Findings of Research Misconduct, 16750-16753 [2022-06247]

Download as PDF 16750 Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 60. Fahtima Isaac, Phoenix, Arizona, Court of Federal Claims No: 22– 0213V 61. Shannon McDonald, Lumberton, New Jersey, Court of Federal Claims No: 22–0215V 62. Anita Enns, Katy, Texas, Court of Federal Claims No: 22–0216V 63. Joyce Glenn on behalf of the Estate of Anthony Glenn, Deceased, Fontana, California, Court of Federal Claims No: 22–0217V 64. April Keen, Greenville, South Carolina, Court of Federal Claims No: 22–0218V 65. Carey Cribbs, Ferndale, Michigan, Court of Federal Claims No: 22– 0219V 66. Sara Davis Buechner, Philadelphia, Pennsylvania, Court of Federal Claims No: 22–0220V 67. Rafael Mauries, Cedar Park, Texas, Court of Federal Claims No: 22– 0224V [FR Doc. 2022–06249 Filed 3–23–22; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Tick-Borne Disease Working Group Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will be discussing and voting on recommendations for the 2022 TBDWG Report to the HHS Secretary and Congress. Most of the recommendations the TBDWG will consider are from the reports of five TBDWG subcommittees, which were created to examine critical topic areas related to tick-borne diseases. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research. DATES: The meeting will be held online via webcast on April 27, 2022–April 28, khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:39 Mar 23, 2022 Jkt 256001 2022 from approximately 9:00 a.m. to 5:00 p.m. ET (times are tentative and subject to change) each day. The confirmed times and agenda items for the meeting will be posted on the TBDWG web page https://www.hhs.gov/ ash/advisory-committees/tickborne disease/meetings/2022-04-27/ index.html when this information becomes available. Dated: March 14, 2022. James J. Berger, Designated Federal Officer, Tick-Borne Disease Working Group, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2022–06226 Filed 3–23–22; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L600, Washington, DC 20024. Email: tickbornedisease@ hhs.gov. Phone: 202–795–7608. SUPPLEMENTARY INFORMATION: Registration information can be found on the meeting website at https:// www.hhs.gov/ash/advisory-committees/ tickbornedisease/meetings/2022-04-27/ index.html when it becomes available. The public will have an opportunity to present their views to the TBDWG orally during the meeting’s public comment session or by submitting a written public comment. Comments should be pertinent to the meeting discussion. Persons who wish to provide verbal or written public comment should review instructions at https://www.hhs.gov/ ash/advisory-committees/tickborne disease/meetings/2022-04-27/ index.html and respond by midnight April 15, 2022 ET. Verbal comments will be limited to three minutes each to accommodate as many speakers as possible during the 30 minute session. Written public comments will be accessible to the public on the TBDWG web page prior to the meeting. Background and Authority: The TickBorne Disease Working Group was established on August 10, 2017, in accordance with Section 2062 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to provide expertise and review federal efforts related to all tickborne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. The TBDWG is required to submit a report to the HHS Secretary and Congress on their findings and any recommendations for the federal response to tick-borne disease every two years. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Findings of research misconduct have been made against Hui (Herb) Bin Sun, Ph.D. (Respondent), formerly Professor of Orthopedic Surgery and Radiation Oncology, Albert Einstein College of Medicine (AECM). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), grant R01 AR050968 and National Heart, Lung, and Blood Institute (NHLBI), NIH, grant P01 HL110900. The administrative actions, including supervision for a period of twelve (12) years, were implemented beginning on March 1, 2022, and are detailed below. FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting 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: Hui (Herb) Bin Sun, Ph.D., Albert Einstein College of Medicine: Based on the report of an investigation conducted by AECM and analysis conducted by ORI in its oversight review, ORI found that Dr. Sun, formerly Professor of Orthopedic Surgery and Radiation Oncology, AECM, engaged in research misconduct in research supported by PHS funds, specifically NIAMS, NIH, grant R01 AR050968 and NHLBI, NIH, grant P01 HL110900. ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/ or fabricating data included in sixteen (16) grant applications submitted for PHS funds: • R01 AR065563–01, ‘‘CITED2 and Chondroprotection,’’ submitted to NIAMS, NIH, on 02/05/2013. SUMMARY: E:\FR\FM\24MRN1.SGM 24MRN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices • R01 AR066009–01, ‘‘Remote Loading for Osteoarthritis,’’ submitted to NIAMS, NIH, on 06/04/2013. • R01 AR065563–01A1, ‘‘CITED2 and Chondroprotection,’’ submitted to NIAMS, NIH, on 11/05/2014. • R41 AR070695–01, ‘‘A novel product for tendinopathy treatment,’’ submitted to NIAMS, NIH, on 01/05/ 2015. • R01 AG069693–01, ‘‘Chondrocyte fate regulation and cartilage protection,’’ submitted to National Institute on Aging (NIA), NIH, on 06/05/2015. • R01 AG039561–06, ‘‘Human tendon stem progenitor cell aging and regeneration,’’ submitted to NIA, NIH, on 03/15/2016 (original grant funding