[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Rules and Regulations]
[Pages 16933-16935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6518]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 558
New Animal Drugs; Limitations of Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the limitations to conditions of use for
products approved under 22 new animal drug applications (NADAs) and 5
abbreviated new animal drug applications (ANADAs). In error, a label
statement warning against the use of these products in calves to be
processed for veal was not codified at the time supplemental NADAs or
ANADAs were approved. FDA is also amending the animal drug regulations
to reflect the approved preslaughter withdrawal periods and milk
withholding period in cattle following use of penicillin G procaine
aqueous suspension. This action is being taken to improve the accuracy
of the animal drug regulations.
DATES: This rule is effective April 4, 2005.
FOR FURTHER INFORMATION CONTACT: Jeffrey Punderson, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-4109, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Over the past decade, FDA's Center for
Veterinary Medicine (CVM) asked sponsors of certain products approved
for use in cattle to place this warning on their labels: ``A withdrawal
period has not been established for this product in preruminating
calves. Do not use in calves to be processed for veal.'' This was done
to reduce the frequency of unsafe residues of animal drugs in veal.
While many sponsors complied and filed applications to change their
labels, CVM did not always codify this limitation to approved
conditions of use when the supplemental application was approved. At
this time, FDA is amending the animal drug regulations to reflect the
limitations to conditions of use for the following products:
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Application No. 21 CFR Section Trade Name
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NADA 011-060 520.1660c TERRAMYCIN Scour Tablets
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NADA 012-350 558.55 AMPROVINE 25%; AMPROL 25%
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NADA 012-350 520.100c CORID 1.25% Crumbles
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NADA 012-965 522.2640a TYLAN Injection 50 mg; TYLAN Injection 200 mg
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NADA 013-149 520.100a CORID 9.6% Solution
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NADA 030-434 520.540a AZIUM Powder
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NADA 030-435 520.540b AZIUM Boluses 10 mg
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NADA 031-715 520.2220b ALBON; AGRIBON Boluses-2.5, -5.0, and -15.0
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NADA 033-127 520.2200a PRINZONE, PYRADAN, and VETISULID Boluses
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NADA 033-165 520.100b CORID 20% Soluble Powder
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NADA 033-373 520.2200b PRINZONE, PYRADAN, and VETISULID Powder
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NADA 033-318 522.2200 PRINZONE, PYRADAN, and VETISULID Injection
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NADA 041-245 522.2220 AGRIBON Injection 40%; ALBON
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NADA 065-010 522.1696b AGRICILLIN Pen Aqueous; AQUA-CILLIN; Penicillin G Co-op
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NADA 065-110 522.1696b PRO-PEN G in Aqueous Suspension
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NADA 065-140 520.2345d TET-SOL 10 and TET-SOL 324
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NADA 065-269 520.2345d POLYOTIC Soluble Powder
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NADA 065-441 520.2345d POLYOTIC Soluble Powder Concentrate
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NADA 065-493 522.1696b Penicillin G Procaine Aqueous Suspension
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NADA 065-496 520.2345d Tetracycline Soluble Powder
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[[Page 16934]]
NADA 093-107 520.2220b ALBON S.R.
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NADA 138-955 522.2640a Tylosin Injection
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NADA 141-002 520.1660c OXY 500 and 1000 Calf Boluses
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ANADA 200-038 522.2220 DI-METHOX Injection 40%; Sulfadimethoxine Injection 40%
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ANADA 200-049 520.2345d TETRA-BAC 324 Soluble Powder; Tetracycline Hydrochloride Soluble Powder-324.
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ANADA 200-136 520.2345d Tetracycline HCL Powder; Tetracycline Hydrochloride Soluble Powder-324.
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ANADA 200-177 522.2220 Sulfadimethoxine Injection 40%
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ANADA 200-234 520.2345d TETRASOL Soluble Powder
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Accordingly, the agency is amending the regulations in 21 CFR
520.100a, 520.100b, 520.100c, 520.540a, 520.540b, 520.1660c, 520.2200a,
520.2200b, 520.2220b, 520.2345d, 522.1696b, 522.2200, 522.2220,
522.2640a, and 558.55.
