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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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
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(e)(1) - Investigators (Disclosure)
42 CFR 50.604(e)(2) - Investigators (Disclosure)
42 CFR 50.604(e)(3) - Investigators (Disclosure)
42 CFR 50.604(f) (Disclosure)
42 CFR 50.604(i)-Institutional files (Recordkeeping)
42 CFR 50.605(a)(1) (Disclosure)
42 CFR 50.605(a)(3) (Disclosure)
42 CFR 50.605(a)(3)(i) (Disclosure)
42 CFR 50.605(a)(3)(ii) (Disclosure)
42 CFR 50.605(a)(3)(iii) (Disclosure)
42 CFR 50.605(a)(4) (Disclosure)
42 CFR 50.605(a)(5) - Institutions (Disclosure)
42 CFR 50.605(b)(4) (Reportimg)
42 CFR 50.606(c) (Disclosure)
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)
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
Agency Contact:
Mikia Currie 3014350941
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
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