from 08/15/2012–04/30/2018). • R43 AT009414–01, ‘‘A novel nutraceutical drug for tendinopathy treatment,’’ submitted to National Center for Complementary and Alternative Medicine (NCCAM), NIH, on 04/05/2016. • R01 AR070431–01A1, ‘‘The role of Panx1 in the pathogenesis and pain of osteoarthritis,’’ submitted to NIAMS, NIH, on 07/19/2016. • R41 AG056246–01A1, ‘‘A novel product for tendinopathy treatment,’’ submitted to NIA, NIH, on 09/06/2016, funded from 09/15/2017–08/31/2019. • R01 AG056623–01, ‘‘Chondrocyte fate regulation and osteoarthritis,’’ submitted to NIA, NIH, on 10/05/2016. • R01 AR072038–01, ‘‘MSC-derived exosomes and tendon disorders,’’ submitted to NIAMS, NIH, on 10/05/ 2016. • R43 AT009414–01A1, ‘‘A novel nutraceutical drug for tendinopathy treatment,’’ submitted to NCCAM, NIH, on 04/05/2017, funded from 08/01/ 2018–07/31/2020. • R01 AR073194–01, ‘‘Chondrocyte fate regulation and cartilage protection,’’ submitted to NIAMS, NIH, on 06/05/ 2017. • R01 AR074802–01, ‘‘The role of Panx1 in the pathogenesis and pain of osteoarthritis,’’ submitted to NIAMS, NIH, on 04/02/2018. • R01 AR074802–01A1, ‘‘The role of Panx1 in the pathogenesis and pain of osteoarthritis,’’ submitted to NIAMS, NIH, on 08/01/2018. • R44 AG065089–01, ‘‘Botanical drug for spontaneous osteoarthritis,’’ submitted to NIA, NIH, on 01/07/2019. ORI found that Respondent intentionally, knowingly, or recklessly reported falsified and/or fabricated Western blot and histological image data for chronic deep tissue conditions including osteoarthritis (OA) and tendinopathy in murine models. Respondent included image data that were falsely reused and relabeled as VerDate Sep<11>2014 17:39 Mar 23, 2022 Jkt 256001 data representing different experiments in fifty (50) figures included in sixteen (16) PHS grant applications. In the absence of reliable image data, the figures, quantitative data in associated graphs purportedly derived from those images, statistical analyses, and related text also are false. Specifically, ORI found that: 1. Respondent reported falsified Western blot images from the same source that were reused and relabeled to represent different proteins and/or experimental results in: • Figure 4B in R01 AR065563–01 and R01 AR065563–01A1 and Figure 11 in R01 AR069693–01, specifically: — ‘‘b-actin’’ panel for ‘‘Cartilage’’ and ‘‘b-actin’’ panel for ‘‘Liver’’ are the same — ‘‘b-actin’’ panel for ‘‘Bone’’ and ‘‘bactin’’ panel for ‘‘Spleen’’ are the same — ‘‘Cited2’’ blot band for Cartilage in ‘‘WT’’ and ‘‘Sham’’ are the same — ‘‘Cited2’’ blot band for Bone in ‘‘WT’’ and ‘‘Sham’’ are the same — ‘‘Cited2’’ blot band for Liver in ‘‘WT’’ and ‘‘Sham’’ are the same — ‘‘Cited2’’ blot band for Spleen in ‘‘WT’’ and ‘‘Sham’’ are the same • Figure 2A in R01 AG056623–01 and R44 AG065089–01 and Figure 1A in R01 AR073194–01, specifically: —‘‘b-actin’’ panel for ‘‘Cartilage’’ and ‘‘b-actin’’ panel for ‘‘Liver’’ are the same —Cited2 blot bands in ‘‘WT’’ and ‘‘Sham’’ within each of the three panels represent Cartilage, Bone, and Liver 2. Respondent reported falsified Western blot data by copying blot panels representing rAAV-vector and rAAV–GFP in human cartilage explants from Figure 11C in R01 AR065563–01 and Figure 16 in R01 AR066009–01 and manipulating and relabeling the same panels to represent ‘‘Sham’’ and ‘‘KO’’ samples in conditional knock out of Cited2 gene in cartilage of adult mice in: • Figure 4B in R01 AR065563–01 • Figure 4B in R01 AR065563–01A1 • Figure 11 in R01 AR069693–01 • Figure 2A in R01 AG056623–01 • Figure 1A in R01 AR073194–01 • Figure 2A in R44 AG065089–01 3. Respondent reported falsified photomicrographs of supraspinatus tendon tissue from tendinopathy rats exposed to different experimental conditions that were reused and relabeled in: • Figure 2A in R01 AR072038–01 to falsely represent overuse tendinopathy in rats treated with exADSC–2D (control exosomes) PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 16751 • Figure 2A in R01 AG039561–06 to falsely represent overuse tendinopathy nude rats with placebo treatment • Figure 4A in R41 AR070695–01 to falsely represent overuse tendinopathy nude rats with placebo treatment • Figure 3A in R43 AT009414–01 and R43 AT009414–01A1 to falsely represent collagenase induced Achilles tendinopathy in rats with placebo treatment 4. Respondent reported falsified photomicrographs that were reused and relabeled in: • Figure 2A in R01 AR072038–01 to falsely represent overuse tendinopathy in rats injected with exADSC–3D • Figure 1A in R01 AG039561–06 to falsely represent collagenase-induced tendinopathy in rats injected with Cited2 reprogrammed tendon stem/ progenitor cells (TSPCs) 5. Respondent reported falsified photomicrographs that were reused and relabeled from Figure 2C in R01 AR072038–01 representing cleaved collagen-1 stained supraspinatus tendon of overuse tendinopathy rats injected with placebo + ex-ADSC–2D (control exosomes) to falsely represent: • Supraspinatus tendon tissue of overuse tendinopathy in rats after placebo injection in: —Figure 2C in R01 AR072038–01 —Figure 5D in R41 AG056246–01A1 —Figure 2B in R01 AG039561–06 • Achilles tendon tissue of collagenaseinduced tendinopathy rats after placebo injection in Figure 3D in R43 AT009414–01 6. Respondent falsified photomicrographs of human cartilage explants presented in R01 AG069693– 01 that were reused and relabeled, specifically: • Figure 12A representing NITEGE in non-arthritic (non-OA) sample in: —Figure 11A in R01 AR065563–01, Figure 8A in R01 