Department of Health and Human Services August 16, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Experimental Study: Disease Information in Branded Promotional Material.'' The proposed research will explore the nature of including information about a disease and promotional information about a specific drug treatment in the same advertising piece.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Hung Ta Fan for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Fan was convicted of a felony under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Fan was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 13, 2011 (30 days after receipt of the notice), Mr. Fan had not responded. Mr. Fan's failure to respond constitutes a waiver of his right to a hearing concerning this action.

Notice is hereby given that an urgent single-source grant is awarded to Survivors of Torture, International (SOTI), San Diego, CA. The grant will support direct services to persons who have experienced trauma or torture prior to their arrival in the United States. The grant will serve San Diego County, which is the area that has received the greatest number of Iraqi refugee arrivals, as well as a high percentage of other refugees and asylum-seekers. The grantee, SOTI, will provide comprehensive rehabilitative services to Iraqi and other survivors of torture, who are in need of specialized services that will enable these survivors to regain their health and independence and rebuild productive lives. In addition to provision of direct services, SOTI will train other area service providers to more effectively serve this population. SOTI will also focus on sustaining collaborations among providers serving this population. According to the Department of Homeland Security (DHS), in FY 2009, twenty-eight percent of the country's asylum-seekers came to California for resettlement. In 2010, a total of 3,663 refugees were resettled in San Diego. At least 159,550 refugees, asylees, and asylum-seekers in San Diego have come from areas where torture may be practiced. San Diego's numbers include an influx in Iraqi refugees, as one in four Iraqi refugees has resettled in California, with the vast majority resettling in San Diego. SOTI is the only program in San Diego County that provides medical affidavits for torture survivors to use in claiming asylum. They have also reported an 84 percent increase in client intakes during fiscal years (FYs) 2009 and 2010. As a result, an urgent need exists for specialized services for individuals in San Diego who have suffered torture prior to their arrival in the United States. SOTI is well positioned to provide medical, psychological, social, and legal services to Iraqis who have suffered torture and are relocated in the San Diego area. SOTI has developed a large network of pro bono service providers and possesses the clinical and programmatic expertise to serve survivors of torture. For Further Information Contact: Ronald Munia, Director, Division of Community Resettlement, Office of Refugee Resettlement, 901 D Street, SW., Washington, DC 20047. Telephone: 202-401-4559. E-mail: Ronald.Munia@acf.hhs.gov.