2.06a - N0018924RZ0120001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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.

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this modification is to answ er the questions received.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 32

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

16C. DATE SIGNED

BY 22-Feb-2024

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X N0018924RZ012

X 9B. DATED (SEE ITEM 11)

31-Jan-2024

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offer 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 you 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 APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

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

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.

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

22-Feb-2024

CODE

NAVSUP FLC NORFOLK CONTRACTING

NORFOLK OFFICE

ATTN: S SOLLENBERGER

5450 CARLISLE PIKE BOX 2020

MECHANICSBURG PA 17050-2411

N00189 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

N0018924RZ012

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

Q & A Q1. Will the government consider the inclusion of FAR clause FAR 15.404-4 Profit (d) (i) (A) - d) given the costs associated with procuring ODCs for NAMRU-IP that are not covered by indirect cost pools?

A1. The Government will only be providing a fee on labor. These cost should be covered under your G&A and Indirects.

Q2. The COST CLIN is only for FFP TOs. Will the government update CLIN 0003 to include Travel (and ODCs if FAR 15.404-4 is not included) for CPFF CLINs?

A2. The travel and ODC CLIN has been updated to reflect ordering via both FFP and CPFF type task orders.

Q3. Will the government please provide clarity on which part of the level of effort provided under Section B "estimated Level of effort" would be priced under each CLIN (CPFF and FFP), respectively?

A3. The total ceiling price for the IDIQ, all FFP and CPFF task orders, should be priced against the CPFF CLINs utilizing the LOE provided. The FFP CLIN is there as a mechanism for the Government to use to place FFP task orders against once the IDIQ is awarded.

Q4. There are no time periods attached to the CLINs in Section B and there appears to be only one option period.

Will the government confirm that CLINs 0001 - 0003 are for the base period of 60 months and CLINs 1001-1003 are for the 6 month option period?

A4. Please refer to Section F for the appropriate dates Q5. Without LCAT descriptions or minimum qualifications for the Section B LOE LCATs, the government will not be able to comparative cost analysis across all offeror's proposals. Will the government consider conducting price evaluations at the task order level instead since those labor categories are well-defined and can easily be compared across proposals?

A5. Qualification and experience provided for each of the job categories has been provided. Please utilize this information to complete your cost proposal. We will be evaluating cost at the IDIQ level.

Q6. If price evaluation is to be done at the IDIQ-level, will the government provide labor category descriptions with qualifications for all LCATs listed in Section B in order to be able to conduct a valid price comparison.

A6. Qualifications, experience, and language requirements provided.

Q7. Can you please confirm that technical support services (e.g., sample collection, sample testing) which are not covered in the estimated LOE LCATs in Section B will be handled at the TO level?

A7. Yes, these will be handled at the task order level.

Q8. Will the government please confirm that the language referenced below applies to the estimated hours at the task order level and not the IDIQ level?

“Any hours expended in excess of the Estimated Total Hours shall be excluded from all fee computations and adjustments.”

A8. This applies at the TO level.

Q9. Will the government please clarify what the "solicitation pricing pages" are in the below referenced section? If they have not been provided in the RFP, will the government please include them in the amendment?

“The Cost Proposal in Volume II shall include the solicitation pricing pages completed by the offeror. The Government shall not be responsible for compensating the contractor for any costs tied to solicitation requirements but not factored into the proposed prices, either by the contractor’s intention or by mistake.”

A9. Section B where the CLINs are listed.

Q10. If the list of LCATs provided under Section B is illustrative only, how does that affect TOs with LCATs that are not included at the IDIQ level or do not perfectly align? For example, the Indo-Pacific-based Epidemiologist is not included in the IDIQ Section B LOE.

A10. All bill rates will be evaluated for cost/price reasonableness at the Task Order Level.

Q11. The government has provided the level of effort at the ID/IQ level, and has outlined positions by country. Will the Government confirm they will only utilize these labor categories and pricing information in these countries specified, as a change in geographic location can have a significant impact on price?

A11. The LCAT breakdown is an estimate only for ceiling development purpose. Pricing and Rates will be task order specific and will be evaluated for price/cost reasonableness at time of TO placement.

Q12. The full time equivalency hours at the IDIQ and sample TO do not match. Will the government please update Section C so that 1 FTE equals 1912 hours in accordance with the sample TO?

A12. This error has been corrected.

Q13. If the Government agrees to conduct price evaluations at the task order level, will the Government please provide instructions for how they would like the offeror to respond to the Task order PWS?

A13. No pricing is to be submitted for the sample Task Order PWS. The Sample Task Order PWS is for use for Performance Approach only.