AG069693–01, and Figure 1A in R01 AG056623 to falsely represent NITEGE stained non-OA sample —Figure 3 in R01 AR070431–01A1 to falsely represent IL–1b stained OA sample • Figure 8A representing ADAMTS5 in non-OA and OA samples in: —Figure 1A in R01 AG056623–01 to falsely represent p16 stained samples • Figure 8A, two images representing matrix metalloproteinase 13 (MMP– 13) and ADAMTS5 of OA samples in: —Figure 3 in R01 AR070431–01A1 to E:\FR\FM\24MRN1.SGM 24MRN1 khammond on DSKJM1Z7X2PROD with NOTICES 16752 Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices falsely represent NLRP3 or cleaved caspase 1 —Figure 1A in R01 AG056623–01 to falsely represent p21 and p16 • Figure 8B, two images in sham or destabilization of the medial meniscus (DMM) operated mouse representing: —MMP–13 reused and relabeled in Figure 1B in R01 AG056623–01 to falsely represent p21 —ADAMTS5 reused and relabeled in Figure 1B in R01 AG056623–01 to falsely represent p16 7. Respondent reported falsified photomicrographs of non-OA or OA human cartilage explants presented in Figure 3 in R01 AR070431–01A1 that were reused and relabeled representing: • Cleaved caspase 3 to falsely represent b-gal staining in Figure 1A in R01 AG056623–01 • NLRP3 or cleaved caspase-1 staining of non-OA human cartilage to falsely represent p21 and p16 in Figure 1A in R01 AG056623–01 8. Respondent reported falsified photomicrographs from the following published papers that were reused and relabeled to falsely represent unrelated experimental results in NIH grant applications: • Green tea polyphenol treatment is chondroprotective, anti-inflammatory and palliative in a mouse post-traumatic osteoarthritis model. Arthritis Res Ther. 2014 Dec 17;16(6):508; doi: 10.1186/ sl3075–014–0508-y (hereafter referred to as ‘‘Arthritis Res Ther. 2014’’). Erratum in: Arthritis Res Ther. 2019, Jan 3;21(1):1; doi: 10.1186/s13075–018– 1791–9. • Curcumin slows osteoarthritis progression and relieves osteoarthritisassociated pain symptoms in a posttraumatic osteoarthritis mouse model. Arthritis Res Ther. 2016 Jun 3; 18(1):128; doi: 10.1186/s13075–016– 1025-y (hereafter referred to as ‘‘Arthritis Res Ther. 2016’’). • Procyanidins Mitigate Osteoarthritis Pathogenesis by, at Least in Part, Suppressing Vascular Endothelial Growth Factor Signaling. Int. J. Mol. Sci. 2016, 17:2065; doi:10.3390/ ijms17122065 (hereafter referred to as ‘‘Int. J. Mol. Sci. 2016’’). Specifically, in: • R01 AR070431–01A1, Respondent reported a falsified image panel that was reused and relabeled from: —Arthritis Res Ther. 2016: D Figure 6A representing type II collagen cleavage epitope (Col2–3/4 M) vehicle control to falsely represent aggrecan cleavage in DMM WT in Figure 2E in R01 AR070431–01A1 D Figure 6D representing ADAMTS5 staining of a vehicle control twice in VerDate Sep<11>2014 17:39 Mar 23, 2022 Jkt 256001 Figure 2F in R01 AR070431–01A1 to falsely represent IL–1b and cleaved caspase staining —Arthritis Res Ther. 2014: D Figure 2C representing Col2–3/4 M in vehicle treated sham operated mice twice in Figures 2E and 2F in R01 AR070431–01A1 to falsely represent cleaved caspase and IL–1b respectively in sham operated WT mice D Figure 2C representing Col2–3/4 M in epigallocatechin3-gallate (EGCG) treated DMM mice in Figure 2E in R01 AR070431–01A1 to falsely represent Col2–3/4 M in Panx1 KO DMM mice D Figure 3A representing cleaved aggrecan in sham operated EGCG treated mice in Figure 2E in R01 AR070431–01A1 to falsely represent cleaved aggrecan in sham operated untreated WT mice D Figure 3C representing cleaved aggrecan in DMM WT mice treated with EGCG in Figure 2E in R01 AR070431–01A1 to falsely represent cleaved aggrecan in DMM Panx1 KO mice D Figure 4A representing MMP–13 in sham operated EGCG treated mice in Figure 4E in R01 AR070431–01A1 to falsely represent antibody-staining control D Figure 4C representing MMP–13 in sham operated, vehicle treated mice in: ➢Figure 2E in R01 AR074802–01 and R01 AR074802–01A1 to falsely represent ADAMTS5 staining in Pax1 KO DMM mice ➢Figure 2F in R01 AR074802–01 and R01 AR070431–01A1 to falsely represent NLRP3 staining of Pax1 KO DMM D Figure 4C representing MMP–13 in DMM vehicle treated mice in: ➢Figure 2E in R01 AR074802–01 and R01 AR074802–01A1 to falsely represent MMP–13 in DMM WT mice ➢Figure 2F in R01 AR074802–01 and R01 AR070431–01A1 to falsely represent NLRP3 in DMM WT mice D Figure 5C representing ADAMTS5 in sham operated EGCG treated mouse twice in Figures 2E in R01 AR074802–01 and R01 AR074802– 01A1 to falsely represent ADAMTS5 in sham operated WT mice D Figure 5C representing ADAMTS5 in vehicle treated DMM operated mouse sample twice in Figures 2E in R01 AR074802–01 and R01 AR074802– 01A1 to falsely represent ADAMTS5 in DMM WT mouse sample D R01 AG056623–01, Respondent reported a falsified image panel that was reused and relabeled from: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 —Int. J. Mol. Sci. 2016: D Figure 1A representing cartilage from ‘‘sham’’ wildtype C57BL/6 mice treated with oral PBS in Figure 2B in R01 AG056623–01 to represent knee cartilage from ‘‘sham’’ Col2a1CreERTxCited2fl/fl mice injected with corn oil without tamoxifen —Arthritis Res Ther. 2014: D Figure 4A representing MMP–13 in vehicle-treated mice 4-weeks post DMM surgery in: ➢ Figure 8 in R01 AG056623–01 to falsely represent p21 in control mice following DMM surgery ➢ Figure 3 in R01 AG056623–01 to falsely represent b-gal in Cited2 KO mice D Figure 4A representing MMP–13 in EGCG -treated mice 4-weeks post DMM