N62645-18-R-0046-0001.docx

N6264518R0046

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:

QUESTIONS AND ANSWERS

1. L.8.2.1 Electronic Proposal (table with proposal section titles) L.9.2 – L.9.5; Does the government wish to standardize the proposal section titles (i.e., Volume I: Subpart II Management Approach/Risk vs. Volume I, Subpart II: Evaluation Factor I: Management Approach/Risk?

A: Please see the revised Section L in the amendment. All titles have been revised to match the titles in the table in Section L.8.2.1.

2. L.8.2.1 Electronic Proposal (table with proposal section titles) (Key Personnel resumes are an attachment to Subpart III and are not included in the page count.); May bidders provide the key personnel attachment at the end of Volume I (instead of at the end of Subpart III of Volume I) so that there is no confusion with automatic/electronic page numbers and total page count?

A: Yes, offerors may provide the key personnel attachment at the end of Volume I (instead of at the end of Subpart III of Volume I).

3. L.9.4.1 Past Performance Information Sheets; The first four pages will be the submission of a maximum of four Past Performance Information Sheets (Section J, Attachment VI – Past Performance Information Sheet).; Should bidders retain the attachment’s original formatting, which includes Times New Roman 10-point font? Also, we assume it is acceptable to add identifying information in the Attachment IV template, such as proposal page number.

A: The format for the Past Performance Information Sheets should follow the requirements of L.8.2.1. Yes, it acceptable to add identifying information in the Attachment IV template, such as proposal page number.

4. L.9.3; Offerors need to specify any Government Furnished Equipment / Information / Property, necessary to perform this task….This attachment should include the following information: item description, quantity, and current location. Detailed Bills of Materials shall be submitted along with the proposal; noting part numbers, prices, and need dates for all required GFE…; Where should bidders provide this information in the proposal, and is it exempt from page limits/counts? Or is this requirement not necessary for this proposal?

A: Offerors are to specify if any GFP is required to execute their technical approach to the task order. GFP is to be covered as part of Volume I: Subpart III. Please see the revised language from section L.9.3: The page limit for Volume I, Subpart III is 20 pages (excluding resumes and information regarding GFP) and this pages limit encompasses both of the initial task orders.

5. C.2 and C.5 C.2. General Requirements: …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, and vaccine 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… and 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… …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. IRB 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.

We would like to be clear on this contract’s scope, especially the contractor’s own work vs. other projects that are performed by the government or other entities. Are the cited requirements in C.2 and C.5, especially the bold underlined text to the left, limited to the contractor’s own SABER II task orders, or are they inclusive of support for the government’s other work and contracts outside of this contract?

The question arises because part of the scope of SABER II is for PMO operations, and PMOs often are responsible for multiple acquisitions, contractors and vendors. It appears the awarded contractor will be supporting PMO operations in addition to performing R&D.

Also, please clarify the contractual and managerial relationship(s) for the contract awarded as implicated in the following:

“…A close working relationship, via sub-contract, agreement or other appropriate vehicle may also be required with numerous entities…” A: The awarded contractor will be responsible for PMO operations for the various task orders issued under SABER II. Task orders will be developed based on awarded projects, by different government researchers and the awarded contractor will be responsible for coordinating activities. Additionally, NAMRU-2 will require the awarded contractor to provide best practices and/or procedures for PMO operations on SABER II that can be applied by NAMRU-2 to work beyond SABER II as a framework for project initiation, planning, execution, monitoring and close-out. The awarded contractor will not coordinate, direct or provide PMO support for other contracts issued on behalf of NAMRU-2.

Close working relationship term used to convey need for frequent communication by phone, email, collaborative website, etc. to resolve issues that arise working in multiple countries. This will require communications for partners in multiple time-zones, e.g. Singapore, Cambodia and Washington D.C.

Work in foreign countries involves coordination with commercial and government entities. To be successful the awarded contractor should demonstrate the ability to work with multiple entities in a host nation. Sample or data transfers cannot be done by informal agreement; sub-contracts or other appropriate agreements must be in place to satisfy US Navy human research protection program and animal research ethics requirements.

6. FFP TO, page 3; B. Provide in-country research support services outlined below:

There is no outline or description of in-country research support services below this sub-title, which is followed only by brief LCAT descriptions and PMO-related requirements. Will the government please provide details on the in-country research support services referenced here?

