Document ID: FDA-2012-N-0002-0026
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Monensin
Posted Date: 2012-09-19T04:00Z

[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Rules and Regulations]
[Pages 58021-58022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23065]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs for Use in Animal Feeds; Monensin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to remove a warning for growing cattle on pasture or 
in dry lot and to codify all monensin free-choice Type C medicated 
feeds in 21 CFR part 558. This action is being taken to improve the 
accuracy of the regulations.

DATES: This rule is effective September 19, 2012.

FOR FURTHER INFORMATION CONTACT: Christina C. Edwards, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8228, Email: 
christina.edwards@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug 
regulations for certain monensin free-choice Type C medicated feeds for 
growing cattle on pasture or in dry lot (slaughter, stocker, and feeder 
cattle; and dairy and beef replacement heifers) reflect a warning 
statement regarding the overdosing risk posed by uneaten free-choice 
feeds (refusals) that is unnecessary and not required on product 
labeling.
    Refusals of free-choice cattle feeds, including compressed blocks, 
granules, and liquids, are unlikely in practice to be fed to another 
group of cattle. These products are used almost exclusively in pasture-
based systems where the product is placed in the pasture with the 
animals and is left until consumed. In addition, it is extremely 
unlikely that these free-choice cattle feeds would be fed to another 
production class because these products generally are not appropriate 
for the nutritional needs of another production class.
    For these reasons, FDA is revising the regulations to exclude 
monensin free-choice Type C medicated feeds for growing cattle on 
pasture or in dry lot from the requirement to include a warning 
statement. This action is being taken to improve the accuracy of the 
regulations.
    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 520

    Animal drugs.

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 parts 520 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. Sec.  520.1448 and 520.1448a  [Removed]

0
2. Remove Sec. Sec.  520.1448 and 520.1448a.

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. In Sec.  558.355, revise paragraphs (d)(7)(vii), (d)(10)(i), and 
(d)(10)(ii); remove and reserve paragraph (f)(3)(v); redesignate 
paragraph (f)(7) as paragraph (f)(8); and add new paragraph (f)(7) to 
read as follows:

[[Page 58022]]

Sec.  558.355  Monensin.

* * * * *
    (d) * * *
    (7) * * *
    (vii) If feed refusals containing monensin are fed to other groups 
of cattle, the concentration of monensin in the refusals and amount of 
refusals fed should be taken into consideration to prevent monensin 
overdosing (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section).
* * * * *
    (10) * * *
    (i) Cattle (as described in paragraphs (f)(3)(i) through 
(f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i), 
(d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section. Paragraph 
(d)(7)(vii) of this section does not apply to free-choice Type C 
medicated feeds as defined in Sec.  510.455 of this chapter.
    (ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and 
(f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i), 
(d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section. Paragraph 
(d)(7)(vii) of this section does not apply to free-choice Type C 
medicated feeds as defined in Sec.  510.455 of this chapter.
* * * * *
    (f) * * *
    (7) Free-choice feeds--(i) Amount. 150 milligrams per pound of 
protein-mineral block (0.033 percent).
    (a) [Reserved]
    (b) Conditions of use--(1) Indications for use. For increased rate 
of weight gain; and for prevention and control of coccidiosis caused by 
Eimeria bovis and E. zuernii in pasture cattle (slaughter, stocker, 
feeder, and dairy and beef replacement heifers) which may require 
supplemental feed.
    (2) Limitations. Provide 50 to 200 milligrams of monensin (0.34 to 
1.33 pounds of block) per head per day, at least 1 block per 10 to 12 
head of cattle. Roughage must be available at all times. Do not allow 
animals access to other protein blocks, salt or mineral, while being 
fed this product. The effectiveness of this block in cull cows and 
bulls has not been established. See paragraph (d)(10)(i) of this 
section.
    (ii) Amount. 400 milligrams per pound of protein-mineral block 
(0.088 percent).
    (a) Sponsor. See No. 067949 in Sec.  510.600(c) of this chapter.
    (b) Conditions of use--(1) Indications for use. For increased rate 
of weight gain in pasture cattle (slaughter, stocker, feeder, and dairy 
and beef replacement heifers).
    (2) Limitations. Provide 80 to 200 milligrams of monensin (0.2 to 
0.5 pounds of block) per head per day, at least 1 block per 5 head of 
cattle. Feed blocks continuously. Do not feed salt or minerals 
containing salt. The effectiveness of this block in cull cows and bulls 
has not been established. See paragraph (d)(10)(i) of this section.
    (iii) Amount. 175 milligrams per pound of protein-mineral block 
(0.038 percent).
    (a) Sponsor. See No. 066071 in Sec.  510.600(c) of this chapter.
    (b) Conditions of use--(1) Indications for use. For increased rate 
of weight gain in pasture cattle (slaughter, stocker, and feeder).
    (2) Limitations. Provide 40 to 200 milligrams of monensin (0.25 to 
1.13 pounds or 4 to 18 ounces of block) per head per day, at least 1 
block per 4 head of cattle. Do not allow cattle access to salt or 
mineral while being fed this product. Ingestion by cattle of monensin 
at levels of 600 milligrams per head per day and higher has been fatal. 
The effectiveness of this block in cull cows and bulls has not been 
established. See paragraph (d)(10)(i) of this section.
    (iv) Amount. 400 milligrams per pound of block (0.088 percent).
    (a) Sponsor. See No. 051267 in Sec.  510.600(c) of this chapter.
    (b) Conditions of use--(1) Indications for use. For increased rate 
of weight gain in pasture cattle (slaughter, stocker, feeder, and dairy 
and beef replacement heifers).
    (2) Limitations. Provide 50 to 200 milligrams of monensin (2 to 8 
ounces of block) per head per day, at least 1 block per 5 head of 
cattle. Feed blocks continuously. Do not feed salt or mineral 
supplements in addition to the blocks. Ingestion by cattle of monensin 
at levels of 600 milligrams per head per day and higher has been fatal. 
The effectiveness of this block in cull cows and bulls has not been 
established. See paragraph (d)(10)(i) of this section.
* * * * *

    Dated: September 13, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-23065 Filed 9-18-12; 8:45 am]
BILLING CODE 4160-01-P