[Federal Register Volume 78, Number 241 (Monday, December 16, 2013)]
[Rules and Regulations]
[Pages 76059-76060]
From the Federal Register Online via the Government Publishing 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: [email protected].
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]
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