[Federal Register Volume 62, Number 240 (Monday, December 15, 1997)]
[Notices]
[Page 65709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32677]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 1998 
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 next meetings will be held on January 13, 1998; April 14, 
1998; July 14, 1998; and October 13, 1998.

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, 301-827-0379.

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 continues CBER's effort to promote the 
timely, efficient, and consistent review of PLA's, ELA's, and BLA's.
    FDA 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 the FDA's Center for Drug Evaluation 
and Research, and the FDA Chief Mediator and Ombudsman. Meetings will 
ordinarily 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 ``<a href="http://www.fda.gov/cber/
confmeet.htm">http://www.fda.gov/cber/
confmeet.htm</a>''. Publication of any meeting cancellation will be made 
only as time permits.
    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 such 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 
within CBER will notify the sponsor.

    Dated: December 9, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32677 Filed 12-12-97; 8:45 am]
BILLING CODE 4160-01-F