Department of Health and Human Services May 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Useful Written Consumer Medication Information (CMI).'' CMI is written information developed for consumers about prescription drugs that is distributed to consumers when they have prescriptions filled. The guidance discusses general issues and makes recommendations on the content of useful written CMI.

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA), are soliciting public review and comment on a proposed research protocol entitled ``Precursor Preference in Surfactant Synthesis of Newborns.'' The proposed research would be conducted at the St. Louis Children's Hospital and supported by the National Heart, Lung and Blood Institute. Public review and comment are solicited regarding the proposed research protocol under the requirements of HHS and FDA regulations.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antiviral Drug DevelopmentConducting Virology Studies and Submitting the Data to the Agency.'' This guidance is being issued to assist sponsors in developing and submitting nonclinical and clinical virology data, which are important to support clinical trials of antiviral agents. Nonclinical and clinical virology reports are essential components in the review of investigational antiviral drugs. The information in this guidance will facilitate the development of antiviral drug products.

This notice announces the establishment of the Medicaid Commission and discusses the group's purpose and charter. It also solicits nominations for members.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Colorectal Cancer (CRC) is the second leading cause of cancer-related deaths in the United States, following lung cancer (1-American Cancer Society 2005, see Attachment D). Strong scientific evidence indicates that regular screening is effective in reducing CRC incidence and mortality (2Mandel 1993, 3Mandel 2000, 4Selby 1992, 5Kronburg 1996, 6Hardcastle 1996, see Attachment D). Screening rates for CRC are currently lower than other cancer screening services (7Seeff 2004). CRC screening is already occurring in some communities, either in an organized or an opportunistic setting. Some communities are planning to begin screening, but are still building their infrastructure and/or resources. The Centers for Disease Control and Prevention (CDC) announce the availability of funds in fiscal year (FY) 2005 for three to five cooperative agreements to implement demonstration programs designed to increase population-based CRC screening among persons 50 years and older in a geographically defined area, with screening efforts focused on persons 50 years and older with low incomes and inadequate or no health insurance coverage for CRC screening (priority population). Applicants will need to define the geographic area that their program will cover. Applicants will be asked to describe their current CRC screening efforts and to define what they need to increase CRC screening rates in these two populations: (1) The larger geographically-defined population; and (2) the priority sub-population within that geographically- defined area. CDC will choose among applicants based on specific evaluation criteria described in this RFA. These will be three year demonstration programs, pending availability of funds.