[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) * * *

------------------------------------------------------------------------
                                                                   Drug 
                     Firm name and address                       labeler
                                                                   code 
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                                  *****                                 
Anika Research, Inc., 160 New Boston St., Woburn, MA 01801.....   060865
                                  *****                                 
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
  Drug                                                                  
labeler                       Firm name and address                     
  code                                                                  
------------------------------------------------------------------------
                                  *****                                 
060865.  Anika Research, Inc., 160 New Boston St., Woburn, MA 01801     
------------------------------------------------------------------------

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