[Federal Register Volume 61, Number 44 (Tuesday, March 5, 1996)]
[Proposed Rules]
[Pages 8502-8503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5116]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 54, 312, 314, 320, 330, 601, 807, 812, 814, and 860

[Docket No. 93N-0445]


Financial Disclosure by Clinical Investigators; Reopening of 
Comment Period and Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period and notice of 
meeting.

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SUMMARY: The Science Board to the Food and Drug Administration (FDA), 
an FDA advisory committee, will hold an open committee meeting to 
discuss the proposed rulemaking on Financial Disclosure by Clinical 
Investigators, which published in the Federal Register of September 22, 
1994. At the same time, FDA is reopening the comment period for the 
proposed rule. The proposed rule would require that the sponsor of any 
drug, biological product, or device submit certain information 
concerning the compensation to, and financial interests of, any 
clinical investigator conducting clinical studies to determine whether 
that product meets the marketing requirements specified by the agency. 
FDA is taking these actions in order to obtain additional comment on 
whether the provision on``significant payments of other sorts'' should 
be eliminated from the proposed rule.

DATES: The comment period is reopened until April 29, 1996. Those 
desiring to make formal presentations to the Science Board must notify 
the contact person before March 14, 1996, and submit a brief statement 
of the general nature of the evidence or arguments they may wish to 
present, and the names and addresses of proposed participants. Each 
presenter will be limited in time and not all requests to speak may be 
able to be accommodated. All written statements submitted in a timely 
fashion will be provided to the board.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. The meeting will be held at the Sheraton National 
Hotel, North Ballroom, 900 South Orme St. (Columbia Pike and Washington 
Blvd.), Arlington, VA.

FOR FURTHER INFORMATION CONTACT: Mary Gross, Office of External Affairs 
(HF-24), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD, 20857, 301-827-3440; or the FDA Advisory Committee Information 
Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area) 
Science Board to the Food and Drug Administration, code 12603.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 22, 
1994 (59 FR 48708), FDA proposed regulations to require that the 
sponsor of any drug, biological product, or device submit certain 
information concerning the compensation to, and financial interests of 
any clinical investigator conducting clinical studies to determine 
whether that product meets the marketing requirements specified by the 
agency. The agency is proposing to require that sponsors either certify 
to the absence of certain financial interests of clinical investigators 
or disclose those financial interests when clinical studies are 
submitted to FDA in support of product marketing.
    FDA has asked the Science Board to discuss, at the March 29, 1996, 
meeting proposed Sec. 54.4(a)(2)(ii), which would require disclosure by 
clinical investigators of ``significant payments of other sorts'' from 
sponsors. The proposed definition of such payments is ``* * * payments 
that exceed $5,000 (e.g., grants to fund ongoing research, compensation 
in the form of equipment on retainers for ongoing consultation, or 
honoraria) or that exceed 5 percent of the total equity in a publicly 
held and widely traded company.'' FDA specifically seeks discussion of 
the following issues:
    (1) In proposing to require disclosure of any significant equity 
interest held by a clinical investigator in the sponsor, the agency has 
defined a significant equity interest as ``any ownership interest, 
stock options, or other financial interest whose value cannot be 
readily determined through reference to public prices, or any equity 
interest in a publicly traded corporation that exceeds 5 percent of 
total equity.'' Is 5 percent equity interest in a publicly traded 
corporation an appropriate threshold to trigger disclosure of financial 
information to FDA? Should a threshold dollar amount also be specified? 
If so, what might be a reasonable threshold amount?
    (2) Are there financial arrangements that may be overlooked that 
could affect study outcome if FDA eliminates the provision entitled 
``significant payments of other sorts,'' from the proposed rule?
    (3) Does it help to narrow the scope of the provision ``significant 
payments of other sorts'' by raising the current payment level that 
would trigger 

[[Page 8503]]
disclosure of this information from $5,000 to $50,000 annually? Are 
there other options that allow retention of the provision but 
effectively narrow its scope?
    These issues will be discussed at the March 29, 1996, advisory 
committee meeting. Because FDA wants to provide adequate time for the 
submission of all relevant information related to this important public 
health issue, FDA is reopening the comment period.
    Interested persons may, on or before April 29, 1996, submit to 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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.
    For further information on the administrative procedure for holding 
the Science Board to the Food and Drug Administration meeting and the 
general function of this advisory committee, see the document entitled 
``Advisory Committee; notice of meeting,'' that published in the 
Federal Register of February 26, 1996 (61 FR 7117).

    Dated: February 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-5116 Filed 3-4-96; 8:45 am]
BILLING CODE 4160-01-F