98-17145. Financial Disclosure by Clinical Investigators; Correction

[Federal Register Volume 63, Number 124 (Monday, June 29, 1998)]
[Rules and Regulations]
[Page 35134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17145]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 54

[Docket No. 93N-0445]


Financial Disclosure by Clinical Investigators; Correction

Agency: Food and Drug Administration, HHS.

Action: Final rule; correction.

-----------------------------------------------------------------------

Summary: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of February 2, 1998 (63 FR 
5233). The document issued regulations requiring the sponsor of any 
drug, including a biological product, or device marketing application 
(applicant), to submit certain information covering the compensation 
to, and financial interests of, any clinical investigator conducting 
certain clinical studies. The document was published with an error. 
This document corrects that error.

EFFECTIVE DATE: February 2, 1999.

FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Office of External 
Affairs, Food and Drug Administration (HF-60), 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3440, FAX [phone].

SUPPLEMENTARY INFORMATION: In FR Doc. 98-2407 appearing on page 5233 in 
the Federal Register of February 2, 1998, the following correction is 
made:


Sec. 54.4   [Corrected]

    On page 5251, in the first column, in Sec. 54.4 Certification and 
disclosure requirements, paragraph (a), line 3, ``519(k)'' is corrected 
to read ``510(k)''.

    Dated: June 19, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-17145 Filed 6-26-98; 8:45 am]
BILLING CODE 4160-01-F