New Animal Drugs; Amikacin Sulfate, Ampicillin Trihydrate, Ceftiofur Hydrochloride, Cephapirin Benzathine, Chlortetracycline, Fenbendazole, Formalin, Furosemide, Glucose/Glycine/Electrolyte, Pyrantel Pamoate, Sulfadimethoxine, Sulfamethazine, and Tetracycline, 17336-17339 [2011-7313]
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During the selection of these materials,
consideration must also be given to
ensure that the flammability
characteristics of the materials will not
be adversely affected by the use of
cleaning agents and utensils used to
remove cooking stains.
b. Retain the surface materials of the
existing galleys surrounding the
cooktops per the airworthiness approval
of the Boeing 747–2G4B model aircraft
flammability requirements of Part I
(§ 25.853 Amendment 25–59) of
Appendix F of part 25. The use of the
existing flammability approvals of the
galley per the Type Certificate (A20WE)
certification basis for the Boeing 747–
2G4B model is acceptable as this
modification consists of structural
changes strictly to accommodate the
installation of new cooktops.
6. The cooktop must be ventilated
with a system independent of the
airplane cabin and cargo ventilation
system. Procedures and time intervals
must be established to inspect and clean
or replace the ventilation system to
prevent a fire hazard from the
accumulation of flammable oils and be
included in the instructions for
continued airworthiness. The
ventilation system ducting must be
protected by a flame arrestor or an
automatic shutoff valve in the overrange top ventilation system in lieu of
the flame arrestor. [Note: The applicant
may find additional useful information
in Society of Automotive Engineers,
Aerospace Recommended Practice 85,
Rev. E, entitled ‘‘Air Conditioning
Systems for Subsonic Airplanes,’’ dated
August 1, 1991.]
7. Means must be provided to contain
spilled foods or fluids in a manner that
will prevent the creation of a slipping
hazard to occupants and will not lead to
the loss of structural strength due to
corrosion.
8. Cooktop installations must provide
adequate space for the user to
immediately escape a hazardous
cooktop condition.
9. A means to shut off power to the
cooktop must be provided at the galley
containing the cooktop and in the
cockpit. If additional switches are
introduced in the cockpit, revisions to
smoke or fire emergency procedures of
the AFM will be required.
Issued in Renton, Washington, on March
22, 2011.
K.C. Yanamura,
Assistant Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2011–7343 Filed 3–28–11; 8:45 am]
BILLING CODE 4910–13–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
congressional review requirements in 5
U.S.C. 801–808.
Food and Drug Administration
List of Subjects in 21 CFR Parts 520,
522, 526, and 529
21 CFR Parts 520, 522, 526, and 529
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine,
21 CFR parts 520, 522, 526, and 529 are
amended as follows:
[Docket No. FDA–2011–N–0003]
New Animal Drugs; Amikacin Sulfate,
Ampicillin Trihydrate, Ceftiofur
Hydrochloride, Cephapirin Benzathine,
Chlortetracycline, Fenbendazole,
Formalin, Furosemide, Glucose/
Glycine/Electrolyte, Pyrantel Pamoate,
Sulfadimethoxine, Sulfamethazine, and
Tetracycline
AGENCY:
Food and Drug Administration,
HHS.
Final rule; correcting
amendments.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
ACTION:
Authority: 21 U.S.C. 360b.
PO 00000
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2. In § 520.550, revise the section
heading and paragraph (a), the first
sentence in paragraph (c)(1), and
paragraph (c)(3) to read as follows:
■
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
revised human food safety warnings or
updated pathogen nomenclature 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
(FD&C Act) and to improve the accuracy
and readability of the regulations.
DATES: This rule is effective March 29,
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 or the scientific nomenclature
of pathogens 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
SUMMARY:
§ 520.550
Glucose/glycine/electrolyte.
(a) Specifications. The product is
distributed in packets each of which
contains the following ingredients:
Sodium chloride 8.82 grams, potassium
phosphate 4.20 grams, citric acid
anhydrous 0.5 gram, potassium citrate
0.12 gram, aminoacetic acid (glycine)
6.36 grams, and glucose 44.0 grams.
(c) * * *
(1) Glucose/glycine/electrolyte is
indicated for use in the control of
dehydration associated with diarrhea
(scours) in calves.* * *
*
*
*
*
*
(3) The product should not be used in
animals with severe dehydration (down,
comatose, or in a state of shock). Such
animals need intravenous therapy. A
veterinarian should be consulted in
severely scouring calves. The product is
not nutritionally complete if
administered by itself for long periods
of time. It should not be administered
beyond the recommended treatment
period without the addition of milk or
milk replacer.
