Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride Soluble Powder, 1818 [05-524]
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1818
Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
(3) Limitations. Do not use in horses
intended for human consumption.
Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–523 Filed 1–10–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Lincomycin Hydrochloride Soluble
Powder
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
lincomycin soluble powder to make
medicated drinking water for
administration to swine for the
treatment of swine dysentery or to
broiler chickens for the control of
necrotic enteritis.
DATES: This rule is effective January 11,
2005.
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary
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 200–377 for LINCOMED
(lincomycin hydrochloride) Soluble
Powder. The application provides for
oral use of lincomycin soluble powder
to make medicated drinking water for
administration to swine for the
treatment of swine dysentery or to
broiler chickens for the control of
necrotic enteritis. Cross Vetpharm
Group Ltd.’s LINCOMED Soluble
Powder is approved as a generic copy of
Pharmacia & Upjohn Co.’s LINCOMIX
Soluble Powder, approved under NADA
111–636. ANADA 200–377 is approved
as of December 6, 2004, and the
regulations are amended in 21 CFR
520.1263c 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
VerDate jul<14>2003
09:25 Jan 10, 2005
Jkt 205001
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(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
congressional review requirements in 5
U.S.C. 801–808.
DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Parts 1 and 3
[Docket No.: 2004–P–034]
RIN 0651–AB76
Changes To Implement the
Cooperative Research and Technology
Enhancement Act of 2004
United States Patent and
Trademark Office, Commerce.
ACTION: Interim rule.
AGENCY:
SUMMARY: The Cooperative Research and
Technology Enhancement Act of 2004
(CREATE Act) amends the patent laws
to provide that subject matter developed
by another person shall be treated as
owned by the same person or subject to
an obligation of assignment to the same
person for purposes of determining
obviousness if three conditions are met:
The claimed invention was made by or
on behalf of parties to a joint research
List of Subjects in 21 CFR Part 520
agreement that was in effect on or before
Animal drugs.
the date the claimed invention was
made; the claimed invention was made
I Therefore, under the Federal Food,
as a result of activities undertaken
Drug, and Cosmetic Act and under
authority delegated to the Commissioner within the scope of the joint research
agreement; and the application for
of Food and Drugs and redelegated to the
patent for the claimed invention
Center for Veterinary Medicine, 21 CFR
discloses or is amended to disclose the
part 520 is amended as follows:
names of the parties to the joint research
agreement. The United States Patent and
PART 520—ORAL DOSAGE FORM
Trademark Office (Office) is revising the
NEW ANIMAL DRUGS
rules of practice in patent cases to
implement the CREATE Act.
I 1. The authority citation for 21 CFR
DATES: Effective Date: December 10,
part 520 continues to read as follows:
2004.
Authority: 21 U.S.C. 360b.
Comment Deadline Date: To be
ensured of consideration, written
I 2. Section 520.1263c is amended by
revising paragraph (b) to read as follows: comments must be received on or before
February 10, 2005. No public hearing
§ 520.1263c Lincomycin hydrochloride
will be held.
soluble powder.
ADDRESSES: Comments should be sent
*
*
*
*
*
by electronic mail message over the
Internet addressed to:
(b) Sponsors. See Nos. 000009,
046573, 054925, 059130, and 061623 in ab76comments@uspto.gov. Comments
§ 510.600(c) of this chapter for use as in may also be submitted by mail
addressed to: Box Comments—Patents,
paragraph (d) of this section.
Commissioner for Patents, P.O. Box
*
*
*
*
*
1450, Alexandria, VA, 22313–1450, or
by facsimile to (571) 273–7735, marked
Dated: December 29, 2004 .
to the attention of Robert A. Clarke.
Stephen F. Sundlof,
Although comments may be submitted
Director, Center for Veterinary Medicine.
by mail or facsimile, the Office prefers
[FR Doc. 05–524 Filed 1–10–05; 8:45 am]
to receive comments via the Internet. If
BILLING CODE 4160–01–S
comments are submitted by mail, the
Office prefers that the comments be
submitted on a DOS formatted 31⁄2 inch
disk accompanied by a paper copy.
Comments may also be sent by
electronic mail message over the
Internet via the Federal eRulemaking
Portal. See the Federal eRulemaking
PO 00000
Frm 00030
Fmt 4700
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]]>Agencies
[Federal Register Volume 70, Number 7 (Tuesday, January 11, 2005)]
[Rules and Regulations]
[Page 1818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-524]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride
Soluble Powder
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 lincomycin soluble powder to make medicated
drinking water for administration to swine for the treatment of swine
dysentery or to broiler chickens for the control of necrotic enteritis.
DATES: This rule is effective January 11, 2005.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary 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 200-377 for LINCOMED
(lincomycin hydrochloride) Soluble Powder. The application provides for
oral use of lincomycin soluble powder to make medicated drinking water
for administration to swine for the treatment of swine dysentery or to
broiler chickens for the control of necrotic enteritis. Cross Vetpharm
Group Ltd.'s LINCOMED Soluble Powder is approved as a generic copy of
Pharmacia & Upjohn Co.'s LINCOMIX Soluble Powder, approved under NADA
111-636. ANADA 200-377 is approved as of December 6, 2004, and the
regulations are amended in 21 CFR 520.1263c 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.
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 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 520.1263c is amended by revising paragraph (b) to read as
follows:
Sec. 520.1263c Lincomycin hydrochloride soluble powder.
* * * * *
(b) Sponsors. See Nos. 000009, 046573, 054925, 059130, and 061623
in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this
section.
* * * * *
Dated: December 29, 2004 .
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-524 Filed 1-10-05; 8:45 am]
BILLING CODE 4160-01-S
