[Federal Register Volume 59, Number 217 (Thursday, November 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27793]


[[Page Unknown]]

[Federal Register: November 10, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522

 

Animal Drugs, Feeds, and Related Products; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for eight new animal 
drug applications (NADA's) from Hoffmann-La Roche, Inc., to SmithKline 
Beecham Animal Health.

EFFECTIVE DATE: November 10, 1994
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: Hoffmann-LaRoche, Inc., Nutley, NJ 07110, 
has informed FDA that it has transferred ownership of, and all rights 
and interests in, the following approved NADA's to SmithKline Beecham 
Animal Health, 1600 Paoli Pike, West Chester, PA 19380:

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            NADA Number                           Ingredient                             Trade name             
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15-102............................                      Sulfadimethoxine                          Albon Tablets 
31-205............................                      Sulfadimethoxine          Albon Drinking Water Solution 
31-715............................                      Sulfadimethoxine                            Albon Bolus 
41-245............................                      Sulfadimethoxine                    Albon Injection 40% 
43-785............................                      Sulfadimethoxine               Albon Oral Suspension 5% 
46-285............................                      Sulfadimethoxine                   Albon Soluble Powder 
93-107............................                      Sulfadimethoxine          Albon Sustained-Release Bolus 
100-929...........................           Sulfadimethoxine/ormetoprim                         Primor Tablets 
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    Accordingly, the agency is amending the regulations in 21 CFR 
520.2220a(b), 520.2220b(b)(1), 520.2220c(c), 520.2220d(b) and 
522.2220(a)(2)(i) to reflect the change of sponsor.

List of Subjects

21 CFR Part 520

    Animal drugs.

21 CFR Part 522

    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 520 and 
522 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. 520.2220a  [Amended]

    2. Section 520.2220a Sulfadimethoxine oral solution and soluble 
powder is amended in paragraph (b) by removing ``000004'' and by adding 
in its place ``053571''.


Sec. 520.2220b  [Amended]

    3. Section 520.2220b Sulfadimethoxine tablets and boluses is 
amended in paragraph (b)(1) by removing ``000004'' and by adding in its 
place ``053571''.


Sec. 520.2220c  [Amended]

    4. Section 520.2220c Sulfadimethoxine oral suspension is amended in 
paragraph (c) by removing ``000004'' and by adding in its place 
``053571''.


Sec. 520.2220d  [Amended]

    5. Section 520.2220d Sulfadimethoxine-ormetoprim tablets is amended 
in paragraph (b) by removing ``000004'' and by adding in its place 
``053571''.

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

    6. The authority citation of 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 522.2220  [Amended]

    7. Section 522.2220 Sulfadimethoxine injection is amended in 
paragraph (a)(2)(i) by removing ``000004'' and by adding in its place 
``053571''.

    Dated: November 2, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-27793 Filed 11-9-94; 8:45 am]
BILLING CODE 4160-01-F