04.12.2012 Views

The SRA Symposium - College of Medicine

The SRA Symposium - College of Medicine

The SRA Symposium - College of Medicine

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

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

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!