A: This language outlines the positions that are proving services as to differentiate from the project management listed above it (A. Project management).

7. CPFF TO, page 3; B. Provide in-country research support services outlined below:

There is no outline or description of in-country research support services below this sub-title, which is followed only by brief LCAT descriptions and PMO-related requirements. Will the government please provide details on the in-country research support services referenced here?

A: This language outlines the positions that are providing services as to differentiate from the section above (A. Viet Nam military malaria country plan).

8. Reference: RFP Section I, 52.237-7 and Section L, L.9.2; Section I, page 45 and Section L, page 80 RFP Statement: Section I, Page 45: (a) ...The Contractor shall maintain during the term of this contract liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence in Singapore and Phnom Penh, Cambodia.

(b) An apparently successful offeror, upon request by the Contracting Officer, shall furnish prior to contract award evidence of its insurability concerning the medical liability insurance required by paragraph (a) of this clause.

(c) Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided.

Section L, L.9.2: Attachment C: Indemnification and Medical Liability Insurance (IAW with Section H - “Patient Care and Medical Liability Insurance” and FAR 52.237-7): The supporting documentation shall prove that the offeror possesses current insurance and shall show the expiration date of the policies as well as including individual and aggregate limits for each of the required area of coverage.

Question: The FAR clause in Section I states that an apparently successful offeror must, upon request by the Contracting Officer, furnish evidence of it insurability prior to contract award. Section L requests supporting documentation that proves the offeror possesses current insurance, including policy expiration dates. Please verify that evidence of insurability is required from the offeror after determination that the offeror is the apparently successful offeror (i.e., after evaluation, not with the proposal).

A: Proof of insurance is required with your proposal.

9. Reference: RFP Section L, L.9.1.4., page 78 RFP Statement: L.9.1.4 SECTION V: VERIFICATION OF SECURITY CLEARANCE LEVEL The offeror shall submit documentation verifying that they can provide contract employees that possess a secret clearance. A completed DD Form 254 will be provided at time of contract award.

Question: The required Verification of Security Clearance Level section is identified as Section V but follows Section III. Please confirm that the Verification of Security Clearance Level section should be Section IV (rather than Section V).

A: Please see the revised Section L, as this has been corrected to IV.

10. Reference: RFP Section L, L.9.4.1, page 81 RFP Statement: L.9.4.1 Past Performance Information Sheets.

Past Performance has a page limit of eight pages (to include past performance information sheets).

The first four pages will be the submission of a maximum of four Past Performance Information Sheets (Section J, Attachment VI – Past Performance Information Sheet). If more than four Past Performance Information Sheets are provided, only the first four will be considered. If a Past Performance Information Sheet contains more than one page (inclusive of narrative), only the first page will be considered.

The second four pages afford the offeror four pages to cover the items highlighted under the paragraph below titled “Additional Four Pages”.

Question: Can the offeror provide a 1-page introduction to the four Past Performance examples if the response remains within the 8-page limit?

A: No, please follow the format as outlined in the RFP.

11. Reference: RFP Section L, L.9.5.2, Section 2, page 83 RFP Statement: c. Purchasing System – Provide evidence of an approved purchasing system. See FAR Subpart 44.3.

Question: Please confirm that offerors that do not currently meet the required dollar threshold for a request by the Government for a purchasing system review in accordance with FAR 44.3 may provide evidence in the proposal of the company’s ability to comply with the requirements of the Contractor Purchasing System Review (CPSR) program and the company’s commitment to participate in a Government-requested CPSR review by DCMA when annual sales meet the threshold level. The FAR threshold is $25M per year in non-FFP sales, while DoD uses an approved policy that sets the threshold at $50M in non-FFP sales. This second threshold applies for SABER II. Many companies successfully supporting Naval Research contracts (e.g., Omnibus III, SABER, IROC) do not currently meet the annual revenue threshold requirement for a Government-requested purchasing system review. To address this issue, in similar past contracts, RFPs have included the following language: "If the Contractor does not have an approved purchasing system, consent to subcontract is required for any subcontract that—

(1) Is of the cost-reimbursement, time-and-materials, or labor-hour type; or

(2) Is fixed-price and exceeds (dollar figure determined by contract)" Use of similar language in SABER II maintains the standard already established by the Naval Research community for contractor purchasing control while preserving openness in competition.

