Oral Dosage Form New Animal Drugs; Ivermectin Paste, 8513-8514 [05-3280]
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Federal Register / Vol. 70, No. 34 / Tuesday, February 22, 2005 / Rules and Regulations
protective order—(1) Persons who must
file an application for release under
protective order. To be permitted access
to proprietary information in the
administrative record of a determination
under panel review, all persons
described in paragraphs (b)(1), (2), (4),
(5), (6), or (c)(5)(i) of this section shall
file an application for a protective order.
(2) * * *
(ii) Such forms shall require the
applicant to submit a personal sworn
statement that, in addition to such other
conditions as the Commission Secretary
may require, the applicant will:
(A) Not disclose any proprietary
information obtained under protective
order and not otherwise available to any
person other than:
(1) Personnel of the Commission
involved in the particular panel review
in which the proprietary information is
part of the administrative record,
(2) The person from whom the
information was obtained,
(3) A person who is authorized to
have access to the same proprietary
information pursuant to a Commission
protective order, and
(4) A clerical person retained or
employed by and under the direction
and control of a person described in
paragraph (b)(1), (2), (5), or (6) of this
section who has been issued a
protective order, if such clerical person
has signed and dated an agreement,
provided to the Commission Secretary
upon request, to be bound by the terms
set forth in the application for a
protective order of the person who
retains or employs him or her (the
authorized applicant shall be
responsible for retention and accuracy
of such forms and shall be deemed
responsible for such persons’
compliance with the administrative
protective order);
(B) Not use any of the proprietary
information released under protective
order and not otherwise available for
purposes other than the particular
proceedings under Article 1904 of the
Agreement;
(C) Upon completion of panel review,
or at such other date as may be
determined by the Commission
Secretary, return to the Commission, or
certify to the Commission Secretary the
destruction of, all documents released
under the protective order and all other
material (such as briefs, notes, or
charts), containing the proprietary
information released under the
protective order, except that those
described in paragraph (b)(1) of this
section may return such documents and
other materials to the United States
Secretary. The United States Secretary
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12:43 Feb 18, 2005
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may retain a single file copy of each
document for the official file.
(D) Update information in the
application for protective order as
required by the protective order; and
(E) Acknowledge that the person
becomes subject to the provisions of 19
U.S.C. 1677f(f) and to this subpart, as
well as corresponding provisions of
Canadian and Mexican law on
disclosure undertakings concerning
proprietary information.
(3) Timing of applications. An
application for any person described in
paragraph (b)(1) or (b)(2) of this section
may be filed after a notice of request for
panel review has been filed with the
Secretariat. A person described in
paragraph (b)(4) of this section shall file
an application immediately upon
assuming official responsibilities in the
United States, Canadian or Mexican
Secretariat. An application for any
person described in paragraph (b)(5) or
(b)(6) of this section may be filed at any
time after the United States Trade
Representative, the Canadian Minister
of Trade, or the Mexican Secretary of
Economia, as the case may be, has
notified the Commission Secretary that
such person requires access.
(4) * * *
(ii) Applications of persons described
in paragraph (b)(2) of this section—(A)
Filing. A person described in paragraph
(b)(2) of this section, concurrent with
the filing of a complaint or notice of
appearance in the panel review on
behalf of the participant represented by
such person, shall file the completed
original of the form (NAFTA APO Form
C) and three (3) copies with the
Commission Secretary, and four (4)
copies with the United States Secretary.
*
*
*
*
*
(5) Persons who retain access to
proprietary information under a
protective order issued during the
administrative proceedings. (i) If
counsel or a professional has been
granted access in an administrative
proceeding to proprietary information
under a protective order that contains a
provision governing continued access to
that information during panel review,
and that counsel or professional retains
the proprietary information more than
fifteen (15) days after a First Request for
Panel Review is filed with the
Secretariat, that counsel or professional,
and such clerical persons with access on
or after that date, become immediately
subject to the terms and conditions of
NAFTA APO Form C maintained by the
Commission Secretary on that date
including provisions regarding
sanctions for violations thereof.
(ii) Any person described in
paragraph (c)(5)(i) of this section,
PO 00000
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8513
concurrent with the filing of a
complaint or notice of appearance in the
panel review on behalf of the
participant represented by such person,
shall:
(A) File the completed original of the
form (NAFTA APO Form C) and three
(3) copies with the Commission
Secretary; and
(B) File four (4) copies of the
completed NAFTA APO Form C with
the United States Secretary.