surgery Figure 8 in R01 AG056623–01 to falsely represent p21 following DMM surgery in mice overexpressing Cited2 D Figure 4C representing MMP–13 in vehicle-treated mice 8-weeks post sham surgery in Figure 2C in R01 AG056623–01 to falsely represent p21 staining in Cited2 KO mice following DMM surgery D Figure 4C representing MMP–13 in in EGCG-treated mice 8-weeks post DMM surgery in Figure 2C in R01 AG056623–01 to falsely represent p21 in oil-injected control mice for Cited2 was conditionally deleted in cartilage by injection of corn oil without Tamoxifen D Figure 5A representing ADAMTS5 in vehicle-treated DMM-induced OA mice in: ➢ Figure 8 in R01 AG056623–01 to falsely represent p16 in control mice following DMM surgery ➢ Figure 2C in R01 AG056623–01 to falsely represent b-gal in Cited2 KO mice ➢ Figure 3 in R01 AG056623–01 to falsely represent b-gal in WT control mice with conditional deletion of Cited2 in cartilage D Figure 5C representing ADAMTS5 in vehicle-treated DMM-induced OA mice in: ➢ Figure 8 in R01 AG056623–01 to falsely represent Cited2 in Citedoverexpressing mice as well as b-gal in control mice following DMM surgery ➢ Figure 2C in R01 AG056623–01 to falsely represent p16 staining in Cited2 KO mice ➢ Figure 8 in R01 AG056623–01 to falsely represent p16 in control mice following DMM surgery Respondent neither admits nor denies ORI’s findings of research misconduct. E:\FR\FM\24MRN1.SGM 24MRN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices The parties entered into a Voluntary Settlement Agreement (Agreement) to conclude this matter without further expenditure of time, finances, or other resources. The settlement is not an admission of liability on the part of the Respondent. Respondent voluntarily agreed to the following: (1) Respondent will have his research supervised for a period of twelve (12) years beginning on March 1, 2022 (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. 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 is supported by the research record. (3) During the Supervision Period, Respondent will ensure that any institution employing him 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, VerDate Sep<11>2014 17:39 Mar 23, 2022 Jkt 256001 procedures, and methodology are accurately reported 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 his participation was not proposed on a research project for which an application for PHS support was submitted and that he has not participated in any capacity in PHSsupported research. (5) During the Supervision Period, Respondent will exclude himself 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: March 21, 2022. Wanda K. Jones, Acting Director, Office of Research Integrity, Office of the Assistant Secretary for Health. [FR Doc. 2022–06247 Filed 3–23–22; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–New] Agency Information Collection Request. 60-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before May 23, 2022. ADDRESSES: Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795–7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990–New–60D and project title for reference, to Sherrette A. Funn, email: Sherrette.Funn@hhs.gov, or call (202) 795–7714 the Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 16753 of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: Health Care Readiness Collections. Type of Collection: Revision. OMB No.: 0990–0391. Abstract: The Office of the Assistant Secretary for Preparedness and Response (ASPR) in the Department of Health and Human Services (HHS) administers a portfolio of health care readiness programs and activities, including the Hospital Preparedness Program (HPP) authorized under Section 319C–2 of the Public Health Service (PHS) Act. HPP is a cooperative agreement program that strengthens national health care readiness, supports health care resilience, and enables rapid recovery. Through the Health Care Readiness Portfolio, ASPR provides awards to 62 health departments in all 50 states, territories, freely associated states, and four metropolitan areas to support the health care delivery system through over 320 health care coalitions (HCCs) with nearly 45,000 members. An HCC is a network of public and private organizations that partner to conduct planning, training, and preparedness activities within a state or locality, building that area’s overall readiness. ASPR’s Health Care Readiness Portfolio aligns preparedness activities across health care and also includes the Regional Disaster Health Response System (RDHRS) demonstration sites that establish regional partnerships to develop promising practices in coordinating disaster readiness and regional medical response; the National Special Pathogen System, a nationwide systems-based network approach for special pathogen care; workforce capacity activities; and other initiatives. ASPR collects data annually to understand how federal funding has been spent, measure performance, and monitor adherence with program requirements. These data additionally support ASPR to develop funding opportunities, improve programmatic operations, and inform decision-making. ASPR is also responsible for allocating and monitoring emergency and supplemental funding, understanding recipient and sub-recipient real-time needs, and maintaining situational awareness of the current state of preparedness, response, and recovery activities. When circumstances require rapid information gathering, it is necessary for ASPR to also collect data E:\FR\FM\24MRN1.SGM 24MRN1

