Findings of Research Misconduct, 62800-62803 [2023-19780]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 62800 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. Our records show that FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met and discussed anabolic steroids in January 1984. The advisory committee unanimously concluded that there was no evidence of efficacy for oxandrolone.2 As communicated in the product labeling for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, multiple safety warnings and precautions are associated with the use of this product including peliosis hepatis, sometimes associated with liver failure and intraabdominal hemorrhage; liver cell tumors, sometimes fatal; and blood lipid changes that are known to be associated with increased risk of atherosclerosis.3 Per the product labeling, additional warnings with using this product include the risks associated with cholestatic hepatitis, hypercalcemia in patients with breast cancer, and increased risk for the development of prostatic hypertrophy and prostatic carcinoma in geriatric patients.4 Considering the safety concerns associated with the use of oxandrolone noted in the labeling, the Agency concluded that the benefit-risk profile of the drug product is unfavorable without substantial evidence to support effectiveness. Based on a thorough evaluation of the information we have available to us and an evaluation of the latest version of the drug products’ approved labeling, we have determined that the drug products would not be considered safe and effective if they were reintroduced to the market today. New clinical studies would first need to be conducted to address the concerns described above. Thus, after considering the citizen petition and reviewing Agency records and based on the information we have 2 See minutes from the January 24 to 25, 1984, advisory committee meeting discussing anabolic steroids, at pg. 7. 3 See footnote 1. 4 See footnote 1. VerDate Sep<11>2014 17:37 Sep 12, 2023 Jkt 259001 at this time, FDA has determined under § 314.161 that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness. Accordingly, the Agency will remove Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, from the list of drug products published in the Orange Book per § 314.162. FDA will not accept or approve ANDAs that refer to this drug product. Dated: September 8, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–19796 Filed 9–12–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Findings of research misconduct have been made against Kotha Subbaramaiah, Ph.D. (Respondent), who was a Professor of Biochemistry Research in Medicine, Department of Medicine, Weill Cornell Medical College (WCMC). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P01 CA077839, P01 CA106451, R01 CA108773, R01 CA154481, T32 CA009685, R25 CA105012, and N01 CN43302, National Institute on Deafness and Other Communication Disorders (NIDCD), NIH, grant T32 DC000027, and National Center for Advancing Translational Sciences (NCATS), NIH, grant UL1 TR000457. The administrative actions, including debarment for a period of seven (7) years, were implemented beginning on August 16, 2023, and are detailed below. SUMMARY: 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: Kotha Subbaramaiah, Ph.D., Weill Cornell Medical College: Based on the report of an investigation conducted by WCMC and additional analysis conducted by ORI in its oversight PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 review, ORI found that Kotha Subbaramaiah, Ph.D., former Weill Cornell Medical College, WCMC, engaged in research misconduct in research supported by PHS funds, specifically NCI, NIH, grants P01 CA077839, P01 CA106451, R01 CA108773, R01 CA154481, T32 CA009685, R25 CA105012, and N01 CN43302, NIDCD, NIH, grant T32 DC000027, and NCATS, NIH, grant UL1 TR000457. ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/ or fabricating data included in the following twelve (12) published papers: • Increased levels of COX–2 and prostaglandin E2 contribute to elevated aromatase expression in inflamed breast tissue of obese women. Cancer Discov. 2012 Apr;2(4):356–65. doi: 10.1158/ 2159–8290.CD–11–0241 (hereafter referred to as ‘‘Cancer Discov. 2012’’). Retraction in: Cancer Discov. 2021 May;11(5):1306. doi: 10.1158/2159– 8290.CD–21–0224. • EP2 and EP4 receptors regulate aromatase expression in human adipocytes and breast cancer cells. Evidence of a BRCA1 and p300 exchange. J Biol Chem. 2008 Feb 8;283(6):3433–44. doi: 10.1074/ jbc.M705409200 (hereafter referred to as ‘‘J Biol Chem. 2008’’). Retraction in: J Biol Chem. 2020 Jan 3; 295(1):295. doi: 10.1074/jbc.W119.012140. • HDAC6 modulates Hsp90 chaperone activity and regulates activation of aryl hydrocarbon receptor signaling. J Biol Chem. 2009 Mar 20; 284(12):7436–45. doi: 10.1074/ jbc.M808999200 (hereafter referred to as ‘‘J Biol Chem. 2009’’). Retraction in: J Biol Chem. 2020 Jan 3; 295(1):297. doi: 10.1074/jbc.W119.012142. • p53 protein regulates Hsp90 ATPase activity and thereby Wnt signaling by modulating Aha1 expression. J Biol Chem. 2014 Mar 7;289(10):6513–25. doi: 10.1074/ jbc.M113.532523 (hereafter referred to as ‘‘J Biol Chem. 2014’’). Retraction in: J Biol Chem. 2020 Jan 3; 295(1):289. doi: 10.1074/jbc.W119.012134. • Hsp90 and PKM2 drive the expression of aromatase in Li-Fraumeni syndrome breast adipose stromal cells. J Biol Chem. 2016 Jul 29;291(31):16011– 23. doi: 10.1074/jbc.M115.698902 (hereafter referred to as ‘‘J Biol Chem. 2016’’). Retraction in: J Biol Chem. 2020 Jan 3; 295(1):290. doi: 10.1074/ jbc.W119.012135. • Heat shock protein 90 inhibitors suppress aryl hydrocarbon receptormediated activation of CYP1A1 and CYP1B1 transcription and DNA adduct formation. Cancer Prev Res (Phila). 2008 E:\FR\FM\13SEN1.SGM 13SEN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices Nov;1(6):485–93. doi: 10.1158/1940– 6207.CAPR–08–0149 (hereafter referred to as ‘‘Cancer Prev Res. 2008’’). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2;15(6):415. doi: 10.1158/ 1940–6207.CAPR–22–0200. • Obesity is associated with inflammation and elevated aromatase expression in the mouse mammary gland. Cancer Prev Res (Phila). 