Public Health Service Policies on Research Misconduct (42 CFR Part 93)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form PHS-6315 Assurance of Compliance by Sub-Award Recipients	Form	Modified	Available
Form PHS-6349 Institutional Assurance and Annual Report on Possible Research Misconduct	Form	Modified	Available
Form PHS-6349 Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form	Modified	Repair queued
Form PHS-6315 Assurance of Compliance by Sub-Award Recipients	Form	Modified	Available
Form PHS-6315 Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form	Modified	Repair queued
30-day FRN 2023-10938.pdf	Supplementary Document	Uploaded 2023-05-24	Repair queued
comment 30-Day FRN OS-0937-0198 05_17_2023.docx	Supplementary Document	Uploaded 2023-05-18	Repair queued
60-day FRN 2023-06161.pdf	Supplementary Document	Uploaded 2023-04-12	Repair queued
OMB No_0937-0198_Supporting Statement_04_12_2023.docx	Supporting Statement A	Uploaded 2023-04-12	Repair queued
30-day FRN -0937-0198.pdf	Supplementary Document	Uploaded 2020-05-28	Repair queued
Response VCU comment.pdf	Supplementary Document	Uploaded 2014-04-18	Repair queued
Response to COGR comments.pdf	Supplementary Document	Uploaded 2014-04-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
7747	Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form	Modified	Assurance of Compliance by Sub-Award Recipients
7747	Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form	Modified	Institutional Assurance and Annual Report on Possible Research Misconduct
7747	Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form	Modified
210878	Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form	Modified	Assurance of Compliance by Sub-Award Recipients
210878	Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form	Modified

ICR Details

OMB Control No: 0937-0198	ICR Reference No: 202303-0937-002
Status: Historical Active	Previous ICR Reference No: 202005-0937-001
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/01/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/30/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	08/31/2023
Responses	5,926	0	5,858
Time Burden (Hours)	974	0	1,159
Cost Burden (Dollars)	0	0	0

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Abstract: The Office of Research Integrity is requesting an extension on a currently approved collection. 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. The purpose of the Assurance of Compliance by Sub-Award Recipients forms PHS–6315 is to establish an assurance of compliance for a sub-awardee institution. Forms PHS 6349 and PHS–6315 are also used to provide an annual assurance that the institution has established and will follow administrative policies and procedures for responding to allegations of research misconduct that comply with the Public Health Service (PHS) Policies on Research Misconduct (42 CFR part 93). 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. There were minor revisions made on forms PHS-6349 and PHS-6315. The revisions will not alter the data collection. Need and Proposed Use: The information is needed to fulfill section 493 of the Public Health Service Act (42 U.S.C. 289b), which requires assurances from institutions that apply for financial assistance under the Public Health Service Act for any project or program that involves the conduct of biomedical or behavioral research. In addition, the information is also required to fulfill the assurance and annual reporting requirements of 42 CFR part 93. ORI uses the information to monitor institutional compliance with the regulation. Lastly, the information may be used to respond to congressional requests for information to prevent misuse of Federal funds and to protect the public interest.

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Authorizing Statute(s): PL: Pub.L. 99 - 158 493 Name of Law: Health Research Extension Act of 1985
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 17861	03/24/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 33150	05/23/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

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-6315, PHS-6349	Institutional Assurance and Annual Report on Possible Research Misconduct ,   Assurance of Compliance by Sub-Award Recipients

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	5,926	5,858	0	68	0	0
Annual Time Burden (Hours)	974	1,159	0	-185	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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The number of awardee institutions have slightly increase which went from 5748 to 5770. The number of minutes per online submission have decreased from 11 minutes to 10 minutes. The estimated burden hours per response remains the same for sub-awardee institutions at five minutes per online submission.

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Annual Cost to Federal Government: $58,089

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

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Common Form ICR:  No

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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: 06/30/2023

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