[Federal Register Volume 64, Number 84 (Monday, May 3, 1999)]
[Rules and Regulations]
[Pages 23539-23540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10983]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline 
Hydrochloride

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by PennField Oil Co. The supplemental NADA 
provides for a revised withdrawal period of 1-day following feeding of 
Type B and Type C chlortetracycle feeds to cattle.

EFFECTIVE DATE: May 3, 1999

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: PennField Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, is the sponsor of NADA 138-935 that provides for 
feeding Type B and Type C chlortetracycline medicated feeds to poultry 
cattle, swine, and sheep. The firm has filed a supplemental NADA that 
provides for a revised withdrawal period of 1-day in cattle. The 
supplemental NADA is approved as of March 24, 1999, and the regulations 
are amended in 21 CFR 558.128 to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(3) 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.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    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 part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.128  [Amended]

    2. Section 558.128 Chlortetracycline is amended in the table in 
paragraph (d)(1) in entries (xi) and (xvii) by revising the entry under 
the ``Limitations'' column, and in entry (xii) by revising the entry 
under the ``Indications for use'' column to read as follows:
    (d)(1) * * *

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Chlortetracycline amount            Combination               Indications for use                      Limitations                    Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
              *                    *                    *                    *                    *                    *                    *
(xi) * * *                            * * *                * * *                                 Withdraw 48 h prior to slaughter.    * * *
                                                                                                  For sponsor 000004 zero withdrawal
                                                                                                  time. For sponsor 053389 1 d
                                                                                                  withdrawal time.
(xii) * * *                           * * *                1. Calves, beef and nonlactating      * * *                                * * *
                                                            dairy cattle; treatment of
                                                            bacterial enteritis caused by E.
                                                            coli and bacterial pneumonia caused
                                                            by P. multocida organisms
                                                            susceptible to chlortetracycline.
                                                            For sponsor 053389 1 d withdrawal
                                                            time.
                                                           2. * * *
 
              *                    *                    *                    *                    *                    *                    *
(xvii) * * *                          * * *                * * *                                 Withdraw 48 h prior to slaughter.    * * *
                                                                                                  For sponsor 000004 zero withdrawal
                                                                                                  time. For sponsor 053389 1 d
                                                                                                  withdrawal time.
 
              *                    *                    *                    *                    *                    *                    *
 
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 23540]]

* * * * *

    Dated: April 22, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-10983 Filed 4-30-99; 8:45 am]
BILLING CODE 4160-01-F