Vaccines, Blood & Biologics
Revised Instructions for Listing Other HCT/Ps on Form 3356 or in eHCTERS
Purpose: Many HCT/Ps are not specifically listed on the Form FDA 3356 or in eHCTERs and establishments are adding them utilizing various spellings and formats (currently we have a listing of over 70 “other products” that establishments have written in). IMC our database contractors suggested a limited dropdown menu to alleviate these variations and to address problems where establishments are listing products that are not HCT/Ps. The following attempts to address these issues. Once the drop down menu is implemented in eHCTERS, DHT will address the listings that don't conform by contacting the establishments.
1. New drop down menu for listing HCT/Ps that are not printed on Form FDA 3356 and not otherwise listed in eHCTERS
- Amniotic Membrane
- Cardiac Tissue, Non-valved
- Nerve Tissue
- Ovarian Tissue
- Pancreatic Islet Cells, autologous
- Testicular Tissue
- Therapeutic Cells
- Tooth Pulp
2. New Instructions for the drop down menu: Add under HCT/P Listing Information Screen
If your HCT/P is not listed on the screen, click the Add Other HCT/Ps button
Note that the intent of HCT/P listing is to capture general types of HCT/Ps that you are currently manufacturing. On the drop down menu indicate the HCT/P you wish to add to your HCT/P listing. If you do not see the HCT/P on the menu, you will need to email FDA to request that we add this HCT/P to the drop down menu listing. Email email@example.com with this request. You should save the registration and listing information you have entered to date, and await a response from FDA before completing your registration.
Note that whole hearts or whole eyes are source material for HCT/Ps and should not be listed (e.g., lists as heart valves, cornea, sclera). You should only list HCT/Ps that are intended for implantation, transplantation, infusion or transfer into a human recipient. See HCT/P definition at 21 CFR Part 1271.3 (d).
Note that the drop down menu is limited. The following information may assist you determine how to list your HCT/Ps:
- Bone marrow: Note that minimally manipulated bone marrow is not an HCT/P and should not be listed. Bone marrow that is more than minimally manipulated or for a non-homologous use or combined with another article would be listed as a Somatic Cell Therapy Product and regulated as a biological product. You do not have to register your establishment or list these HCT/Ps until the product is licensed by FDA.
- Pancreatic Islet cells: For purposes of registration, autologous islet cells that are minimally manipulated should list using the drop down menu and also indicate that they are regulated as HCT/Ps described in 21 CFR Part 1271.10. List other pancreatic islet cells as Somatic Cell Therapy Products and indicate that they are HCT/Ps regulated as a biological drug.
- Therapeutic Cells: For the purposes of HCT/P listing, a Therapeutic Cell (TC) is an HCT/P that contains leukocytes collected from the peripheral blood by leukapheresis or venipuncture (other than peripheral blood stem cells). For example, if you recover donor leukocytes or lymphocytes for infusion you would list these as Therapeutic Cells.
- Somatic Cell Therapy Products: Most other cell therapy products that are not specifically indicated on the main listing menu or the drop down menu should be listed as Somatic Cell Therapy Products. Examples of Somatic Cell Therapy Products include but are not limited to: hepatocytes, myocytes, fibroblasts, dendritic cells, mesenchymal cells, adipose stem cells. allogeneic pancreatic islet cells and certain bone marrow cells that have been more than minimally manipulated as described above.
- FDA currently views, for the most part, that somatic cell therapy products include the cell therapies as explained in the Federal Register Notice (Vol. 58 No 197, 10/14/1993, p53248), “Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products”. These cell therapies do not fit the 21 CFR Part 1271.10 criteria for regulation solely under section 361 of the PHS Act and are regulated as biological products subject to pre-market review and licensure. Human somatic cell therapy products include autologous or allogeneic cells that have been propagated, expanded, pharmacologically treated, or otherwise altered in biological characteristics ex vivo to be administered to humans and applicable to the prevention, treatment, cure, diagnosis, or mitigation of disease or injuries.