60466 Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices 

TABLE 1—ELIGIBILITY CRITERIA—Continued 

Element Inclusion criteria Exclusion criteria 

Comparators ............ KQ1: Confirmation of diagnosis by a neurosurgeon or neurologist.

KQ2–4: No surgery, sham surgery, no treatment, or alternative treatments for effectiveness outcomes; no comparator is required for studies reporting adverse events 

of interest (eligible adverse events will be determined 

with the help of the TEP).

KQ 1: no comparator. 

For KQ 2–4, Studies without comparator except for studies 

for an adverse event of interest. 

Outcomes ................ KQ1: Diagnostic performance (e.g., diagnostic accuracy 

measured as concordance with neurosurgeon or neurologist diagnosis); adverse events of the diagnostic procedure; and clinical impact of a correct or incorrect diagnosis such as (e.g., overtreatment due to misdiagnosis, 

delayed treatment, or undertreatment due to missed diagnosis).

Provider satisfaction and frequency of procedures. 

KQ2–4: Patient health and other patient effects such as leg 

weakness, leg numbness, leg pain, other pain, gait, walking difficulty, bowel incontinence, bladder incontinence, 

scoliosis, disability, adverse events, postoperative complications, infection, 30-day complication rate, morbidity, 

quality of life, or general health status, as well as process measures such as repeat surgery.

Timing ...................... No restrictions regarding the timing or duration of the intervention or the follow up.N/A. 

Setting ..................... Settings compatible with US healthcare settings, no restrictions regarding the clinical setting.Very low resource countries or conflict zones. 

Study Design ........... KQ1: Diagnostic accuracy and diagnostic impact analyses

KQ2–4: Randomized controlled trials (RCTs), clinical trials 

without randomization, cohort studies comparing two cohorts, controlled post-only studies, and case-control studies. Experimental single arm trials and observational 

case series, with or without structured pre- and postintervention data, need to report on neurological status or 

bladder or bowel function to be eligible.

Secondary data, but systematic reviews will be retained for 

reference-mining. 

Other limiters ........... Data published in journal manuscript and trial records ........ Data reported in abbreviated format (e.g., conference abstracts). 

Note: KQ key question, TEP technical expert panel. 

Dated: August 29, 2023. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2023–18984 Filed 8–31–23; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Surangi (Suranji) Jayawardena, Ph.D. 

(Respondent), who was an Assistant 

Professor of Chemistry, University of 

Alabama in Huntsville (UAH). 

Respondent engaged in research 

misconduct in grant applications 

submitted for U.S. Public Health Service 

(PHS) funds, specifically R21 AI154256, 

R21 AI152064, R21 AI149142, and R15 

AI146978 submitted to the National 

Institute of Allergy and Infectious 

Diseases (NIAID), National Institutes of 

Health (NIH). The administrative 

actions, including supervision for a 

period of four (4) years, were 

implemented beginning on August 18, 

2023, and are detailed below. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Garrity, JD, MPH, MBA, Director, 

Office of Research Integrity, 1101 

Wootton Parkway, Suite 240, Rockville, 

MD 20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the Office of Research 

Integrity (ORI) has taken final action in 

the following case: 

Surangi (Suranji) Jayawardena, Ph.D., 

University of Alabama in Huntsville: 

Based on the report of an investigation 

conducted by UAH, an admission by 

Respondent, and additional analysis 

conducted by ORI in its oversight 

review, ORI found that Surangi (Suranji) 

Jayawardena, Ph.D., who was an 

Assistant Professor of Chemistry, UAH, 

engaged in research misconduct in grant 

applications submitted for PHS funds, 

specifically R21 AI154256, R21 

AI152064, R21 AI149142, and R15 

AI146978 submitted to NIAID, NIH. 

ORI found that Respondent engaged 

in research misconduct by intentionally, 

knowingly, or recklessly falsifying and/ 

or fabricating data in twelve (12) figure 

panels in the following four (4) NIH 

grant applications: 

• R21 AI154256, ‘‘Designing artificial 

glycoforms to inhibit binding of 

Clostridioides difficile flagellin to 

TLR5,’’ submitted to NIAID, NIH, on 

October 16, 2019, withdrawn on 

November 5, 2019 

• R21 AI152064, ‘‘Multivalent 

glycoconjugates to inhibit binding of 

Clostridioides difficile flagella to TLR5,’’ 

submitted to NIAID, NIH, on June 14, 

2019, administratively withdrawn on 

November 1, 2021 

• R21 AI149142, ‘‘Rapid Low-cost 

Diagnostics Assay for Mycobacteria 

through Magnetic Concentration,’’ 

submitted to NIAID, NIH, on February 

15, 2019, administratively withdrawn 

on July 1, 2021 

• R15 AI146978, ‘‘BACTERIA 

HOMING–IN GLYCAN SENSING,’’ 

submitted to NIAID, NIH, on October 

25, 2018, administratively withdrawn 

on March 1, 2021 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices 60467 

Specifically, ORI found that 

Respondent intentionally, knowingly, or 

recklessly falsified and/or fabricated the 

following image data by reusing data 

from the same source and falsely 

relabeling the data as representing 

different experimental conditions with 

antibiotic particles or bacteria: 

