Oral Dosage Form New Animal Drugs; Spectinomycin, 6607 [E8-2065]
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Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Rules and Regulations
Eileen M. Albanese,
Director for Office of Exporter Services.
[FR Doc. 08–480 Filed 2–4–08; 8:45 am]
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
and for 1 day following each
vaccination.
1. The authority citation for 21 CFR
part 520 continues to read as follows:
(2) Limitations. Do not administer to
laying chickens. Do not administer
within 5 days of slaughter.
I 5. Revise § 520.2123c to read as
follows:
I
BILLING CODE 3510–33–P
Authority: 21 U.S.C. 360b.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I
Food and Drug Administration
§ 520.2123
forms.
21 CFR Part 520
I
Oral Dosage Form New Animal Drugs;
Spectinomycin
§ 520.2123a
AGENCY:
2. Revise § 520.2123 to read as
follows:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
rmajette on PROD1PC64 with RULES
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to correct an
error in the indications for use for
spectinomycin oral solution in swine.
FDA is also amending the regulations
for other oral dosage forms of
spectinomycin to reflect a current
format. These actions are being taken to
improve the accuracy and readability of
the animal drug regulations.
DATES: This rule is effective February 5,
2008.
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, email: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has
noticed that the animal drug regulations
do not reflect the approved indications
for use for spectinomycin oral solution
in swine. At this time, FDA is amending
the animal drug regulations in
§ 520.2123c (21 CFR 520.2123c) to
correct this error. FDA is also amending
the regulations in § 520.2123a for
spectinomycin tablets and in
§ 520.2123b for spectinomycin powder
to reflect a current format. These actions
are being taken to improve the accuracy
and readability of the animal drug
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 Part 520
Animal drugs.
I 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 part 520 is amended as follows:
VerDate Aug<31>2005
15:28 Feb 04, 2008
Jkt 214001
6607
Spectinomycin oral dosage
3. Revise § 520.2123a to read as
follows:
Spectinomycin tablets.
(a) Specifications. Each tablet
contains spectinomycin
dihydrochloride pentahydrate
equivalent to 100 milligrams (mg)
spectinomycin.
(b) Sponsor. See No. 061623 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally to provide
10 mg per pound (lb) of body weight
twice daily. Dosage may be continued
for 4 consecutive days.
(2) Indications for use. For the
treatment of infectious diarrhea and
gastroenteritis caused by organisms
susceptible to spectinomycin.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
I 4. Revise § 520.2123b to read as
follows:
§ 520.2123b
Spectinomycin powder.
(a) Specifications. Each gram (g) of
powder contains spectinomycin
dihydrochloride pentahydrate
equivalent to 0.5 g spectinomycin.
(b) Sponsor. See No. 061623 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.600
of this chapter.
(d) Conditions of use in chickens. It is
administered in the drinking water of
growing chickens as follows:
(1) Indications for use and amounts—
(i) For increased rate of weight gain and
improved feed efficiency in broiler
chickens, administer 0.5 g per gallon of
water as the only source of drinking
water for the first 3 days of life and for
1 day following each vaccination.
(ii) As an aid in controlling infectious
synovitis due to Mycoplasma synoviae
in broiler chickens, administer 1 g per
gallon of water as the only source of
drinking water for the first 3 to 5 days
of life.
(iii) As an aid in the prevention or
control of losses due to CRD associated
with M. gallisepticum (PPLO) in
growing chickens, administer 2 g per
gallon of water as the only source of
drinking water for the first 3 days of life
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
§ 520.2123c
Spectinomycin solution.
(a) Specifications. Each milliliter of
solution contains spectinomycin
dihydrochloride pentahydrate
equivalent to 50 milligrams (mg)
spectinomycin.
(b) Sponsors. See Nos. 000856,
059130, and 061623 in § 510.600(c) of
this chapter.
(c) Related tolerances. See § 556.600
of this chapter.
(d) Conditions of use in swine—(1)
Amount. Administer 5 mg per pound
(lb) of body weight orally twice daily for
3 to 5 days.
(2) Indications for use. For the
treatment and control of porcine enteric
colibacillosis (scours) caused by E. coli
susceptible to spectinomycin in pigs
under 4 weeks of age.
