Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Standardized Work Plan (SWP) Form for Use With Applications to the Bureau of Health Workforce (BHW) Research and Training Grants and Cooperative Agreements, OMB No. 0906-xxxx-New, 61915-61916 [2019-24715]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 220 / Thursday, November 14, 2019 / Notices
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Persons unable to download
an electronic copy of ‘‘Process to
Request a Review of FDA’s Decision Not
to Issue Certain Export Certificates for
Devices’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number 17044
to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
OMB control
No.
Topic
FD&C Act sections 801(e) and 802 (21 U.S.C. 382) .................
21 CFR part 820 .........................................................................
Export certificates for FDA regulated products ..........................
Current Good Manufacturing Practice (CGMP); Quality System
(QS) Regulation.
Electronic Submission of Medical Device Registration and Listing.
Appeals process .........................................................................
21 CFR part 807, subparts A through E ....................................
‘‘Center for Devices and Radiological Health Appeals Processes‘‘.
[FR Doc. 2019–24717 Filed 11–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Standardized Work Plan
(SWP) Form for Use With Applications
to the Bureau of Health Workforce
(BHW) Research and Training Grants
and Cooperative Agreements, OMB No.
0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR have been provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this Notice has
closed.
DATES: Comments on this ICR should be
received no later than December 16,
2019.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
FD&C Act section; 21 CFR part; or guidance
Dated: November 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
VerDate Sep<11>2014
17:47 Nov 13, 2019
Jkt 250001
61915
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
SWP Form for Use with Applications to
BHW Research and Training Grants and
Cooperative Agreements, OMB No.
0906–xxxx–NEW
Abstract: BHW requires applicants for
training and research grants and
cooperative agreements to submit a
work plan that describes the timeframes
and deliverables required during the
grant period of performance to address
each of the needs detailed in the
Purpose and Need section of the
application, as required in the Notice of
Funding Opportunity announcement.
Applicants are currently able to submit
work plans in a non-standardized
format.
In order to standardize the data
provided by applicants to make
informed decisions about funding and
assist with monitoring awardee
progress, BHW plans to require
applicants to complete a SWP form in
lieu of submitting a work plan in the
applicant’s own format. Applicants will
use the SWP form when they submit
their proposals, and grantees and Project
Officers will use the SWP information to
assist in monitoring progress once
HRSA makes the awards.
ADDRESSES:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
0910–0498
0910–0073
0910–0625
0910–0738
A 60-day notice was published in the
Federal Register on June 19, 2019, Vol.
84, No. 118, pp.28560–28561. There was
one public comment and it was
thoroughly addressed.
Need and Proposed Use of the
Information: The information collected
by the SWP form is necessary to
standardize and streamline the data
used by HRSA in reviewing applications
and monitoring awardees. The form will
ask applicants to provide a description
of the activities or steps the recipient
will take to achieve each of the
objectives proposed during the entire
period of performance. The current
variation in formats and data submitted
by applicants reduces efficiency in
reviewing, awarding, and monitoring
each project, so this change will remedy
that inefficiency. In addition, seeking
OMB approval comports with the
regulatory requirement imposed by 45
CFR 75.206(a), Paperwork clearances.
The proposed SWP form will be used
to provide information to assess
applications for awards including
ranking applications as part of the grant
review process. BHW will also use the
information to assess whether current
recipients of grant funding have met
statutory and programmatic
requirements.
Likely Respondents: Respondents will
be applicants to HRSA’s research and
training programs in BHW.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
E:\FR\FM\14NON1.SGM
14NON1
61916
Federal Register / Vol. 84, No. 220 / Thursday, November 14, 2019 / Notices
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Standardized Work Plan ......................................................
