[Federal Register Volume 59, Number 9 (Thursday, January 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-811]


[[Page Unknown]]

[Federal Register: January 13, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

 

Animal Drugs, Feeds, and Related Products; Starch, Pregelatinized

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to remove those portions of the regulations that 
reflect approval of a new animal drug application (NADA) held by 
Shulcon Industries, Inc. The NADA provides for use of pregelatinized 
starch as an antidiarrheal in newborn calves. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADA.

EFFECTIVE DATE: January 13, 1994.

FOR FURTHER INFORMATION CONTACT: William C. Keller, Center for 
Veterinary Medicine (HFV-210), 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 111-
068 for use of Scourx Calf Antidiarrheal (pregelatinized 
starch) in nonmedicated liquid feed or water for the symptomatic 
treatment (i.e., increasing fecal consistency) of nonspecific diarrhea 
in newborn calves. The NADA is held by Shulcon Industries, Inc., 4351 
East Sarnac Dr., Tucson, AZ 86718. The agency is taking this action 
because the firm failed to respond to a notice of opportunity for a 
hearing on a proposal to withdraw approval of the NADA due to the 
firm's failure to submit the reports required by 21 CFR 510.300. This 
document amends 21 CFR 510.600(c)(1) and (c)(2) to remove references to 
the firm because it is no longer the sponsor of an approved NADA, and 
removes 21 CFR 520.2155 to reflect the withdrawal of approval of this 
NADA.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.
    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 
520 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 ``Shulcon Industries, Inc.,'' and in 
the table in paragraph (c)(2) by removing the entry for ``052292''.

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. 520.2155  [Removed]

    4. Section 520.2155 Starch, pregelatinized is removed.

    Dated: January 4, 1994.
 Richard H. Teske,
 Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-811 Filed 1-12-94; 8:45 am]
BILLING CODE 4160-01-F