[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
[Page 68290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32743]



Food and Drug Administration

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 1999 
meetings of its 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 (PLA's), establishment license applications 
(ELA's), and biologics license applications (BLA's). CBER's RTF 
oversight committee examines all RTF decisions that occurred during the 
previous quarter to assess consistency across CBER offices and 
divisions in RTF decisions.

DATES: The meetings will be held on February, 9, 1999; May 11, 1999; 
August 10, 1999; and November 9, 1999.

Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-

SUPPLEMENTARY INFORMATION: In the Federal Register of May 15, 1995 (60 
FR 25920), FDA announced the establishment and first meeting of CBER's 
standing oversight committee. As explained in the notice, the 
importance to the public health of getting new biological products on 
the market as efficiently as possible has made improving the biological 
product evaluation process an FDA priority. CBER's managed review 
process focuses on specific milestones or intermediate goals to ensure 
that a quality review is conducted within a specified time period. 
CBER's RTF oversight committee meetings continue CBER's effort to 
promote the timely, efficient, and consistent review of PLA's, ELA's, 
and BLA's.
    FDA's regulations on filing PLA's, ELA's, and BLA's are found in 21 
CFR 601.2 and 601.3. A sponsor who receives an RTF notification may 
request an informal conference with CBER, and thereafter may ask that 
the application be filed over protest, similar to the procedure for 
drugs described under 21 CFR 314.101(a)(3).
    CBER's standing RTF oversight committee consists of senior CBER 
officials, a senior official from FDA's Center for Drug Evaluation and 
Research, and FDA's Chief Mediator and Ombudsman. Meetings, ordinarily, 
will be held once a quarter to review all of the RTF decisions. The 
purpose of such a review is to assess the consistency within CBER in 
rendering RTF decisions. If there are no RTF decisions to review, 
however, the meeting may be cancelled. FDA intends to post any meeting 
cancellation on the CBER home page at ``http://www.fda.gov/cber/
    Because the committee's deliberations will deal with confidential 
commercial information, all meetings will be closed to the public. The 
committee's deliberations will be reported in the minutes of the 
meeting. Although those minutes will not be publicly available because 
they will contain confidential commercial information, summaries of the 
committee's deliberations, with all confidential commercial information 
omitted, may be requested in writing from the Freedom of Information 
Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 
12A-16, Rockville, MD 20857, approximately 15 working days after the 
meeting, at a cost of 10 cents per page. If, following the committee's 
review, an RTF decision changes, the appropriate division will notify 
the sponsor.

    Dated: November 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-32743 Filed 12-9-98; 8:45 am]