[Federal Register Volume 61, Number 241 (Friday, December 13, 1996)]
[Notices]
[Pages 65580-65581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31745]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Investigational Biological Product Trials; Procedure to Monitor 
Clinical Hold Process; Meeting of Review Committee and Request for 
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a meeting 
of its clinical hold review committee, which reviews the clinical hold 
orders that the Center for Biologics Evaluation and Research (CBER) has 
placed on certain investigational biological product trials. 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 meeting will be held on February 11, 1997. Biological 
product companies may submit review requests for the February meeting 
by January 9, 1997.

ADDRESSES: Submit clinical hold review requests to Amanda Bryce Norton, 
FDA Chief Mediator and Ombudsman, Office of the Commissioner (HF-7), 
Food and Drug Administration, 5600 Fishers Lane, rm. 14-105, Rockville, 
MD 20857, 301-827-3390.

FOR FURTHER INFORMATION CONTACT: Joy A. Cavagnaro, Center for Biologics 
Evaluation and Research (HFM-2), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0379.

SUPPLEMENTARY INFORMATION: FDA 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

[[Page 65581]]

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 a review committee 
to review clinical holds (see 61 FR 1033, January 11, 1996). CBER held 
its first clinical hold review committee meeting on May 17, 1995, and 
plans to conduct further quality assurance oversight of the IND 
process. The committee last met in November 1996. 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 some of the 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 review 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.
    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 at its February 
11, 1997, meeting. Submissions should be made by January 9, 1997, to 
Amanda Bryce Norton, FDA Chief Mediator and Ombudsman (address above).

    Dated: December 9, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31745 Filed 12-12-96; 8:45 am]
BILLING CODE 4160-01-F