[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Rules and Regulations]
[Pages 46368-46369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22198]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Change of 
Sponsor

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 for an approved new 
animal drug application (NADA) from Dow B. Hickam, Inc., to Bertek 
Pharmaceuticals, Inc.

DATES: This rule is effective September 5, 2001.

FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION: Dow B. Hickam, Inc., Pharmaceuticals, P.O. 
Box 35413, Houston, TX 77035, has informed FDA that it has transferred 
to Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 
77478, ownership of, and all rights and interests in NADA 39-583. 
Accordingly, the agency is amending the regulations in 21 CFR 524.2620 
to reflect the transfer of ownership.
    In addition, Bertek Pharmaceuticals, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c)(1) and (c)(2) is being 
amended to add entries for the firm.
    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 524

    Animal drugs.

    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 
524 are 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 
removing the entry for ``Dow B. Hickam, Inc.'' and by alphabetically 
adding an entry for ``Bertek Pharmaceuticals, Inc.'' and in the table 
in paragraph (c)(2) by removing the entry for ``000514'' and by 
numerically adding an entry for ``062794'' 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
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
Bertek Pharmaceuticals, Inc., 12720  062794
 Dairy Ashford, Sugar Land, TX
 77478
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

    (2) * * * 

------------------------------------------------------------------------
         Drug labeler code                   Firm name and address
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
062794                               Bertek Pharmaceuticals, Inc., 12720
                                      Dairy Ashford, Sugar Land, TX
                                      77478
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------


[[Page 46369]]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec. 524.2620  [Amended]

    4. Section 524.2620 Liquid crystalline trypsin, Peru balsam, castor 
oil is amended in paragraph (a)(2) by removing ``000514'' and adding in 
its place ``062794''.

    Dated: August 23, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-22198 Filed 9-4-01; 8:45 am]
BILLING CODE 4160-01-S