In addition, FDA has found that the animal drug regulations do not
reflect the approved preslaughter withdrawal period for cattle, sheep,
and swine for PRO-PEN G in Aqueous Suspension sponsored by Phoenix
Scientific, Inc., approved under NADA 065-110. FDA has also found that
the animal drug regulations do not reflect the approved milk
withholding period for Penicillin G Procaine Aqueous Suspension
sponsored by G.C. Hanford Manufacturing Co. (NADA 065-493) and
AGRICILLIN Pen Aqueous, AQUA-CILLIN, and Penicillin G Co-op sponsored
by Norbrook Laboratories Ltd. (NADA 065-010). At this time, the
regulations are being amended in 21 CFR 522.1696b to correct these
errors.
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
21 CFR Parts 520 and 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 520,
522, and 558 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.
Sec. 520.100a [Amended]
0
2. Section 520.100a is amended in paragraphs (d)(2)(i)(b) and
(d)(2)(ii)(b) by adding ``A withdrawal period has not been established
for this product in preruminating calves. Do not use in calves to be
processed for veal.'' at the end of the paragraph.
Sec. 520.100b [Amended]
0
3. Section 520.100b is amended in paragraphs (d)(1)(ii) and (d)(2)(ii)
by adding ``A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.'' at the end of the paragraph.
Sec. 520.100c [Amended]
0
4. Section 520.100c is amended in paragraphs (d)(1)(ii) and (d)(2)(ii)
by adding ``A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.'' at the end of the paragraph.
Sec. 520.540a [Amended]
0
5. Section 520.540a is amended in paragraph (c)(4) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 520.540b [Amended]
0
6. Section 520.540b is amended in paragraph (a)(3)(vi) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 520.1660c [Amended]
0
7. Section 520.1660c is amended in paragraph (d)(3) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 520.2200a [Amended]
0
8. Section 520.2200a is amended in paragraph (e)(3) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 520.2200b [Amended]
0
9. Section 520.2200b is amended in paragraph (e)(1)(iii) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 520.2220b [Amended]
0
10. Section 520.2220b is amended in paragraph (d)(1)(iii) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 520.2345d [Amended]
0
11. Section 520.2345d is amended in paragraph (d)(1)(iii) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
12. The authority citation for 21 CFR part 522 continues to read as
follows:
[[Page 16935]]
Authority: 21 U.S.C. 360b.
0
13. Section 522.1696b is amended by revising paragraph (d)(2)(iii) to
read as follows:
Sec. 522.1696b Penicillin G procaine aqueous suspension.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Not for use in horses intended for food. Milk
that has been taken during treatment and for 48 hours after the last
treatment must not be used for food.
(A) For Nos. 053501 and 061623: Do not exceed 7 days of treatment
in nonlactating dairy and beef cattle, sheep, and swine, or 5 days in
lactating cattle. Discontinue treatment for the following number of
days before slaughter: Nonruminating cattle (calves)--7; all other
cattle--4; sheep--8; and swine--6.
(B) For Nos. 010515, 055529, and 059130: Treatment should not
exceed 4 consecutive days. Discontinue treatment for the following
number of days before slaughter: Cattle--10; sheep--9; and swine--7. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
Sec. 522.2200 [Amended]
0
14. Section 522.2200 is amended in paragraph (e)(3) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 522.2220 [Amended]
0
15. Section 522.2220 is amended in paragraph (a)(3)(iii)(c) by adding
``A withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
Sec. 522.2640a [Amended]
0
16. Section 522.2640a is amended in paragraph (e)(1)(iii) by adding ``A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.''
at the end of the paragraph.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
17. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.55 [Amended]
0
18. Section 558.55 is amended in paragraphs (d)(1)(i)(b) and
(d)(1)(ii)(b) by adding ``A withdrawal period has not been established
for this product in preruminating calves. Do not use in calves to be
processed for veal.'' at the end of the paragraph.
Dated: March 25, 2005.
Daniel G. McChesney,
Director, Office of Surveillance and Compliance, Center for Veterinary
Medicine.
[FR Doc. 05-6518 Filed 4-1-05; 8:45 am]
BILLING CODE 4160-01-S