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Comments to FDA on Draft Guidance “Investigating and Reporting Adverse Reactions Related to HCT/Ps Regulated Solely under Section 361 of the PHS Act and 21 CFR Part 1271”

​April 21, 2015

Division of Dockets Management (HFA–305)
Food and Drug Administration
10903 New Hampshire Ave, Bldg 71, Rm 3128
Silver Spring, MD 20993-0002

Re: Docket No. FDA-2015-D-0349 “Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Draft Guidance for Industry”

Dear Dockets Manager:

AABB appreciates the opportunity to comment on “Investigating and Reporting Adverse Reactions Related to HCT/Ps Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271.” The draft guidance document provides clarification on FDA’s thinking with respect to regulatory considerations for manufacturers of HCT/Ps for which no premarket submissions are required. We are grateful that the Agency has taken the step of publishing a draft guidance and we look forward to a finalized version.

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.

The Center for Cellular Therapies appreciates the opportunity to comment on the draft guidance. Though we have no comments at this time, we look forward to the publication of a finalized guidance document.

Sincerely,
 
Naynesh Kamani, MD
Vice President, Center for Cellular Therapies & Research