Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 32423 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave. Bldg. 71, Rm. 

1244, Silver Spring, MD 20993–0002, 

240–402–8054, ctgtac@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, before coming to the meeting, 

you should always check the Agency’s 

website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications. 

SUPPLEMENTARY INFORMATION:

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

Committee will meet in open session on 

both days to discuss the current 

regulatory expectations for 

xenotransplantation products. The 

discussion topics include human cells 

that have had ex vivo contact with 

animal cells, and animal organs and 

cells for transplantation into human 

subjects. On June 29, 2022, in the 

morning, under session 1, the 

Committee will meet to discuss and 

make recommendations on human cells 

that have ex vivo contact with animal 

cells. In the afternoon under session 2, 

the Committee will begin to discuss and 

make recommendations on animal 

organs and cells for transplantation into 

human subjects and their associated 

risks. On June 30, 2022, the Committee 

will continue to discuss and make 

recommendations on animal organs and 

cells for transplantation into human 

subjects. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

June 22, 2022, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 1:15 p.m. and 2:15 p.m. 

Eastern Time on June 29, 2022, and 1 

p.m. and 2 p.m. Eastern Time on June 

30, 2022. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation, on 

or before June 16, 2022. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by June 17, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Christina Vert 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11563 Filed 5–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0895] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC). The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. This meeting will be 

held to discuss an Emergency Use 

Authorization (EUA) request by 

Novavax for a vaccine to prevent 

COVID–19 in individuals 18 years of age 

and older. The meeting will be open to 

the public. FDA is establishing a docket 

for public comment on this document. 

DATES: The meeting will be held 

virtually on June 7, 2022, from 8:30 a.m. 

to 5 p.m. Eastern Time. Submit either 

electronic or written comments on this 

public meeting by June 6, 2022. 

Comments received on or before June 1, 

2022, will be provided to the committee. 

Comments received after June 1, 2022, 

and by June 6, 2022, will be taken into 

consideration by FDA. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://youtu.be/ 

DfdMsAqkneE. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0895. 

The docket will close on June 6, 2022. 

Submit either electronic or written 

comments on this public meeting by 

June 6, 2022. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

June 6, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 


khammond on DSKJM1Z7X2PROD with NOTICES
32424 Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 

Comments received on or before June 

1, 2022, will be provided to the 

committee. Comments received June 1, 

2022, and by June 6, 2022, will be taken 

into consideration by FDA. In the event 

that the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–N–0895 for ‘‘Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC); Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Eastern Time Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify the information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Prabhakara Atreya or Sussan Paydar, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 240–506–4946, via email at 

CBERVRBPAC@fda.hhs.gov; or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: Consistent 

with FDA’s regulations, this notice is 

being published with less than 15 days 

prior to the date of the meeting based on 

a determination that convening a 

meeting of the VRBPAC as soon as 

possible is warranted. This notice could 

not be published 15 days prior to the 

date of the meeting due to the need for 

prompt discussion on an EUA request 

by Novavax for a vaccine to prevent 

COVID–19 in individuals 18 years of age 

and older. 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On June 7, 

2022, the committee will meet in open 

session to discuss an EUA request by 

Novavax for a vaccine to prevent 

COVID–19 in individuals 18 years of age 

and older. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the time 

of the advisory committee meeting, and 

the background material will be posted 

on FDA’s website after the meeting. 

Background material is available at 

https://www.fda.gov/Advisory

Committees/Calendar/default.htm. 

Scroll down to the appropriate advisory 

committee meeting link. The meeting 

will include slide presentations with 

audio components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: On June 7, 2022, from 8:30 

a.m. to 5 p.m. Eastern Time, the meeting 

is open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

June 1, 2022, will be provided to the 

committee. Comments received after 

June 1, 2022, and by June 6, 2022, will 

be taken into consideration by FDA. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Eastern Time. Those 

individuals interested in making formal 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 32425 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and email addresses 

of proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before 6 p.m. ET on June 1, 2022. 

Time allotted for each presentation may 

be limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by June 

3, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Prabhakara 

Atreya or Sussan Paydar (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11668 Filed 5–26–22; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0887] 

TG Therapeutics, Inc.; Withdrawal of 

Approval of New Drug Application for 

UKONIQ (Umbralisib Tosylate) Tablets, 

Equivalent to 200 Milligrams Base 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of the new drug 

application (NDA) for UKONIQ 

(umbralisib tosylate) Tablets, equivalent 

to (EQ) 200 milligrams (mg) Base, held 

by TG Therapeutics, Inc., 3020 

Carrington Mill Blvd., Morrisville, NC 

27560. TG Therapeutics, Inc. (TGT) has 

voluntarily requested that FDA 

withdraw approval of this application 

and has waived its opportunity for a 

hearing. 

