Department of Health and Human Services August 23, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the record retention requirement of the soy protein/coronary heart disease health claim.

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 Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Participants for Delayed Adverse Events,'' dated August 2005. The draft guidance provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in participants who have been exposed to gene therapy products. When finalized, this guidance will supplement the recommendations in the ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors'' (Retroviral Vector guidance), dated October 2000, for study participant long-term followup. However, the recommendations in the Retroviral Vector guidance regarding the length of followup will be superseded by this Gene Therapy Clinical Trials guidance.