30 October 2007
Division of Dockets Management, HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Via electronic submission: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm
RE Docket 2007N-0264 Direct Final Rule/Proposed Rule: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma.
Dear FDA Dockets Manager:
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.
AABB is appreciative of the opportunity to comment on Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, direct final rule/proposed rule. We have no significant adverse comments and commend FDA on the changes to the regulations designed to provide consistency with current practices in the blood industry and to remove unnecessary or outdated requirements. Elsewhere, comments have been submitted from the AABB Interorganizational Plasma Task Force.
Below are three areas that we wish to draw your attention to.
21 CFR 640.4 Collection of the blood
(h) Storage
Current
(h) Storage. Immediately after collection, unless the blood is to be used as a source for Platelets, it shall be placed in storage at a temperature between 1 and 6 deg. C unless it must be transported from the donor clinic to the processing laboratory. In the latter case, the blood shall be placed in temporary storage having sufficient refrigeration capacity to cool the blood continuously toward a range between 1 and 6 deg. C until it arrives at the processing laboratory, where it shall be stored at a temperature between 1 and 6 deg. C. Blood from which Platelets is to be prepared shall be held in an environment maintained at a temperature range 20 to 24 deg. C until the platelets are separated. The red blood cells shall be placed in storage at a temperature between 1 and 6 deg. C immediately after the platelets are separated.
Proposed
(h) Storage. Whole blood must be placed in storage at a temperature between 1 and 6[deg] C immediately after collection unless the blood is to be further processed into another component or the blood must be transported from the donor center to the processing laboratory. If transported, the blood must be placed in temporary storage having sufficient refrigeration capacity to cool the blood continuously at a temperature range between 1 and 10[deg] C until arrival at the processing laboratory. At the processing laboratory, the blood must be stored at a temperature between 1 and 6[deg] C. Blood from which a component is to be prepared must be held in an environment maintained at a temperature range specified for that component in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER.
Comment
Recognition of 1-10 C as the proper temperature for transportation is appropriate. The previous language referenced cooling the blood toward [the appropriate temperature range]. It seems appropriate to keep “toward” rather than revise the language to “cool the blood continuously at [the appropriate temperature range].”
21 CFR 640.25 General Requirements
(b) Quality Control testing
(2)
Current
pH of not less than 6.0 measured at the storage temperature of the unit
Proposed
pH of not less than 6.2 measured at the storage temperature of the unit
Comment
Revising the pH level for platelets for quality control from 6.0 to 6.2 is appropriate and is consistent with industry practice. Silence on the number of units tested that must meet this requirement results in an inference that 100% of the units must meet the requirement. 100% compliance is not achievable.
Additional Note: 21 CFR 640.24 Processing
(d)
Current
The volume of original plasma used for resuspension of the platelets shall be determined by the maintenance of a pH of not less than 6.0 during the storage period. The pH shall be measured on a sample of platelets which has been stored for the maximum dating period at the selected storage temperature.
Proposed
None
Comment
This CFR section also references platelet pH of 6.0 and should be revised to be consistent with the recommendation for 6.2 in 640.25(b)(2).
M. Allene Carr-Greer
Director, Regulatory Affairs