FY08BAA-Final.doc

BAA 08-1

05 DEC 07

HQ AF/SGR

Overview Information To access hyperlinks from this electronic solicitation – hit CTRL and click on the hyperlink.

Federal Agency Name: AF/SGRM

Broad Agency Announcement Type: This is the initial announcement.

Agency Announcement Number: BAA 08-1

THIS WILL BE A TWO-STEP SOLICITATION:

First Step: WHITE PAPER DUE DATE AND TIME: 22 January 2008 at 3:00 PM EST Only white papers are due at this time.

Second Step: PROPOSAL DUE DATE AND TIME: To be provided in response to the Requests for Proposals sent to offerors that submit White Papers considered to meet the needs of the Air Force.

NOTE: White Paper/Proposal receipt after the due date and time shall be governed by the provisions of FAR 52.215-1(c)(3). It should be noted that this installation observes strict security procedures to enter the facility. These security procedures are NOT considered an interruption of normal Government processes, and proposals received after the above stated date and time as a result of security delays will be considered “late.” Furthermore, note that if offerors utilize commercial carriers in the delivery of proposals, they may not honor time-of-day delivery guarantees on military installations. Early White Paper submission is encouraged.

Solicitation Request: Air Force Surgeon General-Modernization is soliciting White Papers on the research effort described below. White Papers should be addressed to the Contracting Point of Contact (POC) stated in the Full Text Announcement. This is an unrestricted solicitation. Small businesses are encouraged to propose on all or any part of this solicitation. The NAICS Code for this acquisition is 541712, and the small business size standard is 500 employees. White Papers/Proposals submitted shall be in accordance with this announcement. There will be no other solicitation issued in regard to this requirement except as provided herein. Offerors should be alert for any BAA amendments that may permit extensions to the White Paper submission date.

On-line Representations and Certifications (ORCA): Potential offerors are notified that effective 01 Jan 2005 to be eligible for an award, they must submit annual Electronic Representations and Certifications, otherwise known as On-line Representations and Certifications Application (ORCA) via the Business Partner Network (BPN) at http://www.bpn.gov/orca. These FAR level representations and certifications are required in addition to the representations and certifications specific to this acquisition. Before submitting the Electronic Representations and Certifications, contractors must be registered in the Central Contractor Registration (CCR) Database. On-line registration instructions can be accessed from the DISA CCR home page at http://www.ccr.gov/ Type of Contract/Instrument: Cost, CPFF or FFP

Estimated Program Cost: To Be Determined Anticipated Number of Awards: The Air Force anticipates awarding 10 awards under this announcement.

Brief Program Summary: The scope of this effort encompasses identification, exploration, demonstration, and validation of new, advanced health surveillance technologies in realistic scenarios. Research program areas focus on specialized medical materiel or procedures designed to enhance force health protection, restore health, prevent casualties, and maintain a fit and healthy force. The scope of this effort and the priorities attached to specific projects are influenced by changes in military and civilian medical science and technology, operational requirements, military threat assessments, and national defense strategies. The extramural research and development program plays a vital role in the fulfillment of the objectives established by the AFMS.

Address technical questions to: Lt Col Dave Byer at david.byer@pentagon.af.mil or by mail:

5201 Leesburg Pike

Suite 1400 Falls Church, VA 22041

Address contracting questions to: Jeanette Snyder at jeanette.snyder@bolling.af.mil or Stephanie Cruz at stephanie.cruz@afncr.af.mil

FULL TEXT ANNOUNCEMENT

Headquarters United States Air Force

Surgeon General - Modernization

DEPARTMENT OF DEFENSE

BROAD AGENCY ANNOUNCEMENT

BAA 08-1

05Dec 2007

Headquarters United States Air Force Surgeon General (HQ AF/SG)

And

Air Force District of Washington (AFDW)/A7KM

PREFACE

The U.S. Air Force Surgeon General’s (AF/SG) mission is to develop and implement medical programs and policies that provide for the health care of active duty and retired military personnel and their family members. AF/SG optimizes Air Force readiness potential to support national security strategies and defines and disseminates health care policy in support of the 42,000 personnel of the Air Force Medical Service (AFMS), the 20,000 members assigned to the AF Reserves and the Air National Guard, and 74 Medical Treatment Facilities (MTFs). In addition, AF/SG ensures a quality, cost-effective, prevention-based health care continuum for 2.4 million beneficiaries worldwide. The AF/SG serves as the functional manager of the AFMS. In this capacity, AF/SG advises the Secretary of the Air Force and Air Force Chief of Staff, as well as the Assistant Secretary of Defense for Health Affairs, on matters pertaining to the medical aspects of the air expeditionary force and the health of Air Force personnel. The AF/SG has the authority to commit resources worldwide for the AFMS, to make decisions affecting the delivery of medical services, and to develop plans, programs and procedures to support worldwide medical service missions. The Office of Headquarters, U.S. Air Force Surgeon General, Modernization Directorate (HQ AF/SGR), is charged with identifying shortfalls within the current health delivery system and planning, programming, budgeting, and fielding the technology and services required to surmount that shortfall.

