[Federal Register Volume 65, Number 3 (Wednesday, January 5, 2000)]
[Notices]
[Pages 493-494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Investigational Biological Product Trials; Procedure to Monitor
Clinical Hold Process; Meeting of Oversight Committee and Request for
Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 494]]
SUMMARY: The Food and Drug Administration (FDA) is announcing the year
2000 meetings of its clinical hold oversight committee, which reviews
the clinical hold orders that the Center for Biologics Evaluation and
Research (CBER) has placed on certain investigational biological
product trials. For each meeting, FDA is inviting any interested
biological product company to use this confidential mechanism to submit
to the committee for its review the name and number of any
investigational biological product trial placed on clinical hold during
the past 12 months that the company wants the committee to review
DATES: The meetings will be held on February 10, 2000; May 11, 2000;
August 10, 2000; and November 9, 2000. Biological product companies may
submit review requests for the February meeting by January 20, 2000;
for the May meeting by March 30, 2000; for the August meeting by June
29, 2000; and for the November meeting by September 28, 2000.
ADDRESSES: Submit clinical hold review requests to Steven H. Unger, FDA
Acting Ombudsman, Office of the Commissioner (HF-7), 5600 Fishers Lane,
rm. 14-105, Rockville, MD 20857, 301-827-3390.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION: FDA's regulations in part 312 (21 CFR part
312) provide procedures that govern the use of investigational new
drugs and biologics in human subjects. If FDA determines that a
proposed or ongoing study may pose significant risks for human subjects
or is otherwise seriously deficient, as discussed in the
investigational new drug regulations, it may order a clinical hold on
the study. The clinical hold is one of FDA's primary mechanisms for
protecting subjects who are involved in investigational new drug or
biologic trials. Section 312.42 describes the grounds for ordering a
clinical hold.
A clinical hold is an order that FDA issues to a sponsor to delay a
proposed investigation or to suspend an ongoing investigation. The
clinical hold may be ordered on one or more of the investigations
covered by an investigational new drug application (IND). When a
proposed study is placed on clinical hold, subjects may not be given
the investigational drug or biologic as part of that study. When an
ongoing study is placed on clinical hold, no new subjects may be
recruited to the study and placed on the investigational drug or
biologic, and patients already in the study should stop receiving
therapy involving the investigational drug or biologic, unless FDA
specifically permits it.
When FDA concludes that there is a deficiency in a proposed or
ongoing clinical trial that may be grounds for ordering a clinical
hold, ordinarily FDA will attempt to resolve the matter through
informal discussions with the sponsor. If that attempt is unsuccessful,
a clinical hold may be ordered by or on behalf of the director of the
division that is responsible for the review of the IND.
FDA regulations in Sec. 312.48 provide dispute resolution
mechanisms through which sponsors may request reconsideration of
clinical hold orders. The regulations encourage the sponsor to attempt
to resolve disputes directly with the review staff responsible for the
review of the IND. If necessary, the sponsor may request a meeting with
the review staff and management to discuss the clinical hold.
CBER began a process to evaluate the consistency and fairness of
practices in ordering clinical holds by instituting an oversight
committee to review clinical holds (see 61 FR 1033, January 11, 1996).
CBER held its first clinical hold oversight committee meeting on May
17, 1995, and plans to conduct further quality assurance oversight of
the IND process. The review procedure of the committee is designed to
afford an opportunity for a sponsor who does not wish to seek formal
reconsideration of a pending clinical hold to have that clinical hold
considered ``anonymously.'' The committee consists of senior managers
of CBER, a senior official from the Center for Drug Evaluation and
Research, and the FDA Chief Mediator and Ombudsman.
Clinical holds to be reviewed will be chosen randomly. In addition,
the committee will review clinical holds proposed for review by
biological product sponsors. In general, a biological product sponsor
should consider requesting review when it disagrees with FDA's
scientific or procedural basis for the decision.
Requests for committee review of a clinical hold should be
submitted to the FDA Chief Mediator and Ombudsman, who is responsible
for selecting clinical holds for review. The committee and CBER staff,
with the exception of the FDA Chief Mediator and Ombudsman, are never
advised, either in the review process or thereafter, which of the
clinical holds were randomly chosen and which were submitted by
sponsors. The committee will evaluate the selected clinical holds for
scientific content and consistency with FDA regulations and CBER
policy.
The meetings of the oversight committee are closed to the public
because committee discussions deal with confidential commercial
information. Summaries of the committee deliberations, excluding
confidential commercial information, may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the meeting, at a cost of 10 cents
per page. If the status of a clinical hold changes following the
committee's review, the appropriate division will notify the sponsor.
For each meeting, FDA invites biological product companies to
submit to the FDA Chief Mediator and Ombudsman the name and IND number
of any investigational biological product trial that was placed on
clinical hold during the past 12 months that they want the committee to
review. Submissions should be made by January 20, 2000, for the
February meeting; by March 30, 2000, for the May meeting; by June 29,
2000, for the August meeting; and by September 28, 2000, for the
November meeting to Steven H. Unger, FDA Acting Ombudsman (address
above).
Dated: December 28, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-109 Filed 1-4-00; 8:45 am]
BILLING CODE 4160-01-F