[Federal Register Volume 60, Number 225 (Wednesday, November 22, 1995)]
[Rules and Regulations]
[Page 57832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28542]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 522
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 three new
animal drug applications (NADA's) from Vet-A-Mix, Inc., to Lloyd, Inc.
EFFECTIVE DATE: November 22, 1995.
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: Vet-A-Mix, Inc., 604 West Thomas Ave., P.O.
Box A, Shenandoah, IA 51601, has informed FDA of a change of sponsor
name for approved NADA's 92-836 (diethylcarbamazine citrate), 140-866
(yohimbine hydrochloride injectable), and 140-921 (prednisolone
tablets) to Lloyd, Inc., 604 West Thomas Ave., Shenandoah, IA 51601.
Accordingly, FDA is amending the regulations in 21 CFR 520.622c,
520.1880, and 522.2670 to reflect the change of sponsor name.
List of Subjects in 21 CFR Parts 520 and 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. 520.622c [Amended]
2. Section 520.622c Diethylcarbamazine citrate chewable tablets is
amended in paragraph (b)(3) by removing ``011789'' and adding in its
place ``061690''.
Sec. 520.1880 [Amended]
3. Section 520.1880 Prednisolone tablets is amended in paragraph
(b) by removing ``011789'' and adding in its place ``061690''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
4. 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. 522.2670 [Amended]
5. Section 522.2670 Yohimbine injectable is amended in paragraph
(b) by removing ``032998'' and adding in its place ``061690''.
Dated: November 13, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-28542 Filed 11-21-95; 8:45 am]
BILLING CODE 4160-01-F
