Health Center Program, 29870-29871 [2016-11413]
Download as PDF
<![CDATA[
29870
Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
which next generation sequencing
(NGS) technology can now be used to
detect the presence of clinically
important pathogenic organisms in
human specimens.
In contrast to human sequencing
diagnostics, infectious disease
sequencing diagnostics carry an
absolute need for immediate and
actionable results, sometimes within
hours, as incorrect initial diagnoses
potentially leads to fatalities.
Furthermore, the broad range of
specimen types (e.g., urine, blood,
cerebrospinal fluid (CSF), stool, sputum,
etc.) and the large diversity of the
infectious disease agents that can be
present in the sample do not allow
straightforward pre-analytical-,
biochemical-, or bioinformatics
processes. Each unique specimen type
may require a different nucleic acid
extraction procedure, a different library
preparation protocol, and even a
different bioinformatics algorithm to
generate the final clinical result. The
opportunity for repeat testing is
expected to be limited due to a
frequently small specimen quantity
(e.g., CSF) and the necessity to make a
prompt and timely infectious disease
treatment decision for the patient.
This draft guidance, when finalized,
provides detailed information on the
types of studies the FDA recommends to
support a premarket application for
these devices. This draft guidance
specifically addresses Infectious Disease
NGS devices that employ targeted or
agnostic (metagenomic) sequencing, to
identify the presence or absence of
infectious disease organisms, and/or to
detect the presence or absence of
antimicrobial resistance and virulence
markers. This draft guidance is not
intended to address devices that utilize
detection mechanisms other than
nucleic acid based approaches. Further,
this draft guidance does not apply to
devices that are intended to screen
donors of blood and blood components
as well as donors of human cells,
tissues, and cellular and tissue-based
products for communicable diseases.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Infectious Disease Next Generation
Sequencing Based Diagnostic Devices:
Microbial Identification and Detection
of Antimicrobial Resistance and
Virulence Markers.’’ It neither creates
nor confers any rights for or on any
person and is not binding on FDA or the
public. An alternative approach may be
VerDate Sep<11>2014
18:05 May 12, 2016
Jkt 238001
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Infectious Disease Next Generation
Sequencing Based Diagnostic Devices:
Microbial Identification and Detection
of Antimicrobial Resistance and
Virulence Markers; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1500016 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
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. 3501–3520). The collections
of information in 21 CFR parts 801 and
809 have been approved under OMB
control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; and
the collections of information in 21 CFR
part 814 have been approved under
OMB control number 0910–0231.
Dated: May 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–11237 Filed 5–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
Health Resources and Services
Administration, HHS.
AGENCY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Notice of Class Deviations from
the Requirements for Competition and
Application Period for the Health Center
Program.
ACTION:
In accordance with the Grants
Policy and Administration Manual
(GPAM) Part F: Chapter 2.b.34 and Part
F: Chapter 3.b.16, the Bureau of Primary
Health Care (BPHC) has been granted
class deviations from the requirements
for competition contained in the GPAM
Part F: Chapter 2.a.1 and the
requirements for application period
contained in the GPAM Part F: Chapter
3.b.3 to expeditiously award funds to
new health centers to improve access to
services and clinical outcomes for the
nation’s most vulnerable populations
through the patient centered medical
home model.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Health Center Program award recipients
receiving Health Center Program
funding for the first time in fiscal years
(FYs) 2012, 2013, 2014, and 2015.
Amount of Competitive Awards:
Approximately $10 million will be
awarded in FY 2016 through a one-time
supplement.
Period of Supplemental Funding:
Anticipated 12 month project period is
August 1, 2016, through July 31, 2017.
SUMMARY:
CFDA Number: 93.224
Authority: Section 330 of the Public
Health Service Act, as amended (42 U.S.C.
254b, as amended).
Justification: Targeting the nation’s
neediest populations and geographic
areas, the Health Center Program
supports more than 1,300 health centers
that operate over 9,000 service delivery
sites in every state, the District of
Columbia, Puerto Rico, the Virgin
Islands, and the Pacific Basin. Nearly 23
million patients received
comprehensive, culturally competent,
quality primary health care services
through the Health Center Program
award recipients in 2014.
The FY 2016 Health Center Program
Patient Centered Medical Home
Supplement is a one-time supplemental
funding opportunity that supports the
upfront costs new Health Center
Program award recipients face to
become patient centered medical
homes. Organizational transformation to
achieve initial and more advanced
levels of patient centered medical home
recognition is costly. As of September
2015, data show that among the health
centers eligible for this award only
approximately 20 percent have achieved
patient centered medical home
recognition compared to 65 percent
across all health centers. The
E:\FR\FM\13MYN1.SGM
13MYN1
Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
discrepancy suggests the efficacy of
BPHC’s past investments in FY 2011
and FY 2012 that supported health
centers funded before FY 2012 achieve
patient centered medical home
recognition. The FY 2016 Health Center
Program Patient Centered Medical
Home Supplement is the first funding
not tied to capital improvements that
BPHC has offered to support health
centers’ evolution to patient centered
medical homes since FY 2012.
