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    IDSA Comments on the Addition of Avian Influenza to the Select Agent List (PDF)

    IDSA responded to an HHS Notice of Proposed Rule Making to add influenza viruses that contain A/Gs/Gd/1/96 Hemagglutinin (HA), including wild-type viruses, as non-Tier 1 select agents and viruses that have additionally made transmissible among mammals by respiratory droplets in a laboratory as Tier 1 select agents.  IDSA supported this proposal, and reaffirmed the importance of maintaining a balance between the public health risk of impeding research with these viruses against the public health risk of an accidental laboratory risk or act of bioterrorism.

    IDSA Submits Comments on 2015-2018 Draft National Health Security Strategy (PDF)

    IDSA submitted comments to the Assistant Secretary for Preparedness and Response (ASPR) on the agency's 2015-2018 draft National Health Security Strategy (NHSS).  IDSA applauds the agency's comprehensive approach to national security and the inclusion of "One Health" principles in the strategy, while offering substantive comments on various components of the NHSS most relevant to ID physicians and their patients.

    IDSA Comments on Institutional Oversight of Life Sciences Dual Use Research of Concern (PDF)

    IDSA Supports the principles underlying the draft U.S. Government (USG) policy, but urges the USG to re-define the scope of oversight and provide much more specific guidance, analytical tools and other resources to assist institutions in implementation.

    IDSA Comments on HHS H5N1 Select Agent Proposal (PDF)

    IDSA advocates balancing the public health risk of impeding the conduct of H5N1 research against the public health risk of an accidental laboratory release or act of bioterrorism.  IDSA recommends that naturally occurring H5N1 viruses and vaccine strains be regulated as HHS select agents with current biosafety and biosecurity regulations, while H5N1 viruses that have been engineered for greater transmissibility or pathogenicity be regulated as Tier 1 select agents, and with increased biosafety and biosecurity restrictions.

    IDSA Comments on FDA Development of Multiplexed Diagnostics (PDF)

    FDA sought comments on options being considered for the performance validation of highly multiplexed microbiology/medical countermeasure (MCM) diagnostic devices.  In responding to the FDA concept paper, IDSA addressed the clinical and public health need for better infectious diseases diagnostic devices, clinical considerations for device design, and key issues for device validation.

    IDSA Comments on Select Agents and Toxins Proposed Rule (PDF)

    IDSA conveyed its appreciation to CDC/HHS for aspects of the Proposed Rule that provide greater clarification for managing select agents and toxins.  However, IDSA offered five overarching recommendations that improve biosecurity while taking into account the impact of regulations on research essential to public health and national security.

    IDSA Comments on FDA Guidance to Industry on Antivirals for Treatment or Prophylaxis of Influenza (PDF)

    IDSA submitted comments to FDA on its revised influenza antiviral guidance, which has many improvements from the 2009 draft guidance.  However, IDSA remains concerned with aspects of the document’s recommendations regarding study design for influenza treatment in uncomplicated illness and in hospitalized patients, as well as with its interpretation of the available clinical outcomes data.

    IDSA Outlines Priorities for FDA's Incoming Leaders (PDF)

    In a letter to Commissioner Peggy Hamburg, IDSA requested a meeting with top agency officials to discuss issues and strategies related to novel H1N1 influenza, impediments to antibacterial drug development, strategies to better address antimicrobial resistance and the use of antimicrobials in animals.

    IDSA Comments on FDA Draft Guidance to Industry on Antivirals for Treatment or Prophylaxis of Influenza (PDF)

    In its comments, IDSA raised concerns about FDA's proposal to approve new antivirals for influenza based on superiority or dose-ranging trials vs. non-inferiority trials.  IDSA also is concerned about FDA's adherence to Pediatric Research Equity Act requirements, which may act as an impediment to drug development in this critical area.

    IDSA Comments on the Development of Influenza Antiviral Home MedKits (PDF)

    At a meeting of FDA advisory committee regarding development of an influenza antiviral home MedKit, IDSA provided public comments about the challenges to safe and effective use posed by the unknowns regarding use of current antivirals in a pandemic, combined with the absence of medical supervision in the proposed scenario of home based use.

    IDSA, Major Medical Societies Oppose Home Stockpiling of Antivirals (PDF)

    IDSA, along with AMA, AAP, and AAFP, opposes federal plan to take a permissive approach to public purchase and home stockpiling of antivirals ahead of a potential influenza pandemic, citing clinical and public health considerations and the need for further study.

    IDSA Comments on HHS Draft Pandemic Influenza Vaccine Prioritization Guidance (PDF)

    IDSA endorses the vaccine prioritization framework while also urging the federal government to create an integrated prioritization scheme across essential medical countermeasure including pandemic vaccine, pre-pandemic vaccine, antivirals and other countermeasures in order to rationalize pandemic response.  IDSA likewise recommends establishment of a joint panel to reassess prioritization plans at the time of a pandemic, among other suggestions.

    IDSA Comments on HHS Draft Pandemic Antiviral Drug Strategies Guidance (PDF)

    IDSA suggests that the federal government first focus on creating consistency among state antiviral stockpiles for treatment and secondly, focus on establishing stockpiles intended for the prophylaxis of the health care sector and essential emergency personnel.

    IDSA Issues Comments on HHS Countermeasures Prioritization Plan (PDF)

    IDSA's comments are directed at HHS' draft "Public Health Emergency Medical Countermeasure Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats" which outlines steps and criteria for prioritizing countermeasures for federally funded development and acquisition under the BARDA and Project Bioshield programs.

    Letter to HHS on IDSA's Pandemic Vaccine Master Program Concept (PDF)

    IDSA supports an intensified U.S.-led effort to develop pandemic vaccine, coordinated through the Office of the Assistant Secretary for Preparedness and Response, to ensure the availability of an effective and available vaccine in the event of a pandemic.

    IDSA Provides Comments to HHS on Prioritizing Pre-Pandemic and Pandemic Vaccines (PDF)

    Widespread use of a pandemic vaccine should be the central strategy for protection of human health during a pandemic event. National guidelines for prioritization of pre-pandemic and pandemic influenza vaccine are a critical component of this strategy.

    IDSA and SHEA Comment on the Implementation Plan for the National Strategy for Pandemic Influenza (PDF)

    IDSA and SHEA share concerns about the Plan's core orientation and the signficant work remaining, leadership and resources.

    IDSA Letter to FDA on Licensure of Pandemic Flu Vaccines (PDF)

    IDSA comments to FDA on its document entitled "Guidance for Industry:  Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines."

    IDSA Comments on HHS Pandemic Flu Plan (PDF)

    IDSA letter to Secretary Leavitt regarding the HHS Pandemic Influenza Plan and section-by-section comments on the Plan.

    IDSA Recommends Stockpiling Antivirals to Prepare for Pandemic Influenza (PDF)

    IDSA letter to HHS Secretary Michael Leavitt on the stockpiling of antivirals in preparation for pandemic influenza.

    IDSA Comments on HHS Draft Pandemic Influenza Preparedness and Response Plan (PDF)

    IDSA applauds HHS' efforts in the development of a Plan to address a future influenza pandemic and provides recommendations to strengthen U.S. preparedness and response.


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