
[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57956-57957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0588]


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, 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 September 25, 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.

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

OMB Control Number 0910-0116--Revision

    This information collection helps support FDA implementation of 
statutory and regulatory requirements that govern current good 
manufacturing practice (CGMP) for blood and blood components. We have 
issued regulations in parts 606, 610, 630, and 640 (21 CFR parts 606, 
610, 630, and 640) setting forth applicable standards and procedures 
that include associated reporting, recordkeeping, and disclosure 
requirements. 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. We 
provide information on our website at https://www.fda.gov/vaccines-blood-biologics/blood-blood-products regarding CGMP for blood and blood 
products, including available Agency resources.
    We are revising the information collection to support 
implementation of annual reporting to FDA of the release of unsuitable 
blood donations from establishments that intend for their activities to 
fall under the compliance policy set forth in the draft guidance for 
industry entitled ``Compliance Policy Regarding Blood and Blood 
Component Donation Suitability, Donor Eligibility and Source Plasma 
Quarantine Hold Requirements'' (May 2022). The draft guidance describes 
FDA's compliance policy for certain regulations. Blood establishments 
that collect blood and blood components, including Source Plasma, must 
comply with requirements in Sec.  630.30 regarding donation 
suitability. However, the draft guidance explains the conditions under 
which FDA does not intend to take regulatory action for a blood 
establishment's failure to comply with this requirement and describes 
proposed procedures for such an establishment's filing of annual 
reports on the release of unsuitable donations to FDA. Specifically, 
under this policy, when finalized, when the donation is otherwise 
suitable under Sec.  630.30(a), FDA does not intend to take regulatory 
action if blood establishments release donations for transfusion or 
further manufacture when the review of records, required after donation 
under Sec.  630.30(a)(2), identifies the donation as unsuitable because 
of inadvertent failure to follow procedures to ensure that the donation 
would not adversely affect the health of the donor, namely for:
     blood pressure (Sec.  630.10(f)(2));
     pulse (Sec.  630.10(f)(4));
     weight (Sec.  630.10(f)(5));
     donation frequency for Whole Blood and Red Blood Cells 
collected by apheresis (Sec.  630.15(a)(1));
     pregnancy (Sec.  630.10(e)(2)(v)); and
     red blood cell loss for plasma collected by plasmapheresis 
(Sec.  630.15(b)(6)).
    The draft guidance sets forth that FDA intends to apply the 
compliance policy provided blood establishments that elect to release 
unsuitable units as described in the guidance report the release of 
unsuitable donations to FDA annually. The draft guidance document is 
available for download at https://www.fda.gov/media/158608/download. We 
issued the guidance document consistent with our Good Guidance Practice 
regulations in 21 CFR 10.115, which provide for public comment at any 
time. We intend on finalizing the guidance document upon OMB approval 
of the attendant information collection. When finalized, the guidance 
will supersede the guidance entitled, ``Alternative Procedures for 
Blood and Blood Components During the COVID-19 Public Health Emergency; 
Guidance for Industry,'' dated April 2020.
    As explained in section III.A of the guidance, licensed and 
registered-only blood establishments must maintain records as required 
under Sec.  606.160; investigate the error that resulted in the 
collection of an unsuitable donation under Sec.  630.30(a)(2); and 
submit a report to FDA annually if they intend for their activities to 
fall under this

[[Page 57957]]

compliance policy. The report should describe the number and type of 
donations released under these conditions. The report should also 
describe the corrective actions taken to prevent recurrence of errors 
and to ensure compliance with the applicable regulations. The final 
guidance will clarify that the report may be submitted in summary 
format.
    The submission of these reports will allow us to monitor error 
rates associated with the collection of unsuitable units and work with 
establishments to implement corrective actions, if necessary. We expect 
that this compliance policy will increase the availability of blood and 
blood components, including Source Plasma, while maintaining the health 
of blood donors and the safety of blood and blood components. If, based 
upon the available scientific evidence, the risk to the safety of the 
blood supply or the risk to donors' health significantly changes, FDA 
may revise this compliance policy as warranted.
    In the Federal Register of May 24, 2022 (87 FR 31440), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. We received six comment letters, each of which contained 
multiple comments, in response to the notice. Some comments were not 
responsive to the four information collection topics solicited.
    (Comment 1) With regard to the statement in the draft guidance that 
``licensed and registered-only blood establishments must maintain 
records as required under 21 CFR 606.160; investigate the error that 
resulted in the collection of an unsuitable donation under 21 CFR 
630.30(a)(2); and submit a report to FDA annually if they intend for 
their activities to fall under this compliance policy,'' one comment 
asked that we clarify whether post-donation information (PDI) related 
to blood pressure, pulse, weight, and red blood cell loss would need to 
be investigated and reported to us in the report on an annual basis.
    (Response 1) PDI is information received by the blood establishment 
after donation from the donor or another source that is out of the 
control of the establishments. We do not consider the receipt of PDI to 
be an error that must be reported to FDA on an annual basis as 
described in the guidance. However, the blood establishment's 
measurement of a donor's blood pressure, pulse or red blood cell loss 
are in the control of the establishment, and errors in such measurement 
would not be identified through PDI.
    We have considered the comment and have determined that the comment 
does not present information that would warrant changes to the guidance 
document at this time.
    (Comment 2) Another comment requested that the annual report not 
include corrective actions taken for each error because this would 
represent duplication of information already available to FDA via its 
inspection compliance program. The comment noted that each 
establishment has a defined deviation management and corrective action 
program and each error related to donor eligibility determination is 
investigated. The comment further noted that FDA should not request 
this report because the information can be reviewed during FDA's 
inspection compliance program.
    (Response 2) We disagree that including a summary of corrective 
actions on the annual report would represent duplication of 
information. Establishments may submit the information already 
developed as part of their deviation management and corrective action 
program. A new investigation does not need to be completed and new 
documentation does not need to be created. Receiving annual information 
about the corrective actions taken will allow us to better assess the 
robustness of the establishment's GMP system in a timely manner. We 
also note that blood establishments may elect not to use the 
enforcement discretion provided in the guidance to release certain 
unsuitable blood components, and therefore, would not submit a report 
to FDA.
    Comments are being considered as the guidance is being finalized. 
We are clarifying in the final guidance that the annual report about 
the corrective actions taken may be submitted in summary format. This 
change in wording did not affect our estimate of the burden.
    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.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
 Activity/draft guidance section     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Annual report of released                     50               1              50               4             200
 unsuitable units--Licensed
 blood collection establishments/
 section III.A..................
Annual report of released                     50               1              50               4             200
 unsuitable units--Registered-
 only blood establishments/
 section III.A..................
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    Total.......................  ..............  ..............  ..............  ..............             400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimate of the proposed reporting on our experience 
with similar information collections and a review of similar reporting 
data.

    Dated: August 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18245 Filed 8-23-23; 8:45 am]
BILLING CODE 4164-01-P


