[Federal Register Volume 71, Number 246 (Friday, December 22, 2006)]
[Rules and Regulations]
[Page 76902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 812

[Docket No. 2006N-0494]


Medical Device Regulations; Disqualification of a Clinical 
Investigator; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending a medical 
device regulation to include references to the Center for Biologics 
Evaluation and Research (CBER) and the Center for Drug Evaluation and 
Research (CDER). This regulation pertains to the disqualification of a 
clinical investigator. Currently, only a reference to the Center for 
Devices and Radiological Health is listed in this regulation. This 
action is being taken to ensure the accuracy of FDA's regulations.

DATES: This rule is effective December 22, 2006.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is amending 21 CFR 812.119(a) to include references to CBER and 
CDER. This regulation pertains to the disqualification of a clinical 
investigator. Currently, only a reference to the Center for Devices and 
Radiological Health is listed in this regulation. The appropriate 
Center that has regulatory responsibility for the medical device 
subject to this regulation is responsible for corresponding with the 
investigator of the study concerning any possible violations of the 
applicable requirements. Therefore, FDA is updating this regulation to 
include the references to CBER and CDER.
    Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that 
notice and public comment are unnecessary because this amendment to the 
regulations provides only a technical change to update references in 
the Code of Federal Regulations, and is nonsubstantive.

List of Subjects in 21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

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Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public 
Health Service Act, and under authority delegated to the Commissioner 
of Food and Drugs, 21 CFR part 812 is amended as follows:

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

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1. The authority citation for 21 CFR part 812 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 
262, 263b-263n.

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2. Section 812.119 is amended by revising paragraph (a) to read as 
follows:


Sec.  812.119  Disqualification of a clinical investigator.

    (a) If FDA has information indicating that an investigator has 
repeatedly or deliberately failed to comply with the requirements of 
this part, part 50, or part 56 of this chapter, or has repeatedly or 
deliberately submitted false information either to the sponsor of the 
investigation or in any required report, the Center for Devices and 
Radiological Health, the Center for Biologics Evaluation and Research, 
or the Center for Drug Evaluation and Research will furnish the 
investigator written notice of the matter under complaint 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 and accepted by the applicable Center, the 
disqualification process will be terminated. If an explanation is 
offered but not accepted by the Center, the investigator will be given 
an opportunity for a regulatory hearing under part 16 of this chapter 
on the question of whether the investigator is entitled to receive 
investigational devices.
* * * * *

    Dated: December 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21952 Filed 12-21-06; 8:45 am]
BILLING CODE 4160-01-S