Q14. Will the government provide a pricing sheet or template for how they would like offerors to respond to pricing instructions in order to provide uniformity in cost proposals?

A14. There is no standardized pricing template. Please follow requirements specified in Section L “Instructions to Offerors”: “The Cost Proposal in Volume II shall include the solicitation pricing pages completed by the offeror and a complete and detailed breakdown of the offeror’s cost plus fixed fee (CPFF) CLIN with all supporting documentation. The offeror’s cost proposal shall not deviate from the level of effort set forth in Section B of the solicitation. The cost proposal shall support the non-cost proposal. The cost proposal shall include all elements of cost and such other cost information as considered appropriate to support the offeror’s proposal. The burden of proof for establishing the realism of all proposed costs rests with the offeror. Offeror’s shall not lock out spreadsheets, so that formulas are not visible or link to other spreadsheets where the Government cannot access the underlying value.

All calculations and formulas shall allow the Government to view all numerical values in the calculations or shall link to cells in the same spreadsheet that allow the Government to view the values.”

Q15. Will the Government provide the minimum amounts required for indemnification and medical liability insurance?

A15. TBD

Q16. Please confirm that the General Liability and Indemnification and Medical Liability minimum coverage amounts required at the IDIQ level will be sufficient for all task orders required under this contract.

A16. The minimum coverage should cover and exceed minimum amounts in all task order places of performance/countries.

Q17. Does the government intend to evaluate relevancy in scope and magnitude of effort in relation to the sample task order, to the IDIQ as a whole, or both?

A17. Past Performance Relevancy only applies to the IDIQ as a whole. Sample Task Order is only to be utilized for the Performance Approach Section.

Q18. Given that the management approach at the IDIQ level is the most important evaluation factor which includes an approach to managing cost, schedule, and performance of multiple task orders simultaneously, will the government allow at least one past performance reference by the Prime as a collection of task orders under a single-award IDIQ in order to evaluate the likelihood of successful performance of a prime contractor in managing multiple task orders simultaneously at the magnitude that this IDIQ is expected to produce.

A18. The Government request that in accordance with the instructions in Section L, only a singular task order be provided. The exact instructions is as follows: "Contract references for IDIQ contract vehicles shall provide the basic contract number and task order number. Such references that do not provide this information will not be reviewed or considered. For example, an IDIQ contract number, GSA Schedule contract, or BPA number will not be considered since performance occurs at the task order level. A singular task order number under one IDIQ contract equates to one effort. The Government is evaluating a maximum of three (3) efforts."

Q19. Please confirm that we may make minor changes to the format of the past performance information form to improve readability of the information (e.g., bolding, spacing) as long as we do not change the basic structure.

A19. Yes, as long as you still adhere to the following requirements listed in Section L: "Each “page” is defined as one sheet, 8 ½” x 11”, with at least one inch margins on all sides, using a font with Lines shall, at a minimum, be single-spaced." “Past Performance Information Form,” including any continuation sheets may be completed with point size of 10 or greater. Pages submitted in excess of the page limitations described above will not be evaluated.

The Navy may exercise discretion in determining which specific pages are considered to be in excess of the page limitations.”

Q20. Please confirm we are allowed to delete the in-cell instructions in the past performance information form in order to allow room for the information to be provided.

A20. Yes, as long as you adhere to the requirements listed in section L and in response to A19 above.

Q21. Does the Government require resumes for the sample task order key personnel?

A21. Key Personnel requirement has been removed. No resumes should be provided.

Q22. If resumes are required for key personnel, please confirm they do not count against the page count.

A22. Key personnel requirement removed. No resumes should be provided.

Q23. Does the government intend to award the sample TO as proposed in our response to the Performance Approach?

A23. The sample TO is for Performance Approach Evaluation purposes only. This TO will not be awarded.

Q24. Because effective performance of the sample task order requires both management and technical expertise, we recommend the government include the Senior Epidemiologist/Analyst as Key Personnel. This role performs essential duties for the success of the mission, and it will reduce risk to the government by ensuring the selected contractor is able to fill this important position prior to contract awarded.

A24. Key Personnel requirement removed.

Q25. Please confirm that local time is Eastern Time A25. Yes, local time is Eastern Standard Time.

Q26. Please confirm that the Management Approach is our approach to the IDIQ PWS tasks, while the performance approach is our approach to the task order PWS tasks.

A26. Management Approach is at the IDIQ level, performance approach is based off the sample Task Order PWS.

Q27. Given the nature of our questions and the impact they have on putting together proposal pricing, it may be difficult to respond to significantly changing pricing proposal instructions in the time remaining from Q&A release to proposal due date. Will the government provide answers to this first round a questions sooner than the current questions due date of 02/21/24 and then allow a second round of questions to be submitted by that 02/21/24 due date?

