[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47149-47151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0343]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Current Good 
Manufacturing Practice for Blood and Blood Components and Reducing the 
Risk of Transfusion-Transmitted Infections

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by August 21, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0116. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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.

[[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 Sec.  630.3(h) (21 CFR 630.3(h)) set forth a list of 
relevant transfusion-transmitted infections (RTTIs) (Sec.  630.3(h)(1)) 
and the conditions under which a TTI would meet the definition of an 
RTTI (Sec.  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 of Trypanosoma 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 Sec.  630.3(h)(2), we 
will modify the information collection accordingly.


[[Page 47151]]


    Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15458 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P