The scope of this effort encompasses identification, exploration, demonstration, and validation of new, advanced health surveillance technologies in realistic scenarios. Research program areas focus on specialized medical materiel or procedures designed to enhance force health protection, restore health, prevent casualties, and maintain a fit and healthy force. The scope of this effort and the priorities attached to specific projects are influenced by changes in military and civilian medical science and technology, operational requirements, military threat assessments, and national defense strategies. The extramural research and development program plays a vital role in the fulfillment of the objectives established by the AFMS.

This Broad Agency Announcement (BAA) is intended to solicit research ideas, and is issued under the provisions of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented in the Federal Acquisition Regulation (FAR). This Announcement provides a general description of AFMS research programs, including specific areas of interest, general information, the evaluation and selection criteria, and proposal instructions. The Appendices include forms that are required with the submission of a full proposal. Research proposals are sought from educational institutions, nonprofit organizations, private industry, and military organizations. This announcement is open from 05 Dec 2007 through 22 Jan 2008. White Papers may be submitted and will be evaluated after the close of this period, unless otherwise noted or stated in a separate announcement.

Amendments will be advertised in FEDBIZOPPS (www.fedbizopps.gov). From time-to-time separate announcements or calls for proposals may supplement this BAA.

Questions concerning the preparation of White Papers and/or proposals can be directed to:

Ms. Jeanette Snyder Contracting OfficerAFDW/A7KM110 Luke Ave, Suite 240 Bolling Air Force Base, D.C. 20032 jeanette.snyder@bolling.af.mil

(202) 404-6686

BAA 08-1

TABLE OF CONTENTS

1I. RESEARCH AREAS OF INTEREST

1A.

HEALTH SURVEILLANCE

2B. HUMAN PERFORMANCE AND SYSTEMS INTEGRATION

3C. OPERATIONAL MEDICINE / INVESTIGATIONS

4D. DIRECTED ENERGY

5E. SPECIAL PROGRAMS

6II.

GENERAL INFORMATION

6A. HQ AF/SGR AWARDS

7C. DISCLOSURE OF INFORMATION OUTSIDE THE GOVERNMENT

7D. GOVERNMENT OBLIGATION

7E. INFORMATION SERVICE

8F. WHITE PAPERS

8G. PROPOSALS

8H. SECURITY REQUIREMENTS

9I. INFORMATION ASSURANCE

9J. DEFENSE BUSINESS TRANSFORMATION

9K. DoD CENTRAL CONTRACTOR REGISTRATION DATABASE

9L. PROTECTION OF Human Subjects

12M. PROTECTION OF ANIMAL Subjects

12N. US FOOD AND DRUG ADMINISTRATION (FDA)

14III.

EVALUATION AND SELECTION

14A. EVALUATION FACTORS

15B. SELECTION

16IV. OTHER INFORMATION

19V.

AWARD ADMINISTRATION

19A. INFORMATION RELEASE NOTIFICATIONS

19B. FREEDOM OF INFORMATION ACT REQUESTS

20C. REPORTS

I. RESEARCH AREAS OF INTEREST

A. HEALTH SURVEILLANCE

The Air Force Medical Service (AFMS) conducts health surveillance to protect the war fighter and its beneficiary population, utilizing diagnostic, therapeutic, and forensic science and technology. The Air Force Surgeon General’s Directorate of Modernization (AF/SGR) is currently seeking to enhance its health surveillance capabilities through the integration of advanced diagnostic platforms, patient intake devices, decision support tools and real-time informatics for alerting and warning.

1. Advanced Diagnostics: The advanced diagnostics modernization effort focuses on prevention, diagnosis, treatment of endemic diseases that possess the capability to decrease military operational effectiveness, or disorders associated with trauma and/or critical illness. Endemic diseases of principal interest are infectious diseases of operational significance, particularly respiratory, infectious and diarrhea diseases caused by bacterial or viral pathogens. Other noteworthy areas include, but are not limited to: metabolic disorders/diseases, hematological and immune systems, ophthalmology (vision correction, injury and biomarkers), traumatic brain injury, systemic inflammation (mediators, genomics, proteomics and metabonomics) associated with trauma and critical illness, and other diseases or syndromes of interest to the military medical system. In order to implement Advanced Diagnostics into the AFMS, clinical decision support systems integrating advanced diagnostics with an inference to generate case-specific advice will be considered. Specific areas of research being sought are:

a. Diagnostic Platforms: The advanced diagnostics thrust area supports the development of diagnostic platforms for detection, identification and surveillance of infectious agents of military medical relevance, and the development of immunological-based and nucleic acid-based platforms as well as genomics, proteomics, and metabonomics platforms pertinent to the direct and indirect agent detection, surveillance and diagnosis of systemic inflammation associated with trauma and critical illness. Other system specifications and areas of interest that will be considered for funding include: miniaturization and/or ruggedization of diagnostic platforms that can be used outside the lab or in the field (e.g., handheld-type devices); point-of-care laboratory diagnostics; robotics; and investigations to improve specimen collection, storage, shipment, and/or processing techniques.

