1. CBER Hemoglobin/Hematocrit Acceptance Standards and Interdonation Interval in Blood Donors Summary and Questions for the Committee Blood Products Advisory Committee July 27, 2010

2. CBER 12 Key issues Consideration of the balance between donor safety and blood supply Donor safety issues Hemoglobin standards Interdonation interval Blood supply issues Impact of any changes in hemoglobin standards or interdonation interval on blood supply

3. CBER 23 Current FDA regulatory requirements 21CFR 640.3(b)(3) – Blood hemoglobin level no less than 12.5g/dL or hematocrit no less than 38% 21CFR 640.3(b) – Interdonation interval: Not more than once every 8 weeks ~ 6 donations/year

4. CBER 34 International Standards CountryMinimum hemoglobin Interdonation interval or frequency per year United States12.556 days Canada12.556 days United Kingdom12.5 for women 13.5 for men 112 days Australia12.0 for women 13.0 for men 84 days Netherlands12.5 for women 13.5 for men Women: 18 weeks, 3x/year Men:10 – 11 weeks, 5x/year Hong Kong11.5 for women 13.0 for men Women: 3x/year Men: 4x/year

5. CBER 5 Hemoglobin / Hematocrit Standards in Male Donors Possible options – 12.5g/dL – 13.0g/dL – 13.5g/dL http://www.anemia.org

6. CBER 56 Hemoglobin / Hematocrit Standards in Female Donors – 12.5g/dL – 12.0g/dL http://www.anemia.org Possible Options

7. CBER 7 Hemoglobin / Hematocrit Standards in Female Donors Possible Options – 12.5g/dL – 12.0g/dL http://www.anemia.org

8. CBER 68 Effect of frequent donations Studies show that iron deficiency occurs more often among frequent blood donors. Iron deficiency may exist despite hemoglobin levels within the acceptable range Anemia related to iron deficiency anemia may lead to donor deferral and loss

9. CBER 79 Increasing the interdonation interval May allow more time for iron recovery May decrease the risk of iron deficiency May decrease future donor deferral for low hemoglobin

10. CBER 810 Summary: Donor safety issues Raising Hb standard for men – May prevent donations from “anemic” men Lowering Hb standard for women – May result in a modest increase in iron deficiency Increasing interdonation interval – May prevent iron deficiency in frequent blood donors

11. CBER 911 Summary- Blood supply issues Potential gain of female blood donors – If hemoglobin standard is dropped Potential loss of male blood donors – If hemoglobin standard is raised Potential loss of male and female donors – If the interdonation interval is increased

12. CBER 1012 Questions for the Committee 1.Does available scientific evidence support changing the donor hemoglobin acceptance standard for males? a) If yes, what hemoglobin acceptance standards does the committee recommend?

13. CBER 1113 Questions for the Committee 2.Does available scientific evidence support changing the donor hemoglobin acceptance standard for females? a) If yes, what hemoglobin acceptance standards does the committee recommend?

14. CBER 1214 Questions for the Committee 3.Please comment on the risks and benefits of extending interdonation intervals as a strategy to prevent iron deficiency in male donors.

15. CBER 1315 Questions for the Committee 4.Please comment on the risks and benefits of extending interdonation intervals as a strategy to prevent iron deficiency in female donors.

16. CBER 1416 Questions for the Committee 5.If any changes to the hemoglobin standard or interdonation interval were to be made, what mitigations can be considered to lessen possible adverse effects on the blood supply?