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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:
201809-0925-001
Status:
Historical Active
Previous ICR Reference No:
201112-0925-005
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought 42 CFR Part 50 Subpart F and Responsible Prospective Contractors (NIH/OPERA)
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
01/30/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/21/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2022
36 Months From Approved
02/28/2015
Responses
136,382
0
950
Time Burden (Hours)
677,820
0
950
Cost Burden (Dollars)
0
0
0
Abstract:
The regulations provided in 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) are necessary to promote objectivity of the design, conduct, and reporting of research funded by the Public Health Service (PHS). The NIH failed to respond timely to the expiration of this submission and the submission of a reinstatement with change is due to NIH’s focused efforts on the consideration of the analysis of comments received during the Notice of Proposed Rule Making (NPRM) in development of the Final Rule and its implementation to the research community to ensure their understanding and compliance with the different requirements.
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 165
08/25/2011
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 11763
03/16/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 45455
09/07/2018
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
23
IC Title
Form No.
Form Name
42 CFR - 50.604(c)(1) - from subrecipients (Disclosure)
42 CFR 50.604(a) or 45 CFR 94.4 for investigators (Disclosure)
42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions (Disclosure)
42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for investigators (Disclosure)
42 CFR 50.604(d) or 45 CFR 94.4 for Institutions (Disclosure)
42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for - Investigators (Disclosure)
42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for- Investigators (Disclosure)
42 CFR 50.604(e)(3) or 45 CFR 94.4 (e)(3) for - Investigators (Disclosure)
42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions (Disclosure)
42 CFR 50.604(i)-Institutional files or 45 CFR 94.4(1) from awardee institutions (Recordkeeping)
42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for institutions (Disclosure)
42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for institutions (Disclosure)
42 CFR 50.605(a)(3)(i) or 45 CFR (a)(3)(i) (Disclosure)
42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) (Disclosure)
42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5 (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) or 45 CFR 94.6(c) (Disclosure)
Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions
Initial Reports- 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5 (b)(1) and (b) (3) from awardee Institutions (Reporting)
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 94.5(a)(3)(iii) and (b)(2) from awardee Institutions
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 94.5(a)(3)(iii) and (b)(2) from awardee Institutions (Reportimg)
Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions (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
136,382
950
0
1,207
0
134,225
Annual Time Burden (Hours)
677,820
950
0
13,690
0
663,180
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The adjustment of 992 for the initial reports represents an increase in respondents (those reporting an initial FCOI) vs. additional requirements. The initial table published was an estimate and with this reinstatement with change, we had some data on actual numbers. The increase in burden is only an increase in the actual reported initial FCOI reports than was originally estimated.
Annual Cost to Federal Government:
$14,897
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
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:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
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:
09/11/2018
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