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FDA is announcing the availability of a guidance for industry entitled “Acute Bacterial Otitis Media: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the overall clinical development of drugs to support an indication for the treatment of ABOM, defined in the guidance as “the recent or acute onset of inflammation of the middle ear caused by a bacterial pathogen.” This guidance finalizes the revised draft guidance issued on January 18, 2008, which in turn revised the draft guidance for industry entitled “Acute Otitis Media—Developing Antimicrobial Drugs for Treatment” issued in 1998. Changes from the revised draft guidance are incorporated in the appropriate sections of the guidance and are based on comments received to the docket for the draft guidance. In addition, developments in scientific and medical information and technology in the treatment of ABOM are included in this guidance. This guidance fulfills the statutory requirement described in the Food and Drug Administration Amendments Act of 2007 that directed FDA to update the guidance within 5 years.
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 the treatment of ABOM. 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.
This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget 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 0910-0014 and 0910-0001, respectively. The collections of information referred to in the guidance for clinical trial sponsors entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” have been approved under 0910-0581.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
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