[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Page 14303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7547]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Chlortetracycline; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the new 
animal drug regulations that provided for approval of five supplemental 
new animal drug applications (NADA's) filed by Hoffmann-LaRoche, Inc.; 
Pfizer, Inc.; ALPHARMA, Inc.; ADM Animal Health & Nutrition Div.; and 
PennField Oil Co. to reflect conclusions of the National Academy of 
Sciences/National Research Council (NAS/NRC) review of the use of 
chlortetracycline Type A articles to make certain Type C medicated 
feeds, and FDA's conclusions based on that review.

DATES: Effective March 26, 1997.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 9, 1996 (61 
FR 35949), FDA published a document reflecting approval of the NAS/NRC 
supplements for Hoffmann-LaRoche's NADA 48-761, Pfizer's NADA's 92-286 
and 92-287, ALPHARMA's NADA 46-699, ADM Animal Health and Nutrition 
Div.'s NADA 48-480, and PennField Oil's NADA 138-935. The July 9, 1996, 
document failed to include certain amendments to the regulation 
including a warning against use of certain medicated articles in duck 
eggs for human food.
    In addition, 21 CFR 558.128(c) is redesignated as paragraph (d) and 
new paragraph (c) is reserved for future use to provide for more 
uniformity, flexibility, and consistency in the regulations.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

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

    1. 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. 558.128  [Amended]

    2. Section 558.128 Chlortetracycline is amended by redesignating 
paragraph (c) as paragraph (d), by reserving new paragraph (c), and by 
amending newly redesignated paragraph (d) as follows:

    a. In paragraph (d)(1)(vi), in the ``Limitations'' column in the 
second entry by adding a second sentence to read ``Do not feed to ducks 
producing eggs for human consumption.''
    b. In paragraph (d)(1)(xii), in the ``Limitations'' column in the 
first entry by removing the word ``excluding'' in the second phrase and 
adding in its place the word ``including'', and in the first and third 
entries by adding a new first sentence to read ``Feed approximately 400 
g/t, varying with body weight and feed consumption to provide 10 mg/lb 
per day.''
    c. In paragraph (d)(1)(xvii), in the third column, in entry 1. by 
removing the phrase ``Cattle (under 700 lb)'' and adding in its place 
``Beef cattle''.

    Dated: March 13, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-7547 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F