2011 Mar;4(3):329–46. doi: 10.1158/1940– 6207.CAPR–10–0381 (hereafter referred to as ‘‘Cancer Prev Res. 2011’’). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2; 15(6):413. doi: 10.1158/ 1940–6207.CAPR–22–0202. • Carnosol, a constituent of Zyflamend, inhibits aryl hydrocarbon receptor-mediated activation of CYP1A1 and CYP1B1 transcription and mutagenesis. Cancer Prev Res (Phila). 2012 Apr;5(4):593–602. doi: 10.1158/ 1940–6207.CAPR–12–0002 (hereafter referred to as ‘‘Cancer Prev Res. 2012a’’). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2;15(6):412. doi: 10.1158/ 1940–6207.CAPR–22–0203. • Pioglitazone, a PPARg agonist, suppresses CYP19 transcription: evidence for involvement of 15hydroxyprostaglandin dehydrogenase and BRCA1. Cancer Prev Res (Phila). 2012 Oct;5(10):1183–94. doi: 10.1158/ 1940–6207.CAPR–12–0201 (hereafter referred to as ‘‘Cancer Prev Res. 2012b’’). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2;15(6):411. doi: 10.1158/1940–6207.CAPR–22–0204. • Caloric restriction reverses obesityinduced mammary gland inflammation in mice. Cancer Prev Res (Phila). 2013 Apr;6(4):282–9. doi: 10.1158/1940– 6207.CAPR–12–0467 (hereafter referred to as ‘‘Cancer Prev Res. 2013’’). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2; 15(6):410. doi: 10.1158/ 1940–6207.CAPR–22–0205. • p53 modulates Hsp90 ATPase activity and regulates aryl hydrocarbon receptor signaling. Cancer Prev Res (Phila). 2014 Jun;7(6):596–606. doi: 10.1158/1940–6207.CAPR–14–0051 (hereafter referred to as ‘‘Cancer Prev Res. 2014’’). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2;15(6):408. doi: 10.1158/1940–6207.CAPR–22–0207. • Id1 deficiency protects against tumor formation in Apc(Min/+) mice but not in a mouse model of colitisassociated colon cancer. Cancer Prev Res (Phila). 2015 Apr;8(4):303–11. doi: 10.1158/1940–6207.CAPR–14–0411 (hereafter referred to as ‘‘Cancer Prev Res. 2015’’). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2;15(6):407. doi: 10.1158/1940–6207.CAPR–22–0208. Specifically, ORI found that Respondent reused Western blot images from the same source and falsely VerDate Sep<11>2014 17:37 Sep 12, 2023 Jkt 259001 relabeled them to represent different proteins and/or experimental results in: • Cancer Discov. 2012: —Figure 2B, b-Actin panel, representing b-Actin expression in inflamed breast tissue with different levels of inflammation: D All lanes are duplicated by reusing a same source band with manipulation —Figure 4C, representing the expression of progesterone receptor (PR) and bActin in inflamed breast tissue with different levels of inflammation: D PR panel: Lanes 1, 2, and 14–16 are duplicated by reusing a same source band with manipulation; lanes 3, 6–9, 13, and 17 are duplicated by reusing a same source band with manipulation D b-Actin panel: All lanes are duplicated by reusing a same source band with manipulation —Figure 5H, b-Actin panel, representing b-Actin expression in macrophages with different treatments: • Lane 2 and lane 4 are identical • J Biol Chem 2008 —Figure 2B, lanes 1–3, aromatase panel, representing aromatase expression in adipocytes treated with PGE1 alcohol, and Figure 2E, lanes 2–4, Aromatase panel, representing aromatase expression in adipocytes treated with PGE2 with or without ONO, are duplicated by reusing the same source images with manipulation —Figure 3B, 18S rRNA panel, representing 18S rRNA expression in adipocytes with different treatments: D Lanes 2 and 6 are identical D Lanes 3 and 7 are identical —Figure 5A, 18S rRNA panel, representing 18S rRNA expression in adipocytes treated with different doses of PGE2: D Lanes 1 and 5 are identical D Lanes 2 and 6 are identical —Figure 5B, b-actin panel, representing b-actin expression in adipocytes treated with different doses of PGE2: D Lanes 1, 3, and 4 are identical —Figure 6D, BRCA1 and Aromatase panels, representing expression of both BRCA1 and aromatase in SKBR3 cells treated with different doses of PGE1 alcohol: D Lanes 3–4, BRCA1 panel and lanes 1–2, Aromatase panel are duplicated by reusing the same source images with manipulation —Figure 5A, BRCA1 panel, representing BRCA1 expression in adipocytes treated with different doses of PGE2: D Lanes 3–6 are falsified and/or fabricated —Figure 5C, 18S rRNA panel, representing 18S rRNA expression in adipocytes treated with different doses of butaprost: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 62801 D Entire 18S rRNA panel is falsified and/or fabricated —Figure 5E: D Lane 4, BRCA1 panel and lane 1, 18S rRNA panel are identical —Figures 6C, 6D, 6E, and 6F: D Images used in the following figures are duplicated by reusing the same source images with manipulation: ➢ Figure 6C, lane 1, BRCA1 panel, representing BRCA1 expression in control sample without treatment of butaprost ➢ Figure 6C, lane 3, Aromatase panel, representing aromatase expression with 0.25 mM butaprost treatment ➢ Figure 6D, lane 1, BRCA1 panel, representing BRCA1 expression in control sample without treatment of PGE1 alcohol ➢ Figure 6F, lane 1, BRCA1 panel, representing BRCA1 expression in control sample without treatment of PGE2 and ONO D Images used in the following figures are duplicated by reusing the same source images with manipulation: ➢ Figure 6C, lane 2, BRCA1 panel, representing BRCA1 expression in sample treated with 0.10 mM butaprost ➢ Figure 6D, lane 3, Aromatase panel, representing aromatase expression in sample treated with 0.25 mM PGE1 alcohol D Images used in the following figures are duplicated by reusing the same source images with manipulation: ➢ Figure 6C, lane 3, BRCA1 panel, representing BRCA1 expression in sample treated with 0.25 mM butaprost ➢ Figure 6D, lane 3, BRCA1 panel, representing BRCA1 expression in sample treated with 0.25 mM PGE1 alcohol ➢ Figure 6D, lane 2, Aromatase panel, representing aromatase expression in sample treated with 0.10 mM PGE1 alcohol D Images used in the following figures are duplicated by reusing the same source images with manipulation: ➢ Figure 6C, lane 4, BRCA1 panel, representing BRCA1 expression in sample treated with 0.50 mM butaprost ➢ Figure 6C, lane 1, Aromatase panel, representing aromatase expression in control sample without treatment of butaprost ➢ Figure 6D, lane 1, Aromatase panel, representing aromatase