BAA 08-02 Amendment 4.doc

BAA 08-2

2 APR 08

HQ AF/SGR

BAA 08-2

03 APR 08

HQ AF/SGR

Amendment 4 The purpose of this amendment is to change the following information in the preface of BAA 08-01 and BAA 08-02;

From:

White Papers may be submitted and will be evaluated after the close of this period, unless otherwise noted or stated in a separate announcement.

To:

White papers may be submitted during the stated open period only. Only acceptable white papers received in a timely manner will be evaluated.

And

In Section III B – “Selection” the following has been changed;

From:

Submitted White Papers will be evaluated after the close of the submission period.

To:

White papers may be submitted during the stated open period only. Only acceptable white papers received in a timely manner will be evaluated.

And

The following has been added to the overview information section for BAA 08-01 and BAA 08-02:

On-line Representations and Certifications (ORCA): Offerors shall submit one (1) full copy of Representations and Certifications with proposals. For offerors that submit proposals for more than one research area of interest, the offeror shall provide a copy of Representations and Certifications with each submission package.

And

The following was added to Section I Research Areas of Interest:

Note: For BAA 08-02, only White Papers submitted under the following three (3) research areas of interest will be evaluated - Ensure that white papers are labeled clearly as submitted under Personalized Medicine, Directed Energy, or Special Programs.

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 second call against the original announcement. Please submit white papers in accordance with the attached appendices labeled: 2nd call appendices. A few minor changes/clarifications are addressed below:

IN ORDER TO HAVE YOUR WHITE PAPER SUBMISSION EVALUTED, YOU MUST SUBMIT A COMPLETE SUBMISSION PACKAGE.

A COMPLETE SUBMISSION PACKAGE MUST INCLUDE:

1. 6 HARD COPIES OF YOUR WHITE PAPER

2. 1 CD

PLEASE MAIL YOUR SUBMISSION TO:

MSgt. Barry Snyder

5201 Leesburg Pike STE 1500

Falls Church, VA 22041 Agency Announcement Number: BAA 08-2

THIS WILL BE A TWO-STEP SOLICITATION:

First Step: WHITE PAPER DUE DATE AND TIME: 7 April 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. Offerors shall submit one (1) full copy of Representations and Certifications with proposals. For offerors that submit proposals for more than one research area of interest, the offeror shall provide a copy of Representations and Certifications with each submission package. 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 6 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 1012 Falls Church, VA 22041

Address contracting questions to: Tonico Beope at tonico.beope@bolling.af.mil or MSgt Barry Snyder at barry.snyder@bolling.af.mil

FULL TEXT ANNOUNCEMENT

Headquarters United States Air Force

Surgeon General - Modernization

DEPARTMENT OF DEFENSE

BROAD AGENCY ANNOUNCEMENT

BAA 08-2

Second Call for White Papers

07 April 2008 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 06 March 2008 through 07 April 2008. White papers may be submitted during the stated open period only. Only acceptable white papers received in a timely manner will be evaluated. Amendments will be advertised in FEDBIZOPPS (www.fedbizopps.gov). From time-to-time separate announcements or calls for proposals may supplement this BAA. This is a separate call for white papers.

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

Mr. Tonico Beope, Contracting Officer, AFDW/A7KM 110 Luke Ave, Suite 240 Bolling Air Force Base, D.C. 20032.

tonico.beope@bolling.af.mil

(202) 767-7986

BAA 08-2

TABLE OF CONTENTS

1I. RESEARCH AREAS OF INTEREST

1A.

PERSONALIZED MEDICINE

1B. DIRECTED ENERGY

1C. SPECIAL PROGRAMS

3II.

GENERAL INFORMATION

3A. HQ AF/SGR AWARDS

4C. DISCLOSURE OF INFORMATION OUTSIDE THE GOVERNMENT

4D. GOVERNMENT OBLIGATION

4E. INFORMATION SERVICE

5F. WHITE PAPERS

5G. PROPOSALS

5H. SECURITY REQUIREMENTS

6I. INFORMATION ASSURANCE

6J. DEFENSE BUSINESS TRANSFORMATION

6K. DoD CENTRAL CONTRACTOR REGISTRATION DATABASE

6L. PROTECTION OF Human Subjects

9M. PROTECTION OF ANIMAL Subjects

9N. US FOOD AND DRUG ADMINISTRATION (FDA)

11III.

