatments at least 4
weeks before main honey flow.
Dated: November 3, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-22752 Filed 11-15-05; 8:45 am]
BILLING CODE 4160-01-S
