97-91. Product, Establishment, and Biologics License Applications, Refusal to File; Meeting of Oversight Committee; Correction

[Federal Register Volume 62, Number 2 (Friday, January 3, 1997)]
[Notices]
[Page 415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-91]


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


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Product, Establishment, and Biologics License Applications, 
Refusal to File; Meeting of Oversight Committee; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of December 19, 1996 (61 FR 
67020). The document announced a meeting of the FDA standing oversight 
committee in the Center for Biologics Evaluation and Research (CBER) 
that conducts a periodic review of CBER's use of its refusal to file 
(RTF) practices on product license applications, establishment license 
applications, and biologics license applications. The agency 
inadvertently omitted two sentences. This document corrects that error.

DATES: The meeting will be held on January 7, 1997.

FOR FURTHER INFORMATION CONTACT: Joy A. Cavagnaro, Center for Biologics 
Evaluation and Research (HFM-4), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3079.

    In FR Doc. 96-32272, appearing on page 67020 in the Federal 
Register of Thursday, December 19, 1996, the following correction is 
made: On page 67020, in the 2d column, under the SUPPLEMENTARY 
INFORMATION caption, in the 3d paragraph, in the 11th line, the 
sentences ``If there are no RTF decisions to review, however, the 
meeting may be cancelled. Publication of any meeting cancellation will 
be made only as time permits.'' are added at the end of the paragraph.

    Dated: December 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-91 Filed 1-2-97; 8:45 am]
BILLING CODE 4160-01-F