New Animal Drugs For Use in Animal Feeds; Tylosin, 34184-34185 [E8-13606]
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Federal Register / Vol. 73, No. 117 / Tuesday, June 17, 2008 / Rules and Regulations
information in the administrative
record, including any submission made
by the manufacturer or person. The
decision of whether a cease and desist
order should be issued shall be made
within 30 days after receipt of any
information and argument submitted by
the manufacturer or person. The cease
and desist order shall be final unless the
affected manufacturer or person
requests a reconsideration of the order
to the Administrator, Agricultural
Marketing Service, within 30 days after
the date of the issuance of the order.
§ 1170.15
Appeals.
If the cease and desist order is
confirmed by the Administrator,
Agricultural Marketing Service, the
manufacturer or person may appeal the
order in the appropriate United States
District Court not later than 30 days
after the date of the confirmation of the
order.
§ 1170.16
Enforcement.
(a) If a person subject to the Dairy
Product Mandatory Reporting program
fails to obey a cease and desist order
after the order has become final and
unappealable, or after the appropriate
United States district court has entered
a final judgment in favor of the
Administrator, Agricultural Marketing
Service, the United States may apply to
the appropriate United States district
court for enforcement of the order.
(b) If the court determines that the
cease and desist order was lawfully
made and duly served and that the
manufacturer or person violated the
order, the court shall enforce the order.
(c) If the court finds that the
manufacturer or person violated the
cease and desist order, the manufacturer
or person shall be subject to a civil
penalty of not more than $10,000 for
each offense.
Dated: June 10, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing
Service.
[FR Doc. E8–13550 Filed 6–16–08; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Cross Vetpharm Group Ltd. The
supplemental ANADA adds
effectiveness claims against various
species of internal parasites when
horses are treated with ivermectin paste.
DATES:
2008.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed a
supplement to ANADA 200–326 for
BIMECTIN (ivermectin) Paste 1.87%
adding effectiveness claims against
various species of internal parasites of
horses. The supplemental ANADA is
approved as of May 23, 2008, and 21
CFR 520.1192 is amended 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.
The agency has determined under 21
CFR 25.33(a)(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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 520
yshivers on PROD1PC62 with RULES
21 CFR Part 520
Animal drugs.
Oral Dosage Form New Animal Drugs;
Ivermectin Paste
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
VerDate Aug<31>2005
13:09 Jun 16, 2008
This rule is effective June 17,
Jkt 214001
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:
I
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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 § 520.1192, remove paragraphs
(b)(4) and (e)(1)(ii)(C) and revise
paragraph (b)(3) to read as follows:
I
§ 520.1192
Ivermectin paste.
*
*
*
*
*
(b) * * *
(3) Nos. 051311, 054925, and 061623
for use of a 1.87 percent paste for use
as in paragraphs (e)(1)(i), (e)(1)(ii)(A),
and (e)(1)(iii) of this section.
*
*
*
*
*
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–13607 Filed 6–16–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; 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, A Division of Eli
Lilly & Co. The supplemental NADA
provides for revision of an effectiveness
claim and pathogen nomenclature for a
tylosin phosphate and sulfamethazine
Type A medicated article used to
manufacture medicated swine feeds.
DATES: This rule is effective June 17,
2008.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116, email: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 41–275 that
provides for use of TYLAN 40 SULFA–
G (tylosin phosphate and
sulfamethazine) Elliptical Pellets, a
Type A medicated article. The
E:\FR\FM\17JNR1.SGM
17JNR1
Federal Register / Vol. 73, No. 117 / Tuesday, June 17, 2008 / Rules and Regulations
supplement provides for revision of an
effectiveness claim and pathogen
nomenclature. The supplemental NADA
is approved as of May 8, 2008, and the
regulations in 21 CFR 558.630 are
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.
FDA has determined under 21 CFR
25.33(a)(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 558
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:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
I
2. Revise § 558.630 to read as follows:
yshivers on PROD1PC62 with RULES
§ 558.630
Tylosin and sulfamethazine.
(a) Specifications. Type A medicated
articles containing equal amounts of
tylosin phosphate and sulfamethazine,
available in concentrations of 4, 5, 10,
20, or 40 grams each, per pound.
