60-day FRN

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Federal Register / Vol. 82, No. 240 / Friday, December 15, 2017 / Notices
Topic

801 and 809 .........................................................................................................
‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.
807, subparts A through D ...................................................................................
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission
Program and Meetings with Food and Drug Administration Staff’’.
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’.

Labeling ............................................................
CLIA waiver ......................................................

0910–0485
0910–0598

Registration and listing .....................................
Q-submissions ..................................................

0910–0625
0910–0756

De Novo classification process ........................

0910–0844

Dated: December 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26987 Filed 12–14–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Rural Health
Opioid Program Grant Performance
Measures, OMB No. 0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 13,
2018.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
SUMMARY:

Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Health Opioid Program Grant
Performance Measures.
OMB No. 0906–xxxx–New.
Abstract: The Rural Health Opioid
Program aims to promote rural health
care services outreach by expanding the
delivery of opioid related health care
services to rural communities. The
program will work to reduce the
morbidity and mortality related to
opioid overdoses in rural communities
through the development of broad
community consortiums to prepare
individuals with opioid-use disorder to
start treatment, implement care
coordination practices to organize
patient care activities, and support
individuals in recovery through the
enhancement of behavioral counselling
and peer support activities.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
Number of
respondents

Form name

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OMB control
No.

21 CFR part; guidance; or FDA form

Number of
responses per
respondent

enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act (GPRA) of 1993. These
measures cover the principal topic areas
of interest to the Federal Office of Rural
Health Policy (FORHP), including: (a)
Target population demographics; (b)
referrals to substance abuse treatment;
(c) substance abuse treatment process
and outcomes; (d) education of health
care providers and community
members; and (e) rates of fatal and nonfatal opioid-related overdose. All
measures will speak to FORHP’s
progress toward meeting the goals set.
Likely Respondents: The respondents
would be recipients of the Rural Health
Opioid Program grant funding.
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
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:
Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Rural Health Opioid Program Grant Performance Measures ...................................................................................

10

1

10

11

110

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

10

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

10

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

110

HRSA specifically requests comments
on: (1) The necessity and utility of the
proposed information collection for the

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proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance

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the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques

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Federal Register / Vol. 82, No. 240 / Friday, December 15, 2017 / Notices

or other forms of information
technology to minimize the information
collection burden.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.

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

AGENCY:

[FR Doc. 2017–27013 Filed 12–14–17; 8:45 am]

ACTION:

BILLING CODE 4165–15–P

Findings of research
misconduct have been made on the part
of Matthew Endo, former graduate
student, Department of Chemistry,
University of Illinois at UrbanaChampaign. The questioned research
was supported by National Institute of
General Medical Sciences (NIGMS),
National Institutes of Health (NIH),
grant R01 GM080436. The
administrative actions, including three
(3) years of supervision, which are
implemented beginning on November
16, 2017, are detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Interim
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
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:
Matthew Endo, University of Illinois
at Urbana-Champaign: Based on the
Respondent’s admission, an assessment
conducted by University of Illinois at
Urbana-Champaign (UIUC), and analysis
conducted by ORI in its oversight
review, ORI found that Mr. Matthew
Endo, a former graduate student,
Department of Chemistry, UIUC,
engaged in research misconduct in
research supported by National Institute
of General Medical Sciences (NIGMS),
National Institutes of Health (NIH),
grant R01 GM080436.
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly causing false
data to be recorded, falsifying and/or
fabricating data and related images by
alteration and/or reuse and/or relabeling
of experimental data, and reporting
falsified and/or fabricated data in one
(1) manuscript subsequently submitted
for publication:
• ‘‘Amphotericin primarily kills human
cells by binding and extracting
cholesterol.’’ Submitted for
publication to the Proceedings of the
National Academy of Sciences
[withdrawn prior to peer review]
(hereafter referred to as ‘‘Manuscript
1’’)
SUMMARY:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination Concerning a Petition
To Add a Class of Employees to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).

AGENCY:

ACTION:

Notice.

HHS gives notice of a
determination concerning a petition to
add a class of employees from the
Carborundum Company, in Niagara
Falls, New York, to the Special
Exposure Cohort (SEC) under the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA).

SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 1090
Tusculum Avenue, MS C–46,
Cincinnati, OH 45226–1938, Telephone
1–877–222–7570. Information requests
can also be submitted by email to
[email protected].
SUPPLEMENTARY INFORMATION:

Authority: [42 U.S.C.7384q].

sradovich on DSK3GMQ082PROD with NOTICES

On November 16, 2017, the Acting
Secretary of HHS determined that the
following class of employees does not
meet the statutory criteria for addition
to the SEC as authorized under
EEOICPA:
All employees who worked in any area of
the Carborundum Company facility on
Buffalo Avenue, Niagara Falls, New York,
from January 1, 1943, through December 31,
1976.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2017–27039 Filed 12–14–17; 8:45 am]
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Specifically, ORI found that:
• In Manuscript 1, Respondent caused
falsified and/or fabricated results to

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be recorded by knowingly requesting
biological testing of a mixture of
compounds that he falsely claimed to
be a single compound
• In Manuscript 1, Respondent falsified
and/or fabricated the results on page
S26 of the Supporting Information by
modifying the HPLC trace through
peak erasure to make the preparation
of C35deOAmB appear more pure
than in the actual results of
experimentation
• In Manuscript 1, Respondent falsified
and/or fabricated the results of
Surface Plasmon Resonance data on
page S7 of the Supporting Information
to make the error bars smaller than
the actual results of experimentation
• In Manuscript 1, Respondent falsified
and/or fabricated the results of a
WST08 Cell Proliferation Assay on
page S32 of the Supporting
Information by falsely claiming to run
the reaction in triplicate when it was
only performed in duplicate
• In correspondence with his advisor,
Respondent falsified and/or fabricated
the results of the preparation of
putative C2deoAmB where
Respondent modified and relabeled a
HPLC trace and relabeled an NMR
spectrum to falsely claim
characterization, purity, and
identification of sample that was sent
for biological assay
Mr. Endo entered into a Voluntary
Settlement Agreement and voluntarily
agreed for a period of three (3) years,
beginning on November 16, 2017:
(1) To have his research supervised;
Respondent agreed to ensure that prior
to the submission of an application for
PHS support for a research project on
which Respondent’s participation is
proposed and prior to Respondent’s
participation in any capacity on PHSsupported research, the institution
employing him must submit a plan for
supervision of Respondent’s duties to
ORI for approval; the plan for
supervision must be designed to ensure
the scientific integrity of Respondent’s
research contribution; Respondent
agreed that he will not participate in
any PHS-supported research until a plan
for supervision is submitted and
approved by ORI;
(2) that any institution employing him
must submit in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHS
supported 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

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