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)

OMB 0925-0417

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.

The latest form for 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) expires 2022-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
pub 30-day FRN2022-08986.pdf Supplementary Document
Attachment 1 Privacy Impact Assessment.pdf Supplementary Document
0925-0417_SUPPORTING_STATEMENT A final(dd 4-14-2022).docx Supporting Statement A
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) Instruction
Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions Instruction
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 Instruction
42 CFR 50.606(c) or 45 CFR 94.6(c) (Disclosure) Instruction
42 CFR 50.604(e)(3) or 45 CFR 94.4 (e)(3) for - Investigators (Disclosure) Instruction
42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for- Investigators (Disclosure) Instruction
42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for - Investigators (Disclosure) Instruction
42 CFR 50.605(a)(4) (Disclosure) Instruction
42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5 (a)(3)(iii) (Disclosure) Instruction
42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) (Disclosure) Instruction
42 CFR 50.605(a)(3)(i) or 45 CFR (a)(3)(i) (Disclosure) Instruction
42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for institutions (Disclosure) Instruction
42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for institutions (Disclosure) Instruction
42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions (Disclosure) Instruction
42 CFR 50.604(d) or 45 CFR 94.4 for Institutions (Disclosure) Instruction
42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions (Disclosure) Instruction
42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for investigators (Disclosure) Instruction
42 CFR 50.604(a) or 45 CFR 94.4 for investigators (Disclosure) Instruction
42 CFR - 50.604(c)(1) - from subrecipients (Disclosure) Instruction
42 CFR 50.605(a)(5) - Institutions (Disclosure) Instruction
42 CFR 50.604(i)-Institutional files or 45 CFR 94.4(1) from awardee institutions (Recordkeeping) Instruction
Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions (Reporting) Instruction
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) Instruction

All Historical Document Collections

202204-0925-001 Approved without change	Extension without change of a currently approved collection	2022-04-27
201809-0925-001 Approved without change	Reinstatement with change of a previously approved collection	2018-12-21
201112-0925-005 Approved with change	Revision of a currently approved collection	2011-12-23
200810-0925-005 Approved without change	Extension without change of a currently approved collection	2008-10-16
200508-0925-002 Approved without change	Extension without change of a currently approved collection	2005-08-24
200206-0925-001 Approved without change	Reinstatement with change of a previously approved collection	2002-06-19
199809-0925-002 Approved without change	Extension without change of a currently approved collection	1998-09-04
199507-0925-001 Approved without change	Revision of a currently approved collection	1995-07-14
199407-0925-003 Approved without change	New collection (Request for a new OMB Control Number)	1994-07-06

OMB Details

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)

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