[Federal Register: June 22, 1999 (Volume 64, Number 119)]
[Notices]
[Page 33313-33314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn99-103]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1737]

Public Availability of Information on Clinical Trials for
Investigational Devices Intended to Treat Serious or Life-Threatening
Conditions; Request for Comments

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

-----------------------------------------------------------------------

Summary: The Food and Drug Administration (FDA), Center for Devices and
Radiological Health, is requesting comments concerning the feasibility
of including information for device investigations for serious or life-
threatening diseases and conditions in a public data bank. This action
is being taken to assist the agency in preparing a report to Congress
required under the FDA Modernization Act of 1997 (FDAMA). Elsewhere in
this issue of the Federal Register, FDA is announcing an open public
meeting on this subject.

Dates: Written comments by August 23, 1999.
Addresses: Written comments concerning this document must be submitted
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Comments should be identified with the docket number found in brackets
in the heading of this document.
For Further Information Contact: Robert R. Gatling, Center for Devices
and Radiological Health (HFZ-404), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1190, ext. 140 or e-mail
``rrg@cdrh.fda.gov''.
Supplementary Information: FDAMA (Pub. L. 105-115) was enacted on
November 21, 1997. Section 113(a) of FDAMA amends section 402 of the
Public Health Service Act (PHS Act) (42 U.S.C. 282) by adding a new
section 402(j). This new section directs the Secretary of Health and
Human Services (the Secretary), acting through the Director of the
National Institutes of Health (NIH), to establish, maintain, and
operate a data bank of information on clinical trials for drugs for
serious or life-threatening diseases and conditions.
    Section 113(b) of FDAMA (collaboration and report) directs the
Secretary, the Director of NIH, and the Commissioner of Food and Drugs
to collaborate to determine the feasibility of including device
investigations within the scope of the data bank under new section
402(j) of the PHS Act. In addition, section 113(b) of FDAMA directs the
Secretary to prepare and submit to the Committee on Labor and Human
Resources of the Senate and the Committee on Commerce of the House of
Representatives a report on the following:
    1. The public health need, if any, for inclusion of device
investigations within the scope of the data bank under section 402(j)
of the PHS Act;
    2. The adverse impact, if any, on device innovation and research in
the United States if information relating to such device investigations
is required to be publicly disclosed; and,
    3. Such other issues relating to section 402(j) of the PHS Act as
the Secretary determines to be appropriate.
    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360j(g)) permits the investigational use of devices by
experts qualified by scientific training and experience to investigate
the safety and effectiveness of such devices. Part 812 (21 CFR part
812) contains the implementing regulations for section 520(g) of the
act. In accordance with part 812 and the agency's public information
regulations, FDA generally will not disclose the existence of an
investigational device exemptions (IDE) application unless its
existence has previously been publicly disclosed or acknowledged, until
FDA approves an application for premarket approval (PMA) for the
device, or until a notice of completion of a product development
protocol (PDP) for the device has become effective. The establishment
of a data bank intended to contain publicly available information about
certain IDE's would require changes in these implementing regulations.
Section 113(b) of FDAMA requires the Secretary to evaluate whether
public disclosure of IDE information would adversely impact device
innovation and research.
    The provisions of section 113 of FDAMA apply to drugs for ``serious
or life-threatening diseases and conditions.'' Any consideration of
inclusion of device trials within the scope of the data bank requires a
definition of what types of devices would be covered. FDA does not
currently have a definition for ``serious'' or ``life-threatening,'' as
those terms would apply to devices.
    In the Federal Register of September 18, 1997 (62 FR 48940), FDA
published a final rule for treatment use of an investigational device.
The rule added Sec. 812.36 (21 CFR 812.36). In the preamble to the
final rule, FDA explained that it did not define ``serious disease or
condition'' because the agency concluded that defining the term

[[Page 33314]]

could be unduly restrictive and limit the agency's discretion when
determining whether certain stages of a disease or condition are
``serious.'' Instead, Sec. 812.36(a) applies the treatment IDE rule to
``immediately life-threatening'' diseases, and defines that as a stage
of a disease in which there is a reasonable likelihood that death would
occur within a matter of months or in which premature death is likely
without early treatment.
    This definition could be used to help define the category of device
trials that could be included in a clinical trials data bank. The
clinical trials data bank could contain a list of clinical trials,
whether Federally or privately funded, of investigational devices for
serious or life-threatening diseases, a description of the
investigational device, eligibility criteria for patients, the location
of clinical trials sites, and a point of contact for those wanting to
enroll in the trial. In evaluating the public health need for a device
trials data bank and the effects a mandatory public data bank would
have on innovation and research, FDA is currently assuming the devices
that would fall within the scope of the provision are those intended to
treat such ``immediately life-threatening'' situations, but FDA invites
public comment on this issue.
    FDA is in the process of consulting with NIH on the feasibility of
adding device trials to the data bank. In addition, through this
notice, FDA is soliciting comments and information that will help the
agency draft its report to Congress under section 113(b) of FDAMA. In
particular, FDA seeks input in response to the following questions:
    1. Is there a public health need for inclusion of device
investigations within the scope of the data bank under 402(j) of the
PHS Act?
    2. If there is a public health need, what category of device trials
should be made publicly available and how should this category be
defined? FDA's treatment IDE regulation applies only to devices for
which no comparable or satisfactory alternative exists. Should a data
bank for IDE's be similarly restricted? Should the trials that become
part of the data bank include feasibility/pilot trials or only studies
that are intended to demonstrate reasonable assurance of safety and
effectiveness?
    3. Investigational device trials have historically been smaller in
numbers of subjects and numbers of investigational sites than
investigational drug trials. What impact, both positive and negative,
would the release of information have on these device trials, the
sponsors, the investigators, the investigational sites, and the
patients? Will a public data bank create pressures to increase the size
of device trials or number of sites in situations where such expansion
may increase risk to patients?
    4. IDE information is generally protected from public disclosure
under FDA regulations. If public disclosure were voluntary, would
disclosure by one sponsor put pressure on sponsors of similar
investigations to disclose the existence of their studies against their
better judgment? Is this in the interest of the public health?
    5. If disclosure is mandatory, is it likely to hamper innovations
and investment in research and development? Would disclosure of these
investigational device trials help or hinder research by increasing
patient enrollment?
    6. Because sponsors can recover some of the costs of the device
research and development under the investigational device regulations,
should FDA be concerned that publicly available information concerning
investigational device trials will result in undue financial pressure
or incentives on the trial sponsors to add subjects to the trials
without appropriate consideration of risk? Should FDA be concerned
about the possibility that improper promotion and commercialization
will occur as a result of a public data bank for IDE trials?
    7. Will public disclosure of information about device trials for
products to treat serious or life-threatening diseases or conditions
affect reimbursement policies of third party payers?
    8. What other important information or issues should the agency
consider?
    FDA is planning a public meeting to give interested parties a
chance to present their views on the feasibility, utility, and effects
of a data bank for device trials. Information regarding the date and
place of this meeting is published elsewhere in this issue of the
Federal Register.
    Interested persons may, on or before August 23, 1999Dockets
Management Branch (address above) written comments regarding this
notice. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.

    Dated: June 14, 1999.
 Linda S. Kahan,
 Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-15757 Filed 6-21-99; 8:45 am]
BILLING CODE 4160-01-F