A27. Question deadline has been extended to 12:00 pm EST 3/1/2024 and solicitation closing date has been extended to 12:00 pm EST 3/11/2024.

Q28. Will the government provide evaluation criteria definitions for how they will rate the performance approach and management approach?

A28. The evaluation ratings will be assessed consistent with the DoD Source Selection Procedures and its standard rating tables found within the document.

Q29. Is the government requiring the offeror to submit proof of security clearance level? If so, will the government confirm that this may be provided as an attachment or appendix and is not subject to page limits?

A29. Yes, it will be an attachment to your Management Approach and is not subject to the page limit.

SECTION A - SOLICITATION/CONTRACT FORM

The required response date/time has changed from 04-Mar-2024 12:00 PM to 11-Mar-2024 12:00 PM.

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0003

The CLIN description has changed from NAMRU-2 Research Support Services to NAMRU-2 Research Support ODCs and Travel.

The CLIN extended description has changed from:

Firm Fixed Price Task Orders. ODC and Travel

To:

ODC and Travel

CLIN 1003

The CLIN description has changed from NAMRU-2 Research Support Services to NAMRU-2 Research Support ODCs and Travel.

The CLIN extended description has changed from:

Firm Fixed Price Task Orders. ODC and Travel

To:

ODC and Travel

The following have been modified:

SECTION B

METHOD OF PROPOSAL SUBMISSION (SEP 2015)

The NECO website has a "submit bid" button next to the solicitation number.

DO NOT use the "submit bid" button on NECO to submit your proposal.

Offerors shall follow the method of proposal submission set forth in the Section L “Submission of Proposals”.

LEVEL OF EFFORT (COST TYPE CONTRACT) (SINGLE AWARD IDIQ) (SEP 2015)

(a) The Estimated Total Hours to be ordered under this contract during the contract ordering period is based upon the following level of effort:

NAMRU INDO PAFICIC FY24 IDIQ: Estimated level of effort per year

Location Job category Hours USA Program manager 1912 USA Project associate 1912 USA Epidemiologist 956 Laos Project manager, scientists 19120 Laos Study coordinator, technicians, project assistants 30592 Vietnam Project manager, scientists 7648 Vietnam Study coordinator, technicians, project assistants 19120 Vietnam Database administrator 1912 Peninsula Malaysia Project manager, scientists 11472 Peninsula Malaysia Study coordinator, technicians, project assistants 30592 Peninsula Malaysia Database administrator 1912 East Malaysia Project manager, scientists 5736 East Malaysia Study coordinator, technicians, project assistants 17208 Papua New Guinea Project manager, scientists 3824 Papua New Guinea Study coordinator, technicians, project assistants 9560 Papua New Guinea Database administrator 1912

Philippines Project manager, scientists 5736 Philippines Project assistant, study coordinator, research technicians 7648 Australia Bioinformatician 1912 Japan Research nurse, laboratory coordinator 1912 Japan Research technician, logistician 4780 Guam Project manager, scientist 956 Guam Study coordinator, technicians 956 Mongolia Project manager, scientist 5736 Mongolia Study coordinator, technicians 15296 Mongolia Drivers 7648

Program Manager Qualification and experience: Bachelor’s degree in human resource management, business administration, or science-related field. An advanced degree or equivalent is preferred but not required. PMP certification is preferred. At least 3 years’ experience in supporting US military medical R&D programs and at least 3 years of experience as a Contract Program Manager supporting US Government funded research. Functional knowledge of US Federal regulations on research with human subjects and animals. Demonstrated experience in consultant and vendor sub-contracting establishment. Solid organizational skills; ability to be flexible and work well under pressure in a fast-paced multi-task team environment. Level 3-4 for speaking, reading, and writing in English.

Project Associate Qualification and experience: Bachelor’s degree in business administration or a related field with at least 2 years of post-degree experience; project management experience preferred but not required; excellent written and oral communication skills; solid organizational skills; ability to be flexible and work well under pressure in a fast-paced multi-task team environment. Level 3 for speaking, reading, and writing in English.

Epidemiologist Qualification and experience: Doctoral degree (M.D. and/or Ph.D.) in public health, epidemiology, biostatistics, biology, or a subfield of biology with strong statistical analysis skills, or another related field from an accredited college or university. At least 2-3 years of post-doc experience in clinical and epidemiological research is preferred.

At least 1-2 years of previous international work experience, the ability to work both independently and on a team in an interdisciplinary environment are essential. Have knowledge of public health datasets, agencies, and programs such as the CDC and Census Bureau, have experience in grant writing and preparation of grant applications, be fluent in one or more of the following statistical programs: SAS, SPSS, Stata, R, and be familiar with various data mapping and visualization tools. Level 4 for speaking, reading, and writing in English.

