Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability, 20689-20690 [2011-8817]

Download as PDF Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 3520). The collections of information 21 CFR part 814, subparts B and E, have been approved under OMB control number 0910–0231; the collections of information 21 CFR part 814, subpart H, have been approved under OMB control number 0910–0332; the collections of information 21 CFR part 820 have been approved under OMB control number 0910–0073; the collections of information in FDA form 3601 have been approved under OMB control number 0910–0511; and the collections of information in FDA form 3602a have been approved under OMB control number 0910–0508. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/ RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Always access an FDA guidance document by using FDA’s Web site listed previously to find the most current version of the guidance. Dated: April 7, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–8886 Filed 4–12–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0044] mstockstill on DSKH9S0YB1PROD with NOTICES Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 SUMMARY: VerDate Mar<15>2010 18:37 Apr 12, 2011 Jkt 223001 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 https://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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 20689 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., realtime 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. E:\FR\FM\13APN1.SGM 13APN1 20690 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// 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] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Cincinnati, OH; Regional Public Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSKH9S0YB1PROD with NOTICES ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing a public meeting entitled ‘‘Preparation for ICH Steering Committee and Expert Working Group Meetings in Cincinnati, Ohio’’ to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Cincinnati, OH. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Cincinnati, OH, scheduled on June 11 through 17, 2011, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The public meeting will be held on May 19, 2011, from 2 p.m. to 4 p.m. Location: The public meeting will be held at the Washington Theater room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: All participants must register with Kimberly Franklin, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, email: Kimberly.Franklin@fda.hhs.gov, or FAX: 301–595–7937. Registration and Requests for Oral Presentations: Send registration VerDate Mar<15>2010 18:37 Apr 12, 2011 Jkt 223001 information (including name, title, firm name, address, telephone, and fax number), written material, and requests to make oral presentations to the contact person (see Contact Person) by May 16, 2011. Interested persons may present data, information, or views orally or in writing, on issues pending at the public meeting. Public oral presentations will be scheduled between approximately 3:30 p.m. and 4 p.m. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person (see Contact Person) by May 16, 2011, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses, telephone number, fax, and email of proposed participants, and an indication of the approximate time requested to make their presentation. If you need special accommodations due to a disability, please contact Kimberly Franklin (see Contact Person) at least 7 days in advance. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information, 12420 Parklawn Dr., Rockville, MD 20857. SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 initiatives to be developed with input from both regulatory and industry representatives. ICH is concerned with harmonization among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical Manufactures Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and Health Canada, the European Free Trade Area and the World Health Organization. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the three ICH regions. The current ICH process and structure can be found at the following Web site: https://www.ich.org. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) The agenda for the public meeting will be made available on the Internet at https://www.fda.gov/Drugs/ NewsEvents/ucm248489.htm. Dated: April 8, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–8816 Filed 4–12–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] International Consortium of Orthopedic Registries; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘International Consortium of Orthopedic Registries (ICOR).’’ The E:\FR\FM\13APN1.SGM 13APN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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]
BILLING CODE 4160-01-P
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