[Federal Register Volume 65, Number 112 (Friday, June 9, 2000)]
[Rules and Regulations]
[Pages 36615-36616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14464]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's 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's address for Medicis
Dermatologics, Inc.
DATES: This rule is effective June 9, 2000.
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: Medicis Dermatologics, Inc., 4343 East
Camelback Rd., suite 250, Phoenix, AZ 85018-2700, has informed FDA of a
change of sponsor's address to 8125 North Hayden Rd., Scottsdale, AZ
85258. Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) to reflect the change of sponsor's address.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
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: 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
revising the entry for ``Medicis Dermatologics, Inc.'' and in the table
in paragraph (c)(2) by revising the entry for ``099207'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 36616]]
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Firm name and address Drug labeler code
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* * * *
* * *
099207 Medicis Dermatologics, Inc., 8125
North Hayden Rd., Scottsdale, AZ
85258
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
099207 Medicis Dermatologics, Inc., 8125
North Hayden Rd., Scottsdale, AZ
85258
* * * *
* * *
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Dated: May 29, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 00-14464 Filed 6-8-00; 8:45 am]
BILLING CODE 4160-01-F