EVALUATION AND SELECTION

11A. EVALUATION FACTORS

12B. SELECTION

13IV. OTHER INFORMATION

16V.

AWARD ADMINISTRATION

16A. INFORMATION RELEASE NOTIFICATIONS

16B. FREEDOM OF INFORMATION ACT REQUESTS

17C. REPORTS

I. RESEARCH AREAS OF INTEREST

Note: For BAA 08-02, only White Papers submitted under the following three (3) research areas of interest will be evaluated - Ensure that white papers are labeled clearly as submitted under Personalized Medicine, Directed Energy, or Special Programs.

A. PERSONALIZED MEDICINE

AF/SGR is standing up a Personalized Medicine Program (PMP), whereby its laboratories will support a wide range of clinical studies on thousands of subjects for a variety of biological pathogens ranging from influenza and adenovirus to other pathogens of operational concern, as well as identification of and pharmacogenetics for the treatment and mitigation of chronic diseases, beginning with diabetes. To successfully stand up the PMP, the following research is needed:

1. A controlled genomic study of genetic risk factors that contribute to the physiologic development of Type II Diabetes, the results of which will provide early detection of genetic risk factors. The AFMS is interested in this study to reduce the onset and delay the risk of T2D and its associated complications that add significant cost to military healthcare.

2. As AF/SGR stands up the PMP diabetes effort, AF/SGR is interested in seeking advice from diabetes experts as to how to implement the program, as it relates to diabetes. AF/SGR seeks to engage several experts in the field of personalized medicine for diabetes that can provide recommendations that will collectively provide a strategic roadmap for the diabetes PMP.

B. DIRECTED ENERGY

Exponential growth in availability and proliferation of inexpensive commercial off-the-self (COTS) medical directed energy (DE) technologies has ushered a global paradigm shift in conventional and asymmetric risk to the occupational health and safety of military and civilian personnel. DE has demonstrated increased potential for harm to humans, civilian infrastructure, and electronic systems.

AF/SGR requires research, analysis, and procurement support services for an open-source data compilation, including related bioeffects, of COTS medical DE technologies with potential for dual-use. Dual-use COTS medical DE technologies could include systems marketed to clinical, scientific, and public health practitioners, or for occupational and environmental sensing and detection.

C. 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. 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 only the 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 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 07 APRIL 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 MSgt Barry Snyder at 703-681-6951 or via email at barry.snyder@bolling.af.mil or to Mr. Tonico Beope, at (202) 767-7986 or tonico.beope@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. Organization’s 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:

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

White papers may be submitted during the stated open period only. Only acceptable white papers received in a timely manner will be evaluated. 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 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.

3. Wide Area Work Flow: NOTICE: Any contract award resulting from this solicitation will contain the clause at DFARS 252.232-7003, Electronic Submission of Payment Requests, which requires electronic submission of all payment requests. The clause cites three possible electronic formats through which to submit electronic payment requests. Pursuant to that clause, the Department of Defense is adopting Wide Area Work Flow-Receipt and Acceptance (WAWF-RA). Any contract resulting from this solicitation will establish a requirement to use WAWF-RA for invoicing and receipt/acceptance, and provide coding instructions applicable to this contract. Contractors are encouraged to take advantage of available training (both web-based and through your local DCMA office), and to register in the WAWF-RA system. Information regarding WAWF-RA, including the web-based training and registration, can be found at https://wawf.eb.mil.

4. Item Identification and Valuation. Any contract award resulting from this solicitation may contain the clause at DFARS 252.211-7003, Item Identification and Valuation, (APR 2005) which requires unique item identification and valuation of any deliverable item for which the Government’s unit acquisition cost is $5,000 or more; subassemblies, components, and parts embedded within an item valued at $5,000 or more; or items for which the Government’s unit acquisition cost is less than $5,000 when determined necessary by the requiring activity for serially managed, mission essential, or controlled inventory. Also included are any DoD serially managed subassembly, component, or part embedded within a delivered item and the parent item that contains the embedded subassembly, component, or part. Per DFARS 211.274-3 Policy for Valuation, it is DoD policy that contractors shall be required to identify the Government’s unit acquisition cost for all items delivered, even if none of the criteria for placing a unique item identification mark applies. Therefore, your proposal must clearly break out the unit acquisition cost for any deliverable items. Per DFARS 211.274-3, Policy for Valuation, “The Government’s unit acquisition cost is the Contractor’s estimated fully burdened unit cost at time of delivery to the Government for cost type or undefinitized line, subline, or exhibit line items” (Per DoD, “fully burdened unit costs” to the Government would include all direct, indirect, G&A costs, and an appropriate portion of fee.). If you have questions regarding the Unique Item Identification requirements, please contact the Contracting Point of Contact listed above. For more information, see the following website: http://www.acq.osd.mil/uid.

