Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the Start Printed Page 1523animal 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).
This rule is effective January 9, 2004.Start Further Info
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@example.com.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
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:End Amendment Part
(c) * * *
(1) * * *
|Firm name and address||Drug labeler code|
|* * * * *|
|Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500||068287|
|* * * * *|
(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 FEEDSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part Start Amendment Part
4. Section 558.311 is amended by adding paragraphs (b)(9) and (e)(1)(xix) to read as follows:End Amendment Part
(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) * * *
|Lasalocid sodium activity in grams per ton||Combination in grams per ton||Indications for use||Limitations||Sponsor|
|* * * * * * *|
|(xix) 300||Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain.||Feed continuously on a free-choice basis at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.||068287|
Dated: December 29, 2003.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 04-429 Filed 1-8-04; 8:45 am]
BILLING CODE 4160-01-S