Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 21129 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information for investigational new drug 

applications under have been approved 

under OMB control number 0910–0014; 

the collections of information for review 

of new drug applications in have been 

approved under OMB control number 

0910–0001; and the collections of 

information for review of biologic 

licensing applications in have been 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.regulations.gov, https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances. 

Dated: April 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07690 Filed 4–8–22; 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 

Toni M. Brand, Ph.D. (Respondent), 

who was a graduate student in the 

Department of Human Oncology, 

University of Wisconsin-Madison 

(UWM), and subsequently a research 

fellow in the Department of 

Otolaryngology—Head and Neck 

Surgery, University of California San 

Francisco (UCSF). 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 P30 

CA014520, K99 CA160639, T32 

CA108462, and U54 CA209891, 

National Center for Research Resources 

(NCRR), NIH, grant UL1 RR025011, 

National Center for Translational 

Sciences (NCATS), NIH, grants U54 

TR000021 and UL1 TR000427, National 

Institute of General Medical Sciences 

(NIGMS), NIH, grant T32 GM081061, 

and National Institute of Dental and 

Craniofacial Research (NIDCR), NIH, 

grant R01 DE023685. The administrative 

actions, including supervision for a 

period of four (4) years, were 

implemented beginning on March 23, 

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: 

Toni M. Brand, Ph.D., University of 

Wisconsin-Madison and University of 

California San Francisco: Based on the 

reports of investigations conducted by 

UWM and UCSF and additional analysis 

conducted by ORI in its oversight 

review, ORI found that Dr. Toni M. 

Brand, who was a graduate student in 

the Department of Human Oncology, 

UWM, and subsequently a research 

fellow in the Department of 

Otolaryngology—Head and Neck 

Surgery, UCSF, engaged in research 

misconduct in research supported by 

PHS funds, specifically NCI, NIH, grants 

P30 CA014520, K99 CA160639, T32 

CA108462, and U54 CA209891, NCRR, 

NIH, grant UL1 RR025011, NCATS, 

NIH, grants U54 TR000021 and UL1 

TR000427, NIGMS, NIH, grant T32 

GM081061, and NIDCR, NIH, grant R01 

DE023685. 

ORI found that Respondent engaged 

in research misconduct by knowingly or 

recklessly falsifying or fabricating 

western blot data, by reusing and 

relabeling data to represent expression 

of proteins in control experiments 

measuring the purity of cytoplasmic and 

nuclear cell fractionation, 

measurements of proteins of interest, 

and measurements of the same protein 

under different experimental conditions 

or loading controls, included in twentyfour (24) figures in the following grant 

application submitted to NIDCR, NIH, 

her Ph.D. Thesis Dissertation, and seven 

(7) published papers: 

• K99 DE027699–01, ‘‘Targeting HPVdriven immunosuppressive signaling 

pathways in head and neck cancer,’’ 

submitted to NIDCR, NIH, on June 8, 

2017. 

• Ph.D. Thesis Dissertation, 

‘‘Investigations of Nuclear HER family 

receptors in cancer and resistance to 

cetuximab therapy,’’ Department of 

Human Oncology, UWM, March 21, 

2014 (hereafter referred to as ‘‘Thesis’’). 

• Mapping C-terminal transactivation 

domains of the nuclear HER family 

receptor tyrosine kinase HER3. PLoS 

One 2013 Aug 8;8(8):e71518; doi: 

10.1371/journal.pone.0071518. 

eCollection 2013 (hereafter referred to as 

‘‘PLoS One 2013’’). 

• Nuclear EGFR as a molecular target 

in cancer. Radiother Oncol. 2013 

Sep;108(3):370–7; doi: 10.1016/ 

j.radonc.2013.06.010 (hereafter referred 

to as ‘‘Radiother Oncol. 2013’’). 

Corrected in: Radiother Oncol. 2019 

Jan;130:195; doi: 10.1016/ 

j.radonc.2018.10.011. 