Project manager Qualification and experience: Bachelor’s degree biomedical, biological or health sciences or in a related field or in entomology with at least 2 years of post-degree related experience; project management experience, supervisory experience preferred; excellent written and oral communication skills; proven ability to effectively manage inter and intra-agency relationships; familiarity with countries in the region preferred; solid organizational skills; ability to be flexible and work well under pressure in a fast-paced multi-task team environment; ability to travel to countries in the region. Level 3 for speaking, reading, and writing in English. Level 3 for speaking, reading, and writing in national language.

Scientist (Junior) Qualification and experience: Bachelor’s degree in biomedical, biological or health sciences or in a related field or in entomology. At least 2 years of post-degree experience preferred. Strong research skills and ability to work independently. Demonstrated ability to interact professionally with other researchers and collaborators and work in an interdisciplinary environment. Level 3 for speaking, reading, and writing in English. Level 3 for speaking, reading, and writing in national language.

Scientist (Senior) Qualification and experience: Degree in Medicine or PhD degree in health-related fields (Biomedical Sciences, Immunology, Public Health or Epidemiology). A minimum of 5 years’ post-doc experience in implementing research studies and leading a team of scientists/research assistants/laboratory technicians. Demonstrated ability to interact professionally with other researchers and collaborators and work in an interdisciplinary environment.

Level 4 for speaking, reading, and writing in English. Level 4 for speaking, reading, and writing in national language.

Study coordinator Qualification and experience: Bachelor’s degree in biomedical, biological or health sciences or in a related field or in entomology. Certified good clinical practices training. At least 2 years’ experience as a study coordinator in conducting human research. Level 3 for speaking, reading, and writing in English. Level 3 for speaking, reading, and writing in national language.

Technicians/Research technicians Qualification and experience: Associate’s degree in biology, laboratory technology or related fields. At least 2 years post-degree experience preferred. Level 1-2 for speaking, reading, and writing in English. Level 3 for speaking, reading, and writing in national language.

Project assistants Qualification and experience: Bachelor’s degree in microbiology, biochemistry, entomology or in related fields. At least 2 years post-degree experience in conducting research study activities preferred. Level 2-3 for speaking, reading, and writing in English. Level 3 for speaking, reading, and writing in national language.

Data administrator/manager Qualifications and experience: A minimum of a master’s degree in public health, epidemiology, biostatistics, biology, or a subfield of biology with strong data management skills, or another related field from an accredited college or university. At least 3-5 years’ experience in data management of datasets from clinical and/or epidemiological research is preferred. Knowledge and experience with public health datasets, agencies, and programs such as the CDC and Census Bureau and statistical programs (e.g., SAS, SPSS, Strata, R) and with various data mapping and visualization tools. Level 3-4 for speaking, reading, and writing in English. Level 4 for speaking, reading, and writing in national language.

Bioinformatician Qualifications and experience: A minimum of a bachelor’s degree in statistics, mathematics, computer science or associated disciplines. Master’s degree is preferred. Minimum 2 years’ experience in conducting biostatistical analyses in a health research/services environment. Level 3-4 for speaking, reading, and writing in English. Level 4 for speaking, reading, and writing in national language.

Research nurse Qualifications and experience: Nursing degree or equivalent. At least 2 years’ experience working in research (administration of consent, previous work at a hospital preferred, previous experience in supervisory role). Level 3- 4 for speaking, reading, and writing in English. Level 3-4 for speaking, reading, and writing in national language, if applicable.

Laboratory coordinator

Qualifications and experience: Technical degree in phlebotomy, nursing and/or laboratory services or certified laboratory technician. At least 2 years’ working in laboratory areas (laboratory work, biosecurity, ethics); at least 2 years’ experience with human subject’s research (consent form application, filling out questionnaires on paper or electronically); at least 1 year in handling biological samples (storage, cold chain, biosecurity); at least 6 months experience as a laboratory coordinator. Level 3-4 for speaking, reading, and writing in English. Level 3-4 for speaking, reading, and writing in national language.

Logistician Qualifications and experience: Bachelor’s degree in logistics, supply chain management or related fields. At least 6 month’s post-degree experience. Level 3 for speaking, reading, and writing in English. Level 3 for speaking, reading, and writing in national language.

Drivers Qualification and experience: Must have local driver’s license appropriate to vehicles to be operated. Ability to deliver passengers and materials expeditiously and safely, At least two years of professional driving experience.

Level 0-1 for speaking, reading, and writing in English. Level 2-3 for speaking, reading, and writing in national language.

