46250 Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of submission 

(21 CFR section) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Supplements to applications approved 6/30/01 

to 6/30/15 (§§ 314.70(b), 601.12(f)(1)).

390 26 10,140 (Submitted 3rd, 

4th, and 5th years 

after 6/30/15).

120 1,216,800 

Annual report submission of revised labeling 

for applications that contain a pregnancy category, approved before 6/30/01 

(§§ 314.70(d), 601.12(f)(3)).

320 ∼17 5,500 (Submitted 3rd 

year after 6/30/15).

40 220,000 

Total ............................................................ ........................ .......................... ........................................ ........................ 1,436,800 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Type of submission 

(21 CFR section) 

Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

New Drug Applications (NDAs)/Abbreviated 

New Drug Applications (ANDAs)/Biologics License Applications (BLAs)/efficacy supplements submitted on or after 6/30/15, including 

amendments to applications pending as of 6/ 

30/15 (§§ 314.50) 314.60, 314.70(b), 601.2, 

601.12(f)(1)).

390 ∼10 4,000 (Submitted during 

10-year period after 

6/30/15).

40 160,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA estimates that approximately 

4,000 applications containing the 

subject labeling will be submitted by 

approximately 390 applicants and 

repackagers and relabelers to FDA over 

the 10-year period beginning June 30, 

2015. This figure (4,000 applications) 

includes labeling for approximately 800 

applications submitted under section 

505(b) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

505(b)) or section 351 of the Public 

Health Service Act (42 U.S.C. 262), 

1,200 applications submitted under 

section 505(j) of the FD&C Act, and 

2,000 revised drug product labeling 

from repackagers and relabelers for 

approximately 2,000 applications. This 

estimate also includes labeling 

amendments submitted to FDA for 

applications pending as of the effective 

date of the final rule. FDA estimates that 

it will take applicants approximately 40 

hours to prepare and submit the subject 

labeling. This estimate applies only to 

the requirements of the final rule and 

does not indicate the total hours 

required to prepare and submit 

complete labeling for these applications. 

The information collection burden to 

prepare and submit labeling in 

accordance with §§ 201.56 (21 CFR 

201.56), 201.57, and 201.80 is approved 

by OMB under control numbers 0910– 

0572 and 0910–0001. 

In addition, during the 3rd, 4th, and 

5th years after the effective date of the 

final rule, the Agency estimates that it 

will receive approximately 10,150 

supplements to applications that were 

either approved from June 30, 2001, to 

the effective date or were pending as of 

the effective date. This estimate 

includes supplements for approximately 

1,080 NDAs, BLAs, and efficacy 

supplements; 1,320 ANDA 

supplements; and 7,750 drug product 

labeling supplements from repackagers 

and relabelers. FDA estimates that 

approximately 390 application holders, 

repackagers, and relabelers will submit 

these supplements, and that it will take 

approximately 120 hours to prepare and 

submit each supplement. 

FDA also estimates that application 

holders will submit approximately 

5,500 annual reports to FDA during the 

third year after the effective date for 

applications that contain a pregnancy 

category, approved before June 30, 2001. 

This estimate includes approximately 

1,340 NDAs and BLAs, and 

approximately 4,160 ANDAs containing 

labeling changes as a result of the final 

rule. FDA estimates that approximately 

320 application holders will submit 

these annual reports, and that it will 

take approximately 40 hours for each 

submission. 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21292 Filed 10–3–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Patient Engagement Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

amendments to the notice of meeting of 

the Patient Engagement Advisory 

Committee. This meeting was 

announced in the Federal Register of 

July 26, 2017. The amendments are 

being made to reflect time changes in 

the DATES and Procedure sections and to 

add Webcast Information to the 

document. There are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Letise Williams, Center for Devices and 

Radiological Health, Food and Drug 


sradovich on DSK3GMQ082PROD with NOTICES
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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