RD-INOBAADocumentFinal.doc

DEFENSE THREAT REDUCTION AGENCY

BROAD AGENCY ANNOUNCEMENT

HDTRA1-07-RDINO- BAA

R&D INNOVATION OFFICE

SCIENCE AND TECHNOLOGY

NEW INITIATIVES

AUGUST 2007

TABLE OF CONTENTS

Section No.

Page No.

41. INTRODUCTION AND BACKGROUND

42. PURPOSE

43. BAA APPROACH AND OVERVIEW

54. ELIGIBILITY

65. POINTS OF CONTACT

66. PROPOSAL SUBMISSION

137. TOPICS

138. INFORMATION TO BE REQUESTED FROM SUCCESSFUL OFFERORS

149. MILITARY RECRUITING

1410. EXPORT CONTROL NOTIFICATION

1411. LIMITATION ON OTHER TRANSACTIONS

1512. TECHNICAL AND ADMINISTRATIVE SUPPORT BY NON–GOVERNMENT PERSONNEL

1613. MANUFACTURING READINESS LEVELS (MRL)

1714. CERTIFICATIONS AND REPRESENTATIONS

1715. CENTRAL CONTRACTOR REGISTRATION (CCR)

1816. PROTECTION OF HUMAN SUBJECTS

1917. ANIMAL USE

2018. BIOLOGICAL DEFENSE RESEARCH PROGRAM (BDRP) REQUIREMENTS:

2019. ORGANIZATIONAL CONFLICT OF INTEREST ADVISORY

2120. INTELLECTUAL PROPERTY

2221. SUBCONTRACTING

2322. RECOMMENDED PROCUREMENT INSTRUMENT AND PRICING ARRANGEMENT

2323. AUTHORIZED OFFEROR PERSONNEL

2424. STATEMENT OF CURRENT AND PENDING SUPPORT

2425. Defense Contract Management Agency (DCMA), Office of Navel Research (ONR) AND Defense Contract Audit Agency (DCAA) REPRESENTATIVES

2426. CONFIRMED PROPOSAL EXPIRATION DATE

27. 25ATTACHMENTS

ATTACHMENT 1. 26quad chart template

ATTACHMENT 2. 27technology readiness level (trl) definitions

30ATTACHMENT 3. n/a

ATTACHMENT 4. 31phase ii technical proposal format and preparation instructions

ATTACHMENT 5. 33phase ii cost proposal format and preparation instructions

ATTACHMENT 6. 35statement of work format and preparation instructions

ATTACHMENT 7. 38proposal submission checklist

39ATTACHMENT 8. proposal topics

48ATTACHMENT 9.

HYPERLINK \l "_Toc173566528" evaluation criteria and selection process

50ATTACHMENT 10. notice regarding use of grants.gov apply

1. INTRODUCTION AND BACKGROUND

1.1. Introduction. The Defense Threat Reduction Agency’s (DTRA) mission is to safeguard America and its allies from Weapons of Mass Destruction (WMD) (chemical, biological, radiological, nuclear, and high yield explosives) by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects. In November 2005, DTRA’s Research and Development Enterprise established the Technology Innovation Office (RD-INO) to search for and execute strategic investments in innovative technologies for combating WMD. The Technology Innovation Office receives and coordinates all initial submittals to this announcement.

1.2. Scope. This BAA is an extramural endeavor focused on innovative research and development activities and related study efforts to advance technical state-of-the-art, or increase knowledge and understanding of overarching challenges for combating WMD. Technical investigations are limited to projects starting at or between Technology Readiness Levels (TRL) two through five.

2. PURPOSE

2.1 The purpose of this Broad Agency Announcement (BAA) is to solicit proposals for DTRA R&D program requirements. Topic areas are in Attachment 8.

3. BAA APPROACH AND OVERVIEW

3.1. Two general categories of projects will be considered—technical investigations to advance state-of-the-art in materiel and technically-based studies to inform the employment of or investment in future combating WMD capabilities.

3.2. The Government encourages proposals that span a wide spectrum of possible technical and business solutions in response to the specific technology topics stated in Attachment 8 of this BAA. The Government reserves the right to award any combination of approaches which offer the best overall value to the Government, and to oversee any and all processes and approaches once ongoing.

3.3. This BAA, in addition to any amendments issued in conjunction with this BAA, will be posted to the Federal Business Opportunities (FedBizOpps) website and the Grant Opportunities Website and for informational purposes on the DTRA website.

3.4. The full range of flexible assistance and acquisition related statutory authority arrangements available to DTRA are possible results from this announcement including but not limited to contracts, grants, and other transaction agreements. Each of the several applicable procurement instruments offer different advantages, liabilities and responsibilities for offerors and the Government. Offerors must specify in their submittal their recommended approach (e.g. to contract, grant, other transaction agreement); however, the government reserves the right to negotiate and award the types of procurement instruments determined most appropriate under the circumstances. If warranted, portions of resulting awards may be segregated into pre-priced options. Except for Other Transaction Agreements, the Government actions under this BAA shall adhere to the requirements of the FAR, DFARS and/or DODGARS depending on type of instrument awarded.

