[Federal Register Volume 61, Number 166 (Monday, August 26, 1996)]
[Rules and Regulations]
[Pages 43654-43656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21654]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs For Use In Animal Feeds; Bambermycins
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 Hoechst-Roussel Agri-Vet Co. The
supplemental NADA provides for using bambermycins Type A medicated
articles to make a bambermycins free-choice Type C medicated loose
mineral feed for pasture cattle (slaughter, stocker, and feeder) for
increased rate of weight gain.
EFFECTIVE DATE: August 26, 1996.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0217.
[[Page 43655]]
SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Rt. 202-206,
P.O. Box 2500, Somerville, NJ 08876-1258, filed supplemental NADA 141-
034, which provides for using 10-grams per pound (g/lb)
Flavomycin (bambermycins) Type A medicated articles to make
free-choice Type C medicated loose mineral feeds containing 120 g/ton
bambermycins for pasture cattle (slaughter, stocker, and feeder). The
Type C feeds are fed at 10- to 20-milligrams (mg) bambermycins per head
per day for increased rate of weight gain. The supplemental NADA is
approved as of August 26, 1996, and the regulations are amended in 21
CFR 558.95(b)(4)(iii) to reflect the approval. The basis of approval is
discussed in the freedom of information summary.
-As required by 21 CFR 510.455, use of a Type A medicated article
to make a free-choice Type C medicated feed/medicated loose mineral
feed requires an approved Form FDA 1900.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
-Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies
for 3 years of marketing exclusivity beginning August 26, 1996, because
it contains reports of new clinical or field investigations (other than
bioequivalence or residue studies) essential to the approval and
conducted or sponsored by the applicant. Marketing exclusivity applies
only to the new use.
The agency has determined under 21 CFR 25.24(d)(1)(iii) 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: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
-2. Section 558.95 is amended by adding new paragraph (b)(4)(iii)
to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
-(b) * * *
-(4) * * *
-(iii) Used as a free-choice Type C medicated loose mineral feed
for pasture cattle (slaughter, stocker, and feeder) as follows:
-(a) Specifications.
------------------------------------------------------------------------
Ingredient International Feed No. Percent
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Deflorinated phosphate
(20.5% calcium, 18.5%
phosphorus) 6-01-080 42.50
Sodium chloride (salt) 6-04-152 20.10
Calcium carbonate (38%
calcium) 6-01-069 15.24
Corn distillers dried
grains w/solubles 5-28-236 9.57
Magnesium oxide 6-02-756 5.15
Vitamin and trace
mineral premix * ......... 3.72
Mineral oil ......... 1.00
Yeast (primary
dehydrated yeast) 7-05-533 0.75
Bambermycins Type A
article (10 g/lb) ......... 0.60
Iron oxide 6-02-431 0.50
Magnesium sulfate
(67%) 6-02-758 0.32
Selenium premix (270
mg/lb) * ......... 0.21
Copper sulfate 6-01-720 0.18
Potassium sulfate
(0.33%) 6-06-098 0.16
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*Content of vitamin/trace mineral premix may be varied. However, they
should be comparable to those used for other free-choice feeds.
Formulation modifications require FDA approval prior to marketing.
Selenium must comply with 21 CFR 573.920. Ethylenediamine
dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
Sec. 651.100 (CPG 7125.18).
[[Page 43656]]
-(b) Amount per ton. 120 grams.
-(c) Indications for use. For increased rate of weight gain.
-(d) Limitations. For free-choice feeding to pasture cattle
(slaughter, stocker, and feeder). Feed a nonmedicated commercial
mineral product for 6 weeks to stabilize consumption between 2.66 and
5.33 ounces per head per day. Feed continuously to provide 10- to 20-
milligrams bambermycins per head per day. Not for use in animals
intended for breeding. Each use of this free-choice Type C medicated
feed must be the subject of an approved Form FDA 1900 as required by 21
CFR 510.455.
* * * * *
Dated: August 16, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-21654 Filed 8-23-96; 8:45 am]
BILLING CODE 4160-01-F
