[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