January 21, 2014
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA–2013–D–1143, 24 October 2013, "Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products."
Dear Dockets Manager:
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.
AABB appreciates the opportunity to provide comments on the draft guidance titled "Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products." In developing these comments, AABB collected feedback from several member groups including the Cellular Therapy Standards Program Unit, the Cellular Therapy Regulatory Affairs Subsection, and the Transfusion Transmitted Diseases Committee. In general, we agree with the requirement to test HCT/P donors for evidence of West Nile Virus (WNV) infection using nucleic acid test (NAT) technology. The addition of this donor testing requirement will enhance patient safety and safeguard public health by reducing the risk of transmission of this relevant communicable disease agent and disease.
However, the recommendations for testing HCT/P donors should be revised to incorporate more flexible language which would allow for future scientific and regulatory advances in donor screening assays. AABB's comment to the proposed recommendations is provided below:
Section - III. RECOMMENDATIONS FOR TESTING DONORS OF HCT/PS. Page 8, pargraph 1. "As noted above and as described at greater length in the 2007 Donor Eligiblity Guidance, WNV is a relevant communicable disease agent or disease as defined in 21 CFR 1271.3(r)(2). We now determine that testing for WNV is necessary to adequately and appropriately reduce the risk of transmission of WNV. Therefore, FDA recommends that:
- HCT/P donors should be tested for WNV by ID-NAT using a licensed NAT donor screening test.
- Any HCT/P donor whose specimen tests negative (or non-reactive) for WNV by ID-NAT should be considered to be negative (or non-reactive) for WNV for purposes of determining donor eligibility.1
Any HCT/P donor whose specimen tests positive (or reactive) for WNV must be considered ineligible to donate (21 CFR 1271.50(b)(2), 1271.80(d)(1)).
1 FDA's recommendations regarding donor screening for WNV can be found in sections IV.E. and IV.F. of the 2007 Donor Eligibility Guidance (Ref. 1). Consistent with this guidance, persons who have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days should be considered ineligible."
Recommendation – AABB strongly recommends revising the first recommendation to read: "HCT/P donors should be tested for WNV using a licensed NAT donor screening test according to the manufacturer's package insert."
Background – The proposed recommendation is too restrictive from a regulatory perspective. The recommendation as revised by AABB is more flexible and allows opportunities for future scientific and regulatory advances to be wholly addressed. While the two donor screening tests currently licensed by the FDA for testing HCT/P donors for WNV infection by NAT (the Procleix WNV Assay manufactured by Gen-Probe, Inc. and the Cobas TaqScreen Assay manufactured by Roche Molecular Systems, Inc) are only approved to test HCT/P donors using individual donor (ID) samples, current and future manufacturers may pursue supplemental or new indications for use, respectively, which may possibly permit the use of WNV testing using pooled HCT/P donor samples. Revising the recommendation does not negate FDA's proposed recommendation, but it does however leave room for advances in the field of HCT/P donor testing.
Thank you for the opportunity to offer these comments. Should you have any questions regarding these comments or would like additional information, please contact Rafael Cassata by email (email@example.com) or telephone (301.215.6542).
Rafael Cassata, MS, RAC (US, EU)
Deputy Director, Regulatory Affairs