E7-19577. Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the opening of a docket to receive information and comments from manufacturers of vaccines and other interested persons concerning the development of safety and effectiveness assessments of vaccines used for pandemic influenza. FDA is interested in obtaining comments and information to aid in the development of programs for adverse events surveillance following administration of pandemic influenza vaccines, and in the development of protocols to study effectiveness of influenza vaccines in pre-pandemic and pandemic situations.

DATES:

Submit written or electronic comments on the safety and effectiveness assessments of vaccines for pandemic influenza use, and comments on information submitted to the docket by other interested persons by December 3, 2007.

ADDRESSES:

Submit written comments and information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852-1448. Submit electronic comments or information to either http://www.fda.gov/​dockets/​ecomments or http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Paul E. Levine, Jr. 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

The National Strategy for Pandemic Influenza was issued by President Bush in November 2005. This National Strategy identifies the U.S. Department of Health and Human Services (HHS) as the lead for medical response and is intended to guide our nation's preparedness and response to pandemic influenza.

The Implementation Plan for the National Strategy for Pandemic Influenza (the Implementation Plan) was issued by the President on May 3, 2006. The Implementation Plan translates the Strategy into more than 300 actions for Federal departments and agencies and sets expectations for State and local governments and other non-Federal entities. FDA's Center for Biologics Evaluation and Research is the lead for the vaccine action items under section 6.1.13.9 parts (1) and (3) of chapter 6 of the Implementation Plan. This section, in part, states that HHS, in coordination with the Department of Defense, the Veteran's Administration, and in collaboration with State, territorial, tribal, and local partners, shall develop and refine mechanisms to: (1) Track adverse events following vaccine and antiviral administration; and (2) define protocols for conducting vaccine- and antiviral-effectiveness studies during a pandemic, within 18 months.

FDA conveyed in our May 31, 2007, Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (72 FR 30599), that all sponsors who seek licensure of a pandemic influenza vaccine should expect FDA to seek their involvement in working with FDA and other governmental agencies on plans to collect additional safety and effectiveness data, such as through epidemiological studies, when the vaccine is used (see http://www.fda.gov/​cber/​gdlns/​panfluvac.htm). FDA and the Centers for Disease Control and Prevention are engaged in discussions about adverse events surveillance during early use of influenza vaccines for pre-pandemic and pandemic situations. Relevant to the actions outlined in the preceding paragraph, we are inviting vaccine manufacturers who are pursuing the development of pre-pandemic and pandemic influenza vaccines, as well as other interested persons, to provide comments and information concerning mechanisms to track adverse events following vaccination, and the development of protocols to study effectiveness of influenza vaccines during a pandemic.

Specifically, we are requesting information on the design of potential studies to assess the effectiveness of influenza vaccine in a pandemic situation, including comments on the potential usefulness of randomized trials, case control studies, or additional study designs, as well as, potential endpoints. In addition, we are seeking comments on organizations and entities, such as managed care organizations, or other public or private entities that may be able to partner with manufacturers and sponsors to assess safety and effectiveness.

We are requesting comments and information to help us understand the complex issues encountered in trying to obtain these data during a pandemic. Your comments and information might assist us in the development of additional guidance documents for the conduct of postmarketing safety surveillance and effectiveness studies for pandemic influenza vaccines.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and information regarding this document. 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 this document 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.

III. Electronic Access

Persons with access to the Internet may obtain the National Strategy for Pandemic Influenza, issued November 2005, and the Implementation Plan for the National Strategy, issued May 3, 2006, at (http://www.pandemicflu.gov/​plan/​federal/​index.html).

Dated: September 27, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.