[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Proposed Rules]
[Page 13232]
[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,<PHONE_NUMBER>.

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