[Federal Register Volume 59, Number 212 (Thursday, November 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27316]
[[Page Unknown]]
[Federal Register: November 3, 1994]
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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; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a
proposed rule that appeared in the Federal Register of September 22,
1994 (59 FR 48708). The document proposed 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 document was published with an error. This document corrects that
error.
DATES: Written comments on or before December 21, 1994. The agency is
proposing that any final rule that may issue based on this proposed
rule become effective 6 months after the date of its publication in the
Federal Register.
FOR FURTHER INFORMATION CONTACT: John S. Ensign, Office of Health
Affairs (HFY-22), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20852, 301-443-1382.
In FR Doc. 94-23414, appearing on page 48708 in the Federal
Register of Thursday, September 22, 1994, the following correction is
made:
Sec. 54.4 [Corrected]
On page 48717, in Sec. 54.4 Disclosure requirements, in the first
column, in paragraph (a), in the last line, the phrase ``(a)(2) of this
section'' is corrected to read ``(a)(3) of this section.''
Dated: October 28, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-27316; Filed 11-2-94; 8:45 am]
BILLING CODE 4160-01-F