Language levels:

Level 1 - Rudimentary verbal skills Level 2 – Limited knowledge, speaking, reading & writing Level 3 – Good working knowledge, speaking, reading & writing Level 4 – Fluent speaking/reading/writing, may include the ability to translate Level 5 – Professional translator/Interpreter

(b) For the purposes of paragraph (e) below, the Estimated Total Hours shall be the number of hours associated with the base ordering period as increased by the number of hours associated with any exercised option ordering periods.

(c) The Estimated Total Hours include overtime and subcontracting hours but exclude holidays, sick leave, vacation days and other absences.

(d) CPFF task orders resulting from this contract may be either term or completion type. The number of hours expended per month under each resulting term-type task order shall be commensurate with the pursuit of performance of the task order’s statement of work, provided that such fluctuation does not result in the utilization of the task order hours prior to the expiration of the task order. The number of hours for any labor category may be utilized by the contractor for any other labor category if necessary in performance of the contract.

(e) The contractor shall not be obligated to accept orders beyond the contract’s Estimated Total Hours, except that the Contracting Officer may place orders in excess of the Estimated Total Hours until the contract’s total estimated cost has been expended. In that the contract’s fixed fee is to be paid out at an hourly rate based on the contract’s Total Estimated Hours, the government will not be obligated to pay fee on any hours ordered in excess of the Estimated Total Hours. Any hours expended in excess of the Estimated Total Hours shall be excluded from all fee computations and adjustments. The Contracting Officer may also place orders in excess of the total estimated cost until the Estimated Total Hours have been expended. In no event, however, will the Contracting Officer, pursuant to this paragraph (e), place orders in excess of the Estimated Total hours if the Contracting Officer has placed orders in excess of the total estimated cost. Nor will the Contracting Officer, pursuant to this paragraph (e), place orders in excess of the total estimated cost if the Contracting Officer has placed orders in excess of the Estimated Total Hours. The Contracting Officer may extend the contract period in order to place orders up to the total estimated cost and the Estimated Total Hours.

(f) If at any time during this contract the contractor expends in excess of 85% of the available estimated manhours of direct labor (at the contract and task order levels), the contractor shall immediately notify the Contracting Officer in writing. Nothing herein shall be construed to alter or waive any of the rights or obligations of either party pursuant to the clause entitled “Limitation of Cost” and/or “Limitation of Funds.”

(g) For any resultant fixed-price task orders, the hours proposed shall be considered against the contract’s Estimated Total Hours.

(h) It is understood and agreed that for each CPFF task order issued under this contract, the number of hours and the total dollar amount for each labor category specified in the task order are estimates only and shall not limit the use of hours or dollar amounts in any labor category which may be required and provided for under an individual task order. Accordingly, in the performance of any CPFF task order, the contractor shall be allowed to adjust the quantity of labor hours provided for within labor categories specified in the order provided that in so performing the contractor shall not in any event exceed the ceiling price restrictions of any order, including modifications thereof.

PAYMENT OF FIXED FEE (CPFF SINGLE AWARD IDIQ) (SEP 2015)

The fixed fee for work performed under this contract is $__*__ provided that approximately __**__ hours of technical effort are employed by the contractor in performance of this contract. If substantially fewer than __**__ hours of technical effort are employed, the fixed fee shall be equitably reduced to reflect the reduction of work. The Government shall make monthly payments of the fixed fee at the rate of $__***__ per direct labor hour invoiced by the contractor. For the purposes of tracking the contract’s total fixed fee, the “fixed fee” associated with any fixed-price task order will be the product of the above rate(s) multiplied by the total hours proposed for the task order. All payments shall be in accordance with the provisions of FAR 52.216-8, “Fixed Fee,” and FAR 52.216-7, “Allowable Cost and Payment.” Payments shall be subject to the withholding provisions of Paragraph (b) of FAR 52.216-8, provided that the total of all such monthly payment shall not exceed eighty-five (85%) percent of the fixed fee. Any balance of fixed fee due the contractor shall be paid to the Contractor, and any over-payment of fixed fee shall be repaid to the Government by the Contractor, or otherwise credited to the Government at the time of final payment.