■ 3. In § 520.905a, revise paragraphs
(e)(2)(i), (e)(2)(iii), (e)(3)(i), and (e)(3)(iii)
to read as follows:
§ 520.905a
Fenbendazole suspension.
*
*
*
*
*
(e) * * *
(2) * * *
(i) Amount. Administer orally 5 mg/
kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to
6 weeks.
*
*
*
*
*
(iii) Limitations. Cattle must not be
slaughtered within 8 days following last
treatment. A withdrawal period has not
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been established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
(3) * * *
(i) Amount. Administer orally 10 mg/
kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to 6
weeks.
*
*
*
*
*
(iii) Limitations. Cattle must not be
slaughtered within 8 days following last
treatment. A withdrawal period has not
been established for this product in
preruminating calves. Do not use in
calves to be processed for veal. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
*
*
*
*
*
■ 4. In § 520.905c, revise paragraph
(e)(2)(iii) to read as follows:
§ 520.905c
Fenbendazole paste.
*
*
*
*
*
(e) * * *
(2) * * *
(iii) Limitations. Cattle must not be
slaughtered within 8 days following last
treatment. A withdrawal period has not
been established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
■ 5. In § 520.1422, revise paragraph (b)
to read as follows:
§ 520.1422
Metoserpate hydrochloride.
*
*
*
*
*
(b) Sponsor. See No. 053501 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 6. In § 520.2043, revise paragraph
(d)(1)(iii) to read as follows:
§ 520.2043
Pyrantel pamoate suspension.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Do not use in horses
intended for human consumption.
When the drug is for administration by
stomach tube, it shall be labeled:
‘‘Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.’’
*
*
*
*
*
■ 7. In § 520.2044, revise paragraph
(d)(2) to read as follows:
§ 520.2044
Pyrantel pamoate paste.
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*
*
*
*
*
(d) * * *
(2) Limitations. Do not use in horses
intended for human consumption.
8. In § 520.2220a, revise paragraph
(d)(3)(ii) to read as follows:
■
§ 520.2220a Sulfadimethoxine oral
solution and soluble powder.
*
*
*
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*
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(d) * * *
(3) * * *
(ii) Indications for use. For the
treatment of shipping fever complex and
bacterial pneumonia associated with
Pasteurella spp. sensitive to
sulfadimethoxine; and calf diphtheria
and foot rot associated with
Fusobacterium necrophorum
(Sphaerophorus necrophorus) sensitive
to sulfadimethoxine.
*
*
*
*
*
■ 9. In § 520.2220b, revise paragraph (d)
to read as follows:
§ 520.2220b
boluses.
Sulfadimethoxine tablets and
*
*
*
*
*
(d) Conditions of use—(1) Cattle—(i)
Amount. Administer 2.5 grams per 100
pounds body weight for 1 day followed
by 1.25 grams per 100 pounds body
weight per day; treat for 4 to 5 days.
(ii) Indications for use. For the
treatment of shipping fever complex and
bacterial pneumonia associated with
Pasteurella spp. sensitive to
sulfadimethoxine; and calf diphtheria
and foot rot associated with
Fusobacterium necrophorum sensitive
to sulfadimethoxine.
(iii) Limitations. Do not administer
within 7 days of slaughter; milk that has
been taken from animals during
treatment and 60 hours (5 milkings)
after the latest treatment must not be
used for food. A withdrawal period has
not been established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
(2) Dogs and cats—(i) Amount.
Administer 25 milligrams per pound of
body weight on the first day followed by
12.5 milligrams per pound of body
weight per day until the animal is free
of symptoms for 48 hours.
(ii) Indications for use. Treatment of
sulfadimethoxine-susceptible bacterial
infections.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(3) Beef cattle and nonlactating dairy
cattle—(i) Amount. Administer one
12.5-gram-sustained-release bolus for
the nearest 200 pounds of body weight,
i.e., 62.5 milligrams per pound of body
weight. Do not repeat treatment for 7
days.
(ii) Indications for use. Treatment of
shipping fever complex and bacterial
pneumonia associated with organisms
such as Pasteurella spp. sensitive to
sulfadimethoxine; calf diphtheria and
foot rot associated with Fusobacterium
necrophorum sensitive to
sulfadimethoxine.
(iii) Limitations. Do not use in female
dairy cattle 20 months of age or older.
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17337
Do not administer within 12 days of
slaughter. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
■ 10. In § 520.2260a, revise paragraph
(a)(3)(iii) to read as follows:
§ 520.2260a
and bolus.
