Department of Health and Human Services September 25, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small-Packaged Cigars.'' The guidance is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in FDA's regulations deeming other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance describes FDA's compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The guidance explains that FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a guidance entitled ``Minutes of Institutional Review Board Meetings; Guidance for Institutions and Institutional Review Boards.'' The guidance is intended for institutions and Institutional Review Boards (IRBs) that are responsible for the review and oversight of human subject research conducted or supported by the U.S. Department of Health and Human Services (HHS) or regulated by FDA. The purpose of the guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings (also referred to in the guidance as minutes) that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The guidance also provides general recommendations on the type and amount of information to be included in the minutes. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2015.

The Food and Drug Administration (FDA or we) is announcing that Idemitsu Kosan, Cp. Ltd. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as a carrier for flavors for use in animal feed.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.