Lot I To be specified at time of award xx,xxx */** Lot II To be specified at time of award xx,xxx Lot III To be specified at time of award xx,xxx Lot IV To be specified at time of award xx,xxx Lot V To be specified at time of award xx,xxx */**

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

PWS

Performance Work Statement (PWS) The U.S Naval Medical Research Unit (NAMRU) INDO PACIFIC’s

INDO-PACIFIC BIOSURVEILLANCE & EPIDEMIOLOGY RESEARCH

C.1 Background & Assumptions / Constraints

Contemporary pandemics and outbreaks of disease, such as the COVID-19 pandemic, Ebola virus outbreak and Zika virus, serve as poignant reminders of our global vulnerability to emergent human health threats. Current global disease control focuses almost exclusively on responding to pandemics after they have emerged, highlighting our current inability to predict or prevent such events. Nevertheless, dramatic failures in pandemic control as highlighted by the threats to our forces both CONUS and OCONUS, have shown that this wait-and-respond approach is not sufficient. The development of systems to prevent pandemics before they are established is imperative to force health protection. The early detection of emergent threats to human health is even more important given the speed with which disease-causing agents are now capable of being distributed around the globe through air travel and global trade. Because the success of some pathogens depends on their abilities to spread from human-to-human or to utilize a vector to spread, their abilities to cross continents rapidly poses a unique challenge to emerging infectious disease control. In today’s world of global interconnectedness, a pathogen that may have remained a regional phenomenon in an era before globalization now has few barriers to rapid global distribution. Despite this, our current disease surveillance systems, and our ability to identify and respond to emergent diseases early are inadequate. Developing more robust surveillance programs to identify pathogens early and to respond to their emergence appropriately is crucial to a coherent strategy for combating future threats infectious disease threats to human health.

The U.S. Naval Medical Research Unit INDO PACIFIC (NAMRU INDO PACIFIC), based in Singapore, is at the forefront of the U.S. Department of Defense (DoD)’s disease surveillance and product development efforts in the US Indo-Pacific Command (INDOPACOM) Area of Responsibility (AOR). Within the context of its ongoing research activities, NAMRU INDO PACIFIC is well-positioned to perform biosurveillance, evaluate novel diagnostics products and therapeutic interventions, test disease control strategies, and to develop local expertise (training to detect and respond to emergent disease threats). In consonance with its mission, NAMRU INDO PACIFIC requires contractor services to support the ongoing development, performance, and management of research across the Indo-Pacific region and in collaboration with host-country partners. Generally, the support required does not include staffing of existing laboratories and/or the development and staffing of new laboratories.

For task orders that are considered severable services, the task order shall be performance based and shall include a Performance Work Statement (PWS) that identifies the tasks to be performed and a Quality Assurance Surveillance Plan (QASP) and Performance Requirement Standards (PRS) that establishes performance metrics for these tasks. It is anticipated that most task orders that provide severable services will be Firm Fixed Price (FFP). Task orders may include “surge” CLIN(s) for optional task(s). The number of optional tasks, if any, will be determined at the task order level.

For task orders that are considered non-severable services, the task order will not be performance based and will not include a PWS, PRS or QASP. It is anticipated that most of the non-severable task orders will be incrementally funded Cost Plus Fixed-Fee (CPFF). A CPFF arrangement addresses research and development because of the unpredictability of the level of support.

This effort is not considered a new requirement (legacy contracts W911QY-16-D-0058 and N6264518D5058) and therefore the right of first refusal concerning incumbent employees with the successful offeror is relevant (please reference Section H and 52.222-17).

Human use research is expected under the task orders that will be issued under this base Indefinite Delivery Indefinite Quantitate (IDIQ) contract. Research with human subjects may not begin until the Contractor (and all subcontractors) obtains a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A Human Research Protection Officer (HRPO) review must be in place before any human use research can be supported.

Travel is expected in support of the research efforts at NAMRU INDO PACIFIC. The number of Contractor personnel required shall be determined at the discretion of the Contracting Officer Representative (COR). All travel must be approved by the COR in writing via e-mail prior to incurring costs. Travel costs may include medical evacuation (MEDEVAC) and repatriation insurance. All travel shall be conducted in accordance with NAMRU INDO PACIFIC procedures and the DoD with Joint Travel Regulations (JTR) and US Department of State (DoS) regulations. An estimated travel amount shall be delineated at the task order level. The estimated travel amount (provided at the task order level) is an estimated amount and is before contractor burdens. Contractor burdens must be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

Other Direct Costs (ODC) are expected in support of the research efforts at NAMRU INDO PACIFIC. All ODC costs must be approved by the COR in writing via e-mail prior to incurring costs. ODCs shall be specified at the task order level but shall typically include (but are not limited to) contractor-procured supplies, equipment, disposable and non-disposable items, IT support, and equipment.

An estimated ODC amount shall be delineated at the task order level. The estimated ODC amount (provided at the task order level) is an estimated amount and is before contractor burdens. Contractor burdens must be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

Task orders issued under this base IDIQ contract require indemnification and medical liability insurance. The Federal Tort Claims act does not apply.

