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), 11763-11765 [2018-05384]

Download as PDF Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice must be complete and in acceptable form by the expiration date of this Notice to be considered for a license. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: March 8, 2018. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2018–05310 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health daltland on DSKBBV9HB2PROD with NOTICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Research. Date: April 3, 2018. Time: 1:00 p.m. to 5:00 p.m. VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Shalanda A Bynum, Ph.D., MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3206, Bethesda, MD 20892, 301–755–4355, bynumsa@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Research. Date: April 6, 2018. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Robert Freund, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301–435– 1050, freundr@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Endocrinology, Metabolism, Nutrition, and Reproductive Science. Date: April 6, 2018. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Elaine Sierra-Rivera, Ph.D., Scientific Review Officer, EMNR IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6182 MSC 7892, Bethesda, MD 20892, 301 435– 2514, riverase@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Research. Date: April 6, 2018. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, Bethesda, MD 20892, 301–451–8754, tuoj@ nei.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: March 12, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–05308 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 11763 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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. 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. SUMMARY: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. DATES: 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 FCOICompliance@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\16MRN1.SGM 16MRN1 11764 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 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 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 PHSfunded 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. 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 ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents based on applicable section of regulation daltland on DSKBBV9HB2PROD with NOTICES 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. 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. Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions. Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions. Record Keeping: Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from awardee institutions. Disclosure: Under 42 CFR 50.604(a) or 45 CFR 94.4 for Investigators. Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Investigators. Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions. Under 42 CFR 50.604(c)(1) or 45 CFR 94.4(c)(1) from subrecipients. Under 42 CFR 50.604(d) or 45 CFR 94.4 for Institutions. Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for Investigators. Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for Investigators. Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) for Investigators. Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions 1. Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for Institutions. Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for Institutions. Under 42 CFR 50.605(a)(3)(i) or 45 CFR 94.5(a)(3)(i). Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii). Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5(a)(3)(iii). VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 Frequency of responses Number of respondents Average time per response (in hours) Total annual burden hour 992 ................................................................. 1 2 1,984 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 ........................................ 2,031 .............................................................. 1 1 2 1 10 2,031 20 ................................................................... 1 10 200 2,000 .............................................................. 1 4 8,000 3,000 .............................................................. 1 81 243,000 38,000 ............................................................ 1 30/60 19,000 2,000 .............................................................. 1 6 12,000 500 ................................................................. 1 1 500 3,000 4 ............................................................ 1 1 3,000 38,000 ............................................................ 1 4 152,000 38,000 ............................................................ 1 1 38,000 950 ................................................................. 1 30/60 475 2,000 .............................................................. 1 1 2,000 2,000 5 ............................................................ 1 82 164,000 500 6 ............................................................... 1 3 1,500 50 7 ................................................................. 1 80 4,000 50 8 ................................................................. 1 80 4,000 50 ................................................................... 1 1 50 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 11765 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Type of respondents based on applicable section of regulation Average time per response (in hours) Frequency of responses Number of respondents Total annual burden hour Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4). Public Website Posting under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) from awardee Institutions. Under 42 CFR 50.606(c) or 45 CFR 94.6(c). 950 ................................................................. 1 12 11,400 2,000 .............................................................. 1 5 10,000 50 9 ................................................................. 3 10 18/60 45 Total .................................................. 136,143 .......................................................... 136,243 ........................ 677,295 4 Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all Investigators. an estimated 950 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 × 950 cases = 76,000 hours. 6 Assuming that this is a rare occurrence based on prior experience. 7 Assuming only a fraction of the newly identified SFIs will constitute FCOI. 8 Assuming only a fraction of the newly identified SFIs will constitute FCOI. 9 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. 10 Assuming an average of 3 publications annually. 5 Although Dated: March 10, 2018. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2018–05384 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings daltland on DSKBBV9HB2PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: BTSS and SAT. Date: March 26, 2018. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Guo Feng Xu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 Health, 6701 Rockledge Drive, Room 5122, MSC 7854, Bethesda, MD 20892, 301–237– 9870, xuguofen@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–17– 086/7: Tobacco Use and HIV in Low and Middle-Income Countries. Date: March 28, 2018. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Mark P. Rubert, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1775, rubertm@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: March 12, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–05307 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Magnetic Resonance Imaging System and Method for the Measurement of Geometric Features of Axons (Including Without Limitation Diameter, Radius, Perimeter, Volume, Surface and Angle) for the Characterization and Diagnosis of Central Nervous System Diseases and Disorders AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Brainvivo Ltd. (Brainvivo), located in Tel Aviv, Israel, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice. DATES: Only written comments and/or complete applications for a license which are received by the NCI Technology Transfer Center on or before April 2, 2018 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Surekha Vathyam, Ph.D., SUMMARY: E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11763-11765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05384]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

