[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Rules and Regulations]
[Pages 4735-4736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2688]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 61, No. 27 / Thursday, February 8, 1996 /
Rules and Regulations
[[Page 4735]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor Name and Address
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 from
DuPont Pharmaceuticals to DuPont Merck Pharmaceutical Co.
EFFECTIVE DATE: February 8, 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: DuPont Pharmaceuticals, One Rodney Square,
Wilmington, DE 19898, has informed FDA of a change of sponsor name and
address to DuPont Merck Pharmaceutical Co., DuPont Merck Plaza, MR2117,
Wilmington, DE 19805. 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 for ``DuPont Pharmaceuticals '' and by
alphabetically adding a new entry for ``DuPont Merck Pharmaceutical
Co.,'' and in the table in paragraph (c)(2) in the entry for ``000056''
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) * * *
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Firm name and address-- Drug labeler code
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* * * *
* * *
DuPont Merck Pharmaceutical Co., 000056
DuPont Merck Plaza, MR2117,
Wilmington, DE 19805.
* * * *
* * *
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--(2)-* * *
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Drug labeler code----- Firm name and address
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* * * *
* * *
000056----............................ DuPont Merck Pharmaceuticals
Co., DuPont Merck Plaza,
MR2117, Wilmington, DE 19805
* * * *
* * *
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[[Page 4736]]
Dated: February 1, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-2688 Filed 2-7-96; 8:45 am]
BILLING CODE 4160-01-F