[Federal Register Volume 69, Number 6 (Friday, January 9, 2004)]
[Rules and Regulations]
[Pages 1522-1524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-429]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


New Animal Drugs; Lasalocid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the

[[Page 1523]]

animal drug regulations to reflect approval of a new animal drug 
application (NADA) filed by Ridley Block Operations, Inc. The NADA 
provides for the use of a lasalocid Type A medicated article to 
manufacture free-choice, Type C medicated protein feed blocks used for 
increased rate of weight gain in pasture cattle (slaughter, stocker, 
feeder cattle, and dairy and beef replacement heifers).

DATES: This rule is effective January 9, 2004.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Ridley Block Operations, Inc., 424 North 
Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500, filed NADA 141-
187 that provides for use of BOVATEC 68 (lasalocid) Type A medicated 
article to manufacture CRYSTALYX IONO-LYX, free-choice Type C medicated 
protein feed blocks containing 300 grams lasalocid per ton. The free-
choice medicated feed protein block is used for increased rate of 
weight gain in pasture cattle (slaughter, stocker, feeder cattle, and 
dairy and beef replacement heifers). The NADA is approved as of 
December 12, 2003, and the regulations are amended in 21 CFR 558.311 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In addition, Ridley Block Operations, 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) is being amended to add 
entries for the firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning.
    The agency has determined under 21 CFR 25.33(a)(6) 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 558

    Animal drugs, Animal feeds.

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 
558 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. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Ridley Block Operations Inc.'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``068287'' 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
------------------------------------------------------------------------
                                * * * * *
Ridley Block Operations Inc., 424 North       068287
 Riverfront Dr., P.O. Box 8500, Mankato, MN
 56002-8500.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
068287                       Ridley Block Operations Inc., 424 North
                              Riverfront Dr., P.O. Box 8500, Mankato, MN
                              56002-8500
                                * * * * *
------------------------------------------------------------------------

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

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
4. Section 558.311 is amended by adding paragraphs (b)(9) and 
(e)(1)(xix) to read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (b) * * *
    (9) 15 percent activity to No. 068287 for use in free-choice 
protein blocks for cattle as in paragraphs (e)(1)(xix) of this section.
* * * * *
    (e) * * *
    (1) * * *

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   Lasalocid sodium
 activity in grams per    Combination in grams      Indications for use           Limitations          Sponsor
          ton                   per ton
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                                                  * * * * * * *
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(xix) 300               .......................  Pasture cattle            Feed continuously on a         068287
                                                  (slaughter, stocker,      free-choice basis at a
                                                  feeder cattle, and        rate of not less than
                                                  dairy and beef            60 mg nor more than 200
                                                  replacement heifers):     mg of lasalocid per
                                                  for increased rate of     head per day.
                                                  weight gain.
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    Dated: December 29, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 04-429 Filed 1-8-04; 8:45 am]
BILLING CODE 4160-01-S