3.5. DTRA intends to create an environment where potential offerors are willing to share commercially generated research and development with the Government. The Government will negotiate terms and conditions to leverage the successful offerors’ advances. The Government seeks to ultimately acquire the best commercial products and technology in addition to offering the appropriate level of protection of corporate and institutional intellectual property rights, thus encouraging participation by a broad spectrum of leading-edge technology developers.

3.6. All coordination and communication between offerors and the government will be conducted using the e-mail address associated with this BAA specified in Section 5.

3.7. The schedule of major milestones for this BAA is presented in Section 6.1.

3.8. Funding for participation in this program is highly competitive and the cost of proposed technologies should be considered. Awards resulting from this BAA will be made based on the evaluation results of a two-phased proposal process described in Attachment 9. The Government reserves the right to fund all, some, one, or none of the proposals submitted; may elect to fund only part of a submitted proposal; and may incrementally fund any or all awards under this BAA. All awards are subject to the availability of funds. While award is anticipated to occur according to the events stated in Section 6.1, the Government may select for funding any full proposal or portions of a proposal at any time during the fiscal year.

4. ELIGIBILITY

4.1. Proposals submitted for this BAA will be considered from the following U.S. and Foreign Enterprises:

· Industrial/commercial concerns including small businesses

· Accredited Degree granting colleges and universities

· Not-for-profit organizations

· DoD sponsored Federally Funded Research and Development Centers (FFRDCs) specified in DoD FAR Supplement 235.017-1 (http://farsite.hill.af.mil/VFDFARA.HTM) and click on ‘DFARS Part 35’

· DOE sponsored FFRDCs provided that authorization is obtained from the DOE sponsor.

Proposals are encouraged from Historically Black Colleges and Universities (as determined by the Secretary of Education to meet requirements of Title III of the Higher Education Act of 1965, as amended (20 U.S.C. § 1061)) and from Minority Institutions defined as institutions “whose enrollment of a single minority or a combination of minorities…exceeds 50 percent of the total enrollment.” [20 U.S.C. § 1067k(3) and 10 U.S.C. § 2323(a)(1)(C)].

4.2. The following entities may not participate as prime contractors nor furnish principal investigators in awards made under BAA but may act as subcontractors:

· Federal laboratories other than those DoD and DoE sponsored FFRDCs specified in section 4.1 above.

· U.S. Government agencies and organizations

· Academic institutions that are federal government organizations (e.g., Naval Postgraduate School)

5. POINTS OF CONTACT

http://grants.gov

http://grants.gov (see Section 6.3.1)

Questions regarding the technical and administrative content of this BAA must be addressed to the e-mail address listed above. All questions must include the BAA number in the subject line. DTRA will post questions and answers to the FedBizOpps website that are relevant to all potential offerors. It is the offeror’s responsibility to periodically check the FedBizOpps website (www.fbo.gov) to view postings of questions and answers, in addition to any applicable amendments to the BAA. Please note, answers will not be provided, nor any judgment made, related to questions concerning the applicability of certain projects to the scope of this BAA.

6. PROPOSAL SUBMISSION

6.1. Major Milestones:

Note:

(1) Actual award dates will vary based on complexity, statutory requirements, quality of proposal, pricing considerations, DCAA audits of proposed rates, type of instrument, number of awards, and other considerations. All dates are subject to change.

6.2. Submission Overview: Offerors interested in providing a submission or submissions in response to this BAA must register by electronic means in accordance with instructions in Section 6. Failure to register as stated will prevent an offeror’s submission of documents required for Phase I and will render them ineligible for participation in this BAA. For each phase of submission, Offerors will complete a Cover Sheet on the DTRA proposal submission website. Phase I is for receipt of Quad Charts/White Papers. Phase II of this BAA is by invitation only. Invitation to the Phase II, full proposal submission (Volume I - technical proposal, Volume II - cost proposal and Volume III - supplemental information to include, but not limited to, a Statement of Work and updated Quad Chart/White Paper) will be based on the evaluation results in Phase I.

6.3. Application and Submission Information.

6.3.1. Submission Process. Registration at the DTRA proposal submission website prior to submission of Phase I proposals is required. Proposals must be submitted electronically through the DTRA proposal submission website stated in Section 5. Detailed registration and submission instructions are available at the site. Offerors submitting an assistance instrument (e.g., grants) as their recommended approach must submit their proposal through the DTRA proposal submission website and are encouraged to also submit through the Grants.Gov APPLY website: http://www.grants.gov/applicants/apply for_grants.jsp. Attachment 10 provides offerors with an overview of the Grants.Gov APPLY process.

