Agency Information Collection Request. 30-Day Public Comment Request, 23835-23836 [2020-09108]
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Federal Register / Vol. 85, No. 83 / Wednesday, April 29, 2020 / Notices
and submissions received after the
deadline will not be reviewed.
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:
Background: 42 CFR part 93
establishes several requirements
regarding the reporting and
investigation of research misconduct to
which institutions must adhere to
receive Public Health Service (PHS)
funding. Per § 93.305(a), an institution
must:
jbell on DSKJLSW7X2PROD with NOTICES
Either before or when the institution
notifies the respondent of the allegation,
inquiry or investigation, promptly take all
reasonable and practical steps to obtain
custody of all the research records and
evidence needed to conduct the research
misconduct proceeding, inventory the
records and evidence, and sequester them in
a secure manner, except that where the
research records or evidence encompass
scientific instruments shared by a number of
users, custody may be limited to copies of the
data or evidence on such instruments, so
long as those copies are substantially
equivalent to the evidentiary value of the
instruments. . . . [Emphasis added].
Failing to properly sequester data can
have a significant detrimental impact on
the outcome of a research misconduct
proceeding. Common issues that can
negatively affect the examination of
evidence include:
• Notifying a respondent about a
misconduct proceeding before
sequestration
• failing to sequester all relevant
evidence, such as digital data stored
on personal computers and storage
devices
• failing to sequester forensic images of
hard drives
• failing to fully document the
sequestration process and maintain a
detailed chain of custody for each
item sequestered
To better support institutions in
carrying out their responsibility for
maintenance and custody of research
records and evidence, ORI intends to
publish guidelines that will inform
interested parties of best practices for
sequestering evidence during a research
misconduct proceeding.
Request for information and
comments: In preparation for producing
guidelines on sequestration, ORI is
interested in learning what major
challenges exist in the sequestration
process and approaches to overcome
them. ORI is particularly interested in
best practices in the sequestering of
digital evidence. Specific topics of
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interest include but are not limited to
the following:
• Digital data can be an important
source of evidence for research
misconduct proceedings. What unique
challenges exist when collecting digital
data and what approaches successfully
address them? ORI is especially
interested in learning the following:
➢ How do institutions identify
sources of digital data that need to be
sequestered?
➢ Digital data may be located on
devices not necessarily owned by the
institution, such as personal computers
and storage devices, cloud-based and
online services, and personal email.
What approaches are successful in
securing data in these situations? What
data policies address this issue?
• ORI has observed that sequestration
tends to be more successful when
institutions assemble a team of
individuals with different expertise to
assist in in the gathering and securing
of evidence. Thus, ORI is interested in
learning the following:
➢ What is the technical makeup of
successful teams, especially regarding
digital evidence?
➢ How are members selected and
trained?
• Institutions may have their own
specific policies, procedures,
guidelines, instructions, or other tools to
enable them to meet their broad
obligation under § 93.305(a) to properly
sequester evidence for research
misconduct proceedings. Thus, ORI is
interested in learning the following:
➢ What institutional policies,
procedures, and guidelines have been
effective in ensuring successful
sequestration?
➢ To assist institutions in
formulating their own policies, the ORI
website provides example Policies and
Procedures for Research Misconduct at
https://ori.hhs.gov/sample-policyprocedures-responding-researchmisconduct-allegations. Although
institutions are not required to adopt the
exact text as presented, ORI considers
institutions that do so to be compliant
with their obligation under
§ 93.302(a)(1) to establish policies and
procedures in compliance with 42 CFR
part 93. What additions or changes are
appropriate for these sample Policies
and Procedures to reflect the growing
digital landscape, especially regarding
sequestering digital evidence?
Collection of Information
Requirements: Please note: This RFI is
issued solely for information and
planning purposes; it does not
constitute a Request for Proposals
(RFPs), applications, proposal abstracts,
or quotations. This RFI does not commit
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23835
the U.S. Government to contract for any
supplies or services or to make a grant
award. Further, ORI is not seeking
proposals through this RFI and will not
accept unsolicited proposals.
Responders are advised that the U.S.
Government will not pay for any
information or administrative costs
incurred in responding to this RFI; all
costs associated with responding to this
RFI will be solely at the expense of the
interested parties. ORI notes that not
responding to this RFI does not
preclude participation in any future
procurement, if conducted. It is the
responsibility of the potential
responders to monitor this RFI
announcement for additional
information pertaining to this request.
ORI will actively consider all input as
our office develops future regulatory
proposals or future sub-regulatory
policy guidance. ORI may or may not
choose to contact individual responders.
Such communications would be for the
sole purpose of clarifying statements in
the responders’ written responses.
Responses to this notice are not offers
and cannot be accepted by the U.S.
Government to form a binding contract
or to issue a grant. Information obtained
as a result of this RFI may be used by
the U.S. Government for program
planning on a non-attribution basis.
Respondents should not include any
information that might be considered
proprietary or confidential. This RFI
should not be construed as a
commitment or authorization to incur
cost for which reimbursement would be
required or sought. All submissions
become U.S. Government property and
will not be returned.
Dated: April 22, 2022.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office
of the Assistant Secretary for Health.
[FR Doc. 2020–09086 Filed 4–28–20; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990-new]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
SUMMARY:
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23836
Federal Register / Vol. 85, No. 83 / Wednesday, April 29, 2020 / Notices
following summary of a proposed
collection for public comment.
Comments on the ICR must be
received on or before May 29, 2020.
DATES:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
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
0990-New-30D and project title for
reference.
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.
SUPPLEMENTARY INFORMATION:
Title of the Collection: Substance Use
Disorder Patient Placement Criteria
Used By States.
