[Federal Register Volume 60, Number 127 (Monday, July 3, 1995)]
[Notices]
[Pages 34543-34544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16205]



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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92N-0371]


New Drug Applications; Refusal to File; Change in Procedures to 
Include Industry Representatives in 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 review process conducted by the Center for Drug Evaluation and 
Research's (CDER's) Refusal to File (RTF) review committee. The new 
procedures will permit applicants that have received an RTF to attend 
the meeting at which the RTF review committee evaluates the RTF imposed 
on its application. This change, which will be implemented on a trial 
basis, may enhance understanding of and participation in the RTF review 
committee process. Additional changes to the procedures may be useful 
and comments are requested.

DATES: Comments may be submitted at any time.

ADDRESSES: Submit written comments on this change in procedures to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Janet M. Jones, Center for Drug 
Evaluation and Research (HFD-014), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5445.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 18, 1993 (58 
FR 28983), FDA announced the establishment of a standing committee in 
CDER's to conduct periodic review of the CDER's RTF decisions. The 
committee was established on a 1-year trial basis. Initially, the 
committee invited companies to submit requests for review of RTF's that 
they considered to have been made inappropriately. 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.
    CDER created the RTF review committee because it believes that a 
clear, well-understood, and consistently applied RTF policy may improve 
substantially the efficiency of the new drug evaluation process. The 
practice of submitting an incomplete or inadequate application and then 
providing additional information during an extended review period is 
inherently inefficient and a waste of agency resources. In addition, it 
is unfair to those applicants who fulfill their scientific and legal 
obligations by submitting complete applications to have the review of 
their applications delayed while other incomplete applications 
submitted earlier undergo review and repair.
    FDA regulations on filing applications, including grounds and 
procedures for RTF's, are found in Sec. 314.101 (21 CFR 314.101). In 
the past, some CDER review divisions refused to 

[[Page 34544]]
file applications only where the deficiencies were extreme while other 
divisions applied the regulation more broadly. When deciding whether to 
file an application, CDER exercises discretion, considering in 
particular whether the application is for a medically important drug. 
The RTF procedure is used in the context of CDER's effort to promote 
rapid development and review of applications.
    Although an RTF is not a final determination, it is a significant 
step that delays full review of an application. The applicant who 
receives an RTF notification may request an informal conference with 
FDA and thereafter may ask that the application be filed over protest 
as described under Sec. 314.101(a)(3). CDER believes that an RTF 
decision is, in general, of benefit to applicants as an early signal 
that the application has major deficiencies.
    When the RTF review began, FDA invited companies to request review 
of RTF decisions that they wanted FDA to reconsider. As explained in 
the Federal Register of September 21, 1994 (59 FR 48440), in January 
1994, the RTF review committee began to meet bimonthly and to review 
all of the RTF decisions that CDER makes, rather than only some of 
them, and requests by drug companies were no longer necessary. CDER 
decided to review all of the RTF decisions because the number of those 
decisions had decreased over the previous year and because RTF 
decisions have other effects related to user fees. Under section 
736(a)(1)(D) of the Prescription Drug User Fee Act of 1992 (21 U.S.C. 
379h(a)(1)(D)), FDA is authorized to retain 25 percent of the total 
user fee assessed for each NDA that it refuses to file. If the agency 
incorrectly refuses to file an application, FDA needs to identify and 
correct the error promptly so that the application may be filed and a 
review initiated and so that incorrectly retained fees may be returned 
to the applicant.
    To increase the understanding of and participation in this process, 
the RTF review committee has decided to invite each company whose 
application has been refused for filing to the committee meeting 
scheduled to review that RTF decision. The committee usually will 
review no more than four RTF's per meeting. At the RTF review meeting, 
the CDER division that made the RTF decision will present to the 
committee the deficiencies present in the application and will explain 
the RTF decision. The applicant will not attend this portion of the 
meeting as the discussion generally involves, among other things, 
predecisional deliberations and internal management issues. After the 
division's presentation, the applicant will be invited to give a brief 
presentation (approximately 10 minutes), and may be asked questions by 
the committee. For the reasons specified above, the applicant will not 
remain for the committee deliberations on the appropriateness of the 
RTF, but will be advised of its decision. The agency also may send 
followup correspondence to the applicant after the meeting. Because the 
presentations may deal with confidential commercial information, 
applicants will not be permitted to be present during presentations 
made by other companies.
    The change in the procedures will be implemented on a trial basis 
at the next meeting to review RTF decisions. Additional changes to the 
procedures may be appropriate, and comments are requested.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding this 
change in procedures. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 26, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-16205 Filed 6-30-95; 8:45 am]
BILLING CODE 4160-01-F