[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