[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