68624 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 

FOR FURTHER INFORMATION CONTACT: Joan 

Dailey, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6248, Silver Spring, 

MD 20993–0002, 301–796–6357, 

Joan.Dailey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

ULTRAM (tramadol hydrochloride) 

Tablets, 50 mg, is the subject of NDA 

020281, held by Janssen 

Pharmaceuticals, Inc., and initially 

approved on March 3, 1995. ULTRAM 

is indicated for the management of pain 

severe enough to require an opioid 

analgesic and for which alternative 

treatments are inadequate. 

ULTRAM (tramadol hydrochloride) 

Tablets, 50 mg, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Hyman, Phelps & McNamara, P.C. 

submitted a citizen petition dated June 

28, 2023 (Docket No. FDA–2023–P– 

2656), under 21 CFR 10.30, requesting 

that the Agency determine whether 

ULTRAM (tramadol hydrochloride) 

Tablets, 50 mg, was withdrawn from 

sale for reasons of safety or 

effectiveness. The citizen petition noted 

that FDA has already determined that 

the 100 mg tablet strength of the same 

drug was not discontinued for reasons 

of safety or effectiveness (see the 

Federal Register of April 27, 2022 (87 

FR 25028)). 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that ULTRAM (tramadol 

hydrochloride) Tablets, 50 mg, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that ULTRAM (tramadol 

hydrochloride) Tablets, 50 mg, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of ULTRAM 

(tramadol hydrochloride) Tablets, 50 

mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ULTRAM (tramadol 

hydrochloride) Tablets, 50 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: September 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21990 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–4158] 

User Fee Rates for Fiscal Year 2024; 

Change of Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice that the courier address for the 

U.S. Bank will change. This change has 

a direct impact on the Fiscal Year 2024 

Federal Register notices for the 

following FDA User Fee programs: 

Prescription Drug User Fee 

Amendments (PDUFA), Medical Device 

User Fee Amendments (MDUFA), 

Generic Drug User Fee Amendments 

(GDUFA), Biosimilar User Fee 

Amendments (BsUFA), Food Safety 

Modernization Act (FSMA), and 

Compounding Quality Act (CQA). The 

new physical address will be 3180 Rider 

Trail South, Earth City, MO 63045. 

FOR FURTHER INFORMATION CONTACT: 

Olufunmilayo Ariyo, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 62080, Beltsville, MD 20705–4304, 

240–402–4989; or the User Fees Support 

Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of this notice is to inform the 

public that the physical address for 

overnight packages for the U.S. Bank 

will change on October 6, 2023. The 

building’s street address has changed 

from 1005 Convention Plaza, St. Louis, 

MO 63101, to 3180 Rider Trail South, 

Earth City, MO 63045. The last date to 

use the old address to deliver a check 

by courier, such as Federal Express or 

UPS, is October 5, 2023, and payers 

must use the new address for any 

packages beginning October 6, 2023, to 

prevent any disruption to the processing 

of their overnight package payments. 

Note that this new address is for courier 

delivery only. 

If checks are to be sent by a courier 

that requires a street address, the courier 

can deliver the checks to: 

• For CQA and MDUFA: U.S. Bank, 

ATTN: Government Lockbox 979033, 

3180 Rider Trail South, Earth City, MO 

63045. 

• For BsUFA, FSMA, and GDUFA: 

U.S. Bank, ATTN: Government Lockbox 

979108, 3180 Rider Trail South, Earth 

City, MO 63045. 

• For PDUFA: U.S. Bank, ATTN: 

Government Lockbox 979107, 3180 


lotter on DSK11XQN23PROD with NOTICES1
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 


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