We Don't Know Yet
you know, the new
rules set deadlines. The time for compliance with some of the provisions
draws near. However, some employees may be unable to fulfill their obligations
under the regulations because there are implementation questions unanswered
and necessary procedures yet to be established. Please continue to be
patient. We are working as quickly as possible to get answers, to make
the rules clear and understandable, and to make their implementation fair
and efficient. Here are the most critical details we are working out as
The NIH Catalyst goes to press:
application of the rules to various members of the NIH community.
Certain classes of NIHers may be exempt from the total prohibited holding
ban or may be switched from the total ban to the de minimis rule.
the stock divestiture period will begin.
Right now, its set for April 5, but an extension of the filing date
for the supplemental disclosure reports may be issued. If this happens,
it will also push back the start of the divestiture period.
breadth of the definition of "substantially affected organization
(SAO)." The definition says that an SAO is an entity that
is "significantly involved, directly or through subsidiaries, in
the research, development, or manufacture of biotechnological, biostatistical,
pharmaceutical, or medical devices, equipment, preparations, treatments,
or products." But "significantly involved" still needs
to be interpreted.
employees should report the information required by the new rules.
We are revising and developing some new forms and will distribute
these shortly, along with instructions for their use.
operating procedures. There are numerous procedural provisions
in the regulations, several of which allow employees to ask for extensions,
exemptions, exceptions, or waivers of the application of the rules. For
now, employees should file any such requests with their IC ethics office.
As we get answers,
procedures, or changes in the COI policies, we will send out NIH-Staff-list
messages and post the updates through a link on the NIH
Office of Intramural Research
TO SEND YOUR COMMENTS
NIH community may be able to have an impact on whether and how the the
rules are changed. Anyone interested in expressing their views can communicate
with NIH leadership and federal regulators at the addresses below.
To respond to the federal regulators regarding the February
3 Federal Register regulation, comments must
be submitted by April 4, 2005.
Write to: Office
of the General Counsel, Ethics Division, DHHS, Room 700-E, Hubert H. Humphrey
Bldg., 200 Independence Ave. SW, Washington, DC 20201, Attn. Linda L.
Or send e-mail HERE.
Important: The subject line should include: "Comments on Interim
Final HHS Supplemental Ethics Rule."
To contact NIH leadership, send e-mail HERE.
Important: The subject
line should begin with: "Question:" or "Comment:"
Note that this address is accessible to individuals outside NIH.