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

Forms and Documents

Document Name	Status
Form Form No. PHS 6349 Public Health Service Policies on Research Misconduct (42 CFR Part 93) Form and Instruction	Modified
OMB-0937-0198 Supporting Statement Revised(3).doc Supporting Statement A	2009-03-24

IC Document Collections

IC ID	Document Title	Status
7747	Public Health Service Policies on Research Misconduct (42 CFR Part 93) Form and Instruction	Modified

ICR Details

OMB Control No: 0937-0198	ICR Reference No: 200903-0937-001
Status: Historical Active	Previous ICR Reference No: 200601-0937-001
Agency/Subagency: HHS/OASH	Agency Tracking No:
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: 05/29/2009
	Date Received in OIRA: 03/31/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	36 Months From Approved	05/31/2009
Responses	5,246	0	3,800
Time Burden (Hours)	525	0	400
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:
	74 FR 5159	01/29/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 14128	03/30/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Public Health Service Policies on Research Misconduct (42 CFR Part 93)	Form No. PHS 6349	Annual HHS Report on Research Misconduct

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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	5,246	3,800	0	1,446	0	0
Annual Time Burden (Hours)	525	400	0	125	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: No

Burden Reduction Due to:

Short Statement: The program has been reduced substantially for two reasons. First, the new definition of research misconduct in the PHS Polices on Research Misconduct is limited to fabrication, falsification, and plagiarism. The clause, "other practices that serously diviate from tose that are commonly accepted with the scientific community" was deleted from the difinition, thereby,m reducing the amount of information that needed to be collected and reported. Second, the previous estimate of one hour per institution to complete the report was grossly overestimated because about 97 percent of the institutions have no misconduct activity to report and those that do have misconduct activity to report usually have only one case. The current estimate for on-line submission is six minutes.

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Annual Cost to Federal Government: $34,500

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 03/31/2009

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