[Federal Register: December 22, 2006 (Volume 71, Number 246)]
[Rules and Regulations]
[Page 76902]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de06-4]
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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