27644 Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 

addiction medicine; health disparities 

and social determinants of health. 

Additional study section descriptive 

information can be found here: 

Study Section Rosters: http://

www.ahrq.gov/funding/process/studysection/peerrev. 

Study Section Descriptions: http://

www.ahrq.gov/funding/process/studysection/peerdesc. 

Study Section Research Foci: http://

www.ahrq.gov/funding/process/studysection/resfoci. 

Interested individuals may nominate 

themselves, and organizations and 

individuals may nominate one or more 

qualified persons for study section 

membership. A diversity of perspectives 

is valuable to AHRQ’s work. To help 

obtain a diversity of perspectives among 

nominees, AHRQ encourages 

nominations of women and members of 

minority groups. AHRQ also seeks broad 

geographic representation. All 

nominations must be submitted 

electronically, and should include: 

1. A copy of the nominee’s current 

curriculum vitae and contact 

information, including mailing address, 

phone number, and email address. 

2. Preferred study section assignment. 

Dated: May 3, 2022. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–09834 Filed 5–6–22; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0728] 

Celgene Corporation and Teva 

Pharmaceutical Industries Ltd.; 

Withdrawal of Approval of Peripheral 

T-Cell Lymphoma Indication for 

ISTODAX (Romidepsin) for Injection 

and Romidepsin Injection 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that it is withdrawing 

approval of the peripheral T-cell 

lymphoma (PTCL) indication for 

ISTODAX (romidepsin) for injection, 

approved under new drug application 

(NDA) 022393, held by Celgene 

Corporation, 86 Morris Ave., Summit, 

NJ 07901 (Celgene). We are also 

announcing the withdrawal of approval 

of the same indication for Romidepsin 

injection, approved under NDA 208574, 

held by Teva Pharmaceuticals USA, 

Inc., 400 Interpace Parkway, Building A, 

Parsippany, NJ 07054 (Teva). Celgene 

and Teva have voluntarily requested 

that FDA withdraw approval of this 

indication and have waived their 

opportunity for a hearing. 

DATES: Approval was withdrawn as of 

May 9, 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 June 

16, 2011, FDA approved an additional 

indication for Celgene’s new drug 

application (NDA) 22393 for ISTODAX 

(romidepsin) for injection, 10 mg, 

specifically for treatment of peripheral 

T-cell lymphoma (PTCL) in adult 

patients who have received at least one 

prior therapy, under the Agency’s 

accelerated approval regulations, 21 

CFR part 314, subpart H. The 

accelerated approval of Celgene’s 

ISTODAX (romidepsin) for injection for 

PTCL included a required 

postmarketing clinical trial intended to 

verify the clinical benefit of romidepsin 

(the Ro-CHOP study) for PTCL. 

On March 13, 2020, FDA approved 

Teva’s NDA 208574 for Romidepsin 

injection, 10 mg/2 milliliter, for 

treatment of peripheral T-cell 

lymphoma (PTCL) in adult patients who 

have received at least one prior therapy, 

under the Agency’s accelerated approval 

regulations, 21 CFR part 314, subpart H. 

The accelerated approval of Teva’s 

Romidepsin injection for PTCL also 

included a required postmarketing 

clinical trial intended to verify the 

clinical benefit of romidepsin for PTCL. 

Teva’s Romidepsin injection product 

was approved under the 505(b)(2) 

approval pathway, and the listed drug 

relied upon is Celgene’s NDA 22393, 

ISTODAX (romidepsin) for injection. 

On August 6, 2020, Celgene submitted 

high level results from the Ro-CHOP 

study to FDA, which indicated the 

study failed to meet its primary 

endpoint of progression free survival. 

On May 14, 2021, Celgene informed 

FDA that after careful consideration, 

Celgene decided to voluntarily 

withdraw the PTCL indication from 

ISTODAX (romidepsin) for injection. 

On June 17, 2021, Celgene submitted 

a supplemental NDA proposing to 

remove the PTCL indication. On July 14, 

2021, Celgene submitted a letter asking 

FDA to withdraw approval of the PTCL 

indication pursuant to § 314.150(d) (21 

CFR 314.150(d)) and waiving its 

opportunity for a hearing. 

On August 27, 2021, Teva submitted 

a labeling supplement proposing to 

remove the PTCL indication. On 

September 12, 2021, the Agency 

requested Teva voluntarily request 

withdraw of the PTCL indication 

pursuant to § 314.150(d) and waive its 

opportunity for a hearing. On September 

14, 2021, Teva amended its supplement 

by submitting a cover letter requesting 

withdrawal of approval of the PTCL 

indication pursuant to § 314.150(d) and 

waiving its opportunity for a hearing. 

Therefore, under § 314.150(d), 

approval of the PTCL indications for 

ISTODAX (romidepsin) for injection, 

and Romidepsin injection, is withdrawn 

effective May 9, 2022. Withdrawal of 

approval of the PTCL indication does 

not affect any other approved 

indication(s) for ISTODAX (romidepsin) 

for injection or Romidepsin injection. 

