Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a document entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” dated February 2007. The guidance document assists establishments with making eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products. The guidance announced in this document finalizes the draft guidance, “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” dated May 2004. This guidance also finalizes the draft guidance, “Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” dated June 2002 (Docket No. 2002D-0266).

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments .

FOR FURTHER INFORMATION CONTACT:

Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” dated February 2007. The guidance announced in this document assists HCT/P establishments with complying with the requirements under part 1271 (21 CFR part 1271), subpart C. These regulations require HCT/P establishments to perform an eligibility determination for most cell and tissue donors, based on donor testing and screening for relevant communicable disease agents and diseases. This guidance applies only to cells and tissues procured on or after the effective date of the regulations contained in part 1271, subpart C (effective date May 25, 2005). This guidance does not replace the guidance on 21 CFR part 1270, “Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation,” dated July 29, 1997, which continues to apply to certain tissues recovered before May 25, 2005.

In the Federal Register of June 25, 2002 (67 FR 42789), FDA announced the availability of the draft guidance entitled “Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” dated June 2002. The draft guidance provides information intended to assist manufacturers of HCT/Ps in minimizing the risk of transmission of CJD and vCJD by HCT/P donors that have been possibly exposed to the agents of CJD and vCJD.

In the Federal Register of May 25, 2004 (69 FR 29835), FDA announced the availability of the draft guidance entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” dated Ma 2004. The draft guidance provided to HCT/P establishments recommendations for the appropriate screening and testing of cell and tissue donors for relevant communicable disease agents and diseases, and recommendations for complying with the regulations for eligibility determination for donors of HCT/Ps.

FDA issued these two draft guidances to assist manufacturers in minimizing the risk of communicable disease transmission by donors of HCT/Ps. FDA received numerous comments on the two draft guidances and those comments were considered as the guidance was finalized. Based on these comments and additional data, FDA has identified West Nile Virus, Sepsis, and Vaccinia as relevant communicable disease agents or diseases (RCDAD). On the other hand, FDA has not included severe acute respiratory syndrome (SARS-CoV) as an RCDAD in this guidance because there has been no laboratory-confirmed person-to-person transmission of SARS-CoV worldwide since July 2003. In addition, the guidance recommends nucleic acid amplification testing (NAT) for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) for both living and cadaveric donors. The guidance also modifies and/or clarifies the following:

• Recommendations for risk factors for vCJD;
• Physical examination of a living HCT/P donor;
• Exceptions to the requirement for determining donor eligibility and appropriate labeling;
• Screening criteria for HIV-1 group O, viral hepatitis, syphilis, Chlamydia trachomatis and Neisseria gonorrhea;
• Deferral criteria for receipt of human-derived clotting factors;
• Procedures for communicable disease testing laboratories;
• FDA's approach to identifying new RCDADs; and
• Use of gestational carriers or surrogates.

The guidance announced in this document finalizes the previously described draft guidances dated June 2002 and May 2004. The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 1271, subpart C have been approved under OMB Control No. 0910-0543. The collections of information in part 1271, subpart D have been approved under OMB Control No. 0910-0559.

III. Comments

Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the guidance announced in this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm .