Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 46251 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5441, Silver Spring, 

MD 20993–0002, 301–796–8398; or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code PEAC. 

Please call the Information Line for upto-date information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 26, 2017 (82 FR 

34681), FDA announced that a meeting 

of the Patient Engagement Advisory 

Committee would be held on October 11 

and 12, 2017. On page 34681, in the 

third column, the DATES section is 

changed to reflect the time of these 

meetings on the announced dates. 

On page 34682, in the first column, in 

the Procedure section, the third 

sentence is changed to reflect new times 

for oral presentations on October 11 and 

12. 

On page 34682, in the second column, 

a Webcast Information section is added 

before the last paragraph of the 

document. The amendments read as 

follows: 

DATES: The meeting will be held on 

October 11, 2017, from 12:30 p.m. to 6 

p.m. and October 12, 2017, from 8 a.m. 

to 5 p.m. 

Procedure: Oral presentations from 

the public will be scheduled between 

approximately 2:30 p.m. to 3 p.m. on 

October 11, 2017, and approximately 1 

p.m. to 2:30 p.m. on October 12, 2017. 

Webcast Information: This meeting 

will also be made available to the public 

via webcast. The links for the webcasts 

are below: October 11, 2017: ‘‘Patient 

Engagement Advisory Committee 

Meeting, Day 1,’’ https://

event.webcasts.com/ 

starthere.jsp?ei=1157277&tp_

key=5580d0c7a5. October 12, 2017: 

‘‘Patient Engagement Advisory 

Committee Meeting, Day 2,’’ Morning 

Session—https://event.webcasts.com/ 

starthere.jsp?ei=1157280&tp_

key=dfcde848fe; and Afternoon 

Session—https://event.webcasts.com/ 

starthere.jsp?ei=1157282&tp_

key=6d832a247e. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21317 Filed 10–3–17; 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: Notice is hereby given that 

the Office of Research Integrity (ORI) 

has taken final action in the following 

case: 

Azza El-Remessy, Ph.D., University of 

Georgia, College of Pharmacy: Based on 

the report of an investigation conducted 

by the University of Georgia, College of 

Pharmacy (UGCP) and additional 

analysis conducted by ORI in its 

oversight review, ORI found that Dr. 

Azza El-Remessy, former Associate 

Professor, Department of Clinical and 

Administrative Pharmacy, UGCP, 

engaged in research misconduct in 

research supported by National Eye 

Institute (NEI), National Institutes of 

Health (NIH), grants R01 EY011766, R01 

EY022408, and R01 EY04618, National 

Heart, Lung, and Blood Institute 

(NHLBI), NIH, grant R01 HL056259, and 

National Cancer Institute (NCI), NIH, 

grant K01 CA89689. 

ORI found that false Western blot data 

were included in: 

• J Cell Sci. 118(Pt. 1):243–52, 2005 

(hereafter referred to as ‘‘J Cell Sci. 

2005’’). Retraction in: J Cell Sci. 

129(16):3203, 2016. 

• FASEB J. 21(10):2528–39, 2007 

(hereafter referred to as ‘‘FASEB J. 

2007’’). Retraction in: FASEB J. 

31(1):421, 2017. 

• PLoS One 8(8):e71868, 2013 

(hereafter referred to as ‘‘PLoS One 

2013’’). 

As a result of its investigation, UGCP 

recommended that PLoS One 2013 be 

corrected. As a result of the 

investigation, J Cell Sci. 2005 and 

FASEB J. 2007 have been retracted. 

ORI found that Respondent 

intentionally, knowingly, or recklessly 

used the same Western blot bands to 

represent different experimental results. 

Specifically, Respondent reused and 

relabeled bands in: 

1. Figure 3B, J Cell Sci. 2005, to 

represent p38 bands from retinal 

cultured endothelial cells in high 

glucose in the absence of exogenous 

VEGF and also cells in peroxynitrite in 

the presence of exogenous VEGF. 

2. Figure 4A, J Cell Sci. 2005, to 

represent nitrotyrosine 

immunoprecipitations from retinal 

endothelial cells cultured in normal 

glucose in the presence or absence of 

FeTTP; the Respondent also duplicated 

controls for p85 immunoprecipitation 

by using three bands representing 2 

normal glucose and 1 high glucose 

treatments, flipping them horizontally 

(mirror images) to also represent 2 high 

glucose and 1 peroxynitrite treatments. 

3. Figure 4B, J Cell Sci. 2005, to 

represent p85 immunoprecipitations 

from retinal endothelial cells stimulated 

with VEGF and also cells treated with 

either high glucose or peroxynitrite. 

4. Figure 4A, PLoS One 2013, to 

represent immunoprecipitations for 

phosphorylated GSK-3 (p-GSK-3) in 

cells with normal glucose or high 

glucose for day 1 and to also represent 

cells treated with VEGF or VEGF+VEGFI 

(inhibitor); the Respondent also 

duplicated GSK-3 controls by using the 

same bands to represent high glucose 

treatment for day 1 and day 3 

treatments, flipping them horizontally, 

to also represent for VEGF and VEGFRI 

treatments. 

