[Federal Register: March 10, 2006 (Volume 71, Number 47)]
[Notices]
[Page 12366-12367]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr06-80]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0088]
Draft Guidance for Industry on Clinical Data Needed to Support
the Licensure of Pandemic Influenza Vaccines; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Clinical Data Needed to Support the Licensure of Pandemic Influenza
Vaccines,'' dated March 2006. The draft document is intended to provide
to sponsors of pandemic influenza vaccines guidance on clinical
development approaches to facilitate and expedite the licensure of
influenza vaccines for the prevention of disease caused by pandemic
influenza viruses. The draft guidance provides recommendations for
clinical data to support biologics license application (BLA) license
approval either as a supplement or as a new BLA using the accelerated
approval pathway.
DATES: Submit written or electronic comments on the draft guidance by
June 8, 2006 to ensure their adequate consideration in preparation of
the final guidance. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research, 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 The draft guidance may also be obtained by
mail by calling the Center for Biologics Evaluation and Research at 1-
800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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 draft document entitled
``Guidance for Industry: Clinical Data Needed to Support the Licensure
of Pandemic Influenza Vaccines,'' dated March 2006. The draft guidance
is intended to provide to sponsors of pandemic influenza vaccines
guidance on clinical development approaches to facilitate and expedite
the licensure of influenza vaccines for the prevention of disease
caused by pandemic influenza viruses. The approaches apply to ``split
virus'' and whole virus inactivated pandemic vaccines propagated in
embryonated chicken eggs, and are also applicable to cell-culture
derived, recombinant hemagglutinin-based protein, and adjuvanted
pandemic influenza vaccines. The draft guidance provides
recommendations for clinical data to support BLA approval either as a
supplement or as a new BLA using the accelerated approval. The draft
guidance also addresses live attenuated influenza vaccines, but does
not address influenza vaccines that do not contain a hemagglutinin
component. The draft guidance does not address the nonclinical
development of investigational vaccines, or the chemistry,
manufacturing, control, or inspection of the manufacturing facility
needed for licensure.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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 requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft 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.
III. Comments
The draft guidance is being distributed for comment purposes only
[[Page 12367]]
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft 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 brackets in the
heading of this document. A copy of the draft 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 draft guidance
at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default
.htm.
Dated: March 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3371 Filed 3-9-06; 8:45 am]
BILLING CODE 4160-01-S