expression in control sample without treatment of PGE1 alcohol ➢ Figure 6E, lane 2, BRCA1 panel, representing BRCA1 expression in sample treated with PGE2 without AH6809 E:\FR\FM\13SEN1.SGM 13SEN1 ddrumheller on DSK120RN23PROD with NOTICES1 62802 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices D Images used in the following figures are duplicated by reusing the same source images with manipulation: ➢ Figure 6C, lane 2, Aromatase panel, representing aromatase expression in sample treated with 0.10 mM butaprost ➢ Figure 6E, lane 3, BRCA1 panel, representing BRCA1 expression in sample treated with PGE2 and 25 mM AH6809 ➢ Figure 6F, lane 2, BRCA1 panel, representing BRCA1 expression in sample treated with PGE2 but without ONO D Images used in the following figures are duplicated by reusing the same source images with manipulation: ➢ Figure 6C, lane 4, Aromatase panel, representing aromatase expression in sample treated with 0.50 mM butaprost ➢ Figure 6D, lane 2, BRCA1 panel, representing BRCA1 expression in sample treated with 0.10 mM PGE1 alcohol ➢ Figure 6E, lane 4, BRCA1 panel, representing BRCA1 expression in sample treated with PGE2 and 50 mM AH6809 ➢ Figure 6F, lane 3, BRCA1 panel, representing BRCA1 expression in sample treated with PGE2 and 0.10 mM ONO D Images used in the following figures are duplicated by reusing the same source images with manipulation: ➢ Figure 6D, 18S rRNA panel, representing 18S rRNA expression in samples treated with different doses of PGE1 alcohol ➢ Figure 6F, 18S rRNA panel, representing 18S rRNA expression in samples treated with different doses of PGE2 and ONO • J Biol Chem. 2009: —Figures 2A and 2B, b-actin panels, representing b-actin expression in KYSE450 cells and MSK-Leuk1 cells, respectively: D The two panels are identical —Figure 3B, representing protein expression at two different time points: D Column 4, 1-hour panel, and column 2, 3-hour panel, are duplicated by reusing the same source images with resizing —Figure 6H, representing expression of different proteins with different treatments: D Column 1, Control group and column 3, Control siRNA group are identical —Figure 6I, representing expression of different proteins with different treatments: D Lanes 2 and 5, column 1 are identical VerDate Sep<11>2014 17:37 Sep 12, 2023 Jkt 259001 D Lane 3, column 1 and lane 5, column 2 are identical —Figure 8G, Input panel, representing input protein expression in A549 cells with different treatments: D Lanes 2 and 3 are identical —Figure 9B, Input panel, representing input protein expression in different samples: D Lanes 2 and 3 are identical —Figures 8E and 9D: D Images used in the following figures are duplicated by reusing a same source band with resizing: ➢ Figure 8E, lane 2, AhR panel, representing AhR expression in sample treated with B[a]P ➢ Figure 9D, lane 3, b-actin panel, representing b-actin expression in K/R sample treated with TS —Figure 9D, b-actin panel, representing b-actin expression under different experimental conditions: D Lane 1 is falsified and/or fabricated —Figure 9C, Input panel, representing input protein expression in K/A sample: D Lane 5 is falsified and/or fabricated —Figure S1A, p23 panel, representing p23 expression in MSK-Leuk1 cells and A549 cells: D Lanes 1 and 2 are identical —Figure S1C, XAP–2 panel, representing XAP–2 expression in control and sample treated with HDAC6 KD: D Lanes 1 and 2 are identical —Figure S1B, representing expression of different proteins in MSK-Leuk1 cells with different treatments: D Lanes 3 and 4, Hsp90 panel are identical D Lanes 1 and 2, AhR panel are identical D Lanes 1 and 2, b-actin panel are identical D Lanes 3 and 4, b-actin panel are identical —Figure S1E, representing expression of different proteins in MSK-Leuk1 cells with different treatments: D Lane 1, Hsp90 panel, and lanes 1 and 2, HDAC6 panel, are identical D Lane 3, Hsp90 panel, and lane 3, XAP–2 panel, are identical —Figure S2, representing expression of different proteins in MSK-Leuk1 cells with different treatments: D Last lane, IB AcK panel, and lanes 3 and 5, IB HSP90 panel, are duplicated with resizing D Lane 4, IB AcK panel, and lanes 1, 4, and 6, IB HSP90 panel, are duplicated with resizing D Lane 4, IB AcK panel, is falsified and/or fabricated • J Biol Chem. 2014: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 —Figure 1D, representing expression of different proteins treated with control or p53 siRNA: D Lane 1, p53 panel, and lanes 1 and 2, b-actin panel, are duplicated by reusing a same source band with manipulation —Figure 2B, b-actin panel, representing b-actin expression in HCT–15 cells treated with different doses of CP– 31398: D Lane 1 and lane 5 are identical D Lane 2 and lane 6 are identical —Figure 4K, p23 panel, representing p23 expression in samples treated with different doses of CP–31398 in HCT–15 cells: D Lanes 2–4 are identical —Figures 4H, 4I, and 4L, b-actin panels, representing b-actin expression under different experimental conditions: D b-actin panels in Figures 4H and 4I, and lanes 3–4, b-actin panel in Figure 4L are duplicated by reusing the same source images with manipulation —Figures 4J, 4K, and 4L, representing expression of HOP (Figure 4J) and bactin (Figures 4K and 4L) under different experimental conditions: D Lanes 1–2, HOP panel in Figure 4J, lanes 3–4, b-actin panel in Figure 4K, and lanes 1–2, b-actin panel in Figure 4L are duplicated by reusing the same source images with manipulation —Figures 5A and 5B, b-actin panels, representing b-actin expression in both HCT–15 cells and EB–1 cells, are identical —Figure 5H, c-Myc panel and Naked-1 panel, representing expression of cMyc and Naked-1 in EB–1 cells, are duplicated with resizing —Figures 10A and 10B, representing bactin (Figure 10A) and Aha1 (Figure 10B) expression: D Lanes 2–3, b-actin panel in Figure 10A and lanes 2–3, Aha1 panel in Figure 10B are duplicated with resizing • J Biol Chem. 2016: —Figures 1C and 7A, b-actin panels, representing b-actin expression in different cells: D Lanes 1–2, b-actin panel in Figure 1C and lanes 2–3, b-actin panel in Figure 7A are duplicated by reusing the same source images with manipulation —Figure 5B, representing expression of different proteins with