[Federal Register: March 10, 2006 (Volume 71, Number 47)]
[Notices]
[Page 12367]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr06-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0083]
Draft Guidance for Industry on Clinical Data Needed to Support
the Licensure of Trivalent Inactivated Influenza Vaccines; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Clinical Data Needed to Support the Licensure of Trivalent Inactivated
Influenza Vaccines,'' dated March 2006. The draft guidance document is
intended to provide to sponsors of trivalent inactivated influenza
vaccines guidance on the clinical data needed to support a Biologics
License Application (BLA). The draft guidance summarizes clinical
development approaches to facilitate and expedite the licensure of new
trivalent inactivated influenza vaccines and addresses both traditional
and accelerated approval.
DATES: Submit written or electronic comments on the draft guidance by
June 8, 2006 to ensure their adequate consideration in preparation of
the final guidance. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. The draft guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Clinical Data Needed to Support the Licensure
of Trivalent Inactivated Influenza Vaccines,'' dated March 2006. The
draft guidance is intended to provide to sponsors of trivalent
inactivated influenza vaccines guidance on the clinical data needed to
support a BLA. The draft guidance summarizes clinical development
approaches to facilitate and expedite the licensure of new ``split
virus'' trivalent inactivated influenza vaccines and addresses both
traditional and accelerated approval. The approaches are also
applicable to vaccines made with other manufacturing processes; e.g.,
whole virus inactivated, cell-culture based inactivated, recombinant
protein, and adjuvanted influenza vaccines. The draft guidance does not
address live attenuated influenza vaccines or influenza vaccines that
do not contain a hemagglutinin component. The draft guidance also does
not address the nonclinical development of investigational vaccines, or
the chemistry, manufacturing, control, or inspection of the
manufacturing facility needed for licensure.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
information collection provisions in this guidance for 21 CFR part 601
have been approved under OMB control number 0910-0338.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in the brackets in
the heading of this document. A copy of the draft guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default
.htm.
Dated: February 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3370 Filed 3-9-06; 8:45 am]
BILLING CODE 4160-01-S