Sulfamethazine oblet, tablet,
(a) * * *
(3) * * *
(iii) Limitations. Administer daily
until animal’s temperature and
appearance are normal. If symptoms
persist after using for 2 or 3 days consult
a veterinarian. Fluid intake must be
adequate. Treatment should continue
24 to 48 hours beyond the remission of
disease symptoms, but not to exceed
5 consecutive days. Follow dosages
carefully. Do not treat cattle within
10 days of slaughter. Do not use in
female dairy cattle 20 months of age or
older. Use of sulfamethazine in this
class of cattle may cause milk residues.
A withdrawal period has not been
established in preruminating calves. Do
not use in calves to be processed for
veal. Do not use in horses intended for
human consumption.
*
*
*
*
*
■ 11. In § 520.2261a, revise the section
heading; the first sentence in paragraph
(c)(2)(iii); and paragraph (c)(3) to read as
follows:
§ 520.2261a
Sulfamethazine solution.
*
*
*
*
*
(c) * * *
(2) * * *
(iii) Chickens and turkeys. In chickens
for control of infectious coryza
(Avibacterium paragallinarum),
coccidiosis (Eimeria tenella, Eimeria
necatrix), acute fowl cholera
(Pasteurella multocida), and pullorum
disease (Salmonella pullorum). * * *
(3) Limitations. Add the required dose
to that amount of water that will be
consumed in 1 day. Consumption
should be carefully checked. Have only
medicated water available during
treatment. Withdraw medication from
cattle, chickens, and turkeys 10 days
prior to slaughter for food. Withdraw
medication from swine 15 days before
slaughter for food. Do not medicate
chickens or turkeys producing eggs for
human consumption. Treatment of all
diseases should be instituted early.
Treatment should continue 24 to 48
hours beyond the remission of disease
symptoms, but not to exceed a total of
5 consecutive days in cattle or swine.
Medicated cattle, swine, chickens, and
turkeys must actually consume enough
medicated water which provides the
recommended dosages. Do not use in
female dairy cattle 20 months of age or
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Federal Register / Vol. 76, No. 60 / Tuesday, March 29, 2011 / Rules and Regulations
older. Use of sulfamethazine in this
class of cattle may cause milk residues.
A withdrawal period has not been
established in preruminating calves. Do
not use in calves to be processed for
veal.
*
*
*
*
*
■ 12. In § 520.2261b, revise paragraph
(d)(1)(ii) and paragraph (d)(4)(iii) to read
as follows:
§ 520.2261b
Sulfamethazine powder.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) Indications for use. For control of
infectious coryza (Avibacterium
paragallinarum), coccidiosis (Eimeria
tenella, E. necatrix), acute fowl cholera
(Pasteurella multocida), and pullorum
disease (Salmonella pullorum).
*
*
*
*
*
(4) * * *
(iii) Limitations. Add the required
dose to that amount of water that will
be consumed in 1 day. Consumption
should be carefully checked. Have only
medicated water available during
treatment. Withdraw medication from
cattle 10 days prior to slaughter for food.
Treatment of all diseases should be
instituted early. Treatment should
continue 24 to 48 hours beyond the
remission of disease symptoms, but not
to exceed a total of 5 consecutive days.
Medicated cattle must actually consume
enough medicated water which
provides the recommended dosages. Do
not use in female dairy cattle 20 months
of age or older. Use of sulfamethazine in
this class of cattle may cause milk
residues. A withdrawal period has not
been established in preruminating
calves. Do not use in calves to be
processed for veal.
■ 13. In § 520.2345d, revise paragraph
(b)(2), the first sentence in paragraph
(d)(1)(iii), and paragraph (d)(2)(iii) to
read as follows:
§ 520.2345d
Tetracycline powder.
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*
*
*
*
*
(b) * * *
(2) No. 000010: 25, 102.4, and 324
grams per pound as in paragraph (d) of
this section.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Administer for 3 to 5
days; do not slaughter animals for food
within 4 days of treatment for No.
000010 and within 5 days of treatment
for Nos. 046573, 054925, 057561,
059130, and 061623; prepare a fresh
solution daily; use as the sole source of
tetracycline. * * *
(2) * * *
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(iii) Limitations. Administer for 3 to 5
days; do not slaughter animals for food
within 7 days of treatment for No.
000010 and within 4 days of treatment
for Nos. 046573, 054925, 057561,
059130, and 061623; prepare a fresh
solution daily; use as the sole source of
tetracycline.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
14. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
15. Revise § 522.56 to read as follows:
§ 522.56
Amikacin.
(a) Specifications. Each milliliter of
solution contains 50 milligrams (mg) of
amikacin as amikacin sulfate.
(b) Sponsors. See Nos. 000856 and
059130 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. 5 mg/pound (lb) of body
weight twice daily by intramuscular or
subcutaneous injection.
