0116 Nonsub change request Aug 2019

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. The discussion below
regarding notification to consignees was inadvertently omitted in our change request of
December 11, 2018, along with the notification item we did discuss. 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Availability of Platelets for Transfusion; Draft Guidance for Industry” (“Bacterial draft
guidance”). The Bacterial draft guidance provides blood collection establishments and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As stated in the Bacterial draft guidance, platelets may only be stored beyond day 5 and up to
day 7 if certain conditions are met. To store platelets up to 7 days, each platelet product must
be tested using a bacterial detection device cleared by FDA and labeled for use as a “safety
measure” according to its instructions for use. Furthermore, the platelet storage container
being used to store such platelets must be FDA cleared or approved for 7-day storage. We
recommend blood establishments communicate to their consignees the type of storage
container the platelets are stored in, for example, a storage container approved for 5-day
storage or storage container approved for 7-day storage. This recommendation will help to
ensure that only platelets stored in appropriately labeled containers are labeled with a 7-day
expiration date.
FDA is in the process of finalizing the Bacterial draft guidance, which must be published by
September 30, 2019 in order to comply with an appropriations rider in FDA’s Fiscal Year
2019 Appropriations Act. Therefore, we are requesting that the recommendation in the
guidance for blood establishments to communicate to consignees the type of storage container

the platelets are stored in (for example, a storage container approved for 5-day storage or
storage container approved for 7-day storage), as discussed above, be included in this
approved collection of information since this notification is considered usual and customary
business practice. 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: August 2019

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