Department of Health and Human Services September 21, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled ``Marketed Unapproved DrugsCompliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs'' (CPG 440.100). CPG 440.100 describes how FDA intends to exercise its enforcement discretion with regard to drug products marketed in the United States that do not have required FDA approval for marketing. CPG 440.100 has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the CPG apply only to unapproved new drug products that are being commercially used or sold as of September 19, 2011. All unapproved new drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth in CPG 440.100.

In compliance with the requirement 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, 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. Proposed Collection: Title: Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI). Type of Information Collection Request: Reinstatement with change of a previously approved collection (OMB No. 0925-0405, expiration 02/28/2011). Need and Use of Information Collection: By conducting a fourth cohort follow-up survey in an ongoing cohort study of U.S. Radiologic Technologists (USRT), updated information will be collected on cancer and other medical outcomes, personal medical radiation procedures, and other risk factors from all participants, plus detailed employment data from subgroups of participants who performed or assisted with fluoroscopically-guided or radioisotope procedures. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 23,454 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. The fourth survey will be administered by mail to approximately 93,000 living and located cohort members who completed at least one of the three previous surveys to collect information on new cancers and other disease outcomes, detailed work patterns and practices from technologists who worked with radioisotopes and interventional radiography procedures, and new or updated risk factors that may influence health risks. New occupational and medical radiation exposure information will be used to improve radiation dose estimates. The annual reporting burden is reported in Table 1. There are no capital costs, operating costs and/or maintenance costs to report.

With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) requests public comment on the draft Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ Transplantation (Draft Guideline). The Draft Guideline can be found at https://www.regulations.gov under Docket No. CDC-2011-0011. Also found at the docket is a supporting document for reference, the Evidence Report. The Evidence Report includes primary evidence, studies, and data tables that were used by the Guideline authors in developing the recommendations in the Guideline. The Draft Guideline is for use by organ procurement organizations (OPOs); transplant centers, including physicians, nurses, administrators, and clinical coordinators; laboratory personnel responsible for testing and storing donor and recipient specimens; and persons responsible for developing, implementing, and evaluating infection prevention and control programs for OPOs and transplant centers. This Draft Guideline provides evidence-based recommendations for reducing unexpected transmission of HIV, HBV and HCV from deceased and living organ donors.