Evaluation of the Impacy of New Conflicts of Interest Regulations

Forms and Documents

Document Name	Status
Form 2 Evaluation of the Impact of New NIH Conflicts of Interest regulations Form	New
Form 1 Evaluation of the Impact of New NIH Conflicts of Interest Regulations Form	New
Memo 6-15-07.doc Supplementary Document	2007-06-26
Section B.doc Supporting Statement B	0000-00-00
SS.A.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
179140	Evaluation of the Impact of New NIH Conflicts of Interest regulations Form	New
179139	Evaluation of the Impact of New NIH Conflicts of Interest Regulations Form	New

ICR Details

OMB Control No: 0925-0579	ICR Reference No: 200703-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Evaluation of the Impacy of New Conflicts of Interest Regulations
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/03/2007
	Date Received in OIRA: 03/21/2007
Terms of Clearance: This ICR is approved on the understanding that NIH will conduct analyses of non-response bias as described in the memo of 6/15/07. Since the costs as well as the benefits of regulatory changes need to be assessed before changes are made as detailed in OMB Circular A4, the limitations of this survey will be acknowledged if results from this survey are used to justify any regulatory changes. Finally, as NIH does not have statutory authority to provide assurances of confidentiality, all uses of the word "confidential" will be deleted and replaced with "private to the extent permitted by law."

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2008	06/30/2008
Responses	500	0	0
Time Burden (Hours)	117	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study will assess the impact of NIH's new interim final conflict-of-interest regulations on its ability to recruit and retain staff. Guaging both the immediate and potential impact of the regulations which have been in effect since February 3, 2005, is crucial to the NIH's ability to develop and maintain the skilled, experienced staff necessary to fulfill its mission of protecting and improving the public health. Understanding both the current and potential impact will allow NIH to determine how to best handle any impact the regulations have on recruitment and retention.

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Authorizing Statute(s): None

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:
	71 FR 4922	01/30/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 10768	03/09/2007
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Evaluation of the Impact of New NIH Conflicts of Interest Regulations	1	Survey
Evaluation of the Impact of New NIH Conflicts of Interest regulations	2	Survey

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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	500	0	0	500	0	0
Annual Time Burden (Hours)	117	0	0	117	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: This is a new collection.

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Annual Cost to Federal Government: $93,259

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 03/21/2007

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