New Animal Drugs; Trilostane, 21767-21768 [E9-10927]
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21767
Rules and Regulations
Federal Register
Vol. 74, No. 89
Monday, May 11, 2009
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Trilostane
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
original approval of a new animal drug
application (NADA) filed by Dechra,
Ltd. The NADA provides for the
veterinary prescription use of trilostane
capsules in dogs for treatment of
pituitary-dependent
hyperadrenocorticism and for treatment
of hyperadrenocorticism due to
adrenocortical tumor.
DATES: This rule is effective May 11,
2009.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Dechra,
Ltd., Dechra House, Jamage Industrial
Estate, Talke Pits, Stoke-on-Trent,
Staffordshire, ST7 1XW, United
Kingdom, filed NADA 141–291 that
provides for veterinary prescription use
of VETORYL (trilostane) Capsules in
dogs for treatment of pituitarydependent hyperadrenocorticism and
for treatment of hyperadrenocorticism
due to adrenocortical tumor. The NADA
is approved as of December 5, 2008, and
the regulations are amended in 21 CFR
part 520 to reflect the approval.
In addition, Dechra, Ltd. is not
currently listed in the animal drug
VerDate Nov<24>2008
12:48 May 08, 2009
Jkt 217001
regulations as a sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to add
entries for this sponsor.
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)(i) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
marketing exclusivity beginning on the
date of approval.
Under section 573(c) of the act (21
U.S.C. 360ccc–2), the approval of
trilostane capsules for treatment of
hyperadrenocorticism due to
adrenocortical tumor in dogs qualifies
for 7 years of exclusive marketing rights
beginning on the date of approval
because the new animal drug has been
declared a designated new animal drug
by FDA under section 573(a) of the act.
The agency 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.
CFR parts 510 and 520 are amended as
follows:
PART 510—NEW ANIMAL DRUGS
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.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Dechra, Ltd.’’; and in the table
in paragraph (c)(2), numerically add an
entry for ‘‘043264’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Dechra, Ltd., Dechra
House, Jamage Industrial
Estate, Talke Pits, Stokeon-Trent, Staffordshire,
ST7 1XW, United Kingdom
*
*
*
Drug labeler
code
*
043264
*
*
*
(2) * * *
Drug labeler
code
*
043264
*
*
*
Firm name and address
*
*
*
Dechra, Ltd., Dechra
House, Jamage Industrial
Estate, Talke Pits, Stokeon-Trent, Staffordshire,
ST7 1XW, United Kingdom
*
*
*
List of Subjects
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
21 CFR Part 510
■
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Animal drugs.
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
■
Frm 00001
Fmt 4700
Authority: 21 U.S.C. 360b.
■
4. Add § 520.2598 to read as follows:
§ 520.2598
21 CFR Part 520
PO 00000
3. The authority citation for 21 CFR
part 520 continues to read as follows:
Sfmt 4700
Trilostane.
(a) Specifications. Each capsule
contains 30 or 60 milligrams (mg)
trilostane.
(b) Sponsor. See No. 043264 in
§ 510.600 of this chapter.
(c) Conditions of use in dogs—(1)
Amount. The starting dose is 1.0 to 3.0
E:\FR\FM\11MYR1.SGM
11MYR1
21768
Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Rules and Regulations
milligrams per pound (2.2 to 6.7
milligrams per kilogram) once a day.
(2) Indications for use. For treatment
of pituitary-dependent
hyperadrenocorticism. For treatment of
hyperadrenocorticism due to
adrenocortical tumor.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: May 5, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–10927 Filed 5–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA–2009–N–0665]
New Animal Drugs; Carprofen
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
List of Subjects
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
original approval of an abbreviated new
animal drug application (ANADA) filed
by Norbrook Laboratories, Ltd. The
ANADA provides for the veterinary
prescription use of carprofen caplets in
dogs.
DATES: This rule is effective May 11,
2009.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
ANADA 200–498 that provides for
veterinary prescription use of
NOROCARP (carprofen) Caplets 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. The ANADA is
approved as of November 25, 2008, and
the regulations are amended in 21 CFR
520.309 to reflect the approval.
In addition, FDA has found that a
sponsor of another generic carprofen
caplet product is not currently listed in
the animal drug regulations as a sponsor
of an approved application.
SUMMARY:
VerDate Nov<24>2008
12:48 May 08, 2009
Accordingly, 21 CFR 510.600(c) is being
amended to add entries for IMPAX
Laboratories, Inc.
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.
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.
