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), 45455-45457 [2018-19339]
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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
FDA website listed in the previous
sentence to find the most current
version of the guidance.
III. Paperwork Reduction Act
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 101.36 have
been approved under OMB control
number 0910–0381.
Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19367 Filed 9–6–18; 8:45 am]
forth in the National Organ Transplant
Act of 1984, as amended.
The charter renewal for the ACOT
was approved on August 31, 2018,
which will also stand as the filing date.
Renewal of the ACOT charter gives
authorization for the Committee to
operate until August 31, 2020.
A copy of the ACOT charter is
available on the ACOT website at:
https://www.organdonor.gov/legislation/
advisory.html. A copy of the charter can
also be obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The website for the
FACA database is https://
www.facadatabase.gov/.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
BILLING CODE 4164–01–P
[FR Doc. 2018–19454 Filed 9–6–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4165–15–P
Charter Renewal for the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration (HRSA), The
Department of Health and Human
Services (HHS).
ACTION: Notice of charter renewal.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
HHS is hereby giving notice
that the Advisory Committee on Organ
Transplantation (ACOT) has been
rechartered. The effective date of the
renewed charter is August 31, 2018.
FOR FURTHER INFORMATION CONTACT:
Robert Walsh, Executive Secretary,
Advisory Committee on Organ
Transplantation, Health Resources and
Services Administration, Department of
Health and Human Services, Room
08W60, 5600 Fishers Lane, Rockville,
Maryland 20857. Phone: (301) 443–
6839; fax: (301) 594–6095; email:
rwalsh@hrsa.gov.
SUPPLEMENTARY INFORMATION: The ACOT
was authorized by section 121.12 of the
amended Final Rule of the Organ
Procurement and Transplantation
Network (OPTN) (42 CFR part 121). In
accordance with the Federal Advisory
Committee Act (FACA), Public Law 92–
463, it was initially chartered on
September 1, 2000, and was renewed at
the appropriate intervals.
The ACOT provides advice to the
Secretary on all aspects of organ
donation, procurement, allocation, and
transplantation, and on such other
matters that the Secretary determines.
The recommendations of the ACOT will
facilitate the Department’s efforts to
oversee the Organ Procurement and
Transplantation Network (OPTN), as set
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SUMMARY:
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National Institutes of Health
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.
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.
SUMMARY:
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,
OIRA_submission@omb.eop.gov 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
ADDRESSES:
PO 00000
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45455
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: deand@
od31em1.od.nih.gov.
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-
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
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
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.
Number of
responses per
respondent
Total annual
burden hours
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).
5 Mitigation Reports .....................
2,031 ............................................
1
2
100
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 1 ..........................................
1
1
3,000
38,000 ..........................................
1
4
152,000
38,000 ..........................................
1
1
38,000
992 ...............................................
1
30/60
496
2,000 ............................................
1
1
2,000
2,000 2 ..........................................
1
82
164,000
500 3 .............................................
1
3
1,500
50 4 ...............................................
1
80
4,000
50 5 ...............................................
1
80
4,000
50 .................................................
1
1
50
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.
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).
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) .............
992 ...............................................
2,000 ............................................
1
1
12
5
11,904
10,000
50 6 ...............................................
73
18/60
45
Total ....................................................................
136,282 ........................................
136,382
........................
677,820
1 Assuming
that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all Investigators.
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.
2 Although
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Average
burden
per response
(in hours)
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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
Dated: August 30, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018–19339 Filed 9–6–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2018–0791]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0018
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting an
extension of its approval for the
following collection of information:
1625–0018, Official Logbook; without
change. Our ICR describes the
information we seek to collect from the
public. Before submitting this ICR to
OIRA, the Coast Guard is inviting
comments as described below.
DATES: Comments must reach the Coast
Guard on or before November 6, 2018.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2108–0791] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public participation and
request for comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–612), Attn: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE, Stop
7710, Washington, DC 20593–7710.
FOR FURTHER INFORMATION CONTACT: Mr.
Anthony Smith, Office of Information
Management, telephone 202–475–3532,
or fax 202–372–8405, for questions on
these documents.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
Public Participation and Request for
Comments
This Notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. Chapter 35, as amended. An
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ICR is an application to OIRA seeking
the approval, extension, or renewal of a
Coast Guard collection of information
(Collection). The ICR contains
information describing the Collection’s
purpose, the Collection’s likely burden
on the affected public, an explanation of
the necessity of the Collection, and
other important information describing
the Collection. There is one ICR for each
Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology. In response to
your comments, we may revise this ICR
or decide not to seek an extension of
approval for the Collection. We will
consider all comments and material
received during the comment period.
