[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Rules and Regulations]
[Page 58631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29389]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related Products; Tylosin
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 that portion reflecting approval of a new
animal drug application (NADA) held by Countrymark Cooperative, Inc.
(formerly Indiana Farm Bureau Cooperative Association, Inc.). The NADA
provides for use of a tylosin Type A medicated article for making a
tylosin Type C medicated swine feed. In a notice published elsewhere in
this issue of the Federal Register, FDA is withdrawing approval of the
NADA.
EFFECTIVE DATE: November 29, 1996.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this
issue of the Federal Register, FDA is withdrawing approval of NADA 125-
226 held by Countrymark Cooperative, Inc., 950 North Meridian St.,
Indianapolis, IN 46204-3909 (formerly Indiana Farm Bureau Cooperative
Association, Inc., 120 East Market St., Indianapolis, IN 46204). The
NADA provides for use of tylosin Type A medicated articles to make
tylosin Type C medicated swine feeds. Countrymark Cooperative, Inc.,
voluntarily requested withdrawal of approval of the NADA because it no
longer makes Type A medicated articles for use in medicated feeds. This
document removes the entry in 21 CFR 558.625(b) to reflect the
withdrawal of approval of this NADA.
This NADA was originally held by Indiana Farm Bureau Cooperative
Association, Inc. The regulations had not been amended in
Sec. 510.600(c) (21 CFR 510.600(c)) to reflect the sponsor change to
Countrymark Cooperative. At this time, Indiana Farm Bureau Cooperative
Association is no longer the sponsor of any approved NADA's. Therefore,
Sec. 510.600(c) is amended to remove the entries for the firm.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 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 paragraph (c)(1) by
removing the entry for ``Indiana Farm Bureau Cooperative Association,
Inc.,'' and in paragraph (c)(2) by removing the entry for ``021502.''
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. 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. 558.625 [Amended]
4. Section 558.625 Tylosin is amended by removing and reserving
paragraph (b)(76).
Dated: October 18, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-29389 Filed 11-15-96; 8:45 am]
BILLING CODE 4160-01-F
