Department of Health and Human Services August 12, 2014 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting September 9-10, 2014. The meeting is open to the public. However, pre-registration is required for both public attendance and public comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac. Participants may also register by emailing nvpo@hhs.gov or by calling 202-690-5566 to provide your name, organization, and email address.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On September 22, 2006, then Secretary of Homeland Security, Michael Chertoff, determined pursuant to section 319F-2 of the Public Health Service Act, 42 U.S.C. 247d-6b, that the Ebola virus presents a material threat against the United States population sufficient to affect national security. On the basis of this determination, on August 4, 2014 the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement beverages 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 feedings. We are taking this action in response to a petition filed by Abbott Laboratories (Abbott).