[Federal Register Volume 66, Number 167 (Tuesday, August 28, 2001)]
[Notices]
[Pages 45317-45318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0348]


Index and Copies of Presiding Officer Reports and Commissioner 
Decisions on the Eligibility of a Clinical Investigator to Continue to 
Receive Investigational Products; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 45318]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the presiding officer summary decisions, presiding 
officer reports, and the Commissioner of Food and Drugs (the 
Commissioner) decisions that are issued concerning a regulatory hearing 
on the proposed disqualification of a clinical investigator from 
eligibility to continue to receive investigational products for use in 
clinical investigations. These reports and decisions and an index are 
available at the FDA Internet site.

ADDRESSES: Copies of an index to presiding officer summary decisions, 
presiding officer reports, and Commissioner decisions, as well as the 
reports and decisions themselves, may be obtained from the Freedom of 
Information Office home page at http://www.fda.gov/foi/clinicaldis.
    Copies of the index and reports and decisions are also available at 
the Dockets Management Branch, Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nancy E. Pirt, Office of the Ombudsman 
(HF-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3390.

SUPPLEMENTARY INFORMATION: FDA regulates scientific studies, known as 
clinical investigations, designed to test the safety and effectiveness 
of investigational human and animal drugs, biological products, and 
medical devices. The data from these clinical investigations may be 
used as the basis of applications to FDA for approval to market the 
investigational products. The clinical investigators who conduct 
clinical trials must comply with FDA's regulations that govern clinical 
investigations. FDA may seek to disqualify a clinical investigator if 
the agency has information indicating that the investigator has 
repeatedly or deliberately failed to comply with the requirements of 
the regulations for conducting clinical investigations, or repeatedly 
or deliberately submitted false data to the FDA or the study's sponsor. 
If the Commissioner makes this determination, 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 criteria for disqualification are set forth in FDA's 
regulations. For clinical investigations involving human drugs and 
biologic products, the applicable regulation is found at 21 CFR 312.70. 
For clinical investigations involving medical devices, the applicable 
regulation is found at 21 CFR 812.119. For clinical investigations 
involving investigational animal drugs, the applicable regulation is 
found at 21 CFR 511.1.
    The disqualification process is initiated when FDA's Center for 
Biologics Evaluation and Research, Center for Drug Evaluation and 
Research, Center for Devices and Radiological Health, or Center for 
Veterinary Medicine sends the investigator a written notice of the 
matter complained of, and offers the investigator an opportunity to 
explain in writing or, at the option of the investigator, at an 
informal conference. If the Center does not find the investigator's 
explanation to be acceptable, the agency will send the investigator a 
notice of opportunity for a hearing. If a regulatory hearing is held, 
it will be conducted under part 16 (21 CFR part 16). Under part 16, if 
a clinical investigator requests a hearing, a presiding officer is 
appointed to hear the case. A request for a hearing may be denied if 
the Commissioner or his or her delegate determines that there is no 
genuine and substantial issue of fact to justify a hearing. A written 
notice of this determination will be given to the parties. In addition, 
the presiding officer may issue a summary decision on any issue in the 
hearing if the presiding officer determines that there is no genuine 
and substantial issue of fact respecting that issue.
    After a hearing is conducted, the presiding officer, under 
Sec. 16.60, prepares a written report of the hearing, including a 
recommended decision with a statement of the reasons, on the proposed 
disqualification. The written report will include a recommended 
decision with a statement of reasons, unless the Commissioner directs 
otherwise. The presiding officer's report is one component of the 
administrative record of the hearing. Based on the administrative 
record, the Commissioner issues a written decision on the question of 
whether the investigator is entitled to receive investigational 
products. If the Commissioner finds that the clinical investigator 
repeatedly or deliberately failed to comply with agency regulations, or 
repeatedly or deliberately submitted false information to FDA or the 
sponsor, the investigator may be disqualified from receiving 
investigational products.
    Disqualification hearings are informal, and presiding officer 
summary decisions, presiding officer reports, and Commissioner 
decisions are not published in the Federal Register; they have been 
made publicly available to parties that request regulatory hearings on 
clinical investigator disqualifications. They are also publicly 
available under the Freedom of Information Act. The purpose of this 
notice is to announce that an index to, and copies of, presiding 
officer summary decisions, presiding officer reports, and Commissioner 
decisions on clinical investigator disqualification matters are now 
available on FDA's Internet site. These records are also available for 
public examination in the Dockets Management Branch (address above) 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21663 Filed 8-27-01; 8:45 am]
BILLING CODE 4160-01-S