(2) Indications for use. For treatment
of genitourinary tract infections
(cystitis) caused by susceptible strains
of Escherichia coli and Proteus spp. and
skin and soft tissue infections caused by
susceptible strains of Pseudomonas spp.
and E. coli.
(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.
■ 16. In § 522.90b, revise the section
heading and paragraphs (a), (b), and (d)
to read as follows:
§ 522.90b
Ampicillin trihydrate.
(a) Specifications. Each milliliter of
aqueous suspension constituted from
ampicillin trihydrate powder contains
50, 100, or 250 milligrams (mg)
ampicillin equivalents.
(b) Sponsors. See Nos. 000010 and
010515 in § 510.600(c) of this chapter.
*
*
*
*
*
(d) Conditions of use—(1) Dogs and
cats—(i) Amount. 3 mg/pound (lb) of
body weight twice daily by
subcutaneous or intramuscular
injection.
(ii) Indications for use. For treatment
of strains of organisms susceptible to
ampicillin and associated with
respiratory tract infections, urinary tract
infections, gastrointestinal infections,
skin infections, soft tissue infections,
and postsurgical infections.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
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(2) Cattle—(i) Amount. 2 to 5 mg/lb of
body weight once daily by
intramuscular injection.
(ii) Indications for use. For treatment
of respiratory tract infections caused by
organisms susceptible to ampicillin,
bacterial pneumonia (shipping fever,
calf pneumonia, and bovine pneumonia)
caused by Aerobacter spp., Klebsiella
spp., Staphylococcus spp.,
Streptococcus spp., Pasteurella
multocida, and Escherichia coli.
(iii) Limitations. Do not treat cattle for
more than 7 days. Milk from treated
cows must not be used for food during
treatment or for 48 hours (4 milkings)
after the last treatment. Cattle must not
be slaughtered for food during treatment
or 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.
■ 17. In § 522.313b, revise paragraph (a)
to read as follows:
§ 522.313b
Ceftiofur hydrochloride.
(a) Specifications. Each milliliter of
ceftiofur hydrochloride suspension
contains 50 milligrams (mg) ceftiofur
equivalents.
*
*
*
*
*
■ 18. In § 522.1010, redesignate
paragraph (d)(3)(iii) as paragraph
(d)(2)(iii); and add new paragraph
(d)(3)(iii) to read as follows:
§ 522.1010
Furosemide.
*
*
*
*
*
(d) * * *
(3) * * *
(iii) Limitations. Treatment not to
exceed 48 hours post-parturition. Milk
taken during treatment and for 48 hours
(four milkings) after the last treatment
must not be used for food. Cattle must
not be slaughtered for food within 48
hours following last treatment.
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
19. The authority citation for 21 CFR
part 526 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
20. In § 526.363, revise paragraph
(d)(1) and the first sentence in
paragraph (d)(3) to read as follows:
■
§ 526.363
Cephapirin benzathine.
*
*
*
*
*
(d) * * *
(1) Amount. Infuse the contents of one
syringe into each quarter.
*
*
*
*
*
(3) Limitations. Infuse each quarter
following last milking, but no later than
30 days before calving. * * *
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Federal Register / Vol. 76, No. 60 / Tuesday, March 29, 2011 / Rules and Regulations
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
DEPARTMENT OF HOMELAND
SECURITY
21. The authority citation for 21 CFR
part 529 continues to read as follows:
Coast Guard
■
33 CFR Part 100
Authority: 21 U.S.C. 360b.
§ 529.50 [Redesignated as § 529.56 and
Amended]
[Docket No. USCG–2009–0996]
22. Redesignate § 529.50 as § 529.56
and revise it to read as follows:
RIN 1625–AA08
■
§ 529.56
Amikacin.
(a) Specifications. Each milliliter (mL)
of solution contains 250 milligrams of
amikacin as amikacin sulfate.
(b) Sponsors. See Nos. 000856 and
059130 in § 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 2 grams (8 mL)
diluted with 200 mL of sterile
physiological saline by intrauterine
infusion daily for 3 consecutive days.
(2) Indications for use. For treating
genital tract infections (endometritis,
metritis, and pyometra) in mares caused
by susceptible organisms including
Escherichia coli, Pseudomonas spp.,
and Klebsiella spp.
(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.
23. In § 529.1030, revise paragraphs
(d)(1)(i) and (d)(1)(iv) to read as follows:
■
§ 529.1030
Formalin.
