[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR73a.735-502]

[Page 197]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 73a--STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT
--Table of Contents
 
                     Subpart E--Financial Interests
 
Sec. 73a.735-502  Employees in regulatory activities.

    (a) An employee in regulatory activities (``control activity'' 
employee) may hold financial interests in an FDA-regulated organization 
only if either of the following conditions are met:
    (1) The regulated activities of the organization are an 
``insignificant'' part of its total business operations, or
    (2) Written approval for an individual exception is granted by the 
Commissioner in accordance with Sec. 73a.735-504; however, such approval 
will not be considered unless all of the following conditions are met:
    (i) Retention of the financial interest does not give rise to an 
actual conflict of interest;
    (ii) Acquisition of the financial interest occurred by marriage or 
inheritance, or the interest was held prior to an FDA reorganization, 
change in regulations, or similar circumstances beyond the control of 
the employee that resulted in the interest becoming prohibited;
    (iii) No direct relationship exists between the employee's official 
duties and the regulated activities of the organization in which the 
financial interest is held;
    (iv) The employee occupies a position below that of Bureau/Deputy 
Bureau Director (or Assistant/Deputy General Counsel, Food and Drug 
Division, Office of the General Counsel); and
    (v) The employee agrees to refrain from engaging, either directly or 
indirectly, in transactions that are designed to increase the value of 
his ``excepted'' financial interest.
    (b) To administer provisions within this part, the following 
interpretations apply:
    (1) A ``control activity'' employee (``control activity'' positions 
are identified in Appendix C to Part 73 of this chapter), means one who:
    (i) Occupies an FDA position classified at GS-11 or above, or PHS 
Commissioned Officer 0-3 or above, or equivalent;
    (ii) Occupies an FDA position below GS-11 with duties of a nature 
that the employee could in the discharge of his official duties and 
responsibilities cause an economic advantage for or impose a handicap on 
a non-Federal enterprise (includes investigators, inspectors, regulatory 
analysts);
    (iii) Occupies a position at GS-11 or above in the Office of the 
Assistant General Counsel, Food and Drug Division.
    (2) ``Insignificant'' (part of an organization's total business 
operations) means that the FDA-regulated products constitute no more 
than 10 percent of the organization's annual gross sales.