[Federal Register Volume 64, Number 119 (Tuesday, June 22, 1999)]
[Pages 33313-33314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15757]



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 
``[email protected]''.
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 
    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 
    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]