[Federal Register: August 28, 2001 (Volume 66, Number 167)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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
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
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