Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment, 49922 [2021-19220]
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Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Rules and Regulations
exempt (some only conditionally), the
sections of the Act from which
exempted, and the reasons therefor are
as follows:
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(G) Investigation and Threat
Management Records—COMMERCE/
DEPT–27, but only on condition that the
general exemption claimed in
§ 4.33(b)(4) is held to be invalid;
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(4)(i) Exempt under 5 U.S.C.
552a(k)(5 ). The systems of records
exempt (some only conditionally), the
sections of the Act from which
exempted, and the reasons therefor are
as follows:
(A) Applications to U.S. Merchant
Marine Academy (USMMA)—
COMMERCE/MA–1;
(B) USMMA Midshipman Medical
Files—COMMERCE/MA–17;
(C) USMMA Midshipman Personnel
Files—COMMERCE/MA–18;
(D) USMMA Non-Appropriated Fund
Employees—COMMERCE/MA–19;
(E) Applicants for the NOAA Corps—
COMMERCE/NOAA–I;
(F) Commissioned Officer Official
Personnel Folders—COMMERCE/
NOAA–3;
(G) Conflict of lnterest Records,
Appointed Officials—COMMERCE/
DEPT–3;
(H) Investigative and Inspection
Records—COMMERCE/DEPT–12, but
only on condition that the general
exemption claimed in § 4.33(b)(3) is
held to be invalid;
(I) Investigative Records—Persons
within the Investigative Jurisdiction of
the Department COMMERCE/DEPT–13;
(J) Litigation, Claims, and
Administrative Proceeding Records—
COMMERCE/DEPT–14;
(K) Access Control and Identity
Management System—COMMERCE/
DEPT–25, but only on condition that the
general exemption claimed in
§ 4.33(b)(4) is held to be invalid; and
(L) Investigation and Threat
Management Records—COMMERCE/
DEPT–27, but only on condition that the
general exemption claimed in
§ 4.33(b)(4) is held to be invalid.
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[FR Doc. 2021–19315 Filed 9–3–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 610
[Docket No. FDA–2021–N–0011]
Revision to Restrictions on Shipment
or Use for Human Blood and Blood
Components Exceptions; Technical
Amendment
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule; technical
amendment.
AGENCY:
The Food and Drug
Administration (FDA or we) is
amending the biologics regulation to
improve clarity and revise an incorrect
citation. This action is being taken to
ensure the accuracy and clarity of the
biologics regulation.
DATES: This rule is September 7, 2021.
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:
SUMMARY:
I. Background
In the Federal Register of May 22,
2015 (80 FR 29842), FDA published a
final rule entitled ‘‘Requirements for
Blood and Blood Components Intended
for Transfusion or for Further
Manufacturing Use’’ (May 2015 final
rule). In the May 2015 final rule, FDA
amended § 610.40(h)(2)(vii) (21 CFR
610.40(h)(2)(vii)), which provides for
exceptions to the restrictions on
shipment or use of human blood and
blood components. The May 2015 final
rule included an incorrect regulatory
citation in this provision.
II. Description of the Technical
Amendments
In § 610.40(h)(2)(vii), as amended by
the May 2015 final rule, FDA
inadvertently cited § 640.65(a)(2)(ii).
The reference to § 640.65(a)(2)(ii) is an
incorrect citation. Accordingly, FDA is
removing the reference to
§ 640.65(a)(2)(ii). Additionally, to
improve the clarity of the regulation, we
are also amending § 610.40(h)(2)(vii) to
replace the reference to § 640.65(b)(2)(i)
through (iv) with a reference to
§ 640.65(b)(2)(ii) through (iv). This
amendment aligns with the preamble of
the May 2015 final rule, which stated
PO 00000
Frm 00020
Fmt 4700
Sfmt 9990
that FDA was ‘‘removing [the citation
to] § 640.65(b)(2), and replacing it with
the more precise citation to
§ 640.65(b)(2)(ii) through (b)(2)(iv)’’
(May 2015 final rule, 80 FR 29842 at
29886). FDA notes that donor protein
composition assessment under
§ 640.65(b)(2)(i) is required for
plasmapheresis procedures irrespective
of whether or not the syphilis screening
requirements under § 640.65(b)(2)(ii)
through (iv) are applicable.
