Public Health Service
Policies on Research Misconduct (42 CFR Part 93)
Revision of a currently approved collection
No
Regular
12/08/2025
Requested
Previously Approved
36 Months From Approved
08/31/2026
7,433
5,926
222,256
974
0
0
The Office of Research Integrity (ORI)
is seeking a revision of its collection instruments to reflect
updates in the Public Health Service Policies on Research
Misconduct (42 CFR 93) published on September 17, 2024. The purpose
of the Institutional Assurance and Annual Report on Possible
Research Misconduct form PHS-6349 is to provide data on the amount
of research misconduct activity occurring in institutions
conducting PHS-supported research. Research misconduct is defined
as receipt of an allegation of research misconduct and/or the
conduct of an inquiry and/or investigation into such allegations.
These data enable the ORI to monitor institutional compliance with
the PHS regulation. Form PHS-6349 has undergone minor revisions,
but its function is unchanged. The purpose of the Assurance of
Compliance by Sub-Award Recipients form PHS-6315 establishes an
assurance of compliance for a sub-awardee institution. Form
PHS-6315 is being discontinued because the updated regulation
requires all awardees to have an assurance with ORI and does not
distinguish sub-awardees. In its place, ORI developed a new form,
the Research Integrity Assurance Establishment form PHS-7091. This
form allows all institutions conducting PHS-supported research to
establish an assurance with ORI. Additionally, ORI developed a
second new form, the Institutional Record Transmittal form
PHS-7092, which accounts for the varied types of information
collection that can occur during the course of institutional
research misconduct proceedings.
Although 42 CFR Part 93 revises
and clarifies institutional research misconduct proceedings in
which ORI has oversight, institutional activities (and associated
burden) as they relate to addressing allegations of research
misconduct have not fundamentally changed since the original
publication of 42 CFR Part 93 in 2005. In the past two decades and
moving forward, institutions conducting PHS-supported research may
continue to assess research misconduct allegations, conduct
inquiries and investigations, sequester and analyze evidence,
conduct interviews, convene committees, make determinations, and
report to ORI on a case-by-case basis; however, these burden hours
were not calculated in ORI’s previous PRA clearance requests.
$56,192
No
No
No
No
No
No
No
Jason Weixelbaum 443 980-0288
jason.weixelbaum@hhs.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form PHS-6349 Public Health Service Policies on Research Misconduct (42 CFR Part 93)
OMB No_0937-0198_Supporting Statement A.pdf
Public Health Service Policies on Research Misconduct (42 CFR Part 93)