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