[Federal Register Volume 74, Number 107 (Friday, June 5, 2009)]
[Rules and Regulations]
[Pages 26951-26952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13126]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Change of Sponsor; Fomepizole
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 a new animal drug
application (NADA) for fomepizole solution for injection from Jazz
Pharmaceuticals, Inc., to Paladin Labs (USA), Inc.
DATES: This rule is effective June 5, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Jazz Pharmaceuticals, Inc., 3180 Porter Dr.,
Palo Alto, CA 94304, has informed FDA that it has transferred ownership
of, and all rights and interest in, NADA 141-075 for ANTIZOL-VET
(fomepizole) to Paladin Labs (USA), Inc., 160 Greentree Dr., suite 101,
Dover, DE 19904. Accordingly, the agency is amending the regulations in
21 CFR 522.1004 to reflect the transfer of ownership.
Following these changes of sponsorship, Jazz Pharmaceuticals, Inc.,
is no longer the sponsor of an approved application. Accordingly, 21
CFR 510.600(c) is being amended to remove the entries for this sponsor.
In addition, Paladin Labs (USA), Inc., is not currently listed in
the animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
sponsor.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
Animal drugs.
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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
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1. The authority citation for 21 CFR part 510 continues to read as
follows
[[Page 26952]]
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
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2. In Sec. 510.600, in the table in paragraph (c)(1) remove the entry
for ``Jazz Pharmaceuticals, Inc.'' and alphabetically add a new entry
for ``Paladin Labs, Inc.''; and in the table in paragraph (c)(2) remove
the entry for ``068727'' and numerically add a new entry for ``046129''
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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* * * * *
Paladin Labs (USA), Inc., 160 Greentree Dr., 046129
suite 101, Dover, DE 19904
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
046129 Paladin Labs (USA), Inc., 160 Greentree
Dr., suite 101, Dover, DE 19904
* * * * *
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1004 [Amended]
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4. In paragraph (b) of Sec. 522.1004, remove ``068727'' and add in its
place ``046129''.
Dated: June 1, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-13126 Filed 6-4-09; 8:45 am]
BILLING CODE 4160-01-S