Department of Health and Human Services March 2007 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Allied Chemical Corporation Plant in Metropolis, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 1, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

AHRQ invites nominations of topics for evidence reports, technology assessments, and comparative and effectiveness reviews conducted by its Evidence-based Practice Centers (EPC) Program relating to the prevention, diagnosis, treatment and management of common diseases and clinical condition, as well as, topics relating to the organization and financing of health care. Previous evidence reports and comparative effectiveness reviews can be found at https:// www.ahrq.gov/clinic/epcix.htm and https://effective healthcare.ahrq.gov/ products/progress.cfm, respectively.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and the FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.'' This guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common inappropriate practices. Special attention is given to describing a practice called discrepant resolution and its associated problems.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) are seeking sponsors interested in participating in a pilot project to test the submission of case report form (CRF) data provided electronically in extensible markup language (XML) based on the Operational Data Model (ODM) developed by the Clinical Data Interchange Standards Consortium (CDISC). This pilot will test the ability of a new data format to support all review activity, which our current submission format is incapable of doing. Data supplied in ODM format by sponsors during the pilot project will not replace any regulatory requirements for submitting CRFs. We anticipate that a successful pilot will allow CDER and CBER to routinely accept CRFs from studies employing electronic data capture (EDC) in ODM format in marketing applications provided in electronic format.