Statement of Organization, Functions and Delegations of Authority, 66545-66546 [2015-27592]
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Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
interested in assessing potential trial
participants’ interest, tolerance,
concerns, and willingness to participate
in clinical investigations that involve
nontraditional settings or utilize new
technologies. FDA is also interested in
identifying the factors that affect trial
participant awareness, acceptance,
enrollment, and retention for these
investigations.
a. Are there specific patient groups or
therapeutic areas that could particularly
benefit from these types of technologies
or methods?
b. What new opportunities for the
conduct of clinical investigations are
created through the use of continuous or
intermittent remote monitoring and data
collection?
c. What are some of the anticipated
risks to trial participants that may occur
as a result of the use of these
technologies or off-site methods in
clinical investigations?
d. What are some of the anticipated
benefits to trial participants that may
occur as a result of the use of these
technologies or off-site methods in
clinical investigations?
e. Are there perceived challenges to
participation in clinical investigations
utilizing these types of technologies or
methods because of concerns regarding
inadvertent disclosure of trial
participants’ information or breach of
privacy? Are there concerns relating to
the integrity of data collection or
encryption or the secure transmission of
information?
f. Are there unique considerations for
ensuring integrity of the source data, for
example, authenticity and reliability?
g. How should validation of
participant-operated mobile devices be
addressed?
h. What are the challenges presented
when data are collected using the Bring
Your Own Device (BYOD) model?
BYOD in clinical investigations refers to
the practice of trial participants using
their own devices, such as smartphones
or tablets, for data collection. For
example, participants in a clinical
investigation may use their own
computer devices to access and respond
to study-related questionnaires. What
are the perceived barriers to pooling
data collected from different devices
provided by individual trial
participants, as well as pooling data
from the BYOD model with data
collected at the investigational site or on
paper forms? How should situations
such as mid-study user device switches
be handled?
i. What are the challenges or special
considerations with recruiting and/or
retaining potential trial participants
with low levels of computer literacy or
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individuals who may have limited or no
access to mobile technologies, computer
devices, or the Internet? How can these
challenges or special considerations best
be addressed?
Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27581 Filed 10–28–15; 8:45 am]
66545
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27557 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4164–01–P
Health Resources and Services
Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statement of Organization, Functions
and Delegations of Authority
Food and Drug Administration
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 80 FR 44358 dated
July 27, 2015).
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), Office
of Planning, Analysis, and Evaluation
(RA5). Specifically, this notice: (1)
Establishes the Office of Strategic
Initiatives (RA59) within the Office of
Planning, Analysis, and Evaluation.
[Docket No. FDA–2014–D–2138]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Adverse
Event Reporting for Outsourcing
Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Adverse
Event Reporting for Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug and Cosmetic Act’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
On August
4, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry on
Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0800. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
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Chapter RA5—Office of Planning,
Analysis, and Evaluation
Section RA5—00, Mission
The Office of Planning, Analysis, and
Evaluation (RA5) provide HRSA-wide
leadership on cross-agency initiatives
and Departmental priorities.
Section RA5–10, Organization
Delete the organization for the Office
of Planning, Analysis, and Evaluation in
its entirety and replace with the
following:
The Office of Planning, Analysis, and
Evaluation (RA5) is headed by the
Director, who reports directly to the
Administrator, Health Resources and
Services Administration. The Office of
Planning, Analysis, and Evaluation
includes the following components:
(1) Office of the Director (RA5);
(2) Office of Policy Analysis (RA53);
(3) Office of Research and Evaluation
(RA56);
(4) Office of External Engagement
(RA57);
(5) Office of Performance and Quality
Measurement (RA58); and
(6) Office of Strategic Initiatives
(RA59).
Section RA5–20, Functions
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), Office
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66546
Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
of Planning, Analysis, and Evaluation
(RA5). Specifically, this notice: (1)
Establishes the Office of Strategic
Initiatives (RA59).
Establish the functional statement for
the Office of Strategic Initiatives (RA59)
within the Office of Planning, Analysis,
and Evaluation (RA5).
Office of Strategic Initiatives (RA59)
(1) Provides HRSA-wide leadership
on cross-agency initiatives and
departmental priorities; (2) maintains
liaison between the Administrator, other
OPDIVs, Office of the Secretary staff
components, and other Departments on
priority initiatives; (3) provides
technical assistance to Agency programs
in order to help them respond to
emerging issues affecting the health care
safety net; (4) coordinates outreach to
grantees and stakeholders on high
profile public health initiatives; (5)
establishes an infrastructure and
strategic direction of priority initiatives
and institutionalizes these efforts into
HRSA programs; and (6) coordinates the
Agency’s long-term strategic planning
process.
Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
date of signature.
Dated: October 18, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015–27592 Filed 10–28–15; 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:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Dr. Maria C.P. Geraedts, University of
Maryland, Baltimore: Based on the
report of an investigation conducted by
the University of Maryland, Baltimore
(UMB) and analysis conducted by ORI
in its oversight review, ORI and UMB
found that Dr. Maria C.P. Geraedts,
former postdoctoral fellow, Department
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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of Anatomy and Neurobiology, UMB,
engaged in research misconduct in
research supported by National Institute
on Deafness and Other Communication
Disorders (NIDCD), National Institutes
of Health (NIH), grant R01 DC010110.
ORI found falsified and/or fabricated
data included in the following two (2)
publications:
• Am J Physiol Endocrinol Metab
303:E464–E474, 2012 (hereafter referred
to as ‘‘AJP 2012’’)
• Journal of Neuroscience
33(17):7559–7564, 2013 (hereafter
referred to as ‘‘JN 2013’’)
As a result of the UMB investigation,
JN 2013 and AJP 2012 have been
retracted.
