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 Department of Health and Human Services National Institutes of Health
 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) will publish periodic summaries of proposed 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: Mr. Joel A. Snyderman, 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, Suite 800, MSC 7974, Bethesda, Maryland 20892-7974. or email your request, including your address to: 
                        *joel.snyderman@nih.gov.*
                         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 42 CFR part 50 Subpart F and Responsible Prospective Contractors 45 CFR part 94, 0925-0417, expiration date 04/30/2022, EXTENSION, 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 an Extension of a currently approved collection resulting from regulations regarding, 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. Estimated Annualized Burden Hours
Type of respondents based on applicable section of regulation
Number of respondents
Number of
                             responses per 
                             respondent
Average
                             burden per 
                             response 
                             (in hrs.)
Total annual
                             burden hoursReporting: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
1,984Subsequent 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
1005 mitigation reports
1
2
10( print page 9076)Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions
2,031
1
1
2,031Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions
20
1
10
200Record Keeping:Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from awardee institutions
2,000
1
4
8,000Disclosure:Under 42 CFR 50.604(a) or 45 CFR 94.4 for Investigators
3,000
1
81
243,000Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Investigators
38,000
1
30/60
19,000Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions
2,000
1
6
12,000Under 42 CFR 50.604(c)(1) or 45 CFR 94.4(c)(1) from subrecipients
500
1
1
500Under 42 CFR 50.604(d) or 45 CFR 94.4 for Institutions
3,000 1
1
1
3,000Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for Investigators
38,000
1
4
152,000Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for Investigators
38,000
1
1
38,000Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) for Investigators
992
1
30/60
496Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions
2,000
1
1
2,000Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for Institutions
2,000 2
1
82
164,000Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for Institutions
500 3
1
3
1,500Under 42 CFR 50.605(a)(3)(i) or 45 CFR 94.5(a)(3)(i)
50 4
1
80
4,000Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii)
50 5
1
80
4,000Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5(a)(3)(iii)
50
1
1
50Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4)
992
1
12
11,904Public Website Posting under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) from awardee Institutions
2,000
1
5
10,000Under 42 CFR 50.606(c) or 45 CFR 94.6(c)
50 6
7
                             3
18/60
45Total
136,282
136,282

677,8201
                         Assuming that 3000 institutions solicit disclosures on an annual basis to all Investigators.2
                         Although an estimated 992 reports of Conflict of Interest are expected annually, the 2,000 responding Institutions must review all financial disclosures associated with PHS-funded awards to determine whether any conflicts of interest exist. Thus, the review burden of 76,000 hours is based upon estimates that it will take on the average 2 hours for an institutional official(s) to review each of 38,000 financial disclosures associated with PHS funded awards. The burden for developing a management plan for identified FCOI is estimated at 80 hours × 992 cases = 79,360 hours.3
                         Assuming that this is a rare occurrence based on prior experience.4
                         Assuming only a fraction of the newly identified SFIs will constitute FCOI.5
                         Assuming only a fraction of the newly identified SFIs will constitute FCOI.6
                         Number based on 50.605/94.5(a)(3)(i)—of those only a fraction will relate to a project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, but we are calculating the maximum estimated burden.7
                         Assuming an average of 3 publications annually.
 Dated: February 11, 2022. Tara A. Schwetz, Acting Principal Deputy Director, National Institutes of Health.


[FR Doc. 2022-03463 Filed 2-16-22; 8:45 am] BILLING CODE 4140-01-P