[Federal Register Volume 72, Number 105 (Friday, June 1, 2007)]
[Notices]
[Pages 30599-30600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0088]


Guidance for Industry: 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 document entitled ``Guidance for Industry: Clinical 
Data Needed to Support the Licensure of Pandemic Influenza Vaccines,'' 
dated May 2007. The guidance document provides 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 
guidance provides recommendations concerning clinical data to support 
traditional license approval of a biologics license application (BLA), 
or a BLA using the accelerated approval pathway. The guidance announced 
in this notice finalizes the draft guidance of the same title dated 
March 2006.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), 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 guidance may also be obtained by mail 
by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit written comments on the 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://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Kathleen E. Swisher, 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 document entitled 
``Guidance for Industry: Clinical Data Needed to Support the Licensure 
of Pandemic Influenza Vaccines,'' dated May 2007. This document is 
intended to provide sponsors of pandemic influenza vaccines guidance on 
clinical development approaches to facilitate and expedite the 
licensure of influenza vaccines where the intended indication is for 
active immunization in persons at high risk of exposure to, or during a 
pandemic caused by, pandemic influenza viruses. The approaches in this 
guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based 
pandemic vaccines, including ``split virus,'' subunit, and whole virus 
inactivated vaccines propagated in embryonated chicken eggs or cell-
culture, and to recombinant hemagglutinin-based protein vaccines, and 
DNA vaccines that express hemagglutinin. Also addressed are live 
attenuated influenza vaccines.
    In the Federal Register of March 10, 2006 (71 FR 12366), FDA 
announced the availability of the draft guidance of the same title 
dated March 2006. FDA received several comments on the draft guidance. 
FDA considered those comments when finalizing the guidance. The 
guidance announced in this notice finalizes the draft guidance dated 
March 2006.
    In the March 2006 draft guidance, FDA stated that clinical trial 
data could be submitted as a clinical efficacy supplement to an 
original BLA when the manufacturer has a U.S.-licensed trivalent 
inactivated or live attenuated influenza vaccine. After reviewing 
comments on the draft guidance and considering the matter further, we

[[Page 30600]]

revised our recommendations in the final guidance. All submissions for 
the initial licensure of a pandemic influenza vaccine should be 
submitted as BLAs, which will provide for a trade name and labeling 
specific to the pandemic vaccine. For sponsors with existing licensed 
seasonal inactivated or live attenuated influenza vaccines who intend 
to file a BLA for a pandemic influenza vaccine that utilizes the same 
manufacturing process, we would expect that the BLA would reference the 
original BLA, including the nonclinical and chemistry, manufacturing, 
and controls data in their original BLA. Manufacturers that do not have 
existing licensed influenza vaccines, or that do, but are seeking to 
license a pandemic influenza vaccine utilizing a different 
manufacturing process, may seek accelerated approval according to the 
provisions of 21 CFR 601.41.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This 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 and in 21 CFR part 312 have been approved 
under OMB control number 0910-0014.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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 
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 guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10499 Filed 5-31-07; 8:45 am]
BILLING CODE 4160-01-S