Federal Register, Volume 75, Number 98, May 21, 2010, Pages 28463-28750 Page: 28,691
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Federal Register/Vol. 75, No. 98/Friday, May 21, 2010/Proposed Rules
could manage the FCOI by requiring the
Investigator to reduce his or her
ownership interest by some appropriate
amount, or to sell the ownership interest
in its entirety.
10. PD/PI. This definition would be
new and would mean a project director
or principal investigator of a PHS-
funded research project. We propose to
use "PD/PI" in the regulation in
circumstances in which we may have
traditionally used the term "principal
investigator" (e.g., in the proposed
"investigator" definition, as revised).
11. PHS. We propose to revise the
definition of "PHS" to include a specific
reference to the National Institutes of
Health. NIH is part of the Public Health
Service and provides a substantial
amount of research funding to
Institutions, however, it is not otherwise
referenced specifically in these
regulations. We want to clarify for
Institutions applying for, or receiving,
research funding from the NIH that they
are subject to these PHS regulations.
12. Research. We propose to revise
the definition of "research" to include a
non-exclusive list of examples of
different types of PHS funding
mechanisms to which the definition
applies. As revised, the definition
would include any activity for which
research funding is available from a PHS
Awarding Component through a grant,
cooperative agreement, or contract
whether authorized under the PHS Act
or other statutory authority, such as a
research grant, career development
award, center grant, individual
fellowship award, infrastructure award,
institutional training grant, program
project, or research resources award.
13. Significant Financial Interest. We
propose to revise substantially the
definition of "significant financial
interest" (SFI). Under the current
regulations, a SFI means anything of
monetary value, including but not
limited to, salary or other payments for
services (e.g., consulting fees or
honoraria); equity interests (e.g., stocks,
stock options or other ownership
interests); and intellectual property
rights (e.g., patents, copyrights and
royalties from such rights). The term
does not include: (1) Salary, royalties, or
other remuneration from the applicant
institution; (2) any ownership interests
in the institution, if the institution is an
applicant under the SBIR or STTR
programs; (3) income from seminars,
lectures, or teaching engagements
sponsored by public or nonprofit
entities; (4) income from service on
advisory committees or review panels
for public or nonprofit entities; (5) an
equity interest that when aggregated forthe Investigator and the Investigator's
spouse and dependent children meets
both of the following tests: does not
exceed $10,000 in value as determined
through reference to public prices or
other reasonable measures of fair market
value, and does not represent more than
a five percent ownership interest in any
single entity; or (6) salary, royalties, or
other payments that when aggregated for
the investigator and the investigator's
spouse and dependent children over the
next twelve months, are not expected
(or, in the case of PHS contracts, are not
reasonably expected) to exceed $10,000.
We propose to revise the definition of
"significant financial interest" as
follows, incorporating the proposed
definitions of "financial interest" and
"institutional responsibilities" described
above:
"Significant financial interest means,
except as otherwise specified in this
definition: "(1) A financial interest
consisting of one or more of the
following interests of the Investigator
(and those of the Investigator's spouse
and dependent children) that reasonably
appears to be related to the
Investigator's institutional
responsibilities:
"(i) With regard to any publicly traded
entity, a significant financial interest
exists if the value of any remuneration
received from the entity in the twelve
months preceding the disclosure and
the value of any equity interest in the
entity as of the date of disclosure, when
aggregated, exceeds $5,000. For
purposes of this definition,
remuneration includes salary and any
payment for services not otherwise
identified as salary (e.g., consulting fees,
honoraria, paid authorship, travel
reimbursement); equity interest includes
any stock, stock option, or other
ownership interest, as determined
through reference to public prices or
other reasonable measures of fair market
value;
"(ii) With regard to any non-publicly
traded entity, a significant financial
interest exists if the value of any
remuneration received from the entity
in the twelve months preceding the
disclosure, when aggregated, exceeds
$5,000, or the Investigator (or the
Investigator's spouse or dependent
children) holds any equity interest (e.g.,
stock, stock option, or other ownership
interest); or
"(iii) Intellectual property rights (e.g.,
patents, copyrights), royalties from such
rights, and agreements to share in
royalties related to such rights.
"(2) The term significant financial
interest does not include the following
types of financial interests: salary,
royalties, or other remuneration paid bythe Institution to the Investigator if the
Investigator is currently employed or
otherwise appointed by the Institution;
any ownership interest in the Institution
held by the Investigator, if the
Institution is a commercial or for-profit
organization; income from seminars,
lectures, or teaching engagements
sponsored by a federal, state, or local
government agency, or an institution of
higher education as defined at 20 U.S.C.
1001(a); or income from service on
advisory committees or review panels
for a federal, state, or local government
agency, or an institution of higher
education as defined at 20 U.S.C.
1001(a)."
This revised SFI definition would
differ from the current SFI definition in
a number of respects.
Institutional responsibilities: As
indicated in the discussion of the
"institutional responsibilities" definition
above, SFIs subject to disclosure by an
Investigator to an Institution would be
those that reasonably appear to be
related to the Investigator's
"institutional responsibilities" and
would not be specific to a particular
PHS-funded research project. As a
result, when read in conjunction with
the revised Investigator disclosure
requirements under 42 CFR 50.604 and
45 CFR 94.4 (discussed below), we
anticipate that the revised SFI definition
would result in the disclosure by
Investigators to Institutions of a wider
array of interests on a more frequent
basis. This proposed approach is
consistent with many of the comments
we received in response to the ANPRM,
which supported expansion of the SFIs
that should be disclosed by Investigators
to Institutions.
Monetary threshold: The revised SFI
definition also would lower-and, in
some circumstances, eliminate-the
existing monetary thresholds for
disclosure. Under the current
regulations, a SFI does not include an
equity interest that when aggregated for
the investigator and the investigator's
spouse and dependent children, meets
both of the following tests: Does not
exceed $10,000 in value, and does not
represent more than a five percent
ownership interest in any single entity.
Similarly, a SFI does not include
payments (e.g., salary) that when
aggregated for the Investigator and the
Investigator's spouse and dependent
children over the next twelve months
are not expected to exceed $10,000. The
revised definition would differentiate
between remuneration to the
Investigator (and the Investigator's
spouse and dependent children) from a
publicly traded entity and remuneration
from a non-publicly traded entity. Withregard to a publicly traded entity, a
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United States. Office of the Federal Register. Federal Register, Volume 75, Number 98, May 21, 2010, Pages 28463-28750, periodical, May 21, 2010; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc52679/m1/237/: accessed April 25, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.