[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51821-51822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25909]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 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 for an approved new
animal drug application (NADA) from Fujisawa USA, Inc., to American
Pharmaceutical Partners, Inc.
EFFECTIVE DATE: September 29, 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: Fujisawa USA, Inc., Deerfield, IL 60015-
2548, has informed FDA that it has transferred ownership of, and all
rights and interests in, NADA 100-840 (Chorionic Gonadotropin) to
American Pharmaceuticals Partners, Inc., 2045 North Cornell Ave.,
Melrose Park, IL 60160. Accordingly, the agency is amending the
regulations in 21 CFR 510.600 and 522.1081 to reflect the transfer of
ownership. The agency is also amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) by removing Fujisawa USA, Inc., because the
firm is no longer the sponsor of any approved NADA's, and by
alphabetically adding a new listing for American Pharmaceuticals
Partners, Inc.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 and
522 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.
2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entry for ``Fujisawa USA, Inc.,'' and by alphabetically
adding an entry for ``American Pharmaceutical Partners, Inc.,'' and in
the table in paragraph (c)(2) by removing the entry for ``000469'' and
by numerically adding an entry for ``063323'' to read as follows:
[[Page 51822]]
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * * *
*
American Pharmaceuticals Partners, Inc., 2045 North 063323
Cornell Ave., Melrose Park, IL 60160
* * * * * *
*
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * *
*
063323 American Pharmaceuticals Partners, Inc., 2045 North
Cornell Ave., Melrose Park, IL 60160
* * * * * *
*
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1081 [Amended]
4. Section 522.1081 Chorionic gonadotropin for injection; chorionic
gonadotropin suspension is amended in paragraph (a)(2)(ii) by removing
``Nos. 000469 and 058639'' and adding in its place ``Nos. 058639 and
063323''.
Dated: August 27, 1998.
Margaret Ann Miller,
Acting Director, Office of New Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 98-25909 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F