[Federal Register Volume 71, Number 47 (Friday, March 10, 2006)]
[Notices]
[Page 12367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3370]


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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Draft Guidance for Industry on Clinical Data Needed to Support 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 The draft guidance document is 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 The draft guidance summarizes clinical 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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://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://www.fda.gov/cber/guidelines.htm or 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