Agencies

[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Pages 16750-16753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06247]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Findings of research misconduct have been made against Hui 
(Herb) Bin Sun, Ph.D. (Respondent), formerly Professor of Orthopedic 
Surgery and Radiation Oncology, Albert Einstein College of Medicine 
(AECM). Respondent engaged in research misconduct in research supported 
by U.S. Public Health Service (PHS) funds, specifically National 
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 
National Institutes of Health (NIH), grant R01 AR050968 and National 
Heart, Lung, and Blood Institute (NHLBI), NIH, grant P01 HL110900. The 
administrative actions, including supervision for a period of twelve 
(12) years, were implemented beginning on March 1, 2022, and are 
detailed below.

FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting 
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:
    Hui (Herb) Bin Sun, Ph.D., Albert Einstein College of Medicine: 
Based on the report of an investigation conducted by AECM and analysis 
conducted by ORI in its oversight review, ORI found that Dr. Sun, 
formerly Professor of Orthopedic Surgery and Radiation Oncology, AECM, 
engaged in research misconduct in research supported by PHS funds, 
specifically NIAMS, NIH, grant R01 AR050968 and NHLBI, NIH, grant P01 
HL110900.
    ORI found that Respondent engaged in research misconduct by 
intentionally, knowingly, or recklessly falsifying and/or fabricating 
data included in sixteen (16) grant applications submitted for PHS 
funds:
     R01 AR065563-01, ``CITED2 and Chondroprotection,'' 
submitted to NIAMS, NIH, on 02/05/2013.

[[Page 16751]]

