E7-10497. Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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. 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.