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*
*
*
*
*
(d) * * *
(1) * * *
(i) Select finfish. For control of
external protozoa Ichthyophthirius spp.,
Chilodonella spp., Ichthyobodo spp.,
Ambiphrya spp., Epistylis spp., and
Trichodina spp., and monogenetic
trematodes Cleidodiscus spp.,
Gyrodactylus spp., and Dactylogyrus
spp., on salmon, trout, catfish,
largemouth bass, and bluegill.
*
*
*
*
*
(iv) All finfish. For control of external
protozoa Ichthyophthirius spp.,
Chilodonella spp., Ichthyobodo spp.,
Ambiphrya spp., Epistylis spp., and
Trichodina spp., and monogenetic
trematodes Cleidodiscus spp.,
Gyrodactylus spp., and Dactylogyrus
spp.
*
*
*
*
*
Dated: March 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7313 Filed 3–28–11; 8:45 am]
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Special Local Regulation; Hydroplane
Races Within the Captain of the Port
Puget Sound Area of Responsibility
Coast Guard, DHS.
ACTION: Final rule.
AGENCY:
The Coast Guard is
establishing a special local regulation to
restrict vessel movement in designated
permanent hydroplane race areas in
Dyes Inlet, Lake Washington and Lake
Sammamish, WA during permitted
hydroplane race events. When this
special local regulation is activated, and
thus subject to enforcement, this rule
will limit the movement of nonparticipating vessels within the
regulated race areas immediately prior
to, during and immediately following
the conclusion of permitted hydroplane
marine events. This rule is needed to
provide effective control over these
events while ensuring the safety of the
maritime public.
DATES: This rule is effective March 29,
2011.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2009–0996 and are
available online by going to https://
www.regulations.gov, inserting USCG–
2009–0996 in the ‘‘Keyword’’ box, and
then clicking ‘‘Search.’’ This material is
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 rule, call or
e-mail LTJG Ashley M. Wanzer,
Waterways Management, Sector Puget
Sound, Coast Guard; telephone 206–
217–6175, e-mail
SectorPugetSoundWWM@uscg.mil. If
you have questions on viewing the
docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone
202–366–9826.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
17339
Regulatory Information
On Tuesday, January 19, 2010, we
published a notice of proposed
rulemaking (NPRM) entitled Safety
Zone Regulation; Hydroplane Races
within the Captain of the Port Puget
Sound Area of Responsibility in the
Federal Register (75 FR 2833). On
Wednesday, January 19, 2011, we
published a supplemental notice of
proposed rulemaking (SNPRM), revising
the rulemaking to create a special local
regulation designating three permanent
hydroplane race areas under 33 CFR
part 100 in the Federal Register (76 FR
3057). We did not receive any
comments on the NPRM or SNPRM and
did not receive any requests for a public
meeting. A public meeting was not held.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Immediate action is necessary
to protect life, property and the
environment; therefore, a 30-day notice
is impracticable. Delaying the effective
date would be contrary to the intended
objective of promoting safety during
these permitted events because the
ULHRA Spring Training takes place on
21 April 2011 in the Lake Washington
designated race area and this is less than
30 days after publication in the Federal
Register.
Basis and Purpose
The U.S. Coast Guard is establishing
special local regulations to establish
three permanent designated hydroplane
race areas in Dyes Inlet, Lake
Washington, and Lake Sammamish, WA
within the Captain of the Port, Puget
Sound Area of Responsibility. This
action is necessary in order to restrict
vessel movement in the vicinity of the
race courses thereby promoting safety
on navigable waters during these events.
Background
The Coast Guard receives numerous
marine event permits for hydroplane
races taking place on the waterways of
Dyes Inlet, Lake Washington, and Lake
Sammamish, WA. This rule establishes
a special local regulation to restrict
vessel movement in designated
hydroplane race areas during permitted
hydroplane marine events. This rule
enables event sponsors and the Coast
Guard to adequately provide safety in
support of these marine events.
Initial Enforcement
The Coast Guard will enforce the
special local regulation for Lake
Washington in 33 CFR 100.1308 from
10 a.m. until 4 p.m. on April 21, 2011.
E:\FR\FM\29MRR1.SGM
29MRR1
]]>Agencies
[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Rules and Regulations]
[Pages 17336-17339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 526, and 529
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Amikacin Sulfate, Ampicillin Trihydrate,
Ceftiofur Hydrochloride, Cephapirin Benzathine, Chlortetracycline,
Fenbendazole, Formalin, Furosemide, Glucose/Glycine/Electrolyte,
Pyrantel Pamoate, Sulfadimethoxine, Sulfamethazine, and Tetracycline
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 or
updated pathogen nomenclature 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 (FD&C Act) and to improve the accuracy and
readability of the regulations.
