Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 68625 

Rider Trail South, Earth City, MO 

63045. 

If you have any questions concerning 

courier delivery, contact U.S. Bank at 

800–495–4981. This phone number is 

only for questions about courier 

delivery. 

Note that the address for payments 

made by mail has not changed and 

should continue to be mailed to: 

• CQA and MDUFA: Food and Drug 

Administration, P.O. Box 979033, St. 

Louis, MO 63197–9000. 

• For BsUFA, FSMA, and GDUFA: 

Food and Drug Administration, P.O. 

Box 979108, St. Louis, MO 63197–9000. 

• For PDUFA: Food and Drug 

Administration, P.O. Box 979107, St. 

Louis, MO 63197–9000. 

If a check, bank draft, or U.S. postal 

money order is submitted, make it 

payable to the order of the Food and 

Drug Administration and include the 

user fee ID number to ensure that the 

payment is applied to the correct fee(s). 

The FDA post office box number must 

be written on the check, bank draft, or 

U.S. postal money order. 

In addition, note that the information 

for payments made by wire transfer has 

not changed, and must include the 

unique user fee ID number to ensure 

that the payment is applied to the 

correct fee(s). Without the unique user 

fee ID number, the payment may not be 

applied. If the payment amount is not 

applied, the invoice amount will be 

referred to collections. The originating 

financial institution may charge a wire 

transfer fee. Include applicable wire 

transfer fees with payment to ensure 

fees are fully paid. Questions about wire 

transfer fees should be addressed to the 

financial institution. The following 

account information should continue to 

be used to send payments by wire 

transfer: U.S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, account number: 

75060099, routing number: 021030004, 

SWIFT: FRNYUS33. 

FDA’s tax identification number is 

53–0196965. (Note: Invoice copies do 

not need to be submitted to FDA with 

the payments.) 

Dated: September 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21989 Filed 10–3–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4180] 

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 selfaddressed 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 AllHazards 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 


lotter on DSK11XQN23PROD with NOTICES1
68626 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 

for revocation, as required by section 

564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 

Dated: September 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21995 Filed 10–3–23; 8:45 am] 

BILLING CODE 4164–01–C 


lotter on DSK11XQN23PROD with NOTICES1EN04OC23.020</GPH>

U.S. FOOD & DRUG 

Al:IMINIST!a.MIO.M 

July 11, 2023 

Matthew Trachtenberg, MSE 

Director Regulatory Mairs 

Becton, Dickinson and Co, 

l Becton Drive 

Franklin Lakes, NJ 07417 

Re: Revocation ofEUAZ10465 

Dear Matthew Trachtenberg: 

this letter is in response to the request from .Becton, l)ickihson and Co. ("BD"), in an email 

received June 12, 2023, that the U.S .. Food and Drug Adminisu·ation (FDA) withdraw the EUA 

for the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) issued on July 22, 

2021. BD indicated that they have discontinued the sale ofthe authorized product and requested 

that the litJA be withdrawn. FDA understands that, M of the date of this letter, there are no 

viable BI> Vac,rtainer Plus Citrate Plasma Tubes (UK Manuracturing Site) ren1.aining in 

distribution in the United States. • 

The authorization of a device for emergency iise under section 564 of'th:e Federal Food, Drug, 

and Cosmetic Act (the Act) (21 tJ.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked when circttmstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act). Because BD has requested that FDA withdraw the EUA 

for the BD V acutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), FDA has determined 

that it is appropriate, to protect the publki health or safety, to revoke this. authorization, 

Acc<)tdingly, FDA hereby revokes EUA210465 for the BDVacutainer Plus Citrate Pla.<;ma 

tubes (UK Manufacturing Site), pursuant to section 564(g)(2)(C) ofthe Act. As ofthe date of 

this letter, the BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) are 110 longer 

authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursua11t to section 564(h)(l) 

ofth.e Act. • 

Sincerely, 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

Food and Drug Admillistration