Draft Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability, 7908 [E9-3554]

Download as PDF 7908 Federal Register / Vol. 74, No. 33 / Friday, February 20, 2009 / Notices Dated: February 17, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–3647 Filed 2–19–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0044] Draft Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability AGENCY: Food and Drug Administration, HHS.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 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Influenza: Developing Drugs for Treatment and/or Prophylaxis.’’ Recent concerns about the possibility of pandemic spread of novel influenza strains have increased interest in influenza drug development for both seasonal and pandemic settings. The purpose of this guidance is to assist sponsors in all phases of influenza drug development and to address questions FDA often receives regarding the potential for emergency use of influenza drugs for the treatment and/or prophylaxis of influenza. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by May 21, 2009. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. VerDate Nov<24>2008 17:55 Feb 19, 2009 Jkt 217001 FOR FURTHER INFORMATION CONTACT: Debra Birnkrant, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6332, Silver Spring, MD 20993–0002, 301– 796–0770. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Influenza: Developing Drugs for Treatment and/or Prophylaxis.’’ Because of the public health implications of both seasonal and pandemic influenza, the variable nature of the disease, and the limited therapeutic options and challenges in studying new options, FDA is developing guidance to assist sponsors in all phases of influenza drug development. This draft guidance addresses preclinical 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 the prophylaxis of symptomatic influenza. This guidance also addresses the role of animal data in an influenza drug development program and considerations relating to the potential for emergency use of influenza drugs including advance development of protocols for further exploration and verification of drug effects. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on developing drugs for the treatment and/or prophylaxis of influenza. 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) written or electronic comments regarding this document. Submit a single copy of electronic PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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. 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 eitherhttps://www.fda.gov/cder/ guidance/index.htm or https:// www.regulations.gov. Dated: February 11, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–3554 Filed 2–19–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; A Process Evaluation of the NIH Director’s New Innovator Award (NIA) Program SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director, the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: A Process Evaluation of the NIH Director’s New Innovator Award (NIA) Program. Type of Information Collection Request: New collection. Need and Use of Information Collection: This study will assess the NIA Program operations and the outputs of the identification, evaluation and selection process. The primary objectives of the study are to: (1) Assess the NIA award selection process; (2) determine if the program was implemented as planned; and (3) determine if the process was conducted in accordance with the overall mission of the NIA program. The findings will provide valuable information concerning: (1) The characteristics of applicants and reviewers; (2) the criteria used to evaluate and select awardees; and (3) aspects of the process that could be revised or improved. Frequency of Response: Once. Affected Public: none. Type of E:\FR\FM\20FEN1.SGM 20FEN1

Agencies

[Federal Register Volume 74, Number 33 (Friday, February 20, 2009)]
[Notices]
[Page 7908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3554]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft 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 draft guidance for industry entitled ``Influenza: 
Developing Drugs for Treatment and/or Prophylaxis.'' Recent concerns 
about the possibility of pandemic spread of novel influenza strains 
have increased interest in influenza drug development for both seasonal 
and pandemic settings. The purpose of this guidance is to assist 
sponsors in all phases of influenza drug development and to address 
questions FDA often receives regarding the potential for emergency use 
of influenza drugs for the treatment and/or prophylaxis of influenza.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by May 21, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
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. 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 https://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Debra Birnkrant, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6332, Silver Spring, MD 20993-0002, 301-
796-0770.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Influenza: Developing Drugs for Treatment and/or 
Prophylaxis.'' Because of the public health implications of both 
seasonal and pandemic influenza, the variable nature of the disease, 
and the limited therapeutic options and challenges in studying new 
options, FDA is developing guidance to assist sponsors in all phases of 
influenza drug development. This draft guidance addresses preclinical 
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 the prophylaxis of 
symptomatic influenza. This guidance also addresses the role of animal 
data in an influenza drug development program and considerations 
relating to the potential for emergency use of influenza drugs 
including advance development of protocols for further exploration and 
verification of drug effects.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on developing 
drugs for the treatment and/or prophylaxis of influenza. 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) written or electronic comments regarding this document. 
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. 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 
eitherhttps://www.fda.gov/cder/guidance/index.htm or https://
www.regulations.gov.

    Dated: February 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3554 Filed 2-19-09; 8:45 am]
BILLING CODE 4160-01-S

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