     R01 AR066009-01, ``Remote Loading for Osteoarthritis,'' 
submitted to NIAMS, NIH, on 06/04/2013.
     R01 AR065563-01A1, ``CITED2 and Chondroprotection,'' 
submitted to NIAMS, NIH, on 11/05/2014.
     R41 AR070695-01, ``A novel product for tendinopathy 
treatment,'' submitted to NIAMS, NIH, on 01/05/2015.
     R01 AG069693-01, ``Chondrocyte fate regulation and 
cartilage protection,'' submitted to National Institute on Aging (NIA), 
NIH, on 06/05/2015.
     R01 AG039561-06, ``Human tendon stem progenitor cell aging 
and regeneration,'' submitted to NIA, NIH, on 03/15/2016 (original 
grant funding from 08/15/2012-04/30/2018).
     R43 AT009414-01, ``A novel nutraceutical drug for 
tendinopathy treatment,'' submitted to National Center for 
Complementary and Alternative Medicine (NCCAM), NIH, on 04/05/2016.
     R01 AR070431-01A1, ``The role of Panx1 in the pathogenesis 
and pain of osteoarthritis,'' submitted to NIAMS, NIH, on 07/19/2016.
     R41 AG056246-01A1, ``A novel product for tendinopathy 
treatment,'' submitted to NIA, NIH, on 09/06/2016, funded from 09/15/
2017-08/31/2019.
     R01 AG056623-01, ``Chondrocyte fate regulation and 
osteoarthritis,'' submitted to NIA, NIH, on 10/05/2016.
     R01 AR072038-01, ``MSC-derived exosomes and tendon 
disorders,'' submitted to NIAMS, NIH, on 10/05/2016.
     R43 AT009414-01A1, ``A novel nutraceutical drug for 
tendinopathy treatment,'' submitted to NCCAM, NIH, on 04/05/2017, 
funded from 08/01/2018-07/31/2020.
     R01 AR073194-01, ``Chondrocyte fate regulation and 
cartilage protection,'' submitted to NIAMS, NIH, on 06/05/2017.
     R01 AR074802-01, ``The role of Panx1 in the pathogenesis 
and pain of osteoarthritis,'' submitted to NIAMS, NIH, on 04/02/2018.
     R01 AR074802-01A1, ``The role of Panx1 in the pathogenesis 
and pain of osteoarthritis,'' submitted to NIAMS, NIH, on 08/01/2018.
     R44 AG065089-01, ``Botanical drug for spontaneous 
osteoarthritis,'' submitted to NIA, NIH, on 01/07/2019.
    ORI found that Respondent intentionally, knowingly, or recklessly 
reported falsified and/or fabricated Western blot and histological 
image data for chronic deep tissue conditions including osteoarthritis 
(OA) and tendinopathy in murine models. Respondent included image data 
that were falsely reused and relabeled as data representing different 
experiments in fifty (50) figures included in sixteen (16) PHS grant 
applications. In the absence of reliable image data, the figures, 
quantitative data in associated graphs purportedly derived from those 
images, statistical analyses, and related text also are false.
    Specifically, ORI found that:
    1. Respondent reported falsified Western blot images from the same 
source that were reused and relabeled to represent different proteins 
and/or experimental results in:
     Figure 4B in R01 AR065563-01 and R01 AR065563-01A1 and 
Figure 11 in R01 AR069693-01, specifically:

-- ``[beta]-actin'' panel for ``Cartilage'' and ``[beta]-actin'' panel 
for ``Liver'' are the same
-- ``[beta]-actin'' panel for ``Bone'' and ``[beta]-actin'' panel for 
``Spleen'' are the same
-- ``Cited2'' blot band for Cartilage in ``WT'' and ``Sham'' are the 
same
-- ``Cited2'' blot band for Bone in ``WT'' and ``Sham'' are the same
-- ``Cited2'' blot band for Liver in ``WT'' and ``Sham'' are the same
-- ``Cited2'' blot band for Spleen in ``WT'' and ``Sham'' are the same

     Figure 2A in R01 AG056623-01 and R44 AG065089-01 and 
Figure 1A in R01 AR073194-01, specifically:

--``[beta]-actin'' panel for ``Cartilage'' and ``[beta]-actin'' panel 
for ``Liver'' are the same
--Cited2 blot bands in ``WT'' and ``Sham'' within each of the three 
panels represent Cartilage, Bone, and Liver

    2. Respondent reported falsified Western blot data by copying blot 
panels representing rAAV-vector and rAAV-GFP in human cartilage 
explants from Figure 11C in R01 AR065563-01 and Figure 16 in R01 
AR066009-01 and manipulating and relabeling the same panels to 
represent ``Sham'' and ``KO'' samples in conditional knock out of 
Cited2 gene in cartilage of adult mice in:

 Figure 4B in R01 AR065563-01
 Figure 4B in R01 AR065563-01A1
 Figure 11 in R01 AR069693-01
 Figure 2A in R01 AG056623-01
 Figure 1A in R01 AR073194-01
 Figure 2A in R44 AG065089-01

    3. Respondent reported falsified photomicrographs of supraspinatus 
tendon tissue from tendinopathy rats exposed to different experimental 
conditions that were reused and relabeled in:

 Figure 2A in R01 AR072038-01 to falsely represent overuse 
tendinopathy in rats treated with ex-ADSC-2D (control exosomes)
 Figure 2A in R01 AG039561-06 to falsely represent overuse 
tendinopathy nude rats with placebo treatment
 Figure 4A in R41 AR070695-01 to falsely represent overuse 
tendinopathy nude rats with placebo treatment
 Figure 3A in R43 AT009414-01 and R43 AT009414-01A1 to falsely 
represent collagenase induced Achilles tendinopathy in rats with 
placebo treatment

    4. Respondent reported falsified photomicrographs that were reused 
and relabeled in:

 Figure 2A in R01 AR072038-01 to falsely represent overuse 
tendinopathy in rats injected with ex-ADSC-3D
 Figure 1A in R01 AG039561-06 to falsely represent collagenase-
induced tendinopathy in rats injected with Cited2 reprogrammed tendon 
stem/progenitor cells (TSPCs)

    5. Respondent reported falsified photomicrographs that were reused 
and relabeled from Figure 2C in R01 AR072038-01 representing cleaved 
collagen-1 stained supraspinatus tendon of overuse tendinopathy rats 
injected with placebo + ex-ADSC-2D (control exosomes) to falsely 
represent:

