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HHS Ethics Reform

As you may be aware, HHS has recently undergone significant Ethics Reform, which has resulted in certain restrictions on NIH employees primarily. The effective date for the revised HHS Standards of Supplemental Conduct was February 3, 2005. This message is to provide a brief summary of the new regulations and to explain how the new rules impact CDC. Attached is a side-by-side comparison, which summarizes the Ethics Reform from NIH's perspective and from CDC's perspective. As you will note, the new regulations impose significant restrictions on NIH employees pertaining to activities with outside organizations, prohibited financial holdings and awards to NIH employees. At this time, HHS has decided not to impose these additional restrictions to CDC employees.

Pursuant to the revised Supplemental Regulations, all HHS employees (including CDC employees) for whom outside employment or activity has been approved or who has participated in any outside activity for which prior approval is required, must file an Annual Supplemental Report for all such activities undertaken in the previous calendar year. The deadline for the 2005 Annual Supplemental Report is April 29, 2005. This Annual Supplemental Report should be documented on the HHS-521 form. HHS will make this form available in late March 2005.

Please forward this message to members of your staff for their information. Any questions or concerns regarding this matter should be forwarded to the CDC Ethics Office at ethics@cdc.gov or at the numbers below.


CDC Ethics Regulations

Outside Activities

Requests for approval must be documented on the HHS-520 form. Approval of an outside activity is effective for one year only and must be renewed annually.

Annual Supplemental Report

Any employee for whom outside employment or activity has been approved or who has participated in any outside activity for which prior approval is required must file an annual report for all such activities undertaken in the previous calendar year.*

What Activities Are Not Allowed?

The CDC Ethics Office performs a conflict of interest analysis on CDC employees’ outside activity approval requests on a case-by-case basis. CDC employees are not subject to the new NIH-specific ethics regulations that prohibit outside activities with certain entities.

Outside activities which require advance approval include the following:

  • Writing, editing, or publishing that relates to official duties
  • Teaching, lecturing, or speechmaking that relates to official duties
  • All professional and consultative services, including outside private practice
  • Service on boards or committees, or office-holding activities in professional societies
  • Other activities which specifically employ the general professional expertise related to the employee's CDC responsibilities

* Annual Reports Due April 29, 2005 on the HHS 521 (Forms will be made available in late March)

NIH Ethics Reform

Outside Activities

Requests for approval must be documented on the HHS-520 form. Approval of an outside activity is effective for one year only and must be renewed annually.

Annual Supplemental Report

Any employee for whom outside employment or activity has been approved or who has participated in any outside activity for which prior approval is required must file an annual report for all such activities undertaken in the previous calendar year.*

What Activities Are not Allowed?

Compensated or uncompensated employment, including consulting and advisory or other board service, and compensated teaching, speaking, writing, or editing

With or for the following entities:

  • Substantially affected organizations (includes biotechnology, pharmaceutical,
    medical device companies)
  • Hospitals, clinics, health maintenance organizations, or other health care providers
  • Health insurers
  • Health, science, or health research-related trade organizations, professional associations, or consumer or advocacy groups
  • Educational institutions or non-profit independent research institutes that are or recently were NIH funding applicants, grantees, contractors, or CRADA partners

Also:

NIH employees are prohibited from engaging in self-employment activities involving the sale or promotion of the services or products of the above entities.

* Annual Reports Due April 29, 2005 on the HHS 521 (Forms will be made available in late March)

CDC Financial Disclosure

The CDC Ethics Office performs a conflict of interest analysis on CDC employees’ financial disclosure forms on a case-by-case basis. CDC employees are not subject to the new NIH-specific ethics regulations with respect to prohibited holdings.

CDC employees who file public (SF 278) or confidential (OGE 450) financial disclosure reports are required to disclose their financial interests as well as the interests of their spouse and minor children.

What Must Be Reported:

  • Any interest in property held in a trade or business or for investment or the production of income (real estate, stocks, bonds, securities, futures contracts, beneficial interests in trusts or estates, pensions and annuities, mutual funds, etc.) that meet reporting thresholds
  • Earned income, retirement benefits, honoraria and any other non-investment income
  • Gifts and reimbursements that meet reporting thresholds
  • Liabilities (exceptions apply)
  • Agreements or arrangements with respect to future employment, leaves of absence and continuation of payments or benefits from a former employer; and
  • Outside positions such as an officer, director, trustee, general partner, proprietor, employee, consultant, etc. of any organization.

 

NIH Financial Disclosure

Prohibited Holdings

NIH employees who file public (SF 278) or confidential (OGE 450) financial disclosure reports (and their spouses and minor children) are prohibited:

  • From acquiring or holding financial interests, such as stock, in substantially affected organizations, which include biotechnology, pharmaceutical, and medical device companies and others involved in the research, development, or manufacture of medical devices, equipment, preparations, treatments, or products.
  • Other employees (and their spouses and minor children) who do not file either of these reports are subject to a $15,000 cap on holdings in such companies.

Divestiture:

Employees may have up to 150 days to divest of holdings to comply with the law.

Employees who qualify may apply for a Certificate of Divestiture before selling in order to defer capital gains taxes.

Exception:

Holdings are allowed when resulting from a pension or other employee benefit, arising from employment with a substantially affected organization and widely diversified, publicly traded mutual funds.

Awards To CDC Employees

Employees may accept awards from outside organizations subject to the following guidelines:

  • An employee may accept an award for meritorious public service or achievement, including work performed at CDC if given by a donor who is not substantially affected by the performance or nonperformance of the employee’s official duties.
  • An award that is not a cash award, and has a market value of less than or equal to $200, may be accepted it is a bona fide award, or incident to a bona fide award, that is given for meritorious public service or achievement.*
  • An award that is either a cash award or investment interest, or which has a market value of more than $200, must be reviewed and approved in writing and requires a prior written determination by the Deputy Ethics Counselor that the award is made as part of an established program of recognition.

Awards That May Not Be Accepted

Awards may not be accepted from entities that have interests that may be substantially affected by the performance or nonperformance of the employee's official duties.

* Employees are encouraged to contact the Ethics Office before the receipt of any type of award.

Awards To NIH Employees

Senior employees may not receive a gift that is cash or an investment interest, or that has an aggregate market value of more than $200 that:

  • Is given because of employee’s their official position or from a prohibited source.

Other employees having official responsibility for matters involving or affecting the donor may not receive gifts with an aggregate market value of more than $200, or that is cash or an investment.

Non-senior employees or employees who do not have official duty matters involving the donor, may accept bona fide awards for meritorious public service if:

  • Such awards have been reviewed by an independent advisory committee; and
  • The award is recommended for approval because it meets the regulatory criteria, and the employee is individually approved to receive such an award.
  • Employees, generally, may receive awards that are nothing more than plaques or trophies of little intrinsic value.

Exception:

Prestigious awards that confer an
exceptionally high honor in the fields of medicine or scientific research are acceptable, e.g., Nobel, Lasker, if the award is otherwise approvable.

One Year Disqualification

For one year following the receipt of an award under this provision, an employee is prohibited from participating in any particular matter involving the donor unless authorized by an agency designee.

Last Reviewed: June 7, 2005