[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15604]
[Federal Register: June 28, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 522
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 a change of sponsor name and address for a
new animal drug application (NADA) from Med-Chem Products, Inc. to
Anika Research, Inc.
EFFECTIVE DATE: June 28, 1994.
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: Med-Chem Products, Inc., Woburn, MA 01801,
has informed FDA that it has transferred ownership of, and all rights
and interests in, approved NADA 122-578 for Hyaluronate sodium
injection to Anika Research, Inc., 160 New Boston St., Woburn, MA
01801. Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) by removing Med-Chem Products, Inc., because
the firm is no longer the sponsor of any approved NADA's, and by
alphabetically adding a new listing for Anika Research, 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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (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 ``Med-Chem Products, Inc.'' and by
alphabetically adding a new entry for ``Anika Research, Inc.,'' and in
the table in paragraph (c)(2) by removing the entry for ``053276'' and
by numerically adding a new entry for ``060865'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug
Firm name and address labeler
code
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*****
Anika Research, Inc., 160 New Boston St., Woburn, MA 01801..... 060865
*****
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(2) * * *
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Drug
labeler Firm name and address
code
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*****
060865. Anika Research, Inc., 160 New Boston St., Woburn, MA 01801
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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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.1145 [Amended]
4. Section 522.1145 Hyaluronate sodium injection is amended in
paragraph (a)(2) by removing the number ``053276'' and adding in its
place ``060865''.
Dated: June 17, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-15604 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F
