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)

Forms and Documents

Document Name	Status
pub 30-day FRN2022-08986.pdf Supplementary Document	2022-04-27
Attachment 1 Privacy Impact Assessment.pdf Supplementary Document	2022-04-18
0925-0417_SUPPORTING_STATEMENT A final(dd 4-14-2022).docx Supporting Statement A	2022-04-18

IC Document Collections

IC ID	Document Title	Status
7313	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	Modified
232904	Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions Instruction	Modified
232903	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	Modified
200605	42 CFR 50.606(c) or 45 CFR 94.6(c) (Disclosure) Instruction	Modified
200604	42 CFR 50.604(e)(3) or 45 CFR 94.4 (e)(3) for - Investigators (Disclosure) Instruction	Modified
200603	42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for- Investigators (Disclosure) Instruction	Modified
200602	42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for - Investigators (Disclosure) Instruction	Modified
200600	42 CFR 50.605(a)(4) (Disclosure) Instruction	Modified
200599	42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5 (a)(3)(iii) (Disclosure) Instruction	Modified
200598	42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) (Disclosure) Instruction	Modified
200597	42 CFR 50.605(a)(3)(i) or 45 CFR (a)(3)(i) (Disclosure) Instruction	Modified
200596	42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for institutions (Disclosure) Instruction	Modified
200595	42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for institutions (Disclosure) Instruction	Modified
200594	42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions (Disclosure) Instruction	Modified
200593	42 CFR 50.604(d) or 45 CFR 94.4 for Institutions (Disclosure) Instruction	Modified
200592	42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions (Disclosure) Instruction	Modified
200591	42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for investigators (Disclosure) Instruction	Modified
200590	42 CFR 50.604(a) or 45 CFR 94.4 for investigators (Disclosure) Instruction	Modified
186928	42 CFR - 50.604(c)(1) - from subrecipients (Disclosure) Instruction	Modified
186927	42 CFR 50.605(a)(5) - Institutions (Disclosure) Instruction	Modified
186926	42 CFR 50.604(i)-Institutional files or 45 CFR 94.4(1) from awardee institutions (Recordkeeping) Instruction	Modified
186925	Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions (Reporting) Instruction	Modified
186924	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	Modified

ICR Details

OMB Control No: 0925-0417	ICR Reference No: 202204-0925-001
Status: Received in OIRA	Previous ICR Reference No: 201809-0925-001
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/27/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2022
Responses	136,382	136,382
Time Burden (Hours)	677,820	677,820
Cost Burden (Dollars)	0	0

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Abstract: 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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 9075	02/17/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 25033	04/27/2022
Did the Agency receive public comments on this ICR? No

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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 50.606(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)

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ICR Summary of Burden

	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

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:

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Annual Cost to Federal Government: $54,031

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? No

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Common Form ICR:  No

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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: 04/27/2022

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