[Federal Register Volume 61, Number 95 (Wednesday, May 15, 1996)]
[Rules and Regulations]
[Pages 24443-24444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12156]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 558
Animal Drugs, Feeds, and Related Products; Monensin
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 supplemental new animal drug
applications (NADA's) filed by Elanco Animal Health, Division of Eli
Lilly and Co., Moorman Manufacturing Co., and Farmland Industries, Inc.
Elanco's supplemental NADA provides for use of monensin Type C
medicated feeds fed to pasture cattle weighing less than 400 pounds
(lb) for increased rate of weight gain. Moorman's and Farmland's
supplemental NADA's provide for use of monensin blocks for pasture
cattle weighing less than 400 lb for increased rate of weight gain.
EFFECTIVE DATE: May 15, 1996.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, Division of Eli Lilly
and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed
supplemental NADA 95-735, which provides for use of monensin Type A
medicated articles to make monensin Type C medicated feeds containing
25 to 400 grams per ton monensin as monensin sodium to be fed at 50 to
200 milligrams per head per day to pasture cattle (slaughter, stocker,
feeder, and dairy and beef replacement heifers) weighing less than 400
lb for increased rate of weight gain. Moorman Manufacturing Co.,
Quincy, IL 62301, filed supplemental NADA 115-581, and Farmland
Industries, Inc., Kansas City, MO 64116, filed supplemental NADA 118-
509, providing for free-choice feeding of monensin blocks, all to
pasture cattle weighing less than 400 lb for increased rate of weight
gain.
The supplemental NADA's provide for removal of the restriction
concerning feeding of the products to animals weighing less than 400 lb
body weight as currently approved. The supplemental NADA's are approved
as of March 15, 1996, and the regulations are amended in 21 CFR
520.1448a(c) and 558.355(f)(3)(iii) and (f)(3)(v) to reflect the
approvals. The basis for approval is discussed in the freedom of
information summary for Elanco's supplemental NADA 95-735.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), approval of Elanco Animal
Health's supplemental NADA 95-735 qualifies for 3 years of marketing
exclusivity beginning March 15, 1996, because the supplement 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 of the product.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), approval of Moorman's
supplemental NADA 115-581 and Farmland's supplemental NADA 118-509 do
not qualify for marketing exclusivity because the supplements do not
contain reports of new clinical or field investigations (other than
bioequivalence or residue studies) or new human food safety studies
(other than bioequivalence or residue studies) essential to the
approval and conducted or sponsored by the applicant.
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.
The basis of approval of Moorman's and Farmland's supplemental
NADA's are by authorization to reference data and information in
Elanco's supplemental NADA 95-735. Therefore, a freedom of information
summary of the data and information required for approval of these
NADA's is available under Elanco's supplemental NADA 95-735.
The agency has determined under 21 CFR 25.24(d)(1)(i) 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
21 CFR Part 520
Animal drugs.
21 CFR Part 558 -
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under the authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and
558 are amended as follows:
[[Page 24444]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.1448a [Amended]
2. Section 520.1448a Monensin blocks is amended in paragraph
(c)(4)(iii) by removing the phrase ``weighing more than 400 pounds''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. 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).
Sec. 558.355 [Amended]
4. Section 558.355 Monensin is amended in paragraph (f)(3)(iii)(b)
and (f)(3)(v)(b) by removing the phrase ``weighing more than 400
pounds''.
Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-12156 Filed 5-14-96; 8:45 am]
BILLING CODE 4160-01-F
