[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Rules and Regulations]
[Pages 28265-28266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4534]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


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 Orphan 
Medical, Inc., to Jazz Pharmaceuticals, Inc. The regulations are also 
being amended to reflect approval of a supplemental NADA to remove a 
vial of saline diluent from this product.

DATES: This rule is effective May 16, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

[[Page 28266]]


SUPPLEMENTARY INFORMATION: Orphan Medical, Inc., 13911 Ridgedale Dr., 
suite 475, Minnetonka, MN 55305, has informed FDA that it has 
transferred ownership of, and all rights and interest in, NADA 141-075 
for ANTIZOL-VET (fomepizole) to Jazz Pharmaceuticals, Inc., 3180 Porter 
Dr., Palo Alto, CA 94304. A supplement was also filed to NADA 141-075 
to remove a vial of saline diluent from this product. The supplemental 
NADA is approved as of April 18, 2006, and the regulations are amended 
in 21 CFR 522.1004 to reflect the change of sponsorship, the removal of 
a vial of saline diluent from the product, and a current format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    Following these changes of sponsorship, Orphan Medical, Inc., is no 
longer the sponsor of an approved application. Accordingly, 21 CFR 
510.600(c) is being amended to remove the entries for Orphan Medical, 
Inc.
    The agency has determined under 21 CFR 25.33(d)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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.

0
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

0
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.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Orphan Medical, Inc.'' and alphabetically add a new entry for 
``Jazz Pharmaceuticals, Inc.''; and in the table in paragraph (c)(2) 
remove the entry for ``062161'' and numerically add a new entry for 
``068727'' 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
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                                * * * * *
Jazz Pharmaceuticals, Inc., 3180 Porter Dr.,  068727
 Palo Alto, CA 94304.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
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                                * * * * *
068727                       Jazz Pharmaceuticals, Inc., 3180 Porter
                              Dr., Palo Alto, CA 94304
                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
4. In Sec.  522.1004, revise paragraphs (a), (b), (c)(1), and (c)(3) to 
read as follows:


Sec.  522.1004  Fomepizole.

    (a) Specifications. Each vial contains 1.5 grams fomepizole (1.5 
milliliter (mL) of 1.0 gram per mL solution).
    (b) Sponsor. See No. 068727 in Sec.  510.600(c) of this chapter.
    (c) * * *
    (1) Amount. 20 milligrams per kilogram (mg/kg) of body weight 
intravenously initially, followed by 15 mg/kg at 12 and 24 hours, and 5 
mg/kg at 36 hours.
* * * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-4534 Filed 5-15-06; 8:45 am]
BILLING CODE 4160-01-S