62800 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 

2See minutes from the January 24 to 25, 1984, 

advisory committee meeting discussing anabolic 

steroids, at pg. 7. 

3See footnote 1. 

4See footnote 1. 

were withdrawn from sale for reasons of 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withdrawn for reasons of safety or 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 

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 

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 receptormediated activation of CYP1A1 and 

CYP1B1 transcription and DNA adduct 

formation. Cancer Prev Res (Phila). 2008 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 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 PPARg 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 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 

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: 

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 


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 

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: 

—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: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 62803 

—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: 

—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 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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 


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