[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Pages 53750-53751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18884]


-----------------------------------------------------------------------

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).

-----------------------------------------------------------------------

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 [email protected]. 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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ Hereafter referred to as the ``2005 ORI regulation at 42 CFR 
part 93.''
---------------------------------------------------------------------------

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