Notice to HCT/P Establishments: FDA Form 3356 Annual Tissue Establishment Registration/Listing – 2008
Please be advised that FDA will not be mailing the annual registration form to establishments that register electronically. A reminder announcement will be sent to the email address of the reporting official. Additional information to assist you in submitting your annual registration:
- All establishments are required to submit annual updates to FDA between November 15 and December 31, 2008 regardless of changes. Do not send to FDA before November 15.
- FDA Form 3356 has been revised. Changes under Part II for listing include:
- Infectious disease test laboratories: We have deleted the “No HCT/P Specified” row. The reason for doing this is that per 1271.25(b)(c) your HCT/P listing must indicate the HCT/P for which you perform this manufacturing function. When listing the HCT/P's recovered from the donors you test, please do so to the best of your knowledge.
- Additional HCT/Ps: On the new form all additional HCT/Ps that you previously added to the listing have been deleted. Please see the attached information with revised instructions at http://www.fda.gov/cber/tissue/tisrevinstr.htm for listing other HCT/Ps. If you are registering electronically using eHCTERs there is a new drop down menu for listing these HCT/Ps that are not printed on Form FDA 3356 and not otherwise listed in eHCTERs. Additional instructions are also included in eHCTERs.
- Establishments must provide a legal name of the establishment in Box 4. Legal names should not be an individual's first and last name. Please modify your registration if you have indicated an individual's first and last name in Box 4.
- Establishments that only match reproductive donors (e.g., oocytes, or embryos) with a recipient and do not perform the donor screening interview of record that will be used to make the donor eligibility determination should inactivate their registrations (check Box 2d).
- FDA encourages you to return your annual registration by electronic submission through a secure web page at http://www.fda.gov/cber/tissue/tisreg.htm.
Questions can be addressed to Rosemarie Wiseman 240-402-8369 or email firstname.lastname@example.org.