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Rule

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment

Action

Final Rule; Technical Amendment.

Summary

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.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective April 4, 2008.

FOR FURTHER INFORMATION CONTACT: Back to Top

Pamela K. Esposito, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail: pamela.esposito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Back to Top

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 intramammary 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.

List of Subjects Back to Top

begin regulatory text

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 510, 520, 526, and 558 are amended as follows:

PART 510—NEW ANIMAL DRUGS Back to Top

1.The authority citation for 21 CFR part 510 continues to read as follows:

Authority:

21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

§ 510.600 [Amended]

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”.

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Back to Top

3.The authority citation for 21 CFR part 520 continues to read as follows:

Authority:

21 U.S.C. 360b.

§ 520.390b [Amended]

4.In § 520.390b, in paragraph (b)(1), remove “, 000185,”.

§ 520.2345a [Amended]

5.In § 520.2345a, remove paragraph (b)(3).

PART 526—INTRAMAMMARY DOSAGE FORMS Back to Top

6.The authority citation for 21 CFR part 526 continues to read as follows:

Authority:

21 U.S.C. 360b.

7.Revise § 526.1696a to read as follows:

§ 526.1696a Penicillin G procaine.

(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.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Back to Top

8.The authority citation for 21 CFR part 558 continues to read as follows:

Authority:

21 U.S.C. 360b, 371.

§ 558.274 [Amended]

9.In § 558.274, amend paragraph (a)(2) by removing “Nos. 043733 and” and adding in its place “No.”.

§ 558.625 [Amended]

10.In § 558.625, remove and reserve paragraph (b)(3).

§ 558.630 [Amended]

11.In § 558.630, amend paragraph (b)(10) by removing “043733,”.

end regulatory text

Dated: March 26, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

[FR Doc. E8-7103 Filed 4-3-08; 8:45 am]

BILLING CODE 4160-01-S

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