82 FR 46250 - Patient Engagement Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 191 (October 4, 2017)

Page Range		46250-46251
FR Document		2017-21317

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.

Federal Register, Volume 82 Issue 191 (Wednesday, October 4, 2017)

[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)]
[Notices]
[Pages 46250-46251]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-21317]

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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.

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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

[[Page 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 up-to-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

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
Number of Average
Type of submission Number of Total annual Total
responses per burden per
(21 CFR section) respondents responses hours
respondent response

Supplements to applications approved 6/30/01 390 26 10,140 (Submitted 3rd, 120 1,216,800
to 6/30/15 (§§ 314.70(b), 601.12(f)(1)). 4th, and 5th years
after 6/30/15).
Annual report submission of revised labeling 320 ∼17 5,500 (Submitted 3rd 40 220,000
for applications that contain a pregnancy cat- year after 6/30/15).
egory, approved before 6/30/01
(§§ 314.70(d), 601.12(f)(3)).

Total ............................................................ ........................ .......................... ........................................ ........................ 1,436,800
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Type of submission Number of Total annual Total
disclosures burden per
(21 CFR section) respondents disclosures hours
per respondent disclosure

New Drug Applications (NDAs)/Abbreviated 390 ∼10 4,000 (Submitted during 40 160,000
New Drug Applications (ANDAs)/Biologics Li- 10-year period after
cense Applications (BLAs)/efficacy supple- 6/30/15).
ments 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)).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that approximately In addition, during the 3rd, 4th, and Dated: September 28, 2017.
4,000 applications containing the 5th years after the effective date of the Anna K. Abram,
subject labeling will be submitted by final rule, the Agency estimates that it Deputy Commissioner for Policy, Planning,
approximately 390 applicants and will receive approximately 10,150 Legislation, and Analysis.
repackagers and relabelers to FDA over supplements to applications that were [FR Doc. 2017–21292 Filed 10–3–17; 8:45 am]
the 10-year period beginning June 30, either approved from June 30, 2001, to BILLING CODE 4164–01–P
2015. This figure (4,000 applications) the effective date or were pending as of
includes labeling for approximately 800 the effective date. This estimate
applications submitted under section includes supplements for approximately DEPARTMENT OF HEALTH AND
505(b) of the Federal Food, Drug, and 1,080 NDAs, BLAs, and efficacy HUMAN SERVICES
Cosmetic Act (FD&C Act) (21 U.S.C. supplements; 1,320 ANDA
505(b)) or section 351 of the Public supplements; and 7,750 drug product Food and Drug Administration
Health Service Act (42 U.S.C. 262), labeling supplements from repackagers [Docket No. FDA–2017–N–0001]
1,200 applications submitted under and relabelers. FDA estimates that
section 505(j) of the FD&C Act, and approximately 390 application holders, Patient Engagement Advisory
2,000 revised drug product labeling repackagers, and relabelers will submit Committee; Amendment of Notice
from repackagers and relabelers for these supplements, and that it will take
approximately 2,000 applications. This AGENCY: Food and Drug Administration,
approximately 120 hours to prepare and HHS.
estimate also includes labeling submit each supplement.
amendments submitted to FDA for ACTION: Notice; amendment.
applications pending as of the effective FDA also estimates that application
date of the final rule. FDA estimates that holders will submit approximately SUMMARY: The Food and Drug
it will take applicants approximately 40 5,500 annual reports to FDA during the Administration (FDA) is announcing
hours to prepare and submit the subject third year after the effective date for amendments to the notice of meeting of
labeling. This estimate applies only to applications that contain a pregnancy the Patient Engagement Advisory
the requirements of the final rule and category, approved before June 30, 2001. Committee. This meeting was
does not indicate the total hours This estimate includes approximately announced in the Federal Register of
1,340 NDAs and BLAs, and July 26, 2017. The amendments are
sradovich on DSK3GMQ082PROD with NOTICES

