February 23, 2015
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2014-D-1696 “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff”
Dear Dockets Manager:
AABB appreciates the opportunity to provide comments on the draft guidance for industry and FDA staff “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products”. Comments to specific recommendations in the guidance document are arranged in the following format:
Section – language from draft guidance reprinted.
Recommendation or Request for Clarification – recommendation or clarification request.
Rationale/Supporting Information – rationale in support of the recommendation /clarification request
Section: III: QUESTIONS AND ANSWERS
A. General Concepts
2. How do I determine whether an HCT/P is structural tissue or cellular/nonstructural for purposes of applying the definition of minimal manipulation?
“The main function of the HCT/P, in the donor, determines which definition of minimal manipulation applies.”
Request for Clarification – Use of the term “main function” is a new and undefined term in the regulation. As written, the term is subjective, and we request clarification on how to define and apply the definition.
Section: III: QUESTIONS AND ANSWERS
C. Cells or Nonstructural Tissues
11. What types of tissue are considered cells or nonstructural tissues?
“Cells or nonstructural tissues are generally those that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune, and endocrine functions.
Examples of cells or nonstructural tissues include:
- Reproductive cells or tissues (e.g., oocytes);
- Cord blood;
- Amniotic fluid;
- Bone marrow aspirate;
- Lymph nodes;
- Parathyroid glands;
- Peripheral nerve; and
- Pancreatic tissue.”
Recommendation – The FDA should not list bone marrow aspirate as an example.
Rationale – Since only more than minimally manipulated bone marrow is regulated by the FDA, perhaps bone marrow aspirate should not be listed as an example. Peripheral blood may be a more pertinent example.
Request for Clarification – Is “homologous use” no longer applicable to the determination of whether a cell product is minimally manipulated due to the new application of “original relevant characteristics”?
Rationale – The term “homologous use” is applied in the Draft Guidance for Industry Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations. III. B.
Request for Clarification – Increased clarity from the Agency is necessary regarding the regulatory treatment of certain processes and tissue-based products.
- Freezing or cryopreservation
- Same technique for different tissue
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 and our membership appreciate the opportunity to comment on the draft guidance. Should you have any questions regarding these comments or would like additional information, please contact me at email@example.com.
Naynesh Kamani, MD
Vice President, Center for Cellular Therapies & Research