5. Excessive Pass-Through Charges. As prescribed in DFARS 215.408(3), provision 252.215-7003, “Excessive Pass-Through Charges – Identification of Subcontract Effort, is contained in this solicitation (as shown below). Any contract resulting from this solicitation shall contain the Clause at DFARS 252.215-7004, Excessive Pass-Through Charges (APR 2007) which requires the contractor to identify in its proposal the percentage of effort to be performed by the prime contractor and the percentage expected to be performed by each subcontractor. If the contractor intends to subcontract more than 70% of the total cost of work under the contract or task order, then it shall identify the amount of the contractor's indirect costs and profit applicable to the subcontract work, and a description of the value added by the contractor. If any subcontractor intends to subcontract to a lower tier subcontractor more than 70% of the total cost of it's work, then it shall identify the amount of the subcontractor's indirect costs and profit applicable to the lower tier subcontract work, and a description of the value added by the subcontractor.

252.215-7003 Excessive Pass-Through Charges – Identification of Subcontract Effort.

EXCESSIVE PASS-THROUGH CHARGES –

IDENTIFICATION OF SUBCONTRACT EFFORT (APR 2007)

(a) Definition. “Excessive pass-through charge,” as used in this provision, is defined in the clause of this solicitation entitled “Excessive Pass-Through Charges” (DFARS 252.215-7004).

(b) General. The offeror’s proposal shall exclude excessive pass-through charges.

(c) Performance of work by the Contractor or a subcontractor.

(1) The offeror shall identify in its proposal the percent of effort it intends to perform, and the percent expected to be performed by each subcontractor, under the contract, task order, or delivery order.

(2) If the offeror intends to subcontract more than 70 percent of the total cost of work to be performed under the contract, task order, or delivery order, the offeror shall identify in its proposal—

(i) The amount of the offeror’s indirect costs and profit applicable to the work to be performed by the subcontractor(s); and

(ii) A description of the value added by the offeror as related to the work to be performed by the subcontractor(s).

(3) If any subcontractor proposed under the contract, task order, or delivery order intends to subcontract to a lower-tier subcontractor more than 70 percent of the total cost of work to be performed under its subcontract, the offeror shall identify in its proposal—

(i) The amount of the subcontractor’s indirect costs and profit applicable to the work to be performed by the lower-tier subcontractor(s); and

(ii) A description of the value added by the subcontractor as related to the work to be performed by the lower-tier subcontractor(s).

(End of provision)

6. Ombudsman: The Ombudsman clause, 5352.201-9101 Ombudsman (Aug 2005) will be contained in any contracts or agreements resulting from this Solicitation. The AFDW Ombudsman is Mr. Lavern Miller, Chief, Business Support Branch, AFDW/A7K, (202) 767-8098, email: lavern.miller@bolling.af.mil.

7. Post-Award Small Business Program Rerepresentation: As prescribed in FAR 19.308, FAR Clause 52.219-28, “Post-Award Small Business Program Rerepresentation (JUN 2007),” is incorporated by reference in this solicitation. This clause will be contained in any contracts resulting from this solicitation. This clause requires a contractor to rerepresent its size status when certain conditions apply. The clause provides detail on when the rerepresentation must be complete and what the contractor must do when a rerepresentation is required.

8. White Paper/Proposal Content Checklist: You may be ineligible for award if all requirements of this solicitation are not met on the proposal due date.

a. Step One: White Papers are due to the Contracting POC.

b. Step One: White Papers are due no later than the due date and time specified in this announcement.

c. Step One and Step Two: White Paper and Proposal page limits are strictly enforced. Step One and Step Two: Proposals and White Papers must be submitted in the format specified.

d. Step Two: The Cost/Business Proposal must contain all information as identified within this announcement.

e. Step Two: For any subcontracts proposed, the Cost/Business Proposal must contain a subcontractor analysis IAW FAR 15.404-3(b).

f. Step Two:…