[Federal Register Volume 60, Number 93 (Monday, May 15, 1995)]
[Notices]
[Page 25920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11827]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a standing oversight committee in the Center for 
Biologics Evaluation and Research (CBER) to conduct periodic reviews 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 will examine RTF decisions to assess 
consistency across CBER offices and divisions in RTF decisions and to 
determine whether the guidance currently available to sponsors needs to 
be revised.

ADDRESSES:  Submit written requests for single copies of the CBER RTF 
guidance document to the Office of External Affairs, Industry Liaison 
Staff (HF-50), Food and Drug Administration, rm. 15-61, 5600 Fishers 
Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Jean M. Olson, Center for Biologics 
Evaluation and Research (HFM-635), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-594-3074.

SUPPLEMENTARY INFORMATION: 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, as evidenced by initiatives, such as the following: 
(1) Procedures to expedite marketing approval for therapies for serious 
or life threatening illnesses (53 FR 41516, October 21, 1988; 57 FR 
58942, December 11, 1992); (2) procedures and policies to make such 
therapies available prior to marketing approval through mechanisms such 
as the treatment investigational new drug (52 FR 19466, May 22, 1987) 
and the parallel track (57 FR 13250, April 15, 1992); (3) announcement 
of the availability of a CBER RTF guidance document for sponsors (58 FR 
38770, July 20, 1993); and (4) implementation of a managed review 
process for PLA's, ELA's, and supplements to PLA's and ELA's. The 
managed review process focuses on specific milestones or intermediate 
goals so that a quality review is conducted within specified time 
periods. The establishment and first meeting of CBER's RTF oversight 
committee, announced and described in this notice, continue CBER's 
effort to promote the timely, efficient, and consistent review of PLA's 
and ELA's.
    CBER recognizes that the practice of submitting incomplete or 
inadequate PLA's and ELA's and then providing additional information to 
FDA during an extended review period is inherently inefficient and 
wasteful of FDA resources. Such practice is also unfair to those 
sponsors who fulfill their scientific and legal obligations by 
submitting complete applications; the review of complete applications 
may be delayed while incomplete applications, submitted earlier, 
undergo review and repair.
    By means of an RTF notification, CBER in general declines to file a 
sponsor's PLA or ELA because of omissions or inadequacies so severe as 
to render the application incomplete on its face. Although not a final 
determination, an RTF decision is a significant step that delays, at 
least for a time, full review of an application. CBER believes that an 
RTF decision is, in general, of benefit to sponsors as an early signal 
that the application has major deficiencies.
    FDA regulations on filing PLA's and ELA's are found in 
Secs. 601.2(a) and 601.3 (21 CFR 601.2(a) and 601.3). A sponsor who 
receives an RTF notification may request an informal conference with 
CBER, and thereafter the sponsor may ask that the application be filed 
over protest, similar to the procedure for drugs described under 
Sec. 314.101(a)(3) (21 CFR 314.101(a)(3) (see 57 FR 17950, April 28, 
1992).
    CBER has formed a standing RTF oversight committee, consisting of 
senior CBER officials, a senior official from FDA's Center for Drug 
Evaluation and Research, and FDA's Chief Mediator and Ombudsman. 
Meetings 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 and to determine whether the 
currently available guidance provided to sponsors needs to be revised 
or supplemented.
    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, will be available from the FDA Chief Mediator and 
Ombudsman. If, following the committee's review, an RTF decision 
changes, the reviewing division will notify the sponsor of the change.

    Dated: May 5, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-11827 Filed 5-12-95; 8:45 am]
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