[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Proposed Rules]
[Page 50815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25365]


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NUCLEAR REGULATORY COMMISSION
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. 98N-0361]


Administrative Practices and Procedures; Internal Agency Review 
of Decisions; Companion Document to Direct Final Rule; 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 June 16, 1998 
(63 FR 32772). The document proposed to amend the FDA regulations 
governing the review of agency decisions by inserting a statement that 
sponsors, applicants, or manufacturers of drugs (including biologics) 
or devices may request review of a scientific controversy by an 
appropriate scientific advisory panel, or an advisory committee. The 
document was published with an error. This document corrects that 
error.

FOR FURTHER INFORMATION CONTACT: Silvia R. Fasce, Office of Policy (HF-
27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2996.

SUPPLEMENTARY INFORMATION: In FR Doc. 98-15814, appearing on page 32772 
in the Federal Register of Tuesday, June 16, 1998, the following 
correction is made:
    1. On page 32773, in the third column, under the authority citation 
for 21 CFR part 10, in the second line, ``1451-4161'' is corrected to 
read ``1451-1461''.

    Dated: September 16, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-25365 Filed 9-22-98; 8:45 am]
BILLING CODE 4160-01-F