Oral Dosage Form New Animal Drugs; Carprofen, 68477-68478 [E7-23516]
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Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations
§ 406.143
33. Amend § 406.133 by revising
paragraph (a) introductory text to read
as follows:
I
Discovery.
§ 406.139 Joint procedural or discovery
schedule.
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(b) * * * A party is not required to
file written interrogatories and
responses, requests for production of
documents or tangible items and
responses, and requests for admission
and responses with the Federal Docket
Management System or submit any of
them to the administrative law judge.
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(j) * * *
(3) Notice of deposition. A party must
serve a notice of deposition, stating the
time and place of the deposition and the
name and address of each person to be
examined, on the person to be deposed,
must submit the notice to the
administrative law judge, and must file
the notice with the Federal Docket
Management System, and must serve
the notice on each party, not later than
7 days before the deposition. * * *
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I 38. Amend § 406.173 by revising the
first and second sentence in paragraph
(d) to read as follows:
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§ 406.173
§ 406.133
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Amendments of pleadings.
(a) Time. A party must file with the
Federal Docket Management System and
serve on each other party any
amendment to a complaint or an answer
as follows:
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I 34. Amend § 406.137 by revising
paragraph (a) to read as follows:
§ 406.137
Intervention.
(a) A person may file with the Federal
Docket Management System and serve
on each other party a motion for leave
to intervene as party in an adjudication.
Except for good cause shown, a motion
for leave to intervene must be filed not
later than 10 days before the hearing.
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I 35. Amend § 406.139 by revising
paragraphs (b) introductory text and (d)
to read as follows:
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(b) Form and content of schedule. If
the parties agree to a joint procedural or
discovery schedule, one of the parties
must file with the Federal Docket
Management System and serve the joint
schedule, setting forth the dates to
which the parties have agreed. One of
the parties must draft an order
establishing a joint schedule for the
administrative law judge.
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(d) Order establishing joint schedule.
The administrative law judge must
approve the joint schedule filed by the
parties by signing the joint schedule and
filing it with the Federal Docket
Management System.
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I 36. Amend § 406.141 by revising
paragraph (c) to read as follows:
§ 406.141
Motions.
sroberts on PROD1PC70 with RULES
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(c) Form and time. Except for oral
motions heard on the record, a motion
made prior to the hearing must be in
writing. Unless otherwise agreed by the
parties or for good cause shown, a party
must file any prehearing motion with
the Federal Docket Management System
and serve each other party not later than
30 days before the hearing.
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I 37. Amend § 406.143 by revising the
second sentence in paragraph (b) and by
revising the first sentence in paragraph
(j)(3) to read as follows:
VerDate Aug<31>2005
17:07 Dec 04, 2007
Jkt 214001
Interlocutory appeals.
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(d) Procedure. A party must file with
the Federal Docket Management System
and serve each other party a notice of
interlocutory appeal, with supporting
documents, not later than 10 days after
the administrative law judge’s decision
forming the basis of an interlocutory
appeal of right or not later than 10 days
after the administrative law judge’s
decision granting an interlocutory
appeal for cause. A party must file with
the Federal Docket Management System
a reply brief, if any, and serve a copy of
the reply brief on each party, not later
than 10 days after service of the appeal
brief. * * *
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I 39. Amend § 406.175 by revising
paragraphs (a), (d) introductory text, and
(e) introductory text, by revising the
third sentence in paragraph (f), and by
revising paragraph (g) to read as follows:
§ 406.175
Appeal from initial decision.
(a) Notice of appeal. A party may
appeal the initial decision, and any
decision not previously appealed
pursuant to § 406.173, by filing with the
Federal Docket Management System and
serving on each party a notice of appeal.
A party must file the notice of appeal
not later than 10 days after entry of the
oral initial decision on the record or
service of the written initial decision on
the parties.
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PO 00000
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68477
(d) Appeal briefs. A party must file
the appeal brief with the Federal Docket
Management System and serve each
party.
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(e) Reply brief. Unless otherwise
agreed by the parties, any party may file
a reply brief with the Federal Docket
Management System and serve on each
other party not later than 35 days after
the appeal brief has been served on that
party. If the party relies on evidence
contained in the record for the reply, the
party must specifically refer to the
pertinent evidence contained in the
record in the reply brief.
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(f) * * * A party may file with the
Federal Docket Management System a
motion for permission to file an
additional brief and must serve a copy
of the motion on each other party. * * *
(g) Number of copies. A party must
file the original brief and two copies of
the brief with the Federal Docket
Management System and serve one copy
on each other party.
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I 40. Amend § 406.177 by revising the
second sentence in paragraph (a) to read
as follows:
§ 406.177 Petition to reconsider or modify
a final decision and order of the FAA
decisionmaker on appeal.
(a) * * * A party must file a petition
to reconsider or modify with the Federal
Docket Management System not later
than 30 days after service of the FAA
decisionmaker’s final decision and
order on appeal and must serve a copy
of the petition on each party. * * *
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Issued in Washington, DC on November 28,
2007.
Pamela Hamilton-Powell,
Director, Office of Rulemaking, Aviation
Safety.
[FR Doc. E7–23422 Filed 12–4–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Oral Dosage Form New Animal Drugs;
Carprofen
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
E:\FR\FM\05DER1.SGM
05DER1
68478
Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations
animal drug regulations to reflect
approval of an original abbreviated new
animal drug application (ANADA) filed
by Belcher Pharmaceuticals, Inc. The
ANADA provides for veterinary
prescription use of carprofen caplets in
dogs.
