Regulacje i polityka gospodarcza · 8.10.2008

Proposed Collection; Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), 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: Information Program on Clinical Trials: Maintaining a Registry and Results Databank; Type of Information Collection Request: Revision of currently approved collection [OMB No. 0925-0586, expiration date 01/31/2009], Form Number: NA; Need and Use of Information Collection: The National Institutes of Health is modifying the clinical trial registry databank established under previous law [FDAMA, Section 113] to comply with provisions of Title VIII of Public Law 110-85 (Food and Drug Administration Amendments Act of 2007). The databank collects specified registration and results information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials,