30-day FRN

31520

Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Notices
TABLE 6—CFSAN GUIDANCE
COVID–19 guidance title

Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety
Rule) During the COVID–19 Public Health Emergency.

IV. Electronic Access

Another guidance title
referenced in
COVID–19 guidance

OMB control
No.

21 CFR part 118 ......

...................................

0910–0660

Comments on the ICR must be
received on or before June 25, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0937–0198–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES:

Persons with access to the internet
may obtain COVID–19-related guidances
at:
• the FDA web page entitled
‘‘COVID–19-Related Guidance
Documents for Industry, FDA Staff, and
Other Stakeholders,’’ available at
https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders;
• the FDA web page entitled ‘‘Search
for FDA Guidance Documents,’’
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents; or
• https://www.regulations.gov.
Dated: May 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11238 Filed 5–22–20; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–0198]

Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

CFR cite referenced
in COVID–19
guidance

In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.

SUMMARY:

Title of the Collection: Public Health
Service Polices on Research
Misconduct (42 CFR part 93)—OMB No.
0937–0198—Extension—Office of
Research Integrity.
Abstract: The Office of Research
Integrity is requesting an extension on a
currently approved collection. The
purpose of the Institutional Assurance

and Annual Report on Possible Research
Misconduct form PHS–6349 is to
provide data on the amount of research
misconduct activity occurring in
institutions conducting PHS-supported
research. The purpose of the Assurance
of Compliance by Sub-Award Recipients
form PHS–6315 is to establish an
assurance of compliance for a subawardee institution. Forms PHS 6349
and PHS–6315 are also used to provide
an annual assurance that the institution
has established and will follow
administrative policies and procedures
for responding to allegations of research
misconduct that comply with the Public
Health Service (PHS) Policies on
Research Misconduct (42 CFR Part 93).
Research misconduct is defined as
receipt of an allegation of research
misconduct and/or the conduct of an
inquiry and/or investigation into such
allegations. These data enable the ORI to
monitor institutional compliance with
the PHS regulation.
Need and Proposed Use: The
information is needed to fulfill section
493 of the Public Health Service Act (42
U.S.C. 289b), which requires assurances
from institutions that apply for financial
assistance under the Public Health
Service Act for any project or program
that involves the conduct of biomedical
or behavioral research. In addition, the
information is also required to fulfill the
assurance and annual reporting
requirements of 42 CFR Part 93. ORI
uses the information to monitor
institutional compliance with the
regulation. Lastly, the information may
be used to respond to congressional
requests for information to prevent
misuse of Federal funds and to protect
the public interest.

ESTIMATED ANNUALIZED BURDEN HOUR TABLE
Average
burden hours
per
response

Type of respondent

PHS–6349 .........................................
PHS–6315 .........................................

Awardee Institutions .........................
Sub-Awardee Institutions .................

5748
110

1
1

12/60
5/60

1150
9

Total ...........................................

...........................................................

........................

........................

........................

1159

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19:08 May 22, 2020

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Number of
respondents

Number of
responses per
respondent

Forms
(if necessary)

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Total burden
hours

Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Notices
Dated: May 20, 2020.
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2020–11250 Filed 5–22–20; 8:45 am]
BILLING CODE 4150–31–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

Findings of research
misconduct have been made against Mr.
Logan Fulford (Respondent), who was a
graduate research assistant, Cincinnati
Children’s Hospital Medical Center
(CCHMC), and former graduate student,
University of Cincinnati (UC). Mr.
Fulford engaged in research misconduct
in research supported by National
Cancer Institute (NCI), National
Institutes of Health (NIH), grant R01
CA142724 and National Heart, Lung,
and Blood Institute (NHLBI), NIH, grant
R01 HL084151. The administrative
actions, including supervision for a
period of two (2) years, were
implemented beginning on May 8, 2020,
and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, 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:
Mr. Logan Fulford, Cincinnati
Children’s Hospital Medical Center:
Based on the report of an investigation
conducted by CCHMC and additional
analysis conducted by ORI in its
oversight review, ORI found that Mr.
Logan Fulford, former graduate research
assistant, CCHMC, and former graduate
student, UC, engaged in research
misconduct in research supported by
NCI, NIH, grant R01 CA142724 and
NHLBI, NIH, grant R01 HL084151.
Respondent neither admits nor denies
ORI’s findings of research misconduct;
the settlement is not an admission of
liability on the part of the Respondent.
The parties entered into a Voluntary
Settlement Agreement (Agreement) to
conclude this matter without further
expenditure of time, finances, or other
resources.
ORI found that Respondent engaged
in research misconduct by intentionally,
SUMMARY:

VerDate Sep<11>2014

19:08 May 22, 2020

Jkt 250001

knowingly, and/or recklessly falsifying
data that were included in:
• The transcription factor FOXF1
promotes prostate cancer by stimulating
the mitogen-activated protein kinase
ERK5. Science Signaling 2016
May;9:427 (hereafter referred to as
‘‘Science Signaling 2016’’).
• Foxf1 Deficient Cancer-Associated
Fibroblasts Promote Prostate Cancer
Progression via Paracrine Wnt11
Signaling. Unpublished manuscript
(hereafter referred to as the
‘‘unpublished manuscript’’).
ORI found that Respondent
intentionally, knowingly, and/or
recklessly falsified
immunohistochemistry and western blot
data included in Science Signaling 2016
and in an unpublished manuscript, by
reusing and relabeling images to
represent the expression of different
proteins and/or different experimental
conditions. Specifically:
• In Figure 2C of Science Signaling
2016, Respondent reused one
immunohistochemistry image, to
represent Cle casp-3 expression in
Myc-CaP tumors under both Control
and FoxF1–OE conditions and used
another immunohistochemistry
image to represent Cle casp-3
expression in TRAMP tumors under
both Control and FoxF1–OE
conditions
• in Figure S4E of Science Signaling
2016, Respondent reused and
relabeled western blot panels to
represent the expression of multiple
different proteins under different
experimental conditions.
Specifically:
—Respondent used different
exposures of the source blot to
represent FOXF1 or WNK1
expression in 22RV1 tumors
transfected with scramble RNA or
shFOXF1, or pERK5 expression in
C4–2B tumors transfected with
scramble RNA or shFOXF1
—Respondent used different
exposures and size scaling of the
source blot to represent MAP3K2 or
pERK5 expression in 22RV1 tumors
transfected with scramble RNA or
shFOXF1 or FOXF1 or WNK1
expression in C4–2B tumors
transfected with scramble RNA or
shFOXF1, or FOXF1 or WNK1
expression in C4–2B tumors
transfected with scramble or
shFOXF1
—Respondent used background
lightening/darkening and size
scaling of the source blot to
represent b-ACTIN expression in
22RV1 tumors transfected with
scramble or shFOXF1, or Total

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31521

ERK5 expression in C4–2B tumors
transfected with scramble RNA or
shFOXF1
—Respondent used size scaling and
rotation of the source blot to
represent Total ERK5 in 22RV1
tumors transfected with scramble
RNA or shFOXF1, or b-ACTIN
expression in C4–2B tumors
transfected with scramble RNA or
shFOXF1
• in Figure 7C of Science Signaling
2016, Respondent reused and
relabeled one source western blot
panel to represent the expression of
different proteins in the presence of
FOXF1 overexpression.
Specifically:
—different exposures, size scaling,
and rotation of the same blot were
used to represent b-Actin, pERK5,
Total ERK, and MAP3K2 expression
in FOXF1-overexpressing Myc-CaP
tumors transduced with scramble
RNA, shMAP3K2 RNA, shWNK1, or
both
• in Figure S3B of Science Signaling
2016, Respondent spliced, size
scaled, and rotated the source
western blot representing
expression of Erk5 in TRAMP
tumors and represented it as both
pERK5 and Total ERK5 expression
in TRAMP tumors under both
control and FOXF1–OE conditions
• in Figure 3B of the unpublished
manuscript, Respondent fabricated
the data to falsely represent the
upregulation of Wnt11 mRNA in
human fibroblasts from prostate
cancer samples, compared to those
from normal patient samples
• in Figures 3F and S8 of the
unpublished manuscript,
Respondent reused and relabeled
source western blot panels
representing Wnt11 expression in
HeLa (cervical cancer) to represent
Wnt11 expression in MDA–MB–231
fibroblasts (prostate cancer)
As a result of the investigation, Science
Signaling 2016 was retracted in: Science
Signaling 2018 Jul;11:541.
Mr. Fulford entered into an
Agreement and agreed to the following:
(1) Respondent agreed to have his
research supervised for a period of two
(2) years beginning on May 8, 2020.
Respondent agreed that prior to the
submission of an application for U.S.
Public Health Service (PHS) support for
a project on which 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

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