Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry; Availability, 71736-71737 [2023-22957]
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71736
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 630 and 640
[Docket No. FDA–2022–D–0588]
Compliance Policy Regarding Blood
and Blood Component Donation
Suitability, Donor Eligibility and
Source Plasma Quarantine Hold
Requirements; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Announcement of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Compliance Policy Regarding Blood
and Blood Component Donation
Suitability, Donor Eligibility and Source
Plasma Quarantine Hold
Requirements.’’ The guidance document
addresses certain requirements that
apply to blood establishments that
collect blood and blood components,
including Source Plasma. Specifically,
the guidance explains the conditions
under which FDA does not intend to
take regulatory action for a blood
establishment’s failure to comply with
certain requirements in FDA’s
regulations regarding donation
suitability, donor eligibility, and
quarantine hold for Source Plasma. FDA
expects that the compliance policy
described in the guidance 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. The guidance
announced in this document finalizes
the draft guidance of the same title
dated May 2022, and supersedes the
guidance entitled ‘‘Alternative
Procedures for Blood and Blood
Components During the COVID–19
Public Health Emergency; Guidance for
Industry,’’ dated April 2020.
DATES: The announcement of the
guidance is published in the Federal
Register on October 18, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ddrumheller on DSK120RN23PROD with RULES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
16:15 Oct 17, 2023
Jkt 262001
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–
2022–D–0588 for ‘‘Compliance Policy
Regarding Blood and Blood Component
Donation Suitability, Donor Eligibility
and Source Plasma Quarantine Hold
Requirements; Guidance for Industry.’’
Received comments 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
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Phillip Kurs, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Compliance
Policy Regarding Blood and Blood
Component Donation Suitability, Donor
Eligibility and Source Plasma
E:\FR\FM\18OCR1.SGM
18OCR1
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Rules and Regulations
Quarantine Hold Requirements.’’ The
guidance document addresses certain
requirements that apply to blood
establishments that collect blood and
blood components, including Source
Plasma. Specifically, the guidance
explains the conditions under which
FDA does not intend to take regulatory
action for a blood establishment’s
failure to comply with certain
requirements in Title 21 of the Code of
Federal Regulations (21 CFR 630.30)
regarding donation suitability; 21 CFR
630.10(c)(2) regarding donor eligibility;
and 21 CFR 640.69(f) regarding
quarantine hold for Source Plasma.
In the Federal Register of May 24,
2022 (87 FR 31440), FDA announced the
availability of the draft guidance of the
same title dated May 2022. FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. A summary of changes
includes clarifying the format of the
report discussed in the guidance and
clarifying the scope of the compliance
policy. In addition, editorial changes
were made to improve clarity. The
guidance announced in this document
finalizes the draft guidance dated May
2022, and supersedes the guidance
entitled ‘‘Alternative Procedures for
Blood and Blood Components During
the COVID–19 Public Health
Emergency; Guidance for Industry,’’
dated April 2020.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Compliance Policy
Regarding Blood and Blood Component
Donation Suitability, Donor Eligibility
and Source Plasma Quarantine Hold
Requirements.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
ddrumheller on DSK120RN23PROD with RULES1
II. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information
have been approved under OMB control
number 0910–0116. This guidance also
refers to previously approved FDA
collections of information. The
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338 and
the collections of information in 21 CFR
parts 606, 630, and 640 have been
VerDate Sep<11>2014
16:15 Oct 17, 2023
Jkt 262001
approved under OMB control number
0910–0116.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22957 Filed 10–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
22 CFR Part 171
[Public Notice 12153]
RIN 1400–AE00
Public Access to Information
Department of State.
Final rule.
AGENCY:
ACTION:
The Department of State (the
Department) finalizes the proposed rule
it published on March 3, 2020, relating
to the availability to the public of
information that is under the control of
the Department. These changes were
prompted by changes in the law
governing disclosure of such
information, including the Freedom of
Information Act Improvement Act of
2016. This final rule reflects changes in
the FOIA and consequent changes in the
Department’s procedures since the last
major revision of the Department’s
regulations on public access to
information, which occurred in 2016.
DATES: This rule is effective on
November 17, 2023.
FOR FURTHER INFORMATION CONTACT:
Kellie Robinson, Office of Information
Programs and Services, FOIAstatus@
state.gov, 202–261–8484.
SUPPLEMENTARY INFORMATION: This rule
finalizes the Notice of Proposed
Rulemaking that was published on
March 3, 2020. 85 FR 13104. It
implements the Freedom of Information
Act (FOIA) Improvement Act of 2016,
Public Law 114–185, and updates the
Department’s FOIA regulations at 22
CFR part 171. The following summary
of the substantive changes to Part 171
was included in the NPRM but is
provided here for convenience.
The rule, in § 171.4, provides updated
procedures and addresses for submitting
SUMMARY:
PO 00000
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Fmt 4700
Sfmt 4700
71737
FOIA requests to the Department,
including procedures for requesting
information about the requester and
requests for visa information.
