[Federal Register Volume 61, Number 28 (Friday, February 9, 1996)]
[Rules and Regulations]
[Pages 4874-4875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2846]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520, 522, and 558


New Animal Drugs; 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 name for SmithKline 
Animal Health Products, Division of SmithKline Beckman Corp. to 
SmithKline Beecham Animal Health due to a merger with Beecham 
Laboratories, Division of Beecham, Inc., and to reflect a change of 
sponsor for approved new drug applications (NADA's) previously held by 
SmithKline Beecham Animal Health to Pfizer, Inc.

EFFECTIVE DATE: February 9, 1996.

FOR FURTHER INFORMATION CONTACT: Judith M. O'Haro, Center for 
Veterinary Medicine (HFV-238), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1737.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 8, 1991 
(56 FR 50652), the animal drug regulations were amended to reflect the 
change of sponsor name for SmithKline Animal Health Products, Division 
of SmithKline Beckman Corp. to SmithKline Beecham Animal Health due to 
a merger with Beecham Laboratories, Division of Beecham, Inc. The 
regulations were amended to reflect the change of sponsor for 28 new 
animal drug applications (NADA's) from Beecham Laboratories, Division 
of Beecham Inc., to SmithKline Beecham Animal Health, and the change of 
sponsor for 22 NADA's from Norden Laboratories, Inc., to SmithKline 
Beecham Animal Health also due to the merger. The new company was 
assigned a new sponsor labeler code. The amended regulations did not 
reflect SmithKline Beecham Animal Health as the new sponsor in 
Secs. 558.58, 558.311, 558.355, and 558.625. The sponsor currently 
listed for these products is Pfizer, Inc. Accordingly, the agency is 
amending these sections to reflect the change of sponsor.
    In the Federal Register of November 2, 1995 (60 FR 55657), FDA 
published a document that amended the animal drug regulations to 
reflect a change of sponsor for 62 NADA's from SmithKline Beecham 
Animal Health to Pfizer, Inc. FDA inadvertently amended the regulations 
in 21 CFR 520.2260a, 520.2260b, and 520.2260c to reflect Pfizer, Inc. 
as the sponsor. However, Solvay Animal Health remains the sponsor of 
these sulfamethazine containing applications. The codified sections 
that should have been amended are 520.2220a, 520.2220b, 520.2220c, 
520.2220d, and 522.2220. In addition, the agency omitted an amendment 
to 21 CFR 520.45a(a)(2). Accordingly, the agency is amending these 
sections to reflect this change of sponsor.

List of Subjects

21 CFR Parts 520 and 522

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    
[[Page 4875]]


 PART 520--ORAL DOSAGE FORM NEW 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, 
522, and 558 are amended as follows:
     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.  520.45a  [Amended]

    -2. Section 520.45a Albendazole suspension is amended in paragraph 
(a)(2) by removing ``053571'' and adding in its place ``000069''.


Sec.  520.2220a [Amended]

    -3. Section 520.2220a Sulfadimethoxine oral solution and soluble 
powder is amended in paragraph (b) by removing ``053571'' and adding in 
its place ``000069''.


Sec.  520.2220b  [Amended]

    -4. Section 520.2220b Sulfadimethoxine tablets and boluses is 
amended in paragraph (b)(1) by removing ``053571'' and adding in its 
place ``000069''.


Sec.  520.2220c  [Amended]

    -5. Section 520.2220c Sulfadimethoxine oral suspension is amended 
in paragraph (c) by removing ``053571'' and adding in its place 
``000069''.


 Sec.  520.2220d  [Amended]

    -6. Section 520.2220d Sulfadimethoxine-ormetoprim tablets is 
amended in paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec.  520.2260a  [Amended]

    -7. Section 520.2260a Sulfamethazine oblets and boluses is amended 
in paragraph (b)(1) by removing ``000069'' and adding in its place 
``053501''.


Sec.  520.2260b  [Amended]

    -8. Section 520.2260b Sulfamethazine sustained-release boluses is 
amended in paragraph (b)(1) by removing ``000069'' and adding in its 
place ``053501''.


 Sec.  520.2260c  [Amended]

    -9. Section 520.2260c Sulfamethazine sustained-release tablets is 
amended in paragraph (a) by removing ``000069'' and adding in its place 
``053501''.

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

    -10. The authority citation for 21 CFR part 522 continues to read 
as follows:

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


Sec.  522.2220  [Amended]

    -11. Section 522.2220 Sulfadimethoxine injection is amended in 
paragraph (a)(2)(i) by removing ``053571'' and adding in its place 
``000069''.

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

    -12. 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.  558.58  [Amended]

    -13. Section 558.58 Amprolium and ethopabate is amended in the 
table in paragraph (d)(1), in item (iii), in the entry for 
virginamycin,15, under the ``Limitations'' and the ``Sponsor'' columns 
by removing ``000007'' and adding in its place ``000069''.


Sec.  558.311  [Amended]

    -14. Section 558.311 Lasalocid is amended in paragraph (b)(2) by 
removing ``000007'' and adding in its place ``000069''.


Sec.  558.355  [Amended]

    -15. Section 558.355 Monensin is amended in paragraph (b)(5) by 
removing ``000007'' and adding in its place ``000069''.


Sec.  558.625  [Amended]

    -16. Section 558.625 Tylosin is amended in paragraph (b)(25) by 
removing ``000007'' and adding in its place ``000069''.

    Dated: February 1, 1996.
Robert C. Livingston
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-2846 Filed 2-8-96; 8:45 am]
BILLING CODE 4160-01-F