(iii) Any person described in
paragraph (c)(5)(i) of this section must
submit a new application for a
protective order at the commencement
of a panel review.
*
*
*
*
*
(e) Retention of protective orders;
service list. The Commission Secretary
shall retain, in a public file, copies of
applications granted, including any
updates thereto, and protective orders
issued under this section, including
protective orders filed in accordance
with paragraph (b)(6)(ii) of this section.
The Secretary shall establish a list of
persons authorized to receive
proprietary information in a review,
including parties whose applications
have been granted.
*
*
*
*
*
By Order of the Commission.
Issued: February 16, 2005.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. 05–3292 Filed 2–18–05; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Ivermectin Paste
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 an abbreviated new animal
drug application (ANADA) filed by
Cross Vetpharm Group Ltd. The
ANADA provides for oral use of
ivermectin paste in horses for treatment
and control of various internal parasites
or parasitic conditions.
DATES: This rule is effective February
22, 2005.
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary
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22FER1
8514
Federal Register / Vol. 70, No. 34 / Tuesday, February 22, 2005 / Rules and Regulations
Medicine (HFV–104), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301–827–8549, email: lonnie.luther@fda.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–326 for BIMECTIN
(ivermectin) Paste 1.87%. The
application provides for oral use of 1.87
percent ivermectin paste in horses for
the treatment and control of various
species of internal parasites or parasitic
conditions. Cross Vetpharm Group’s
BIMECTIN Paste 1.87% is approved as
a generic copy of Merial Limited’s
EQVALAN Paste, approved under
NADA 134–314. ANADA 200–326 is
approved as of January 19, 2005, and 21
CFR 520.1192 is 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
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.
List of Subjects in 21 CFR Part 520
§ 520.1192
Ivermectin paste.
*
*
*
*
(b) * * *
(3) No. 061623 for use of a 1.87
percent paste for use as in paragraph
(e)(1)(i), (e)(1)(ii)(C), and (e)(1)(iii) of
this section.
*
*
*
*
*
(e) * * *
(1) * * *
(ii) * * *
*
*
*
*
*
(C) Large strongyles (adults)—
Strongylus vulgaris (also early forms in
blood vessels), S. edentatus (also tissue
stages), S. equinus, and
Triodontophorus spp. including T.
brevicauda and T. serratus; Small
Strongyles (adults, including those
resistant to some benzimidazole class
compounds)—Cyathostomum spp.
including C. catinatum and C.
pateratum, Cylicocyclus spp. including
C. insigne, C. leptostomum, C. nassatus,
and C. brevicapsulatus,
Cylicodontophorus spp., and
Cylicostephanus spp. including C.
calicatus, C. goldi, C. longibursatus, and
C. minutus; Small Strongyles—fourthstage larvae; Pinworms (adults and
fourth-stage larvae)—Oxyuris equi;
Ascarids (adults and third- and fourthstage larvae)—Parascaris equorum;
Hairworms (adults)—Trichostrongylus
axei; Large-mouth Stomach Worms
(adults)—Habronema muscae; Bots (oral
and gastric stages)—Gasterophilus spp.
including G. intestinalis and G. nasalis;
Lungworms (adults and fourth-stage
larvae)—Dictyocaulus arnfieldi;
Intestinal Threadworms (adults)—
Strongyloides westeri; Summer Sores
caused by Habronema and Draschia
spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm
microfilariae, Onchocerca sp.
*
*
*
*
*
Dated: February 8, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–3280 Filed 2–18–05; 8:45 am]
Animal drugs.
BILLING CODE 4160–01–S
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to the
DEPARTMENT OF HOMELAND
Center for Veterinary Medicine, 21 CFR
SECURITY
part 520 is amended as follows:
I
Coast Guard
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
33 CFR Part 117
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Section 520.1192 is amended by
adding paragraphs (b)(3) and (e)(1)(ii)(C)
to read as follows:
I
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Jkt 205001
[CGD01–05–013]
Drawbridge Operation Regulations:
Raritan River, NJ
AGENCY:
PO 00000
Coast Guard, DHS.
Frm 00014
Fmt 4700
Sfmt 4700
Notice of temporary deviation
from regulations.
ACTION:
*
SUMMARY: The Commander, First Coast
Guard District, has issued a temporary
deviation from the drawbridge operation
regulations for the New Jersey Transit
Rail Operations (NJTRO) Bridge, at mile
0.5, across the Raritan River, at Perth
Amboy, New Jersey. Under this
temporary deviation the bridge may
remain in the closed position beginning
at 11 p.m. on Friday through 6 p.m. on
Saturday for four weekends between
March 18 and May 14, 2005. This
temporary deviation is necessary to
facilitate scheduled maintenance at the
bridge.
