[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