• Nuclear epidermal growth factor 

receptor is a functional molecular target 

in triple-negative breast cancer. Mol 

Cancer Ther. 2014 May;13(5):1356–68; 

doi: 10.1158/1535–7163.MCT–13–1021 

(hereafter referred to as ‘‘Mol Cancer 

Ther. 2014’’). Corrected in: Mol Cancer 

Ther. 2019 Apr;18(4):868; doi: 10.1158/ 

1535–7163.MCT–18–1183. 

• AXL mediates resistance to 

cetuximab therapy. Cancer Res. 2014 

Sep 15;74(18):5152–64; doi: 10.1158/ 

0008–5472.CAN–14–0294 (hereafter 

referred to as ‘‘Cancer Res. 2014’’). 

• The receptor tyrosine kinase AXL 

mediates nuclear translocation of the 

epidermal growth factor receptor. Sci 

Signal. 2017 Jan 3;10(460):eaag1064; 

doi: 10.1126/scisignal.aag1064 

(hereafter referred to as ‘‘Sci Signal. 

2017’’). Retracted in: Sci Signal. 2021 

Nov 9;14(708):eabn0168; doi: 10.1126/ 

scisignal.abn0168. 

• Human Papillomavirus Regulates 

HER3 Expression in Head and Neck 

Cancer: Implications for Targeted HER3 

Therapy in HPV + Patients. Clin Cancer 

Res. 2017 Jun 15;23(12):3072–3083; doi: 

10.1158/1078–0432.CCR–16–2203 

(hereafter referred to as ‘‘Clin Cancer 

Res. 2017’’). Corrected in: Clin Cancer 

Res. 2021 Jul 15;27(14):4129; doi: 

10.1158/1078–0432.CCR–21–2141. 

• Cross-talk Signaling between HER3 

and HPV16 E6 and E7 Mediates 

Resistance to PI3K Inhibitors in Head 

and Neck Cancer. Cancer Res. 2018 May 

1;78(9):2383–95; doi: 10.1158/0008– 

5472.CAN–17–1672 (hereafter referred 

to as ‘‘Cancer Res. 2018’’). 


lotter on DSK11XQN23PROD with NOTICES1
21130 Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 

Specifically, ORI found that 

Respondent knowingly or recklessly 

falsified or fabricated data in: 

• Figure 6B of Thesis and Figure 6B 

of PLoS One 2013 by reusing a Tubulin 

western blot panel from cytoplasmic 

sample to represent Histone H3 panel in 

nuclear sample 

• Figure 6, panel C, of Thesis and 

Figure 6C of PLoS One 2013 by using 

identical Her3 western blot data to 

represent samples from different cell 

lines and using a Tubulin western blot 

panel from an unrelated experiment. 

• Figure 6C, inset 1, of Thesis and 

Figure 6C, inset 1, of PLoS One 2013 by 

inappropriately cropping the histone H3 

nuclear sample to represent equal 

loading of the samples when the actual 

data showed an unequal amount. 

• Figure 6C, inset 2, of Thesis and 

Figure 6C, inset 2, of PLoS One 2013 by 

using identical Her3 western panel to 

represent samples from different cell 

lines and falsifying loading control by 

using a Cyclin D western blot panel to 

represent Tubulin. 

• Figure 7A and inset 2 of Thesis and 

Figure 7A and inset 2 of PLoS One 2013 

by using identical Her3 western panel to 

represent samples from different cell 

lines. 

• Figure 2B, SKBr3 inset, of 

Radiother Oncol. 2013 by representing 

unrelated western panel as Tubulin 

loading control for the cytoplasmic 

samples. 

• Figure 2B, SUM229 inset, of 

Radiother Oncol. 2013 by representing 

unrelated western panel as Tubulin 

loading control in non-nuclear samples. 

• Figure 4B of Mol Cancer Ther. 2014 

by using identical pSFKY419 western 

blot panels to represent expression in 

different cell lines. 