ORI found that Respondent falsified
and/or fabricated bar graphs in AJP
2012, by changing ELISA-based
measurements to produce the desired
result for secretion of glucagon-like
peptide-1 (GLP–1) from intestinal
explants from various mouse strains in:
• Figure 2 for GLP–1 release from
duodenum (2A & D), jejunum (2B & E),
and ileum (2C & F).
• Figure 3 for GLP–1 release from
colon (3A & C) and rectum (3D).
• Figure 4 for GLP–1 release from
ileum (4A) and colon (4C) in the
presence or absence of an ATP-sensitive
K+ channel inhibitor.
ORI found that Respondent falsified
and/or fabricated bar graphs in Figure 1,
JN 2013 by changing ELISA-based
measurements to produce the desired
result for the secretion of peptides
found in taste buds (GLP–1, glucagon, or
neuropeptide Y) from mouse lingual
epithelium exposed to various
concentrations of stimuli (glucose,
sucralose, MSG, polycose). These bar
graphs also were included as Figure 7 in
grant application R01 DC010110–06.
Both the Respondent and the U.S.
Department of Health and Human
Services (HHS) want to conclude this
matter without further expenditure of
time or other resources and have
entered into a Voluntary Settlement
Agreement (Agreement) to resolve this
matter. Respondent stated that she is not
currently involved in U.S. Public Health
Service (PHS)-supported research and
has no intention of applying for or
engaging in PHS-supported research or
otherwise working with PHS. Dr.
Geraedts has entered into a Voluntary
Settlement Agreement with ORI and
UMB, in which she voluntarily agreed
to the administrative actions set forth
below. The administrative actions are
required for three (3) years beginning on
the date of Dr. Geraedts employment in
a position in which she receives or
applies for PHS support on or after the
effective date of the Agreement
PO 00000
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(September 22, 2015). If the Respondent
has not obtained employment in a
research position in which she receives
or applies for PHS support within one
(1) year of the effective date of the
Agreement, the administrative actions
set forth below will no longer apply. Dr.
Geraedts has voluntarily agreed:
(1) To have her research supervised as
described below and notify her
employer(s)/institution(s) of the terms of
this supervision; Respondent agreed
that prior to the submission of an
application for PHS support for a
research project on which her
participation is proposed and prior to
her participation in any capacity on
PHS-supported research, Respondent
shall ensure that a plan for supervision
of her duties is submitted to ORI for
approval; the supervision plan must be
designed to ensure the scientific
integrity of her research contribution;
Respondent agreed that she will 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 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; and
(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 period of three (3) years
beginning on September 22, 2015.
FOR FURTHER INFORMATION CONTACT:
Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453–
8200.
Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015–27587 Filed 10–28–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66545-66546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27592]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Statement of Organization, Functions and Delegations of Authority
This notice amends Part R of the Statement of Organization,
Functions and Delegations of Authority of the Department of Health and
Human Services (HHS), Health Resources and Services Administration
(HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 80
FR 44358 dated July 27, 2015).
This notice reflects organizational changes in the Health Resources
and Services Administration (HRSA), Office of Planning, Analysis, and
Evaluation (RA5). Specifically, this notice: (1) Establishes the Office
of Strategic Initiatives (RA59) within the Office of Planning,
Analysis, and Evaluation.
Chapter RA5--Office of Planning, Analysis, and Evaluation
Section RA5--00, Mission
The Office of Planning, Analysis, and Evaluation (RA5) provide
HRSA-wide leadership on cross-agency initiatives and Departmental
priorities.
Section RA5-10, Organization
Delete the organization for the Office of Planning, Analysis, and
Evaluation in its entirety and replace with the following:
The Office of Planning, Analysis, and Evaluation (RA5) is headed by
the Director, who reports directly to the Administrator, Health
Resources and Services Administration. The Office of Planning,
Analysis, and Evaluation includes the following components:
(1) Office of the Director (RA5);
(2) Office of Policy Analysis (RA53);
(3) Office of Research and Evaluation (RA56);
(4) Office of External Engagement (RA57);
(5) Office of Performance and Quality Measurement (RA58); and
(6) Office of Strategic Initiatives (RA59).
Section RA5-20, Functions
This notice reflects organizational changes in the Health Resources
and Services Administration (HRSA), Office
[[Page 66546]]
of Planning, Analysis, and Evaluation (RA5). Specifically, this notice:
(1) Establishes the Office of Strategic Initiatives (RA59).
Establish the functional statement for the Office of Strategic
Initiatives (RA59) within the Office of Planning, Analysis, and
Evaluation (RA5).
Office of Strategic Initiatives (RA59)
(1) Provides HRSA-wide leadership on cross-agency initiatives and
departmental priorities; (2) maintains liaison between the
Administrator, other OPDIVs, Office of the Secretary staff components,
and other Departments on priority initiatives; (3) provides technical
assistance to Agency programs in order to help them respond to emerging
issues affecting the health care safety net; (4) coordinates outreach
to grantees and stakeholders on high profile public health initiatives;
(5) establishes an infrastructure and strategic direction of priority
initiatives and institutionalizes these efforts into HRSA programs; and
(6) coordinates the Agency's long-term strategic planning process.
Delegations of Authority
All delegations of authority and re-delegations of authority made
to HRSA officials that were in effect immediately prior to this
reorganization, and that are consistent with this reorganization, shall
continue in effect pending further re-delegation.
This reorganization is effective upon date of signature.
Dated: October 18, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-27592 Filed 10-28-15; 8:45 am]
BILLING CODE 4165-15-P
