
[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Proposed Rules]
[Page 13232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2012-F-0138]


Abbott Laboratories; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Abbott Laboratories has filed a petition proposing that the food 
additive regulations be amended to provide for the expanded safe use of 
vitamin D3 as a nutrient supplement in food.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a 
food additive petition (FAP 2A4788) has been filed by Abbott 
Laboratories, 3300 Stelzer Rd., Columbus, OH 43219. The petition 
proposes to amend Sec.  172.380 (21 CFR 172.380) to provide for the 
safe use of vitamin D3 as a nutrient supplement in meal 
replacement beverages and meal replacement bars that are not intended 
for special dietary use in reducing or maintaining body weight and for 
use in foods that are sole sources of nutrition for enteral tube 
feeding.
    The Agency has determined under 21 CFR 25.32(k) 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.

    Dated: February 29, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2012-5314 Filed 3-5-12; 8:45 am]
BILLING CODE 4160-01-P