different treatments: D Lane 6, PKM2 panel, and lane 5, Hsp90 panel, are identical —Figure 5A, representing expression of different proteins with different treatments: D Lane 2, HIF–1a panel, and lane 1, b-actin panel, are identical • Cancer Prev Res. 2008: E:\FR\FM\13SEN1.SGM 13SEN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices —Figure 2B, b-actin panel, representing b-actin expression in different cells with different treatments: D Left middle b-actin panel and right middle b-actin panel are duplicated by reusing the same source images with manipulation —Figures 3A and 3B, b-actin panels, representing b-actin expression in different cells with different treatments: D Left top b-actin panel in Figure 3A and left top b-actin panel in Figure 3B are identical D Right top b-actin panel in Figure 3A and left bottom b-actin panel in Figure 3B are duplicated by reusing the same source images with manipulation D Right bottom b-actin panel in Figure 3A and right bottom b-actin panel in Figure 3B are identical • Cancer Prev Res. 2011: —Figure 3A, representing expression of different proteins with different treatments: D Lane 1, aP2 panel, is falsified and/ or fabricated D Lanes 3 and 5, aP2 panel, and lanes 1–6, 18S rRNA panel, are identical • Cancer Prev Res. 2012a: —Figure 4A, representing input expression treated with different doses of Zyflamend with or without 17–AAG: D Lanes 1–5 are identical D Lanes 6–7 are identical —Figure 4B, representing input expression treated with different doses of carnosol with or without 17– AAG: D Lanes 1–5 are identical • Cancer Prev Res. 2012b: —Figure 2, representing expression of different proteins under different experimental conditions: D Lane 1, 15–PGDH panel in Figure 2B and lanes 3–4, b-Actin panel in Figure 2E are duplicated by reusing a same source band with manipulation D Lane 2, b-Actin panel in Figure 2B and lane 1, Snail panel in Figure 2E are duplicated by reusing a same source band with manipulation D Lane 3, Snail panel in Figure 2G and lane 1, 15–PGDH panel in Figure 2H are duplicated by reusing a same source band with manipulation D Lanes 1 and 2, b-Actin panel in Figure 2H are duplicated by reusing a same source band with manipulation D Lanes 1–3, b-Actin panel in Figure 2J and lanes 1–2, b-Actin panel in Figure 2K are duplicated by reusing a same source band with manipulation —Figure 4E, b-Actin panel, representing b-actin expression in control and pioglitazone samples: D Lanes 1 and 2 are identical • Cancer Prev Res. 2013: VerDate Sep<11>2014 17:37 Sep 12, 2023 Jkt 259001 —Figure 3, representing binding of nuclear protein from mammary glands of mice with different treatments: D Lanes 7–9 (first three empty lanes are counted also) and lanes 13–15 are identical • Cancer Prev Res. 2014: —Figures 5A and 5C, representing expression of different proteins with different treatments: D Lanes 2–3, CYP1A1 panel, and lanes 2–3, CYP1B1 panel, in Figure 5A and lane 3, CYP1B1 panel, in Figure 5C are duplicated by reusing a same source band with manipulation —Figure 5B, b-actin panel, representing b-actin expression in different cells with different treatments: D Lanes 2–4 are identical —Figure 5D, b-actin panel, representing b-actin expression in different cells with different treatments: D Lanes 1–4 are duplicated by reusing a same source band with manipulation • Cancer Prev Res. 2015: —Figure 3A, b-actin panel, representing b-actin expression in DLD–1 treated with different doses of PGE2: D Lanes 1, 3, and 5 are identical D Lanes 2 and 4 are identical Respondent entered into a Voluntary Exclusion Agreement (Agreement) and voluntarily agreed to the following: (1) Respondent will exclude himself voluntarily for a period of seven (7) years beginning on August 16, 2023 (the ‘‘Exclusion Period’’), from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement or procurement transactions referred to as ‘‘covered transactions’’ in 2 CFR parts 180 and 376 (collectively the ‘‘Debarment Regulations’’). (2) During the Exclusion 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: September 8, 2023. Sheila Garrity, Director, Office of Research Integrity, Office of the Assistant Secretary for Health. [FR Doc. 2023–19780 Filed 9–12–23; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 62803 Findings of research misconduct have been made against Andrew Dannenberg, M.D. (Respondent), who was a Professor of Medicine, Department of Medicine, Weill Cornell Medical College (WCMC). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P01 CA077839, P01 CA106451, R01 CA108773, R01 CA154481, T32 CA009685, R25 CA105012, and N01 CN43302, National Institute on Deafness and Other Communication Disorders (NIDCD), NIH, grant T32 DC000027, and National Center for Advancing Translational Sciences (NCATS), NIH, grant UL1 TR000457. The administrative actions, including supervision for a period of seven (7) years, were implemented beginning on August 14, 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: Andrew Dannenberg, M.D., Weill Cornell Medical College (WCMC): Based on the report of an investigation conducted by WCMC and additional analysis conducted by ORI in its oversight review, ORI found that Andrew Dannenberg, former Professor of Medicine, Department of Medicine, WCMC, engaged in research misconduct in research supported by PHS funds, specifically NCI, NIH, grants P01 CA077839, P01 CA106451, R01 CA108773, R01 CA154481, T32 CA009685, R25 CA105012, and N01 CN43302, NIDCD, NIH, grant T32 DC000027, and NCATS, NIH, grant UL1 TR000457. ORI found that Respondent engaged in research misconduct by recklessly reporting falsified and/or fabricated data in the following twelve (12) published papers: • Increased levels of COX–2 and prostaglandin E2 contribute to elevated aromatase expression in inflamed breast tissue of obese women. Cancer Discov. 2012 Apr;2(4):356–65. doi: 10.1158/ 2159–8290.CD–11–0241 (hereafter referred to as ‘‘Cancer Discov. 2012’’). Retraction in: Cancer Discov. 2021 May;11(5):1306. doi: 10.1158/2159– 8290.CD–21–0224. • EP2 and EP4 receptors regulate aromatase expression in human SUMMARY: E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62800-62803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19780]


