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

Forms and Documents

Document Name	Status
0925-0417_SUPPORTING_STATEMENT_12-23-2011_SMP_FINAL[1].doc Supporting Statement A	2011-12-23

IC Document Collections

IC ID	Document Title	Status
7313	Initial Reports- 42 CFR 50.605(b)(1) and (b)(3) (Reporting) Instruction	Modified
200605	42 CFR 50.606(c) (Disclosure)	New
200604	42 CFR 50.604(e)(3) - Investigators (Disclosure)	New
200603	42 CFR 50.604(e)(2) - Investigators (Disclosure)	New
200602	42 CFR 50.604(e)(1) - Investigators (Disclosure)	New
200601	42 CFR 50.605(b)(4) (Reportimg)	New
200600	42 CFR 50.605(a)(4) (Disclosure)	New
200599	42 CFR 50.605(a)(3)(iii) (Disclosure)	New
200598	42 CFR 50.605(a)(3)(ii) (Disclosure)	New
200597	42 CFR 50.605(a)(3)(i) (Disclosure)	New
200596	42 CFR 50.605(a)(3) (Disclosure)	New
200595	42 CFR 50.605(a)(1) (Disclosure)	New
200594	42 CFR 50.604(f) (Disclosure)	New
200593	42 CFR 50.604(d) (Disclosure)	New
200592	42 CFR 50.604(b) (Disclosure)	New
200591	42 CFR 50.604(b) (Disclosure)	New
200590	42 CFR 50.604(a) (Disclosure)	New
186928	42 CFR - 50.604(c)(1) - Investigators (Disclosure) Instruction	Modified
186927	42 CFR 50.605(a)(5) - Institutions (Disclosure) Instruction	Modified
186926	42 CFR 50.604(i)-Institutional files (Recordkeeping) Instruction	Modified
186925	Subsequent Reports under 42 CFR 50.606(a) (Reporting) Instruction	Modified
186924	Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) (Reportimg) Instruction	Modified

ICR Details

OMB Control No: 0925-0417	ICR Reference No: 201112-0925-005
Status: Historical Active	Previous ICR Reference No: 200810-0925-005
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought (OPERA)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/16/2012
	Date Received in OIRA: 12/23/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved	02/29/2012
Responses	135,175	0	68,160
Time Burden (Hours)	664,130	0	220,280
Cost Burden (Dollars)	0	0	0

---

Abstract: This request is for Office of Management and Budget (OMB) approval of a revision of a currently approved collection resulting from the development of revised regulations regarding the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94).

---

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: Statute at Large: 42 Stat. 50 Name of Statute: null

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0925-AA53	Final or interim final rulemaking	76 FR 53256	08/25/2011

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 22

IC Title	Form No.	Form Name
Initial Reports- 42 CFR 50.605(b)(1) and (b)(3) (Reporting)
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) (Reportimg)
Subsequent Reports under 42 CFR 50.606(a) (Reporting)
42 CFR 50.604(i)-Institutional files (Recordkeeping)
42 CFR 50.605(a)(5) - Institutions (Disclosure)
42 CFR - 50.604(c)(1) - Investigators (Disclosure)
42 CFR 50.604(a) (Disclosure)
42 CFR 50.604(b) (Disclosure)
42 CFR 50.604(b) (Disclosure)
42 CFR 50.604(d) (Disclosure)
42 CFR 50.604(f) (Disclosure)
42 CFR 50.605(a)(1) (Disclosure)
42 CFR 50.605(a)(3) (Disclosure)
42 CFR 50.605(a)(3)(ii) (Disclosure)
42 CFR 50.605(a)(3)(i) (Disclosure)
42 CFR 50.605(a)(3)(iii) (Disclosure)
42 CFR 50.605(a)(4) (Disclosure)
42 CFR 50.605(b)(4) (Reportimg)
42 CFR 50.604(e)(1) - Investigators (Disclosure)
42 CFR 50.604(e)(2) - Investigators (Disclosure)
42 CFR 50.604(e)(3) - Investigators (Disclosure)
42 CFR 50.606(c) (Disclosure)

---

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	135,175	68,160	67,015	0	0	0
Annual Time Burden (Hours)	664,130	220,280	443,850	0	0	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 estimated total annual burden hours has been increased from 220,080 to 676,130. This upward adjustment is due to the changes to the regulations.

---

Annual Cost to Federal Government: $2,101,400

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]? 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

---

Common Form ICR:  No

---

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: 12/23/2011

---