2023-21995. Revocation of Authorization of Emergency Use of Becton, Dickinson and Company Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site); Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Becton, Dickinson and Co., for the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site). FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

DATES:

The Authorization for the Becton, Dickinson and Co., BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) is revoked as of July 11, 2023.

ADDRESSES:

Submit a written request for a single copy of the revocation to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT:

Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993–0002, 301–796–0311 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On July 22, 2021, FDA issued the Authorization to Becton, Dickinson and Co., for the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on October 28, 2021 (86 FR 59738), as required by section 564(h)(1) of the FD&C Act. Subsequent updates to the Authorization were made available on FDA's website. The authorization of a device for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act).

II. Authorization Revocation Request

In a request received by FDA on June 12, 2023, Becton, Dickinson and Co. requested the withdrawal of, and on July 11, 2023, FDA revoked the Authorization for the Becton, Dickinson and Co.'s BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site). Because Becton, Dickinson and Co., notified FDA that they have discontinued the sale of the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) and requested FDA withdraw the EUA for the Becton, Dickinson and Co.'s BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

III. Electronic Access

An electronic version of this document and the full text of the revocation is available on the internet at https://www.regulations.gov/​.

IV. The Revocation

Having concluded that the criteria for revocation of the Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA of Becton, Dickinson and Co.'s BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site). The revocation in its entirety follows and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.

Dated: September 29, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.