[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]                         

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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Draft Guidance for Industry on Clinical Data Needed to Support 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.

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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 The draft guidance provides recommendations for 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may also be obtained by 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for electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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]

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