[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Rules and Regulations]
[Pages 46547-46548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22486]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 510
New Animal Drugs; Change of Sponsor Name and Address
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 name and address from
Roussel-UCLAF to Roussel-UCLAF SA.
EFFECTIVE DATE: September 4, 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: Roussel-UCLAF, Division Agro-Veterinaire,
163 Avenue Gambetta, 75020 Paris, France, has informed FDA of a change
of sponsor name and address to Roussel-UCLAF SA, Animal Health
Division, 102 Route de Noisy, 93235 Romainville Cedex, France.
Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) to reflect the change of sponsor name and
address.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 part 510 is
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 ``Roussel-UCLAF'' and adding in its place a new
entry for ``Roussel-UCLAF SA'' and in the table in paragraph (c)(2) in
the entry for ``012579'' by revising the sponsor name and address 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
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Roussel-UCLAF SA, Animal Health Division,
102 Route de Noisy, 93235 Romainville
Cedex, France 012579
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
(2) * * *
[[Page 46548]]
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * *
* * *
012579................................. Roussel-UCLAF SA, Animal Health
Division, 102 Route de Noisy,
93235 Romainville Cedex,
France.
* * * *
* * *
------------------------------------------------------------------------
Dated: August 20, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-22486 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F