This deviation is effective from
March 18, 2005 through May 14, 2005.
DATES:
Joe
Arca, Project Officer, First Coast Guard
District, at (212) 668–7165.
FOR FURTHER INFORMATION CONTACT:
The
NJTRO Bridge has a vertical clearance in
the closed position of 8 feet at mean
high water and 13 feet at mean low
water. The existing drawbridge
operation regulations are listed at 33
CFR 117.747.
The bridge owner, New Jersey Transit
Rail Operations (NJTRO), requested a
temporary deviation from the
drawbridge operation regulations to
facilitate necessary scheduled bridge
maintenance, replacement of miter rails,
at the bridge. The bridge must remain in
the closed position during the
performance of these repairs.
Under this temporary deviation the
NJTRO Bridge may remain in the closed
position beginning at 11 p.m. on Friday
through 6 p.m. on Saturday for four
weekends as follows: March 18 through
March 19; April 1 through April 2; April
15 through April 16; and April 29
through April 30, 2005. Two alternate
weekend closure dates, May 6 through
May 7, and May 13 through May 14,
2005, have been authorized in the event
that inclement weather requires
cancellation of any of the above dates.
This deviation from the operating
regulations is authorized under 33 CFR
117.35, and will be performed with all
due speed in order to return the bridge
to normal operation as soon as possible.
SUPPLEMENTARY INFORMATION:
Dated: February 11, 2005.
Gary Kassof,
Bridge Program Manager, First Coast Guard
District.
[FR Doc. 05–3255 Filed 2–18–05; 8:45 am]
BILLING CODE 4910–15–P
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]]>Agencies
[Federal Register Volume 70, Number 34 (Tuesday, February 22, 2005)]
[Rules and Regulations]
[Pages 8513-8514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3280]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin Paste
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 an abbreviated new animal drug
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA
provides for oral use of ivermectin paste in horses for treatment and
control of various internal parasites or parasitic conditions.
DATES: This rule is effective February 22, 2005.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary
[[Page 8514]]
Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301-827-8549, e-mail: lonnie.luther@fda.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-326 for BIMECTIN
(ivermectin) Paste 1.87%. The application provides for oral use of 1.87
percent ivermectin paste in horses for the treatment and control of
various species of internal parasites or parasitic conditions. Cross
Vetpharm Group's BIMECTIN Paste 1.87% is approved as a generic copy of
Merial Limited's EQVALAN Paste, approved under NADA 134-314. ANADA 200-
326 is approved as of January 19, 2005, and 21 CFR 520.1192 is 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 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.
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. Section 520.1192 is amended by adding paragraphs (b)(3) and
(e)(1)(ii)(C) to read as follows:
Sec. 520.1192 Ivermectin paste.
* * * * *
(b) * * *
(3) No. 061623 for use of a 1.87 percent paste for use as in
paragraph (e)(1)(i), (e)(1)(ii)(C), and (e)(1)(iii) of this section.
* * * * *
(e) * * *
(1) * * *
(ii) * * *
* * * * *
(C) Large strongyles (adults)--Strongylus vulgaris (also early
forms in blood vessels), S. edentatus (also tissue stages), S. equinus,
and Triodontophorus spp. including T. brevicauda and T. serratus; Small
Strongyles (adults, including those resistant to some benzimidazole
class compounds)--Cyathostomum spp. including C. catinatum and C.
pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C.
nassatus, and C. brevicapsulatus, Cylicodontophorus spp., and
Cylicostephanus spp. including C. calicatus, C. goldi, C.
longibursatus, and C. minutus; Small Strongyles--fourth-stage larvae;
Pinworms (adults and fourth-stage larvae)--Oxyuris equi; Ascarids
(adults and third- and fourth-stage larvae)--Parascaris equorum;
Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach Worms
(adults)--Habronema muscae; Bots (oral and gastric stages)--
Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms
(adults and fourth-stage larvae)--Dictyocaulus arnfieldi; Intestinal
Threadworms (adults)--Strongyloides westeri; Summer Sores caused by
Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis
caused by neck threadworm microfilariae, Onchocerca sp.
* * * * *
Dated: February 8, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-3280 Filed 2-18-05; 8:45 am]
BILLING CODE 4160-01-S
