96-1513. Product and Establishment License Applications, Refusal to File; Meeting of Oversight Committee; Cancellation

[Federal Register Volume 61, Number 19 (Monday, January 29, 1996)]
[Notices]
[Page 2836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1513]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing 
cancellation of the meeting for January 1996 of its standing oversight 
committee (the 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 (PLA's) 
and establishment applications (ELA's). The meeting is being cancelled 
because there were no RTF actions taken by CBER in the previous 
quarter. CBER's RTF oversight committee examines all RTF decisions 
which occurred during the previous quarter to assess consistency across 
CBER offices and divisions in RTF decisions.

DATES: The meeting scheduled for January 1996 is cancelled. The next 
meeting is scheduled for April 1996.

FOR FURTHER INFORMATION CONTACT: Joy A. Cavagnaro, Center for Biologics 
Evaluation and Research (HFM-2), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0372.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 15, 1995 (60 
FR 25920), FDA announced the establishment of a standing oversight 
committee in CBER to conduct periodic reviews of CBER's use of its RTF 
practices on PLA's and ELA's. The May 15 notice stated that the 
committee meetings would be held quarterly to review all of the RTF 
decisions. The January 1996 committee meeting is being cancelled 
because there were no RTF actions taken by CBER in the previous 
quarter.

    Dated: January 22, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-1513 Filed 1-26-96; 8:45 am]
BILLING CODE 4160-01-F