# Proposed Collection; 60-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 Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director, (OD)
**AGENCY:**
National Institutes of Health, HHS.
**ACTION:**
Notice.
**SUMMARY:**
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director (OD) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
**DATES:**
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
**FOR FURTHER INFORMATION CONTACT:**
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Kathy Hancock, Asst. Grants Compliance Officer, Division of Grants Compliance and Oversight, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892 or call non-toll-free number 301-435-0949 or Email your request to *[email protected].* Formal requests for additional plans and instruments must be requested in writing.
**SUPPLEMENTARY INFORMATION:**
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
*Proposed Collection Title:* Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought 45 CFR part 50 Subpart F and Responsible Prospective Contractors 45 CFR part 94, 0925-0417,—REINSTATEMENT WITHOUT CHANGE Office of Policy and Extramural Research Administration (OPERA) Office of Extramural Research (OER), Office of the Director (OD), 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 677,295.
| Type of respondents based on applicable section of regulation | Number of respondents | Frequency of responses | Average time per response | Total annual burden hour |
| --- | --- | --- | --- | --- |
| 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 | 950 | 1 | 30/60 | 475 |
| 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) | 950 | 1 | 12 | 11,400 |
| 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 | 136,143 | 136,243 | | 677,295 |
Dated: March 10, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.