[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.735-502]



[Page 202-203]

 

                        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.735-502  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:



[[Page 203]]



    (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.