Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 27643 

published in the Federal Register on 

November 21, 2008 (73 FR 70732– 

70814), establish a framework by which 

individuals and entities that meet the 

definition of provider in the Patient 

Safety Rule may voluntarily report 

information to PSOs listed by AHRQ, on 

a privileged and confidential basis, for 

the aggregation and analysis of patient 

safety work product. 

The Patient Safety Act authorizes the 

listing of PSOs, which are entities or 

component organizations whose 

mission and primary activity are to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. 

HHS issued the Patient Safety Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule relating to the listing and operation 

of PSOs. The Patient Safety Rule 

authorizes AHRQ to list as a PSO an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ if 

it is found to no longer meet the 

requirements of the Patient Safety Act 

and Patient Safety Rule, when a PSO 

chooses to voluntarily relinquish its 

status as a PSO for any reason, or when 

a PSO’s listing expires. Section 3.108(d) 

of the Patient Safety Rule requires 

AHRQ to provide public notice when it 

removes an organization from the list of 

PSOs. 

AHRQ has accepted a notification of 

proposed voluntary relinquishment 

from the Ohio Patient Safety Institute to 

voluntarily relinquish its status as a 

PSO. Accordingly, the Ohio Patient 

Safety Institute, PSO number P0041, 

was delisted effective at 12:00 Midnight 

ET (2400) on April 30, 2022. 

Ohio Patient Safety Institute has 

patient safety work product (PSWP) in 

its possession. The PSO will meet the 

requirements of section 3.108(c)(2)(i) of 

the Patient Safety Rule regarding 

notification to providers that have 

reported to the PSO and of section 

3.108(c)(2)(ii) regarding disposition of 

PSWP consistent with section 

3.108(b)(3). According to section 

3.108(b)(3) of the Patient Safety Rule, 

the PSO has 90 days from the effective 

date of delisting and revocation to 

complete the disposition of PSWP that 

is currently in the PSO’s possession. 

More information on PSOs can be 

obtained through AHRQ’s PSO website 

at http://www.pso.ahrq.gov. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–09843 Filed 5–6–22; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Solicitation for Nominations for 

Membership To Serve on Initial Review 

Group for Scientific Peer Review 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for nominations for 

membership to serve on initial review 

group for scientific peer review. 

SUMMARY: This is to invite the public to 

nominate members to the Agency for 

Healthcare Research and Quality 

(AHRQ) Initial Review Group (IRG) 

responsible for the scientific peer 

review of AHRQ grant applications. The 

AHRQ IRG conducts scientific and 

technical review for health services 

research grant applications and is 

comprised of five subcommittees or 

study sections, each with a particular 

research focus. AHRQ is seeking 

nominations for scientific reviewers in 

specific competency domains to 

evaluate grant applications. 

DATES: Nominations should be received 

on or before June 1, 2022. 

ADDRESSES: Nominations should be 

submitted by email to dsr@ahrq.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Celeste Torio, Ph.D., MPH., AHRQ, 

(301) 427–1664 or by email at 

celeste.torio@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: This is to 

invite the public to nominate members 

to the Agency for Healthcare Research 

and Quality (AHRQ) Initial Review 

Group (IRG) responsible for the 

scientific peer review of AHRQ grant 

applications. AHRQ is required to 

conduct appropriate scientific peer 

review of grant applications pursuant to 

42 U.S.C. 299c–1. The AHRQ IRG 

conducts scientific and technical review 

for health services research grant 

applications and is comprised of five 

subcommittees or study sections, each 

with a particular research focus. AHRQ 

is seeking nominations for scientific 

reviewers in specific competency 

domains to evaluate grant applications. 

AHRQ’s mission is to produce 

evidence to make health care safer, 

higher quality, more accessible, 

equitable, and affordable, and to work 

within the U.S. Department of Health 

and Human Services (DHHS) and with 

other partners to make sure that the 

evidence is understood and used. AHRQ 

works to fulfill its mission by 

supporting health services research, 

evaluation, demonstration, 

dissemination, and training grants. 

The peer review of AHRQ grant 

applications involves an assessment 

conducted by panels of qualified experts 

established according to scientific 

disciplines or medical specialty areas. 

Members of the IRG will be selected 

based upon their training and 

experience in relevant scientific and 

technical fields, taking in account, 

among other factors: (1) The level of 

formal education and pertinent 

expertise and experience; (2) extent of 

engagement in relevant research; (3) 

extent of professional recognition; (4) 

need for specialization in relevant field; 

and (5) appropriate representation based 

on gender, racial/ethnic origin, and 

geography. See 42 CFR 67.15(a)(2). 

The IRG is comprised of five 

subcommittees, or study sections, each 

with a particular emphasis around 

which peer reviewer expertise is 

assembled. AHRQ seeks nominations for 

each of the subcommittee competency 

domains described below: 

Health Care Effectiveness and 

Outcomes Research: End-stage renal 

disease; cardiovascular disease; 

pediatrics; pharmacologist in opioid 

management; biostatisticians in health 

services research; health disparities and 

social determinants of health. 

Healthcare Safety and Quality 

Improvement Research: Pharmacists 

with expertise in informatics; infectious 

diseases specialists; geriatricians; 

surgeons with a specialty in diagnostic 

error; health disparities and social 

determinants of health. 

Healthcare Information Technology 

Research: Biomedical and consumer 

health informatics; family medicine; 

health care data analysis; health 

information technology; health services 

research in patient-oriented research; 

electronic health record and data for 

research; population-based studies in 

medicine; epidemiology; telehealth/ 

telemedicine; emergency medicine; 

insurance benefit design; chronic 

condition care; natural language 

processing and machine learning; social 

networking and its determinants of 

health; health disparities and social 

determinants of health. 

Healthcare Systems and Value 

Research: Health statistics; health care 

outcome research; evaluation and 

survey methods; health system and 

service research; health care policy 

research; health economics research; 

large database analysis; private health 

insurance/Medicaid and Medicare; 

learning laboratory development; health 

disparities and social determinants of 

health. 

Health Care Research Training: 

Clinicians with knowledge of health 

policy; Medicare and Medicaid; 


khammond on DSKJM1Z7X2PROD with NOTICES
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. 


khammond on DSKJM1Z7X2PROD with NOTICES