83 FR 11763 - 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)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 52 (March 16, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 52 (March 16, 2018)
| Page Range | 11763-11765 | |
| FR Document | 2018-05384 |
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)] [Notices] [Pages 11763-11765] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11763
The prospective exclusive license will Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND
be royalty bearing, and the prospective applications. HUMAN SERVICES
exclusive license may be granted unless Place: National Institutes of Health, 6701
within fifteen (15) days from the date of Rockledge Drive, Bethesda, MD 20892 National Institutes of Health
this published notice, the National (Telephone Conference Call).
Contact Person: Shalanda A Bynum, Ph.D., Proposed Collection; 60-Day Comment
Cancer Institute receives written MPH, Scientific Review Officer, Center for
evidence and argument that establishes Request; Responsibility of Applicants
Scientific Review, National Institutes of for Promoting Objectivity in Research
that the grant of the license would not Health, 6701 Rockledge Drive, Room 3206,
be consistent with the requirements of for Which Public Health Service (PHS)
Bethesda, MD 20892, 301–755–4355,
35 U.S.C. 209 and 37 CFR part 404. bynumsa@csr.nih.gov.
Funding Is Sought and Responsible
Prospective Contractors, Office of
In response to this Notice, the public Name of Committee: Center for Scientific
Policy for Extramural Research
may file comments or objections. Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research. Administration (OPERA), Office of
Comments and objections, other than
Date: April 6, 2018. Extramural Research (OER), Office of
those in the form of a completed license
Time: 10:00 a.m. to 5:00 p.m. the Director, (OD)
application, will not be treated
confidentially, and may be made Agenda: To review and evaluate grant
AGENCY: National Institutes of Health,
applications.
publicly available. HHS.
Place: National Institutes of Health, 6701
License applications submitted in Rockledge Drive, Bethesda, MD 20892 ACTION: Notice.
response to this Notice must be (Virtual Meeting).
complete and in acceptable form by the Contact Person: Robert Freund, Ph.D., SUMMARY: In compliance with the
expiration date of this Notice to be Scientific Review Officer, Center for requirement of the Paperwork
considered for a license. License Scientific Review, National Institutes of Reduction Act of 1995 to provide
applications submitted in response to Health, 6701 Rockledge Drive, Room 5216, opportunity for public comment on
this Notice will be presumed to contain MSC 7852, Bethesda, MD 20892, 301–435– proposed data collection projects, the
business confidential information and 1050, freundr@csr.nih.gov. National Institutes of Health, Office of
any release of information in these Name of Committee: Center for Scientific Policy and Extramural Research
license applications will be made only Review Special Emphasis Panel; Administration (OPERA), Office of
as required and upon a request under Fellowships: Endocrinology, Metabolism, Extramural Research (OER), Office of
Nutrition, and Reproductive Science. the Director (OD) will publish periodic
the Freedom of Information Act, 5
Date: April 6, 2018. summaries of propose projects to be
U.S.C. 552. Time: 10:00 a.m. to 6:00 p.m. submitted to the Office of Management
Dated: March 8, 2018. Agenda: To review and evaluate grant
and Budget (OMB) for review and
Richard U. Rodriguez, applications.
Place: National Institutes of Health, 6701
approval.
Associate Director, Technology Transfer
Center, National Cancer Institute. Rockledge Drive, Bethesda, MD 20892 DATES: Comments regarding this
(Virtual Meeting). information collection are best assured
[FR Doc. 2018–05310 Filed 3–15–18; 8:45 am]
Contact Person: Elaine Sierra-Rivera, Ph.D., of having their full effect if received
BILLING CODE 4140–01–P Scientific Review Officer, EMNR IRG, Center within 60 days of the date of this
for Scientific Review, National Institutes of publication.
