Animal drugs, feeds, and related products: Chlortetracycline powder, etc.,

[Federal Register: July 13, 1999 (Volume 64, Number 133)]

[Rules and Regulations]

[Page 37672-37673]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13jy99-6]

DEPARTMENT OF HEALTH AND HUMAN RESOURCES

Food and Drug Administration

21 CFR Parts 520 and 558

Animal Drugs, Feeds, and Related Products; Chlortetracycline Powder, Etc.; Technical Amendments

AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to correct errors concerning the sponsor of oral chlortetracycline powder, oral tetracycline powder, and interim use of certain medicated feeds. The amendments are required because the regulations did not reflect a change of sponsor from Fermenta Animal Health to Boehringer Ingelheim Vetmedica.

EFFECTIVE DATE: July 13, 1999. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 30, 1997 (62 FR 35075 through 35077), FDA published a document reflecting the change of sponsor of several new animal drug applications from Fermenta Animal Health Co. to Boehringer Ingelheim Vetmedica, Inc. (at that time known as Boehringer Ingelheim Animal Health, Inc.). In 21 CFR 520.445b(d)(4)(iii)(C) and 520.2345d(a)(1) the regulations failed to reflect the change from ``054273'' to ``000010''. Also, in 21 CFR 558.15(g)(1) and (g)(2), the regulation failed to reflect the change from ``Fermenta Animal Health'' to ``Boehringer Ingelheim Vetmedica.'' At this time, the regulations in 21 CFR parts 520 and 558 are amended to reflect the change of sponsor.

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

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

[[Page 37673]]

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: 21 U.S.C. 360b.

   Sec. 520.445b [Amended]

2. Section 520.445b Chlortetracycline powder (chlortetracycline hydrochloride or chlortetracycline bisulfate) is amended in paragraph (d)(4)(iii)(C) by removing ``012286, 053389, and 054273'' and adding in its place ``000010, 012286, and 053389''.

   Sec. 520.2345d [Amended]

3. Section 520.2345d Tetracycline hydrochloride soluble powder is amended in paragraph (a)(1) by removing ``054273,'' and adding ``000010,'' before ``046573''.

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

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

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

   Sec. 558.15 [Amended]

5. Section 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals is amended in paragraphs (g)(1) and (g)(2) by removing ``Fermenta Animal Health Co.'' and adding in its place ``Boehringer Ingelheim Vetmedica, Inc.''

   Dated: June 28, 1999. Claire M. Lathers, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

   [FR Doc. 99-17761Filed7-12-99; 8:45 am]

   BILLING CODE 4160-01-F