b. Patient Intake Devices: Patient symptoms, vital signs, history, and demographic data are captured through various devices and systems before diagnostic tests can be performed. AF/SGR is looking for faster, more accurate and efficient methods to capture this data in order to speed up the time from when a patient presents themselves to a medical treatment facility, a diagnostic test is performed, and a result/notification/or alert can be sent to the appropriate healthcare provider and/or decision maker. Other essential considerations include: ease-of–use, throughput, reduction of hospital staff work load, and connectivity with appropriate healthcare systems.

c. Decision support Tools: AF/SGR is seeking novel ways to infuse advanced epidemiology Decision Support Tools (DST) with current bio surveillance systems to identify or mitigate the outbreak of natural occurring endemic diseases and/or the covert or overt release of biological agents. The intent of the DST thrust area is to develop a set of web based tools to perform a variety of analyses on health surveillance data. These tools will include data selection/filtering, data interpretation and analysis, data visualization, modeling, simulation and predictive analysis. Ultimately, DST will provide decision-quality information to Commanders and healthcare providers, and deliver enhanced health surveillance situational awareness.

d. Real-time Informatics: AF/SGR is seeking to improve health surveillance situational awareness by integrating advanced diagnostics and other innovative technologies for rapid pathogen identification with relevant information systems currently in operations. The intent of this modernization thrust area is to provide healthcare providers and commanders at all levels the information needed to make time-critical decisions and provide a real time “Detect to Warn” capability. With the advent of real-time diagnostics, AF/SGR is looking for ways to get mission critical health surveillance information out of the labs and into the hands of the operational decision-makers in near real-time. Other considerations include the ability to share health surveillance data with appropriate local installations, and between neighboring and regional application nodes and for national/global centers for biothreat surveillance. Data must not only interface with medical C4I network, but must be interoperable with AF C4I systems (both classified and unclassified networks). Data network should automatically receive alerts from diagnostic platform and health surveillance system, generate a plot of the hazard area, display it on the common operational picture and generate an alerting message to appropriate healthcare provides and operational commanders. The information system needs to reduce the time from diagnosis to warning to less than five minutes.

2. Therapeutics

a. Therapeutics research should center on population health dynamics issues. Research and Development of Therapeutics: ADTRP supports studies for the development of enhanced human performance therapeutics. Studies to screen, synthesize, and develop therapeutics for militarily-relevant infectious agents. Proposals dealing with novel drug delivery systems (such as sustained-release) and methods of targeting drugs (to reduce toxicity) or delivery of drugs to the active sites, elimination of cold-chain product shipment and storage requirements,- are welcomed.

3. Regulatory/Approval Paths for Medical Products Developed For the AFMS

a. Refer to section II. M., FDA, for specific guidance.

B. HUMAN PERFORMANCE AND SYSTEMS INTEGRATION

AFMS human performance research is needed in order to optimize war fighter performance in all environments, maintain war fighter orientation and awareness, and detect, prevent, and mitigate effects of adverse environments and events on the human. The development of analysis aids is essential to Air Force Human Systems Integration, as well as being applicable to human performance. The human performance enhancement effort includes research in the areas of improved cognitive performance, contribution to sustained effectiveness during high operational tempo, operational human performance measurement, injury prevention during high-demand physical training, enhancement of human and machine interface, and enhanced battle space situational awareness. The Human Systems Integration effort includes research into tools and methods for incorporating the human into system design and specification. This includes models of the human suitable for use by engineers to describe the human as part of the system. This research program may be coordinated with programs funded by the Air Force Research Laboratory in the area of Human Effectiveness research.

1.

Current areas of emphasis include:

a.

Performance optimization research on hydration, nutrition, musculoskeletal, fatigue, cognitive, or fitness factors, to include improved physical and cognitive training techniques.

b. Orientation and awareness to address spatial disorientation counter-measures, vision enhancement, auditory enhancement, or proprioceptive enhancement issues.

c. Detection, prevention, and mitigation research covering human exposure and combat casualty assessment and countermeasure efforts.

d. Analysis aids should include the development or application of tools, models, and simulations needed to identify and quantify human effects, particularly with application to engineering disciplines to allow engineers to treat the human as part of the system.

C. OPERATIONAL MEDICINE / INVESTIGATIONS

AFMS operational medicine research/studies/investigations/analysis is needed in the following areas:

1. Occupational Toxicology, with particular interest in nanoparticles and emerging technologies in the workplace (such as Aptamers), new alternative fuels (e.g. Fischer-Tropsch), and fine particulate matter (Desert Dust).

2. Air Evacuation, with particular interest in effects of Air Transport on pathophysiology of critical illness, effects of altitude on physiological parameters in critically ill patients, development of “safe-to-fly” criteria (e.g., association between end-points of resuscitation to include Hb level and qualification for flight), association between development of extremity and abdominal compartment syndrome and flight, evaluation of neurophysiological change and flight, and serum myoglobin level and risk for muscle deterioration in flight.

