Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products
The Food and Drug Administration is announcing a public hearing entitled, “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.”
Purpose and Scope of the Meeting
The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public. For example, FDA would like comments on the scope of the four draft guidances, including the particular topics covered, the particular questions posed, whether there are additional issues for which guidance would be helpful, and whether FDA’s recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders. In addition, FDA welcomes comments that will enhance the usefulness and clarity of these documents. FDA recommends that comments exclude discussion of products that do not meet the definition of an HCT/P, such as platelet rich plasma and other blood products. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.
The public hearing will be held at the following location:
National Institutes of Health Campus
9000 Rockville Pike
Bethesda, MD 20882
Entrance for public workshop participants (non-NIH employees) is through the NIH Gateway Center located adjacent to the Medical Center Metro, where routine security check procedures will be performed. Please visit the following website for location, parking, security and travel information: http://www.nih.gov/about/visitor/index.htm
Persons (including FDA employees) seeking to view the hearing via a live Webcast are not required to register. A link to the Webcast will be made available on this web page.
Persons (including FDA employees) seeking to attend in person, or seeking to attend and speak at the public hearing must register by June 1, 2016 at https://www.eventbrite.com/e/part-15-hearing-on-draft-guidances-relating-to-the-regulation-of-hctps-registration-22921962206.
There is no onsite registration for this hearing. Early registration is recommended because seating is limited. FDA will notify registered speakers of their scheduled times, and make an agenda available on its website on or before July 1, 2016.
Sherri Revell or Loni Warren Henderson
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20990