[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20689-20690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0044]


Guidance for Industry on Influenza: Developing Drugs for 
Treatment and/or Prophylaxis; 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 guidance for industry entitled ``Influenza: 
Developing Drugs for Treatment and/or Prophylaxis.'' This guidance is 
intended to assist sponsors in the clinical development of drugs and 
therapeutic biological products for the treatment and/or prophylaxis of 
illness caused by influenza viruses A and B, including both seasonal 
and pandemic varieties. This guidance finalizes the draft guidance 
issued February 20, 2009.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Jeffrey Murray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Influenza: Development of Drugs for Treatment and/or 
Prophylaxis.'' Because of the public health implications of both 
epidemic and pandemic influenza, the variable nature of the disease, 
the limited therapeutic options, and challenges in studying new 
options, FDA is issuing guidance to assist sponsors in all phases of 
influenza drug development.
    This guidance addresses nonclinical development, early phases of 
clinical development, phase 3 protocol designs and endpoints for the 
treatment of both uncomplicated and serious influenza, and protocol 
designs for prevention of symptomatic influenza. Other issues that are 
addressed in this guidance include the role of animal data in an 
influenza drug development program, and considerations relating to the 
potential for emergency access to influenza drugs, including advance 
development of protocols for further exploration and verification of 
drug effects under epidemic and pandemic conditions.
    A draft notice of availability of this guidance was published for 
comment in the Federal Register of February 20, 2009 (74 FR 7908). 
Comments we received on the draft guidance have been considered and the 
guidance has been revised as follows: (1) Clarification on the size of 
a safety database needed to support filing of a new drug application 
for the treatment of serious influenza; (2) elaboration on why 
virologic endpoints are not currently acceptable primary efficacy 
endpoints in phase 3 studies; (3) a recommendation for the inclusion of 
sensitive and specific assays (e.g., real-time polymerase chain 
reaction assay) for laboratory confirmation of influenza infection to 
assist in defining the infected population for analyses in influenza 
treatment trials; and (4) additional statements regarding proposals for 
potential emergency use authorizations of antiviral drugs for 
influenza.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on developing drugs for treatment and/or 
prophylaxis of influenza illness. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that 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 parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 20690]]

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8817 Filed 4-12-11; 8:45 am]
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