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] 

BILLING CODE 4164–01–P 


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