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AABB Interorganizational Task Force on Pandemic Influenza and the Blood Supply* Comments to FDA on Draft Guidance on Blood Donor Suitability and Blood Safety and H1N1 Pandemic - 12-3-09 

December 3, 2009

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Docket 2009–D–0533, 19 November 2009, “Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus”, Draft Guidance

Dear FDA Dockets Manager:

The AABB Interorganizational Task Force on Pandemic Influenza and the Blood Supply appreciates the opportunity to comment on the draft guidance document “Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus.” The task force, which represents blood centers and hospital-based blood banks that collect virtually the entire nation’s blood supply, finds the reminder of existing regulations, guidance language and clarification helpful.  We have provided a few comments to further our understanding and to strengthen the final recommendations.

III. B. Blood Donor Suitability

 

Draft Guidance: You may clarify a donor’s response to the donor history questionnaire or obtain omitted responses to questions within 24 hours of the collection.

 

Comment:  The agency is to be commended for providing good guidance practices (GGP) language to define the term day of collection as found in 21 CFR 640.3(a) and 640.63(a).  The acknowledgement that on occasion a “donor’s responses to the donor questions presented before collection are found to be incomplete upon review by the blood establishment” and provision of a timeframe within which the establishment can take action (thereby providing an alternative to discarding acceptable units of blood that are collected late on the day of collection) is appreciated.

Request for clarification/recommendation:  It is our understanding that although this language is being provided in this guidance in response to the pandemic H1N1 2009 virus, the “within 24 hours” definition for day of collection as found in 21 CFR 640.3(a) and 640.63(a) is applicable to assessments of blood donor suitability/eligibility in general. The Task Force recommends that this be made explicit in the final recommendations.

III.C. Changes to an Approved Application

Draft Guidance: As provided under 21 CFR 601.12(c)(5), we have determined that the following changes to an approved application for licensed blood establishments may be submitted as a “Supplement-Changes Being Effected”:  Use of a different outside test lab, provided the test lab is registered with FDA and has been performing donor testing.

Comment: A reduction in the reporting requirement from Changes Being Effected in 30 days (requiring supplement submission 30 days prior to distribution of the product) to Changes Being Effected (CBE) (requiring supplement submission prior to distribution of the product) for this contractor change is welcomed. The Task Force agrees that when the collection center is already engaged in outsourcing its samples for routine serologic and infectious disease testing, supplemental and/or confirmatory testing, and all parties are already licensed or registered, there appears to be no reason for the 30-day prior notice. It is reasonable to assume that during a pandemic or other unplanned circumstance a rapid change in contractors may be required. It also makes sense that during the normal course of business a decision may be made to change to a different licensed test lab and the update to the establishment’s biologics license application would be amended by submission of the CBE.

Request for clarification/recommendation: It is our understanding that although this language is being provided in a guidance written under the title of a response to the pandemic H1N1 2009 virus this reduced reporting requirement supersedes the recommendations in FDA’s “Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture” (July 2001) at section IV.C in general, and is not restricted to use in a pandemic.

It is also our understanding that activation of an establishment’s alternate or back-up contractor, in the event of a pandemic or for other reason, remains in the Annual Report category.

The Task Force recommends that these clarifications be made more explicit in the final recommendations.

 III.C. Changes to an Approved Application

Draft Guidance:  As provided under 21 CFR 601.12(c)(5), we have determined that the following changes to an approved application for licensed blood establishments may be submitted as a “Supplement-Changes Being Effected”:  Implementation of self-administered donor history questionnaires, provided you follow the critical control points described in FDA’s “Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self- Administered Questionnaires” (July 2003), and the submission contains the content recommended for all self-administered procedures and computer assisted interactive procedures outlined in the same guidance.

Comment: The Task Force also welcomes the proposed reduction in the reporting requirement from Changes Being Effected in 30 days to Changes Being Effected related to implementation of a self-administered questionnaire. Many facilities have made normal course-of-business decisions to implement self-administered questionnaires and have found them to be of great benefit. A facility that has not previously used self-administered questionnaires may find it useful and necessary to make this change in the event of a pandemic or other unplanned event.  We agree that the proper reporting category is CBE.

Request for clarification: It is our understanding that although this language is being provided in a guidance written under the title of a response to the pandemic H1N1 2009 virus this reduced reporting requirement supersedes the recommendations in FDA’s “Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires” (July 2003) at section IV.A, in general and is not restricted to use in a pandemic. The Task Force recommends that the general use provision be made more explicit in the final recommendations.

Thank you for your consideration of our comments.  If you have any questions or require additional information, please contact Allene Carr-Greer at 919-658-1689 or acarrgreer@aabb.org.

Sincerely,

Louis Katz, MD
Chair, AABB Interorganizational Task Force on Pandemic Influenza and the Blood Supply

 *AABB serves as the designated coordinating entity for the Interorganizational Task Force on Pandemic Influenza and the Blood Supply. In addition to AABB, members include: America's Blood Centers, American Red Cross, Blood Centers of America, and the Advanced Medical Technology Association (AdvaMed). Representatives from the following government agencies also participate in Task Force discussions: Armed Services Blood Program, Centers for Disease Control and Prevention, Department of Health and Human Services, and Food and Drug Administration.

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