All services provided under this base IDIQ contract are non-personal in nature.

There are no known Organizational Conflicts of Interest (OCI) within this effort.

Performance is primarily at Contractor or Sub-contractor sites in USA and in the Indo-Pacific region. The specific place of performance shall be specified at the task order level.

C.2. General Requirements

The Contractor shall provide all personnel, equipment, supplies, facilities (if required by space constraints), transportation, tools, materials, supervision, and other items and non-personal services necessary to perform under this contract, as defined in this PWS except for those items specified as government furnished property/equipment (GFP/GFE) and services, if any (there is no GFP/GFE identified at this time; any GFP/GFE shall be specifically identified at the task order level). Performance includes assisting with the following functions: management, oversight, establishing procedures for planning, allocating, and controlling resources for awarded task orders; scheduling, budgeting, and accumulating expenditures (hours and dollars);

identifying expenditure and schedule problems; tracking order performance; and providing timely detailed performance status to the Government. Assisting with management includes administrative functions performed to oversee an infectious disease research program (e.g., biosurveillance, vector control, product evaluation, and vaccine/therapeutic efficacy programs) from initiation to completion, including but not limited to; report generation to the Government principal investigator(s) and funding sponsors; assisting with the initiation of new field sites;

assisting with establishing agreements in-country; tracking technical progress and expenditures;

travel management, and assisting with the general oversight of research program resources in-country. The Contractor shall perform to the standards in this contract to accomplish the following general requirements:

C.2.1. Assist with administrative and logistical support of NAMRU INDO PACIFIC. This support shall include assisting with project management and administrative support, tracking programmatic milestones, preparing of internal/external research documents, assisting with material/supply procurement support, program logistics, and managing of regulatory requirements for human and animal research, and translation of project/protocol documents from English to local languages and vice versa. This support shall also involve providing management between the US Government and potentially foreign personnel located at the client’s site or

AOR.

C.2.2. Assisting with the design and conduct of protocols with NAMRU INDO PACIFIC and in-country partners to conduct biosurveillance and epidemiology research. The support shall include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NAMRU INDO PACIFIC. Examples of current projects include population-based studies of acute febrile illness, multi-year prospective cohort studies to evaluate the risk potential of emerging viral pathogens, and retrospective and prospective epidemiological studies of emerging disease threats in the Indo-Pacific region.

C.2.3. Design and conduct of protocols with NAMRU INDO PACIFIC and in-country partners to evaluate novel disease diagnostics and therapeutic interventions, as well as disease and vector control strategies. This shall include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NAMRU INDO PACIFIC. Examples of current projects include sensitivity and functionality testing of Role 0 and Role 1 portable diagnostic assays, evaluation of transcriptomic and clustered regularly interspaced short palindromic repeats (CRISPR) based diagnostic and prognostic technologies, vector mapping studies related to tick-borne and bat-borne pathogens in the Indo-Pacific region, and spatial repellency studies involving mosquitoes in the Indo-Pacific region.

C.2.4. Design and conduct training with NAMRU INDO PACIFIC and in-country partners to develop regional expertise to detect and respond to emerging disease threats. This shall include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NAMRU INDO PACIFIC. Examples of current projects include the Biosecurity Engagement Program (BEP) in collaboration with the US DoS, laboratory capacity building and biosafety initiatives in the Indo-Pacific region, and ongoing biosurveillance and emerging disease response activities in support of the Global Emerging Infection Surveillance (GEIS) network.

C.2.5. Serve as subject matter experts and liaisons to sub-contractors and host-country partners within the above associated mission areas.

C.2.6. Quality Control. The Contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s quality control program (QCP) is a procedure intended to ensure that the services provided comply with the requirements of the contract.

C.2.7. Quality Assurance. The Government shall evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government will do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

C.3. Local Staffing Sources and Partnership with Host Nation Organizations

For this contract, it is anticipated that a prime contractor shall work in conjunction with local solution partners or subcontractors to ensure that local sourcing is utilized to the fullest, thereby giving NAMRU INDO PACIFIC the most cost-effective solution, while maintaining an acceptable level of technical performance. Any prime contractor working in-theater AOR must ensure compliance with, and be responsible for, all local tax and labor laws in the country of operation. This includes ensuring that any subcontractor(s) are also in compliance with local laws. Any prime contractor shall also ensure compliance with the cognizant US command of the relevant regions and the US State Department, as there may be high risk when entering the area.

C.3.1. The Contractor shall have established partnerships with local solution partners and subcontractors and host nation organizations. Demonstrated past performance on “Local Staffing Sources and Partnership with Host Nation Organizations” will be considered as part of the technical evaluation of proposals.