 Supraspinatus tendon tissue of overuse tendinopathy in rats 
after placebo injection in:
    --Figure 2C in R01 AR072038-01
    --Figure 5D in R41 AG056246-01A1
    --Figure 2B in R01 AG039561-06
 Achilles tendon tissue of collagenase-induced tendinopathy 
rats after placebo injection in Figure 3D in R43 AT009414-01

    6. Respondent falsified photomicrographs of human cartilage 
explants presented in R01 AG069693-01 that were reused and relabeled, 
specifically:

 Figure 12A representing NITEGE in non-arthritic (non-OA) 
sample in:
    --Figure 11A in R01 AR065563-01, Figure 8A in R01 AG069693-01, and 
Figure 1A in R01 AG056623 to falsely represent NITEGE stained non-OA 
sample
    --Figure 3 in R01 AR070431-01A1 to falsely represent IL-1[beta] 
stained OA sample
 Figure 8A representing ADAMTS5 in non-OA and OA samples in:
    --Figure 1A in R01 AG056623-01 to falsely represent p16 stained 
samples
 Figure 8A, two images representing matrix metalloproteinase 13 
(MMP-13) and ADAMTS5 of OA samples in:
    --Figure 3 in R01 AR070431-01A1 to

[[Page 16752]]

falsely represent NLRP3 or cleaved caspase 1
    --Figure 1A in R01 AG056623-01 to falsely represent p21 and p16
 Figure 8B, two images in sham or destabilization of the medial 
meniscus (DMM) operated mouse representing:
    --MMP-13 reused and relabeled in Figure 1B in R01 AG056623-01 to 
falsely represent p21
    --ADAMTS5 reused and relabeled in Figure 1B in R01 AG056623-01 to 
falsely represent p16

    7. Respondent reported falsified photomicrographs of non-OA or OA 
human cartilage explants presented in Figure 3 in R01 AR070431-01A1 
that were reused and relabeled representing:

 Cleaved caspase 3 to falsely represent [beta]-gal staining in 
Figure 1A in R01 AG056623-01
 NLRP3 or cleaved caspase-1 staining of non-OA human cartilage 
to falsely represent p21 and p16 in Figure 1A in R01 AG056623-01

    8. Respondent reported falsified photomicrographs from the 
following published papers that were reused and relabeled to falsely 
represent unrelated experimental results in NIH grant applications:
     Green tea polyphenol treatment is chondroprotective, anti-
inflammatory and palliative in a mouse post-traumatic osteoarthritis 
model. Arthritis Res Ther. 2014 Dec 17;16(6):508; doi: 10.1186/sl3075-
014-0508-y (hereafter referred to as ``Arthritis Res Ther. 2014''). 
Erratum in: Arthritis Res Ther. 2019, Jan 3;21(1):1; doi: 10.1186/
s13075-018-1791-9.
     Curcumin slows osteoarthritis progression and relieves 
osteoarthritis-associated pain symptoms in a post-traumatic 
osteoarthritis mouse model. Arthritis Res Ther. 2016 Jun 3; 18(1):128; 
doi: 10.1186/s13075-016-1025-y (hereafter referred to as ``Arthritis 
Res Ther. 2016'').
     Procyanidins Mitigate Osteoarthritis Pathogenesis by, at 
Least in Part, Suppressing Vascular Endothelial Growth Factor 
Signaling. Int. J. Mol. Sci. 2016, 17:2065; doi:10.3390/ijms17122065 
(hereafter referred to as ``Int. J. Mol. Sci. 2016'').
    Specifically, in:

