49922 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 Records—COMMERCE/ 
DEPT–27, but only on condition that the general exemption claimed in § 4.33(b)(4) is held to be invalid; 
* * * * * 
(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. 
* * * * * 
[FR Doc. 2021–19315 Filed 9–3–21; 8:45 am] 
BILLING CODE 3510–17–P 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 § 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 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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