-----------------------------------------------------------------------

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 Kotha 
Subbaramaiah, Ph.D. (Respondent), who was a Professor of Biochemistry 
Research in Medicine, Department of Medicine, Weill Cornell Medical 
College (WCMC). Respondent engaged in research misconduct in research 
supported by U.S. Public Health Service (PHS) funds, specifically 
National Cancer Institute (NCI), National Institutes of Health (NIH), 
grants P01 CA077839, P01 CA106451, R01 CA108773, R01 CA154481, T32 
CA009685, R25 CA105012, and N01 CN43302, National Institute on Deafness 
and Other Communication Disorders (NIDCD), NIH, grant T32 DC000027, and 
National Center for Advancing Translational Sciences (NCATS), NIH, 
grant UL1 TR000457. The administrative actions, including debarment for 
a period of seven (7) years, were implemented beginning on August 16, 
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:
    Kotha Subbaramaiah, Ph.D., Weill Cornell Medical College: Based on 
the report of an investigation conducted by WCMC and additional 
analysis conducted by ORI in its oversight review, ORI found that Kotha 
Subbaramaiah, Ph.D., former Weill Cornell Medical College, WCMC, 
engaged in research misconduct in research supported by PHS funds, 
specifically NCI, NIH, grants P01 CA077839, P01 CA106451, R01 CA108773, 
R01 CA154481, T32 CA009685, R25 CA105012, and N01 CN43302, NIDCD, NIH, 
grant T32 DC000027, and NCATS, NIH, grant UL1 TR000457.
    ORI found that Respondent engaged in research misconduct by 
intentionally, knowingly, or recklessly falsifying and/or fabricating 
data included in the following twelve (12) published papers:
     Increased levels of COX-2 and prostaglandin E2 contribute 
to elevated aromatase expression in inflamed breast tissue of obese 
women. Cancer Discov. 2012 Apr;2(4):356-65. doi: 10.1158/2159-8290.CD-
11-0241 (hereafter referred to as ``Cancer Discov. 2012''). Retraction 
in: Cancer Discov. 2021 May;11(5):1306. doi: 10.1158/2159-8290.CD-21-
0224.
     EP2 and EP4 receptors regulate aromatase expression in 
human adipocytes and breast cancer cells. Evidence of a BRCA1 and p300 
exchange. J Biol Chem. 2008 Feb 8;283(6):3433-44. doi: 10.1074/
jbc.M705409200 (hereafter referred to as ``J Biol Chem. 2008''). 
Retraction in: J Biol Chem. 2020 Jan 3; 295(1):295. doi: 10.1074/
jbc.W119.012140.
     HDAC6 modulates Hsp90 chaperone activity and regulates 
activation of aryl hydrocarbon receptor signaling. J Biol Chem. 2009 
Mar 20; 284(12):7436-45. doi: 10.1074/jbc.M808999200 (hereafter 
referred to as ``J Biol Chem. 2009''). Retraction in: J Biol Chem. 2020 
Jan 3; 295(1):297. doi: 10.1074/jbc.W119.012142.
     p53 protein regulates Hsp90 ATPase activity and thereby 
Wnt signaling by modulating Aha1 expression. J Biol Chem. 2014 Mar 
7;289(10):6513-25. doi: 10.1074/jbc.M113.532523 (hereafter referred to 
as ``J Biol Chem. 2014''). Retraction in: J Biol Chem. 2020 Jan 3; 
295(1):289. doi: 10.1074/jbc.W119.012134.
     Hsp90 and PKM2 drive the expression of aromatase in Li-
Fraumeni syndrome breast adipose stromal cells. J Biol Chem. 2016 Jul 
29;291(31):16011-23. doi: 10.1074/jbc.M115.698902 (hereafter referred 
to as ``J Biol Chem. 2016''). Retraction in: J Biol Chem. 2020 Jan 3; 
295(1):290. doi: 10.1074/jbc.W119.012135.
     Heat shock protein 90 inhibitors suppress aryl hydrocarbon 
receptor-mediated activation of CYP1A1 and CYP1B1 transcription and DNA 
adduct formation. Cancer Prev Res (Phila). 2008

[[Page 62801]]

