BAA-11-100-SOL-00009 Amend04_ Special Instructions for Thermal Burn Definitive Care Products_03Feb2012.docx

Final BAA Special Instructions for Thermal Burn Definitive Care Products

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT

ADVANCED RESEARCH AND DEVELOPMENT OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES

Broad Agency Announcement Number: BARDA-CBRN- BAA-11-100-SOL-00009

Amendment Number: 04

Amendment Posting Date: February 3, 2012

Issued By: Biomedical Advanced Research and Development Authority (BARDA) 330 Independence Ave., SW, Room G640 Washington, D.C. 20201

Point of Contact: Primary: Glynis Fisher, Contract Officer Glynis.Fisher@hhs.gov

Alternate: Thomas Hastings-Tickerhoff, Contract Officer Thomas.Hastings-Tickerhoff@hhs.gov

SECTION-I: SUMMARY OF SPECIAL INSTRUCTIONS

1. PURPOSE: The purpose of these special instructions is to solicit proposals for advanced development of existing and prospective medical products that improve ‘Definitive Care’ required for full-skin-thickness burn injuries or deep partial-skin-thickness burn injuries likely to convert to full-skin-thickness injuries. These instructions address treatments such as skin substitutes for thermal burn injuries likely to result from detonation of an improvised nuclear device (see Research Area 4 in the Broad Agency Announcement), recognizing that such treatments may be useful also for burns due to common causes (e.g., flames, scalds, chemicals). As a result, preparedness for a wide range of types of burn injuries, resulting from any cause, and importantly from any mass-casualty incident resulting in many thermal burns, may benefit from these product-development efforts.

Offerors are also directed to review the pertinent additional information on ‘Definitive Care’ in the Sources Sought Notice (SSN) published in August 2011.[footnoteRef:1] [1: SSN is available at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=251d07732170b4e8cb89310334582654&tab=core&_cview=0]

2. REFERENCE: The contents presented below in SECTION-II (Special Instructions- Advanced Development of Definitive Care Products for Thermal Burn Injuries) have been added under Part I (Research Areas of Interest), Area of Interest #4 (Radiological/Nuclear Threat Medical Countermeasures), to solicit new proposals for the purpose mentioned above.

3. SEEKING ADDITIONAL INFORMATION:

A. Questions from industry regarding the special instructions may be emailed to CBRN-BAA@hhs.gov. Questions received on or before Tuesday, February 14, 2012 may be addressed broadly at the pre-proposal conference.

B. A pre-proposal conference will be held Thursday, February 23, 2012. Particulars follow the special instructions section below.

C. The Broad Agency Announcement (BAA) closing date remains unchanged. Except as provided herein, all terms and conditions of the BAA remain unchanged.

D. The last day for submission of proposals under these special instructions is Saturday, March 3, 2012 and coincides with the expiration date for this BAA. It is anticipated that these special instructions may be renewed if the current BAA is renewed. Please see Section –II: Special Instructions, paragraph 5., Proposals Under Special Instructions, subparagraph D, below

SECTION-II: SPECIAL INSTRUCTIONS

ADVANCED DEVELOPMENT OF DEFINITIVE CARE PRODUCTS FOR THERMAL BURN INJURIES

1. BACKGROUND: Within the Federal Government, the Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, procurement, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemics, and emerging infectious diseases. Response and recovery were identified as key elements of national defense in the National Strategy to Combat Weapons of Mass Destruction issued in 2002 (National Security Presidential Directive-17 / Homeland Security Presidential Directive-4; NSPD-17/HSPD-4) and in the National Military Strategy to Combat Weapons of Mass Destruction (NMS-CWMD), released in 2006. The lead role of HHS in the medical and public health response, including development and availability of medical countermeasures, was emphasized in 2004 in Biodefense for the 21st Century (HSPD-10) and in 2007 in Medical Countermeasures against Weapons of Mass Destruction (HSPD-18). The importance of an effective medical countermeasures enterprise for development and provision of medical countermeasures was emphasized in 2009 in the National Health Security Strategy (NHSS) and in the Secretary’s PHEMCE review in 2010 titled Transforming the Enterprise to Meet Long-Range National Needs. These documents represent the foundation for addressing the Nation’s CBRN medical countermeasure needs.

