August 31, 2005
The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This final rule adopts, with certain revisions, the changes made to 5 CFR part 5501 in the interim final rule that was published on February 3, 2005, at 70 FR 5543. After considering comments to that rulemaking, this final rule: Clarifies the definition of an “employee of a component;” Amends the outside activity prior approval requirements applicable to employees of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH); Revises prior approval information collection requirements and the waiver provision applicable to the outside activities prohibitions; Removes professional associations and other science and health-related organizations from the list of entities with which NIH employees are prohibited from engaging in outside activities; Adds exceptions to the NIH outside activities prohibition for delivering a class lecture as part of a regularly scheduled university course, serving on data and safety monitoring boards and grant and scientific review committees, and presenting in Grand Rounds; Limits the prohibition on holding financial interests in substantially affected organizations to senior NIH employees, their spouses, and minor children only, permits investments in such organizations that do not exceed $15,000, and allows holdings capped at $50,000 in sector mutual funds that concentrate their investments in the securities of substantially affected organizations; and Revises the outside award limitations for senior NIH employees by applying an official responsibility test for matters potentially involving an award donor. In addition, the financial disclosure reporting requirements specified in new part 5502 that were added by the interim final rule of February 3, 2005, at 70 FR 5543, and amended by an interim final rule that was published on June 28, 2005, at 70 FR 37009, are adopted as final, subject to certain amendments. The requirement to file a supplemental disclosure of financial interests in substantially affected organizations is refocused to apply to NIH employees who file a public or confidential financial disclosure report and other NIH employees who are designated as investigators in an NIH clinical research protocol approved by an institutional review board. The due date for the initial report is also changed.
https://www.govinfo.gov/content/pkg/FR-2005-08-31/pdf/05-17352.pdf