[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Rules and Regulations]
[Page 26981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12960]
[[Page 26981]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 524
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 the change of sponsor for two approved new
animal drug applications (NADA's) from Mallinckrodt Veterinary
Operations Inc., to Schering-Plough Animal Health Corp.
EFFECTIVE DATE: May 15, 1998.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0213.
SUPPLEMENTARY INFORMATION: Mallinckrodt Veterinary Operations, Inc.,
Mundelein, IL 60060, has informed FDA that it has transferred the
ownership of and all rights and interests in the approved NADA's 102-
020 (dichlorophene and toluene capsules) and 111-349 (selenium
disulfide suspension) to Schering-Plough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083. The agency is amending the regulations in
21 CFR 510.600(c)(1) and (c)(2) to remove the sponsor name for
Mallinckrodt Veterinary Operations, Inc., because the firm no longer is
the holder of any approved NADA's. The agency is also amending 21 CFR
520.580 and 524.2101 to reflect the change of sponsor.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 524
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 510,
520, and 524 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.
Sec. 510.600 [Amended]
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 entry for ``Mallinckrodt Veterinary Operations,
Inc.''; and in the table in paragraph (c)(2) by removing the entry for
``015563''.
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. 520.580 [Amended]
4. Section 520.580 Dichlorophene and toluene capsules is amended in
paragraph (b)(1) by removing ``015563,'' and numerically adding
``000061,''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
5. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.2101 [Amended]
6. Section 524.2101 Selenium disulfide suspension is amended in
paragraph (c) by removing ``015563'' and adding in its place
``000061''.
Dated: May 4, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-12960 Filed 5-14-98; 8:45 am]
BILLING CODE 4160-01-F
