# Submission for OMB Review; 30-Day Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors (Office of the Director)
**AGENCY:**
National Institutes of Health, HHS.
**ACTION:**
Notice.
**SUMMARY:**
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
**DATES:**
Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
**ADDRESSES:**
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, *[email protected]* or by fax to 202-395-6974, Attention: Desk Officer for NIH.
**FOR FURTHER INFORMATION CONTACT:**
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Diane Dean, Director, Division of Grants Compliance and Oversight, Office of Policy for Extramural Research Administration, Office of Extramural Research, National Institutes of Health, 6705 Rockledge Drive, Room 3525, Bethesda, MD 20892, or call non-toll-free number (301) 435-0930 or Email your request, including your address to: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
This proposed information collection was previously published in the *Federal Register* on March 16, 2018, (FR 83 pages 11763-11765) and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
*Proposed Collection:* 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 45 CFR part 94, 0925-0417, expiration date 2/28/2015, REINSTATEMENT WITHOUT CHANGE, Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER), National Institutes of Health (NIH).
*Need and Use of Information Collection:* This request is for Office of Management and Budget (OMB) approval of a Reinstatement Without Change of a currently approved collection resulting from the development of revised regulations regarding the 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). The purpose of these regulations is to promote objectivity in research by requiring institutions to establish standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of PHS- funded research will be biased by any Investigator Financial Conflict of Interest (FCOI).
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 677,820.
| Type of respondents based on applicable | Number of respondents | Number of | Average | Total annual |
| --- | --- | --- | --- | --- |
| Reporting: | | | | |
| Initial Reports under 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5(b)(1) and (b)(3) from awardee Institutions | 992 | 1 | 2 | 1,984 |
| 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 | 50 FCOI reports as in 42 CFR 50.605(a)(3)(ii) and 45 CFR 94.5(a)(3)(ii) | 1 | 2 | 100 |
| | 5 Mitigation Reports | 1 | 2 | 10 |
| Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions | 2,031 | 1 | 1 | 2,031 |
| Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions | 20 | 1 | 10 | 200 |
| Record Keeping: | | | | |
| Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from awardee institutions | 2,000 | 1 | 4 | 8,000 |
| Disclosure: | | | | |
| Under 42 CFR 50.604(a) or 45 CFR 94.4 for Investigators | 3,000 | 1 | 81 | 243,000 |
| Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Investigators | 38,000 | 1 | 30/60 | 19,000 |
| Under 42 CFR 50.604(b) or 45 CFR 94.4 (e)(1) for Institutions | 2,000 | 1 | 6 | 12,000 |
| Under 42 CFR 50.604(c)(1) or 45 CFR 94.4(c)(1) from subrecipients | 500 | 1 | 1 | 500 |
| Under 42 CFR 50.604(d) or 45 CFR 94.4 for Institutions | 3,000 | 1 | 1 | 3,000 |
| Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for Investigators | 38,000 | 1 | 4 | 152,000 |
| Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for Investigators | 38,000 | 1 | 1 | 38,000 |
| Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) for Investigators | 992 | 1 | 30/60 | 496 |
| Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions | 2,000 | 1 | 1 | 2,000 |
| Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for Institutions | 2,000 | 1 | 82 | 164,000 |
| Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for Institutions | 500 | 1 | 3 | 1,500 |
| Under 42 CFR 50.605(a)(3)(i) or 45 CFR 94.5(a)(3)(i) | 50 | 1 | 80 | 4,000 |
| Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) | 50 | 1 | 80 | 4,000 |
| Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5(a)(3)(iii) | 50 | 1 | 1 | 50 |
| Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4) | 992 | 1 | 12 | 11,904 |
| Public Website Posting under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) from awardee Institutions | 2,000 | 1 | 5 | 10,000 |
| Under 42 CFR 50.606(c) or 45 CFR 94.6(c) | 50 | 3 | 18/60 | 45 |
| Total | 136,282 | 136,382 | | 677,820 |
Dated: August 30, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.