Nov;1(6):485-93. doi: 10.1158/1940-6207.CAPR-08-0149 (hereafter 
referred to as ``Cancer Prev Res. 2008''). Retraction in: Cancer Prev 
Res (Phila). 2022 Jun 2;15(6):415. doi: 10.1158/1940-6207.CAPR-22-0200.
     Obesity is associated with inflammation and elevated 
aromatase expression in the mouse mammary gland. Cancer Prev Res 
(Phila). 2011 Mar;4(3):329-46. doi: 10.1158/1940-6207.CAPR-10-0381 
(hereafter referred to as ``Cancer Prev Res. 2011''). Retraction in: 
Cancer Prev Res (Phila). 2022 Jun 2; 15(6):413. doi: 10.1158/1940-
6207.CAPR-22-0202.
     Carnosol, a constituent of Zyflamend, inhibits aryl 
hydrocarbon receptor-mediated activation of CYP1A1 and CYP1B1 
transcription and mutagenesis. Cancer Prev Res (Phila). 2012 
Apr;5(4):593-602. doi: 10.1158/1940-6207.CAPR-12-0002 (hereafter 
referred to as ``Cancer Prev Res. 2012a''). Retraction in: Cancer Prev 
Res (Phila). 2022 Jun 2;15(6):412. doi: 10.1158/1940-6207.CAPR-22-0203.
     Pioglitazone, a PPAR[gamma] agonist, suppresses CYP19 
transcription: evidence for involvement of 15-hydroxyprostaglandin 
dehydrogenase and BRCA1. Cancer Prev Res (Phila). 2012 Oct;5(10):1183-
94. doi: 10.1158/1940-6207.CAPR-12-0201 (hereafter referred to as 
``Cancer Prev Res. 2012b''). Retraction in: Cancer Prev Res (Phila). 
2022 Jun 2;15(6):411. doi: 10.1158/1940-6207.CAPR-22-0204.
     Caloric restriction reverses obesity-induced mammary gland 
inflammation in mice. Cancer Prev Res (Phila). 2013 Apr;6(4):282-9. 
doi: 10.1158/1940-6207.CAPR-12-0467 (hereafter referred to as ``Cancer 
Prev Res. 2013''). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2; 
15(6):410. doi: 10.1158/1940-6207.CAPR-22-0205.
     p53 modulates Hsp90 ATPase activity and regulates aryl 
hydrocarbon receptor signaling. Cancer Prev Res (Phila). 2014 
Jun;7(6):596-606. doi: 10.1158/1940-6207.CAPR-14-0051 (hereafter 
referred to as ``Cancer Prev Res. 2014''). Retraction in: Cancer Prev 
Res (Phila). 2022 Jun 2;15(6):408. doi: 10.1158/1940-6207.CAPR-22-0207.
     Id1 deficiency protects against tumor formation in 
Apc(Min/+) mice but not in a mouse model of colitis-associated colon 
cancer. Cancer Prev Res (Phila). 2015 Apr;8(4):303-11. doi: 10.1158/
1940-6207.CAPR-14-0411 (hereafter referred to as ``Cancer Prev Res. 
2015''). Retraction in: Cancer Prev Res (Phila). 2022 Jun 2;15(6):407. 
doi: 10.1158/1940-6207.CAPR-22-0208.
    Specifically, ORI found that Respondent reused Western blot images 
from the same source and falsely relabeled them to represent different 
proteins and/or experimental results in:
     Cancer Discov. 2012:

--Figure 2B, [beta]-Actin panel, representing [beta]-Actin expression 
in inflamed breast tissue with different levels of inflammation:
    [ssquf] All lanes are duplicated by reusing a same source band with 
manipulation

--Figure 4C, representing the expression of progesterone receptor (PR) 
and [beta]-Actin in inflamed breast tissue with different levels of 
inflammation:
    [ssquf] PR panel: Lanes 1, 2, and 14-16 are duplicated by reusing a 
same source band with manipulation; lanes 3, 6-9, 13, and 17 are 
duplicated by reusing a same source band with manipulation
    [ssquf] [beta]-Actin panel: All lanes are duplicated by reusing a 
same source band with manipulation

--Figure 5H, [beta]-Actin panel, representing [beta]-Actin expression 
in macrophages with different treatments:
     Lane 2 and lane 4 are identical

     J Biol Chem 2008

--Figure 2B, lanes 1-3, aromatase panel, representing aromatase 
expression in adipocytes treated with PGE1 alcohol, and Figure 2E, 
lanes 2-4, Aromatase panel, representing aromatase expression in 
adipocytes treated with PGE2 with or without ONO, are 
duplicated by reusing the same source images with manipulation
--Figure 3B, 18S rRNA panel, representing 18S rRNA expression in 
adipocytes with different treatments:
    [ssquf] Lanes 2 and 6 are identical
    [ssquf] Lanes 3 and 7 are identical

--Figure 5A, 18S rRNA panel, representing 18S rRNA expression in 
adipocytes treated with different doses of PGE2:
    [ssquf] Lanes 1 and 5 are identical

    [ssquf] Lanes 2 and 6 are identical

--Figure 5B, [beta]-actin panel, representing [beta]-actin expression 
in adipocytes treated with different doses of PGE2:
    [ssquf] Lanes 1, 3, and 4 are identical
--Figure 6D, BRCA1 and Aromatase panels, representing expression of 
both BRCA1 and aromatase in SKBR3 cells treated with different doses of 
PGE1 alcohol:
    [ssquf] Lanes 3-4, BRCA1 panel and lanes 1-2, Aromatase panel are 
duplicated by reusing the same source images with manipulation

--Figure 5A, BRCA1 panel, representing BRCA1 expression in adipocytes 
treated with different doses of PGE2:
    [ssquf] Lanes 3-6 are falsified and/or fabricated

--Figure 5C, 18S rRNA panel, representing 18S rRNA expression in 
adipocytes treated with different doses of butaprost:
    [ssquf] Entire 18S rRNA panel is falsified and/or fabricated

--Figure 5E:
    [ssquf] Lane 4, BRCA1 panel and lane 1, 18S rRNA panel are 
identical

--Figures 6C, 6D, 6E, and 6F:
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 1, BRCA1 panel, representing BRCA1 
expression in control sample without treatment of butaprost
    [rtarr8] Figure 6C, lane 3, Aromatase panel, representing aromatase 
expression with 0.25 [mu]M butaprost treatment
    [rtarr8] Figure 6D, lane 1, BRCA1 panel, representing BRCA1 
expression in control sample without treatment of PGE1 alcohol
    [rtarr8] Figure 6F, lane 1, BRCA1 panel, representing BRCA1 
expression in control sample without treatment of PGE2 and 
ONO
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.10 [mu]M butaprost
    [rtarr8] Figure 6D, lane 3, Aromatase panel, representing aromatase 
expression in sample treated with 0.25 [mu]M PGE1 alcohol
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.25 [mu]M butaprost
    [rtarr8] Figure 6D, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.25 [mu]M PGE1 alcohol
    [rtarr8] Figure 6D, lane 2, Aromatase panel, representing aromatase 
expression in sample treated with 0.10 [mu]M PGE1 alcohol
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 4, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.50 [mu]M butaprost
    [rtarr8] Figure 6C, lane 1, Aromatase panel, representing aromatase 
expression in control sample without treatment of butaprost
    [rtarr8] Figure 6D, lane 1, Aromatase panel, representing aromatase 
expression in control sample without treatment of PGE1 alcohol
    [rtarr8] Figure 6E, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 without AH6809

