March 31, 2016
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA–2016–D–0768 for ‘‘Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.’’
Dear Dockets Manager,
AABB appreciates the opportunity to comment on “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.” The final guidance, which was expediently published, provides clear recommendations for screening HCT/P donors for the relevant communicable disease agent or disease Zika virus. However, AABB is concerned that the FDA did not provide the rationale used to defer individuals with Zika-risk exposure from donating for six months post exposure. AABB would appreciate understanding the rationale and data supporting this determination. AABB believes this could potentially have a negative impact on the public cord blood unit inventory. Furthermore, this determination results in an unnecessary burden as it requires labeling potential adult donors as ineligible or incomplete for donor eligibility determination.
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 1,800 institutions and 7,500 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.
The AABB Center for Cellular Therapies appreciates the opportunity to comment on the final guidance. Should you have any questions regarding these comments or would like additional information, please contact me at firstname.lastname@example.org.
Naynesh Kamani, MD
Vice President, Center for Cellular Therapies & Research