The Best Place to Find Information Is the FDA Web Site for HCTP

The best place to find information is the FDA web site for HCTP http://www.fda.gov/cber/tissue/docs.htm This web site has all the documents for HCTP regulation in one place. The top half of the page has “Related Documents” the lower half of the page lists the “Guidance and Rules”.

The full HCTP regulation may be found in the top section under 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr1271_07.html

Other helpful information may be found in the Guidance for Industry documents the FDA publishes. These may be found in the lower section of the page discussed above. In particular, the following should be helpful:

Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps) - Small Entity Compliance Guide - 8/24/2007

Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products - 8/8/2007

FEDERAL REGISTER: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Final Rule - 6/19/2007

Questions and Answers Concerning the June 19, 2007 Final Rule: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing; and Related Labeling

Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests - 1/23/2007

On this site, you will also find older documents with similar names as those listed below. These sometimes have useful information BUT you must be careful that you understand any additions, changes, or modification later versions may have on the regulation.

A very good way to stay current on the FDA regulation is to subscribe to the Tissue Info Email list. This is easy to do by going to the following site (click the link “Subscribe to or Unsubscribe form” below) and completing the forms.

TISSUEINFO - Members of this list will receive tissue-related documents.

Subscribe to or Unsubscribe from TISSUEINFO

The Tissue Info email service will update you of any new tests kits available but in addition it is always advisable to routinely check the approve donor screening test site http://www.fda.gov/cber/tissue/prod.htm This site lists all the approve tests for donors.

There are several seminars available that may also be useful. The AAB annual meeting May 15-17, 2008 in Las Vegas, Nevada is going to have an afternoon dedicated to FDA regulation compliance.

You may also find the AAB HCTP Compliance Procedure Manual very helpful in implementing the FDA regulations into your program. The manual may be purchased at the AAB booth #125 at the upcoming ASRM or by going to the following link to purchase http://www.aab.org/book%20brochure.pdf

Finally, if you have questions you may contact FDA directly by email at [email protected] They are very good about getting back to you promptly with answers to your questions. We are always happy to assist you with you questions as well.

In addition, questions or comments may be submitted to [email protected]. The CRB-Regulatory Task Force will forward or respond as necessary.

Tammie Schalue, PhD, HCLD(ABB), ELD(ABB) ART Regulatory Task Force American Association of Bioanalysts 314-241-1445 (AAB Office) 225-753-6524 (Phone) 225-753-8760 (Fax) 225-354-6242 (Cell) [email protected] [email protected]