Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin, 51995-51996 [E6-14509]
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Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Rules and Regulations
the words ‘‘FAA Order 7400.9N’’ and
adding, in their place, the words ‘‘FAA
Order 7400.9P.’’
§ 71.901
[Amended]
10. Paragraph (a) of section 71.901 is
amended by removing the words ‘‘FAA
Order 7400.9N’’ and adding, in their
place, the words ‘‘FAA Order 7400.9P.’’
I
Issued in Washington, DC, on July 27,
2006.
Edith V. Parish,
Manager, Airspace and Rules.
[FR Doc. E6–12434 Filed 8–31–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Carprofen
AGENCY:
rwilkins on PROD1PC63 with RULES
List of Subjects in 21 CFR Part 520
Animal drugs.
Food and Drug Administration,
HHS.
ACTION:
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.
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
Final rule.
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 IMPAX Laboratories, Inc. The
supplemental ANADA provides for
veterinary prescription use of carprofen
caplets in dogs for the control of
postoperative pain associated with soft
tissue and orthopedic surgeries.
DATES: This rule is effective September
1, 2006.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IMPAX
Laboratories, Inc., 30831 Huntwood
Ave., Hayward, CA 94544, filed a
supplement to ANADA 200–366 for
NOVOX (carprofen) caplets which are
approved for veterinary prescription use
in dogs for the relief of pain and
inflammation associated with
osteoarthritis (70 FR 30625, May 27,
2005). The supplement provides for use
of NOVOX caplets for the control of
postoperative pain associated with soft
tissue and orthopedic surgeries. The
supplemental ANADA is approved as of
July 27, 2006, and 21 CFR 520.309 is
amended to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
VerDate Aug<31>2005
16:15 Aug 31, 2006
Jkt 208001
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 § 520.309, remove paragraphs
(d)(2)(i) and (d)(2)(ii), and revise
paragraphs (b)(2) and (d)(2) to read as
follows:
I
§ 520.309
Carprofen.
*
*
*
*
*
(b) * * *
(2) No. 000115 for use of product
described in paragraph (a)(1) as in
paragraph (d) of this section.
*
*
*
*
*
(d) * * *
(2) Indications for use. For the relief
of pain and inflammation associated
with osteoarthritis and for the control of
postoperative pain associated with soft
tissue and orthopedic surgeries.
*
*
*
*
*
Dated: August 18, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–14508 Filed 8–31–06; 8:45 am]
BILLING CODE 4160–01–S
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51995
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Lincomycin
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 the use of
lincomycin injectable solution in swine
for the treatment of infectious arthritis
and mycoplasma pneumonia.
DATES: This rule is effective September
1, 2006.
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.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–368 that provides for use
of LINCOMED 100 (lincomycin
hydrochloride) and LINCOMED 300
(lincomycin hydrochloride) in swine for
the treatment of infectious arthritis and
mycoplasma pneumonia. Cross
Vetpharm Group Ltd.’s LINCOMED 100
and LINCOMED 300 are approved as
generic copies of LINCOMIX 100
Injectable and LINCOMIX 300
Injectable, sponsored by Pharmacia &
Upjohn Co., a Division of Pfizer, Inc.,
under NADA 034 025. The ANADA is
approved as of July 27, 2006, and the
regulations are amended in § 522.1260
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
E:\FR\FM\01SER1.SGM
01SER1
51996
Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Rules and Regulations
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 Subject in 21 CFR Part 522
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 part 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 522.1260, add paragraphs (a)(4)
and (b)(4) to read as follows:
I
§ 522.1260
Lincomycin.
(a) * * *
(4) 100 or 300 mg lincomycin.
(b) * * *
(4) No. 061623 for use of
concentrations in paragraph (a)(4) of
this section as in paragraph (e)(2) of this
section.
*
*
*
*
*
Dated: August 10, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–14509 Filed 8–31–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–289I]
RIN 1117–AB04
Schedules of Controlled Substances:
Exempt Anabolic Steroid Products
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Interim rule and request for
comments.
rwilkins on PROD1PC63 with RULES
AGENCY:
SUMMARY: The Drug Enforcement
Administration (DEA) is designating six
pharmaceutical preparations as exempt
anabolic steroid products under the
VerDate Aug<31>2005
16:15 Aug 31, 2006
Jkt 208001
Controlled Substances Act. This action
is part of the ongoing implementation of
the Anabolic Steroids Control Act of
1990.
DATES: This rule is effective September
1, 2006. Written comments must be
postmarked, and electronic comments
must be sent, on or before October 31,
2006.
