The SRA Symposium - College of Medicine
The SRA Symposium - College of Medicine
The SRA Symposium - College of Medicine
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lowed holdings capped at $15,000.00. (70 FR 22 (2005), at 5550 - 55510.) But even this exception,<br />
the HHS Federal Register Notice cautioned, might violate the provisions <strong>of</strong> the criminal conflict <strong>of</strong><br />
interest statute at 18 U.S.C. §208.<br />
Mandatory divestitures by NIH employees had to come within 90 days—180 days on showing <strong>of</strong><br />
“good cause.” Certificates <strong>of</strong> financial divestiture could provide deferred tax consequences under<br />
subpart J <strong>of</strong> 5 C.F.R. part 2634—but only if the employee delayed divestiture until having complied<br />
with “the requisite procedures.” (70 FR 22 (2005), at 5551.)<br />
Under the February 2005 Notice and the provisions <strong>of</strong> 5 C.F.R. §5501.111, HHS “depart[ed] from<br />
executive branch uniformity” such that senior NIH employees “and others with <strong>of</strong>ficial responsibility<br />
for matters affecting donor organizations” were prohibited from accepting certain awards<br />
from outside sources—and in any case awards in excess <strong>of</strong> $200.00. (70 FR 22 (2005), at 5552.)<br />
<strong>The</strong> Notice allowed the NIH Director to grant a written exception for acceptance <strong>of</strong> a Nobel Prize<br />
in Physiology or <strong>Medicine</strong> or a Lasker Medical Research Award because “the award will further an<br />
agency interest because it confers and exceptionally high honor * * *.” (70 FR 22 (2005), at 5553.)<br />
HHS amendments at <strong>of</strong> 5 C.F.R. §5501.112 generally barred any NIH employee who have accepted<br />
an award within a year otherwise permitted under <strong>of</strong> 5 C.F.R. §2635.204(d) or §5501.111 from<br />
participating in any matter in which the award donor was involved. (70 FR 22 (2005), at 5554.)<br />
3. <strong>The</strong> New-est Predicate: August 31, 2005<br />
In the wake <strong>of</strong> the 2003 dawn attack, the 2004 Congressional hand-wringing and public thrashings<br />
and the Februry 2005 first round <strong>of</strong> draconian regulations, NIH employees were promised on August<br />
26, 2005, that the new and Final Rule would be posted on the agency website by the next day.<br />
HHS missed its self-imposed deadline. (To be wholly accurate, the deadline had been announced<br />
by NIH management.)<br />
But on Wednesday, August 31, 2005, the agency published its Final Rule at 70 FR 168, at 51559<br />
– 51574. (70 FR 168 (2005)).<br />
Some <strong>of</strong> the changes from the February 3, 2005, rules follow.<br />
Papers<br />
<strong>The</strong> regulations at 5 C.F.R. §5501.101(c) provided that terms used in part 5501 were—unless specifically<br />
defined otherwise—to be defined and understood consistently with the meanings set out<br />
in parts 2635 and 2640 <strong>of</strong> the regulation. Terms included in that listing include “holdings,” “pension<br />
plan,” and “sector mutual funds.” (70 FR 168 (2005), at 51560.)<br />
Changes in the regulations at 5 C.F.R. §5501.102, HHS said, clarified a prior ambiguity in the<br />
definition <strong>of</strong> an “employee” to focus on “the regularly assigned duties and responsibilities <strong>of</strong> an<br />
individual employee rather than that person’s location within the organization.” (70 FR 168 (2005),<br />
at 51560.)<br />
<strong>The</strong> amendments at 5 C.F.R. §5501.106 revised the exception to the FDA prohibited outside activity<br />
rule at §5501.106(c)(3). <strong>The</strong> Notice continued:<br />
2005 <strong>Symposium</strong> Proceedings Book 83