Dated: May 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09889 Filed 5–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0190] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Warning Plans for 

Smokeless Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions associated with 

warning plans for smokeless tobacco 

products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 8, 2022. 


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Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 27645 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before July 8, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of July 8, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2013–N–0190 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Warning 

Plans for Smokeless Tobacco Products.’’ 

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., 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.’’ The 

Agency 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 to 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 this 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, September 18, 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: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Warning Plans for Smokeless Tobacco 

Products 

OMB Control Number 0910–0671— 

Extension 

Tobacco products are governed by 

chapter IX of the Federal Food, Drug, 

and Cosmetic Act (sections 900 through 

920) (21 U.S.C. 387 through 21 U.S.C. 

387t). Section 3 of the Comprehensive 

Smokeless Tobacco Health Education 

Act of 1986 (the Smokeless Tobacco 

Act) (15 U.S.C. 4402) requires, among 

other things, that all smokeless tobacco 

product packages and advertisements 

bear one of four required warning 

statements. Section (b)(3)(A) of 15 

U.S.C. 4402 requires that the warnings 

be displayed on packaging and 

advertising for each brand of smokeless 

tobacco ‘‘in accordance with a plan 

submitted by the tobacco product 

manufacturer, importer, distributor, or 

retailer’’ to, and approved by, FDA. 

To implement these statutory 

requirements, warning plans are 

reviewed by FDA, upon submission by 

respondents. FDA published a draft 

guidance entitled ‘‘Submission of 


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27646 Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 

Warning Plans for Cigarettes and 

Smokeless Tobacco Products’’ on 

September 9, 2011, which describes the 

information and format to be submitted 

for smokeless plans (https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

submission-warning-plans-cigarettesand-smokeless-tobacco-products). 

Submitters may also visit a web page 

that describes the smokeless tobacco 

labeling and warning statement 

requirements (https://www.fda.gov/ 

tobacco-products/labeling-and-warningstatements-tobacco-products/smokelesstobacco-labeling-and-warningstatement-requirements). Additionally, 

FDA considers a submission to be a 

supplement if the submitter is seeking 

approval of a change to an FDAapproved warning plan. Warning plans 

can be submitted either electronically or 

in paper format. The Center for Tobacco 

Products (CTP) Portal, available at 

https://ctpportal.fda.gov/ctpportal/ 

login.jsp, provides a secure online 

system for electronically submitting 

documents and receiving messages from 

CTP. 

Based on our experience with the 

information collection over the past 3 

years, we retain our estimate of 60 hours 

to complete an initial rotational plan. 

We estimate half this time for preparing 

and submitting a supplement to an 

approved plan (30 hours). 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of initial rotational plans for health warning 

statements ........................................................................ 1 1 1 60 60 

Supplement to approved plan .............................................. 4 1 4 30 120 

Total .............................................................................. ........................ ........................ ........................ ........................ 180 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA estimates a total of 1 respondent 

will submit a new original warning plan 

yearly and take 60 hours to complete a 

rotational warning plan for a total of 60 

burden hours. In addition, FDA 

estimates a total of 4 respondents will 

submit a supplement to an approved 

warning plan at 30 hours per response 

for a total of 120 hours. After receiving 

the initial influx of original warnings 

plans, FDA does not expect to receive as 

many original warning plans annually. 

We expect that a few supplements will 

continue to be received as new products 

are marketed or as warning plans are 

revised. Therefore, we have decreased 

our estimate burden by 360 hours. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09885 Filed 5–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0150] 

Revocation of Two Authorizations of 

Emergency Use of In Vitro Diagnostic 

Devices for Detection and/or Diagnosis 

of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorizations (EUAs) (the 

Authorizations) issued to Bio-Rad 

Laboratories, Inc., for the Bio-Rad 

Reliance SARS–CoV–2/FluA/FluB RT– 

PCR Assay Kit and to Applied DNA 

Sciences, Inc., for the Linea COVID–19 

Assay Kit. FDA revoked these 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

The revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted in this 

document. 

DATES: The Authorization for the BioRad Reliance SARS–CoV–2/FluA/FluB 

RT–PCR Assay Kit is revoked as of April 

15, 2022. The Authorization for the 

Linea COVID–19 Assay Kit is revoked as 

of April 20, 2022. 

ADDRESSES: Submit written requests for 

a single copy of the revocations to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, 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 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (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, 

nuclear, and radiological 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 

February 11, 2021, FDA issued an EUA 

to Bio-Rad Laboratories, Inc., for the 

Bio-Rad Reliance SARS–CoV–2/FluA/ 

FluB RT–PCR Assay Kit, subject to the 

terms of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

April 23, 2021 (86 FR 21749), as 

required by section 564(h)(1) of the 

FD&C Act. On May 13, 2020, FDA 

issued an EUA to Applied DNA 

Sciences, Inc. for the Linea COVID–19 

Assay Kit, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on July 14, 2020 (85 FR 

42407), as required by section 564(h)(1) 

of the FD&C Act. Subsequent updates to 

the Authorizations 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 


khammond on DSKJM1Z7X2PROD with NOTICES