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–24715 Filed 11–13–19; 8:45 am]
BILLING CODE 4165–15–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
Deepti Malhotra, Ph.D. (Respondent),
former Doctoral Student and
Postdoctoral Fellow, Department of
Environmental Health Sciences, Johns
Hopkins Bloomberg School of Public
Health (JHSPH). Dr. Malhotra engaged
in research misconduct in research
supported by U.S. Public Health Service
(PHS) funds, specifically National Heart,
Lung, and Blood Institute (NHLBI),
National Institutes of Health (NIH),
grants R01 HL081205, P50 HL084945,
P50 HL084948–01, U01 HL105569–03,
P50 HL107169–01, R01 HL066554–09,
and R03 HL096931–02; National
Institute of Environmental Health
Sciences (NIEHS), NIH, grants P50
ES015903, P01 ES018176–01, and P30
ES003891–25; National Cancer Institute
(NCI), NIH, grant P50 CA058184–18;
and National Institute for Research
Resources (NCRR), NIH, grant UL1
RR025005–02. The administrative
actions, including debarment for a
period of four (4) years, were
implemented beginning on October 1,
2019, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, Interim 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:
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:47 Nov 13, 2019
Jkt 250001
1,000
1,000
Number of
responses per
respondent
1
........................
Deepti Malhotra, Ph.D., Johns
Hopkins Bloomberg School of Public
Health: Based on the report of an
investigation conducted by JHSPH and
analysis conducted by ORI in its
oversight review, ORI found that Dr.
Deepti Malhotra, former Doctoral
Student and Postdoctoral Fellow,
Department of Environmental Health
Sciences, JHSPH, engaged in research
misconduct in research supported by
PHS funds, specifically NHLBI, NIH,
grants R01 HL081205, P50 HL084945,
P50 HL084948–01, U01 HL105569–03,
P50 HL107169–01, R01 HL066554–09,
and R03 HL096931–02; NIEHS, NIH,
grants P50 ES015903, P01 ES018176–01,
and P30 ES003891–25; NCI, NIH, grant
P50 CA058184–18; and NCRR, NIH,
grant UL1 RR025005–02.NCI, NIH, grant
R01 CA122737–01A2.
ORI found that Respondent engaged
in research misconduct by knowingly,
intentionally, and/or recklessly
falsifying and/or fabricating data
included in the following four (4)
published papers and her Ph.D. Thesis:
• Am J Respir Crit Care Med.
2008;178(6):592–604 (hereafter referred
to as ‘‘AJRCCM 2008’’). Retracted in: Am
J Respir Crit Care Med. 2016 Feb
1;193(3):344.
• Am J Respir Crit Care Med.
2009;180(12):1196–1207 (hereafter
referred to as ‘‘AJRCCM 2009’’).
Retracted in: Am J Respir Crit Care Med.
2016 Feb 1;193(3):344.
• J Clin Invest. 2011;121(11):4289–
4302 (hereafter referred to as ‘‘JCI
2011’’). Retracted in:
J Clin Invest. 2014 Dec;124(12):5521.
• PLoS Comput Biol.
2012;8(7):e1002597 (hereafter referred to
as ‘‘PLoS Comput Biol. 2012’’).
• Malhotra D. ‘‘Transcription Factor
Nuclear Factor (Erythroid-Derived 2)
Receptor 2 (Nrf2), A Master Regulator of
Environmental Stress Response, Is A
Modifier Of Chronic Obstructive
Pulmonary Disease (COPD).’’ A
dissertation submitted to the Johns
Hopkins University in conformity with
the requirements for the degree of
Doctor of Philosophy, August 2010
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hours)
Total
responses
1,000
1,000
1
........................
Total burden
hours
1,000
1,000
(hereafter referred to as the ‘‘Ph.D.
Thesis’’).
Respondent knowingly, intentionally,
and/or recklessly falsified and/or
fabricated Western blot data for protein
expression in cultured cell lines and/or
alveolar macrophages of patients with
chronic obstructive pulmonary disease
(COPD) by trimming and manipulating
Western blot images to disguise their
origin or by reversing negative DNA gel
images of the PCR product, reusing and
relabeling them to represent Western
blot data for unrelated experiments in
seventeen (17) figures included in four
(4) published papers and twelve (12)
figures included in her Ph.D. Thesis. In
the absence of original reliable image
data, the quantitative data in associated
plots, statistical analyses, and related
text also are falsified and/or fabricated.