[[Page 62802]]

    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 2, Aromatase panel, representing aromatase 
expression in sample treated with 0.10 [mu]M butaprost
    [rtarr8] Figure 6E, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 and 25 [mu]M AH6809
    [rtarr8] Figure 6F, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 but without ONO
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6C, lane 4, Aromatase panel, representing aromatase 
expression in sample treated with 0.50 [mu]M butaprost
    [rtarr8] Figure 6D, lane 2, BRCA1 panel, representing BRCA1 
expression in sample treated with 0.10 [mu]M PGE1 alcohol
    [rtarr8] Figure 6E, lane 4, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 and 50 [mu]M AH6809
    [rtarr8] Figure 6F, lane 3, BRCA1 panel, representing BRCA1 
expression in sample treated with PGE2 and 0.10 [mu]M ONO
    [ssquf] Images used in the following figures are duplicated by 
reusing the same source images with manipulation:
    [rtarr8] Figure 6D, 18S rRNA panel, representing 18S rRNA 
expression in samples treated with different doses of PGE1 alcohol
    [rtarr8] Figure 6F, 18S rRNA panel, representing 18S rRNA 
expression in samples treated with different doses of PGE2 
and ONO
     J Biol Chem. 2009:

--Figures 2A and 2B, [beta]-actin panels, representing [beta]-actin 
expression in KYSE450 cells and MSK-Leuk1 cells, respectively:
    [ssquf] The two panels are identical

--Figure 3B, representing protein expression at two different time 
points:
    [ssquf] Column 4, 1-hour panel, and column 2, 3-hour panel, are 
duplicated by reusing the same source images with resizing

--Figure 6H, representing expression of different proteins with 
different treatments:
    [ssquf] Column 1, Control group and column 3, Control siRNA group 
are identical

--Figure 6I, representing expression of different proteins with 
different treatments:
    [ssquf] Lanes 2 and 5, column 1 are identical
    [ssquf] Lane 3, column 1 and lane 5, column 2 are identical

--Figure 8G, Input panel, representing input protein expression in A549 
cells with different treatments:
    [ssquf] Lanes 2 and 3 are identical

--Figure 9B, Input panel, representing input protein expression in 
different samples:
    [ssquf] Lanes 2 and 3 are identical

--Figures 8E and 9D:
    [ssquf] Images used in the following figures are duplicated by 
reusing a same source band with resizing:
    [rtarr8] Figure 8E, lane 2, AhR panel, representing AhR expression 
in sample treated with B[a]P

    [rtarr8] Figure 9D, lane 3, [beta]-actin panel, representing 
[beta]-actin expression in K/R sample treated with TS

--Figure 9D, [beta]-actin panel, representing [beta]-actin expression 
under different experimental conditions:
    [ssquf] Lane 1 is falsified and/or fabricated

--Figure 9C, Input panel, representing input protein expression in K/A 
sample:
    [ssquf] Lane 5 is falsified and/or fabricated

--Figure S1A, p23 panel, representing p23 expression in MSK-Leuk1 cells 
and A549 cells:
    [ssquf] Lanes 1 and 2 are identical

--Figure S1C, XAP-2 panel, representing XAP-2 expression in control and 
sample treated with HDAC6 KD:
    [ssquf] Lanes 1 and 2 are identical
--Figure S1B, representing expression of different proteins in MSK-
Leuk1 cells with different treatments:
    [ssquf] Lanes 3 and 4, Hsp90 panel are identical
    [ssquf] Lanes 1 and 2, AhR panel are identical
    [ssquf] Lanes 1 and 2, [beta]-actin panel are identical
    [ssquf] Lanes 3 and 4, [beta]-actin panel are identical

--Figure S1E, representing expression of different proteins in MSK-
Leuk1 cells with different treatments:
    [ssquf] Lane 1, Hsp90 panel, and lanes 1 and 2, HDAC6 panel, are 
identical
    [ssquf] Lane 3, Hsp90 panel, and lane 3, XAP-2 panel, are identical

--Figure S2, representing expression of different proteins in MSK-Leuk1 
cells with different treatments:
    [ssquf] Last lane, IB AcK panel, and lanes 3 and 5, IB HSP90 panel, 
are duplicated with resizing
    [ssquf] Lane 4, IB AcK panel, and lanes 1, 4, and 6, IB HSP90 
panel, are duplicated with resizing
    [ssquf] Lane 4, IB AcK panel, is falsified and/or fabricated
     J Biol Chem. 2014:

--Figure 1D, representing expression of different proteins treated with 
control or p53 siRNA:
    [ssquf] Lane 1, p53 panel, and lanes 1 and 2, [beta]-actin panel, 
are duplicated by reusing a same source band with manipulation

--Figure 2B, [beta]-actin panel, representing [beta]-actin expression 
in HCT-15 cells treated with different doses of CP-31398:
    [ssquf] Lane 1 and lane 5 are identical
    [ssquf] Lane 2 and lane 6 are identical

--Figure 4K, p23 panel, representing p23 expression in samples treated 
with different doses of CP-31398 in HCT-15 cells:
    [ssquf] Lanes 2-4 are identical

--Figures 4H, 4I, and 4L, [beta]-actin panels, representing [beta]-
actin expression under different experimental conditions:
    [ssquf] [beta]-actin panels in Figures 4H and 4I, and lanes 3-4, 
[beta]-actin panel in Figure 4L are duplicated by reusing the same 
source images with manipulation