A. Please see the revised language in section L.

12. Task Order Reference: Project and Program Management Support, Section 1.9, page 1 RFP Statement: The following positions are considered Key Personnel and require a resume to be provided with the offeror technical approach: Epidemiologist and Program Manager.

Question: A full-time Epidemiologist is required on ITO 1. A quarter-time Epidemiologist (0.25 FTE) is required on ITO2. Please confirm that the offeror may use the same individual to meet both requirements.

A: No, because a single FTE cannot provide above a single FTE level of effort.

13. Reference: Project and Program Management Support, Section 1.9, and Process Infrastructure, Section B, Project Manager (.050 FTE or 960 Hours) RFP Statement: Project and Program Management Support, Section 1.9: The following positions are considered Key Personnel and require a resume to be provided with the offeror technical approach: Epidemiologist and Program Manager.

Section B, Project Manager (0.50 FTE or 960 Hours). Provide in-country research support services outlined below: Project Manager and Epidemiologist.

Question: The task order states in Section 1.9 that one of the two key personnel is the Program Manager. Section B describes two positions, a Project Manager and an Epidemiologist. Please confirm that the two key positions for the CPFF Task Order are the Project Manager and the Epidemiologist as listed in Section B.

A: Please see the revised task order. The task order has been revised to state Project Manager in both locations.

14. An FFRDC would like to participate in Naval Medical Research Unit Two (NAMRU-2) Southeast Asia Biosurveillance and Epidemiology Research (SABER) II IDIQ under Solicitation Number: N6264518R0046.

We need to know the eligibility requirements, if FFRDCs can eligible and if DOE approval is required for participation.

A: All offerors must submit proposals that, if the Government awards to that offeror, would comply with all federal laws and regulations. FFRDCs that propose under this solicitation that are not DoD-sponsored FFRDCs must include in their proposal a separate document outlining the references and specific steps that would be unique to the Navy awarding the contract to such an FFRDC.

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

INSTRUCTIONS TO OFFERORS

L.1 CONTRACT SPECIALIST

The Contract Specialist (CS) is the point of contact for this acquisition. Any questions or concerns regarding this acquisition shall be submitted electronically via e-mail to thomas.l.hood26.civ@mail.mil. Please place the RFP number (N62645-18-R-0046) in the subject line.

L.1.1 PERIOD FOR ACCEPTANCE OF OFFERS

The period for acceptance of offers is one hundred eighty (180) days after the closing date of the solicitation.

L.2 PRE CONTRACT COSTS

The Contractor will not be reimbursed for any costs incurred prior to the effective date of the contract.

L.3 CONTRACT AWARD

L.3.1 TYPE OF SOLICITATION

This Solicitation is being issued as a full and open competition under which all contractors eligible for Federal contracts are encouraged to participate.

L.3.2 ONE PROPOSAL

The Government will evaluate only one proposal from each prime offeror.

L.3.3 TYPE OF CONTRACT (FAR 52.216-1) (APR 1984)

The Government contemplates award of a single award IDIQ Contract (with Firm Fixed Price (FFP) and Cost Plus Fixed Fee (CPFF) task orders) resulting from this solicitation.

L.3.4 CEILING AMOUNT AWARD ON BASE IDIQ CONTRACT

At award, a ceiling amount will be added to the basic contract. This ceiling amount shall be, $40,000,000.00, and will serve as the cumulative ceiling for all task orders issued under this contract.

The CLIN values that will be included in the award document will be computed as follows:

The FFP CLIN (non ODC/travel) will be computed using the total value from the Governments IGCE for FFP task orders.

The FFP CLIN (ODC/travel) will be computed using the total value for travel and ODCs from the Governments IGCE for FFP task orders.

The CPFF CLIN will be computed using the total value from Governments IGCE with the successful offerors fee rate applied to this value.

The sum of all three CLIN values will be $38,000,000.00.

L.3.5 GUARANTEED MINIMUM / INITIAL TASK ORDER (ITO)

The Government will distribute the initial task orders simultaneously with the contract award. The ITO award value will be based on the successful offeror’s proposed cost for the ITOs. The ITOs will have a guaranteed (combined) minimum value of $25,000.00. The guaranteed minimum is only applicable to the successful offeror. After satisfying the guaranteed minimum, the successful offeror is not guaranteed any further task orders.