3. Product Developmental Requirements:

a. Research and development efforts aimed at developing devices capable of supporting trauma resuscitation, patients in organ failure, wound care/healing, pain control, and infection control will be considered. These devices need to be small, light, mobile, rugged, man-portable, and airworthy with primary use during flight. Specific examples include:

i. Diagnostic and monitoring equipment

ii. Noise immune stethoscope

iii. Hand-held in-flight medical imaging

iv. Small spinal immobilization device

v. Closed loop resuscitation and maintenance systems

vi. Medical simulation programs for training and contingency planning

4. Telehealth:

The scope of the Air Force telehealth program includes research, identification, exploration, and demonstration of key technologies and their clinical effectiveness. Telehealth is defined as “the use of electronic information and communications technologies to provide and support health care when distance separates the participants.” The goals of this effort are to:

a.

Reduce the medical “footprint” and increase medical mobility while ensuring access to essential medical expertise and support;

b.

Improve the skills and efficiency of care providers;

c.

Improve the delivery and quality of medical/surgical care for AFMS beneficiaries; and d.

Reduce bandwidth and enhance data-packaging and image compression while speeding data transmission between locations.

Note: All research involving a human being as an experimental subject will require prior informed consent of the subject. For the purpose of this BAA, this provision will not be waived.

D. DIRECTED ENERGY

AFMS Directed Energy (DE) is needed to assess war fighter threats, to conduct exposure analysis and assessment, to protect war fighters and individuals from DE threats, to treat and mitigate DE injuries, and to counter-proliferate DE technologies.

1. Threat assessment efforts should focus on the detection and warning of DE threats in the areas of threat warning and standoff detection.

2. The analysis of DE threats seeks DE sensoring technologies and an analytical software package.

3. Human exposure analysis and assessment efforts should be centered on dosimetry and exposure reconstruction (integrating dosimetry and dose reconstruction/ modeling), sub clinical injury detection (field and clinical screening tools), and exposure modeling (intelligence-based threat modeling and post-exposure reconstructive modeling).

4. Human threat protection materiel solutions are sought for ocular hazard protection (protective eyewear, protective coatings for windows and cockpits, and active protection) and skin and whole body protection (protective clothing and shielding).

5. Treatment and mitigation of DE injuries should focus on ocular (clinical tools for retinal injuries and corneal injuries) and DE-induced burns and whole body effects (clinical tools for DE-specific burns and EM-based injuries).

6.

DE counter-proliferation, including medical intelligence and DE-bioeffects analysis and tracking, are sought.

E. SPECIAL PROGRAMS

The AF/SGR is frequently directed by Congress to manage funding of research programs with specific goals and end-points for health related issues relevant to military personnel, military dependents, veterans, and the health of the American public. These research programs are generally concerned with topics relating to health-care delivery; detection, diagnosis, control or eradication of specified diseases, conditions, or syndromes; data management; or other initiatives relevant to health needs, and must align with research areas A through E. Funding of these areas is dependent upon Congressional direction and availability of funds.

Evaluation and selection of proposals is based upon scientific merit, programmatic relevance, and Congressional intent for awarded funds. Military relevance, collaborative efforts with DoD and/or VA scientists and clinicians, or other priorities may also be evaluation criteria or requirements. Criteria and requirements for submission and evaluation of proposals may differ from those of other AF/SGR solicitation instruments, as well as other requirements stated in this BAA. Such differences will be noted in a specific BAA supplement if required, or solicitation instrument. For example, these special programs usually specify a submission closing date and a specific submission process. Other areas where differences may apply are:

1. Submission of Letters of Intent may be required,

2. Full proposal submission requirements may be sent to applicant with an invitation to submit full proposal,

3. Progress reporting requirements and oversight may differ and will be detailed in award document,

4. Points of contact for Principal Investigator (PI) inquiries may be identified,

5. Travel cost guidelines may differ, and

6. PI notification of proposal receipt may differ.

II.

GENERAL INFORMATION

A. HQ AF/SGR AWARDS

1. This announcement constitutes the only solicitation. We are soliciting White Papers. Do not submit a formal proposal at this time. Those White Papers found to be consistent with the intent of the BAA may be invited to submit a technical and cost proposal. Offerors are required to submit an electronic pre-proposal summarizing their proposed approach/solution. SEE APPPENDIX 1 FOR INSTRUCTIONS ON SUBMITTING THE WHITE PAPERS AND APPENDIX 2 FOR THE REQUIRED FORMAT. WHITE PAPERS MUST BE SUBMITTED IN ACCORDANCE WITH APPENDIX 1 OR THEY WILL NOT BE REVIEWED. The purpose of the White Paper is to preclude unnecessary effort on the part of an offeror whose proposed work is not of interest to the Government.

2. The AFDW/A7KM executes the HQ/USAFSG extramural research program through the award of contracts. The type of contract used to reflect the business relationship between the recipient and the Government will be a matter of negotiation prior to award. The contracting office may contact offerors whose proposals are selected for funding for specific certifications and statements required by Federal statutes and regulations. Failure to include all required information and completed forms with submission of the full proposal could delay the award process.

3. Types of Awards: The AFDW/A7KM has the authority to award a variety of contracts, and reserves the right to select the contract type suitable to the acquisition. Note: AFDW is not authorized to issue grants or cooperative agreements or any other type of assistance instrument.

