Department of Health and Human Services May 7, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco.'' This guidance document discusses FDA's intended enforcement policies with respect to two provisions of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. One provision restricts the use of a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product. The second provision requires that labeling or print advertisements appear in a black-and-white text only format, except in certain ``adult only'' locations or in publications that do not have significant readership by children and adolescents under the age of 18. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

Under the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Notice is hereby given that an urgent single-source award will be made to Survivors of Torture International (SOTI), San Diego, CA, to provide comprehensive rehabilitative services to incoming Iraqi and other survivors of torture, who are in need of specialized services, to regain their health and independence and rebuild productive lives. In addition to providing direct services, SOTI will train area providers to effectively serve this population and leverage resources within the community. SOTI will also focus on building and sustaining collaboration among other providers to serve this population.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the University of Arkansas (UA) Institute of Food Science and Engineering, is announcing a public workshop entitled ``Food Protection Workshop.'' This public workshop is intended to provide information about food safety, food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to the Food Protection Plan as it relates to food establishments such as farms, manufacturers, processors, distributors, retailers, and restaurants.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.