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63 FR (09/23/1998) » 98-25365. Administrative Practices and Procedures; Internal Agency Review of Decisions; Companion Document to Direct Final Rule; Correction
98-25365. Administrative Practices and Procedures; Internal Agency Review of Decisions; Companion Document to Direct Final Rule; Correction
[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
Document Information
- Published:
- 09/23/1998
- Department:
- Food and Drug Administration
- Entry Type:
- Proposed Rule
- Action:
- Proposed rule; correction.
- Document Number:
- 98-25365
- Pages:
- 50815-50815 (1 pages)
- Docket Numbers:
- Docket No. 98N-0361
- PDF File:
-
98-25365.pdf
- CFR: (1)
- 21 CFR 10