required to prepare and submit
complete labeling for these applications. approximately 4,160 ANDAs containing being made to reflect time changes in
The information collection burden to labeling changes as a result of the final the DATES and Procedure sections and to
prepare and submit labeling in rule. FDA estimates that approximately add Webcast Information to the
accordance with §§ 201.56 (21 CFR 320 application holders will submit document. There are no other changes.
201.56), 201.57, and 201.80 is approved these annual reports, and that it will FOR FURTHER INFORMATION CONTACT:
by OMB under control numbers 0910– take approximately 40 hours for each Letise Williams, Center for Devices and
0572 and 0910–0001. submission. Radiological Health, Food and Drug

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

Administration, 10903 New Hampshire DEPARTMENT OF HEALTH AND controls for p85 immunoprecipitation
Ave., Bldg. 66, Rm. 5441, Silver Spring, HUMAN SERVICES by using three bands representing 2
MD 20993–0002, 301–796–8398; or FDA normal glucose and 1 high glucose
Advisory Committee Information Line, Office of the Secretary treatments, flipping them horizontally
1–800–741–8138 (301–443–0572 in the (mirror images) to also represent 2 high
Findings of Research Misconduct glucose and 1 peroxynitrite treatments.
Washington, DC area), code PEAC.
Please call the Information Line for up- AGENCY: Office of the Secretary, HHS. 3. Figure 4B, J Cell Sci. 2005, to
to-date information on this meeting. represent p85 immunoprecipitations
ACTION: Notice. from retinal endothelial cells stimulated
SUPPLEMENTARY INFORMATION: In the SUMMARY: Notice is hereby given that with VEGF and also cells treated with
Federal Register of July 26, 2017 (82 FR the Office of Research Integrity (ORI) either high glucose or peroxynitrite.
34681), FDA announced that a meeting 4. Figure 4A, PLoS One 2013, to
has taken final action in the following
of the Patient Engagement Advisory represent immunoprecipitations for
case:
Committee would be held on October 11 phosphorylated GSK-3 (p-GSK-3) in
Azza El-Remessy, Ph.D., University of
and 12, 2017. On page 34681, in the cells with normal glucose or high
Georgia, College of Pharmacy: Based on
third column, the DATES section is glucose for day 1 and to also represent
the report of an investigation conducted
changed to reflect the time of these cells treated with VEGF or VEGF+VEGFI
by the University of Georgia, College of
meetings on the announced dates. (inhibitor); the Respondent also
Pharmacy (UGCP) and additional
duplicated GSK-3 controls by using the
On page 34682, in the first column, in analysis conducted by ORI in its
same bands to represent high glucose
the Procedure section, the third oversight review, ORI found that Dr.
treatment for day 1 and day 3
sentence is changed to reflect new times Azza El-Remessy, former Associate treatments, flipping them horizontally,
for oral presentations on October 11 and Professor, Department of Clinical and to also represent for VEGF and VEGFRI
12. Administrative Pharmacy, UGCP, treatments.
engaged in research misconduct in 5. Figure 3, FASEB J. 2007, to
On page 34682, in the second column, research supported by National Eye
a Webcast Information section is added represent phosphorylated VEGF2 (P-
Institute (NEI), National Institutes of VEGF2) protein expression in
before the last paragraph of the Health (NIH), grants R01 EY011766, R01
document. The amendments read as microvascular endothelial cells in:
EY022408, and R01 EY04618, National Lanes 1 and 8, lanes 2 and 5, and lanes
follows: Heart, Lung, and Blood Institute 6 and 7, where each lane represents
DATES: The meeting will be held on (NHLBI), NIH, grant R01 HL056259, and different experimental conditions.
October 11, 2017, from 12:30 p.m. to 6 National Cancer Institute (NCI), NIH, Dr. El-Remessy entered into a
p.m. and October 12, 2017, from 8 a.m. grant K01 CA89689. Voluntary Settlement Agreement
to 5 p.m. ORI found that false Western blot data (Agreement) to resolve this matter
were included in: without further expenditure of time or
