[Federal Register Volume 61, Number 83 (Monday, April 29, 1996)]
[Rules and Regulations]
[Pages 18671-18672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10546]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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 for approved new animal 
drug applications (NADA's) from Fisons plc, Pharmaceutical Division to 
Alstoe, Ltd., Animal Health.

EFFECTIVE DATE: April 29, 1996.

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: Fisons plc, Pharmaceutical Division, 12 
Derby Rd., Loughborough, Leicestershire, LE11 OBB, England, has 
informed the agency that it has transferred the ownership of, and all 
rights and interests in, approved NADA's 99-667 (Iron Dextran Complex 
Injection) and 110-399 (Gleptoferron Injection) to Alstoe, Ltd., Animal 
Health, 19 Foxhill, Whissendine, Oakham, Rutland, U.K., because the 
firm is no longer the sponsor of any approved NADA's. Accordingly, the 
agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) 
and the

[[Page 18672]]

drug labeler codes in 21 CFR 522.1055 and 522.1182 to reflect those 
changes.

 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 ``Fisons, plc, Pharmaceutical Division'' and by 
alphabetically adding a new entry for ``Alstoe, Ltd., Animal Health'', 
and in the table in paragraph (c)(2) by removing the entry for 
``012525'' and by numerically adding a new entry for ``062408'' to read 
as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

 * * * * *
    (c) * * *
    (1) * * *

                                                                        
------------------------------------------------------------------------
       Firm name and address-----               Drug labeler code       
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Alstoe, Ltd., Animal Health, 19          062408                         
 Foxhill, Whissendine, Oakham, Rutland,                                 
 U.K.                                                                   
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

    (2) * * *

                                                                        
------------------------------------------------------------------------
          Drug labeler code---                Firm name and address     
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
062408----.............................  Alstoe, Ltd., Animal Health, 19
                                          Foxhill, Whissendine, Oakham, 
                                          Rutland, U.K.                 
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

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. 522.1055  [Amended]

    4. Section 522.1055 Gleptoferron injection is amended in paragraph 
(b) by removing ``012525'' and adding in its place ``062408''.


Sec. 522.1182  [Amended]

    5. Section 522.1182 Iron dextran complex injection is amended in 
paragraph (a)(4)(i) by removing ``012525'' and adding in its place 
``062408''.

    Dated: April 15, 1996.
 Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-10546 Filed 4-26-96; 8:45 am]
BILLING CODE 4160-01-F