[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Pages 56772-56773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19577]



Food and Drug Administration

[Docket No. 2007N-0348]

Establishing a Docket for the Development of Safety and 
Effectiveness Assessments of Vaccines Used for Pandemic Influenza; 

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.

[[Page 56773]]

Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.


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 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 

    Dated: September 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19577 Filed 10-3-07; 8:45 am]