[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]
BILLING CODE 4160-01-F
