Oral Dosage Form New Animal Drugs; Domperidone, 67031 [2010-27524]
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Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Rules and Regulations
statutory duties, and contrary to the
public’s national security interests.
In addition, BIS finds good cause to
waive the requirement of 5 U.S.C.
553(d)(3) to delay the effectiveness of
this regulation, because such a delay is
contrary to the public’s interest. When
the U.S. Government has been notified
of or has identified a material change in
circumstances that warrants revocation
or modification of VEU status for an
end-user or a facility of an end-user,
there is a need to quickly alert the
public that the facility is no longer
authorized as a recipient of items under
Authorization VEU. Delaying this
action’s effectiveness could result in
items that otherwise require licenses
being exported, reexported or
transferred (in-country), license-free, to
an ineligible facility. Accordingly, it
would be contrary to the public interest
to delay this rule’s effectiveness.
No other law requires that a notice of
proposed rulemaking and an
opportunity for public comment be
given for this final rule. Because a
notice of proposed rulemaking and an
opportunity for public comment are not
required to be given for this rule under
the Administrative Procedure Act or by
any other law, the analytical
requirements of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) are
not applicable and no regulatory
flexibility analysis has been prepared.
List of Subjects in 15 CFR Part 748
Administrative practice and
procedure, Exports, Reporting and
recordkeeping requirements.
Accordingly, part 748 of the Export
Administration Regulations (15 CFR
parts 730–774) is amended as follows:
■
PART 748—[AMENDED]
1. The authority citation for part 748
continues to read as follows:
■
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; E.O. 13026, 61 FR 58767,
3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice
of August 12, 2010 (75 FR 50681) (August 16,
2010).
2. Supplement No. 7 to part 748 is
amended by removing ‘‘Cension
Semiconductor Manufacturing
Corporation’’ and its address ‘‘(3/F, 8–1
Kexin Road, Export Processing Zone
(West Area), Chengdu, China 611731)’’
from the list of ‘‘Eligible Destinations’’
for ‘‘Validated End-User’’
‘‘Semiconductor Manufacturing
International Corporation’’ in ‘‘China
(People’s Republic of)’’.
mstockstill on DSKH9S0YB1PROD with RULES
■
VerDate Mar<15>2010
16:30 Oct 29, 2010
Jkt 223001
Dated: October 26, 2010.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2010–27517 Filed 10–29–10; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2010–N–0002]
Oral Dosage Form New Animal Drugs;
Domperidone
AGENCY:
Food and Drug Administration,
approval qualifies for 5 years of
marketing exclusivity beginning on the
date of approval.
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 in 21 CFR Part 520
HHS.
ACTION:
Animal drugs.
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
domperidone oral gel for prevention of
fescue toxicosis in periparturient mares.
DATES: This rule is effective November
1, 2010.
FOR FURTHER INFORMATION CONTACT:
Amy L. Omer, Center for Veterinary
Medicine (HFV–114), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8336,
e-mail: amy.omer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Dechra,
Ltd., Dechra House, Jamage Industrial
Estate, Talke Pits, Stoke-on-Trent,
Staffordshire, ST7 1XW, United
Kingdom, filed NADA 141–314 that
provides for veterinary prescription use
of EQUIDONE (domperidone) Gel for
prevention of fescue toxicosis in
periparturient mares. The NADA is
approved as of September 9, 2010, and
the regulations in 21 CFR part 520 are
amended by adding § 520.766 to reflect
the approval.
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
(21 U.S.C. 360b(c)(2)(F)(i)), this
SUMMARY:
PO 00000
Frm 00003
Fmt 4700
67031
Sfmt 9990
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
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 520.766 to read as follows:
§ 520.766
Domperidone.
(a) Specifications. Each milliliter of
gel contains 110 milligrams (mg)
domperidone.
(b) Sponsor. See No. 043264 in
§ 510.600 of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 0.5 mg per pound
(mg/lb) (1.1 mg/kilogram (kg)) by mouth
once daily starting 10 to 15 days prior
to the expected foaling date. Treatment
may be continued for up to 5 days after
foaling if mares are not producing
adequate milk.
(2) Indications for use. For prevention
of fescue toxicosis in periparturient
mares.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
Dated: October 27, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–27524 Filed 10–29–10; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\01NOR1.SGM
01NOR1
]]>Agencies
[Federal Register Volume 75, Number 210 (Monday, November 1, 2010)]
[Rules and Regulations]
[Page 67031]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27524]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2010-N-0002]
Oral Dosage Form New Animal Drugs; Domperidone
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 domperidone oral gel for prevention of
fescue toxicosis in periparturient mares.
DATES: This rule is effective November 1, 2010.
FOR FURTHER INFORMATION CONTACT: Amy L. Omer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8336, e-mail: amy.omer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Dechra, Ltd., Dechra House, Jamage
Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW,
United Kingdom, filed NADA 141-314 that provides for veterinary
prescription use of EQUIDONE (domperidone) Gel for prevention of fescue
toxicosis in periparturient mares. The NADA is approved as of September
9, 2010, and the regulations in 21 CFR part 520 are amended by adding
Sec. 520.766 to reflect the approval.
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 (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning on the date of approval.
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 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. Add Sec. 520.766 to read as follows:
Sec. 520.766 Domperidone.
(a) Specifications. Each milliliter of gel contains 110 milligrams
(mg) domperidone.
(b) Sponsor. See No. 043264 in Sec. 510.600 of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 0.5 mg per
pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to
15 days prior to the expected foaling date. Treatment may be continued
for up to 5 days after foaling if mares are not producing adequate
milk.
(2) Indications for use. For prevention of fescue toxicosis in
periparturient mares.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Dated: October 27, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-27524 Filed 10-29-10; 8:45 am]
BILLING CODE 4160-01-P