Proposals submitted by any means other than the DTRA proposal submission website and the Grants.Gov APPLY website (e.g., hand-carried, postal service, commercial carrier, and e-mail) will not be considered. Offerors are responsible for ensuring compliant and final submission of their proposals, and can verify the submission of the proposal package with the electronic receipt that appears on the screen following submission of a proposal to the DTRA proposal submission website.

For purposes of this BAA, the primary proposal submission website for all types of instruments is the DTRA proposal submission website.

6.3.2. Registration. All offerors interested in submitting proposals must register on the DTRA proposal submission website which begins on or about the date stated in Section 6.1. Registration must be submitted by a central Business Point of Contact (BPOC) rather than individual Principal Investigator personnel. A BPOC is a person who is given the responsibility of coordinating all submissions from individual Principal Investigators at his or her work location and is the only individual who may access the DTRA proposal submission website. The intent is that all submissions from an organization be coordinated and submitted by a single, identified responsible party. Failure to register in accordance with instructions may render them ineligible for participation in this BAA. Interested organizations must register at the DTRA proposal submission website even if previously registered at any other proposal submission site for prior DTRA and/or JSTO-CBD acquisition opportunities. Prior registration at any other proposal submission site does not fulfill registration requirements for participation in this BAA.

6.3.3. IMPORTANT: Registration at the DTRA proposal submission website is NOT the same as registering at the Central Contracting Registration (CCR) website, FedBizOpps or Grants.gov websites. Failure to compliantly register at the DTRA proposal submission website will prevent an offeror’s submission of documents required for Phase I and thus render them ineligible for participation in this BAA.

6.3.4. Using the DTRA proposal submission website, all Offerors must prepare Proposal Cover Sheets (for both Phase I submissions and for invited Phase II submissions), including basic identifying information for the institution and the points of contact. Once the cover sheet is saved, the system will assign a unique proposal number for each Phase I submission and a different unique proposal number for each invited Phase II submission. Cover sheets may be edited as often as necessary until the submission period closes.

6.4. Two-Phased Submission. This BAA will be conducted in two phases as follows:

6.4.1. Phase I – Interested offerors are required to complete a cover sheet using the DTRA proposal submission website, and must submit Quad Chart/White Papers in accordance with instructions provided in this section of the BAA. Proposals will be evaluated against criteria as described in Attachment 9 of this BAA. Based on this evaluation, selected offerors will be invited to submit full proposals for evaluation under Phase II.

6.4.1.1. Phase I – Quad Chart/White Paper Submission and Content. Interested offerors are required to submit a Quad Chart and a two-page narrative (White Paper) that expands on the information provided in the Quad Chart. Each submission (Quad Chart and White Paper narrative) must specify by identifying, at the end of the project title, the specific topic number as presented in Attachment 8 of this BAA. See Quad Chart and White Paper format and narrative guidelines below.

6.4.1.1.1. Quad Chart Format: All Quad Charts should include the information indicated on the sample template located in Attachment 1.

a. Heading: Title, Research Area Addressed, Topic Number, Principal Investigator, Organization

b. Upper Left: Objective, Description of Effort

c. Lower Left: Benefits of Proposed Technology, Challenges, Maturity of Technology, Research Area Addressed. Maturity information should indicate, where possible, the current readiness level of proposed technology and anticipated level of the proposed technology at project completion. Refer to Attachment 2 for established Technology Readiness Level categories.

d. Upper Right: Picture or graphic illustrating proposed technology development

e. Lower Right: Milestones, Cost, Period of Performance, Contact Information

All quad charts must be prepared and submitted in landscape format.

6.4.1.1.2. White Paper Narrative Format. The White Paper narrative expands on the Quad Chart presentation, and must not exceed two pages, 8.5 x 11 inches, single-spaced, with one-inch margins in type not smaller than 12 point font. Any pages submitted that exceed the two-page limit will not be read or evaluated. The Project Title must be included at the top of the page and must cite the Topic Number (refer to Attachment 8) and the Organization (Offeror’s Institution, Company, etc). The content of the White Paper narrative must be limited only to further explanation, as deemed necessary by the offeror, of the information being conveyed as requested in the Quad Chart. Do NOT include corporate or personnel qualifications, past experience, or any supplemental information not requested in the Quad Chart.

