New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin, Gonadotropin Releasing Factor Analog-Diphtheria Toxoid Conjugate, Methylprednisolone, and Sulfamethazine, 53050-53051 [2011-21721]
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53050
Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 / Rules and Regulations
The FAA has determined this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified this rule, when promulgated,
will not have a significant economic
impact on a substantial number of small
entities under the criteria of the
Regulatory Flexibility Act. The FAA’s
authority to issue rules regarding
aviation safety is found in Title 49 of the
U.S. Code. Subtitle 1, Section 106
discusses the authority of the FAA
Administrator. Subtitle VII, Aviation
Programs, describes in more detail the
scope of the agency’s authority. This
rulemaking is promulgated under the
authority described in subtitle VII, part
A, subpart I, section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it creates
additional controlled airspace at Shelby
Airport, Shelby, MT.
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
List of Subjects in 14 CFR Part 71
[Docket No. FDA–2011–N–0003]
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
*
*
*
*
Issued in Seattle, Washington, on August
15, 2011.
John Warner,
Manager, Operations Support Group, Western
Service Center.
[FR Doc. 2011–21648 Filed 8–24–11; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 522
New Animal Drugs; Ampicillin
Trihydrate, Bacitracin Methylene
Disalicylate, Flunixin, Gonadotropin
Releasing Factor Analog-Diphtheria
Toxoid Conjugate,
Methylprednisolone, and
Sulfamethazine
PART 71—DESIGNATION OF CLASS A,
B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
AGENCY:
1. The authority citation for 14 CFR
part 71 continues to read as follows:
SUMMARY:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
srobinson on DSK4SPTVN1PROD with RULES
*
ANM MT E5 Shelby, MT [Modified]
Shelby Airport, MT
(Lat. 48°32′26″ N., long. 111°52′16″ W.)
That airspace extending upward from 700
feet above the surface within a 6.7-mile
radius of Shelby Airport, and within 2.7
miles each side of the 043° bearing from
Shelby Airport extending from the 6.7-mile
radius to 7.4 miles northeast of the airport;
that airspace extending upward from 1,200
feet above the surface within an area
bounded by lat. 48°50′00″ N., long.
111°45′00″ W.; to lat. 48°49′00″ N., long.
111°22′00″ W.; to lat. 48°38′00″ N., long.
111°17′00″ W.; to lat. 48°21′00″ N., long.
111°36′00″ W.; to lat. 48°18′00″ N., long.
112°01′00″ W.; to lat. 48°28′00″ N., long.
112°12′00″ W.; to lat. 48°38′00″ N., long.
112°11′00″ W.; to lat. 48°38′00″ N., long.
112°03′00″ W., thence to the point of
beginning.
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9U,
Airspace Designations and Reporting
Points, dated August 18, 2010, and
effective September 15, 2010 is
amended as follows:
■
VerDate Mar<15>2010
16:26 Aug 24, 2011
Jkt 223001
Food and Drug Administration,
accuracy and readability of the
regulations.
DATES: This rule is effective August 25,
2011.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
e-mail: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has
found that the animal drug regulations
do not reflect certain human food safety
warnings that have been updated on
labeling of various dosage form new
animal drug products. At this time, the
regulations are being amended to reflect
approved labeling. The regulations are
also being amended to correct the
wording of certain other conditions of
use and to correct minor errors. As the
opportunity has presented itself, some
sections have been revised to a current
format. These actions are being taken to
comply with the FD&C Act and to
improve the accuracy and readability of
the regulations.
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 Parts 520 and
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 parts 520 and 522 are 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:
■
HHS.
Authority: 21 U.S.C. 360b.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
revised human food safety warnings on
dosage form new animal drug product
labeling that have not been codified.
The regulations are also being amended
to correct the wording of certain other
conditions of use, to correct minor
errors, and to revise some sections to
reflect a current format. These actions
are being taken to comply with the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) and to improve the
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
2. In § 520.154a, revise the section
heading and paragraphs (d)(1)(i),
(d)(2)(i), (d)(2)(ii), (d)(2)(ii)(A), and
(d)(4)(i) to read as follows:
■
Final rule; correcting
amendments.
ACTION:
§ 520.154a Bacitracin methylene
disalicylate.
*
*
*
*
*
(d) * * *
(1) * * *
(i) Amount. 400 milligrams (mg) per
gallon (gal) in drinking water.
*
*
*
*
*
(2) * * *
(i) Amount. 100 mg per gal in
drinking water.
*
*
*
*
*
E:\FR\FM\25AUR1.SGM
25AUR1
Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 / Rules and Regulations
(ii) Amount. 200 to 400 mg per gal in
drinking water. Administer
continuously 5 to 7 days or as long as
clinical signs persist, then reduce to
prevention levels (100 mg/gal).
(A) Indications for use. Treatment of
necrotic enteritis caused by C.
perfringens susceptible to bacitracin
methylene disalicylate.
*
*
*
*
*
(4) * * *
(i) Amount. 400 mg per gal in
drinking water.