DATES: This rule is effective March 29, 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 or the
scientific nomenclature of pathogens 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, 522, 526, and 529
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
522, 526, and 529 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. 520.550, revise the section heading and paragraph (a), the
first sentence in paragraph (c)(1), and paragraph (c)(3) to read as
follows:
Sec. 520.550 Glucose/glycine/electrolyte.
(a) Specifications. The product is distributed in packets each of
which contains the following ingredients: Sodium chloride 8.82 grams,
potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram,
potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and
glucose 44.0 grams.
(c) * * *
(1) Glucose/glycine/electrolyte is indicated for use in the control
of dehydration associated with diarrhea (scours) in calves.* * *
* * * * *
(3) The product should not be used in animals with severe
dehydration (down, comatose, or in a state of shock). Such animals need
intravenous therapy. A veterinarian should be consulted in severely
scouring calves. The product is not nutritionally complete if
administered by itself for long periods of time. It should not be
administered beyond the recommended treatment period without the
addition of milk or milk replacer.
0
3. In Sec. 520.905a, revise paragraphs (e)(2)(i), (e)(2)(iii),
(e)(3)(i), and (e)(3)(iii) to read as follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(e) * * *
(2) * * *
(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to 6 weeks.
* * * * *
(iii) Limitations. Cattle must not be slaughtered within 8 days
following last treatment. A withdrawal period has not
[[Page 17337]]
been established for this product in preruminating calves. Do not use
in calves to be processed for veal.
(3) * * *
(i) Amount. Administer orally 10 mg/kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to 6 weeks.
* * * * *
(iii) Limitations. Cattle must not be slaughtered within 8 days
following last treatment. A withdrawal period has not been established
for this product in preruminating calves. Do not use in calves to be
processed for veal. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *
0
4. In Sec. 520.905c, revise paragraph (e)(2)(iii) to read as follows:
Sec. 520.905c Fenbendazole paste.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations. Cattle must not be slaughtered within 8 days
following last treatment. A withdrawal period has not been established
for this product in preruminating calves. Do not use in calves to be
processed for veal.
0
5. In Sec. 520.1422, revise paragraph (b) to read as follows:
Sec. 520.1422 Metoserpate hydrochloride.
* * * * *
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
* * * * *
0
6. In Sec. 520.2043, revise paragraph (d)(1)(iii) to read as follows:
Sec. 520.2043 Pyrantel pamoate suspension.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Do not use in horses intended for human
consumption. When the drug is for administration by stomach tube, it
shall be labeled: ``Federal law restricts this drug to use by or on the
order of a licensed veterinarian.''
* * * * *
0
7. In Sec. 520.2044, revise paragraph (d)(2) to read as follows:
Sec. 520.2044 Pyrantel pamoate paste.
* * * * *
(d) * * *
(2) Limitations. Do not use in horses intended for human
consumption.
0
8. In Sec. 520.2220a, revise paragraph (d)(3)(ii) to read as follows:
Sec. 520.2220a Sulfadimethoxine oral solution and soluble powder.
* * * * *
(d) * * *
(3) * * *
(ii) Indications for use. For the treatment of shipping fever
complex and bacterial pneumonia associated with Pasteurella spp.
sensitive to sulfadimethoxine; and calf diphtheria and foot rot
associated with Fusobacterium necrophorum (Sphaerophorus necrophorus)
sensitive to sulfadimethoxine.
* * * * *
0
9. In Sec. 520.2220b, revise paragraph (d) to read as follows:
Sec. 520.2220b Sulfadimethoxine tablets and boluses.
* * * * *
(d) Conditions of use--(1) Cattle--(i) Amount. Administer 2.5 grams
per 100 pounds body weight for 1 day followed by 1.25 grams per 100
pounds body weight per day; treat for 4 to 5 days.
(ii) Indications for use. For the treatment of shipping fever
complex and bacterial pneumonia associated with Pasteurella spp.
sensitive to sulfadimethoxine; and calf diphtheria and foot rot
associated with Fusobacterium necrophorum sensitive to
sulfadimethoxine.
(iii) Limitations. Do not administer within 7 days of slaughter;
milk that has been taken from animals during treatment and 60 hours (5
milkings) after the latest treatment must not be used for food. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
(2) Dogs and cats--(i) Amount. Administer 25 milligrams per pound
of body weight on the first day followed by 12.5 milligrams per pound
of body weight per day until the animal is free of symptoms for 48
hours.
(ii) Indications for use. Treatment of sulfadimethoxine-susceptible
bacterial infections.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(3) Beef cattle and nonlactating dairy cattle--(i) Amount.
Administer one 12.5-gram-sustained-release bolus for the nearest 200
pounds of body weight, i.e., 62.5 milligrams per pound of body weight.
Do not repeat treatment for 7 days.