[[Page 11764]]

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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
    Type of respondents based on        Number of respondents      Frequency of    per response    Total annual
  applicable section of regulation                                   responses      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
Reporting:
    Initial Reports under 42 CFR     992........................               1               2           1,984
     50.605(b)(1) and (b)(3) or 45
     CFR 94.5(b)(1) and (b)(3) from
     awardee Institutions.
    Subsequent Reports under 42 CFR  50 FCOI reports as in 42                  1               2             100
     50.605(a)(3)(iii) and (b)(2)     CFR 50.605(a)(3)(ii) and
     or 45 CFR 94.5(a)(3)(iii) and    45 CFR 94.5(a)(3)(ii).
     (b)(2) from awardee
     Institutions.
                                     5 mitigation reports.......               1               2              10
    Annual Report under 42 CFR       2,031......................               1               1           2,031
     50.605(b)(4) or 45 CFR
     94.5(b)(4) from awardee
     Institutions.
    Subsequent Reports under 42 CFR  20.........................               1              10             200
     50.606(a) or 45 CFR 94.6 from
     awardee Institutions.
Record Keeping:
    Under 42 CFR 50.604(i) or 45     2,000......................               1               4           8,000
     CFR 94.4(i) from awardee
     institutions.
Disclosure:
    Under 42 CFR 50.604(a) or 45     3,000......................               1              81         243,000
     CFR 94.4 for Investigators.
    Under 42 CFR 50.604(b) or 45     38,000.....................               1           30/60          19,000
     CFR 94.4(e)(1) for
     Investigators.
    Under 42 CFR 50.604(b) or 45     2,000......................               1               6          12,000
     CFR 94.4(e)(1) for
     Institutions.
    Under 42 CFR 50.604(c)(1) or 45  500........................               1               1             500
     CFR 94.4(c)(1) from
     subrecipients.
    Under 42 CFR 50.604(d) or 45     3,000 \4\..................               1               1           3,000
     CFR 94.4 for Institutions.
    Under 42 CFR 50.604(e)(1) or 45  38,000.....................               1               4         152,000
     CFR 94.4(e)(1) for
     Investigators.
    Under 42 CFR 50.604(e)(2) or 45  38,000.....................               1               1          38,000
     CFR 94.4(e)(2) for
     Investigators.
    Under 42 CFR 50.604(e)(3) or 45  950........................               1           30/60             475
     CFR 94.4(e)(3) for
     Investigators.
    Under 42 CFR 50.604(f) or 45     2,000......................               1               1           2,000
     CFR 94.4(f) for institutions
     \1\.
    Under 42 CFR 50.605(a)(1) or 45  2,000 \5\..................               1              82         164,000
     CFR 94.5(a)(1) for
     Institutions.
    Under 42 CFR 50.605(a)(3) or 45  500 \6\....................               1               3           1,500
     CFR 94.5(a)(3) for
     Institutions.
    Under 42 CFR 50.605(a)(3)(i) or  50 \7\.....................               1              80           4,000
     45 CFR 94.5(a)(3)(i).
    Under 42 CFR 50.605(a)(3)(ii)    50 \8\.....................               1              80           4,000
     or 45 CFR 94.5(a)(3)(ii).
    Under 42 CFR 50.605(a)(3)(iii)   50.........................               1               1              50
     or 45 CFR 94.5(a)(3)(iii).

[[Page 11765]]

 
    Under 42 CFR 50.605(a)(4) or 45  950........................               1              12          11,400
     CFR 94.5(a)(4).
    Public Website Posting under 42  2,000......................               1               5          10,000
     CFR 50.605(a)(5) or 45 CFR
     94.5(a)(5) from awardee
     Institutions.
    Under 42 CFR 50.606(c) or 45     50 \9\.....................          3 \10\           18/60              45
     CFR 94.6(c).
                                    ----------------------------------------------------------------------------
        Total......................  136,143....................         136,243  ..............         677,295
----------------------------------------------------------------------------------------------------------------
\4\ Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all
  Investigators.
\5\ Although an estimated 950 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 x 950 cases = 76,000 hours.
\6\ Assuming that this is a rare occurrence based on prior experience.
\7\ Assuming only a fraction of the newly identified SFIs will constitute FCOI.
\8\ Assuming only a fraction of the newly identified SFIs will constitute FCOI.
\9\ 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.
\10\ Assuming an average of 3 publications annually.


    Dated: March 10, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-05384 Filed 3-15-18; 8:45 am]
 BILLING CODE 4140-01-P


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