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

Forms and Documents

Document Name	Status
Form 6349 Public Health Service Policies on Research Misconduct (42 CFR Part 93) Form	Modified
Form 6315 Sub -Award Institution's Form	Modified
30-day FRN -0937-0198.pdf Supplementary Document	2020-05-28
Response VCU comment.pdf Supplementary Document	2014-04-18
Response to COGR comments.pdf Supplementary Document	2014-04-18
0937-0198_Supporting Statement_Sherrette Comments2_SGG 2020-05-18.docx Supporting Statement A	2020-05-18

IC Document Collections

IC ID	Document Title	Status
7747	Public Health Service Policies on Research Misconduct (42 CFR Part 93) Form	Modified
210878	Sub -Award Institution's Form	Modified

ICR Details

OMB Control No: 0937-0198	ICR Reference No: 202005-0937-001
Status: Active	Previous ICR Reference No: 201701-0937-001
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: 08/19/2020
	Date Received in OIRA: 05/28/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	5,858	0	5,635
Time Burden (Hours)	1,159	0	923
Cost Burden (Dollars)	0	0	0

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Abstract: Section 493 of the Public Health Service Act and 42 CFR Part 93 requires each institution that applies for research and research- related grants to estabish policies and procedures for investigating and reporting instances of alleged or apparent research miscondut for activity supported by PHS funds and to report such instances to the Secretary.

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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:
	85 FR 10704	02/25/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 31520	05/26/2020
Did the Agency receive public comments on this ICR? No

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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)	6349, 6349	PHS ,   Research Misconduct
Sub -Award Institution's	6315	Assurance of Compliance by Sub-Award Recipients

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ICR Summary 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	5,858	5,635	0	0	223	0
Annual Time Burden (Hours)	1,159	923	0	0	236	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The burden estimate has slightly increased as a result of an increase in the number of awardee institutions, which went from 5,435 to 5,748 and in an increase in the number of minutes per online submission from 10 minutes to 12 minutes, because of the six new questions (n=30) asked on the PHS-6349. The new questions were added to allow institutions to include unique institutional identification numbers for their cases and to include other federal agencies’ unique identification numbers for their cases and to include a specific instruction to contact the National Institutes of Health if a case involves foreign influence. As there were no changes to the sub-awardee form, the estimated burden hours per response would remain the same for sub-awardee institutions at five minutes per online submission.

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Annual Cost to Federal Government: $46,504

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: 05/28/2020

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