*
*
*
*
*
■ 3. Revise § 520.970 to read as follows:
§ 520.970
(a) Specifications. (1) Each 10-gram (g)
packet of granules contains flunixin
meglumine equivalent to 250 milligrams
(mg) of flunixin.
(2) Each 30-g syringe of paste contains
flunixin meglumine equivalent to 1,500
mg of flunixin.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. 0.5 mg of flunixin per pound
of body weight per day.
(2) Indications for use. For alleviation
of inflammation and pain associated
with musculoskeletal disorders.
(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.
■
[Removed]
4. Remove § 520.970a.
§ 520.970b
■
[Removed]
5. Remove § 520.970b.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
6. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
7. In § 522.90b, revise paragraph
(d)(2)(iii) to read as follows:
■
§ 522.90b
Ampicillin trihydrate.
srobinson on DSK4SPTVN1PROD with RULES
*
*
*
*
*
(d) * * *
(2) * * *
(iii) Limitations. Do not treat cattle for
more than 7 days. Milk from treated
cows must not be used for food during
treatment and for 48 hours (4 milkings)
after the last treatment. Cattle must not
be slaughtered for food during treatment
and for 144 hours (6 days) after the last
treatment. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
VerDate Mar<15>2010
16:26 Aug 24, 2011
§ 522.1083 Gonadotropin releasing factor
analog-diphtheria toxoid conjugate.
(a) Specifications. Each milliliter of
solution contains 0.2 milligrams (mg)
gonadotropin releasing factor analogdiphtheria toxoid conjugate.
*
*
*
*
*
■ 9. In § 522.1410, revise the section
heading, remove and reserve paragraph
(c), and revise paragraphs (a) and (d) to
read as follows:
§ 522.1410
Flunixin.
§ 520.970a
8. In § 522.1083, revise the section
heading and paragraph (a) to read as
follows:
■
Jkt 223001
Methylprednisolone.
(a) Specifications. Each milliliter of
suspension contains 20 or 40 milligrams
(mg) of methylprednisolone acetate.
(b) * * *
(c) [Reserved]
(d) Conditions of use—(1) Dogs—(i)
Amount. Administer 2 to 40 mg (up to
120 mg in extremely large breeds or
dogs with severe involvement) by
intramuscular injection or up to 20 mg
by intrasynovial injection.
(ii) Indications for use. For treatment
of inflammation and related disorders;
treatment of allergic and dermatologic
disorders; and as supportive therapy to
antibacterial treatment of severe
infections.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. Administer 10
to 20 mg by intramuscular injection.
(ii) Indications for use. For treatment
of inflammation and related disorders;
treatment of allergic and dermatologic
disorders; and as supportive therapy to
antibacterial treatment of severe
infections.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(3) Horses—(i) Amount. Administer
200 mg by intramuscular injection or 40
to 240 mg by intrasynovial injection.
(ii) Indications for use. For treatment
of inflammation and related disorders.
(iii) 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.
■ 10. In § 522.2260, revise paragraphs
(a), (d)(1), and (d)(3) to read as follows:
§ 522.2260
Sulfamethazine.
(a) Specifications. Each milliliter (mL)
of solution contains 250 milligrams (mg)
sulfamethazine sodium.
*
*
*
*
*
(d) * * *
(1) Amount. Initially administer 20
mL for each 50 pounds (lb) of body
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
53051
weight (100 mg/lb) by intravenous
injection, followed by 20 mL per 100 lb
of body weight (50 mg/lb) by
intravenous injection, daily thereafter.
Treatment should not exceed a total of
5 consecutive days.
*
*
*
*
*
(3) Limitations. Withdraw medication
from cattle 10 days prior to slaughter.
Do not use in female dairy cattle 20
months of age or older. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
Dated: August 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–21721 Filed 8–24–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2011–0755]
RIN 1625–AA00
Safety Zone; ISAF Nations Cup Grand
Final Fireworks Display, Sheboygan,
WI
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone on
the waters of Lake Michigan in
Sheboygan, Wisconsin. This zone is
intended to restrict vessels from a
portion of Sheboygan Harbor during a
fireworks display on September 13,
2011. This temporary safety zone is
necessary to protect spectators and
vessels from the hazards associated with
this fireworks display.
DATES: This rule is effective from 7:45
until 8:45 p.m. on September 13, 2011.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2011–
0755 and are available online by going
to https://www.regulations.gov, inserting
USCG–2011–0755 in the Docket ID box,
pressing Enter, and then clicking
‘‘search.’’ They are also available for
inspection or copying at the Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
SUMMARY:
E:\FR\FM\25AUR1.SGM
25AUR1
]]>Agencies
[Federal Register Volume 76, Number 165 (Thursday, August 25, 2011)]
[Rules and Regulations]
[Pages 53050-53051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21721]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 522
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene
Disalicylate, Flunixin, Gonadotropin Releasing Factor Analog-Diphtheria
Toxoid Conjugate, Methylprednisolone, and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect revised human food safety warnings on
dosage form new animal drug product labeling that have not been
codified. The regulations are also being amended to correct the wording
of certain other conditions of use, to correct minor errors, and to
revise some sections to reflect a current format. These actions are
being taken to comply with the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) and to improve the accuracy and readability of the
regulations.
