Notice2022-18884
Request for Information and Comments on the 2005 Public Health Service Policies on Research Misconduct
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 1, 2022
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services (HHS), Office of Research Integrity (ORI) seeks the perspectives of individuals, research funding agencies, institutional officials, organizations, institutions, and other members of the general public on the 2005 Public Health Service Policies on Research Misconduct to help structure ORI's future plans to revise the regulation. To this end, ORI issues this RFI to collect input on the current regulation (see details in SUPPLEMENTARY INFORMATION section).
Full Text
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<title>Federal Register, Volume 87 Issue 169 (Thursday, September 1, 2022)</title>
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[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Pages 53750-53751]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18884]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Request for Information and Comments on the 2005 Public Health
Service Policies on Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Request for Information (RFI).
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SUMMARY: The Department of Health and Human Services (HHS), Office of
Research Integrity (ORI) seeks the perspectives of individuals,
research funding agencies, institutional officials, organizations,
institutions, and other members of the general public on the 2005
Public Health Service Policies on Research Misconduct to help structure
ORI's future plans to revise the regulation. To this end, ORI issues
this RFI to collect input on the current regulation (see details in
SUPPLEMENTARY INFORMATION section).
DATES: Responses to the RFI must be received electronically no later
than 5:00 p.m. ET on October 31, 2022. Mailed paper submissions and
submissions received after the deadline will not be reviewed.
ADDRESSES: Comments must be submitted electronically to <a href="/cdn-cgi/l/email-protection#89c6c8dac1a4c6dbc0a4d9fcebe5e0eaa4cae6e4e4ece7fdfac9e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="6c232d3f2441233e25413c190e00050f412f0301010902181f2c04041f420b031a">[email protected]</span></a>. Include ``Regulations RFI'' in the subject
line of the email.
FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr., P.H., MT (ASCP),
Acting Director, Office of Research Integrity, 1101 Wootton Parkway,
Suite 240, Rockville, MD 20852, (240) 453-8200.
SUPPLEMENTARY INFORMATION: ORI oversees and directs Public Health
Service (PHS) research integrity activities on behalf of the Secretary
of HHS, with the exception of the regulatory research integrity
activities of the Food and Drug Administration (FDA). ORI's mission is
to protect science and public health and to conserve public funds by
ensuring the integrity of all PHS-supported biomedical and behavioral
research.
The Public Health Service Policies on Research Misconduct, 42 CFR
parts 50 and 93, established several requirements regarding the
handling of allegations of possible research misconduct and
[[Page 53751]]
fostering of an environment that promotes research integrity and
discourages research misconduct. Institutions receiving funding for
research from any of the PHS funding components \1\ must adhere to
these requirements to receive PHS funding.
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\1\ PHS funding components are ``any organizational unit of the
PHS authorized to award grants, contracts, or cooperative agreements
for any activity that involves the conduct of biomedical or
behavioral research, research training or activities related to that
research or research training, e.g., agencies, bureaus, centers,
institutes, divisions, or offices and other awarding units within
the PHS.'' 42 CFR 93.209. This includes the: National Institutes of
Health (NIH), Centers for Disease Control and Prevention (CDC), FDA,
Substance Abuse and Mental Health Services Administration (SAMHSA),
Health Resources and Services Administration (HRSA), Indian Health
Service (IHS), Agency for Healthcare Research and Quality (AHRQ),
Agency for Toxic Substances and Disease Registry (ATSDR), Office of
the Assistant Secretary for Health (OASH), and Administration for
Strategic Preparedness and Response (ASPR).
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ORI conducts oversight of institutional research misconduct
proceedings (inquiries and investigations) as well as institutional
compliance with the PHS Policies on Research Misconduct at 42 CFR part
93. ORI also conducts outreach and develops educational resources that
aid institutional efforts ``to teach the responsible conduct of
research, promote research integrity, prevent research misconduct, and
. . . respond effectively to allegations of research misconduct. . .
.'' 65 FR 30600, 30601 (May 12, 2000).
The Public Health Service Policies on Research Misconduct (42 CFR
part 93) \2\ became effective in June 2005, replacing the
Responsibilities of Awardee and Applicant Institutions for Dealing with
and Reporting Possible Misconduct in Science (42 CFR part 50), which
was promulgated in August 1989. ORI contemplates beginning a regulatory
revision process for the 2005 ORI regulation at 42 CFR part 93 in the
near future, using conventional rulemaking processes and channels for
public notification and comment.
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\2\ Hereafter referred to as the ``2005 ORI regulation at 42 CFR
part 93.''
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Input on the 2005 Public Health Service Policies on Research Misconduct
ORI seeks the perspectives of individuals, research funding
agencies, institutional officials, organizations, institutions, and
other members of the general public to help structure ORI's future work
toward an updated regulation. To this end, ORI issues this RFI to
collect input on the current regulation at 42 CFR part 93.
ORI is not seeking specific regulatory language at this time, only
the identification of potential topic(s), issue(s), or area(s) that
stakeholders and other members of the general public see as being
important to consider when revising the 2005 ORI regulation at 42 CFR
part 93. Responders may find it helpful to consider the following
questions when preparing responses (the order of the questions below
should not be taken to imply importance, priority, or precedence):
(1) Which section(s) should be changed or augmented when revising
42 CFR part 93? Why? How should the section(s) be changed or augmented?
(2) Which section(s) should be retained as it currently is in 42
CFR part 93? Why?
(3) Which section(s) should be considered for removal when revising
42 CFR part 93? Why?
ORI views this RFI as a brainstorming process. Short responses,
limited to just a few words on a given topic, issue, or area will
facilitate the organization and categorization of responses. If an idea
specifically relates to a part of the current regulation, citing that
section (e.g., Sec. 314.3) would be helpful.
Collection of Information Requirements
Please note: This RFI is issued solely for information and planning
purposes. It does not constitute a solicitation for: Request for
Proposals (RFPs), applications, proposal abstracts, or quotations. This
RFI does not commit 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 responding parties. ORI notes that not responding to
this RFI does not preclude participation in future conventional
rulemaking concerning 42 CFR part 93. 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 received as our office
initiates the rule making process in the near future. 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 from this RFI may be used by the
U.S. Government on a non-attribution basis. Responders 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: August 29, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2022-18884 Filed 8-31-22; 8:45 am]
BILLING CODE 4150-31-P
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