Notice2023-18245
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 24, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 163 (Thursday, August 24, 2023)</title>
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[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57956-57957]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#c9999b889abda8afaf89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="49191b081a3d282f2f092f2d286721213a672e263f">[email protected]</span></a>.
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 <a href="https://www.fda.gov/vaccines-blood-biologics/blood-blood-products">https://www.fda.gov/vaccines-blood-biologics/blood-blood-products</a> 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:
<bullet> blood pressure (Sec. 630.10(f)(2));
<bullet> pulse (Sec. 630.10(f)(4));
<bullet> weight (Sec. 630.10(f)(5));
<bullet> donation frequency for Whole Blood and Red Blood Cells
collected by apheresis (Sec. 630.15(a)(1));
<bullet> pregnancy (Sec. 630.10(e)(2)(v)); and
<bullet> 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 <a href="https://www.fda.gov/media/158608/download">https://www.fda.gov/media/158608/download</a>. 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
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