[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