6.4.1.2. Submission File Format. The Quad Chart and White Paper must be uploaded as two separate documents (two individual and separate files). The files must be submitted in a Portable Document File (PDF) format compatible with Adobe Acrobat ® version 7.0 or earlier. The Quad Chart must be positioned in a landscape view. The White Paper must be provided in portrait layout. Each file will not exceed 2 Megabytes of storage space. Movie and sound file attachments, or other additional files, will not be accepted. If multiple proposals are being submitted by the same institution, separate cover sheets must be generated for each proposal and the Quad Chart and White Paper uploaded with the associated cover sheet, since a unique document number will automatically be assigned to each submission by the electronic proposal tracking system. All documents submitted to the DTRA proposal submission website are considered works in progress and are not eligible for evaluation until the offeror submits the final proposal package for consideration. The final submission must be ‘locked’ on the DTRA proposal submission website; until a submission has been ‘locked’ (saved as final), the submission is not eligible for review. Look for this ‘lock’ icon on the DTRA proposal submission web-site. Offerors are responsible for ensuring compliant and final submission of their proposals, and can verify the submission of the proposal package with the electronic receipt that appears on the screen following submission of a proposal to the DTRA proposal submission website. Perform a virus check before uploading any proposal files. If a virus is detected, it may cause rejection of the file. Do not lock or encrypt any files you upload.

6.4.1.3. Classification: All Quad Chart/White Paper submissions must be UNCLASSIFIED. All information provided in the White Paper that is marked appropriately will be considered proprietary information, as indicated in Section 6.5.

6.4.1.4. Notification to Offerors: Debriefings for Quad Charts/White Papers will not be provided due to the nature of the BAA. However, a brief synopsis of the Government’s evaluation in the form of the Summary Statement will be provided upon written request to the e-mail address stated in Section 5.

6.4.1.5. Phase II Invitations: An invitation to submit a full proposal will be extended to those offerors whose submissions were selected in Phase I; the invitation will be transmitted via e-mail to the offeror’s registered BPOC on or about the timeline stated in Section 6.1. The offeror must be aware that it is their responsibility to ensure that this e-mail notification reaches the intended recipient and is not blocked by the use of ‘spam blocker’ software or other means that the recipient’s Internet Service Provider may have implemented as a means to block the receipt of certain e-mail messages. Additionally, it is the responsibility of the BPOC to inform the Principal Investigator (PI) of the invitation to prepare a Phase II submission.

6.4.1.6. Offerors invited to participate in Phase II must submit their full proposals in accordance with the instructions provided in Section 6.4.2 of this BAA. Full proposals will be evaluated against criteria as described in Attachment 9 of this BAA. Submission procedures are detailed in this BAA, and further detail may be given in the invitation. Any submission that does not conform to the requirements outlined in the BAA and in the invitation will not be reviewed and will not be considered further. The due date for the Phase II proposals will be provided by the Contracting Officer in the invitation.

6.4.2. Phase II - Full Proposal Submission and Content. The full proposal must be prepared in three separate volumes: Volume I – Technical Proposal; Volume II – Cost Proposal; and Volume III – Supplemental Information, to include a Statement of Work and an updated Quad Chart.

6.4.2.1. Volume I – Technical Proposal. The technical proposal must not exceed 25 pages. If the proposal exceeds 25 pages, only the first 25 pages will be reviewed. A page is defined as 8 ½ x 11 inches, single-spaced, with one-inch margins in type not smaller than 12 point font. The technical proposal must include the components included in the template as shown in Attachment 4 of this BAA. Phase II technical proposals must be UNCLASSIFIED. All information provided that is marked appropriately will be considered proprietary information, as indicated in Section 6.5.

6.4.2.2. Volume II – Cost Proposal. The cost volume should contain cost estimates sufficiently detailed for meaningful evaluation. Additionally, a cost summary must be prepared and submitted in conjunction with the detailed cost proposal. The cost summary is not to exceed 2-pages; however the cost proposal does not have a page limit. The budget must include the total cost of the project, and the cost proposal must provide a breakdown of the amount(s) by task. The cost proposal must include the components included in the template as shown in Attachment 5 of this BAA. Separate cost proposals should be provided and incorporated into Volume II for any subcontracts or consultants.

6.4.2.3. Volume III – Supplemental Information. This volume contains supplemental data. More information about the specific information to include is located in the sections referenced below. This Volume must contain the following items of information. If any particular item is not relevant to the proposed effort, include a reference to the requested information and state that the particular information is not applicable in order to confirm a negative response.

6.4.2.4. Submission File Formats. Each volume of the proposal must be submitted as a separate Portable Document File (PDF) compatible with Adobe Acrobat ® version 7.0 or earlier. Each individual file will not exceed 5 Mbytes of storage space. Movie and sound file attachments, or other additional files, will not be accepted. If multiple proposals are being submitted by the same institution, separate cover sheets must be generated for each proposal and the full proposal files uploaded with the associated cover sheet, since a unique document number will automatically be assigned to each submission by the electronic proposal tracking system. All documents submitted to the DTRA proposal submission website are considered works in progress and are not eligible for evaluation until the offeror submits the final proposal package for consideration. The final submission must be ‘locked’ on the DTRA proposal submission website; until a submission has been ‘locked’ (saved as final); the submission is not eligible for review. Look for this ‘lock’ icon on the DTRA proposal submission web-site. Offerors are responsible for ensuring compliant and final submission of their proposals, and can verify the submission of the proposal package with the electronic receipt that appears on the screen following submission of a proposal to the DTRA proposal submission website. Perform a virus check before uploading any proposal files. If a virus is detected, it may cause rejection of the file. Do not lock or encrypt any files you upload.

