Children's Online Privacy, March 1, 2010, Closing Date -- FTC is seeking comments on proposed self-regulatory guidelines submitted by i-SAFE, Inc. under the safe harbor provision of the Children's Online Privacy Protection Rule. The Rule contains a ''safe harbor'' provision enabling industry groups or others to submit to the Commission for approval self-regulatory guidelines that would implement the Rule's protections.
Informed Consent Elements, March 1, 2010, Closing Date -- FDA is seeking comments on a proposed rule that, if finalized, would amend the informed consent regulations to require that the informed consent documents and processes for applicable drug, biologic and device clinical investigations include a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank.
Food Product Tracing Systems, March 3, 2010, Closing Date -- The FDA, together with the Food Safety and Inspection Service (FSIS), is seeking comments on mechanisms to enhance product tracing systems for food.
510(k) Review Process, March 5, 2010, Closing Date -- FDA is seeking comments on a number of identified challenges associated with the 510(k) process.
IRB Continuing Review, March 15, 2010, Closing Date -- FDA is seeking comments on a draft guidance entitled ''Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval.'' The draft guidance announced in this notice is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.
Organic Crop Substances, March 15, 2010, Closing Date -- The Agricultural Marketing Service is seeking comments on a proposed rule that would amend the U.S. Department of Agriculture's (USDA's) National List of Allowed and Prohibited Substances to reflect recommendations submitted to the Secretary of Agriculture by the National Organic Standards Board (NOSB).
Abuse Potential of Drugs, March 29, 2010, Closing Date -- FDA is seeking comments on its draft guidance for industry entitled ''Assessment of Abuse Potential of Drugs.'' This draft guidance is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act.