FOR FURTHER INFORMATION CONTACT:
Olivia Shockey, Expansion Division
Director, Office of Policy and Program
Development, Bureau of Primary Health
Care, Health Resources and Services
Administration at 301–443–9282 or
oshockey@hrsa.gov.
Dated: May 5, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016–11413 Filed 5–12–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
ACTION:
Office of the Secretary, HHS.
Notice.
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
John G. Pastorino, Ph.D., Rowan
University School of Osteopathic
Medicine: Based on an assessment
conducted by Rowan University School
of Osteopathic Medicine (RUSOM), the
Respondent’s desire to conclude the
matter, and analysis conducted by ORI
in its oversight review, ORI found that
Dr. John G. Pastorino, Associate
Professor, Department of Molecular
Biology, RUSOM, engaged in research
misconduct in research supported by
National Institute on Alcohol Abuse and
Alcoholism (NIAAA), National
Institutes of Health (NIH), grant R01
AA012897 and National Cancer Institute
(NCI), NIH, grant R01 CA118356.
ORI found that Respondent engaged
in research misconduct by intentionally
falsifying and/or fabricating data
reported in the following eight (8)
published papers, one (1) unpublished
manuscript, and one (1) NIH grant
application:
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
• J. Cell. Sci. 123:894–902, 2010
(hereafter referred to as ‘‘J. Cell. Sci.
2010a’’)
VerDate Sep<11>2014
18:05 May 12, 2016
Jkt 238001
• J. Cell. Sci. 123:4117–4127, 2010
(hereafter referred to as ‘‘J. Cell. Sci.
2010b’’)
• J. Cell. Sci. 125:2995–3003, 2012
(hereafter referred to as ‘‘J. Cell. Sci.
2012’’)
• J. Cell. Sci. 126:274–288, 2013
(hereafter referred to as ‘‘J. Cell. Sci.
2013’’)
• J. Cell. Sci. 127:896–907, 2014
(hereafter referred to as ‘‘J. Cell. Sci.
2014’’)
• Biol. Open. 1–11:10;bio.014712, 2015
(hereafter referred to as ‘‘Biol. Open.
2015’’)
• BioChim Biophys Acta. 1827:38–49,
2013 (hereafter referred to as
‘‘BioChim Biophys Acta. 2013’’)
• J. Biol. Chem. 289:26213–26225, 2014
(hereafter referred to as ‘‘J. Biol.
Chem. 2014’’)
• J. Cell. Science, Submitted
manuscript, 2015 (hereafter referred
to as ‘‘J. Cell. Sci. manuscript 2015’’)
• R01 HL132672–01, ‘‘Regulation by
Sirtuin-3 and Mitoneet of the
Permeability Transition Pore in Heart
during Ischemia/Reperfusion Injury,’’
John Pastorino, Ph.D., Principal
Investigator ORI found that Dr.
Pastorino falsified and/or fabricated
Western blot data for mitochondrial
function related to cell/tissue injury,
in fifty-eight (58) blot panels included
in forty-two (42) figures in eight (8)
publications, one (1) unpublished
manuscript, and one (1) grant
application. In the absence of valid
Western blot images, the Respondent
fabricated and/or falsified quantitative
data in associated bar graphs,
statistical analyses presented in figure
legends, and related text.
Specifically, ORI found that
Respondent duplicated images, or
trimmed and/or manipulated blot
images from unrelated sources to
obscure their origin, and relabeled them
to represent different experimental
results in:
• Figures 2A, 2C, 3B, 5A, 7B, and 8A in
J. Cell. Sci. 2010a
• Figures 2B, 5A, 6A, and 6B in J. Cell.
Sci. 2010b
• Figures 1A, 2A, 2B, 4C, 5A, 5B, 6A,
7A, 7B, and 7C in J. Cell. Sci. 2012
• Figures 4F, 5H, and 6A in J. Cell. Sci.
2013
• Figures 1B, 2B, 2C, 3A, 3B, and 4D in
J. Cell. Sci. 2014
• Figures 3A and 6B in Biol. Open 2015
• Figure 2A in BioChim Biophys Acta.
2013
• Figures 1B, 3A, 4D, 5E, and 6C in J.