Specifically, Respondent falsified and/
or fabricated the following figures
included in:
• AJRCCM 2008
D by reusing sets of repeating blot
band images from unknown and/or
differently labeled film images to falsely
create Western Blot panels of:
➣ GAPDH in Figure 1C, also included
as Figure 2–4B in the Ph.D. Thesis
➣ GAPDH, DJ–1 and KEAP1 in Figure
2B, also included as Figure 2–4C in
the Ph.D. Thesis
➣ GAPDH in Figure 5D, also included
as Figure 2–7A in the Ph.D. Thesis
➣ DJ–1, NRF2, NQO1, and GAPDH in
Figure 6B, also included as Figure 2–
8B in the Ph.D. Thesis
• AJRCCM 2009
D by trimming Western blot panel
representing samples from:
➣ Human subjects in Figure 4C and in
the Ph.D. Thesis, Figure 3–7C, right
column, Figure 3–7G, right column,
and Figure 3–8A, right column,
GAPDH lanes 1–4, and reusing them
to represent samples from mice in
Figure 3A and in the Ph.D. Thesis,
Figure 3–6A
➣ normal human subjects in Figures 4C
and 5A, left column, and in the Ph.D.
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 84, Number 220 (Thursday, November 14, 2019)]
[Notices]
[Pages 61915-61916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24715]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Standardized Work Plan
(SWP) Form for Use With Applications to the Bureau of Health Workforce
(BHW) Research and Training Grants and Cooperative Agreements, OMB No.
0906-xxxx-New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR have been provided to OMB.
OMB will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this Notice has closed.
DATES: Comments on this ICR should be received no later than December
16, 2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: SWP Form for Use with
Applications to BHW Research and Training Grants and Cooperative
Agreements, OMB No. 0906-xxxx-NEW
Abstract: BHW requires applicants for training and research grants
and cooperative agreements to submit a work plan that describes the
timeframes and deliverables required during the grant period of
performance to address each of the needs detailed in the Purpose and
Need section of the application, as required in the Notice of Funding
Opportunity announcement. Applicants are currently able to submit work
plans in a non-standardized format.
In order to standardize the data provided by applicants to make
informed decisions about funding and assist with monitoring awardee
progress, BHW plans to require applicants to complete a SWP form in
lieu of submitting a work plan in the applicant's own format.
Applicants will use the SWP form when they submit their proposals, and
grantees and Project Officers will use the SWP information to assist in
monitoring progress once HRSA makes the awards.
A 60-day notice was published in the Federal Register on June 19,
2019, Vol. 84, No. 118, pp.28560-28561. There was one public comment
and it was thoroughly addressed.
Need and Proposed Use of the Information: The information collected
by the SWP form is necessary to standardize and streamline the data
used by HRSA in reviewing applications and monitoring awardees. The
form will ask applicants to provide a description of the activities or
steps the recipient will take to achieve each of the objectives
proposed during the entire period of performance. The current variation
in formats and data submitted by applicants reduces efficiency in
reviewing, awarding, and monitoring each project, so this change will
remedy that inefficiency. In addition, seeking OMB approval comports
with the regulatory requirement imposed by 45 CFR 75.206(a), Paperwork
clearances.
The proposed SWP form will be used to provide information to assess
applications for awards including ranking applications as part of the
grant review process. BHW will also use the information to assess
whether current recipients of grant funding have met statutory and
programmatic requirements.
Likely Respondents: Respondents will be applicants to HRSA's
research and training programs in BHW.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose
[[Page 61916]]
of collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information; to search data sources; to complete and review the
collection of information; and to transmit or otherwise disclose the
information. The total annual burden hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Standardized Work Plan.......... 1,000 1 1,000 1 1,000
1,000 .............. 1,000 .............. 1,000
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-24715 Filed 11-13-19; 8:45 am]
BILLING CODE 4165-15-P
