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OMB Control No: 0925-0417	ICR Reference No: 202512-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202204-0925-001
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: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 10/02/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	137,471	0
Time Burden (Hours)	680,473	0
Cost Burden (Dollars)	0	0

Abstract: The regulations provided in Promoting Objectivity in Research (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). This request is for Office of Management and Budget (OMB) approval of a reinstatement with a change for three years for a currently approved collection. NIH is implementing an enhancement in the FCOI reporting requirement within the eRA Commons FCOI Module to require the grant and cooperative agreement respondent to identify foreign FCOIs and provide the type of foreign entity and the name of the foreign country. This enhanced requirement is insignificant on the part of respondents.

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:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 30649	07/10/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 60138	09/22/2026
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Request	Change Due to Agency Discretion
Annual Number of Responses	137,471	137,471
Annual Time Burden (Hours)	680,473	680,473
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: This request is for OMB approval of a three-year reinstatement with change for the continued collection of information consistent with the FCOI regulation, except for the future enhancement to require respondents to identify foreign FCOIs in the initial report. After NIH implements the change in the eRA Commons FCOI Module, respondents will be required to report whether the Investigator’s FCOI is a foreign FCOI and, if so, to provide the type of foreign entity and the name of the foreign country (see Attachment 25). This change affects reporting requirements for NIH grant and cooperative agreement respondents and is insignificant on the part of respondents. The adjustment of 1,128 for the initial reports and 2,712 for annual reports represents an increase in respondents (those reporting initial and annual FCOI reports) versus additional requirements. The table from the previous renewal cycle provide the data on actual numbers at that time. The number of actions related to 42 CFR 50.606(c) is reduced from 50 to 2 since the estimate was previously inflated per actual data. The instructions for submitting FCOI reports via the eRA Commons FCOI Module is provided in the eRA Commons FCOI User Guide, along with screen shots of the report types (Original, Annual and Mitigation Report) within the FCOI Module as provided in Attachment 2. The Module User Guide will be revised and published once the collection of foreign FCOI information is implemented.

Annual Cost to Federal Government: $40,860

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

Agency Contact: Mikia Currie 3014350941

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