Type of Collection: New.
The Office of the Assistant Secretary
for Planning and Evaluation (ASPE) at
the U.S. Department of Health and
Human Services (HHS) is requesting
Office of Management and Budget
(OMB) approval for a one-time survey of
state agencies regarding their use of
substance use disorder (SUD) patient
placement criteria and assessment tools.
The proposed survey is one component
of a larger project to assess the
feasibility of gathering and utilizing
needs assessment data to identify and
address unmet patient needs by levels of
care. Results from this survey will
provide ASPE with information about
the types of patient placement data
states collect and maintain, and the
degree to which the data can be used to
understand the SUD treatment gap.
These results will provide ASPE with
information that can be used to develop
a multistate dataset of needs assessment
that can be updated over time. Such a
dataset is necessary for understanding
and addressing treatment needs in the
nation on an ongoing basis.
The 17-question survey requests
information related to state
requirements for using patient
placement criteria and assessment tools
for individuals with SUD. Additional
questions ask how data from the
placement criteria and/or assessment
tools are maintained; if level of care data
has been used to help determine service
gaps and need for greater capacity; and
whether the respondent could provide
weblinks to available information on the
criteria used in their state.
Two individuals from each state and
the District of Columbia will be invited
to respond to the survey. Respondents
will be representatives from each state’s
Single State Authority (SSA) and the
Medicaid Agency. An eighty-five
percent response rate is anticipated,
resulting in an estimated 87 total
participants.
This project falls under Section 301 of
the Public Health Service Act (42U.S.C.
241) [280–1a] which authorizes the
Office of the Secretary to conduct and
coordinate studies relating to the causes,
diagnosis, treatment, control, and
prevention of physical and mental
diseases.
The total annual burden hours
estimated for this information collection
request are summarized in the table
below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Forms
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(hours)
Total annual
burden
(hours)
Survey on SUD Placement Criteria .................................................................
87
1
10/60
14.5
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2020–09108 Filed 4–28–20; 8:45 am]
BILLING CODE 4151–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–New]
Agency Emergency Information
Collection Clearance Request for
Public Comment
Office of the Secretary, HHS.
Notice.
AGENCY:
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
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 information
collection request for public comment.
Interested persons are invited to send
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20:00 Apr 28, 2020
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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.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, email your request,
including your address, phone number,
OMB number, and OS document
identifier, to Sherrette.funn@hhs.gov, or
call the Reports Clearance Office on
(202) 795–7714. Written comments and
recommendations for the proposed
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information collections must be directed
to the OS Paperwork Clearance Officer
at the above email address within 7days.
Proposed Project: COVID–19 by PCR
Requisition Form.
OMB No. 0990–NEW.
Emergency Information Collection
Clearance Request
Office: HHS, Office of the Assistant
Secretary for Health, Office of the
Surgeon General.
Abstract: The COVID–19 by PCR
Requisition Form will be used to collect
information from individuals who are
participating in the federally supported,
state managed, locally executed CBTS
program to obtain COVID–19 laboratory
testing. The COVID–19 by PCR
Requisition Form will be used by
approximately 200,000 individuals. The
Lab Requisition form includes the
ordering physician information, the
laboratory account information, the date
of collection, the time of collection; the
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]]>Agencies
[Federal Register Volume 85, Number 83 (Wednesday, April 29, 2020)]
[Notices]
[Pages 23835-23836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09108]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-new]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
[[Page 23836]]
following summary of a proposed collection for public comment.
DATES: Comments on the ICR must be received on or before May 29, 2020.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-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.
Title of the Collection: Substance Use Disorder Patient Placement
Criteria Used By States.
Type of Collection: New.
The Office of the Assistant Secretary for Planning and Evaluation
(ASPE) at the U.S. Department of Health and Human Services (HHS) is
requesting Office of Management and Budget (OMB) approval for a one-
time survey of state agencies regarding their use of substance use
disorder (SUD) patient placement criteria and assessment tools. The
proposed survey is one component of a larger project to assess the
feasibility of gathering and utilizing needs assessment data to
identify and address unmet patient needs by levels of care. Results
from this survey will provide ASPE with information about the types of
patient placement data states collect and maintain, and the degree to
which the data can be used to understand the SUD treatment gap. These
results will provide ASPE with information that can be used to develop
a multistate dataset of needs assessment that can be updated over time.
Such a dataset is necessary for understanding and addressing treatment
needs in the nation on an ongoing basis.
The 17-question survey requests information related to state
requirements for using patient placement criteria and assessment tools
for individuals with SUD. Additional questions ask how data from the
placement criteria and/or assessment tools are maintained; if level of
care data has been used to help determine service gaps and need for
greater capacity; and whether the respondent could provide weblinks to
available information on the criteria used in their state.
Two individuals from each state and the District of Columbia will
be invited to respond to the survey. Respondents will be
representatives from each state's Single State Authority (SSA) and the
Medicaid Agency. An eighty-five percent response rate is anticipated,
resulting in an estimated 87 total participants.
This project falls under Section 301 of the Public Health Service
Act (42U.S.C. 241) [280-1a] which authorizes the Office of the
Secretary to conduct and coordinate studies relating to the causes,
diagnosis, treatment, control, and prevention of physical and mental
diseases.
The total annual burden hours estimated for this information
collection request are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms Number of responses per per response Total annual
respondents respondent (hours) burden (hours)
----------------------------------------------------------------------------------------------------------------
Survey on SUD Placement Criteria............ 87 1 10/60 14.5
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2020-09108 Filed 4-28-20; 8:45 am]
BILLING CODE 4151-05-P