6.4.2.5. Notifications to Offerors. Offerors will be notified by DTRA of their selection/non-selection status of the Phase II Full Proposal via the DTRA proposal submission website. Debriefings will be provided upon written request (to the e-mail address as stated in Section 5 is acceptable) from a Phase II offeror only and will be provided to offerors via the DTRA proposal submission website.

6.5. Marking of White Paper and Proposal and Disclosure of Proprietary Information other than the Government.

6.5.1. The Quad Chart portion of the submission will not contain information deemed trade secret, confidential or proprietary by the offeror.

6.5.2. The white paper/proposal submitted in response to this BAA may contain technical and other data that the offeror does not want disclosed to the public or used by the Government for any purpose other than proposal evaluation. Public release of information in any white paper/proposal submitted will be subject to existing statutory and regulatory requirements. If proprietary information which constitutes a trade secret, proprietary commercial or financial information, confidential personal information, or data affecting the national security, is provided by an offeror in a white paper/proposal, it will be treated in confidence, to the extent permitted by law, provided that the following legend appears and is completed on the front of the white paper/proposal: “For any purpose other than to evaluate the white paper/proposal, this data shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed in whole or in part, provided that if an award is made to the offeror as a result of or in connection with the submission of this data, the Government shall have the right to duplicate, use or disclose the data to the extent provided in the agreement. This restriction does not limit the right of the Government to use information contained in the data if it is obtained from another source without restriction. The data subject to this restriction is contained in page(s) _____ of this white paper/proposal.” Any other legend may be unacceptable to the Government and may constitute grounds for removing the proposal from further consideration without assuming any liability for inadvertent disclosure. The Government will limit dissemination of properly marked information to within official channels. In addition, the pages indicated as restricted must be marked with the following legend: “Use or disclosure of the white paper/proposal data on lines specifically identified by asterisk (*) are subject to the restriction on the front page of this white paper/proposal.” The Government assumes no liability for disclosure or use of unmarked data and may use or disclose such data for any purpose.

6.5.3. In the event that properly marked data contained in a white paper/proposal submitted in response to this BAA is requested pursuant to the Freedom of Information Act, 5 USC 552, the offeror will be advised of such request and, prior to such release of information, will be requested to expeditiously submit to DTRA a detailed listing of all information in the white paper/proposal which the offeror believes to be exempt from disclosure under the Act. Such action and cooperation on the part of the offeror will ensure that any information released by DTRA pursuant to the Act is properly identified.

6.5.4. By submission of a white paper/proposal, the offeror understands that proprietary information may be disclosed outside the Government for the sole purpose of technical evaluation. The Contracts Office will obtain a written agreement from the evaluator that proprietary information in the white paper/proposal will only be used for evaluation purposes and will not be further disclosed or utilized.

6.6. Late Submissions and Withdrawal of Proposals.

6.6.1. Offerors are responsible for access to the DTRA proposal submission website and for submitting electronic proposals so as to be received at the Government office no later than the date specified by the Contracting Officer in the invitation. When sending electronic files, the offeror will account for potential delays in file transfer from the originator’s computer server to the Government website/computer server. Offerors are encouraged to submit their proposals early to avoid potential file transfer delays due to high demand or problems encountered in the course of the submission.

6.6.2. If the proposal is received at the Government office after the date and time specified by the Contracting Officer for receipt of offers, it is "late" and will not be considered. This applies only to Phase II submissions as Phase I submission is constantly open.

6.6.3. Acceptable evidence to establish the time of receipt at the Government office includes documentary and electronic evidence of receipt maintained by the installation. Offerors should also print, and maintain for their records, the electronic receipt that appears on the screen following submission of a proposal on the DTRA proposal submission website.

6.6.4. If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the date specified in the invitation for full proposal, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the BAA on the first work day on which normal Government processes resume.

6.6.5. Proposals may be withdrawn by written notice received at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer via the e-mail address listed in Section 5.

6.7. The Government may reject Phase I or Phase II submissions that are deemed non-compliant, i.e., that significantly deviate from the instructions in the BAA.

7. TOPICS

Attachment 8 presents the list of topics with associated requirements for which proposals are sought. Each proposal submitted may address one topic only. Offerors should use their best judgment. It is incumbent on the offeror to conduct independent research to understand how the specific technology proposed can be properly applied to DTRA’s campaigns and associated capability areas. Offerors may submit proposals to more than one topic.

8. INFORMATION TO BE REQUESTED FROM SUCCESSFUL OFFERORS

Offerors whose proposals are accepted for funding will be contacted before award to provide additional information required for award. This may include revised budgets or budget explanations and other information as applicable to the proposed award. Offerors that are not responsive to government requests for information in a timely manner, defined as meeting government deadlines established and communicated with the request, may be removed from award consideration.