(b) Approvals. See sponsor numbers
in § 510.600(c) of this chapter for use as
in paragraph (e) of this section.
(1) No. 000986: 10 or 40 grams per
pound each for use as in paragraph
(e)(2)(i) of this section.
(2) No. 021930: 2 grams per pound
each for use as in paragraph (e)(2)(i) of
this section.
(3) No. 051311: 40 grams per pound
each for use as in paragraph (e)(2)(ii) of
this section.
(4) No. 017139: 4, 10, or 20 grams per
pound each for use as in paragraph
(e)(2)(ii) of this section.
(5) Nos. 000986, 010439, 016968,
021930, 024174, 030841, 034936,
035098, 046573, 046987, and 051359: 5,
10, 20, or 40 grams per pound each for
VerDate Aug<31>2005
13:09 Jun 16, 2008
Jkt 214001
use as in paragraph (e)(2)(ii) of this
section.
(6) No. 000986: 40 grams per pound
each for use as in paragraph (e)(2)(iii) of
this section.
(c) Special considerations. Labeling
shall bear the statement: ‘‘Do not use in
medicated feeds containing in excess of
2% bentonite.’’
(d) Related tolerances. See §§ 556.670
and 556.740 of this chapter.
(e) Conditions of use. It is used in feed
for swine as follows:
(1) Amount per ton. 100 grams tylosin
and 100 grams sulfamethazine.
(2) Indications for use–(i) Maintaining
weight gains and feed efficiency in the
presence of atrophic rhinitis; lowering
the incidence and severity of Bordetella
bronchiseptica rhinitis; prevention of
swine dysentery (vibrionic); control of
swine pneumonias caused by bacterial
pathogens (Pasteurella multocida and/
or Corynebacterium pyogenes); for
reducing the incidence of cervical
lymphadenitis (jowl abscesses) caused
by Group E Streptococci. Only the
sulfamethazine portion of this
combination is active in controlling jowl
abscesses.
(ii) Maintaining weight gains and feed
efficiency in the presence of atrophic
rhinitis; lowering the incidence and
severity of Bordetella bronchiseptica
rhinitis; prevention of swine dysentery
(vibrionic); control of swine
pneumonias caused by bacterial
pathogens (Pasteurella multocida and/
or Corynebacterium pyogenes).
(iii) For maintaining weight gains and
feed efficiency in the presence of
atrophic rhinitis; lowering the incidence
and severity of Bordetella
bronchiseptica rhinitis; prevention of
swine dysentery associated with
Brachyspira hyodysenteriae; and control
of swine pneumonias caused by
bacterial pathogens (Pasteurella
multocida and/or Arcanobacterium
pyogenes).
(3) Limitations. Withdraw 15 days
before swine are slaughtered.
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–13606 Filed 6–16–08; 8:45 am]
BILLING CODE 4160–01–S
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34185
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9401]
RIN 1545–BH33
Alternative Simplified Credit Under
Section 41(c)(5)
Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
AGENCY:
SUMMARY: This document contains final
and temporary regulations relating to
the election and calculation of the
alternative simplified credit under
section 41(c)(5) of the Internal Revenue
Code. The final and temporary
regulations implement changes to the
credit for increasing research activities
under section 41 made by the Tax Relief
and Health Care Act of 2006. The final
and temporary regulations will affect
certain taxpayers claiming credit under
section 41. The text of these temporary
regulations also serves as the text of the
proposed regulations (REG–149405–07)
published in the Proposed Rules section
in this issue of the Federal Register.
DATES: Effective Date: These regulations
are effective on June 17, 2008.
Applicability Date: For dates of
applicability, see §§ 1.41–6T(j), 1.41–
8T(b)(5), and 1.41–9T(d).
FOR FURTHER INFORMATION CONTACT:
David A. Selig (202) 622–3040 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Background
This document amends 26 CFR part 1
to provide rules relating to the
alternative simplified credit (ASC),
which may be elected under section
41(c)(5) of the Internal Revenue Code
(Code).
General Overview
Section 41(a) provides an incremental
tax credit for increasing research
activities (research credit), and is based
on a percentage of a taxpayer’s qualified
research expenses (QREs) above a base
amount. The Tax Relief and Health Care
Act of 2006 (Pub. L. 109–432, 120 Stat.