Health, 6701 Rockledge Drive, Room 6182
DEPARTMENT OF HEALTH AND MSC 7892, Bethesda, MD 20892, 301 435– FOR FURTHER INFORMATION CONTACT: To
HUMAN SERVICES 2514, riverase@csr.nih.gov. obtain a copy of the data collection
Name of Committee: Center for Scientific plans and instruments, submit
National Institutes of Health Review Special Emphasis Panel; Member comments in writing, or request more
Conflict: AIDS and AIDS Related Research. information on the proposed project,
Center for Scientific Review; Notice of Date: April 6, 2018. contact: Kathy Hancock, Asst. Grants
Closed Meetings Time: 1:00 p.m. to 5:00 p.m. Compliance Officer, Division of Grants
Agenda: To review and evaluate grant Compliance and Oversight, Office of
Pursuant to section 10(d) of the applications.
Federal Advisory Committee Act, as Policy for Extramural Research
Place: National Institutes of Health, 6701 Administration, 6705 Rockledge Drive,
amended, notice is hereby given of the Rockledge Drive, Bethesda, MD 20892
following meetings. Suite 350, Bethesda, Maryland 20892 or
(Telephone Conference Call).
Contact Person: Jingsheng Tuo, Ph.D., call non-toll-free number 301–435–0949
The meetings will be closed to the
Scientific Review Officer, Center for or Email your request to
public in accordance with the
Scientific Review, National Institutes of FCOICompliance@mail.nih.gov. Formal
provisions set forth in sections
Health, 6701 Rockledge Drive, Room 5207, requests for additional plans and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Bethesda, MD 20892, 301–451–8754, tuoj@ instruments must be requested in
as amended. The grant applications and
nei.nih.gov. writing.
the discussions could disclose
confidential trade secrets or commercial (Catalogue of Federal Domestic Assistance SUPPLEMENTARY INFORMATION: Section
Program Nos. 93.306, Comparative Medicine; 3506(c)(2)(A) of the Paperwork
property such as patentable material,
93.333, Clinical Research, 93.306, 93.333,
and personal information concerning Reduction Act of 1995 requires: Written
93.337, 93.393–93.396, 93.837–93.844,
individuals associated with the grant 93.846–93.878, 93.892, 93.893, National
comments and/or suggestions from the
applications, the disclosure of which Institutes of Health, HHS) public and affected agencies are invited
daltland on DSKBBV9HB2PROD with NOTICES
would constitute a clearly unwarranted to address one or more of the following
Dated: March 12, 2018. points: (1) Whether the proposed
invasion of personal privacy.
Melanie J. Pantoja, collection of information is necessary
Name of Committee: Center for Scientific
Program Analyst, Office of Federal Advisory for the proper performance of the
Review Special Emphasis Panel; Member
Committee Policy. function of the agency, including
Conflict: AIDS and AIDS Related Research.
Date: April 3, 2018. [FR Doc. 2018–05308 Filed 3–15–18; 8:45 am] whether the information will have
Time: 1:00 p.m. to 5:00 p.m. BILLING CODE 4140–01–P practical utility; (2) The accuracy of the
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![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11765
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average time
Type of respondents based on applicable Frequency of Total annual
Number of respondents per response
section of regulation responses burden hour
(in hours)
Under 42 CFR 50.605(a)(4) or 45 CFR 950 ................................................................. 1 12 11,400
94.5(a)(4).
Public Website Posting under 42 CFR 2,000 .............................................................. 1 5 10,000
50.605(a)(5) or 45 CFR 94.5(a)(5)
from awardee Institutions.
Under 42 CFR 50.606(c) or 45 CFR 50 9 ................................................................. 3 10 18/60 45
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 dis-
closures 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 associ-
ated 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.
Dated: March 10, 2018. Health, 6701 Rockledge Drive, Room 5122, DEPARTMENT OF HEALTH AND
Lawrence A. Tabak, MSC 7854, Bethesda, MD 20892, 301–237– HUMAN SERVICES
Deputy Director, National Institutes of Health. 9870, xuguofen@csr.nih.gov.
