0116 Nonsub Change bacterial detection of platelets

U.S. Food and Drug Administration
Current Good Manufacturing Practices and Related Regulations for Blood and Blood
Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
OMB Control No. 0910-0116
Non-substantive Change Request:
FDA is requesting a non-substantive change to OMB Control No. 0910-0116, which supports the
above-captioned FDA regulations for blood and blood components. In addition to the current
good manufacturing practice regulations for blood and blood components in 21 CFR part 606,
there are regulations in 21 CFR part 630 that include requirements for blood and blood
components intended for transfusion or further manufacturing use, and in 21 CFR part 640 that
require additional standards for certain blood and blood products. These regulations implement
FDA’s statutory authority to ensure the safety, purity, and potency of blood and blood
components.
In the Federal Register of December 6, 2018 (83 FR 62873), we published a notice announcing
the availability of a draft document entitled “Bacterial Risk Control Strategies for Blood
Collection Establishments and Transfusion Services to Enhance the Safety and Availability of
Platelets for Transfusion; Draft Guidance for Industry” (“Bacterial draft guidance”). The
Bacterial draft guidance provides blood collection establishments and transfusion services with
recommendations to control the risk of bacterial contamination of room temperature stored
platelets intended for transfusion.
As stated in the Bacterial draft guidance, blood collection establishments and transfusion
services should have in place measures to promptly alert the collection establishment or
transfusion service if a distributed platelet product is subsequently identified as positive for
bacterial contamination. Under 21 CFR 606.145(c), a transfusion service must notify the blood
collection establishment that provided the platelets in the event the transfusion service identifies
platelets as bacterially contaminated. FDA, in the Bacterial draft guidance, recommends blood
collection establishments notify transfusion services to provide this same information. Although
such notifications occur infrequently, we believe that these notification practices are currently
part of the usual and customary business practice for blood collection establishments because
blood collection establishments are required under 21 CFR 606.100(b)(22) to establish
procedures to control the risk of bacterial contamination, including all steps required under 21
CFR 606.145. The collection of information under 21 CFR 606.100(b) is covered in this OMB
package.
After we consider any public comments received, we intend to finalize the Bacterial draft
guidance. Therefore, we are requesting that the recommendation in the guidance for blood
establishments to notify transfusion services, as discussed above, be included in this approved
collection of information since the usual and customary information collection activity contained
in the draft bacterial guidance is similar to that contained under 21 CFR 606.145(c). We

attribute burden in the amount of one hour and one response annually for the information
collection recommendation included in the draft Bacterial guidance.
Dated: December 2018

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