Subpart B of the rule (§§ 171.10
through 171.17) contains the rules
governing the processing of a FOIA
request. Section 171.11 covers the
Department’s initial processing of a
request; it clarifies the information that
is to be provided as part of a request, the
Department’s process for responding to
requests, and consultation and referral
with respect to requests. Section 171.12
covers the timing of responses to a
request, including multi-track
processing, expedited processing, and
‘‘unusual circumstances’’ (as defined in
the FOIA) that might affect the
Department’s ability to respond. Section
171.13 covers responses to requests,
including the procedures upon denial of
a request. The updates add a provision
for consultation with the Department of
Justice’s Office of Information Policy
with respect to invocation of a FOIA
exclusion. Section 171.14 modifies the
Department’s process with respect to
reviews of confidential commercial
information, including procedures for
the owner of the information to object
to the release of the information.
Section 171.15 revises the timeline for
submission of appeals to 90 days and
provides for information to be given to
requesters about dispute resolution
services at various stages of the
processing of a request, in accordance
with the FOIA Improvement Act of
2016. Section 171.16 provides updates
on the fees to be charged for FOIA
requests, including how fees are
calculated. This section provides an
updated explanation of the term,
‘‘representative of the news media.’’
Subpart C contains the rule’s Privacy
Act provisions. There are two
substantive changes in this subpart from
that published in the NPRM. The first
relates to a Privacy Act exemption that
was published after the NPRM was
published. See the final rule on March
9, 2020, ‘‘Privacy Act; STATE–01, Email
Archive Management Records,’’ 85 FR
13482. This SORN was added to the
lists in paragraph (a)(2)(iii), and (b)(1),
(2), (3), (4), (5), (6) and (7). However, the
Department has now determined that
this item was added in error, and the
Department is removing STATE–01
from the lists of Privacy Act exemptions
in §§ 171.26(a)(2)(iii), (b)(2), (b)(3),
(b)(4), (b)(5), (b)(6), and (b)(7). The
reason for this action is that the
Department has determined that its
email records do not constitute a system
of records under the Privacy Act;
therefore, STATE–01, ‘‘Email Archive
Management Records’’, will be
E:\FR\FM\18OCR1.SGM
18OCR1
Agencies
[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Rules and Regulations]
[Pages 71736-71737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22957]
[[Page 71736]]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 630 and 640
[Docket No. FDA-2022-D-0588]
Compliance Policy Regarding Blood and Blood Component Donation
Suitability, Donor Eligibility and Source Plasma Quarantine Hold
Requirements; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Announcement of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Compliance
Policy Regarding Blood and Blood Component Donation Suitability, Donor
Eligibility and Source Plasma Quarantine Hold Requirements.'' The
guidance document addresses certain requirements that apply to blood
establishments that collect blood and blood components, including
Source Plasma. Specifically, the guidance explains the conditions under
which FDA does not intend to take regulatory action for a blood
establishment's failure to comply with certain requirements in FDA's
regulations regarding donation suitability, donor eligibility, and
quarantine hold for Source Plasma. FDA expects that the compliance
policy described in the guidance 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. The guidance announced in this document finalizes the draft
guidance of the same title dated May 2022, and supersedes the guidance
entitled ``Alternative Procedures for Blood and Blood Components During
the COVID-19 Public Health Emergency; Guidance for Industry,'' dated
April 2020.
DATES: The announcement of the guidance is published in the Federal
Register on October 18, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2022-D-0588 for ``Compliance Policy Regarding Blood and Blood
Component Donation Suitability, Donor Eligibility and Source Plasma
Quarantine Hold Requirements; Guidance for Industry.'' Received
comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Phillip Kurs, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Compliance Policy Regarding Blood and Blood Component Donation
Suitability, Donor Eligibility and Source Plasma
[[Page 71737]]
Quarantine Hold Requirements.'' The guidance document addresses certain
requirements that apply to blood establishments that collect blood and
blood components, including Source Plasma. Specifically, the guidance
explains the conditions under which FDA does not intend to take
regulatory action for a blood establishment's failure to comply with
certain requirements in Title 21 of the Code of Federal Regulations (21
CFR 630.30) regarding donation suitability; 21 CFR 630.10(c)(2)
regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine
hold for Source Plasma.
In the Federal Register of May 24, 2022 (87 FR 31440), FDA
announced the availability of the draft guidance of the same title
dated May 2022. FDA received several comments on the draft guidance and
those comments were considered as the guidance was finalized. A summary
of changes includes clarifying the format of the report discussed in
the guidance and clarifying the scope of the compliance policy. In
addition, editorial changes were made to improve clarity. The guidance
announced in this document finalizes the draft guidance dated May 2022,
and supersedes the guidance entitled ``Alternative Procedures for Blood
and Blood Components During the COVID-19 Public Health Emergency;
Guidance for Industry,'' dated April 2020.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Compliance Policy Regarding Blood and
Blood Component Donation Suitability, Donor Eligibility and Source
Plasma Quarantine Hold Requirements.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information have been approved under OMB control number
0910-0116. This guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338 and the
collections of information in 21 CFR parts 606, 630, and 640 have been
approved under OMB control number 0910-0116.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22957 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P