Procedure: Oral presentations from • J Cell Sci. 118(Pt. 1):243–52, 2005 other resources. Dr. El-Remessy accepts
the public will be scheduled between (hereafter referred to as ‘‘J Cell Sci. ORI’s findings of research misconduct
approximately 2:30 p.m. to 3 p.m. on 2005’’). Retraction in: J Cell Sci. as set forth above but neither admits nor
October 11, 2017, and approximately 1 129(16):3203, 2016. denies ORI’s findings of research
p.m. to 2:30 p.m. on October 12, 2017. • FASEB J. 21(10):2528–39, 2007 misconduct. The settlement is not an
Webcast Information: This meeting (hereafter referred to as ‘‘FASEB J. admission of liability on the part of the
will also be made available to the public 2007’’). Retraction in: FASEB J. Respondent. Dr. El-Remessy voluntarily
via webcast. The links for the webcasts 31(1):421, 2017. agreed, beginning on September 12,
are below: October 11, 2017: ‘‘Patient • PLoS One 8(8):e71868, 2013 2017:
Engagement Advisory Committee (hereafter referred to as ‘‘PLoS One (1) To have her research supervised
Meeting, Day 1,’’ https:// 2013’’). for a period of three (3) years beginning
event.webcasts.com/ As a result of its investigation, UGCP with the effective date of the Agreement;
starthere.jsp?ei=1157277&tp_ recommended that PLoS One 2013 be Respondent agreed that prior to the
key=5580d0c7a5. October 12, 2017: corrected. As a result of the submission of an application for U.S.
‘‘Patient Engagement Advisory investigation, J Cell Sci. 2005 and Public Health Service (PHS) support for
FASEB J. 2007 have been retracted. a research project on which the
Committee Meeting, Day 2,’’ Morning
ORI found that Respondent Respondent’s participation is proposed
Session—https://event.webcasts.com/
intentionally, knowingly, or recklessly and prior to Respondent’s participation
starthere.jsp?ei=1157280&tp_
used the same Western blot bands to in any capacity on PHS-supported
key=dfcde848fe; and Afternoon
represent different experimental results. research, Respondent shall ensure that a
Session—https://event.webcasts.com/ Specifically, Respondent reused and plan for supervision of Respondent’s
starthere.jsp?ei=1157282&tp_ relabeled bands in: duties is submitted to ORI for approval;
key=6d832a247e. 1. Figure 3B, J Cell Sci. 2005, to the supervision plan must be designed
This notice is issued under the represent p38 bands from retinal to ensure the scientific integrity of
Federal Advisory Committee Act (5 cultured endothelial cells in high Respondent’s research contribution;
U.S.C. app. 2) and 21 CFR part 14, glucose in the absence of exogenous Respondent agreed that she shall not
VEGF and also cells in peroxynitrite in
sradovich on DSK3GMQ082PROD with NOTICES

relating to the advisory committees. participate in any PHS-supported
Dated: September 29, 2017.
the presence of exogenous VEGF. research until such a supervision plan is
2. Figure 4A, J Cell Sci. 2005, to submitted to and approved by ORI;
Anna K. Abram, represent nitrotyrosine Respondent agreed to maintain
Deputy Commissioner for Policy, Planning, immunoprecipitations from retinal responsibility for compliance with the
Legislation, and Analysis. endothelial cells cultured in normal agreed upon supervision plan;
[FR Doc. 2017–21317 Filed 10–3–17; 8:45 am] glucose in the presence or absence of (2) that for three (3) years beginning
BILLING CODE 4164–01–P FeTTP; the Respondent also duplicated with the effective date of the Agreement,

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Document Created: 2018-10-25 09:54:40
Document Modified: 2018-10-25 09:54:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; amendment.
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.
Contact		Letise Williams, Center for Devices and Radiological Health, Food and Drug 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 up-to-date information on this meeting.
FR Citation		82 FR 46250

82 FR 46250 - Patient Engagement Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 191 (October 4, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration