[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10515-10517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03515]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with current good manufacturing practice (CGMP) for blood 
and blood components, including information collection recommendations 
found in Agency guidance related to reducing the risk of transfusion-
transmitted infection (TTI).

DATES: Either electronic or written comments on the collection of 
information must be submitted by April 24, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 24, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-0343 for ``Current Good Manufacturing Practice for Blood and 
Blood Components and Reducing the Risk of Transfusion-Transmitted 
Infections.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal

[[Page 10516]]

Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information including each proposed 
extension of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 have been 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 donor 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 ineligible donors.
     Blood donations are tested for several relevant 
transfusion-transmitted infections, include 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 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. 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 have developed the 
following guidance documents, consistent with our Good Guidance 
Practice regulations in 21 CFR 10.115, that provide for comment at any 
time. The 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.
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 RTTIs:
     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).
Guidances Recommending Notification Based on Post Donation Information 
Regarding a Risk Factor
    The following guidance documents provide recommendations for 
consignee and physician notification under circumstances where a blood 
establishment may receive information following collection that reveals 
the donor had a risk factor for a 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);
     Revised Recommendations for Reducing the Risk of Human 
Immunodeficiency Virus Transmission by Blood and Blood Products--
Guidance for Industry (August 2020);
     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).
    These guidance documents are available for download from our 
website at https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances.
    We believe such notifications 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 a RTTI or TTI. However, to account 
for burden among respondents that may be attributable to this 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 10517]]


    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03515 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P