9. MILITARY RECRUITING

This is to notify potential offerors that each grant or contract awarded under this announcement to an institution of higher education must include the following term and condition: “As a condition for receipt of funds available to the Department of Defense, DoD, under this award, the recipient agrees that it is not an institution of higher education (as defined in 32 Code of Federal Regulations (CFR) Part 216) that has a policy of denying, and that it is not an institution of higher education that effectively prevents, the Secretary of Defense from obtaining for military recruiting purposes: (A) entry to campuses or access to students on campuses; or (B) access to directory information pertaining to students. If the recipient is determined, using procedures in 32 CFR Part 216 to be such an institution of higher education during the period of performance of this agreement, and therefore to be in breach of this clause, the Government will cease all payments of DoD funds under this agreement and all other DoD grants and cooperative agreements, and it may suspend or terminate such grants and agreements unilaterally for material failure to comply with the terms and conditions of award.” 32 CFR Part 216 may be accessed electronically at http://www.gpoaccess.gov/cfr/index.html. If your institution has been identified under the procedures established by the Secretary of Defense to implement Section 558 of Public Law 103-337, then: (1) no funds available to DoD may be provided to your institution through any grant, including any existing grant; (2) as a matter of policy, this restriction also applies to any cooperative agreement; and (3) your institution is not eligible to receive a grant or cooperative agreement in response to this BAA. This is to notify potential offerors that each contract awarded under this announcement to an institution of higher education must include the clause: Defense Federal Acquisition Regulation Supplement (DFARS) 252.209-7005, Reserve Officer Training Corps and Military Recruiting on Campus.

10. EXPORT CONTROL NOTIFICATION

Offerors are responsible for ensuring compliance with any export control laws and regulations that may be applicable to the export of and foreign access to their proposed technologies. Offerors may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22CFR Parts 120 – 130) and/or the Department of Commerce regarding the Export Administration Regulations (15 CFR Parts 730-774).

11. LIMITATION ON OTHER TRANSACTIONS

Offerors are advised that an Other Transaction for Research Agreement (10 U.S. Code § 2371) will only be awarded if the use of a standard contract, grant or cooperative agreement is not feasible or appropriate. Offerors are advised that an Other Transaction for Prototype Agreement (P.L. Law 103-160 § 845) will only be awarded if there is:

a. At least one nontraditional defense contractor participating to a significant extent in the prototype project, or

b. No nontraditional defense contractor is participating to a significant extent in the prototype project, but at least one of the following circumstances exists:

i. At least one third of the total cost of the prototype project is to be paid out of funds provided by the parties to the transaction other than the federal government. The cost share should generally consist of labor, materials, equipment, and facilities costs (including allocable indirect costs).

ii. Exceptional circumstances justify the use of a transaction that provides for innovative business arrangements or structures that would not be feasible or appropriate under a procurement contract.

c. Although use of one of these options is required to use an Other Transaction for Prototype agreement as the procurement vehicle, no single option is encouraged or desired over the others.

d. NOTE: For purposes of determining whether or not a participant may be classified as a nontraditional defense contractor and whether or not such participation is determined to be participating to a significant extent in the prototype project, the following definitions are applicable:

“Nontraditional defense contractor” means a business unit that has not, for a period of at least one year prior to the date of the OT agreement, entered into or performed on:

i. any contract that is subject to full coverage under the cost accounting standards prescribed pursuant to section 26 of the Office of Federal Procurement Policy Act (41 U.S.C. 422) and the regulations implementing such section; or

ii. any other contract in excess of $500,000 to carry out prototype projects or to perform applied research or advanced development projects for a Federal agency that is subject to the Federal Acquisition Regulation.

“Participating to a significant extent in the prototype project” means that the nontraditional defense contractor is supplying a new key technology or product, is accomplishing a significant amount of the effort wherein the role played is more than a nominal or token role in the research effort, or in some other way plays a significant part in causing a material reduction in the cost or schedule of the effort or an increase in performance of the prototype in question.

e. NOTE: Offerors are cautioned that if they are classified as a traditional defense contractor, and propose the use of an OT for Prototype Agreement, the Government will require submittal of both a cost proposal under the guidelines of the FAR/DFARS, and a cost proposal under the proposed OT for Prototype Agreement, so that an evaluation may be made with respect to the cost tradeoffs applicable under both situations. The Government reserves the right to negotiate either a FAR based procurement contract, or Other Transaction for Prototype Agreement as it deems is warranted under the circumstances.