(ii) Indications for use. Treatment of shipping fever complex and
bacterial pneumonia associated with organisms such as Pasteurella spp.
sensitive to sulfadimethoxine; calf diphtheria and foot rot associated
with Fusobacterium necrophorum sensitive to sulfadimethoxine.
(iii) Limitations. Do not use in female dairy cattle 20 months of
age or older. Do not administer within 12 days of slaughter. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
0
10. In Sec. 520.2260a, revise paragraph (a)(3)(iii) to read as
follows:
Sec. 520.2260a Sulfamethazine oblet, tablet, and bolus.
(a) * * *
(3) * * *
(iii) Limitations. Administer daily until animal's temperature and
appearance are normal. If symptoms persist after using for 2 or 3 days
consult a veterinarian. Fluid intake must be adequate. Treatment should
continue 24 to 48 hours beyond the remission of disease symptoms, but
not to exceed 5 consecutive days. Follow dosages carefully. Do not
treat cattle within 10 days of slaughter. Do not use in female dairy
cattle 20 months of age or older. Use of sulfamethazine in this class
of cattle may cause milk residues. A withdrawal period has not been
established in preruminating calves. Do not use in calves to be
processed for veal. Do not use in horses intended for human
consumption.
* * * * *
0
11. In Sec. 520.2261a, revise the section heading; the first sentence
in paragraph (c)(2)(iii); and paragraph (c)(3) to read as follows:
Sec. 520.2261a Sulfamethazine solution.
* * * * *
(c) * * *
(2) * * *
(iii) Chickens and turkeys. In chickens for control of infectious
coryza (Avibacterium paragallinarum), coccidiosis (Eimeria tenella,
Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and
pullorum disease (Salmonella pullorum). * * *
(3) Limitations. Add the required dose to that amount of water that
will be consumed in 1 day. Consumption should be carefully checked.
Have only medicated water available during treatment. Withdraw
medication from cattle, chickens, and turkeys 10 days prior to
slaughter for food. Withdraw medication from swine 15 days before
slaughter for food. Do not medicate chickens or turkeys producing eggs
for human consumption. Treatment of all diseases should be instituted
early. Treatment should continue 24 to 48 hours beyond the remission of
disease symptoms, but not to exceed a total of 5 consecutive days in
cattle or swine. Medicated cattle, swine, chickens, and turkeys must
actually consume enough medicated water which provides the recommended
dosages. Do not use in female dairy cattle 20 months of age or
[[Page 17338]]
older. Use of sulfamethazine in this class of cattle may cause milk
residues. A withdrawal period has not been established in preruminating
calves. Do not use in calves to be processed for veal.
* * * * *
0
12. In Sec. 520.2261b, revise paragraph (d)(1)(ii) and paragraph
(d)(4)(iii) to read as follows:
Sec. 520.2261b Sulfamethazine powder.
* * * * *
(d) * * *
(1) * * *
(ii) Indications for use. For control of infectious coryza
(Avibacterium paragallinarum), coccidiosis (Eimeria tenella, E.
necatrix), acute fowl cholera (Pasteurella multocida), and pullorum
disease (Salmonella pullorum).
* * * * *
(4) * * *
(iii) Limitations. Add the required dose to that amount of water
that will be consumed in 1 day. Consumption should be carefully
checked. Have only medicated water available during treatment. Withdraw
medication from cattle 10 days prior to slaughter for food. Treatment
of all diseases should be instituted early. Treatment should continue
24 to 48 hours beyond the remission of disease symptoms, but not to
exceed a total of 5 consecutive days. Medicated cattle must actually
consume enough medicated water which provides the recommended dosages.
Do not use in female dairy cattle 20 months of age or older. Use of
sulfamethazine in this class of cattle may cause milk residues. A
withdrawal period has not been established in preruminating calves. Do
not use in calves to be processed for veal.
0
13. In Sec. 520.2345d, revise paragraph (b)(2), the first sentence in
paragraph (d)(1)(iii), and paragraph (d)(2)(iii) to read as follows:
Sec. 520.2345d Tetracycline powder.
* * * * *
(b) * * *
(2) No. 000010: 25, 102.4, and 324 grams per pound as in paragraph
(d) of this section.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 4 days of treatment for No. 000010 and within 5
days of treatment for Nos. 046573, 054925, 057561, 059130, and 061623;
prepare a fresh solution daily; use as the sole source of tetracycline.
* * *
(2) * * *
(iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 7 days of treatment for No. 000010 and within 4
days of treatment for Nos. 046573, 054925, 057561, 059130, and 061623;
prepare a fresh solution daily; use as the sole source of tetracycline.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
14. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
15. Revise Sec. 522.56 to read as follows:
Sec. 522.56 Amikacin.