L.4 AWARD ON INITIAL OFFER

The Government intends to evaluate proposals and award a contract without discussions with Offerors (except clarifications as described in FAR 15.306(a)). Therefore, the Offeror’s initial proposal should contain the Offeror’s best terms from a price and technical standpoint. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary (FAR 52.215-1(f)(4)).

L.5 PROPOSAL SUBMISSION

a. Offerors are invited to submit a proposal in accordance with Paragraph L.8, Proposal Preparation Instructions, to arrive electronically through the AMRDEC SAFE website no later than the proposal due date for this solicitation. The Government does not authorize submission of telegraphic, facsimile, paper or CDROM offers via hand carry or mail carrier for this solicitation.

b. The proposal due date is 10:00 AM Eastern time on 05 July 2018.

c. All proposals submitted in response to this solicitation will be submitted electronically via the AMRDEC SAFE website. No paper copies or electronic copies submitted outside of the SAFE website (i.e., emailed directly to any NMLC email address) will be accepted.

d. Submitting your proposal:

The AMRDEC SAFE application is used to send large files to individuals which would normally be too large to send via email. There are no user accounts for SAFE - authentication is handled via email and Civilian Access Card (CAC). The application is available for use by offerors.

The AMRDEC SAFE application can be accessed via https://safe.amrdec.army.mil/safe.

Offerors shall proceed as “Non- CAC Users” under all circumstances.

After selecting the “Non- CAC Users” option above, the page will be redirected to the package upload form. Fill in all the required input fields (field names are in italics):

Personal Information:

Your Name - Your name, Your Company Name.

Your Email address - Your email address.

Confirm Your Email Address - Re-enter your email address.

File Information:

Description of File(s) - Enter a description for the package;

File(s) - Click the "Browse" button to select your file(s). You may add up to 25 files per package, so long as the total file size does not exceed 2GB. The total file size is the combined file size of all submitted files.

Deletion Date – Leave this date at the default setting of two weeks (14 days) from the submission date.

Recipient Information:

Manually Enter Email Address: Input thomas.l.hood26.civ@mail.mil and hit the add button. (To remove a recipient, highlight their name and click the "Remove" button.)

Email Settings:

Check all four of the boxes:

To the right of “Email Settings” is a nondescript box with two options (None or FOUO). Select the FOUO option and select “sensitive” from the dropdown menu below.

Review all fields for accuracy and hit the ‘submit” button. Clicking the "Submit" button will upload the files and submit the package. Guest users will need to check their email to verify their email address before the recipients will be notified. After the package has been uploaded, the Government will receive a link to the package download page as well as a password. These passwords are unique for each recipient (not the package), and will be disabled once SAFE detects that the user successfully downloaded each file within the package.

Once the offeror has submitted their proposal, they shall send a confirmation email to thomas.l.hood26.civ@mail.mil and provide their company name and contact information as well stating that they have submitted a complete proposal to SAFE in response to solicitation N62645-18-R-0046.

Submission of proposals is a onetime affair (unless in unusual circumstances multiple SAFE submissions are required because an offeror exceeded the 25 file limit per SAFE submission). Additional documents will not be accepted after receipt of the confirmation email from the offeror to thomas.l.hood26.civ@mail.mil, which confirms successful submission of the proposal.

e. Any data previously submitted in response to another solicitation, whether submitted to the Naval Medical Logistics Command or another agency, should be assumed to be unavailable during this proposal evaluation and source selection process. Proposal data shall not be incorporated into the proposal by referring to another proposal or other source.

f. The Government reserves the right to request additional information after receipt of Offeror’s response to the RFP. The proposal shall be valid for not less than 180 calendar days from the proposal due date. The Offeror shall make a clear statement that the proposal is valid until such date in Volume I.

g. Offerors are cautioned that in order for their proposal to be eligible for award, the proposal shall be in compliance with all of the terms and conditions set forth in the RFP.

h. A company with multiple Divisions (and each division registered separately in SAM) is permitted to submit a separate proposal by Division for award consideration. However, Offerors are cautioned that if one company submits separate proposals from multiple Divisions, each Division’s proposal should address the full RFP requirements uniquely based on their particular Division’s capabilities. For example, management processes, small business participation plans, and/or past performance submissions of a different Division may not be used in support of the Division submitting the proposal. The proposal must be specific to the Division submitting the proposal.

