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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:

G Investigation and Threat Management RecordsCOMMERCE/
DEPT27, but only on condition that the general exemption claimed in 4.33b4 is held to be invalid;

4i Exempt under 5 U.S.C.
552ak5 . 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/MA1;
B USMMA Midshipman Medical FilesCOMMERCE/MA17;
C USMMA Midshipman Personnel FilesCOMMERCE/MA18;
D USMMA Non-Appropriated Fund EmployeesCOMMERCE/MA19;
E Applicants for the NOAA Corps COMMERCE/NOAAI;
F Commissioned Officer Official Personnel FoldersCOMMERCE/
NOAA3;
G Conflict of lnterest Records, Appointed OfficialsCOMMERCE/
DEPT3;
H Investigative and Inspection RecordsCOMMERCE/DEPT12, but only on condition that the general exemption claimed in 4.33b3 is held to be invalid;
I Investigative RecordsPersons within the Investigative Jurisdiction of the Department COMMERCE/DEPT13;
J Litigation, Claims, and Administrative Proceeding Records COMMERCE/DEPT14;
K Access Control and Identity Management SystemCOMMERCE/
DEPT25, but only on condition that the general exemption claimed in 4.33b4 is held to be invalid; and L Investigation and Threat Management RecordsCOMMERCE/
DEPT27, but only on condition that the general exemption claimed in 4.33b4 is held to be invalid.

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 610
Docket No. FDA2021N0011

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 209930002, 240
4027911.
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 610.40h2vii 21 CFR
610.40h2vii, 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 610.40h2vii, as amended by the May 2015 final rule, FDA
inadvertently cited 640.65a2ii.
The reference to 640.65a2ii is an incorrect citation. Accordingly, FDA is removing the reference to 640.65a2ii. Additionally, to improve the clarity of the regulation, we are also amending 610.40h2vii to replace the reference to 640.65b2i through iv with a reference to 640.65b2ii through iv. This amendment aligns with the preamble of the May 2015 final rule, which stated
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that FDA was removing the citation to 640.65b2, and replacing it with the more precise citation to 640.65b2ii through b2iv May 2015 final rule, 80 FR 29842 at 29886. FDA notes that donor protein composition assessment under 640.65b2i is required for plasmapheresis procedures irrespective of whether or not the syphilis screening requirements under 640.65b2ii 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. 553b3A 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 610GENERAL 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 h2vii 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 640.65b1i of this chapter, if the donor meets the requirements of 640.65b2ii through iv of this chapter.
Dated: August 31, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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