DATES:
This rule is effective December 5,
List of Subjects
§ 520.309
21 CFR Part 510
I
FOR FURTHER INFORMATION CONTACT:
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
Belcher
Pharmaceuticals, Inc., 12393 Belcher
Rd., Suite 420, Largo, FL 33773, filed
ANADA 200–397 for VETPROFEN
(carprofen) Caplets. The ANADA
provides for veterinary prescription use
in dogs for the relief of pain and
inflammation associated with
osteoarthritis, and for the control of
postoperative pain associated with soft
tissue and orthopedic surgeries. Belcher
Pharmaceuticals, Inc.’s VETPROFEN
Caplets are approved as a generic copy
of RIMADYL Caplets, sponsored by
Pfizer, Inc., under NADA 141–053. The
ANADA is approved as of November 7,
2007, and 21 CFR 520.309 is amended
to reflect the approval.
In addition, Belcher Pharmaceuticals,
Inc., has not been previously listed in
the animal drug regulations as a sponsor
of an approved application. At this time,
21 CFR 510.600(c) is being amended to
add entries for the firm.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 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.
sroberts on PROD1PC70 with RULES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
17:07 Dec 04, 2007
Jkt 214001
4. In paragraph (b)(2) of § 520.309,
remove ‘‘No. 000115’’ and add in its
place ‘‘Nos. 000115 and 062250’’.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Dated: November 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–23516 Filed 12–4–07; 8:45 am]
21 CFR Part 520
2007.
[Amended]
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 Center for Veterinary Medicine, 21
CFR parts 510 and 520 are amended as
follows:
I
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. Section 510.600 is amended in the
table in paragraph (c)(1) by
alphabetically adding a new entry for
‘‘Belcher Pharmaceuticals, Inc.’’ and in
the table in paragraph (c)(2) by
numerically adding a new entry for
‘‘062250’’ to read as follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Belcher Pharmaceuticals,
Inc., 12393 Belcher Rd.,
suite 420, Largo, FL
33773
*
*
*
Drug labeler
code
*
062250
*
*
*
(2) * * *
Drug labeler
code
*
062250
*
*
*
Firm name and address
*
*
*
Belcher Pharmaceuticals,
Inc., 12393 Belcher Rd.,
suite 420, Largo, FL
33773
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
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Fmt 4700
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Monensin
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 revises the
concentration of monensin in two-way
Type B and Type C medicated feeds
containing monensin and tylosin to
cattle fed in confinement for slaughter
and a revision to bacterial pathogen
nomenclature.
DATES:
This rule is effective December 5,
2007.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223,
e-mail: daniel.benz@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 104–646 that
provides for use of RUMENSIN
(monensin USP) and TYLAN (tylosin
phosphate) Type A medicated articles to
make dry and liquid two-way
combination medicated feeds for cattle
fed in confinement for slaughter. The
supplemental NADA provides for an
increased level of monensin in
combination Type B and Type C
medicated feeds and a revision to
bacterial pathogen nomenclature. The
supplemental NADA is approved as of
October 30, 2007, and the regulations in
21 CFR 558.355 are amended to reflect
the approval.
E:\FR\FM\05DER1.SGM
05DER1
]]>Agencies
[Federal Register Volume 72, Number 233 (Wednesday, December 5, 2007)]
[Rules and Regulations]
[Pages 68477-68478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23516]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Oral Dosage Form New Animal Drugs; Carprofen
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
[[Page 68478]]
animal drug regulations to reflect approval of an original abbreviated
new animal drug application (ANADA) filed by Belcher Pharmaceuticals,
Inc. The ANADA provides for veterinary prescription use of carprofen
caplets in dogs.
DATES: This rule is effective December 5, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Belcher Pharmaceuticals, Inc., 12393 Belcher
Rd., Suite 420, Largo, FL 33773, filed ANADA 200-397 for VETPROFEN
(carprofen) Caplets. The ANADA provides for veterinary prescription use
in dogs for the relief of pain and inflammation associated with
osteoarthritis, and for the control of postoperative pain associated
with soft tissue and orthopedic surgeries. Belcher Pharmaceuticals,
Inc.'s VETPROFEN Caplets are approved as a generic copy of RIMADYL
Caplets, sponsored by Pfizer, Inc., under NADA 141-053. The ANADA is
approved as of November 7, 2007, and 21 CFR 520.309 is amended to
reflect the approval.
In addition, Belcher Pharmaceuticals, Inc., has not been previously
listed in the animal drug regulations as a sponsor of an approved
application. At this time, 21 CFR 510.600(c) is being amended to add
entries for the firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
520 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``Belcher Pharmaceuticals, Inc.''
and in the table in paragraph (c)(2) by numerically adding a new entry
for ``062250'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Belcher Pharmaceuticals, Inc., 12393 062250
Belcher Rd., suite 420, Largo, FL 33773
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
062250 Belcher Pharmaceuticals, Inc., 12393
Belcher Rd., suite 420, Largo, FL 33773
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.309 [Amended]
0
4. In paragraph (b)(2) of Sec. 520.309, remove ``No. 000115'' and add
in its place ``Nos. 000115 and 062250''.
Dated: November 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-23516 Filed 12-4-07; 8:45 am]
BILLING CODE 4160-01-S
