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)

ICR 202204-0925-001

OMB: 0925-0417

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2022-04-27
Supplementary Document
2022-04-18
Supporting Statement A
2022-04-18
IC Document Collections
IC ID
Document
Title
Status
7313 Modified
232904 Modified
232903 Modified
200605 Modified
200604 Modified
200603 Modified
200602 Modified
200600 Modified
200599 Modified
200598 Modified
200597 Modified
200596 Modified
200595 Modified
200594 Modified
200593 Modified
200592 Modified
200591 Modified
200590 Modified
186928 Modified
186927 Modified
186926 Modified
186925 Modified
186924 Modified
ICR Details
0925-0417 202204-0925-001
Received in OIRA 201809-0925-001
HHS/NIH
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)
Extension without change of a currently approved collection   No
Regular 04/27/2022
  Requested Previously Approved
36 Months From Approved 04/30/2022
136,382 136,382
677,820 677,820
0 0

The disclosure of Investigators’ Significant Financial Interests (SFIs) to the awardee Institution’s designated official(s) for a determination of a financial conflict of interests adds transparency and enhances regulatory compliance and effective institutional oversight and management of identified Investigator financial conflicts of interests.

US Code: 42 USC 289b-1 Name of Law: Protection against financial conflicts of interests in certain projects of research
  
Statute at Large: 42 Stat. 50

Not associated with rulemaking

  87 FR 9075 02/17/2022
87 FR 25033 04/27/2022
No

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 50.606(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)

  Total Request 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 136,382 136,382 0 0 0 0
Annual Time Burden (Hours) 677,820 677,820 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$54,031
No
    Yes
    Yes
No
No
No
No
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
04/27/2022


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