2922, December 20, 2006) (the Act)
made certain changes to the research
credit, including the addition of another
method of computation that taxpayers
may elect to use in computing the
amount of the research credit. The
relevant Act provisions are effective
generally for tax years after December
31, 2006, but provide certain
E:\FR\FM\17JNR1.SGM
17JNR1
]]>Agencies
[Federal Register Volume 73, Number 117 (Tuesday, June 17, 2008)]
[Rules and Regulations]
[Pages 34184-34185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13606]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; 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, A Division of Eli
Lilly & Co. The supplemental NADA provides for revision of an
effectiveness claim and pathogen nomenclature for a tylosin phosphate
and sulfamethazine Type A medicated article used to manufacture
medicated swine feeds.
DATES: This rule is effective June 17, 2008.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 41-275 that provides for use of TYLAN 40 SULFA-G
(tylosin phosphate and sulfamethazine) Elliptical Pellets, a Type A
medicated article. The
[[Page 34185]]
supplement provides for revision of an effectiveness claim and pathogen
nomenclature. The supplemental NADA is approved as of May 8, 2008, and
the regulations in 21 CFR 558.630 are 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.
FDA has determined under 21 CFR 25.33(a)(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 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. Revise Sec. 558.630 to read as follows:
Sec. 558.630 Tylosin and sulfamethazine.
(a) Specifications. Type A medicated articles containing equal
amounts of tylosin phosphate and sulfamethazine, available in
concentrations of 4, 5, 10, 20, or 40 grams each, per pound.
(b) Approvals. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (e) of this section.
(1) No. 000986: 10 or 40 grams per pound each for use as in
paragraph (e)(2)(i) of this section.
(2) No. 021930: 2 grams per pound each for use as in paragraph
(e)(2)(i) of this section.
(3) No. 051311: 40 grams per pound each for use as in paragraph
(e)(2)(ii) of this section.
(4) No. 017139: 4, 10, or 20 grams per pound each for use as in
paragraph (e)(2)(ii) of this section.
(5) Nos. 000986, 010439, 016968, 021930, 024174, 030841, 034936,
035098, 046573, 046987, and 051359: 5, 10, 20, or 40 grams per pound
each for use as in paragraph (e)(2)(ii) of this section.
(6) No. 000986: 40 grams per pound each for use as in paragraph
(e)(2)(iii) of this section.
(c) Special considerations. Labeling shall bear the statement: ``Do
not use in medicated feeds containing in excess of 2% bentonite.''
(d) Related tolerances. See Sec. Sec. 556.670 and 556.740 of this
chapter.
(e) Conditions of use. It is used in feed for swine as follows:
(1) Amount per ton. 100 grams tylosin and 100 grams sulfamethazine.
(2) Indications for use-(i) Maintaining weight gains and feed
efficiency in the presence of atrophic rhinitis; lowering the incidence
and severity of Bordetella bronchiseptica rhinitis; prevention of swine
dysentery (vibrionic); control of swine pneumonias caused by bacterial
pathogens (Pasteurella multocida and/or Corynebacterium pyogenes); for
reducing the incidence of cervical lymphadenitis (jowl abscesses)
caused by Group E Streptococci. Only the sulfamethazine portion of this
combination is active in controlling jowl abscesses.
(ii) Maintaining weight gains and feed efficiency in the presence
of atrophic rhinitis; lowering the incidence and severity of Bordetella
bronchiseptica rhinitis; prevention of swine dysentery (vibrionic);
control of swine pneumonias caused by bacterial pathogens (Pasteurella
multocida and/or Corynebacterium pyogenes).
(iii) For maintaining weight gains and feed efficiency in the
presence of atrophic rhinitis; lowering the incidence and severity of
Bordetella bronchiseptica rhinitis; prevention of swine dysentery
associated with Brachyspira hyodysenteriae; and control of swine
pneumonias caused by bacterial pathogens (Pasteurella multocida and/or
Arcanobacterium pyogenes).
(3) Limitations. Withdraw 15 days before swine are slaughtered.
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13606 Filed 6-16-08; 8:45 am]
BILLING CODE 4160-01-S