4. Cost sharing or matching: Cost sharing and cost matching are not requirements of this solicitation.

5. To protect the public interest, the Federal Government ensures the integrity of Federal programs by only conducting business with responsible recipients. AFDW/A7KM uses the Excluded Parties List System (EPLS) to exclude parties ineligible to receive Federal awards. The EPLS is online at http://epls.arnet.gov.

6. A recipient organization should meet certain minimum standards pertaining to institutional support, financial resources, prior records of performance, integrity, organization, experience, operational controls, facilities, and conformance with safety and environmental statutes and regulations (OMB Circulars at www.whitehouse.gov/omb).

7. Investigators are cautioned that awards are made to organizations, not individuals. The principal investigator (PI) must submit a proposal through, and be employed by, a university, college, nonprofit research institute, a commercial firm, or a Government Agency in order to receive support. (Federally Funded Research and Development Centers are not eligible for awards in accordance with FAR 35.017.) Should the PI of a funded project leave the recipient institution, both the PI and institution must contact HQ AF/SGR as soon as possible to discuss options for continued support of the research project. Every effort should be made to notify HQ AF/SGR prior to the PI leaving the institution.

8. Organizations located outside of the U.S. may submit a response to the BAA; however, the organizations are responsible for ensuring that the research staff is able to complete the work without intercession by the DoD for a J-1 Visa Waiver on behalf of a foreign national in the United States. More information on the J-1 Visa Waiver can be found at http://www.acq.osd.mil/ecs/.

9. Organizations must be registered in the Central Contractor Registration database, which requires annual updates, to receive an award under this BAA. Registration may be completed online at www.ccr.gov or by calling 1-800-841-4421, 616-961-5757, or DSN 932-5757.

B. CONFLICT OF INTEREST

There are certain post-employment restrictions on former federal officers and employees as defined in Section 207 of Title 14 United States Code and Federal Acquisition Regulation (FAR), Part 3.104-4(c). If a submitter believes a post-employment restriction or conflict of interest exists, the situation should be discussed with the servicing legal office of the previous office of federal employment. In addition, notify the contracting officer identified herein of the potential conflict.

Due to potential Organizational Conflicts of Interest, Contractors that are involved with the Air Force Surgeon General’s Office in any of the following ways are not permitted to submit proposals under this BAA:

a) Strategic Planning and Implementation

b) Acquisition Planning Process for BAA 08-01

c) Technical Evaluations of proposals under BAA 08-01

C. DISCLOSURE OF INFORMATION OUTSIDE THE GOVERNMENT

Proposals will only be disclosed outside of the Government for the sole purpose of technical evaluation. AFDW/A7KM obtains a written agreement from the evaluators that information in the proposal will only be used for evaluation purposes and will not be further disclosed. Proposals for funded projects will be subject to public release under the Freedom of Information Act (FOIA) to the extent that they may be incorporated into an award document; proposals that are not selected for funding will generally not be subject to public release. Therefore, offerors are responsible for marking proposals with the appropriate legends as indicated in FAR 15.609(a) and (b).

D. GOVERNMENT OBLIGATION

Only a warranted Contracting Officer may obligate the Government to the expenditure of funds for awards under this BAA. The Government does not fund bid and proposal costs or support research that is inferred from discussions with technical project officers.

E. INFORMATION SERVICE

Submitters should use the technical reference facilities of the National Technical Information Service (www.ntis.gov), 5285 Port Royal Road, Springfield, VA 22161, 703-605-6000 or 1-800-553-6847, to acquire information on existing research to avoid duplication of scientific and engineering effort.

F. WHITE PAPERS

PIs are required to explore HQ AF/SGR interest by submitting a preliminary research proposal, referred to as a White Paper. White Papers may be submitted at any time from release of this BAA until 18 Jan 2008 describing a specific idea or project that pertains to any of the research areas of interest outlined in the BAA. (White Paper instructions are provided in Appendix 1 of the appendices.) The Brochures or other descriptions of general organizational or individual capabilities will not be accepted as a White Paper. All White Papers will be assigned an identification number and an email will acknowledge receipt of the White Paper. Offerors will receive a Request for Proposal (RFP) or a letter, via email, declining interest in the White Paper within 30 days of the close of the submission period.

Multiple White Papers within the purview of this announcement may be submitted by each offeror. If the offeror wishes to restrict its White Papers, they must be marked with the restrictive language stated in FAR 15.609(a) and (b).

Funding Restrictions: The cost of preparing White Papers or proposals in response to this announcement is not considered an allowable direct charge to any resulting contract or agreement, but may be an allowable expense to the normal bid and proposal indirect cost specified in FAR 31.205-18.

Questions concerning the preparation of White Papers may be directed to Ms. Stephanie Cruz at 703-681-7037 or via email at stephanie.cruz@bolling.af.mil or to Ms. Jeanette Snyder, at (202) 404-6686 or jeanette.snyder@bolling.af.mil.

