[Federal Register Volume 72, Number 128 (Thursday, July 5, 2007)]
[Rules and Regulations]
[Page 36595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524


New Animal Drugs; Change of Sponsor's Name; Liquid Crystalline 
Trypsin, Peru Balsam, Castor Oil

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor's name from Mylan 
Bertek Pharmaceuticals, Inc., to UDL Laboratories, Inc.

DATES: This rule is effective July 5, 2007.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Mylan Bertek Pharmaceuticals, Inc., 12720 
Dairy Ashford, Sugar Land, TX 77478, has informed FDA that it has 
changed its name to UDL Laboratories, Inc., and is using a new drug 
labeler code. Accordingly, the agency is amending the regulations in 21 
CFR 510.600(c) to reflect these changes. A conforming change is being 
made in 21 CFR 524.2620 for this sponsor's sole product.
    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.

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 
524 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 ``Mylan Bertek Pharmaceuticals, Inc.'' and alphabetically add a new 
entry for ``UDL Laboratories, Inc.''; and in the table in paragraph 
(c)(2) remove the entry for ``062749'' and numerically add a new entry 
for ``051079'' 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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                                * * * * *
UDL Laboratories, Inc., 12720 Dairy Ashford,  051079
 Sugar Land, TX 77478.
                                * * * * *
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    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
051079                        UDL Laboratories, Inc., 12720 Dairy
                              Ashford, Sugar Land, TX 77478
                                * * * * *
------------------------------------------------------------------------

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

0
3. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec.  524.2620  [Amended]

0
4. In paragraph (a)(2) of Sec.  524.2620, remove ``062794'' and add in 
its place ``051079''.

    Dated: June 21, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-13010 Filed 7-3-07; 8:45 am]
BILLING CODE 4160-01-S