Document ID: FDA-2021-N-0011-0001
Agency: fda
Document Type: Rule
Title: Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment
Posted Date: 2021-09-07T04:00Z

[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]
BILLING CODE 4164-01-P