G. PROPOSALS

Proposals should be submitted within 30 days of Government request. (Proposal instructions may be found in the attached appendices.) Receipt of proposals will be acknowledged via email. The identification log number for the proposal will be the same number used for the White Paper. Proposals should be prepared according to the instructions under Proposal Preparation. Proposal forms (Appendices 4 to 9) should be completed and included as part of the submission package. Electronic and scanned signatures are acceptable. The period of performance and the associated proposal cost/price should be commensurate with the nature and complexity of the proposed research. Generally, proposals are awarded for one to three years, and in no case should the period of performance exceed five years.

H. SECURITY REQUIREMENTS

Depending on the work to be performed, the offeror may require up to a Top Secret/Sensitive Compartmented Information (TS/SCI) facility clearance and safeguarding capability; therefore, personnel identified for assignment to a classified effort must be cleared for access up to TS/SCI information at the time of award. The offeror also may be required to have, or have access to, a certified and Government-approved facility to support work under this BAA. Data subject to export control constraints may be involved and only firms holding certification under the US/Canada Joint Certification Program (JCP) (www.dlis.dla.mil/jcp) are allowed access to such data. Any project employees requiring direct access to a DoD network or performing software design and/or development require the appropriate background investigation IAW DoDI 8500.2, Table E3-T1.

I. INFORMATION ASSURANCE

Information assurance requirements shall be identified and included in the design, acquisition, installation, operation, upgrade, or replacement of all DoD information systems in accordance with 10 USC, Section 2224, 44 USC Section 3541, OMB Circular A-130 and supporting/implementing DoD and Air Force directives, instructions, policies and directive-type memoranda.

All contractor or contract leased or supported IT systems that process, sort, transmit, or access sensitive but unclassified government information or information systems will obtain security certification and accreditation IAW DOD Directive 8500.1, Information Assurance (IA); Air Force Instruction 33-202, Volume 1, Computer Security under the Interim Department of Defense Certification and Accreditation (C&A) Process Guidance, dated 6 Jul 2006, for the DoD Information Assurance Certification and Accreditation Process (DIACAP) prior to placement in a production environment.

J. DEFENSE BUSINESS TRANSFORMATION

Information systems are required to be certified by the DoD prior to contract award. Defense Business Transformation certification requires the vendor to submit architecture diagrams upon request, in accordance with the DoD Architectural Framework (UML diagrams, OV diagrams, etc.).

K. DoD CENTRAL CONTRACTOR REGISTRATION DATABASE

In accordance with DoD policy, prospective contractors must be registered in the Central Contractor Registration (CCR) database, which can be accessed via www.ccr.gov prior to award of a contract, basic agreement, basic ordering agreement, or blanket purchase agreement. By submission of an offer resulting from this BAA, the offeror acknowledges the requirement that a prospective contractor must be registered in the CCR database prior to award, during performance, and through final payment of any contract resulting from this BAA.

L. PROTECTION OF Human Subjects

1. Air Force and DoD Regulations and Guidance on Human Research Protection

(a) Awardee institutions must comply with the following regulations and guidance when conducting, reviewing, approving, overseeing, supporting, or managing DoD-supported research with human subjects:

(1) The Belmont Report[vl]

(2) 32 CFR 219, Department of Defense Regulations, “Protection of Human Subjects”

(3) 45 CFR 46, Department of Health and Human Services Regulations, “Protection of Human Subjects”

(4) 21 CFR 50, 56, 312, 600, 812, Food and Drug Administration (FDA) Regulations

(5) DoD Directive (DoDD) 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-supported Research”

(6) DoDD 3210.7, “Research Integrity and Misconduct”

(7) DoDD 6200.2, “Use of Investigational New Drugs in Force Health Protection”

(8) Air Force Instruction 40-402, “Protection of Human Subjects in Research”

(b) The regulations and guidance identified in (a) above address such matters as:

(1) Initial and continuing research ethics training for all personnel who conduct, review, approve, oversee, support, or manage human subject research

(2) Written determination by a designated institutional official (other than investigators) whether research meets criteria for exemption

(3) Additional protections for military research subjects to minimize undue influence

(4) Provisions for research-related injury

(5) Requirements for reporting unanticipated problems, adverse events, and research-related injury

(6) Appointment of a Medical Monitor

(7) Additional safeguards for research conducted with international populations

(8) Additional protections for pregnant women, prisoners, and children

(9) Limitations on research where consent by legally authorized representatives is proposed Limitation on exceptions from informed consent in emergency research

(10) Limitations on compensation for U. S. military personnel

(11) Additional review for DoD-sponsored survey research or survey research within DoD

(12) Addressing and reporting allegations of non-compliance with human research protections

(13) Addressing and reporting allegations of research misconduct

(14) Procedures for addressing conflicting and competing interests

(15) Prohibition of research with prisoners of war (POW) and detainees

(16) Provisions for research with human subjects using investigational test articles (drugs, device, and biologics)

(17) Recordkeeping requirements

(18) Oversight by the sponsoring DoD Component

(c) The regulations and guidance identified in (a) above provide the following definitions:

(1) The regulations [32 CFR 219.102(d)] define research as a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.