DATES: Approval is withdrawn as of 

May 31, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

February 5, 2021, FDA approved NDA 

213176 for UKONIQ (umbralisib 

tosylate) Tablets, EQ 200 mg base, for 

the treatment of adult patients with: (1) 

Relapsed or refractory marginal zone 

lymphoma (MZL) who have received at 

least one prior anti-CD20-based regimen 

and (2) relapsed or refractory follicular 

lymphoma (FL) who have received at 

least three prior lines of systemic 

therapy, under the Agency’s accelerated 

approval regulations, 21 CFR part 314, 

subpart H. The accelerated approval of 

UKONIQ (umbralisib tosylate) Tablets, 

EQ 200 mg base, for MZL and FL 

included required postmarketing trials 

intended to verify the clinical benefit of 

UKONIQ. 

On February 3, 2022, FDA issued a 

Drug Safety Communication about a 

possible increased risk of death with 

UKONIQ (umbralisib tosylate) Tablets, 

EQ 200 mg base. FDA’s initial review of 

data from a phase 3, randomized, 

controlled clinical trial in patients with 

chronic lymphocytic leukemia (CLL) 

who were administered UKONIQ 

(umbralisib tosylate) Tablets, EQ 200 mg 

base, in combination with a monoclonal 

antibody drug compared to the control 

arm showed a possible increased risk of 

death in patients receiving the 

combination of UKONIQ (umbralisib 

tosylate) Tablets, EQ 200 mg base, and 

the monoclonal antibody (UNITY–CLL 

trial). Those patients receiving the 

combination also experienced more 

serious adverse events than those in the 

control arm. FDA considered the data 

from the UNITY–CLL trial conducted in 

patients with CLL to have implications 

for UKONIQ’s approved uses for MZL 

and FL. 

On March 10, 2022 (87 FR 13736), 

FDA published the Federal Register 

notice ‘‘Oncologic Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments,’’ announcing 

that UKONIQ (umbralisib tosylate) 

Tablets, EQ 200 mg base, would be 

discussed at an Oncologic Drugs 

Advisory Committee (ODAC) meeting 

scheduled for April 22, 2022. 

FDA met with TGT on April 14, 2022, 

to discuss voluntary withdrawal of 

UKONIQ (umbralisib tosylate) Tablets, 

EQ 200 mg base, pursuant to 

§ 314.150(d) (21 CFR 314.150(d)) due to 

the decrement in overall survival and 

increased serious adverse events 

observed with UKONIQ (umbralisib 

tosylate) Tablets, EQ 200 mg base, in the 

UNITY–CLL trial. FDA recommended 

the applicant voluntarily request 

withdrawal of approval of UKONIQ 

(umbralisib tosylate) Tablets, EQ 200 mg 

base, for the follicular lymphoma and 

marginal zone lymphoma indications 

pursuant to § 314.150(d) and requested 

TGT waive its opportunity for a hearing. 

On April 15, 2022, TGT submitted a 

letter asking FDA to withdraw approval 

of NDA 213176 for UKONIQ (umbralisib 

tosylate) Tablets, EQ 200 mg base, 

pursuant to § 314.150(d) and waiving its 

opportunity for a hearing. On April 18, 

2022, FDA acknowledged TGT’s request 

for withdrawal of approval of the NDA 

and waiver of its opportunity for a 

hearing. FDA also cancelled the ODAC 

meeting scheduled for April 22, 2022, 

because the meeting was unnecessary 

considering the applicant’s withdrawal 

request. 

For the reasons discussed above, and 

in accordance with the applicant’s 

request, approval of NDA 213176 for 

UKONIQ (umbralisib tosylate) Tablets, 

EQ 200 mg base, and all amendments 

and supplements thereto, is withdrawn 

under § 314.150(d). Distribution of 

UKONIQ (umbralisib tosylate) Tablets, 

EQ 200 mg base, into interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(a) and 

331(d)). 

Dated: May 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11631 Filed 5–27–22; 8:45 am] 

BILLING CODE 4164–01–P 


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