[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Rules and Regulations]
[Page 15111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8048]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 558
Animal Drugs, Feeds, and Related Products; Ronnel; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to remove that portion of the regulations reflecting
approval of new animal drug applications (NADA's) held by Moorman
Manufacturing Co. and Pitman-Moore, Inc., that provide for the use of
ronnel oral dosage forms and ronnel Type A medicated article. The
approval of these NADA's were previously withdrawn. This action is
necessary to ensure the accuracy and consistency of the regulations.
EFFECTIVE DATE: March 31, 1997.
FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary
Medicine (HFV-238), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1737.
SUPPLEMENTARY INFORMATION: FDA has discovered that certain errors have
been incorporated into the agency's codified regulations on animal
drugs. The errors in the regulations addressed in this document follow.
In a notice published in the Federal Register of July 19, 1989 (54
FR 30268), the agency announced that Pitman-Moore, Inc., had requested
that FDA withdraw NADA's 12-360 and 12-361. In a final rule published
in that same issue of the Federal Register (54 FR 30205), the agency
inadvertently omitted an amendment to the regulations to remove
Sec. 520.2080 (21 CFR 520.2080).
In a notice published in the Federal Register of June 18, 1990 (55
FR 24646), the agency announced that Moorman Manufacturing Co. had
requested that FDA withdraw NADA 13-450. In a final rule published in
that same issue of the Federal Register (55 FR 24556), the agency
inadvertently omitted an amendment to the regulations to remove
Sec. 558.525 (21 CFR 558.525).
At this time, the agency is correcting these errors. Accordingly,
Secs. 520.2080 and 558.525 are removed because the sections no longer
represent approved products.
List of Subjects
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 520 and
558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. 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. 520.2080 [Removed]
2. Section 520.2080 Ronnel oral dosage forms is removed.
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. 558.525 [Removed]
4. Section 558.525 Ronnel is removed.
Dated: March 4, 1997.
Linda Tollefson,
Director, Office of Surveillance and Compliance, Center for Veterinary
Medicine.
[FR Doc. 97-8048 Filed 3-28-97; 8:45 am]
BILLING CODE 4160-01-F
