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, 57956-57957 [2023-18245]
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57956
Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: August 21, 2023.
Marquita Cullom,
Associate Director.
BILLING CODE 4160–90–P
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
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:08 Aug 23, 2023
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Current Good Manufacturing Practice
for Blood and Blood Components and
Reducing the Risk of TransfusionTransmitted Infections
OMB Control Number 0910–0116—
Revision
[FR Doc. 2023–18221 Filed 8–23–23; 8:45 am]
AGENCY:
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.
ADDRESSES:
Jkt 259001
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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 § 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
§ 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 § 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 (§ 630.10(f)(2));
• pulse (§ 630.10(f)(4));
• weight (§ 630.10(f)(5));
• donation frequency for Whole
Blood and Red Blood Cells collected by
apheresis (§ 630.15(a)(1));
• pregnancy (§ 630.10(e)(2)(v)); and
• red blood cell loss for plasma
collected by plasmapheresis
(§ 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 § 606.160;
investigate the error that resulted in the
collection of an unsuitable donation
under § 630.30(a)(2); and submit a
report to FDA annually if they intend
for their activities to fall under this
E:\FR\FM\24AUN1.SGM
24AUN1
57957
Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices
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 60day 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 postdonation 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 registeredonly 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
Number of
respondents
Activity/draft guidance section
Annual report of released unsuitable units—Licensed
blood collection establishments/section III.A ...................
Annual report of released unsuitable units—Registeredonly blood establishments/section III.A ............................
Total ..............................................................................
1 There
Total annual
responses
Average
burden per
response
Total hours
50
1
50
4
200
50
1
50
4
200
........................
........................
........................
........................
400
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
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
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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17:08 Aug 23, 2023
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24AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/draft guidance section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 400
----------------------------------------------------------------------------------------------------------------
\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