(2) The regulations [32 CFR 219.102(f)] define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of cadaver materials alone is governed by other DoD policies and applicable State and local laws and is not directly regulated by 32 CFR 219 and DoD Directive 3216.02.Applicability of Human Research Protection Requirements to Contractor Activities

2. Applicability of Human Research Protection Requirements

(a) This clause applies to all activities meeting the definitions of human subject [32 CFR 219.102(f)]and research [32 CFR 219.102(d)] regardless of DoD Program Element Code for funding (e.g., this is not limited to work funded by Major Force Program 6, Research and Development, or Major Force Program 8, Defense Health Program). Additionally, this clause applies to activities supported by any DoD Component, not just research and medical organizations.

3. Responsibilities of Contractors Conducting Research with Human Subjects

(a) Safeguarding the rights and welfare of human subjects in research supported by DoD is a primary responsibility of the organization(s) to which support is awarded. The DoD organization sponsoring the research has the responsibility for oversight of compliance. Each DoD Component sponsoring research involving human subjects has a “Human Research Protection Official” designated by the Head of the Component and identified in the Component’s Human Research Protection Management Plan. This official is responsible for the oversight and execution of the requirements in this clause. For research that is covered by 32 CFR 219, the Contractor shall have a federal assurance of compliance with the regulations for the protection of human research subjects in accordance with 32 CFR Part 219, and furnish evidence of such assurance to the Contracting Officer (or the Human Research Protection Official) before beginning said research. The Human Research Protection Official shall determine whether or not the federal assurance is appropriate for the research under the contract, and the Contractor shall not perform research involving human subjects, to include human anatomical substances or human data, until the Contracting Officer informs the Contractor that the federal assurance is accepted. The Contractor shall notify the Contracting Officer immediately of any suspensions or terminations of their federal assurance.

(b) For research that is covered by 32 CFR 219, the Contractor shall obtain Institutional Review Board (IRB) approval for research involving human subjects in accordance with 32 CFR 219 and DoD Directive 3216.02 and furnish evidence of such IRB approval to the Contracting Officer (or the Human Research Protection Official). The Human Research Protection Official shall determine whether or not the IRB-approved research protocol is compliant with Air Force policies, and the Contractor shall not perform research involving human subjects, to include human anatomical substances or human data, until the Contracting Officer informs the Contractor that the protocol is accepted. The Contractor shall notify the Contracting Officer immediately of any suspensions or terminations of the protocol.

(c) For research that is exempt from 32 CFR 219 (see 32 CFR 219.101(b)), the Contractor shall furnish evidence of an exempt determination to the Contracting Officer (or Human Research Protection Official) before beginning such research. The Human Research Protection Official shall determine whether or not the exemption is compliant with DoD policies, and the Contractor shall not perform such research until the Contactor has received acceptance of the exemption determination.

(d) DoD staff, consultants, and advisory groups may independently review and inspect research and research processes and procedures involving human subjects, and based on such findings, the DoD may prohibit research which presents unacceptable hazards or otherwise fails to comply with DoD procedures.

(e) The Contracting Officer may immediately suspend, in whole or in part, work and further payment under this contract for failure to comply with paragraphs (a) through (h) of this clause.

(1) The suspension shall stay in effect until the Contractor complies with the requirements.

(2) Failure to complete corrective action within the time specified by the Contracting Officer may result in termination of the contract for default and revocation of the Air Force’s acceptance or approval of the Contractor’s federal assurance of compliance.

(f) The Contractor shall include this clause, including this paragraph (j), in all subcontracts involving human subjects.

M. PROTECTION OF ANIMAL Subjects

The Contractor shall comply with Air Force Manual (AFMAN) 40-401, The Care and Use of Laboratory Animals in DOD Programs, if providing research requiring animal subjects.

N. US FOOD AND DRUG ADMINISTRATION (FDA)

Certain medical products that are developed for the AF require appropriate regulatory clearance, approval, etc. These entities, among others, include the United States Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) for Clinical Laboratory Improvement Amendments (CLIA), i.e., waiver for reimbursement for diagnostic tests.

The offeror/vendor/sponsor shall indicate if they have previous experience in the appropriate regulatory arena. They shall describe how that experience is pertinent to the proposal under consideration. If they do not have previous experience in the regulatory arena, the offeror/vendor/sponsor shall describe how they will build that capability, with an appropriate quality management system, to assure regulatory success.

The offeror/vendor/sponsor shall describe if they presently have registered current Good Manufacturing Procedures (cGMP) / Quality Management System facility(ies) already in place or under contract. If not presently available, the offeror shall describe what steps would be taken to get those facilities on line and when they would be compliant.

The offeror/vendor/sponsor shall describe their regulatory strategy. This shall include a time line of accomplishments, and what specific steps they plan to take. Issues to be covered include, but are not limited to:

1. Meetings with the FDA.

2. Intended conduct and structure of pre-clinical safety trials (including animal studies, if needed). This would include trial design and facility accreditation status and/or assurances.

