[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Pages 34854-34855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16971]



Product and Establishment 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 a meeting 
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) and establishment license applications (ELA'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.

[[Page 34855]]

DATES: The meeting will be held in July 1996.

FOR FURTHER INFORMATION CONTACT: Joy A. Cavagnaro, Center for Biologics 
Evaluation and Research (HFM-5), 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 meetings continue CBER's effort to 
promote the timely, efficient, and consistent review of PLA's and 
    FDA regulations on filing PLA's and ELA's are found in 21 CFR 
601.2(a) 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) (see 57 FR 17950, April 28, 
    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.
    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: June 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-16971 Filed 7-2-96; 8:45 am]