12. TECHNICAL AND ADMINISTRATIVE SUPPORT BY NON–GOVERNMENT PERSONNEL

It is the intent of DTRA to use non-government personnel (e.g. contractor support personnel) in the review and administration of all submittals for this BAA. Participation in this BAA requires Northrop Grumman and their subcontractors, C-Systems International, and BRTRC Incorporated employees to have access to proposal information including information that may be considered proprietary. All individuals in this category having access to any proprietary data must certify that they will not disclose any information pertaining to this BAA including any submittal, the identity of any submitters, or any other information relative to this BAA. The contracts with these companies contain Organizational Conflict of Interest provisions and includes contractual specifications for non-disclosure of proprietary contractor information. Additionally, Northrop Grumman Information Technology and its subcontractor employees, in their role as an Advisory and Assistance Services contractor to the Defense Threat Reduction Agency, will provide technical input in an advisory role, as Subject Matter Experts, to the Government reviewers in addition to providing administrative support in the management of the proposals and their technical review. Submission of a Phase I or Phase II proposal to this BAA constitutes the offeror’s consent to the disclosure of their information to Northrop Grumman and their subcontractors, C-Systems International and BRTRC employees under these conditions.

13. MANUFACTURING READINESS LEVELS (MRL)

13.1 The Government Accountability Office (GAO) has issued a Report to Congressional Committees titled “Best Practices: Stronger Practices Needed to Improve DoD Technology Transition Processes” (September 2006, GAO-06-883). The report can be accessed at: http://www.zyn.com/sbir/reference/GAO-d06883.pdf or obtain summary at: http://www.gao.gov/highlights/d06883high.pdf

13.2 In an attempt to address the concerns of the GAO, certain technology topics in this BAA (Section 7) state “MRL should be considered”. For those topics, refer to the following questions presented below. Although these questions do not need to be specifically addressed in the proposal submission, these questions will be addressed during the project’s period of performance to facilitate opportunities to better improve the potential for transitioning the technology development to an acquisition program.

13.3 Manufacturing Readiness Level Questions

13.3.1 Has the technology reached a minimum Technology Readiness Level (TRL) 4 or higher? Refer to Attachment 2 for TRL definitions.

13.3.2 If yes, give consideration to the following Manufacturing Readiness Level questions, where applicable:

13.3.2.1 General

· Is the technology reproducible?

· If so, have the critical features and attributes been characterized using quantitative methods?

· Are the performance and/or purity requirements measurable using standard laboratory methods?

13.3.2.2 Technology and Industrial Base

· Have manufacturing capabilities been anticipated/identified that are not readily available in the current industrial base?

· Are any potential manufacturing shortfalls documented?

· Are new materials, components, skills, and facilities anticipated?

· If so, are any potential sources/resources identified and documented?

· Have commercial potentials (e.g., spin-on, spin-off and dual-use) been considered?

13.3.2.3 Materials

· Have all concept materials been compared to EPA lists of hazardous materials?

· Are any potential hazards identified and documented for the manufacture or use of the technology?

14. CERTIFICATIONS AND REPRESENTATIONS

14.1. Certifications and representations must be completed at the time of Phase II submission. This information must be included in Volume III, Supplemental Information, of the Phase II full proposal. Additional information beyond these certifications may be required from successful offerors and may be requested at any time.

· The Federal Acquisition Regulation Online Representations and Certifications Application (ORCA) are located at website http://orca.bpn.gov. Contract specific certification packages must be completed.

14.2. The following certifications must be submitted separately as they are not included in the ORCA.

· Disclosure of Ownership or Control by the Government of a Terrorist Country: DFARS Provision 252.209-7001, Disclosure of Ownership or Control by the Government of a Terrorist Country, is a certification which is required. Review it in its entirety and acknowledge in the affirmative that you are aware of its requirement and will comply as delineated.

· Representation of Extent of Transportation by Sea: DFARS Provision 252.247-7022, Representation of Extent of Transportation by Sea, is a certification which is required. Review it in its entirety and acknowledge in the affirmative that you are aware of its requirement and will comply as delineated.

· Secondary Arab Boycott of Israel: This certification is required only if the offeror is a foreign company. DFARS 252.225-7031, Secondary Arab Boycott of Israel, is a certification which is required of all foreign companies. Review it in its entirety and acknowledge in the affirmative that you are aware of its requirement and will comply as delineated.

14.3 The SOW shall not contain proprietary data or restrictive markings. Phase II offerors shall submit a specific acknowledgement that should it be awarded a contract under this BAA, it consents to the potential public release of its Statement of Work.

15. CENTRAL CONTRACTOR REGISTRATION (CCR)

Prospective contractors/grantees must be registered in the DoD CCR database. By submission of an offer resulting from this BAA, the offeror acknowledges the requirement that a prospective contractor/grantee must be registered in the CCR database prior to award, during performance, and through final payment of any contract/agreement resulting from this BAA.

IMPORTANT: We require that all offerors be registered in the CCR database at the time of Phase I proposal submission. CCR registration information also must be included in Volume III, Supplemental Information, of the Phase II full proposal.