HHS, through an interagency enterprise called the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), has undertaken a two-stage approach to planning for, developing, and acquiring medical countermeasures for CBRN threats. The first stage was the development of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy for CBRN Threats (HHS PHEMCE Strategy), published in the Federal Register in March 2007 (Vol.72, No.53, March 20, 2007). In collaboration with public and private stakeholders, the HHS PHEMCE Strategy established the goals and objectives that HHS is using to ensure that medical countermeasures are provided against the highest-priority CBRN threats facing the Nation. The second stage in this process was the development of the HHS PHEMCE Implementation Plan for CBRN MCMs (HHS PHEMCE Implementation Plan), published in the Federal Register in April 2007 (Vol.72, No.77, April 23, 2007). The Implementation Plan delineates HHS Medical Countermeasures priorities for research, development, and acquisition to address the highest-priority CBRN threats.

HHS has requirements for the capability to treat thousands of burn victims following a nuclear detonation. Given (a) the labor- and resource-intensive care needed for people with substantial portions of their body burned severely and (b) the limitations in the health care system, the need is particularly high to develop products that can reduce the labor-intensity and resource-intensity of care for severe and widespread burns. For a mass-casualty situation, this includes reducing the need for highly-skilled and highly-trained labor and reducing the need for specialized care facilities, which would be severely limited in availability in a context of providing “standard-of-care” treatment for thousands of burn victims.

2. SCOPE: These special instructions focus on products for Definitive Care for thermal burn injuries in medical facilities with the resources and trained medical professionals needed for surgical burn care (e.g., excision and grafting), not for field care. However, as noted, particularly favorable are products that will reduce the level of specialized medical training necessary to apply or administer the product and will reduce the amount, complexity, level, and, therefore, expense of surgical or other specialized medical care.

A. Advanced-development proposals solicited under these special instructions, primarily cover three (3) product categories (specifically, referred as numbers 2, 3, and 4 in the SSN) as detailed in Table 1 (below).

B. Proposals can also include or exclusively focus on associated products with a potential to enhance the use or functionality of products in the categories noted in Table 1 below. For example, debridement methods that reduce the need for surgical care or enhance the ease of adequate wound preparation or the ease of use or functionality of treatment products are desirable.

C. Combinations of products and technologies that provide enhanced attributes that are not readily available using only one of the individual components are encouraged. Collaborations among product manufacturers that together provide unique or comprehensive solutions for care in mass-casualty situations are desirable.

Table 1: Description of Product Categories Supported Under BAA-Special Instructions

3. GOALS: Advanced development of Definitive Care products for thermal burn injuries promotes two primary goals.

A. Foster the development of products that will be market competitive and improve the standard-of-care for conventional burn injuries. These improved products would eventually integrate sustainably into routine clinical use while simultaneously improving the quality of mass casualty care.

B. Increase market acceptance and the potential for manufacturing surge capacity thereby improving availability of the products for national emergency preparedness.

4. ENHANCED PRODUCT ATTRIBUTES: To meet the goals, the following product attributes are of significant interest to serve all members of the U.S. population who would be in need in a mass-casualty situation to include at–risk populations identified as children, the elderly, pregnant women, and persons with compromised immune systems, mental or physical disabilities. The products are expected to serve the diverse citizenry, including the general adult population, infants and children, the elderly, pregnant women, individuals with mental or physical disabilities, immuno-compromised people, hyper-allergenic people, and those with other pre-existing medical conditions like diabetes. Products with limited or no applicability for at-risk populations are less desirable. Products that only address the needs of one or more at-risk populations, without general applicability, are beyond the scope of this special instruction. A more comprehensive discussion is available in the SSN published in August 2011 (see footnote 1).

A. Lower Cost of Goods and Care: Products are favorable that would lower the overall cost of manufacture as well as comprehensive patient care to maximize health-care benefit. The factors that influence this could include, but are not limited to, reduction in the number and/or complexity of surgical procedures; efficacy in a context of less-intensive care, potentially including less-complete debridement or greater ease of effective debridement; faster healing; lower frequency of rejection; reduction in the need for regrafting at a given wound location; reduction in the length of stay in hospitals; reduction in the frequency and/or number of doctor visits; reduction in the need for complementary medical supplies (for example, analgesics).

B. Increased Ease of Use: Products are favorable that would be amenable for use by a wider range of trained professionals than current products require, including professionals with lower levels of training. In a mass-casualty incident, a wider range of personnel could provide treatment (for example, skilled general or plastic surgeons, physician assistants, surgical nurses, non-surgeon physicians, and/or non-surgical nurses might provide elements of care beyond their current scope in burn treatment).

C. Increased Stability and Manufacturability: Products are favorable with longer shelf-life and more favorable storage conditions (room temperature over refrigeration; refrigeration over frozen; high-temperature frozen over deep-frozen), making them more fully suitable for stockpiling and/or using stock-rotating managed-inventory solutions. Products are favorable for which a warm-base manufacturing capability can be readily provided to allow for substantial surge capacity in case of increased demand associated with mass-casualty response.

