Amendment 0001_RFP 70RWMD23R00000007_Topic Sol 15_5.19.23 FINAL w att.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a)By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE

DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

# Reference Contractor Question Government Response 1 OBAA Solicitation

70RWMD23R00000007,

page 24: 52.244-2 Alt I

SUBCONTRACTS

Can a subcontract award be based on Fixed Price rather than CPFF if the subcontractor does not have an "Approved purchasing system"?

DHS intends to award a CPFF for the prime contract award. DHS has not indicated any preference on the type of subcontract(s) the prime contractor may chose to issue in performance of this prime contract.

Please adhere to FAR 52.244-2 Alt I for all subcontracts awarded.

2 OBAA Solicitation

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52.227-15, Representation of Limited Rights Data and Restricted Computer

Does "data" include specific antibody formulations, wavelengths of interest for pathogen, instrument settings, etc.? Can background IP associated with this "data" be offered with limited/restricted rights, if the background IP is required for development of a new antibody/biomarker/etc., in the performance of any contract awarded?

Please see FAR section 52.227-14 for the definition of what constitutes data. The final establishment of data rights assertions will be determined during contract negotiations.

3 OBAA Solicitation

70RWMD23R00000007,

Attachment 1, page 1.

It is stated that "There will be no exceptions to the time and date on which responses are due, unless determined otherwise by the Government." Is it possible to get an extension of the due date to 30 June 2023 due to summer work schedule rotations?

Per the solicitation, the due date is June 20th 2023 and remains unchanged.

4 OBAA Solicitation

70RWMD23R00000007,

Attachment 1, 5. Research Opportunity Description - Objective, page 2.

It is stated that the Objective is to develop, prototype, and test a biodetection system capable of providing species level identification of biological agents without the use of reagents or detection methods that are specific to an individual agent. Would the employment of on-board specific biological markers and optical (light source) markers fall into the category of reagents, or are they considered "consumables"? Is it permitted to use on-board specific biomarkers and optical markers, which would require periodic replenishment?

Employment of a set of specific biomarkers that result in the identification of an unknown threat via pattern recognition that is sufficiently discriminatory for species identification is acceptable. Replenishment of these reagents is acceptable.

5 OBAA Solicitation

70RWMD23R00000007,

Attachment 1, Requirements, page 3.

The threshold requirement states that the intended coverage area to protect is a "Specified building interior in a 100ft perimeter of the building". This is somewhat ambiguous. Did you mean specified building interior, and exterior to the building within 100 feet from the perimeter of the building. What is the threshold requirement for the outdoor environment, or is the threshold requirement only focused on indoor requirement?

The intended protection coverage is the entire interior of the building and the exterior out to a 100 ft perimeter. Indoor and outdoor requirements are the same.

6 OBAA Solicitation

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Attachment 1, Requirements, page 3.

For the requirement to detect and identify specified biothreats to the species level, what is the minimum concentration to detect for each type of threat? Are threshold/objective requirements the same for outdoor scenarios and for indoor scenarios?

Sensitivity threshold is 1/10 the LD50 for each target. Toxin thresholds can be either 1/10 the LD50 or at or below the no-observed-adverse-effect-level (NOAEL) for the given agent. Indoor and outdoor requirements are the same.

7 OBAA Solicitation

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Attachment 1, Requirements, page 4, "multiple sensor/system

Regarding Threshold requirement: sampling capability for water and/or soil samples, what is the context for water and for soil ?

The ability to accommodate wastewater and soil matrices.

8 OBAA Solicitation

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Attachment 1, Requirements, page 4, "multiple sensor/system

Regarding Objective requirement: fully automated water sensing, can you describe the context?

Effluent water from a variety of sources, not limited to ports of entry and medical complexes.

9 OBAA Solicitation

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Attachment 1, Requirements, page 4.

Do systems need to detect Category A, B and C bioterrorism agents for every mission set, or will there be a subset of these agents that apply to each mission set?

Yes, though it is likely that certain agents have a higher probability of use in certain 'mission sets', the requirement shall remain the same for all mission sets.

10 OBAA Solicitation

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Attachment 1, Requirements, page 4.

The requirement states that all software must be available as Open Source, meaning that source code must be available to others who would like to view that code, copy it, learn from it, alter it, or share it.

However, when reviewing the applicable FAR clauses in the solicitation, it appears that proprietary rights can be asserted to the Government with restrictions on use of pre-existing software, results, prototypes, or systems supporting and/or necessary in the performance of the contract.