C.4. Period of Performance The ordering period for this contract shall be for 60 months, with the option to extend an additional 6 months if the option is exercised, pursuant to FAR 52.217-8.

C.5. Scientific/Technical Requirements

In addition to the US management provided under this contract, the purpose of this acquisition includes providing scientific/technical (including administrative support) services in support of medical research and development, whether that be directly provided by the prime contractor or indirectly provided by a host-country subcontractor, or a third party entity not under this contract, for NAMRU INDO PACIFIC that are not personal services, inherently governmental functions, or subject to OMB Circular A76. NAMRU INDO PACIFIC R&D activities are generally categorized under the following topic areas: (1) Disease Surveillance and Epidemiology, (2) Evaluation of Novel Diagnostics, Therapeutic Interventions, and Vector Control Strategies, (3) Disease Ecology, and (4) Capacity Development and Training. Support for these activities will include, but is not limited to: general project oversight; study protocol and document development; development and validation of training materials and standard operating procedures, management of the regulatory requirements pertaining to the conduct of ethical human and animal research (e.g. Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) submissions and approvals); non-Governmental procurement support; logistical support for shipping and travel; field-site evaluation and selection; subject recruitment and follow-up; biological or environmental sample collection/accessioning/storage; laboratory characterization of collected samples; data management and analysis; translation services to and from English; report generation; and manuscript preparation. A close working relationship, via sub-contract, agreement or other appropriate vehicle may also be required with numerous entities including, but not limited to, regional academic institutions and local health care facilities, as well as with foreign governmental institutions such as Ministries of Health, Ministries of Defense, Environmental and Wildlife Ministries. Additional details for each of the study categories are provided below:

C.5.1. Disease Surveillance and Epidemiology. Support is required on a variety of disease surveillance and related epidemiology activities; including but not limited to retrospective and prospective epidemiology studies, active disease surveillance studies, as well as cohort, case-control, and cross-sectional studies.

C.5.2. Evaluation of Novel Diagnostics, Therapeutic Interventions, and Vector Control Strategies. Support is required for studies aimed at evaluating the performance of (yet to be determined) novel disease diagnostics, therapeutic interventions, and disease vector control strategies. Focus shall be on development and evaluation of products for the benefit of public health and military force health protection.

C.5.3. Disease Ecology. Support is required for studies aimed at elucidating the ecological relationships between disease pathogens and the environment. The principal goal of these studies is to understand the environmental conditions that are permissive to pathogen emergence or proliferation of the pathogen’s vectors or reservoirs and the characterization of the necessary and/or sufficient factors that increase the risk of transmission. Identification of such risk factors may point to potential mitigation strategies for disease control and identification of hazards for deploying forces.

C.5.4. Capacity Development and Training. Support is required for the development of regional capacity to detect and safely respond to emergent disease threats. It is envisioned that capacity development shall take the form of targeted and distinct training topics. Examples of such training include but are not limited to Biosafety/Biosecurity Training, Field Diagnostics Training, and Epidemiological Investigation Training.

C.6 Level of Effort Estimate

General: Task orders issued under the base IDIQ contract may include the labor categories outlined in the table below. The list is a sample and the Government is not limited to these labor categories. The Government’s estimated labor categories are delineated at the task order level.

The Contractor’s proposed level of effort at the task order level will require the Contractor to implement a Contractor-developed system for ensuring adequate staffing at all times and shall provide continuous support services in accordance with the hours of operation.

NAMRU INDO PAFICIC FY24 IDIQ: Estimated level of effort per year

Location Job category Hours USA Program manager 1912 USA Project associate 1912 USA Epidemiologist 956 Laos Project manager, scientists 19120 Laos Study coordinator, technicians, project assistants 30592 Vietnam Project manager, scientists 7648 Vietnam Study coordinator, technicians, project assistants 19120 Vietnam Database administrator 1912 Peninsula Malaysia Project manager, scientists 11472 Peninsula Malaysia Study coordinator, technicians, project assistants 30592 Peninsula Malaysia Database administrator 1912 East Malaysia Project manager, scientists 5736 East Malaysia Study coordinator, technicians, project assistants 17208 Papua New Guinea Project manager, scientists 3824 Papua New Guinea Study coordinator, technicians, project assistants 9560 Papua New Guinea Database administrator 1912 Philippines Project manager, scientists 5736 Philippines Project assistant, study coordinator, research technicians

Australia Bioinformatician 1912 Japan Research nurse, laboratory coordinator 1912 Japan Research technician, logistician 4780 Guam Project manager, scientist 956 Guam Study coordinator, technicians 956 Mongolia Project manager, scientist 5736 Mongolia Study coordinator, technicians 15296…