[Federal Register Volume 68, Number 119 (Friday, June 20, 2003)]
[Rules and Regulations]
[Pages 36912-36913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15618]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 524


Dosage Form New Animal Drugs; Change of Sponsor; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for four approved new 
animal drug applications (NADAs) from Anthony Products, Co. to Cross 
Vetpharm Group, Ltd.

DATES: This rule is effective June 20, 2003.

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: Anthony Products, Co., 5600 Peck Rd., 
Arcadia, CA 91006, has informed FDA that it has transferred ownership 
of, and all rights and interest in, the following four approved NADAs 
to Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, 
Ireland.

----------------------------------------------------------------------------------------------------------------
             NADA Number                           Trade Name                          21 CFR Section
----------------------------------------------------------------------------------------------------------------
049-187                               PHEN-BUTA (phenylbutazone) Vet        520.1720a
                                       Tablets;
                                      Phenylbutazone Tablets (Dogs)
----------------------------------------------------------------------------------------------------------------
122-447                               FURA-SEPTIN (nitrofurazone) Soluble   524.1580b
                                       Dressing
----------------------------------------------------------------------------------------------------------------
130-136                               Oxytocin Injection                    522.1680
----------------------------------------------------------------------------------------------------------------
140-582                               BIOCYL 50; BIOCYL 100                 522.1662a
                                       (oxytetracycline)
----------------------------------------------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in Sec. Sec.  
522.1662a, 522.1680, and 524.1580b (21 CFR 522.1662a, 522.1680, and 
524.1580b) to reflect the transfer of ownership. No amendment of 21 CFR 
520.1720a is necessary as each sponsor owns additional phenylbutazone 
products.
    In addition, Sec.  522.1662a is being revised to reflect current 
format. This action is being taken to improve consistency between 
sections of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because

[[Page 36913]]

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 Parts 522 and 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 522 and 
524 are amended as follows:

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

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

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


Sec.  522.1662a  [Amended]

0
2. Section 522.1662a Oxytetracycline hydrochloride injection is amended 
in paragraph (k)(2) by removing ``000864'' and by adding in its place 
``061623''.

0
3. Section 522.1680 is amended in paragraph (b) by removing ``000864'' 
and by numerically adding ``061623''; in paragraph (c) by removing the 
footnote; in paragraphs (c)(1)(i) and (c)(1)(ii) in the table headings 
by removing ``ml'' and by adding in its place ``mL''; and by revising 
paragraphs (a) and (c)(3) to read as follows:


Sec.  522.1680  Oxytocin injection.

    (a) Specifications. Each milliliter (mL) of solution contains 20 
USP units oxytocin.
* * * * *
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  524.1580b  [Amended]

0
5. Section 524.1580b Nitrofurazone ointment is amended in paragraph (b) 
by removing ``000864,''.

    Dated: June 3, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-15618 Filed 6-19-03; 8:45 am]
BILLING CODE 4160-01-S