Department of Health and Human Services April 3, 2012 – Federal Register Recent Federal Regulation Documents

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires the Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS), to prepare and to periodically revise toxicological profiles on hazardous substances. ATSDR is initiating the development of its 26th set of toxicological profiles (CERCLA Set 26). This notice announces the list of substances that will be evaluated for CERCLA Set 26 toxicological profile development. ATSDR's Division of Toxicology and Human Health Sciences (proposed) is soliciting public nominations from the list of substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional substances that are not included on this list that may have public health implications, on the basis of ATSDR's authority to prepare toxicological profiles for substances not found at sites on the National Priorities List. The agency will do so in order to ``* * * establish and maintain inventory of literature, research, and studies on the health effects of toxic substances'' under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and to support the site- specific response actions conducted by ATSDR, as otherwise necessary.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information Under the Affordable Care Act.'' This draft guidance is intended to provide information regarding the Agency's implementation of the drug sample transparency reporting provisions of section 6004 of the Patient Protection and Affordable Care Act. The draft guidance notifies entities covered by the reporting obligations in section 6004 that FDA does not intend to object until at least October 1, 2012, if manufacturers and authorized distributors of record (ADRs) do not submit information under those reporting provisions and that the Agency intends to provide notice before revising its exercise of discretion with respect to compliance.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act.'' The purpose of this draft guidance is to assist persons reporting to FDA the quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance explains that FDA does not intend, at this time, to enforce reporting on the entire established HPHC list where a manufacturer or importer completes testing and reporting for an abbreviated list of HPHCs within the timeframes specified in the guidance.