Oral Dosage Form New Animal Drugs; Clindamycin Capsules and Tablets, 39203-39204 [E6-10877]
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39203
Rules and Regulations
Federal Register
Vol. 71, No. 133
Wednesday, July 12, 2006
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 TRANSPORTATION
Federal Aviation Administration
14 CFR Part 23
[Docket No. CE252, Special Condition No.
23–192–SC]
Special Conditions; Cessna Aircraft
Company Model 510 Airplane; Full
Authority Digital Engine Control
(FADEC) System
Federal Aviation
Administration (FAA), DOT.
ACTION: Final special conditions; request
for comments; correction.
wwhite on PROD1PC61 with RULES
AGENCY:
SUMMARY: On June 16, 2006, we
published a document on special
conditions for Cessna Aircraft Company
on the Model 510 airplane for full
authority digital engine control system.
There was an error in the background of
the document in reference to the future
type certificate number. This notice
removes that sentence from the
background; no change to the special
conditions portion is necessary.
DATES: Comments must be received on
or before July 17, 2006.
ADDRESSES: Comments on this proposal
may be mailed in duplicate to: Federal
Aviation Administration, Regional
Counsel, ACE–7, Attention: Rules
Docket Clerk, Docket No. CE252, Room
506, 901 Locust, Kansas City, Missouri
64106. All comments must be marked:
Docket No. CE252. Comments may be
inspected in the Rules Docket
weekdays, except Federal holidays,
between 7:30 a.m. and 4 p.m.
FOR FURTHER INFORMATION CONTACT:
Peter L. Rouse, Aerospace Engineer,
Standards Office (ACE–110), Small
Airplane Directorate, Aircraft
Certification Service, Federal Aviation
Administration, Room 301, 901 Locust
Street, Kansas City, Missouri 64106;
telephone (816) 329–4135.
VerDate Aug<31>2005
18:11 Jul 11, 2006
Jkt 208001
SUPPLEMENTARY INFORMATION:
Need for Correction
The FAA published a document on
June 16, 2006 (71 FR 34789), that issued
final special conditions with a request
for comments. In the background, the
sentence ‘‘The Cessna 510 will be
approved under TC No. A24CE’’
appears. However, this will not be the
type certificate number for the airplane,
and this sentence is removed from the
background to correct the error. There
will be no change to the special
conditions.
Correction of Publication
Accordingly, the background of the
special conditions is revised to remove
the sentence, ‘‘The Cessna 510 will be
approved under TC No. A24CE’’ from
the document.
Comments Invited
Interested persons are invited to
participate in the making of these
special conditions by submitting such
written data, views, or arguments as
they may desire. Communications
should identify the regulatory docket or
notice number and be submitted in
duplicate to the address specified above.
All communications received on or
before the closing date for comments
will be considered by the Administrator.
The proposals described in this notice
may be changed in light of the
comments received. All comments
received will be available in the Rules
Docket for examination by interested
persons, both before and after the
closing date for comments. A report
summarizing each substantive public
contact with FAA personnel concerning
this rulemaking will be filed in the
docket. Persons wishing the FAA to
acknowledge receipt of their comments
submitted in response to this notice
must include with those comments a
self-addressed stamped postcard on
which the following statement is made:
‘‘Comments to Docket No. CE252.’’ The
postcard will be date stamped and
returned to the commenter.
Background
The original background of the special
conditions contained the following
sentence: ‘‘The Cessna 510 will be
approved under TC No. A24CE.’’ This
type certificate number is incorrect, and
the sentence is removed from the
background of the special conditions.
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Since this change has no effect on the
special conditions, the remainder of the
document, which includes the special
condition portion, will not be changed.
Issued in Kansas City, Missouri on June 23,
2006.
John Colomy,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E6–10469 Filed 7–11–06; 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;
Clindamycin Capsules and Tablets
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 a supplemental abbreviated
new animal drug application (ANADA)
filed by Virbac AH, Inc. The
supplemental ANADA provides for an
expanded dose range and revised
wording of indications for the oral use
of clindamycin hydrochloride tablets in
dogs for the treatment of certain
bacterial diseases.
DATES: This rule is effective July 12,
2006.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Virbac
AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, filed a supplement to
ANADA 200–316 for CLINITABS
(clindamycin hydrochloride) tablets for
the treatment of certain bacterial
diseases in dogs. The supplemental
ANADA provides for an expanded dose
range and revised wording of
indications. The supplemental ANADA
is approved as of June 2, 2006, and the
regulations are amended in 21 CFR
520.446 to reflect the approval and a
current format.
E:\FR\FM\12JYR1.SGM
12JYR1
39204
Federal Register / Vol. 71, No. 133 / Wednesday, July 12, 2006 / Rules and Regulations
Approval of this supplemental
ANADA did not require review of
additional safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
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 the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 520
Animal drugs.
I 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:
Authority: 21 U.S.C. 360b.
