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
Response VCU comment.pdf Supplementary Document	2014-04-18
Response to COGR comments.pdf Supplementary Document	2014-04-18
OMB-0937-0198_Supporting Statement_04_26_2017_FINAL.doc Supporting Statement A	2017-04-26

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: 201701-0937-001
Status: Historical Active	Previous ICR Reference No: 201403-0937-001
Agency/Subagency: HHS/OASH	Agency Tracking No: 21329
Title: Public Health Service Policies on Research Misconduct (42 CFR Part 93)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/26/2017
	Date Received in OIRA: 04/26/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	5,635	0	6,296
Time Burden (Hours)	923	0	1,033
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:
	82 FR 6582	01/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 18304	04/18/2017
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 ,   Annual Report Possible 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	5,635	6,296	0	0	-661	0
Annual Time Burden (Hours)	923	1,033	0	0	-110	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: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: The burden estimate has been slightly reduced as a result of a decrease in the number of awardee institutions, which went from 6,096 to 5,435. The estimated burden hours per response remain the same for either awardee or sub-awardee institutions: 10 minutes per online submission for the former, five minutes per online submission for the latter.

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Annual Cost to Federal Government: $46,500

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 04/26/2017

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