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View ICR - Agency Submission
COMMENT
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OMB Control No:
0937-0198
ICR Reference No:
202509-0937-001
Status:
Received in OIRA
Previous ICR Reference No:
202303-0937-002
Agency/Subagency:
HHS/OASH
Agency Tracking No:
21329
Title:
Public Health Service Policies on Research Misconduct (42 CFR Part 93)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
12/08/2025
Requested
Previously Approved
Expiration Date
36 Months From Approved
08/31/2026
Responses
7,433
5,926
Time Burden (Hours)
222,256
974
Cost Burden (Dollars)
0
0
Abstract:
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.
Authorizing Statute(s):
PL:
Pub.L. 99 - 158 493
Name of Law: Health Research Extension Act of 1985
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0937-AA12
Final or interim final rulemaking
89 FR 76280
09/16/2024
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 46901
09/30/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 56775
12/08/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Public Health Service Policies on Research Misconduct (42 CFR Part 93)
PHS-6315
Assurance of Compliance by Sub-Award Recipients
Public Health Service Policies on Research Misconduct (42 CFR Part 93)
PHS-7091, PHS-6349, PHS-7092
RESEARCH INTEGRITY ASSURANCE AND ANNUAL REPORT ON POSSIBLE RESEARCH MISCONDUCT
,
INSTITUTIONAL RECORD TRANSMITTAL FORM
,
RESEARCH INTEGRITY ASSURANCE ESTABLISHMENT FORM
ICR Summary of Burden
Total Request
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
7,433
5,926
0
1,507
0
0
Annual Time Burden (Hours)
222,256
974
0
221,282
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$56,192
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Jason Weixelbaum 443 980-0288 jason.weixelbaum@hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/08/2025
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