(a) Specifications. Each milliliter of solution contains 50
milligrams (mg) of amikacin as amikacin sulfate.
(b) Sponsors. See Nos. 000856 and 059130 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in dogs--(1) Amount. 5 mg/pound (lb) of body
weight twice daily by intramuscular or subcutaneous injection.
(2) Indications for use. For treatment of genitourinary tract
infections (cystitis) caused by susceptible strains of Escherichia coli
and Proteus spp. and skin and soft tissue infections caused by
susceptible strains of Pseudomonas spp. and E. coli.
(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.
0
16. In Sec. 522.90b, revise the section heading and paragraphs (a),
(b), and (d) to read as follows:
Sec. 522.90b Ampicillin trihydrate.
(a) Specifications. Each milliliter of aqueous suspension
constituted from ampicillin trihydrate powder contains 50, 100, or 250
milligrams (mg) ampicillin equivalents.
(b) Sponsors. See Nos. 000010 and 010515 in Sec. 510.600(c) of
this chapter.
* * * * *
(d) Conditions of use--(1) Dogs and cats--(i) Amount. 3 mg/pound
(lb) of body weight twice daily by subcutaneous or intramuscular
injection.
(ii) Indications for use. For treatment of strains of organisms
susceptible to ampicillin and associated with respiratory tract
infections, urinary tract infections, gastrointestinal infections, skin
infections, soft tissue infections, and postsurgical infections.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cattle--(i) Amount. 2 to 5 mg/lb of body weight once daily by
intramuscular injection.
(ii) Indications for use. For treatment of respiratory tract
infections caused by organisms susceptible to ampicillin, bacterial
pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused
by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus
spp., Pasteurella multocida, and Escherichia coli.
(iii) Limitations. Do not treat cattle for more than 7 days. Milk
from treated cows must not be used for food during treatment or for 48
hours (4 milkings) after the last treatment. Cattle must not be
slaughtered for food during treatment or 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
17. In Sec. 522.313b, revise paragraph (a) to read as follows:
Sec. 522.313b Ceftiofur hydrochloride.
(a) Specifications. Each milliliter of ceftiofur hydrochloride
suspension contains 50 milligrams (mg) ceftiofur equivalents.
* * * * *
0
18. In Sec. 522.1010, redesignate paragraph (d)(3)(iii) as paragraph
(d)(2)(iii); and add new paragraph (d)(3)(iii) to read as follows:
Sec. 522.1010 Furosemide.
* * * * *
(d) * * *
(3) * * *
(iii) Limitations. Treatment not to exceed 48 hours post-
parturition. Milk taken during treatment and for 48 hours (four
milkings) after the last treatment must not be used for food. Cattle
must not be slaughtered for food within 48 hours following last
treatment.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
20. In Sec. 526.363, revise paragraph (d)(1) and the first sentence in
paragraph (d)(3) to read as follows:
Sec. 526.363 Cephapirin benzathine.
* * * * *
(d) * * *
(1) Amount. Infuse the contents of one syringe into each quarter.
* * * * *
(3) Limitations. Infuse each quarter following last milking, but no
later than 30 days before calving. * * *
[[Page 17339]]
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
21. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.50 [Redesignated as Sec. 529.56 and Amended]
0
22. Redesignate Sec. 529.50 as Sec. 529.56 and revise it to read as
follows:
Sec. 529.56 Amikacin.
(a) Specifications. Each milliliter (mL) of solution contains 250
milligrams of amikacin as amikacin sulfate.
(b) Sponsors. See Nos. 000856 and 059130 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 2 grams (8
mL) diluted with 200 mL of sterile physiological saline by intrauterine
infusion daily for 3 consecutive days.
(2) Indications for use. For treating genital tract infections
(endometritis, metritis, and pyometra) in mares caused by susceptible
organisms including Escherichia coli, Pseudomonas spp., and Klebsiella
spp.
(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.
0
23. In Sec. 529.1030, revise paragraphs (d)(1)(i) and (d)(1)(iv) to
read as follows:
Sec. 529.1030 Formalin.
* * * * *
(d) * * *
(1) * * *
(i) Select finfish. For control of external protozoa
Ichthyophthirius spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya
spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes
Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp., on salmon,
trout, catfish, largemouth bass, and bluegill.
* * * * *
(iv) All finfish. For control of external protozoa Ichthyophthirius
spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis
spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus
spp., Gyrodactylus spp., and Dactylogyrus spp.
* * * * *
Dated: March 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7313 Filed 3-28-11; 8:45 am]
BILLING CODE 4160-01-P