--Figures 4J, 4K, and 4L, representing expression of HOP (Figure 4J) 
and [beta]-actin (Figures 4K and 4L) under different experimental 
conditions:
    [ssquf] Lanes 1-2, HOP panel in Figure 4J, lanes 3-4, [beta]-actin 
panel in Figure 4K, and lanes 1-2, [beta]-actin panel in Figure 4L are 
duplicated by reusing the same source images with manipulation
--Figures 5A and 5B, [beta]-actin panels, representing [beta]-actin 
expression in both HCT-15 cells and EB-1 cells, are identical
--Figure 5H, c-Myc panel and Naked-1 panel, representing expression of 
c-Myc and Naked-1 in EB-1 cells, are duplicated with resizing
--Figures 10A and 10B, representing [beta]-actin (Figure 10A) and Aha1 
(Figure 10B) expression:
    [ssquf] Lanes 2-3, [beta]-actin panel in Figure 10A and lanes 2-3, 
Aha1 panel in Figure 10B are duplicated with resizing

     J Biol Chem. 2016:

--Figures 1C and 7A, [beta]-actin panels, representing [beta]-actin 
expression in different cells:
    [ssquf] Lanes 1-2, [beta]-actin panel in Figure 1C and lanes 2-3, 
[beta]-actin panel in Figure 7A are duplicated by reusing the same 
source images with manipulation

--Figure 5B, representing expression of different proteins with 
different treatments:
    [ssquf] Lane 6, PKM2 panel, and lane 5, Hsp90 panel, are identical

--Figure 5A, representing expression of different proteins with 
different treatments:
    [ssquf] Lane 2, HIF-1[alpha] panel, and lane 1, [beta]-actin panel, 
are identical

     Cancer Prev Res. 2008:


[[Page 62803]]


--Figure 2B, [beta]-actin panel, representing [beta]-actin expression 
in different cells with different treatments:
    [ssquf] Left middle [beta]-actin panel and right middle [beta]-
actin panel are duplicated by reusing the same source images with 
manipulation
--Figures 3A and 3B, [beta]-actin panels, representing [beta]-actin 
expression in different cells with different treatments:
    [ssquf] Left top [beta]-actin panel in Figure 3A and left top 
[beta]-actin panel in Figure 3B are identical
    [ssquf] Right top [beta]-actin panel in Figure 3A and left bottom 
[beta]-actin panel in Figure 3B are duplicated by reusing the same 
source images with manipulation
    [ssquf] Right bottom [beta]-actin panel in Figure 3A and right 
bottom [beta]-actin panel in Figure 3B are identical
     Cancer Prev Res. 2011:
--Figure 3A, representing expression of different proteins with 
different treatments:
    [ssquf] Lane 1, aP2 panel, is falsified and/or fabricated
    [ssquf] Lanes 3 and 5, aP2 panel, and lanes 1-6, 18S rRNA panel, 
are identical
     Cancer Prev Res. 2012a:
--Figure 4A, representing input expression treated with different doses 
of Zyflamend with or without 17-AAG:
    [ssquf] Lanes 1-5 are identical
    [ssquf] Lanes 6-7 are identical
--Figure 4B, representing input expression treated with different doses 
of carnosol with or without 17-AAG:
    [ssquf] Lanes 1-5 are identical
     Cancer Prev Res. 2012b:
--Figure 2, representing expression of different proteins under 
different experimental conditions:
    [ssquf] Lane 1, 15-PGDH panel in Figure 2B and lanes 3-4, [beta]-
Actin panel in Figure 2E are duplicated by reusing a same source band 
with manipulation
    [ssquf] Lane 2, [beta]-Actin panel in Figure 2B and lane 1, Snail 
panel in Figure 2E are duplicated by reusing a same source band with 
manipulation
    [ssquf] Lane 3, Snail panel in Figure 2G and lane 1, 15-PGDH panel 
in Figure 2H are duplicated by reusing a same source band with 
manipulation
    [ssquf] Lanes 1 and 2, [beta]-Actin panel in Figure 2H are 
duplicated by reusing a same source band with manipulation
    [ssquf] Lanes 1-3, [beta]-Actin panel in Figure 2J and lanes 1-2, 
[beta]-Actin panel in Figure 2K are duplicated by reusing a same source 
band with manipulation
--Figure 4E, [beta]-Actin panel, representing [beta]-actin expression 
in control and pioglitazone samples:
    [ssquf] Lanes 1 and 2 are identical
     Cancer Prev Res. 2013:
--Figure 3, representing binding of nuclear protein from mammary glands 
of mice with different treatments:
    [ssquf] Lanes 7-9 (first three empty lanes are counted also) and 
lanes 13-15 are identical
     Cancer Prev Res. 2014:
--Figures 5A and 5C, representing expression of different proteins with 
different treatments:
    [ssquf] Lanes 2-3, CYP1A1 panel, and lanes 2-3, CYP1B1 panel, in 
Figure 5A and lane 3, CYP1B1 panel, in Figure 5C are duplicated by 
reusing a same source band with manipulation
--Figure 5B, [beta]-actin panel, representing [beta]-actin expression 
in different cells with different treatments:
    [ssquf] Lanes 2-4 are identical
--Figure 5D, [beta]-actin panel, representing [beta]-actin expression 
in different cells with different treatments:
    [ssquf] Lanes 1-4 are duplicated by reusing a same source band with 
manipulation
     Cancer Prev Res. 2015:
--Figure 3A, [beta]-actin panel, representing [beta]-actin expression 
in DLD-1 treated with different doses of PGE2:
    [ssquf] Lanes 1, 3, and 5 are identical
    [ssquf] Lanes 2 and 4 are identical
    Respondent entered into a Voluntary Exclusion Agreement (Agreement) 
and voluntarily agreed to the following:
    (1) Respondent will exclude himself voluntarily for a period of 
seven (7) years beginning on August 16, 2023 (the ``Exclusion 
Period''), from any contracting or subcontracting with any agency of 
the United States Government and from eligibility for or involvement in 
nonprocurement or procurement transactions referred to as ``covered 
transactions'' in 2 CFR parts 180 and 376 (collectively the ``Debarment 
Regulations'').
    (2) During the Exclusion 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: September 8, 2023.
Sheila Garrity,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2023-19780 Filed 9-12-23; 8:45 am]
BILLING CODE 4150-31-P
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