[Federal Register Volume 59, Number 221 (Thursday, November 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28331]


[[Page Unknown]]

[Federal Register: November 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Parts 510, 520, and 558

 

Animal Drugs, Feeds, and Related Products; Tetracycline 
Hydrochloride Capsules; Dichlorophene/Toluene Capsules; Hygromycin B 
Type B Medicated Feed

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 remove those portions of the regulations that 
reflect approval of three new animal drug applications (NADA's). The 
sponsors requested the withdrawals of approval. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADA's.

EFFECTIVE DATE:  November 28, 1994.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0749.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of (1) NADA 
65-467 for Tetracycline Hydrochloride Capsules held by Lemmon Co., 650 
Cathill Rd., Sellersville, PA 18960; (2) NADA 119-844 for 
Dichlorophene/Toluene Capsules held by Banner Pharmacaps, Inc. 
(formerly Pharmacaps, Inc.), P.O. Box 547, 1111 Jefferson Ave., 
Elizabeth, NJ 07207; and (3) NADA 129-160 for Hygromix O.6 (hygromycin 
B Type B medicated feed) held by Nutra-Blend Corp., Rt. 7, Box 192A, 
Neosho, MO 64850. The sponsors requested withdrawal of approval of the 
NADA's. This document amends 21 CFR 520.580, 21 CFR 520.2345a, and 21 
CFR 558.274 to reflect the withdrawal of approval of these NADA's.
    Additionally, this document amends 21 CFR 510.600(c)(1) and (c)(2) 
to remove the entries for Pharmacaps, Inc., because the firm is no 
longer the sponsor of any approved NADA's.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    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, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).


Sec. 510.600   [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``Pharmacaps, Inc.,'' and in the table 
in paragraph (c)(2) by removing the entry for ``010888''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 520.580   [Amended]

    4. Section 520.580 Dichlorophene and toluene capsules is amended in 
paragraph (b)(1) by removing ``010888,''.


Sec. 520.2345a  [Amended]

    5. Section 520.2345a Tetracycline hydrochloride capsules is amended 
in paragraph (b)(1) by removing ``Nos. 000009 and 000693'' and 
replacing it with ``No. 000009''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

    Authority:  Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).


Sec. 558.274  [Amended]

    7. Section 558.274 Hygromycin B is amended in paragraph (a)(4) by 
removing ``050568,'' and in the table in paragraph (c)(1), under the 
heading ``Sponsor,'' in entries (i) and (ii) by removing ``050568,''.

    Dated: October 31, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-28331 Filed 11-16-94; 8:45 am]
BILLING CODE 4160-01-F