[Federal Register Volume 72, Number 105 (Friday, June 1, 2007)]
[Notices]
[Pages 30600-30601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10497]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0083]


Guidance for Industry: Clinical Data Needed to Support the 
Licensure of Seasonal 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 document entitled ``Guidance for Industry: Clinical 
Data Needed to Support the Licensure of Seasonal Inactivated Influenza 
Vaccines,'' dated May 2007. The guidance document is intended to 
provide to sponsors of seasonal inactivated influenza vaccines guidance 
on clinical development approaches to support a biologics license 
application (BLA). The guidance provides recommendations concerning 
clinical data to support traditional and accelerated license approvals 
for new seasonal inactivated influenza vaccines. The guidance announced 
in this notice finalizes the draft ``Guidance for Industry: Clinical 
Data Needed to Support the Licensure of Trivalent Inactivated Influenza 
Vaccine'' dated March 2006.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 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 guidance 
document.
    Submit written comments on the 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: Kathleen E. Swisher, 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 document entitled 
``Guidance for Industry: Clinical Data Needed to Support the Licensure 
of Seasonal Inactivated Influenza Vaccines,'' dated May 2007. The 
guidance is intended to provide to sponsors of seasonal inactivated 
influenza vaccines guidance on the clinical data needed to support a 
BLA. The approaches in the guidance apply to both nonadjuvanted and 
adjuvanted hemagglutinin-based seasonal vaccines, including ``split 
virus,'' subunit, and whole virus inactivated vaccines propagated in 
embryonated chicken eggs or cell-culture, and to recombinant 
hemagglutinin-based protein vaccines, and DNA vaccines that express 
hemagglutinin.
    Licensure of seasonal inactivated influenza vaccines may be sought 
through either traditional or accelerated pathways. The guidance 
provides recommendations for clinical data to support traditional and 
accelerated license approvals for new seasonal inactivated influenza 
vaccines.
    In the Federal Register of March 10, 2006 (71 FR 12367), FDA 
announced the availability of the draft guidance entitled ``Clinical 
Data Needed to Support the Licensure of Trivalent Inactivated Influenza 
Vaccines'' dated March 2006. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. The changes in the final guidance include a change from the 
term ``trivalent'' inactivated influenza vaccines to ``seasonal'' 
inactivated influenza vaccines. This change was made to provide 
flexibility for evolving public health needs, including the development 
of vaccines with either more than three or less than three antigens. In 
addition, editorial changes were made to improve clarity.

[[Page 30601]]

The guidance announced in this notice finalizes the draft guidance 
dated March 2006.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This 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 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338; those in 21 CFR part 600 have been 
approved under OMB control number 0910-0308; and those in 21 CFR part 
312 have been approved under OMB control number 0910-0014.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (See ADDRESSES) written or electronic comments 
regarding the 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 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 guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10497 Filed 5-31-07; 8:45 am]
BILLING CODE 4160-01-S