[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Rules and Regulations]
[Pages 15683-15684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558


Animal Drugs, Feeds, and Related Products; Technical Amendments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

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SUMMARY:  The Food and Drug Administration (FDA) is updating the animal 
drug regulations to reflect corrections of previously approved new 
animal drug applications (NADA's). Several sponsors currently specified 
in the list of sponsors of approved applications and in the animal drug 
approval regulations are incorrect. This action is being taken to 
improve the accuracy of the regulations.

EFFECTIVE DATE:  April 1, 1999.
FOR FURTHER INFORMATION CONTACT:  Judith M. O'Haro, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-3664.

SUPPLEMENTARY INFORMATION:  FDA has found several errors in the 
agency's regulations concerning approval of animal drugs, feeds, and 
related products including the list of sponsors of approved 
applications. To correct those errors, FDA is amending 21 CFR 
510.600(c)(1) and (c)(2) to remove several sponsor names and drug 
labeler codes because the firms are no longer the holders of any 
approved NADA's. This document is also amending the animal drug 
approval regulations by correcting the nonsubstantive errors in 21 CFR 
520.260, 520.2184, 520.2220b, 522.723, 522.800, 558.140, 558.485, and 
558.635.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520 and 522

    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 510, 
520, 522, 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: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    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 entries for ``Affiliated Laboratories Division, 
Whitmoyer Laboratories, Inc.'', ``Albers Milling Co.'', ``Allied 
Pharmacal, Division of K.C. Pharmacal, Inc.'', ``Ayerst Laboratories, 
Division of American Home Products, Corp.'', ``Bristol Laboratories, 
Div. of Bristol-Myers Co.'', ``Cooper U.S.A., Inc.'', ``Cutter 
Laboratories, Inc.'', ``Dawes Laboratories, Inc.'', ``Feed Products, 
Inc.'', ``H. Clay Glover Co., Inc.'', ``Gooch Feed Mill Corp.'', 
``Grain Processing Corp.'', ``ICI Americas, Inc.'', ``KASCO-EFCO 
Laboratories, Inc.'', ``Dr. LeGear, Inc.'', ``McNeil Laboratories, 
Inc.'', ``Triple ``F'', Inc.'', ``Tutag Pharmaceuticals, Inc.'', and 
``Western Serum Co.''; by alphabetically adding a new entry for ``Equi 
Aid Products, Inc.''; and in the table in paragraph (c)(2) by removing 
the entries for ``000015, 000045, 000046, 000124, 000161, 000794, 
010471, 010616, 011398, 011490, 011492, 011511, 011825, 011950, 012983, 
013959, 017826, 021798, 022591, and 024264''; and by numerically adding 
a new entry for ``062240'' to read as follows:


Sec. 510.600   Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

 
------------------------------------------------------------------------
       Firm name and address                  Drug labeler code
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*                    *                    *                    *
                    *                    *                    *
Equi Aid Products, Inc., 1517 West   062240
 Knudsen Dr., Phoenix, AZ 85027
*                    *                    *                    *
                    *                    *                    *
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    (2) * * *

[[Page 15684]]



 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
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*                    *                    *                    *
                    *                    *                    *
062240                               Equi Aid Products, Inc., 1517 West
                                      Knudsen Dr., Phoenix, AZ 85027
*                    *                    *                    *
                    *                    *                    *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. 520.260   [Amended]

    4. Section 520.260 n-Butyl chloride capsules is amended in 
paragraph (b)(2) by removing ``012983'' and adding in its place 
``038782''.


Sec. 520.2184   [Amended]

    5. Section 520.2184 Sodium sulfachloropyrazine monohydrate is 
amended in paragraph (b) by removing the phrase ``Nos. 010042 and 
053501'' and adding in its place ``No. 010042''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    6-7. The authority citation for 21 CFR part 522 continues to read 
as follows:

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

Sec. 522.723   [Amended]

    8. Section 522.723 Diprenorphine hydrochloride injection is amended 
in pargraph (c) by removing ``010042'' and adding in its place 
``053923''.


Sec. 522.800   [Amended]

    9. Section 522.800 Droperidol and fentanyl citrate injection is 
amended in pargraph (b) by removing ``000045'' and adding in its place 
``000061''.

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

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

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

Sec. 558.140   [Amended]

    11. Section 558.140 Chlortetracycline and sulfamethazine is amended 
in paragraph (a) by removing ``000004'' and adding in its place 
``063238''.


Sec. 558.485   [Amended]

    12. Section 558.485 Pyrantel tartrate is amended by removing and 
reserving paragraph (a)(17).


Sec. 558.635   [Amended]

    13. Section 558.635 Virginiamycin is amended in paragraph (b)(2) by 
removing ``011490'' and adding in its place ``046573''.

    Dated: March 23, 1999.
 Margaret Ann Miller,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-7925 Filed 3-31-99; 8:45 am]
BILLING CODE 4160-01-F