[Federal Register Volume 62, Number 38 (Wednesday, February 26, 1997)]
[Notices]
[Page 8744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4731]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Product, Establishment, and Biologics License Applications,
Refusal to File; Meeting of Oversight Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
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), establishment license applications (ELA's), and
biologics license applications (BLA'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.
DATES: The meeting will be held on April 8, 1997.
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 continues CBER's effort to promote the
timely, efficient, and consistent review of PLA's, ELA's, and BLA's.
FDA regulations on filing PLA's, ELA's, and BLA's are found in 21
CFR 601.2 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).
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 will
ordinarily 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. If there are no RTF decisions to review,
however, the meeting may be cancelled. Publication of any meeting
cancellation will be made only as time permits.
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, 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
within CBER will notify the sponsor.
Dated: February 18, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-4731 Filed 2-25-97; 8:45 am]
BILLING CODE 4160-01-F