2. In § 520.446, revise paragraphs
(b)(1) and (b)(2); remove paragraph (c);
redesignate paragraph (d) as paragraph
(c); and revise newly redesignated
paragraph (c) to read as follows:
I
Clindamycin capsules and
wwhite on PROD1PC61 with RULES
*
*
*
*
(b) * * *
(1) Nos. 000009 and 059130 for use of
capsules described in paragraph (a)(1) of
this section.
(2) No. 051311 for use of tablets
described in paragraph (a)(2) of this
section.
(c) Conditions of use in dogs—(1)
Amount. Wounds, abscesses, and dental
infections: 2.5 to 15 mg per pound (/lb)
body weight every 12 hours for a
maximum of 28 days. Osteomyelitis: 5.0
to 15 mg/lb body weight every 12 hours
for a minimum of 28 days.
(2) Indications for use. For the
treatment of skin infections (wounds
and abscesses) due to susceptible strains
of coagulase-positive staphylococci
(Staphylococcus aureus or S.
intermedius), deep wounds and
abscesses due to susceptible strains of
Bacteroides fragilis, Prevotella
melaninogenicus, Fusobacterium
necrophorum, and Clostridium
perfringens, dental infections due to
16:27 Jul 11, 2006
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Hyaluronate
Sodium Injection
ACTION:
1. The authority citation for 21 CFR
part 520 continues to read as follows:
VerDate Aug<31>2005
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
I
*
Dated: June 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–10877 Filed 7–11–06; 8:45 am]
AGENCY:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 520.446
tablets.
susceptible strains of S. aureus, B.
fragilis, P. melaninogenicus, F.
necrophorum, and C. perfringens, and
osteomyelitis due to susceptible strains
of S. aureus, B. fragilis, P.
melaninogenicus, F. necrophorum, and
C. perfringens.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA
provides for a revised food safety
warning on labeling for hyaluronate
sodium injectable solution.
DATES: This rule is effective July 12,
2006.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed a supplement to NADA 112–048
for HYLARTIN (sodium hyaluronate)
Injection, approved for veterinary
prescription use by intra-articular
injection for the treatment of joint
dysfunction in horses due to
noninfectious synovitis associated with
equine osteoarthritis. The supplemental
NADA provides for a revised food safety
warning on the labeling. The
application is approved as of May 30,
2006, and the regulations are amended
in 21 CFR 522.1145 to reflect the
approval.
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Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(d)(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.
List of Subjects in 21 CFR Part 522
Animal drugs.
I 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
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 522.1145
[Amended]
2. In § 522.1145, in the heading
remove the word ‘‘injection’’; and in
paragraph (a)(3)(iii) remove the sentence
‘‘Not for use in horses intended for
food.’’ and add in its place ‘‘Do not use
in horses intended for human
consumption’’.
I
Dated: June 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–10879 Filed 7–11–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Melengestrol, Lasalocid, and
Tylosin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\12JYR1.SGM
Final rule.
12JYR1
]]>Agencies
[Federal Register Volume 71, Number 133 (Wednesday, July 12, 2006)]
[Rules and Regulations]
[Pages 39203-39204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10877]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Clindamycin Capsules and
Tablets
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 a supplemental abbreviated new
animal drug application (ANADA) filed by Virbac AH, Inc. The
supplemental ANADA provides for an expanded dose range and revised
wording of indications for the oral use of clindamycin hydrochloride
tablets in dogs for the treatment of certain bacterial diseases.
DATES: This rule is effective July 12, 2006.
FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, filed a supplement to ANADA 200-316 for CLINITABS
(clindamycin hydrochloride) tablets for the treatment of certain
bacterial diseases in dogs. The supplemental ANADA provides for an
expanded dose range and revised wording of indications. The
supplemental ANADA is approved as of June 2, 2006, and the regulations
are amended in 21 CFR 520.446 to reflect the approval and a current
format.
[[Page 39204]]
Approval of this supplemental ANADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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 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. In Sec. 520.446, revise paragraphs (b)(1) and (b)(2); remove
paragraph (c); redesignate paragraph (d) as paragraph (c); and revise
newly redesignated paragraph (c) to read as follows:
Sec. 520.446 Clindamycin capsules and tablets.
* * * * *
(b) * * *
(1) Nos. 000009 and 059130 for use of capsules described in
paragraph (a)(1) of this section.
(2) No. 051311 for use of tablets described in paragraph (a)(2) of
this section.
(c) Conditions of use in dogs--(1) Amount. Wounds, abscesses, and
dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12
hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body
weight every 12 hours for a minimum of 28 days.
(2) Indications for use. For the treatment of skin infections
(wounds and abscesses) due to susceptible strains of coagulase-positive
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds
and abscesses due to susceptible strains of Bacteroides fragilis,
Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium
perfringens, dental infections due to susceptible strains of S. aureus,
B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens,
and osteomyelitis due to susceptible strains of S. aureus, B. fragilis,
P. melaninogenicus, F. necrophorum, and C. perfringens.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: June 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-10877 Filed 7-11-06; 8:45 am]
BILLING CODE 4160-01-S
