Responsibility of Applicants for Promoting Objectivity in Reserch for which Public Health Service Funding is Sought(OPERA)

Forms and Documents

Document Name	Status
Attach 1 Grants Policy Statement Rev-12-1-2003.pdf Supplementary Document	2008-09-18
SUPPORTING STATEMENT (09172008).doc Supporting Statement A	2008-09-18

IC Document Collections

IC ID	Document Title	Status
7313	Initial Reports Instruction	Modified
186928	42 CFR - Investigators (Disclosure) Instruction	New
186927	42 CFR Institutions (Disclosure) Instruction	New
186926	42 CFR- Institutional files (Recordkeeping) Instruction	New
186925	Subsequent Reports under 42 CFR 50.606 Instruction	New
186924	Subsequent Reports under 42 CFR 50.604 Instruction	New

ICR Details

OMB Control No: 0925-0417	ICR Reference No: 200810-0925-005
Status: Historical Active	Previous ICR Reference No: 200508-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Responsibility of Applicants for Promoting Objectivity in Reserch for which Public Health Service Funding is Sought(OPERA)
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 without change	Conclusion Date: 12/23/2008
	Date Received in OIRA: 10/16/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	12/31/2008
Responses	68,160	0	42,800
Time Burden (Hours)	220,280	0	232,000
Cost Burden (Dollars)	0	0	4,000

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Abstract: The purpose of the regulations is to promote objectivity in research by requiring institutions to establish standards which ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by a conflicting financial interest of an investigator.

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Authorizing Statute(s): US Code: 42 USC 289b-1 Name of Law: Protection against financial conflicts of interests in certain projects of research
  

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:
	73 FR 40354	07/14/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 57365	10/02/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Subsequent Reports under 42 CFR 50.604
Subsequent Reports under 42 CFR 50.606
Initial Reports
42 CFR- Institutional files (Recordkeeping)
42 CFR Institutions (Disclosure)
42 CFR - Investigators (Disclosure)

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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	68,160	42,800	0	0	25,360	0
Annual Time Burden (Hours)	220,280	232,000	0	0	-11,720	0
Annual Cost Burden (Dollars)	0	4,000	0	0	-4,000	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:

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Annual Cost to Federal Government: $482,400

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)? Uncollected

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: 10/16/2008

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