*** BACKGROUND *** The National Pandemic Influenza Plan (Nov. 1, 2005) designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response for pandemic preparedness. Following the issuance of the HHS Pandemic Plan of 2005, the Office of the Assistant Secretary for Preparedness and Response (ASPR) was charged with gathering information, developing policies and issuing recommendations on specific medical countermeasures (e.g., stockpile acquisitions) that may be used to contain, control, and mitigate the mortality and morbidity associated with influenza pandemics in the United States. The Office of Public Health Emergency Medical Countermeasures (OPHEMC) in ASPR is responsible for the tactical and logistical implementation of policies and decisions regarding these pandemic medical countermeasures. This is a Request for Information (RFI) on current manufacturing capabilities and new technology development for respiratory protection devices that might be used in the event of a pandemic influenza outbreak. It is not a request for proposals and does not commit the U.S. Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the U.S. Government and will not be returned.



*** OBJECTIVE *** During an influenza pandemic the need for respiratory protection devices may increase significantly. To meet an increased demand, the existing supply and baseline production capacity of respiratory protection devices in the U.S. may need to expand, and the capability to increase production in the time of actual emergency (i.e., surge capacity) may require enhancement. This is potentially achievable by expanding existing manufacturing facilities, erecting new manufacturing facilities, converting existing manufacturing plants and/or stockpiling respiratory protection devices. To better understand these issues and formulate specific recommendations, HHS/ASPR/OPHEMC is requesting information on manufacturing capabilities for specific respiratory devices. HHS/ASPR/OPHEMC is also interested in new technologies or devices under development that are relevant to respiratory protection during an influenza pandemic. For the purpose of this RFI, HHS/ASPR/OPHEMC distinguishes between the following categories of devices:



Category 1 - National Institute for Occupational Safety and Health (NIOSH)-certified (42 CFR Part 84) N95 filtering face-piece respirators that have been cleared by the US Food and Drug Administration Center for Devices and Radiological Health for medical use (FDA-cleared);

Category 2 - NIOSH-certified N95 filtering face-piece respirators that have not been cleared by the FDA (i.e. are currently marketed for non-medical use;

Category 3 - FDA-cleared surgical face masks also referred to as “medical procedure masks, isolation masks, laser masks, dental masks, face masks"; and

Category 4 - New technologies, devices under development or proposed changes in existing devices that could potentially afford similar or superior respiratory protection to devices in categories 1, 2 or 3.



***CURRENTLY MARKETED DEVICES*** Categories 1, 2 and 3 refer to respiratory protection devices that are currently marketed and that have received NIOSH certification and/or FDA-clearance. For devices in Categories 1, 2 and 3, please provide the following specific information:



1. List each facility (domestic or international) where the device is manufactured. Include the following details:



a) Name of manufacturing facility;

b) Address; and

c) FDA Device Establishment Registration Number (if it exists);



2. For each manufacturing facility listed, describe the specific device that is manufactured. Include the following details/address the following questions:



a) Proprietary name of the device;

b) Category to which the device belongs (see categories above;

c) Specific features of the device including ease of use, durability or useful life, whether it is intended as a single-use or multi-use device;

d) Current unit price;

e) Whether the manufactured device is labeled with a finite ‘shelf-life.’ If yes, what specific factors determine its labeled ‘shelf-life,’ and the technical feasibility of extending the ‘shelf-life;

f) Existing inventory, production cycle time, baseline production rates and current surge capacity for the product at that facility;

g) Plans for expanding production of the device at that manufacturing site, estimated costs and timeline for this planned expansion;

h) If the manufacturing facility is located in the US, describe specific dependencies on raw materials from non-domestic sources, and the feasibility of converting to domestic sources for these raw materials;

i) Storage requirements for the product including pallet size (footprint), number of units (masks) per pallet, and special environmental requirements (e.g., temperature, UV protection, etc.);

j) Current storage capabilities (or feasibility of expanding such storage) for the product at this manufacturing facility that might enable stockpiling of respiratory devices under a vendor managed inventory; and

k) Ability to track distribution of the product after it has left the manufacturing facility.



3. Describe plans for building new facilities or converting existing facilities to increase manufacturing capabilities of currently marketed devices.





*** NEW TECHNOLOGY/DEVICES UNDER DEVELOPMENT*** Category 4 refers to new technologies, devices under development or proposed changes in existing devices that could potentially afford similar or superior respiratory protection during an influenza pandemic. Please provide the following specific information:



1) For new technology, describe how it may potentially enhance existing device performance or manufacturing capabilities;

2) For devices under development, describe anticipated comparability to currently-marketed devices with respect to:

a) Respiratory protection,

b) Ease of use and fit,

c) Durability, anticipated useful life, potential for re-use, ‘shelf-life’ (if applicable),

d) Production cycle times,

e) Source materials and source material constraints on manufacture, and

f) Timelines.



3. Describe the stage of technology or new device development or, if applicable, the stage of integration into existing device designs;

4. If seeking NIOSH certification, describe the current stage in the certification process and timeline to clearance; and

5. If seeking FDA clearance, describe the current stage in the regulatory process and timeline to clearance.



Organizations that currently develop or manufacture the devices described in this RFI or that have technologies, devices or manufacturing capabilities under development are invited to submit statements to HHS.



Data obtained from this RFI will be used by HHS in making recommendations and decisions on the development of an appropriate planning and procurement strategy for National Pandemic Preparedness.



All information submitted to HHS will be kept confidential as allowed by relevant Federal law and will be eligible for additional special protections under the conditions of the Protected Critical Infrastructure Information (PCII) Program outlined in the Critical Infrastructure Information Act of 2002.

Information must be submitted by 3:00 p.m.,(EST) on May 18, 2007. Include the name, email address and telephone number of a primary contact point at your organization for this RFI in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 25 pages. Data sets (e.g., tables, charts, graphs) and documents which are pertinent to the response can also be submitted as appendices to the primary submission.

Your response to this RFI must be submitted electronically in .pdf format and emailed to RFI-OPHEMC-07-01@hhs.gov. In your submission, indicate if the product or item meets the Federal Acquisition Regulations (FAR) definition of “commercial item” as specified in FAR 2.101. The type of business submitting the response (i.e., small business, large business, hub-zone, small and disadvantaged business, etc.) must be identified in your response. If the product can be acquired on a GSA schedule, VA schedule, or other Government-wide acquisition vehicle, please supply the contract title and number, contract point of contact information and the name of the awarding agency.