ADDRESSES: To ensure proper handling
of comments, please reference Docket
No. DEA–289 on all written and
electronic correspondence. Written
comments sent via regular mail should
be sent to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Attention: DEA Federal Register
Representative/ODL. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/ODL,
2401 Jefferson-Davis Highway,
Alexandria, VA 22301. Comments may
be sent electronically to
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided at
that site. DEA will accept attachments to
electronic comments in Microsoft Word,
Word Perfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file formats other than those specifically
listed here.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration,
Washington, DC 20537, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION:
Background
The Anabolic Steroids Control Act
(ASCA) of 1990 (Title XIX of Pub. L.
101–647) placed anabolic steroids into
Schedule III of the Controlled
Substances Act (CSA) (21 U.S.C. 801 et
seq.). Section 1903 of the ASCA
provides that the Attorney General may
exempt products which contain
anabolic steroids from all or any part of
the Controlled Substances Act if the
products have no significant potential
for abuse. The authority to exempt these
products was delegated from the
Attorney General to the Administrator
of the Drug Enforcement Administration
(28 CFR 0.100(b)), who in turn,
redelegated this authority to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (28 CFR Part 0,
Appendix to Subpart R, section 7(g)).
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The procedure for implementing this
section of the ASCA is found in
§ 1308.33 of Title 21 of the Code of
Federal Regulations. Three applications
which were in conformance with 21
CFR 1308.33 were received and
forwarded to the Secretary of Health and
Human Services for evaluation. The
purpose of this rule is to identify six
products which the Deputy Assistant
Administrator, Office of Diversion
Control, finds meet the exempt anabolic
steroid product criteria.
Anabolic Steroid Products Being Added
to the List of Products Exempted From
Application of the CSA
DEA received three letters dated June
8, 2005, July 1, 2005 and August 22,
2005, written to the DEA on behalf of
Interpharm Inc., Lannett Company Inc.,
and ANDAPharm, LLC, respectively.
Each of these three letters contained an
application to exempt from control
under the CSA two products, each
containing esterified estrogens and
methyltestosterone. In two letters dated
November 14, 2005, DEA provided a
copy of the Lannett and ANDAPharm
applications to the Department of
Health and Human Services (DHHS)
along with a request for evaluation and
a recommendation. In a letter dated
November 15, 2005, DEA provided a
copy of the Interpharm application to
DHHS along with a request for
evaluation and recommendation. In
three separate letters dated March 30,
2006, the Assistant Secretary of Health
for DHHS recommended that all six
products, two products of esterified
estrogen and methyltestosterone from
each of the three applications, be
exempted from control under the CSA
based on their similarity to the products
Estratest, Estratest H.S., EssianTM and
EssianTM H.S., which have been
exempted from control under the CSA.
DEA agrees with DHHS regarding the
similarity of these products to products
which have already been exempted from
the regulatory controls of the Controlled
Substances Act. Further, after reviewing
several law enforcement databases, DEA
has not found evidence of significant
abuse or trafficking of these types of
products.
The Deputy Assistant Administrator,
having reviewed the applications,
recommendations of the Secretary, and
other relevant information, finds that
the following six products have no
significant potential for abuse: Esterified
Estrogens and Methyltestosterone, USP
(1.25 mg/2.5 mg); Esterified Estrogens
and Methyltestosterone, USP (0.625 mg/
1.25 mg); Methyltestosterone and
Esterified Estrogens (2.5 mg/1.25 mg);
Methyltestosterone and Esterified
E:\FR\FM\01SER1.SGM
01SER1
]]>Agencies
[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Rules and Regulations]
[Pages 51995-51996]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14509]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Lincomycin
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 the use of lincomycin injectable solution in swine for the
treatment of infectious arthritis and mycoplasma pneumonia.
DATES: This rule is effective September 1, 2006.
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: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-368 that provides for use
of LINCOMED 100 (lincomycin hydrochloride) and LINCOMED 300 (lincomycin
hydrochloride) in swine for the treatment of infectious arthritis and
mycoplasma pneumonia. Cross Vetpharm Group Ltd.'s LINCOMED 100 and
LINCOMED 300 are approved as generic copies of LINCOMIX 100 Injectable
and LINCOMIX 300 Injectable, sponsored by Pharmacia & Upjohn Co., a
Division of Pfizer, Inc., under NADA 034 025. The ANADA is approved as
of July 27, 2006, and the regulations are amended in Sec. 522.1260 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
[[Page 51996]]
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 Subject in 21 CFR Part 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.1260, add paragraphs (a)(4) and (b)(4) to read as
follows:
Sec. 522.1260 Lincomycin.
(a) * * *
(4) 100 or 300 mg lincomycin.
(b) * * *
(4) No. 061623 for use of concentrations in paragraph (a)(4) of
this section as in paragraph (e)(2) of this section.
* * * * *
Dated: August 10, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-14509 Filed 8-31-06; 8:45 am]
BILLING CODE 4160-01-S
