[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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