Proprietary data rights and open source software for government access and sharing will be determined after award selection and SOW finalization. Claimed proprietary rights and restrictions will be justified during that time.

11 OBAA Solicitation

70RWMD23R00000007,

Attachment 1, page 5.

It is stated that performers shall provide DHS CWMD all data formats and a detailed explanation of said data including raw data prior to processing, as well as full access to all algorithm software and system prototype electronic technical data packages (to include 3D models) to enable prototype production with full rights to provide data as Government Furnished Information (GFI) for future development and production. Is it correct to assume that FAR 52.227-14(a) and 52.227-15 apply, wherein proprietary rights can be asserted to the Government with restrictions on use of pre-existing results, prototypes, or systems supporting and/or necessary in the performance of the contract?

That is correct, barring that the proprietary restrictions are justified after award selection and during SOW finalization.

12 OBAA Solicitation

70RWMD23R00000007,

Attachment 1, page 5.

The program has a stated four Phase structure (Phases I - IV), with four 12-month periods. Will the Government accept an accelerated plan of performance, where the technology offering at the beginning of the program is greater than TRL 5? For instance, combining Phases I - III into a single phase, with period of performance of 1 year, and a final phase with period of performance of 1 year with the delivery being TRL 8 or higher?

The phases are not required to have 12-month periods, the language of the RFP intends to allow offerors to set the period for each phase at their discretion as long as all four phases can be completed within the 48-month period.

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Attachment 6, Section 8.4 Export Control

Does ITAR apply to this solicitation, wherein foreign nationals must meet the requirements for participation set by those regulations?

Yes, International Traffic in Arms Regulations (ITAR) applies to this solicitation.

Amendment # 0001 Offeror Questions & Responses RFP # 70RWMD23R00000007

General Would the government please clarify an assumed start date for pricing purposes?

There are currently two contemplated timelines for the awards resulting from this solicitation. Some awardees may have an award date to be determined no later than September 2023 (for FY23 Awards), and the remaining award selectees may have an award date tentatively in December 2023 (for FY24 Awards).

OBAA Solicitation section 5.3.2, Page 17-18

Section 5.3.2 (Page 18) states that "Volume Ill will only be accepted in Microsoft Excel format (only .xls and .xlsx files are acceptable)." Section

5.3.2.3 (Page 26) mentions a Cost Proposal which is typically a word document - "for the Government to determine the reasonableness.

realism. and completeness of the cost proposal...." Would it be acceptable to submit a word document?

For the Government to determine the reasonableness, realism, and completeness of the cost proposal, the Offeror shall submit Microsoft Excel spreadsheet(s) with a detailed cost breakdown of all proposed costs by cost categories, including quotes, receipts, historical pricing, payroll records, catalogue pricing, etc. The Volume III Cost Proposal is to provide detailed backup information for the summary costs provided in Volume 1.

OBAA Solicitation section 5.3.2.3, Page 26

"....the Offeror shall submit Microsoft Excel spreadsheet(s) with a detailed cost breakdown of all proposed costs by cost categories..." Will the government provide a template?

No. Please see Attachment 1, Page 10 for examples.

OBAA Solicitation Attachment 1; Section 5, Is there a more specific sensitivity requirement than general statements of equal to ELISA or PCR?

The sensitivity requirements are general on purpose. For organisms the minimal acceptable sensitivity is 1/10 LD50. For toxins it would be below the no-observed-adverse-effect-level (NOAEL) for the given agent or 1/10 LD50.

Attachment 1; Section 5, page 3 Is there a threshold bioaerosol concentration range?

The threshold sensitivity is 1/10 LD50 per liter of unconcentrated air ingested by the collector.

19 OBAA Solicitation Attachment 1; Section 5, Is there a threshold frequency of results (e.g., provide results of no detect/detect every X hrs.)? Or, can collections only be triggered when bioparticles detected?

For continuous monitoring hourly reporting is acceptable. Triggered collections are acceptable with reporting occurring within an hour of trigger.

Is there a desire to maintain viability during collection and archival for laboratory confirmatory analyses?

Yes.

21 OBAA Solicitation Attachment 1; Section 5, What level of manual sampling/preparation is acceptable for water and soil samples? Is additional hardware/software modules to address these alternate modes acceptable?

Sample preparation must occur in the operational environment. Manual sample management is acceptable for early phase prototypes with the end goal being automation.

