[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR73a.735-501]



[Page 202]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 73a_STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION 

SUPPLEMENT--Table of Contents

 

                      Subpart E_Financial Interests

 

Sec.  73a.735-501  General provisions.





    (a) No restrictions are placed on ownership of diversified mutual 

funds.

    (b) An FDA employee, other than a control activity employee (defined 

in Sec.  73a.735-502), may have financial interests:

    (1) In an organization whose FDA-regulated activities are an 

insignificant part of its total operations, i.e., no more than 10 

percent of the organization's annual gross sales are in products 

regulated by FDA; or

    (2) In an organization whose FDA-regulated business activities are a 

significant part of its total business operations: Provided, That:

    (i) The holding is less than $5,000 (value or cost at time of 

initial reporting),

    (ii) The holding represents less than 1 percent of the total 

outstanding stock shares of that organization, and

    (iii) No more than 50 percent of the employee's total investment 

value is concentrated in organizations whose FDA-regulated business 

activities are a significant part of their business operations.

    (c) Notwithstanding the provisions of this part permitting employees 

to hold financial interests in organizations subject to FDA regulation, 

an employee holding such an interest shall not participate in an 

official matter whose outcome would have a direct and predictable effect 

on his financial interest. However, this prohibition is not applicable 

to:

    (1) Diversified mutual funds, which are exempted from 18 U.S.C. 208 

by Sec.  73.735-501(a) of this chapter.

    (2) Financial interests for which the Commissioner has in advance 

granted a written exception on the ground that the public interest would 

be served if a particular employee is allowed to participate in an 

official matter whose outcome may have a direct and predictable effect 

on the employee's financial interest. Such exemptions will be granted 

only in exceptional circumstances. Any determination to authorize such 

exceptions shall be made in accordance with 18 U.S.C. 208(b)(1) and 

documented for public inspection in accordance with Sec.  73a.735-504.