You may register with CCR by calling the CCR Assistance Center at 1-888-227-2423 or you may register online at http://www.ccr.gov. You will NOT be able to complete your CCR registration until CCR has confirmed your Employer Identification Number (EIN) or Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS).

Please note that it will take 24-48 hours for IRS to validate your TIN. According to the IRS, if you do not currently have an EIN and need to apply for one over the phone or Internet, you will be given a tentative EIN, but your EIN may not become active for up to two (2) weeks. If you have questions about your EIN, please call 1-800-829-4933.

If you have the necessary information ready, online registration will take about 30 minutes to complete, depending upon the size and complexity of your organization. If the organization completes the CCR registration process by 6:00 PM EST, the organizational representatives will be able to begin their registration process the very next business day.

16. PROTECTION OF HUMAN SUBJECTS

16.1. If the proposed research involves human subjects or materials, offerors are asked to outline the human use, to include the source of the human subjects or materials involved in the research. This information, if applicable, must be included in Volume III, Supplemental Information, of the Phase II full proposal. Further information may be required if the proposal is successful.

16.2. All research under any award made under this BAA involving human subjects must be conducted in accordance with 32 CFR 219, 10 U.S.C. § 980, and DoD Directive 3216.2, and, as applicable, 21 CFR parts 11, 50, 56, GCP, the ICH as well as other applicable federal and state regulations. Contractors must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as regards vulnerable populations (32 CFR 219 modifications to subparts B-D of 45 CFR 46), recruitment of military research subjects (32 CFR 219), and surrogate consent (10 U.S.C. § 980).

16.3. DTRA Directive 3216.01 of January 28, 2005 establishes the DTRA Human Subjects Protection Program, sets forth the policies, defines the applicable terms, and delineates the procedures necessary to ensure DTRA compliance with federal and DoD regulations and legislation governing human subject research. The regulations mandate that all DoD activities, components, and agencies protect the rights and welfare of human subjects of study in DoD supported research, development, test and evaluation, and related activities hereafter referred to as “research.” The requirement to comply with the regulations applies to new starts and to continuing research.

16.4. The DTRA Directive requires that research using human subjects may not begin or continue until the DTRA Human Research Oversight Board (HROB) has reviewed and approved the proposed protocol. Contractors and subcontractors are required to submit a valid federal assurance for their organization (institution, laboratory, facility) that has been issued by either DoD or the Department of Health and Human Services, and documentation of review of proposed protocols by the local Institutional Review Board (IRB) to include consent forms for any planned research using human subjects to the DTRA HROB for its review through the contracting officer’s representative (if assigned) or the contracting officer. The HROB review is separate from, and in addition to, local IRB review.

16.5. A study is considered to involve human research subjects if: 1) there is interaction with the subject (even simply talking to the subject qualifies; no needles are required); and 2) if the study involves collection and/or analysis of personal/private information about an individual, or if material used in the study contains links to such information.

16.6. Written approval to begin research or to subcontract for the use of human subjects under the proposed protocol will be provided in writing from the DTRA HROB, through the contracting officer. Both the contractor and the Government must maintain a copy of this approval. Any proposed modifications or amendments to the approved protocol or consent forms must be submitted to the local IRB and the DTRA HROB for review and approval. Examples of modifications/amendments to the protocol include but are not limited to:

· a change of the Principal Investigator;

· changes in duration or intensity of exposure to some stimulus or agent;

· changes in the information requested of volunteers, or changes to the use of specimens or data collected; or

· changes in perceived or measured risks or benefits to volunteers that require changes to the study.

16.7. Research pursuant to such modifications or amendments must not be initiated without IRB and HROB approval except when necessary to eliminate apparent and immediate hazards to the subject(s).

16.8. Research projects lasting more than one year require IRB review at least annually, or more frequently as required by the responsible IRB. HROB review and approval is required annually. The contractor or subcontractor must provide documentation of continued IRB review of protocols for HROB review and approval in accordance with the Contract Data Requirements List. Research must not continue without renewed HROB approval unless necessary to eliminate apparent and immediate hazards to the subject(s).

16.9. Non-compliance with any provision of this clause may result in withholding of payments under the contract pursuant to the contract’s payments clause(s) and/or contract termination pursuant to the contract’s termination clause(s). The Government shall not be responsible for any costs incurred for research involving human subjects prior to protocol approval by the HROB.

17. ANIMAL USE

17.1. Any proposals that include animal studies or animal work must submit detailed information on the animal protocols to be used and verify the location where the studies will be conducted. Animal studies are subject to review and approval for safety and adherence to regulation. This information, if applicable, must be included in Volume III, Supplemental Information, of the Phase II full proposal. Further information may be required if the proposal is successful.

17.2. DoD Directive 3216.1, dated April 17, 1995, provides policy and requirements for the use of animals in DoD-funded research. The DoD definition of animal is any live nonhuman vertebrate.