[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.70]

[Page 78-79]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
        Subpart D_Responsibilities of Sponsors and Investigators
 
Sec. 312.70  Disqualification of a clinical investigator.

    (a) If FDA has information indicating that an investigator 
(including a sponsor-investigator) has repeatedly or deliberately failed 
to comply with the requirements of this part, part 50, or part 56 of 
this chapter, or has submitted to

[[Page 79]]

FDA or to the sponsor false information in any required report, the 
Center for Drug Evaluation and Research or the Center for Biologics 
Evaluation and Research will furnish the investigator written notice of 
the matter complained of and offer the investigator an opportunity to 
explain the matter in writing, or, at the option of the investigator, in 
an informal conference. If an explanation is offered but not accepted by 
the Center for Drug Evaluation and Research or the Center for Biologics 
Evaluation and Research, the investigator will be given an opportunity 
for a regulatory hearing under part 16 on the question of whether the 
investigator is entitled to receive investigational new drugs.
    (b) After evaluating all available information, including any 
explanation presented by the investigator, if the Commissioner 
determines that the investigator has repeatedly or deliberately failed 
to comply with the requirements of this part, part 50, or part 56 of 
this chapter, or has deliberately or repeatedly submitted false 
information to FDA or to the sponsor in any required report, the 
Commissioner will notify the investigator and the sponsor of any 
investigation in which the investigator has been named as a participant 
that the investigator is not entitled to receive investigational drugs. 
The notification will provide a statement of basis for such 
determination.
    (c) Each IND and each approved application submitted under part 314 
containing data reported by an investigator who has been determined to 
be ineligible to receive investigational drugs will be examined to 
determine whether the investigator has submitted unreliable data that 
are essential to the continuation of the investigation or essential to 
the approval of any marketing application.
    (d) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are inadequate to support a conclusion that it is 
reasonably safe to continue the investigation, the Commissioner will 
notify the sponsor who shall have an opportunity for a regulatory 
hearing under part 16. If a danger to the public health exists, however, 
the Commissioner shall terminate the IND immediately and notify the 
sponsor of the determination. In such case, the sponsor shall have an 
opportunity for a regulatory hearing before FDA under part 16 on the 
question of whether the IND should be reinstated.
    (e) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the continued approval of the drug product for which the data were 
submitted cannot be justified, the Commissioner will proceed to withdraw 
approval of the drug product in accordance with the applicable 
provisions of the act.
    (f) An investigator who has been determined to be ineligible to 
receive investigational drugs may be reinstated as eligible when the 
Commissioner determines that the investigator has presented adequate 
assurances that the investigator will employ investigatioal drugs solely 
in compliance with the provisions of this part and of parts 50 and 56.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 
FR 11580, Mar. 29, 1990; 62 FR 46876, Sept. 5, 1997; 67 FR 9586, Mar. 4, 
2002]