5. Figure 3, FASEB J. 2007, to 

represent phosphorylated VEGF2 (PVEGF2) protein expression in 

microvascular endothelial cells in: 

Lanes 1 and 8, lanes 2 and 5, and lanes 

6 and 7, where each lane represents 

different experimental conditions. 

Dr. El-Remessy entered into a 

Voluntary Settlement Agreement 

(Agreement) to resolve this matter 

without further expenditure of time or 

other resources. Dr. El-Remessy accepts 

ORI’s findings of research misconduct 

as set forth above but neither admits nor 

denies ORI’s findings of research 

misconduct. The settlement is not an 

admission of liability on the part of the 

Respondent. Dr. El-Remessy voluntarily 

agreed, beginning on September 12, 

2017: 

(1) To have her research supervised 

for a period of three (3) years beginning 

with the effective date of the Agreement; 

Respondent agreed that prior to the 

submission of an application for U.S. 

Public Health Service (PHS) support for 

a research project on which the 

Respondent’s participation is proposed 

and prior to Respondent’s participation 

in any capacity on PHS-supported 

research, Respondent shall ensure that a 

plan for supervision of Respondent’s 

duties is submitted to ORI for approval; 

the supervision plan must be designed 

to ensure the scientific integrity of 

Respondent’s research contribution; 

Respondent agreed that she shall not 

participate in any PHS-supported 

research until such a supervision plan is 

submitted to and approved by ORI; 

Respondent agreed to maintain 

responsibility for compliance with the 

agreed upon supervision plan; 

(2) that for three (3) years beginning 

with the effective date of the Agreement, 


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46252 Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 

any institution employing her shall 

submit, in conjunction with each 

application for PHS funds, or report, 

manuscript, or abstract involving PHSsupported 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; 

(3) to exclude herself voluntarily from 

serving in any advisory capacity to PHS 

including, but not limited to, service on 

any PHS advisory committee, board, 

and/or peer review committee, or as a 

consultant for a period of three (3) years, 

beginning with the effective date of the 

Agreement; and 

(4) that as a condition of the 

Agreement, Respondent will request 

that PLoS One 8(8):e71868, 2013 be 

corrected or retracted. 

FOR FURTHER INFORMATION CONTACT: 

Director, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8200. 

Kathryn M. Partin, 

Director, Office of Research Integrity. 

[FR Doc. 2017–21367 Filed 10–3–17; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

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

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Human 

Genome Research Institute Special Emphasis 

Panel, SEP U24 Research Resource. 

Date: November 30, 2017. 

Time: 11:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Human Genome Research 

Institute, 5635 Fishers Lane, Suite 3146, 

Rockville, MD 20852 (Telephone Conference 

Call). 

Contact Person: Rudy O. Pozzatti, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Human Genome Research 

Institute, 5635 Fishers Lane, Suite 4076, MSC 

9306, Rockville, MD 20852, (301) 402–0838, 

pozzattr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: September 28, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–21263 Filed 10–3–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

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

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; Multisite Clinical Trials. 

Date: October 19, 2017. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Shang-Yi Anne Tsai, 

Ph.D., Scientific Review Officer, Office of 

Extramural Policy and Review, Division of 

Extramural Research, National Institute on 

Drug Abuse, NIH, DHHS, 6001 Executive 

Boulevard, Room 4228, MSC 9550, Bethesda, 

MD 20892, 301–827–5842, shangyi.tsai@

nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIDA 

Mentored Clinical Scientists Development 

Program Award in Drug Abuse and 

Addiction (K12). 

Date: October 25, 2017. 

Time: 9:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Susan O. McGuire, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Blvd., 

Room 4245, Rockville, MD 20852, (301) 827– 

5817, mcguireso@mail.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIH 

Pathway to Independence Award (K99/R00). 

Date: October 25, 2017. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Susan O. McGuire, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Blvd., 

Room 4245, Rockville, MD 20852, (301) 827– 

5817, mcguireso@mail.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; (T32) 

Ruth L. Kirschstein National Research 

Service Award (NRSA) Institutional Research 

Training Grants. 

Date: October 26–27, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Susan O. McGuire, Ph.D. 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Blvd., 

Room 4245, Rockville, MD 20852, (301) 827– 

5817, mcguireso@mail.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Exploring Novel RNA Modifications in HIV/ 

AIDS and Substance Use Disorders (R01, 

R21). 

Date: November 1, 2017. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, 

Contact Person: Susan O. McGuire, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Blvd., 

Room 4245, Rockville, MD 20852, (301) 827– 

5817, mcguireso@mail.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; CuttingEdge Basic Research Awards (CEBRA) (R21). 

Date: November 29, 2017. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 


sradovich on DSK3GMQ082PROD with NOTICES