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[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Notices]
[Page 56772-56773]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc07-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
[[Page 56773]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.pandemicflu.gov/plan/federal/index.html).
Dated: September 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19577 Filed 10-3-07; 8:45 am]
BILLING CODE 4160-01-S