Oral Dosage Form New Animal Drugs; Phenylpropanolamine, 15961 [2012-6553]
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Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Rules and Regulations
Dated: March 14, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
nor an environmental impact statement
is required.
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.
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.
[FR Doc. 2012–6544 Filed 3–16–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2011–N–0003]
Oral Dosage Form New Animal Drugs;
Phenylpropanolamine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Pegasus
Laboratories, Inc. The NADA provides
for the veterinary prescription use of
phenylpropanolamine hydrochloride
chewable tablets for the control of
urinary incontinence due to urethral
sphincter hypotonus in dogs.
DATES: This rule is effective March 19,
2012.
FOR FURTHER INFORMATION CONTACT: Lisa
M. Troutman, Center for Veterinary
Medicine (HFV–116), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8322,
email: lisa.troutman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pegasus
Laboratories, Inc., 8809 Ely Rd.,
Pensacola, FL 32514, filed NADA 141–
324 that provides for the veterinary
prescription use of PROIN
(phenylpropanolamine hydrochloride)
Chewable Tablets for the control of
urinary incontinence due to urethral
sphincter hypotonus in dogs. The
NADA is approved as of August 4, 2011,
and the regulations are amended in
21 CFR part 520 to reflect the approval.
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 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
emcdonald on DSK29S0YB1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
11:27 Mar 16, 2012
Jkt 226001
List of Subjects in 21 CFR Part 520
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 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 § 520.1760 to read as follows:
§ 520.1760
Phenylpropanolamine.
(a) Specifications. Each chewable
tablet contains 25, 50, or 75 milligram
(mg) phenylpropanolamine
hydrochloride.
(b) Sponsors. See No. 055246 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer 2 mg/kg of body
weight twice daily.
(2) Indications for use. For the control
of urinary incontinence due to urethral
sphincter hypotonus in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: March 14, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–6553 Filed 3–16–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA–2012–N–0222]
Revision of Organization and
Conforming Changes to Regulations
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
ACTION:
15961
Final rule.
The Food and Drug
Administration (FDA) is issuing this
final rule to amend the regulations to
reflect organizational change in the
Agency and to make other conforming
changes. This action is editorial in
nature and is intended to improve the
accuracy of the Agency’s regulations.
DATES: This rule is effective April 1,
2012.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Vanessa Starks, Human Capital
Management, Food and Drug
Administration, 19903 New Hampshire
Ave., Silver Spring, MD 20903, 301–
796–8846.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this final rule to
amend its regulations by updating the
organizational information in part 5
(21 CFR part 5).
The portion of this final rule updating
the organizational information in part 5,
subpart M is a rule of Agency
organization, procedure, or practice.
FDA is issuing these provisions as a
final rule without publishing a general
notice of proposed rulemaking because
such notice is not required for rules of
Agency organization, procedure, or
practice under 5 U.S.C. 553(b)(3)(A). For
the conforming changes to the other
regulations, the Agency finds good
cause under 5 U.S.C. 553(b)(3)(B) to
dispense with prior notice and
comment, and good cause under 5
U.S.C. 553(d)(3) to make these
conforming changes effective less than
30 days after publication because such
notice and comment and delayed
effective date are unnecessary and
contrary to the public interest. These
conforming changes merely update the
footnotes in part 5, subpart M. These
changes do not result in any substantive
change in the regulations.
II. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866,
Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct Agencies to
assess all costs and benefits of available
regulatory alternatives and, when
regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
Agency believes that this final rule is
E:\FR\FM\19MRR1.SGM
19MRR1
]]>Agencies
[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Rules and Regulations]
[Page 15961]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6553]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2011-N-0003]
Oral Dosage Form New Animal Drugs; Phenylpropanolamine
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 original new animal drug
application (NADA) filed by Pegasus Laboratories, Inc. The NADA
provides for the veterinary prescription use of phenylpropanolamine
hydrochloride chewable tablets for the control of urinary incontinence
due to urethral sphincter hypotonus in dogs.
DATES: This rule is effective March 19, 2012.
FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8322, email:
lisa.troutman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pegasus Laboratories, Inc., 8809 Ely Rd.,
Pensacola, FL 32514, filed NADA 141-324 that provides for the
veterinary prescription use of PROIN (phenylpropanolamine
hydrochloride) Chewable Tablets for the control of urinary incontinence
due to urethral sphincter hypotonus in dogs. The NADA is approved as of
August 4, 2011, and the regulations are amended in 21 CFR part 520 to
reflect the approval.
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 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.
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.
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.
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. 520.1760 to read as follows:
Sec. 520.1760 Phenylpropanolamine.
(a) Specifications. Each chewable tablet contains 25, 50, or 75
milligram (mg) phenylpropanolamine hydrochloride.
(b) Sponsors. See No. 055246 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 2 mg/kg of
body weight twice daily.
(2) Indications for use. For the control of urinary incontinence
due to urethral sphincter hypotonus in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: March 14, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-6553 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P