III. Notice and Public Comment
Publication of this document
constitutes final action of these changes
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
this rulemaking meets the notice and
comment exemption requirements in 5
U.S.C. 553(b)(3)(A) and (B). FDA has
determined that notice and public
comment are unnecessary because the
amendments to the regulation provide
only technical changes and are
nonsubstantive.
List of Subjects in 21 CFR Part 610
Biologics, Labeling, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, 21 CFR part
610 is amended as follows:
PART 610—GENERAL BIOLOGICAL
PRODUCTS STANDARDS
1. The authority citation for part 610
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360c, 360d, 360h, 360i, 371,
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
2. In § 610.40, revise paragraph
(h)(2)(vii) to read as follows:
■
§ 610.40
Test requirements.
*
*
*
*
*
(h) * * *
(2) * * *
(vii) You may use Source Plasma from
a donor who tests reactive by a
screening test for syphilis as required
under § 640.65(b)(1)(i) of this chapter, if
the donor meets the requirements of
§ 640.65(b)(2)(ii) through (iv) of this
chapter.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–19220 Filed 9–3–21; 8:45 am]
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]]>Agencies
[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Rules and Regulations]
[Page 49922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19220]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 610
[Docket No. FDA-2021-N-0011]
Revision to Restrictions on Shipment or Use for Human Blood and
Blood Components Exceptions; Technical Amendment
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
biologics regulation to improve clarity and revise an incorrect
citation. This action is being taken to ensure the accuracy and clarity
of the biologics regulation.
DATES: This rule is September 7, 2021.
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
In the Federal Register of May 22, 2015 (80 FR 29842), FDA
published a final rule entitled ``Requirements for Blood and Blood
Components Intended for Transfusion or for Further Manufacturing Use''
(May 2015 final rule). In the May 2015 final rule, FDA amended Sec.
610.40(h)(2)(vii) (21 CFR 610.40(h)(2)(vii)), which provides for
exceptions to the restrictions on shipment or use of human blood and
blood components. The May 2015 final rule included an incorrect
regulatory citation in this provision.
II. Description of the Technical Amendments
In Sec. 610.40(h)(2)(vii), as amended by the May 2015 final rule,
FDA inadvertently cited Sec. 640.65(a)(2)(ii). The reference to Sec.
640.65(a)(2)(ii) is an incorrect citation. Accordingly, FDA is removing
the reference to Sec. 640.65(a)(2)(ii). Additionally, to improve the
clarity of the regulation, we are also amending Sec. 610.40(h)(2)(vii)
to replace the reference to Sec. 640.65(b)(2)(i) through (iv) with a
reference to Sec. 640.65(b)(2)(ii) through (iv). This amendment aligns
with the preamble of the May 2015 final rule, which stated that FDA was
``removing [the citation to] Sec. 640.65(b)(2), and replacing it with
the more precise citation to Sec. 640.65(b)(2)(ii) through
(b)(2)(iv)'' (May 2015 final rule, 80 FR 29842 at 29886). FDA notes
that donor protein composition assessment under Sec. 640.65(b)(2)(i)
is required for plasmapheresis procedures irrespective of whether or
not the syphilis screening requirements under Sec. 640.65(b)(2)(ii)
through (iv) are applicable.
III. Notice and Public Comment
Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that this rulemaking meets the notice and comment exemption
requirements in 5 U.S.C. 553(b)(3)(A) and (B). FDA has determined that
notice and public comment are unnecessary because the amendments to the
regulation provide only technical changes and are nonsubstantive.
List of Subjects in 21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR
part 610 is amended as follows:
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
0
1. The authority citation for part 610 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
0
2. In Sec. 610.40, revise paragraph (h)(2)(vii) to read as follows:
Sec. 610.40 Test requirements.
* * * * *
(h) * * *
(2) * * *
(vii) You may use Source Plasma from a donor who tests reactive by
a screening test for syphilis as required under Sec. 640.65(b)(1)(i)
of this chapter, if the donor meets the requirements of Sec.
640.65(b)(2)(ii) through (iv) of this chapter.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19220 Filed 9-3-21; 8:45 am]
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