[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.735-201]



[Page 200-201]

 

                        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 B_Miscellaneous Provisions

 

Sec.  73a.735-201  Control activity employees formerly associated with 

organizations subject to FDA regulation.





    (a) For a period of 1 year after FDA appointment, or appointment to 

the Food and Drug Division, Office of the General Counsel, a control 

activity employee who was employed in a regulated organization within 1 

year before FDA employment shall not participate in any regulatory 

action before FDA that involves the former employer organization. 

Exceptions may be authorized only under paragraph (e) of this section.

    (b) A control activity employee who was previously employed in a 

regulated organization shall not participate in any regulatory action 

before FDA in which the employee had participated personally and 

substantially in behalf of the former employer organization, e.g., drug 

investigations/applications, food additive petitions, matters dealing 

with compliance in areas of radiation-producing products or medical 

devices. Exceptions may be authorized only under paragraph (e) of this 

section.



[[Page 201]]



    (c) Employment in a regulated organization includes contractual 

relationships, e.g., attorneys who may have represented an FDA-regulated 

firm or industry or an association of such firms and individuals who may 

have served a firm, industry or association in a consultant capacity.

    (d) Within 30 days after assignment to a control activity position, 

an employee shall submit to his supervisor detailed information 

concerning former industry employers, and dates and substance of 

involvement in such regulatory matters as may be subject to the 

prohibition in paragraph (b) of this action.

    (e) The Commissioner may grant individual exceptions to paragraphs 

(a) and (b) of this section whenever he determines that strict 

application would not be in the best interests of the United States. A 

memorandum of any exception granted shall be filed for public inspection 

in the Public Records and Documents Center, Food and Drug 

Administration, Room 4-68, 5600 Fishers Lane, Rockville, Md. 20857, 

within 10 days after the Commissioner's decision. The memorandum shall 

include the employee's name, title, grade, summary of official duties, 

prior pertinent industry involvement, a brief description of the 

specific regulatory action in which the employee has been permitted to 

participate, and a statement explaining why such strict application of 

the subpart would not be in the best interests of the United States.



Subpart C [Reserved]