L.6 SEQUENCE OF EVENTS

The Government will employ source selection techniques to evaluate proposals, conduct negotiations and determine the successful Offeror in this acquisition. "Offer," for the purposes of this solicitation, shall be defined as a response to the solicitation that, if accepted, would bind the Offeror to perform the resultant contract. If the Government deems discussions necessary, a competitive range determination will be made.

The following describes the sequence of events Offerors can expect during proposal evaluation and negotiation:

a. The Offeror's proposal shall be submitted in accordance with Paragraph L.8, Proposal Preparation Instructions.

b. Upon receipt, the proposals will be reviewed for completeness and compliance with RFP requirements. If a proposal is incomplete or received late (in part or in full) the Contracting Officer does not have to evaluate the proposal. The proposals will receive a detailed evaluation employing the process and criteria identified in Section M of this RFP.

c. In accordance with FAR 15.306, the Government may conduct exchanges with Offerors after receipt of proposals leading to the establishment of the competitive range and any subsequent competitive range determination that may be made.

d. The Government may conduct exchanges with Offerors prior to establishment of the competitive range that may be made in order to enhance the Government’s understanding of proposals; allow reasonable interpretation of the proposal; or facilitate the Government's evaluation process. Such communications shall not be used to cure proposal deficiencies or material omissions, materially alter the technical or price elements of the proposal, and/or otherwise revise the proposal. Such communications may be considered in rating proposals for the purpose of establishing the competitive range. Furthermore, such communications do not and will not permit Offeror's to modify, revise, or otherwise change any element of their proposal.

e. The Government reserves the right to make award without entering into discussions. Offerors shall be prepared to enter into discussions and/or negotiations and, if authorized by the Contracting Officer, may be allowed to revise or modify their proposals. For those Offerors in the competitive range, the Government will submit Discussion Items, which will require a response per instructions that will be provided at that time.

f. The Government will incorporate into the resultant contract any and/or all commitments made in the Offeror’s proposal.

L.7 NOTICE OF HUMAN USE RESEARCH

There is a high probability that Human Use Research will be conducted by the successful offeror under their proposed PWS that would be incorporated into a task order award.

a. The performance of research involving human subjects shall be conducted in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.235-7004 “Protection of Human Subjects,” 32 CFR 219 “The Common Rule,” 10 USC 980 “Limitation on Use of Humans as Experimental Subjects,” Department of Defense (DoD) Instruction 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research,” and Secretary of the Navy Instruction 3900.39 (series) “Human Research Protection Program,” as well as other applicable federal and state law and regulations, and Department of the Navy guidance.

Bureau of Medicine and Surgery (BUMED) Instruction 6500.3 (Series) “Research Integrity, Responsible Conduct of Research Education, and Research Misconduct” applies to research sponsored or funded by Navy Medicine.

Federal regulations governing current Good Clinical Practice (cGCP) are found in 21CFR 11, 50, 54, 56, 312, and 314 and important guidelines are in the FDA Information Sheets. Additional regulations for human subjects protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice are also standards governing the conduct of research trials.

The Contractor must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as they regard vulnerable populations, recruitment of military research subjects, and informed consent and surrogate consent and chemical and biological agent research. Food and Drug Administration regulation and policies may also apply. The Contractor shall rely on the local command’s designated Institutional Review Board (IRB) as the IRB of record for the research to be supported under the contract. The Contractor shall also comply with the standard research training requirements of NAMRU-2.

The Contractor shall hold an active (i.e., not expired) Federalwide Assurance (FWA) appropriate for research to be supported under the contract. The FWA shall remain active for the duration of the contract. The FWA is issued by the Department of Health and Human Services.

b. The following requirements must be completed prior to the Contractor’s performance of research involving human subjects or expenditure of funding on such effort, whichever occurs first:

(1) The Contractor shall enter into a DoD Institutional Agreement for Institutional Review Board (IRB) Review (IAIR) with the local command. The IAIR will apply to all human subject research supported under the contract. The IAIR shall be executed by the parties no later than 30 days after the effective date of the contract, or before commencement of performance of research involving human subjects or expenditure of funding, whichever occurs first.

(2) Contractor personnel providing support under the contract shall complete initial and ongoing research ethics and human subject protections training appropriate to each individual’s level of involvement, duties, and responsibilities.

