SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. ( printed page 47150)

Current Good Manufacturing Practice for Blood and Blood Components and Reducing the Risk of Transfusion-Transmitted Infections

OMB Control Number 0910-0116—Revision

The FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulatory oversight of the U.S. blood supply. FDA issues and enforces requirements for blood collection and for the manufacturing of blood products, including both blood components intended for transfusion or for further manufacturing use. To implement applicable statutory provisions, regulations are codified at 21 CFR part 606—Current Good Manufacturing Practice for Blood and Blood Components; 21 CFR part 610—General Biological Products Standards; 21 CFR part 630—Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; and 21 CFR part 640—Additional Standards for Human Blood and Blood Products. The regulations establish quality standard requirements applicable to blood and blood products including information collection provisions.

CBER works closely with other parts of the Department of Health and Human Services to identify and respond to potential threats to blood safety and to monitor the availability of the blood supply. FDA has progressively strengthened the overlapping safeguards that help to ensure donor health and the safety of the blood supply for recipients of blood and blood products. For example:

• Blood donors answer medical history questions to identify risk factors that could indicate possible infection with a relevant-transfusion transmitted infection.
• FDA requires blood establishments to maintain a record of deferred donors to prevent collections from ineligible donors.
• Blood donations are tested for several relevant transfusion-transmitted infections, including HIV, hepatitis B virus, and hepatitis C virus.

FDA also inspects blood establishments and monitors reports of errors, accidents, and adverse events associated with blood donation or transfusion.

Description of Respondents: Respondents to the collection of information are licensed and registered-only establishments that collect blood and blood components intended for transfusion or further manufacturing use.

For operational efficiency, we are revising the information collection to account for burden that may be attributable to recommendations found in associated FDA guidance documents, as listed below, and currently approved in OMB control number 0910-0681. FDA regulations in § 630.3(h) (21 CFR 630.3(h)) set forth a list of relevant transfusion-transmitted infections (RTTIs) (§ 630.3(h)(1)) and the conditions under which a TTI would meet the definition of an RTTI (§ 630.3(h)(2)). We developed Agency guidance documents, consistent with our good guidance practice regulations in 21 CFR 10.115, that provide for comment at any time. These guidance documents include recommendations specific to certain RTTI or TTI regarding the collection of blood and blood components and discuss corresponding recordkeeping and/or notification activities. The guidance documents are available for download from our website at https://www.fda.gov/​vaccines-blood-biologics/​biologics-guidances/​blood-guidances.

A. Guidances Recommending Notification Based on Reactive Test Results

The following guidance documents provide recommendations for consignee and physician notification relating to donations that test reactive for an RTTI:

• Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion (November 2009);
• Use of Serological Tests to Reduce the Risk of Transmission ofTrypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry (December 2017);
• Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry (May 2019); and
• Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II); Guidance for Industry (February 2020).

B. Guidances Recommending Notification Based on Post Donation Information Regarding a Risk Factor or History of an RTTI or TTI

The following guidance documents provide recommendations for consignee and, in some instances, physician notification under circumstances where a blood establishment may receive information following collection that reveals the donor had a history of or risk factor for an RTTI or TTI at the time of collection and should have been deferred for the risk factor:

• Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry (January 2017);
• Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry (May 2022); and
• Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry (December 2022).

In the Federal Register of February 21, 2023 (88 FR 10515), we published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four information collection topics solicited. On our own initiative we have since revised the information collection to reflect recent finalization of the guidance document entitled “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products,” announced in the Federal Register of May 12, 2023 (88 FR 30765). The recommendations included in the guidance document will potentially expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.

We believe the notifications discussed in the respective guidance documents are rare and that these notification practices would be part of the usual and customary business practice for blood establishments and consignees in addressing the RTTIs or TTIs under the regulations. We also believe respondents would have already developed standard operating procedures for notifying consignees and the recipient's physician of record regarding distributed blood components potentially at risk for an RTTI or TTI. However, to account for burden among respondents that may be attributable to the notification activity we allot one response and 1 hour annually. As additional guidance is developed by FDA addressing other RTTIs under § 630.3(h)(2), we will modify the information collection accordingly.

88 FR 47149