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Comments to FDA on "Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis)"

January 31, 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Re: Docket No. FDA–2013–D–1213, 5 November 2013, “Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis).”

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AABB appreciates the opportunity to provide comments on the draft guidance titled “Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis).” The recommendations contained in the draft guidance document were reviewed by several member groups including the Cellular Therapy Standards Program Unit, the Cellular Therapy Regulatory Affairs Subsection, and the Transfusion Transmitted Diseases Committee.

In general, AABB agrees with the recommendations made in Section III - Recommendations of the draft guidance.  We also commend FDA for continually evaluating the status of the infectious disease testing landscape and updating recommendations based on scientific developments. 

AABB supports FDA’s efforts to enhance patient safety and safeguard public health by reducing the risk of transmission of relevant communicable disease agents and diseases. Should you have any questions regarding these comments or would like additional information, please contact Rafael Cassata by email (rcassata@aabb.org) or telephone (301.215.6542).


Respectfully Submitted,


Rafael Cassata, MS, RAC (US, EU)
Deputy Director, Regulatory Affairs