Biol. Chem. 2014
• Figure 3A in J. Cell. Sci. manuscript
2015
• Figures 3, 8A, 12, and 13A in R01
HL132672–01 NIH grant application
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
29871
Dr. Pastorino has entered into a
Voluntary Exclusion Agreement
(Agreement) and has voluntarily agreed
for a period of five (5) years, beginning
on April 27, 2016:
(1) To exclude himself from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility or involvement in
nonprocurement programs of the United
States Government referred to as
‘‘covered transactions’’ pursuant to
HHS’ Implementation (2 CFR part 376 et
seq.) of OMB Guidelines to Agencies on
Governmentwide Debarment and
Suspension, 2 CFR part 180 (collectively
the ‘‘Debarment Regulations’’);
(2) that he will neither apply for nor
permit his name to be used on any
application, proposal, or other request
for funds to the United States
Government or any of its agencies, as
defined in the Debarment Regulations;
Respondent will further ensure that
during the period of the voluntary
exclusion, he will neither receive nor be
supported by funds of the United States
Government and its agencies made
available through grants, subgrants,
cooperative agreements, contracts, or
subcontracts, as discussed in the
Debarment Regulations; and
(3) to exclude himself from serving in
any advisory capacity to the U.S. Public
Health Service (PHS) including, but not
limited to, service on any PHS advisory
committee, board, and/or peer review
committee, or as a consultant.
FOR FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
Kathryn Partin,
Director, Office of Research Integrity.
[FR Doc. 2016–11317 Filed 5–12–16; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information for Developing
the National Cancer Moonshot
Initiative
This Request for Information
(RFI) describes ways in which the
cancer research community and public
can provide new ideas and comment on
proceedings of the National Cancer
Advisory Board (NCAB) Blue Ribbon
Panel under the umbrella of the
National Cancer Moonshot Initiative.
DATES: Responses should be submitted
to the National Cancer Institute (NCI),
National Institutes of Health (NIH) on or
before 5:00 p.m. EST on July 1, 2016.
SUMMARY:
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29870-29871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11413]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Health Center Program
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of Class Deviations from the Requirements for
Competition and Application Period for the Health Center Program.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Grants Policy and Administration Manual
(GPAM) Part F: Chapter 2.b.34 and Part F: Chapter 3.b.16, the Bureau of
Primary Health Care (BPHC) has been granted class deviations from the
requirements for competition contained in the GPAM Part F: Chapter
2.a.1 and the requirements for application period contained in the GPAM
Part F: Chapter 3.b.3 to expeditiously award funds to new health
centers to improve access to services and clinical outcomes for the
nation's most vulnerable populations through the patient centered
medical home model.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: Health Center Program award
recipients receiving Health Center Program funding for the first time
in fiscal years (FYs) 2012, 2013, 2014, and 2015.
Amount of Competitive Awards: Approximately $10 million will be
awarded in FY 2016 through a one-time supplement.
Period of Supplemental Funding: Anticipated 12 month project period
is August 1, 2016, through July 31, 2017.
CFDA Number: 93.224
Authority: Section 330 of the Public Health Service Act, as
amended (42 U.S.C. 254b, as amended).
Justification: Targeting the nation's neediest populations and
geographic areas, the Health Center Program supports more than 1,300
health centers that operate over 9,000 service delivery sites in every
state, the District of Columbia, Puerto Rico, the Virgin Islands, and
the Pacific Basin. Nearly 23 million patients received comprehensive,
culturally competent, quality primary health care services through the
Health Center Program award recipients in 2014.
The FY 2016 Health Center Program Patient Centered Medical Home
Supplement is a one-time supplemental funding opportunity that supports
the upfront costs new Health Center Program award recipients face to
become patient centered medical homes. Organizational transformation to
achieve initial and more advanced levels of patient centered medical
home recognition is costly. As of September 2015, data show that among
the health centers eligible for this award only approximately 20
percent have achieved patient centered medical home recognition
compared to 65 percent across all health centers. The
[[Page 29871]]
discrepancy suggests the efficacy of BPHC's past investments in FY 2011
and FY 2012 that supported health centers funded before FY 2012 achieve
patient centered medical home recognition. The FY 2016 Health Center
Program Patient Centered Medical Home Supplement is the first funding
not tied to capital improvements that BPHC has offered to support
health centers' evolution to patient centered medical homes since FY
2012.
FOR FURTHER INFORMATION CONTACT: Olivia Shockey, Expansion Division
Director, Office of Policy and Program Development, Bureau of Primary
Health Care, Health Resources and Services Administration at 301-443-
9282 or oshockey@hrsa.gov.
Dated: May 5, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016-11413 Filed 5-12-16; 8:45 am]
BILLING CODE 4165-15-P