• Transmission electron microscopy 

(TEM) images of: 

—(left) NeuNAc-AuNPs and (middle) 

enlarged image showing binding of 

NeuNAc-AuNP binding to flagella and 

(right) Man-AuNPs in Figure 1b of 

R21 AI152064 

—(left) NeuNAc-[60]fullerene and 

(middle) enlarged image showing 

binding of NeuNAc-[60]fullerene 

binding to flagella and (right) Man- 

[60]fullerene in Figure 1e of R21 

AI154256 

• photos of the formation of magnetic 

precipitate in a microcentrifuge tube 

representing: 

—CSL3-magSNPs binding Pseudomonas 

aeruginosa in Figure 3a of R15 

AI146978 

—ConA-mag beads binding 

Mycobacterium bovis in Figure 2A of 

R21 AI149142 

• photos of the lack of magnetic 

precipitate in a microcentrifuge tube 

representing CSL3 magSNPs remaining 

in solution in the presence of: 

—Staphylococcus aureus in Figure 3b of 

R15 AI146978 

—Mycobacteria smegmatis in Figure 3d 

of R15 AI146978 

Additionally, Respondent reported 

the following images that were falsely 

relabeled to represent different bacterial 

experimental conditions: 

• photos of the formation of magnetic 

precipitate in a microcentrifuge tube 

representing: 

—lectin or antibody treated magnetic 

beads binding Mycobacterium bovis 

in Figures 2A, 2B, and 2C of R21 

AI149142 

Respondent entered into a Voluntary 

Settlement Agreement (Agreement) and 

voluntarily agreed to the following: 

(1) Respondent will have her research 

supervised for a period of four (4) years 

beginning on August 18, 2023 (the 

‘‘Supervision Period’’). Prior to the 

submission of an application for PHS 

support for a research project on which 

Respondent’s participation is proposed 

and prior to Respondent’s participation 

in any capacity in PHS-supported 

research, Respondent will submit a plan 

for supervision of Respondent’s duties 

to ORI for approval. The supervision 

plan must be designed to ensure the 

integrity of Respondent’s research. 

Respondent will not participate in any 

PHS-supported research until such a 

supervision plan is approved by ORI. 

Respondent will comply with the 

agreed-upon supervision plan. 

(2) The requirements for Respondent’s 

supervision plan are as follows: 

i. A committee of 2–3 senior faculty 

members at the institution who are 

familiar with Respondent’s field of 

research, but not including 

Respondent’s supervisor or 

collaborators, will provide oversight and 

guidance for a period of four (4) years 

from the effective date of the 

Agreement. The committee will review 

primary data from Respondent’s 

laboratory on a quarterly basis and 

submit a report to ORI at six (6) month 

intervals setting forth the committee 

meeting dates and Respondent’s 

compliance with appropriate research 

standards and confirming the integrity 

of Respondent’s research. 

ii. The committee will conduct an 

advance review of each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved. The review will include a 

discussion with Respondent of the 

primary data represented in those 

documents and will include a 

certification to ORI that the data 

presented in the proposed application, 

report, manuscript, or abstract are 

supported by the research record. 

(3) During the Supervision Period, 

Respondent will ensure that any 

institution employing her submits, in 

conjunction with each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved, a certification to ORI that the 

data provided by Respondent are based 

on actual experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported and not plagiarized 

in the application, report, manuscript, 

or abstract. 

(4) If no supervision plan is provided 

to ORI, Respondent will provide 

certification to ORI at the conclusion of 

the Supervision Period that her 

participation was not proposed on a 

research project for which an 

application for PHS support was 

submitted and that she has not 

participated in any capacity in PHSsupported research. 

(5) During the Supervision Period, 

Respondent will exclude herself 

voluntarily from serving in any advisory 

or consultant capacity to PHS including, 

but not limited to, service on any PHS 

advisory committee, board, and/or peer 

review committee. 

Dated: August 29, 2023. 

Sheila Garrity, 

Director, Office of Research Integrity, Office 

of the Assistant Secretary for Health. 

[FR Doc. 2023–18954 Filed 8–31–23; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel NIDCD 

Institutional Training Grant Review Meeting. 

Date: September 27, 2023. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Kausik Ray, Ph.D., 

Scientific Review Officer, National Institute 

on Deafness and Other Communication 

Disorders, National Institutes of Health, 6001 

Executive Blvd., Rockville, MD 20852, 301– 

402–3587, rayk@nidcd.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: August 28, 2023. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–18932 Filed 8–31–23; 8:45 am] 

BILLING CODE 4140–01–P 


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