Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability, 58274-58275 [2024-15228]
Download as PDF
58274
Federal Register / Vol. 89, No. 138 / Thursday, July 18, 2024 / Rules and Regulations
7. Supplement no. 4 to part 744 is
amended by revising the introductory
text to read as follows:
■
Supplement No. 4 to Part 744—Entity
List
This supplement lists certain entities
subject to license requirements for specified
items under this part 744 and part 746 of the
EAR. License requirements for these entities
include exports, reexports, and transfers (incountry) unless otherwise stated. A license is
required, to the extent specified on the Entity
List, to export, reexport, or transfer (incountry) any item subject to the EAR when
an entity that is listed on the Entity List is
a party to the transaction as described in
§ 748.5(c) through (f). of the EAR This list of
entities is revised and updated on a periodic
basis in this Supplement by adding new or
amended notifications and deleting
notifications no longer in effect.
*
*
*
*
*
PART 772—DEFINITIONS OF TERMS
8. The authority citation for 15 CFR
part 772 continues to read as follows:
■
Authority: 50 U.S.C. 4801–4852; 50 U.S.C.
4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783.
9. Section 772.1 is amended by
a. Revising the definition of
‘‘Standards-related activity.’’
The revisions read as follows:
■
■
Electronic Submissions
§ 772.1 Definitions of Terms as Used In the
Export Administration Regulations (EAR).
*
*
*
*
*
Standards-related activity. See
§ 734.10 of the EAR.
*
*
*
*
*
Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
[FR Doc. 2024–15810 Filed 7–17–24; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 630
khammond on DSKJM1Z7X2PROD with RULES
[Docket No. FDA–2022–D–0362]
Blood Pressure and Pulse Donor
Eligibility Requirements: Compliance
Policy; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
SUMMARY:
VerDate Sep<11>2014
15:44 Jul 17, 2024
Jkt 262001
guidance entitled ‘‘Blood Pressure and
Pulse Donor Eligibility Requirements:
Compliance Policy; Guidance for
Industry.’’ The guidance document
addresses certain regulatory
requirements for determining donor
eligibility that apply to blood
establishments that collect blood and
blood components for transfusion or for
further manufacturing use, including
Source Plasma. In a final rule dated May
22, 2015, FDA amended the regulations
applicable to blood establishments for
determining donor eligibility and testing
blood and blood components. The
revised requirements were implemented
in order to assure the safety of the blood
supply and to protect donor health. This
guidance finalizes the draft guidance
entitled ‘‘Blood Pressure and Pulse
Donor Eligibility Requirements:
Compliance Policy; Draft Guidance for
Industry’’ issued on May 24, 2022.
DATES: The announcement of the
guidance is published in the Federal
Register on July 18, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
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–0362 for ‘‘Blood Pressure and
Pulse Donor Eligibility Requirements:
Compliance Policy; 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-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
E:\FR\FM\18JYR1.SGM
18JYR1
Federal Register / Vol. 89, No. 138 / Thursday, July 18, 2024 / Rules and Regulations
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:
Myrna Hanna, 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:
khammond on DSKJM1Z7X2PROD with RULES
I. Background
FDA is announcing the availability of
a document entitled ‘‘Blood Pressure
and Pulse Donor Eligibility
Requirements: Compliance Policy.’’ The
document addresses certain regulatory
requirements for determining donor
eligibility that apply to blood
establishments that collect blood
components for transfusion or for
further manufacturing use, including
Source Plasma. In the final rule dated
May 22, 2015 (80 FR 29841) entitled
‘‘Requirements for Blood and Blood
Components Intended for Transfusion
or for Further Manufacturing Use,’’ FDA
amended the regulations applicable to
blood establishments for determining
donor eligibility and testing blood and
blood components.1 The revised
requirements were implemented in
order to assure the safety of the blood
supply and to protect donor health. The
final rule became effective on May 23,
2016. FDA has developed the document
in response to feedback from blood
establishments regarding the donor
eligibility requirements for blood
pressure and pulse in 21 CFR 630.10
and the corresponding requirements for
medical supervision in 21 CFR 630.5.
1 The Office of the Federal Register has published
this document under the category ‘‘Rules and
Regulations’’ pursuant to 1 CFR 5.9(b). The
categorization is solely for purposes of publication
in the Federal Register and does not change the
nature of the document and is not intended to affect
its validity, content, or intent. See 1 CFR 5.1(c).
VerDate Sep<11>2014
15:44 Jul 17, 2024
Jkt 262001
The guidance describes the
circumstances in which FDA does not
intend to take regulatory action for a
blood establishment’s failure to comply
with certain regulations for determining
the eligibility of blood donors with
blood pressure or pulse measurements
outside of the specified limits.
This guidance finalizes the draft
guidance entitled ‘‘Blood Pressure and
Pulse Donor Eligibility Requirements:
Compliance Policy; Draft Guidance for
Industry’’ issued on May 24, 2022 (87
FR 31567). Changes made from the draft
to the final guidance took into
consideration comments received. After
considering the comments, we made a
few clarifying edits to the guidance and
other editorial changes.