5. PROPOSALS UNDER SPECIAL INSTRUCTIONS:

A. BARDA is seeking safe and effective medical products that can be used to treat full-skin-thickness burn injuries or deep partial-skin-thickness burn injuries likely to convert to full-skin-thickness injuries. Proposals are expected to leverage preliminary data on key product attributes of existing current-generation products, including, but not necessarily limited to, skin substitutes,[footnoteRef:2] and provide significant enhancements including some or all listed above, in a Statement of Work (SOW) covering up to five (5) years. Proposals could include clinical and non-clinical (animal model-based) studies to seek FDA approval for the desired indication in all populations. Studies should adequately propose examination of treatment effects on cutaneous injuries caused by thermal radiation. [2: As defined in American Burn Association White Paper: Surgical Management of the Burn Wound and the Use of Skin Substitutes, 2009; available at http://www.ameriburn.org/WhitePaperFinal.pdf?PHPSESSID=d0267c90548d8aaa2f064adf7e705c0d; ]

B. BARDA will give high priority to proposals for developing enhancements to products that already are approved by the FDA for treating thermal burns, to increase and/or demonstrate suitability for mass-casualty care according to the criteria noted above in section II-4, Enhanced Product Attributes. Offerors are also encouraged to provide comprehensive solutions as feasible, including, as necessary or useful, through collaborations or partnerships as described above in section II-2-C.

Cost-sharing in the development of dual-use technology – technology that can be marketed for conventional care as well as being suitable for mass-casualty care as outlined in section II-4 – is encouraged as a favorable element, with the Offeror providing a portion of the development costs, given anticipation of commercial profitability. Evidence of a willingness and capability for cost-sharing may be requested in the full proposal.

C. Instructions: Offerors are required to follow the proposal submission guidelines in the BARDA-CBRN-BAA-11-100-SOL-00009. Quad Charts and White Papers will not be accepted after the Saturday, March 3, 2012, which is the expiration date of the current BAA. The 12 month period of performance for the current BAA cannot and will not be extended.

D. Potential Renewal of the BAA and the Special Instructions

There is a potential that a renewed BAA with a new reference number will be issued for a period of performance not to exceed 12 months beginning on or after March 4, 2012. Please check FedBizOpps for any postings.

Should a renewed BAA be issued, it may contain renewed Thermal Burn Definitive Care Special Instructions. Quad Charts and White Papers submitted in response to the renewed Special Instructions must reference the new BAA number and comply with the submission guidelines. Please carefully refer to any instructions in any potential new BAA for complete submission guidelines.

PLEASE NOTE: The Special Instructions contained in the renewed BAA may be open for less than 12 months.

PRE-PROPOSAL CONFERENCE

A pre-proposal conference is planned to provide clarification and additional information as necessary regarding this Special Instructions under the BAA. The conference may also provide an opportunity for product developers to interact with others in the field, leading to collaborations that together provide unique or comprehensive solutions as envisioned in section II-2-C and encouraged under section II-5-B.

The pre-proposal conference will be held on Thursday, February 23, 2012, between 9:00am – 11:00am at US Dept. of Health and Human Services, Hubert H. Humphrey Building, 200 Independence Avenue SW Washington, DC 20201

Please note the following regarding the pre-proposal conference:

1. Enter the Humphrey Building at the Independence Avenue entrance.

2. Arrive at least 30 minutes early to allow time to clear security.

3. Bring your photo identification

4. The closest metro stop is Federal Center SW serviced by Blue and Orange Metrorail lines

5. Questions from industry regarding the special instructions may be emailed to CBRN-BAA-11@hhs.gov. Questions received on or before Tuesday, February 14, 2012 may be addressed broadly at the pre-proposal conference.

6. Attendance is limited to a maximum of two (2) people per company. Email the names of your attendees to CBRN-BAA-11@hhs.gov by 5:00 PM EST Tuesday, February 14, 2012. Please specify organizational affiliations and citizenship of all participants. Foreign nationals intending to participate are required to complete Attachment 1: Foreign Visitor Information Sheet and email it to CBRN-BAA-11@hhs.gov and allow at least 12 business days for processing to ensure access.

7. Tape recorders and video recording using any media are prohibited.

8. It is anticipated that meeting slides will be posted on the FedBizOps as an amendment to the BAA prior to the pre-proposal conference.

NOTE: For those who are unable to attend, please use the following dial-in information: 1-800-369-1848 Participant code # 59411.

Procurement-Sensitive