Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications (NADAs) because FDA is withdrawing approval of the NADAs.
This rule is effective April 4, 2008.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
The following sponsors have requested that FDA withdraw approval of the seven NADAs listed below because the products are no longer manufactured or marketed:
|Sponsor||NADA Number Product (Drug)||21 CFR Cite Affected (Sponsor Drug Labeler Code)|
|Eon Labs Manufacturing, Inc., 227-15 North Conduit Ave., Laurelton, NY 11413||NADA 65-063, Tetracycline capsules||520.2345a (000185)|
|NADA 65-345, Chloramphenicol capsules||520.390b (000185)|
|G.C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201||NADA 65-465, AQUA-MAST (penicillin G procaine)||526.1696a (010515)|
|International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127||NADA 95-551, TYLAN 5 Premix (tylosin phosphate)||558.625 (043733)|
|NADA 109-688, HYGROMIX 2.4 Premix (hygromycin B)||558.274 (043733)|
|NADA 109-816, TYLAN 10 SULFA-G Premix (tylosin phosphate and sulfamethazine)||558.630 (043733)|
|Pfizer, Inc., 235 East 42d St., New York, NY 10017||NADA 103-758, TERAMIX-10 Premix (oxytetracycline)||Not codified|
Following the withdrawal of approval of these NADAs, Eon Labs Manufacturing, Inc., is no longer sponsor of an approved application. Therefore, 21 CFR 510.600(c) is amended to remove entries for this sponsor.
As provided below, the animal drug regulations are amended to reflect the withdrawal of approvals. The regulations for penicillin G procaine Start Printed Page 18442intramammary dosage forms (21 CFR 526.1696a) are also amended to correct several errors and to reflect a current format.
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.Start List of Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
and 526End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Eon Labs Manufacturing, Inc.”; and in the table in paragraph (c)(2) remove the entry for “000185”.End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. In § 520.390b, in paragraph (b)(1), remove “, 000185,”.End Amendment Part
5. In § 520.2345a, remove paragraph (b)(3).End Amendment Part Start Part
PART 526—INTRAMAMMARY DOSAGE FORMSEnd Part Start Amendment Part
6. The authority citation forEnd Amendment Part Start Amendment Part
7. Revise § 526.1696a to read as follows:End Amendment Part
(a) Specifications. Each 10-milliliter single-dose syringe contains penicillin G procaine equivalent to 100,000 units of penicillin G.
(b) Related tolerances. See § 556.510 of this chapter.
(c) Sponsors. See Nos. 010515 and 050604 in § 510.600(c) of this chapter.
(d) Conditions of use in lactating cows—(1) Amount. Infuse one 10-milliliter dose into each infected quarter. Treatment may be repeated at 12-hour intervals for not more than three doses, as indicated by clinical response.
(2) Indications for use. For the treatment of mastitis caused by Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating cows.
(3) Limitations. Milk that has been taken from animals during treatment and for 60 hours after the latest treatment must not be used for food. Animals must not be slaughtered for food during treatment or within 3 days after the latest treatment.
(e) Conditions of use in dry cows—(1) Amount. Infuse one 10-milliliter dose into each infected quarter at time of drying-off.
(2) Indications of use. For the treatment of mastitis caused by Streptococcus agalactiae in dry cows.
(3) Limitations. Discard all milk for 72 hours (6 milkings) following calving, or later as indicated by the marketable quality of the milk. Animals must not be slaughtered for food within 14 days postinfusion.Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
8. The authority citation forEnd Amendment Part
9. In § 558.274, amend paragraph (a)(2) by removing “Nos. 043733 and” and adding in its place “No.”.End Amendment Part
10. In § 558.625, remove and reserve paragraph (b)(3).End Amendment Part
11. In § 558.630, amend paragraph (b)(10) by removing “043733,”.End Amendment Part Start Signature
Dated: March 26, 2008.
Director, Center for Veterinary Medicine.
[FR Doc. E8-7103 Filed 4-3-08; 8:45 am]
BILLING CODE 4160-01-S