DATES: This rule is effective August 25, 2011.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail:
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has found that the animal drug
regulations do not reflect certain human food safety warnings that have
been updated on labeling of various dosage form new animal drug
products. At this time, the regulations are being amended to reflect
approved labeling. The regulations are also being amended to correct
the wording of certain other conditions of use and to correct minor
errors. As the opportunity has presented itself, some sections have
been revised to a current format. These actions are being taken to
comply with the FD&C Act and to improve the accuracy and readability of
the regulations.
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 Parts 520 and 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 parts 520 and
522 are 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. 520.154a, revise the section heading and paragraphs
(d)(1)(i), (d)(2)(i), (d)(2)(ii), (d)(2)(ii)(A), and (d)(4)(i) to read
as follows:
Sec. 520.154a Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(1) * * *
(i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water.
* * * * *
(2) * * *
(i) Amount. 100 mg per gal in drinking water.
* * * * *
[[Page 53051]]
(ii) Amount. 200 to 400 mg per gal in drinking water. Administer
continuously 5 to 7 days or as long as clinical signs persist, then
reduce to prevention levels (100 mg/gal).
(A) Indications for use. Treatment of necrotic enteritis caused by
C. perfringens susceptible to bacitracin methylene disalicylate.
* * * * *
(4) * * *
(i) Amount. 400 mg per gal in drinking water.
* * * * *
0
3. Revise Sec. 520.970 to read as follows:
Sec. 520.970 Flunixin.
(a) Specifications. (1) Each 10-gram (g) packet of granules
contains flunixin meglumine equivalent to 250 milligrams (mg) of
flunixin.
(2) Each 30-g syringe of paste contains flunixin meglumine
equivalent to 1,500 mg of flunixin.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. 0.5 mg of flunixin per
pound of body weight per day.
(2) Indications for use. For alleviation of inflammation and pain
associated with musculoskeletal disorders.
(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.
Sec. 520.970a [Removed]
0
4. Remove Sec. 520.970a.
Sec. 520.970b [Removed]
0
5. Remove Sec. 520.970b.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 522.90b, revise paragraph (d)(2)(iii) to read as follows:
Sec. 522.90b Ampicillin trihydrate.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Do not treat cattle for more than 7 days. Milk
from treated cows must not be used for food during treatment and for 48
hours (4 milkings) after the last treatment. Cattle must not be
slaughtered for food during treatment and for 144 hours (6 days) after
the last treatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
0
8. In Sec. 522.1083, revise the section heading and paragraph (a) to
read as follows:
Sec. 522.1083 Gonadotropin releasing factor analog-diphtheria toxoid
conjugate.
(a) Specifications. Each milliliter of solution contains 0.2
milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid
conjugate.
* * * * *
0
9. In Sec. 522.1410, revise the section heading, remove and reserve
paragraph (c), and revise paragraphs (a) and (d) to read as follows:
Sec. 522.1410 Methylprednisolone.
(a) Specifications. Each milliliter of suspension contains 20 or 40
milligrams (mg) of methylprednisolone acetate.
(b) * * *
(c) [Reserved]
(d) Conditions of use--(1) Dogs--(i) Amount. Administer 2 to 40 mg
(up to 120 mg in extremely large breeds or dogs with severe
involvement) by intramuscular injection or up to 20 mg by intrasynovial
injection.
(ii) Indications for use. For treatment of inflammation and related
disorders; treatment of allergic and dermatologic disorders; and as
supportive therapy to antibacterial treatment of severe infections.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. Administer 10 to 20 mg by intramuscular
injection.
(ii) Indications for use. For treatment of inflammation and related
disorders; treatment of allergic and dermatologic disorders; and as
supportive therapy to antibacterial treatment of severe infections.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(3) Horses--(i) Amount. Administer 200 mg by intramuscular
injection or 40 to 240 mg by intrasynovial injection.
(ii) Indications for use. For treatment of inflammation and related
disorders.
(iii) 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.
0
10. In Sec. 522.2260, revise paragraphs (a), (d)(1), and (d)(3) to
read as follows:
Sec. 522.2260 Sulfamethazine.
(a) Specifications. Each milliliter (mL) of solution contains 250
milligrams (mg) sulfamethazine sodium.
* * * * *
(d) * * *
(1) Amount. Initially administer 20 mL for each 50 pounds (lb) of
body weight (100 mg/lb) by intravenous injection, followed by 20 mL per
100 lb of body weight (50 mg/lb) by intravenous injection, daily
thereafter. Treatment should not exceed a total of 5 consecutive days.
* * * * *
(3) Limitations. Withdraw medication from cattle 10 days prior to
slaughter. Do not use in female dairy cattle 20 months of age or older.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
Dated: August 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-21721 Filed 8-24-11; 8:45 am]
BILLING CODE 4160-01-P