(3) Limitations. Do not administer to
pigs over 15 lb body weight or over 4
weeks of age. Do not administer within
21 days of slaughter.
Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–2065 Filed 2–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 110
[Docket No. USCG–2007–0036, formerly
CGD07–122]
RIN 1625–AA01
Anchorage Regulation; Port
Everglades, FL
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard amends the
anchorage regulations for Port
Everglades, Florida. The amendment
modifies the current anchorage area by
eliminating that portion of the
anchorage closest to sensitive coral reef
areas, expands that portion of the
anchorage area that poses less risk to
these areas, and limits the amount of
time a vessel may remain in the
anchorage area. These changes ensure
E:\FR\FM\05FER1.SGM
05FER1
]]>Agencies
[Federal Register Volume 73, Number 24 (Tuesday, February 5, 2008)]
[Rules and Regulations]
[Page 6607]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2065]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Spectinomycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to correct an error in the indications for use for
spectinomycin oral solution in swine. FDA is also amending the
regulations for other oral dosage forms of spectinomycin to reflect a
current format. These actions are being taken to improve the accuracy
and readability of the animal drug regulations.
DATES: This rule is effective February 5, 2008.
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 noticed that the animal drug
regulations do not reflect the approved indications for use for
spectinomycin oral solution in swine. At this time, FDA is amending the
animal drug regulations in Sec. 520.2123c (21 CFR 520.2123c) to
correct this error. FDA is also amending the regulations in Sec.
520.2123a for spectinomycin tablets and in Sec. 520.2123b for
spectinomycin powder to reflect a current format. These actions are
being taken to improve the accuracy and readability of the animal drug
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 Part 520
Animal drugs.
0
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 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. Revise Sec. 520.2123 to read as follows:
Sec. 520.2123 Spectinomycin oral dosage forms.
0
3. Revise Sec. 520.2123a to read as follows:
Sec. 520.2123a Spectinomycin tablets.
(a) Specifications. Each tablet contains spectinomycin
dihydrochloride pentahydrate equivalent to 100 milligrams (mg)
spectinomycin.
(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally to
provide 10 mg per pound (lb) of body weight twice daily. Dosage may be
continued for 4 consecutive days.
(2) Indications for use. For the treatment of infectious diarrhea
and gastroenteritis caused by organisms susceptible to spectinomycin.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
4. Revise Sec. 520.2123b to read as follows:
Sec. 520.2123b Spectinomycin powder.
(a) Specifications. Each gram (g) of powder contains spectinomycin
dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin.
(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.600 of this chapter.
(d) Conditions of use in chickens. It is administered in the
drinking water of growing chickens as follows:
(1) Indications for use and amounts--(i) For increased rate of
weight gain and improved feed efficiency in broiler chickens,
administer 0.5 g per gallon of water as the only source of drinking
water for the first 3 days of life and for 1 day following each
vaccination.
(ii) As an aid in controlling infectious synovitis due to
Mycoplasma synoviae in broiler chickens, administer 1 g per gallon of
water as the only source of drinking water for the first 3 to 5 days of
life.
(iii) As an aid in the prevention or control of losses due to CRD
associated with M. gallisepticum (PPLO) in growing chickens, administer
2 g per gallon of water as the only source of drinking water for the
first 3 days of life and for 1 day following each vaccination.
(2) Limitations. Do not administer to laying chickens. Do not
administer within 5 days of slaughter.
0
5. Revise Sec. 520.2123c to read as follows:
Sec. 520.2123c Spectinomycin solution.
(a) Specifications. Each milliliter of solution contains
spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams
(mg) spectinomycin.
(b) Sponsors. See Nos. 000856, 059130, and 061623 in Sec.
510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.600 of this chapter.
(d) Conditions of use in swine--(1) Amount. Administer 5 mg per
pound (lb) of body weight orally twice daily for 3 to 5 days.
(2) Indications for use. For the treatment and control of porcine
enteric colibacillosis (scours) caused by E. coli susceptible to
spectinomycin in pigs under 4 weeks of age.
(3) Limitations. Do not administer to pigs over 15 lb body weight
or over 4 weeks of age. Do not administer within 21 days of slaughter.
Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-2065 Filed 2-4-08; 8:45 am]
BILLING CODE 4160-01-S