We encourage you to respond to this
request by submitting comments and
related materials. Comments must
contain the OMB Control Number of the
ICR and the docket number of this
request, [USCG–2018–0791], and must
be received by November 6, 2018.
Submitting Comments
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that website’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
the docket, you may review a Privacy
Act notice regarding the Federal Docket
Management System in the March 24,
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45457
2005, issue of the Federal Register (70
FR 15086).
Information Collection Request
Title: Official Logbook.
OMB Control Number: 1625–0018.
Summary: The Official Logbook
contains information about the voyage,
the vessel’s crew, drills, watches, and
operations conducted during the
voyage. Official Logbook entries identify
particulars of the voyage, including the
name of the ship, official number, port
of registry, tonnage, names and
merchant mariner credential numbers of
the master and crew, the nature of the
voyage, and class of ship. In addition, it
also contains entries for the vessel’s
drafts, maintenance of watertight
integrity of the ship, drills and
inspections, crew list and report of
character, a summary of laws applicable
to Official Logbooks, and miscellaneous
entries.
Need: Title 46 U.S.C. 11301, 11302,
11303, and 11304 require applicable
merchant vessels to maintain an Official
Logbook. The Official Logbook contains
information about the vessel, voyage,
crew, and watch. Lack of these
particulars would make it difficult for a
seaman to verify vessel employment and
wages, and for the Coast Guard to verify
compliance with laws and regulations
concerning vessel operations and safety
procedures. The Official Logbook serves
as an official record of recordable events
transpiring at sea such as births, deaths,
marriages, disciplinary actions, etc.
Absent the Official Logbook, there
would be no official civil record of these
events. The courts accept log entries as
proof that the logged event occurred. If
this information was not collected, the
Coast Guard’s commercial vessel safety
program would be negatively impacted,
as there would be no official record of
U.S. merchant vessel voyages. Similarly,
those seeking to prove that an event
required to be logged occurred would
not have an official record available.
Forms: CG–706B, Official Logbook.
Respondents: Shipping companies.
Frequency: On occasion.
Hour Burden Estimate: The estimated
annual burden remains at 1,750 hours a
year.
Authority: The Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended.
Dated: August 30, 2018.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of
Information Management.
[FR Doc. 2018–19412 Filed 9–6–18; 8:45 am]
BILLING CODE 9110–04–P
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]]>Agencies
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45455-45457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19339]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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-
[[Page 45456]]
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents based on Number of respondents responses per per response Total annual
applicable section of regulation respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
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) or CFR 50.605(a)(3)(ii)
45 CFR 94.5(a)(3)(iii) and (b)(2) and 45 CFR
from awardee Institutions. 94.5(a)(3)(ii).
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 CFR 2,000................... 1 4 8,000
94.4(i) from awardee institutions.
Disclosure:
Under 42 CFR 50.604(a) or 45 CFR 3,000................... 1 81 243,000
94.4 for Investigators.
Under 42 CFR 50.604(b) or 45 CFR 38,000.................. 1 30/60 19,000
94.4(e)(1) for Investigators.
Under 42 CFR 50.604(b) or 45 CFR 2,000................... 1 6 12,000
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 CFR 3,000 \1\............... 1 1 3,000
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 45 992..................... 1 30/60 496
CFR 94.4(e)(3) for Investigators.
Under 42 CFR 50.604(f) or 45 CFR 2,000................... 1 1 2,000
94.4(f) for institutions.
Under 42 CFR 50.605(a)(1) or 45 2,000 \2\............... 1 82 164,000
CFR 94.5(a)(1) for Institutions.
Under 42 CFR 50.605(a)(3) or 45 500 \3\................. 1 3 1,500
CFR 94.5(a)(3) for Institutions.
Under 42 CFR 50.605(a)(3)(i) or 45 50 \4\.................. 1 80 4,000
CFR 94.5(a)(3)(i).
Under 42 CFR 50.605(a)(3)(ii) or 50 \5\.................. 1 80 4,000
45 CFR 94.5(a)(3)(ii).
Under 42 CFR 50.605(a)(3)(iii) or 50...................... 1 1 50
45 CFR 94.5(a)(3)(iii).
Under 42 CFR 50.605(a)(4) or 45 992..................... 1 12 11,904
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 CFR 50 \6\.................. \7\ 3 18/60 45
94.6(c).
-------------------------------------------------------------------------
Total......................... 136,282................. 136,382 .............. 677,820
----------------------------------------------------------------------------------------------------------------
\1\ Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification 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 x 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.
[[Page 45457]]
Dated: August 30, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-19339 Filed 9-6-18; 8:45 am]
BILLING CODE 4140-01-P
