[Federal Register Volume 59, Number 182 (Wednesday, September 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23275]


[[Page Unknown]]

[Federal Register: September 21, 1994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 92N-0371]

 

New Drug Applications; Refusal to File; Change in Schedule of 
Meetings of the Review Committee

 AGENCY: Food and Drug Administration, HHS.

 ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a change 
in the procedure that the Center for Drug Evaluation and Research 
(CDER) uses to review its use of its refusal to file (RTF) procedure, 
by which it refuses to file new drug applications (NDA's) that are 
facially deficient under FDA's regulations. Since January 1994, the 
committee has been meeting bi-monthly rather than quarterly. Because 
the committee will review all RTF decisions rather than only a few, new 
drug application (NDA) applicants will not need to submit requests for 
review.

FOR FURTHER INFORMATION CONTACT: Janet M. Jones, Center for Drug 
Evaluation and Research (HFD-2), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6740.

SUPPLEMENTARY INFORMATION: FDA regulations on filing applications, 
including grounds and procedures for refusals to file, are found in 21 
CFR 314.101. In the past, some review divisions in CDER have refused to 
file applications only where the deficiencies were extreme, e.g., the 
total omission of a section required by 21 CFR 314.50, or the absence 
of any study even arguably adequate and well controlled, while others 
have applied this regulation more broadly.
    In the Federal Register of May 18, 1993 (58 FR 28983), FDA 
announced the establishment and first regular meeting of a standing 
committee in CDER to conduct periodic review of CDER's RTF procedure. 
CDER established the RTF review committee to periodically review RTF 
decisions to assess their scientific and procedural quality. The RTF 
review committee consists of senior CDER officials, a senior official 
from the Center for Biologics Evaluation and Research, and FDA's Chief 
Mediator and Ombudsman. The committee reviews, among other things, the 
consistency of RTF practices across new drug evaluation offices and 
divisions, the need for additional guidance on NDA content and format, 
and the need to modify FDA's RTF policy. The committee was established 
on a 1-year trial basis and scheduled to meet quarterly for that year. 
The committee has held two pilot meetings and several regular meetings 
since the publication of that notice. For each of the pilot meetings 
and for the first two of the regular meetings, FDA invited NDA 
applicants to use the committee's confidential mechanism to request 
review of any RTF decision during the preceding 12 months. RTF 
decisions reviewed by the committee were chosen for review by the 
Office of the FDA Chief Mediator and Ombudsman through a combination of 
random selection and selection from among those submitted by NDA 
applicants for review.
    The RTF review committee has decided to change its procedures from 
those presented in the Federal Register of May 18, 1993 (58 FR 28983). 
Since January 1994, the committee has been meeting every other month 
(six times a year) and reviews all the RTF decisions that CDER makes, 
rather than only some of them.
    There are two primary reasons for this change. One reason is that 
the number of applications with RTF decisions each month has decreased 
over the past year, so that it is feasible for the committee to review 
all such applications rather than only selected applications. The 
second reason is that RTF decisions have additional effects related to 
user fees. Under section 736(a)(1)(D) of the Prescription Drug User Fee 
Act of 1992 (21 U.S.C. Sec. 379h(a)(1)(D)), FDA is authorized to retain 
25 percent of the total user fee assessed for each NDA that is refused 
for filing. If the agency incorrectly refuses to file an application, 
the error needs to be promptly identified and corrected, so that the 
application may be filed and a review initiated, and the retained fees 
may be returned to the applicant. The review of all RTF decisions on a 
bimonthly basis will allow the agency to identify incorrect RTF 
decisions and take corrective measures in a timely manner.
    Under this new procedure, NDA applicants will no longer need to 
submit requests for committee review to the Office of the Chief 
Mediator and Ombudsman. Applicants may continue to contact that office, 
however, to discuss concerns regarding refusal to file and other 
issues, as needed.
    The committee believes that this change in its approach to 
reviewing RTF decisions will facilitate the agency's efforts to promote 
the timely, efficient, and consistent review of NDA's. After 1 year, 
the value of the bimonthly committee review of all RTF applications 
will be assessed.
    Because the committee's deliberations will deal with confidential 
commercial information, the RTF review meetings are closed to the 
public. Summaries of the committee's deliberations, excluding all such 
confidential commercial information, 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 applicant 
of the change.

    Dated: September 13, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-23275 Filed 9-20-94; 8:45 am]
BILLING CODE 4160-01-F