• Figure 2D of prpS6 western blot 

panel from HP cell line in Cancer Res. 

2014 by using a western blot panel from 

an unrelated experiment. 

• Figure 1A of Sci Signal. 2017 by 

using identical western blot panels to 

represent Histone H3 in non-nuclear 

samples and Tubulin in nuclear 

samples. 

• Figure 2A of Sci Signal. 2017 by 

using loading control panels from an 

unrelated experiment in the HC8 

experiment. 

• Figure 2C of Sci Signal. 2017 by 

using a panel from an unrelated 

experiment to represent histoneH3 in 

the nuclear samples. 

• Figure 2C inset of Sci Signal. 2017 

by using a panel from an unrelated 

experiment to represent tubulin. 

• Figure 4A of Sci Signal. 2017 by 

reusing identical panels to represent 

tubulin (negative) control experiments. 

• Figure 5E of Sci Signal. 2017 by 

selective cropping and use of loading 

control panels from unrelated 

experiments. 

• Tubulin western blot panels in 

Figure 3A of K99 DE027699–01 by 

reusing the same data to represent two 

different cell lines or related data to 

represent a different cell line. 

• Figure 3A of Clin Cancer Res. 2017 

by using the identical western blot data 

to represent expression of HER3 and 

HER3–Y1197 in the SCC47 cell line. 

• Supplemental Figure 3A of Cancer 

Res. 2018 by using identical western 

blot data to represent pAKT–S473 and 

pAKT–T308 expression in the SCC90 

sample. 

• Figure 1C of Clin Cancer Res. 2017 

and Figure 1B of K99 DE027699–01 by 

representing the same western blot 

panels to represent E6 and E7 

expression in different experiments. 

Respondent neither admits nor denies 

ORI’s findings of research misconduct. 

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 her research 

supervised for a period of four (4) years 

beginning on March 23, 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 during the Supervision Period. 

The committee will review primary data 

from Respondent’s laboratory on a 

quarterly basis and submit a report to 

ORI at six (6) month intervals setting 

forth the committee meeting dates and 

Respondent’s compliance with 

appropriate research standards and 

confirming the integrity of Respondent’s 

research. 

ii. The committee will conduct an 

advance review of each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved. The review will include a 

discussion with Respondent of the 

primary data represented in those 

documents and will include a 

certification to ORI that the data 

presented in the proposed application, 

report, manuscript, or abstract are 

supported by the research record. 

(3) During the Supervision Period, 

Respondent will ensure that any 

institution employing her submits, in 

conjunction with each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved, a certification to ORI that the 

data provided by Respondent are based 

on actual experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript, or abstract. 

(4) If no supervision plan is provided 

to ORI, Respondent will provide 

certification to ORI at the conclusion of 

the Supervision Period that her 

participation was not proposed on a 

research project for which an 

application for PHS support was 

submitted and that she has not 

participated in any capacity in PHSsupported research. 

(5) During the Supervision Period, 

Respondent will exclude herself 

voluntarily from serving in any advisory 

or consultant capacity to PHS including, 

but not limited to, service on any PHS 

advisory committee, board, and/or peer 

review committee. 

(6) Respondent will request that the 

following papers be corrected or 

retracted: 

• PLoS One 2013 Aug 8;8(8):e71518 

• Cancer Res. 2014 Sep 

15;74(18):5152–64 

• Cancer Res. 2018 May 1;78(9):2383– 

95 

Respondent will copy ORI and the 

Research Integrity Officers at UWM and 

UCSF on the correspondence with the 

journals. 

Dated: April 5, 2022. 

Wanda K. Jones, 

Acting Director, Office of Research Integrity, 

Office of the Assistant Secretary for Health. 

[FR Doc. 2022–07632 Filed 4–8–22; 8:45 am] 

BILLING CODE 4150–31–P 


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