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 blood pressure and
pulse donor eligibility requirements and
explains our compliance policy with
respect to these 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
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information 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 in
21 CFR part 601 have been approved
under OMB control number 0910–0338;
the collections of information in 21 CFR
parts 606 and 630 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-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15228 Filed 7–17–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
58275
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 10004]
RIN 1545–BM19
Guidance Under Section 367(b)
Related to Certain Triangular
Reorganizations and Inbound
Nonrecognition Transactions
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
This document contains final
regulations regarding the treatment of
property used to acquire parent stock or
securities in connection with certain
triangular reorganizations involving one
or more foreign corporations; the
consequences to persons that receive
parent stock or securities pursuant to
such reorganizations; and the treatment
of certain subsequent inbound
nonrecognition transactions following
such reorganizations and certain other
transactions. The final regulations affect
corporations engaged in certain
triangular reorganizations involving one
or more foreign corporations, certain
shareholders of foreign corporations
acquired in such reorganizations, and
foreign corporations that participate in
certain inbound nonrecognition
transactions.
DATES:
Effective date: These regulations are
effective on July 17, 2024.
Applicability dates: For dates of
applicability, see §§ 1.367(a)–
3(g)(1)(viii), 1.367(b)–3(g)(7)(i),
1.367(b)–4(i), 1.367(b)–6(a)(1)(v) and
(vi), 1.367(b)–10(e)(2), (3), and (5), and
1.1411–10(i).
FOR FURTHER INFORMATION CONTACT:
Brady Plastaras at (202) 317–6937 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
On October 6, 2023, the Department
of the Treasury (Treasury Department)
and the IRS published proposed
regulations (REG–117614–14) in the
Federal Register (88 FR 69559) under
section 367(b) of the Internal Revenue
Code (the ‘‘Proposed Regulations’’) that
would implement the regulations
announced and described in Notice
2014–32 (2014–20 IRB 1006) and Notice
2016–73 (2016–52 IRB 908), with
modifications. This document finalizes
the Proposed Regulations without
substantive change. Terms used but not
defined in this preamble have the
E:\FR\FM\18JYR1.SGM
18JYR1
Agencies
[Federal Register Volume 89, Number 138 (Thursday, July 18, 2024)]
[Rules and Regulations]
[Pages 58274-58275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15228]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 630
[Docket No. FDA-2022-D-0362]
Blood Pressure and Pulse Donor Eligibility Requirements:
Compliance Policy; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Blood Pressure and
Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for
Industry.'' The guidance document addresses certain regulatory
requirements for determining donor eligibility that apply to blood
establishments that collect blood and blood components for transfusion
or for further manufacturing use, including Source Plasma. In a final
rule dated May 22, 2015, FDA amended the regulations applicable to
blood establishments for determining donor eligibility and testing
blood and blood components. The revised requirements were implemented
in order to assure the safety of the blood supply and to protect donor
health. This guidance finalizes the draft guidance entitled ``Blood
Pressure and Pulse Donor Eligibility Requirements: Compliance Policy;
Draft Guidance for Industry'' issued on May 24, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on July 18, 2024.
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-0362 for ``Blood Pressure and Pulse Donor Eligibility
Requirements: Compliance Policy; 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
[[Page 58275]]
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: Myrna Hanna, 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 ``Blood
Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.''
The document addresses certain regulatory requirements for determining
donor eligibility that apply to blood establishments that collect blood
components for transfusion or for further manufacturing use, including
Source Plasma. In the final rule dated May 22, 2015 (80 FR 29841)
entitled ``Requirements for Blood and Blood Components Intended for
Transfusion or for Further Manufacturing Use,'' FDA amended the
regulations applicable to blood establishments for determining donor
eligibility and testing blood and blood components.\1\ The revised
requirements were implemented in order to assure the safety of the
blood supply and to protect donor health. The final rule became
effective on May 23, 2016. FDA has developed the document in response
to feedback from blood establishments regarding the donor eligibility
requirements for blood pressure and pulse in 21 CFR 630.10 and the
corresponding requirements for medical supervision in 21 CFR 630.5. The
guidance describes the circumstances in which FDA does not intend to
take regulatory action for a blood establishment's failure to comply
with certain regulations for determining the eligibility of blood
donors with blood pressure or pulse measurements outside of the
specified limits.
---------------------------------------------------------------------------
\1\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to 1
CFR 5.9(b). The categorization is solely for purposes of publication
in the Federal Register and does not change the nature of the
document and is not intended to affect its validity, content, or
intent. See 1 CFR 5.1(c).
---------------------------------------------------------------------------
This guidance finalizes the draft guidance entitled ``Blood
Pressure and Pulse Donor Eligibility Requirements: Compliance Policy;
Draft Guidance for Industry'' issued on May 24, 2022 (87 FR 31567).
Changes made from the draft to the final guidance took into
consideration comments received. After considering the comments, we
made a few clarifying edits to the guidance and other editorial
changes.
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 blood pressure and pulse donor eligibility
requirements and explains our compliance policy with respect to these
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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information 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 in 21
CFR part 601 have been approved under OMB control number 0910-0338; the
collections of information in 21 CFR parts 606 and 630 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: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15228 Filed 7-17-24; 8:45 am]
BILLING CODE 4164-01-P