
[Federal Register Volume 78, Number 241 (Monday, December 16, 2013)]
[Rules and Regulations]
[Pages 76059-76060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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


New Animal Drugs for Use in Animal Feeds; Bambermycins

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 dairy replacement heifers from the pasture 
cattle class for which free-choice, loose-mineral medicated feeds 
containing bambermycins are approved. This action is being taken 
because a level of selenium for inclusion in such feeds has not been 
established for dairy cattle under the food additive regulation for 
selenium.

DATES: This rule is effective December 16, 2013.

FOR FURTHER INFORMATION CONTACT: Amey L. Adams, Center for Veterinary 
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8108, email: amey.adams@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug 
regulations for bambermycins free-choice, loose-mineral Type C 
medicated feeds for pasture cattle (slaughter, stocker, and feeder 
cattle; and dairy and beef replacement heifers) specify formulations 
including trace mineral premixes that include selenium. However, the 
food additive regulation for selenium in salt-mineral mixtures for 
free-choice feeding (21 CFR 573.920(c)(3)) does not provide for use in 
dairy cattle. For this reason, FDA is revising the regulations to 
remove dairy replacement heifers from the pasture cattle class for 
which free-choice medicated feeds containing bambermycins are approved. 
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 in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

[[Page 76060]]

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

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

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


0
2. In Sec.  558.95, revise the introductory text in paragraphs 
(d)(4)(iii) and (d)(4)(iv), and the first sentence in paragraph 
(d)(4)(iii)(d) to read as follows:


Sec.  558.95  Bambermycins.

* * * * *
    (d) * * *
    (4) * * *
    (iii) Used as a free-choice Type C medicated loose-mineral feed for 
pasture cattle (slaughter, stocker, and feeder cattle; and beef 
replacement heifers) as follows:
* * * * *
    (d) Limitations. For free-choice feeding to pasture cattle 
(slaughter, stocker, and feeder cattle; and beef replacement heifers). 
* * *
    (iv) Use free-choice Type C medicated feeds for pasture cattle 
(slaughter, stocker, and feeder cattle; and beef replacement heifers) 
as follows:
* * * * *

    Dated: December 11, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-29810 Filed 12-13-13; 8:45 am]
BILLING CODE 4160-01-P