Jkt 217001
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 520
Firm name and address
*
*
*
IMPAX Laboratories, Inc.,
30831 Huntwood Ave.,
Hayward, CA 94544
*
*
*
Drug labeler
code
*
*
000115
*
*
(2) * * *
Drug labeler
code
*
000115
*
*
*
Firm name and address
*
*
*
IMPAX Laboratories, Inc.,
30831 Huntwood Ave.,
Hayward, CA 94544
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.309
[Amended]
4. In paragraph (b)(2) of § 520.309,
remove ‘‘000115 and 062250’’ and add
in its place ‘‘000115, 055529, and
062250’’.
■
Dated: May 6, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–10925 Filed 5–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE INTERIOR
Animal drugs.
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:
Office of Surface Mining Reclamation
and Enforcement
PART 510—NEW ANIMAL DRUGS
AGENCY: Office of Surface Mining
Reclamation and Enforcement (OSM),
Interior.
ACTION: Final rule: clarification.
■
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.
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add a
new entry for ‘‘IMPAX Laboratories,
Inc.’’; and in the table in paragraph
(c)(2) numerically add a new entry for
‘‘000115’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
PO 00000
Frm 00002
*
Fmt 4700
*
Sfmt 4700
30 CFR Part 938
[PA–148–FOR; OSM–2008–0014]
Pennsylvania Regulatory Program
SUMMARY: We recently approved an
amendment to the Pennsylvania
regulatory program (the Pennsylvania
program) under the Surface Mining
Control and Reclamation Act of 1977
(SMCRA or the Act). The changes
related to blasting for the development
of shafts for underground mines and
other changes to the blasting regulations
in the Pennsylvania program. After our
approval of the amendment, the
Pennsylvania Department of
Environmental Protection (PADEP)
requested a clarification of our findings
in support of that approval. Therefore,
E:\FR\FM\11MYR1.SGM
11MYR1
]]>Agencies
[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Rules and Regulations]
[Pages 21767-21768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10927]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Rules and
Regulations
[[Page 21767]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Trilostane
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the original approval of a new animal drug
application (NADA) filed by Dechra, Ltd. The NADA provides for the
veterinary prescription use of trilostane capsules in dogs for
treatment of pituitary-dependent hyperadrenocorticism and for treatment
of hyperadrenocorticism due to adrenocortical tumor.
DATES: This rule is effective May 11, 2009.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Dechra, Ltd., Dechra House, Jamage
Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW,
United Kingdom, filed NADA 141-291 that provides for veterinary
prescription use of VETORYL (trilostane) Capsules in dogs for treatment
of pituitary-dependent hyperadrenocorticism and for treatment of
hyperadrenocorticism due to adrenocortical tumor. The NADA is approved
as of December 5, 2008, and the regulations are amended in 21 CFR part
520 to reflect the approval.
In addition, Dechra, Ltd. is not currently listed in the animal
drug regulations as a sponsor of an approved application. Accordingly,
21 CFR 510.600(c) is being amended to add entries for this sponsor.
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)(i) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval
qualifies for 5 years of marketing exclusivity beginning on the date of
approval.
Under section 573(c) of the act (21 U.S.C. 360ccc-2), the approval
of trilostane capsules for treatment of hyperadrenocorticism due to
adrenocortical tumor in dogs qualifies for 7 years of exclusive
marketing rights beginning on the date of approval because the new
animal drug has been declared a designated new animal drug by FDA under
section 573(a) of the act.
The agency 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
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. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Dechra, Ltd.''; and in the table in paragraph
(c)(2), numerically add an entry for ``043264'' 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
------------------------------------------------------------------------
* * * * *
Dechra, Ltd., Dechra House, Jamage 043264
Industrial Estate, Talke Pits, Stoke-on-
Trent, Staffordshire, ST7 1XW, United
Kingdom
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
043264 Dechra, Ltd., Dechra House, Jamage
Industrial Estate, Talke Pits, Stoke-on-
Trent, Staffordshire, ST7 1XW, United
Kingdom
* * * * *
------------------------------------------------------------------------
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.
0
4. Add Sec. 520.2598 to read as follows:
Sec. 520.2598 Trilostane.
(a) Specifications. Each capsule contains 30 or 60 milligrams (mg)
trilostane.
(b) Sponsor. See No. 043264 in Sec. 510.600 of this chapter.
(c) Conditions of use in dogs--(1) Amount. The starting dose is 1.0
to 3.0
[[Page 21768]]
milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.
(2) Indications for use. For treatment of pituitary-dependent
hyperadrenocorticism. For treatment of hyperadrenocorticism due to
adrenocortical tumor.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: May 5, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-10927 Filed 5-8-09; 8:45 am]
BILLING CODE 4160-01-S