[FR Doc. 2018–05384 Filed 3–15–18; 8:45 am] This notice is being published less than 15 National Institutes of Health
BILLING CODE 4140–01–P days prior to the meeting due to the timing
limitations imposed by the review and Prospective Grant of Exclusive Patent
funding cycle. License: Magnetic Resonance Imaging
DEPARTMENT OF HEALTH AND System and Method for the
Name of Committee: Center for Scientific
HUMAN SERVICES Review Special Emphasis Panel; PAR–17–
Measurement of Geometric Features of
086/7: Tobacco Use and HIV in Low and
Axons (Including Without Limitation
National Institutes of Health Middle-Income Countries.
Diameter, Radius, Perimeter, Volume,
Date: March 28, 2018. Surface and Angle) for the
Center for Scientific Review; Notice of Characterization and Diagnosis of
Time: 11:00 a.m. to 2:00 p.m.
Closed Meetings Agenda: To review and evaluate grant Central Nervous System Diseases and
Pursuant to section 10(d) of the applications. Disorders
Federal Advisory Committee Act, as Place: National Institutes of Health, 6701 AGENCY: National Institutes of Health,
amended, notice is hereby given of the Rockledge Drive, Bethesda, MD 20892 HHS.
following meetings. (Virtual Meeting).
ACTION: Notice.
The meetings will be closed to the Contact Person: Mark P. Rubert, Ph.D.,
public in accordance with the Scientific Review Officer, Center for SUMMARY: The Eunice Kennedy Shriver
provisions set forth in sections Scientific Review, National Institutes of National Institute for Child Health and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Health, 6701 Rockledge Drive, Room 5218,
Human Development (NICHD), an
as amended. The grant applications and MSC 7852, Bethesda, MD 20892, 301–435–
institute of the National Institutes of
the discussions could disclose 1775, rubertm@csr.nih.gov.
Health, Department of Health and
confidential trade secrets or commercial This notice is being published less than 15 Human Services, is contemplating the
property such as patentable material, days prior to the meeting due to the timing grant of an Exclusive Patent License to
and personal information concerning limitations imposed by the review and Brainvivo Ltd. (Brainvivo), located in
individuals associated with the grant funding cycle. Tel Aviv, Israel, to practice the
applications, the disclosure of which (Catalogue of Federal Domestic Assistance inventions embodied in the patent
would constitute a clearly unwarranted Program Nos. 93.306, Comparative Medicine; applications listed in the
invasion of personal privacy. 93.333, Clinical Research, 93.306, 93.333, Supplementary Information section of
Name of Committee: Center for Scientific 93.337, 93.393–93.396, 93.837–93.844, this notice.
Review Special Emphasis Panel; Member 93.846–93.878, 93.892, 93.893, National
DATES: Only written comments and/or
Conflict: BTSS and SAT. Institutes of Health, HHS)
Date: March 26, 2018. complete applications for a license
Time: 2:00 p.m. to 4:00 p.m. Dated: March 12, 2018. which are received by the NCI
daltland on DSKBBV9HB2PROD with NOTICES
Agenda: To review and evaluate grant Melanie J. Pantoja, Technology Transfer Center on or before
applications. Program Analyst, Office of Federal Advisory April 2, 2018 will be considered.
Place: National Institutes of Health, 6701
Committee Policy. ADDRESSES: Requests for copies of the
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call). [FR Doc. 2018–05307 Filed 3–15–18; 8:45 am] patent applications, inquiries, and
Contact Person: Guo Feng Xu, Ph.D., BILLING CODE 4140–01–P comments relating to the contemplated
Scientific Review Officer, Center for Exclusive Patent License should be
Scientific Review, National Institutes of directed to: Surekha Vathyam, Ph.D.,
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Document Created: 2018-03-16 01:12:01
Document Modified: 2018-03-16 01:12:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 11763 |
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