 R01 AR070431-01A1, Respondent reported a falsified image panel 
that was reused and relabeled from:
--Arthritis Res Ther. 2016:
[ssquf] Figure 6A representing type II collagen cleavage epitope (Col2-
3/4 M) vehicle control to falsely represent aggrecan cleavage in DMM WT 
in Figure 2E in R01 AR070431-01A1
[ssquf] Figure 6D representing ADAMTS5 staining of a vehicle control 
twice in Figure 2F in R01 AR070431-01A1 to falsely represent IL-1[beta] 
and cleaved caspase staining
--Arthritis Res Ther. 2014:
[ssquf] Figure 2C representing Col2-3/4 M in vehicle treated sham 
operated mice twice in Figures 2E and 2F in R01 AR070431-01A1 to 
falsely represent cleaved caspase and IL-1[beta] respectively in sham 
operated WT mice
[ssquf] Figure 2C representing Col2-3/4 M in epigallocatechin3-gallate 
(EGCG) treated DMM mice in Figure 2E in R01 AR070431-01A1 to falsely 
represent Col2-3/4 M in Panx1 KO DMM mice
[ssquf] Figure 3A representing cleaved aggrecan in sham operated EGCG 
treated mice in Figure 2E in R01 AR070431-01A1 to falsely represent 
cleaved aggrecan in sham operated untreated WT mice
[ssquf] Figure 3C representing cleaved aggrecan in DMM WT mice treated 
with EGCG in Figure 2E in R01 AR070431-01A1 to falsely represent 
cleaved aggrecan in DMM Panx1 KO mice
[ssquf] Figure 4A representing MMP-13 in sham operated EGCG treated 
mice in Figure 4E in R01 AR070431-01A1 to falsely represent antibody-
staining control
[ssquf] Figure 4C representing MMP-13 in sham operated, vehicle treated 
mice in:
    [rtarr8]Figure 2E in R01 AR074802-01 and R01 AR074802-01A1 to 
falsely represent ADAMTS5 staining in Pax1 KO DMM mice
    [rtarr8]Figure 2F in R01 AR074802-01 and R01 AR070431-01A1 to 
falsely represent NLRP3 staining of Pax1 KO DMM
[ssquf] Figure 4C representing MMP-13 in DMM vehicle treated mice in:
    [rtarr8]Figure 2E in R01 AR074802-01 and R01 AR074802-01A1 to 
falsely represent MMP-13 in DMM WT mice
    [rtarr8]Figure 2F in R01 AR074802-01 and R01 AR070431-01A1 to 
falsely represent NLRP3 in DMM WT mice
[ssquf] Figure 5C representing ADAMTS5 in sham operated EGCG treated 
mouse twice in Figures 2E in R01 AR074802-01 and R01 AR074802-01A1 to 
falsely represent ADAMTS5 in sham operated WT mice
[ssquf] Figure 5C representing ADAMTS5 in vehicle treated DMM operated 
mouse sample twice in Figures 2E in R01 AR074802-01 and R01 AR074802-
01A1 to falsely represent ADAMTS5 in DMM WT mouse sample
[ssquf] R01 AG056623-01, Respondent reported a falsified image panel 
that was reused and relabeled from:
--Int. J. Mol. Sci. 2016:
[ssquf] Figure 1A representing cartilage from ``sham'' wildtype C57BL/6 
mice treated with oral PBS in Figure 2B in R01 AG056623-01 to represent 
knee cartilage from ``sham'' Col2a1CreERTxCited2fl/fl mice injected 
with corn oil without tamoxifen
--Arthritis Res Ther. 2014:
[ssquf] Figure 4A representing MMP-13 in vehicle-treated mice 4-weeks 
post DMM surgery in:
    [rtarr8] Figure 8 in R01 AG056623-01 to falsely represent p21 in 
control mice following DMM surgery
    [rtarr8] Figure 3 in R01 AG056623-01 to falsely represent [beta]-
gal in Cited2 KO mice
[ssquf] Figure 4A representing MMP-13 in EGCG -treated mice 4-weeks 
post DMM surgery Figure 8 in R01 AG056623-01 to falsely represent p21 
following DMM surgery in mice overexpressing Cited2
[ssquf] Figure 4C representing MMP-13 in vehicle-treated mice 8-weeks 
post sham surgery in Figure 2C in R01 AG056623-01 to falsely represent 
p21 staining in Cited2 KO mice following DMM surgery
[ssquf] Figure 4C representing MMP-13 in in EGCG-treated mice 8-weeks 
post DMM surgery in Figure 2C in R01 AG056623-01 to falsely represent 
p21 in oil-injected control mice for Cited2 was conditionally deleted 
in cartilage by injection of corn oil without Tamoxifen
[ssquf] Figure 5A representing ADAMTS5 in vehicle-treated DMM-induced 
OA mice in:
    [rtarr8] Figure 8 in R01 AG056623-01 to falsely represent p16 in 
control mice following DMM surgery
    [rtarr8] Figure 2C in R01 AG056623-01 to falsely represent [beta]-
gal in Cited2 KO mice
    [rtarr8] Figure 3 in R01 AG056623-01 to falsely represent [beta]-
gal in WT control mice with conditional deletion of Cited2 in cartilage
[ssquf] Figure 5C representing ADAMTS5 in vehicle-treated DMM-induced 
OA mice in:
    [rtarr8] Figure 8 in R01 AG056623-01 to falsely represent Cited2 in 
Cited-overexpressing mice as well as [beta]-gal in control mice 
following DMM surgery
    [rtarr8] Figure 2C in R01 AG056623-01 to falsely represent p16 
staining in Cited2 KO mice
    [rtarr8] Figure 8 in R01 AG056623-01 to falsely represent p16 in 
control mice following DMM surgery

    Respondent neither admits nor denies ORI's findings of research 
misconduct.

[[Page 16753]]

The parties entered into a Voluntary Settlement Agreement (Agreement) 
to conclude this matter without further expenditure of time, finances, 
or other resources. The settlement is not an admission of liability on 
the part of the Respondent.
    Respondent voluntarily agreed to the following:
    (1) Respondent will have his research supervised for a period of 
twelve (12) years beginning on March 1, 2022 (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. 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 
is supported by the research record.
    (3) During the Supervision Period, Respondent will ensure that any 
institution employing him 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 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 his participation was not proposed on a research project 
for which an application for PHS support was submitted and that he has 
not participated in any capacity in PHS-supported research.
    (5) During the Supervision Period, Respondent will exclude himself 
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: March 21, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2022-06247 Filed 3-23-22; 8:45 am]
BILLING CODE 4150-31-P