OBAA Solicitation Attachment 1; Section 5, Is the timing of the PDR meant to be the final gate to conclude Phase II and proceed into Phase III (similar to SCR in Phase I)? Same question for CDR in Phase III.

PDR is not the final gate for Phase II. Demonstration of successful and acceptable performance in a laboratory setting is the final gate. Similarly the CDR is not the final gate for Phase III. Demonstrated successful performance in an operational environment is the final gate.

23 OBAA Solicitation Attachment 1; Section 5, Is a fully automated, end-to-end system (collection to detection) required in Phase II PoC testing? Or can some manual transfer (of sample or data) be acceptable?

Full automation is not required for successful completion of Phase II.

24 OBAA Solicitation Attachment 1; Section 5, Are there additional details and metrics for the Government test events (laboratory, virtual, chamber, etc.) at the different phases of the program?

Yes. The specifics will be recommended by vendor to govt for approval after award selection. Vendors are expected to provide their recommended approach in the proposals

To support Government testing, are their specific surrogates the Offeror should consider including?

Surrogates and simulants should be relevant, but non-pathogenic approximations of the intended target.

OBAA Solicitation, Attachment 1; Section 11, "The first two sections are mandatory (Resumes and Statement of Work);

other sections... are optional". Please clarify which additional sections are considered optional.

The Résumés and Statement of Work must be included in this section and are considered "mandatory" because they will apply to all offerors. The other sections (Management Approach, Small Business Considerations, Employee Eligibility Verification, and Assertion of Data Rights) are only stated as "optional" because these sections may not apply to all offerors.

If an "optional" section does apply, please include it with your submission to meet compliance.

OBAA Solicitation

70RWMD23R00000007,

pages 41-42, Requirements Table, Row 11

Can the government elaborate on the envisioned Concept of Operation for the liquid and soil sampling?

Potential vendors should consider all possible CONOPs relevant to the CWMD mission, operational users, to include Component, Federal, and State level users. Part of the vetting process of proposal submission is for potential vendors to showcase their knowledgebase about applicable technologies, understanding of CWMD mission, and ability to engage with user community to develop applicable use cases to meet user needs.

General What overlap in technologies and operational requirements, if any, exist between this solicitation and the 70RWMD22R00000001 project for Urban BioThreat Identification Sensor project?

No technologies are pre-defined nor will the government provide candidate or desired technology types. Proposers are expected to provide the most viable and technically feasible approach to meet the performance requirements. Part of the vetting process of proposal submission is for potential vendors to showcase their knowledgebase about applicable technologies and understanding of CWMD mission

Amendment # 0001 Offeror Questions & Responses RFP # 70RWMD23R00000007

Attachment 8 Phase Activities & Exit Criteria RFP # 70RWMD23R00000007

Phase Activities Exit Criteria Phase Review

Cost Ceiling (per Award)

I - System concept R&D development

- Model and simulation, analysis, trade studies

- Data collection, analysis, lab experimentation

- Defined system concept with technical feasibility to meet requirements

- Coherent system design plan

- TRL 3 achieved

System Concept Review (SCR)

$1M

II - Design engineering and lab analyses

- Benchtop h/w development and lab testing

- Preliminary design & modeling

- Data collection & algorithm development

- Govt approved system design and technical approach

- Lab results meeting sensitivity threshold requirements, 70% FAR, & alert time requirements

- Simulated results meeting area coverage requirements

- TRL 4 achieved

Preliminary Design Review (PDR)

$2M

III - System/prototype design development

- Design testing and iteration

- Performance measures and assessment

- User input to develop relevant test scenarios

- Fully developed system/prototype ready for testing in relevant environment

- Acceptable Performance Measures by RDD

- Acceptable system/prototype test plan

- TRL 5 achieved

Critical Design Review (CDR)

$2M

IV - System/prototype iteration based on user feedback

- System/prototype testing and requirements verification

- Test setup/environment development

- Test analysis and assessment

- Test results verifying all requirements met

- User and SSD acceptance of test results

- Complete system/prototype delivered

- TRL 6 achieved

Transition Readiness Review (TRR)

$1M

U.S. Dept. of Homeland Security, 301 7th Street SW, Mailstop 0115, MGMT/OPO/Mailstop 0115 Washington, DC, 20528-0115, US

AMD_ISSUING_OFFICE_LOCCODE: 70RWMD