3. Clinical trials (including trial strategy(ies)).

4. Institutional Review Board (IRB) considerations (if necessary).

5. Investigational Device Exemptions (IDE) and Pre-IDE meetings with FDA.

6. Description of cGMP/QMS compliant facility(ies).

7. Software Validation (if necessary).

8. Information Management / Information Technology / Information Assurance needs including connectivity (if necessary).

9. Other appropriate related items, that will lead to successful FDA and AF program outcomes.

The offeror/vendor/sponsor shall describe how they would meet regulatory requirements associated with marketing an approved FDA product, including annual reports, adverse event reporting, etc.

The offeror/vendor/sponsor shall address sustainability of the medical products throughout their AF intended lifecycle and as it relates to commercialization and non-AF/DOD markets.

The offeror/vendor/sponsor shall address how new/emerging medical product developments will be incorporated into current medical products. The offeror/vendor/sponsor shall address what impact these developments would have on the regulatory path, availability, sustainability, etc.?

The offeror/vendor/sponsor shall clearly state that they will take the necessary steps to achieve regulatory (FDA, CLIA waiver, etc.) approvals that are appropriate and consistent with the medical products covered by the BAA proposal and serve as the sponsor of record to the regulatory agency(ies).

III.

EVALUATION AND SELECTION

A. EVALUATION FACTORS

The HQ AF/SGR scientists and/or outside experts will evaluate White Papers for scientific merit and programmatic/military relevance. Organizations whose White Papers meet preliminary qualifications may be invited to submit full proposals. Full proposals will be evaluated using a two-tiered review process: peer review and programmatic review. HQ AF/SGR scientists and outside experts will conduct the peer review. Peer reviewers evaluate proposals and assign ratings based on the following factors (in descending order of importance). No further evaluation criteria will be used in selecting proposals: Are these the evaluation criteria for both?

1. Military and Program Relevance: Does the proposal clearly address a relevant and significant military-related problem that can be solved by research and development studies? Does the proposed research meet current HQ AF/SGR program needs and goals?

2. Research Objectives: Are the stated objectives clear, valid, and logical? Is the research innovative?

3. Scientific Excellence: Are the plans, methods, techniques, and procedures feasible, clear, valid, adequately referenced, and state-of-the-art?

4. Impact: How are the results of this research expected to affect the intended beneficiaries? Is there a dual purpose for this research?

5. PI and Key Personnel Qualifications: Are the qualifications, capabilities and experience of the proposed PI and other key personnel sufficient to achieve the proposed objectives?

6. Facilities: Are the proposed facilities and equipment, or unique combinations of these, adequate for the proposed objectives?

7. Cost/Price: Does the budget reflect the actual needs of the proposed work? Have the requests for personnel, subcontracts, consultants, equipment, supplies and travel been fully justified and are the costs reasonable?

Offerors are advised that employees of commercial firms under contract to the Government may be used to administratively process proposals, monitor contract performance, or perform other administrative duties requiring access to other contractors' proprietary information. These support contracts include nondisclosure agreements prohibiting their contractor employees from disclosing any information submitted by other contractors or using such information for any purpose other than that for which it was furnished. In addition, the programmatic review, the second tier of evaluations, may be conducted by a team consisting of expert HQ AF/SGR scientists, other federal agency representatives, outside scientists with diverse expertise, clinicians, consumers, or combinations thereof. Vendor proposals will be reviewed by any combination or all of the following support contractors: MELE Associates, PSI, IMS Health, SAIC, the Texas Biomedical Sciences Consortium (TBSC), and AIBS.

The programmatic review is primarily concerned with three criteria: peer review recommendations, programmatic priorities, and portfolio balance. Other programmatic priorities that may be considered include:

1. Congressional guidance

2. Military mission, relevance, health, medicine, beneficiaries

3. DoD priorities

4. VA priorities

5. Collaborations with federal researchers

B. SELECTION

Submitted White Papers will be evaluated after the close of the submission period. Those White Papers found to be consistent with the intent of this BAA may be invited to submit a full proposal consisting of technical and cost information, as described in Appendix 3. Such invitation does not guarantee that the submitting organization will be awarded a contract as all awards are subject to successful negotiations and availability of funds. Those White Papers not selected to submit a proposal will be notified by email or letter. Prospective offerors are advised that only Contracting Officers are legally authorized to commit the Government.

After the two-tiered evaluation, proposals recommended for funding may be prioritized. A prioritized listing of proposal candidates may also be prepared when warranted. Subsequent awards depend upon the availability of funds and fulfillment of requirements and priorities determined to exist at the time of award. In some cases, funding priorities may change as certain scientific tasks are addressed and new mission assignments arise. Award is also dependent upon demonstration by the applicant that they have adequately addressed the following requirements:

1. Research involving Human Subjects/Anatomical Substances (if proposed),

2. Use of Animals (if proposed),

3. FDA regulations and requirements (if required)

4. Facility Safety Plan (FSP) (as appropriate for research proposed and in accordance with State and Federal Laws),

5. Certificate of Environmental Compliance, and

6. Representations for Assistance Agreements or Representations & Certifications for a Contract, as appropriate.

IV. OTHER INFORMATION

1. Acquisition of Commercial Items: Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government’s requirement with a commercial item within 15 days of this notice.

2. Support contractors: Offerors are advised that employees of commercial…