(3) The Contractor shall obtain written notice from the local command that: (i) Contractor personnel identified as supporting human subject research under the contract have been added to the applicable research protocol; (ii) performance of the protocol has been approved by the Command’s Institutional Official and that performance may begin; (iii) a determination that the protocol meets exemption criteria including the exemption category or classification of research risk (e.g., minimal risk); (iv) confirmation of continuing acceptability of the Contractor’s assurances; and (v) Human Research Protection Official (HRPO) review of the protocol in accordance with DFARS clause 252.235-7004 has been completed. Contractor personnel shall not commence performance of research involving human subjects until stated notice is received.

(4) The Contractor shall notify the local command of personnel changes under the contract. New personnel that will perform research involving human subjects will be required to complete applicable training and will be added to the applicable research protocol(s) as discussed above.

c. The Contractor shall support administrative efforts by the local command to ensure compliance with the terms of this requirement. This support includes identifying Contractor personnel that may support human subject research under the contract and maintaining records of training and other documentation to demonstrate compliance with human research protection requirements under the contract. The Contractor shall also assist with the continuing review of the human subject research that is supported under the contract.

d. Failure of the Contractor to comply with the terms of this requirement will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 (Alt 1) to immediately suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer.

e. The terms of this requirement are applicable to and shall be included in all Subcontracts that may include the support of human subject research.

L.8 PROPOSAL PREPARATION INSTRUCTIONS

L.8.1 SOLICITATION QUESTIONS

Questions concerning the proposal are due no later than 2:00 PM Eastern Time on 18 June 2018. RFP number N62645-18-R-0046 shall be included in the email subject line. Questions shall be submitted to the Contract Specialist at thomas.l.hood26.civ@mail.mil by the required time, and no questions shall be addressed after this cutoff date. Offerors shall submit one set of questions only; multiple emails shall not be accepted. An amendment to the solicitation will be issued providing responses to the questions.

L.8.2 ELECTRONIC PROPOSAL SUBMISSION

Proposals shall be submitted in two electronic Volumes:

Volume I: Non-Price/Cost Volume II: Price/Cost

Volume I and Volume II will be reviewed and evaluated. Each volume shall be a stand-alone document and shall clearly and completely provide the information being requested. The two volumes will be evaluated as part of the source selection evaluation process (see Section M).

L.8.2.1 ELECTRONIC PROPOSAL

The overall proposal shall consist of the following separate, individually titled volumes.

MS Word is an acceptable file format for Volume I of the proposal. MS Word and MS Excel are acceptable file formats for Volume II of the proposal. Adobe Acrobat is an acceptable format for those items requiring fill-in.

Volumes and number of copies each are identified below. The Government cannot consider pages submitted in excess of the stated page limitations. Page limitations include all text, graphs, pictures, appendices, references and exhibits unless otherwise noted. Cross reference matrices, tabs, index sheets, tables of contents, dividers and other such aids that are solely used to assist the evaluator in locating information and are advisory in nature, imparting no other information other than the identification of content, will not be counted against any page limits stated within this RFP. Type shall be no smaller than a font size of eleven (11) and shall have 1.0 line spacing. Type for graphics, tables and reproductions shall be no smaller than a font size of 10 with a minimum of 1” margins. Page size shall not exceed 8 ½” x 11”. The page limits described below do not include Title Page, Table of Contents, and Glossary. Double column pages are not allowed. Separate electronic files shall be used for Volume I and Volume II.

Page Limit

Section I- Executive Summary

Sec I- 1 Page limit

Section II- Solicitation Documents

Sec II- Signed SF33 front page and all acknowledged amendments

Section III- Reps and Certs

Section IV- Verification of Security Clearance Level

Sec III- No page limit

Sec V- No page limit

20 Page Limit

20 Page Limit (Key Personnel resumes are an attachment to Subpart III and are not included in the page count.)

8 Page Limit

20 Page Limit

No Page Limit

No Page Limit

L.9 EVALUATION APPROACH

L.9.1 VOLUME I, SUBPART I: ADMINISTRATIVE

The offeror shall submit all of the following sections to Volume I: Subpart I or the proposal will be considered incomplete:

L.9.1.1 SECTION I: EXECUTIVE SUMMARY

The offeror shall provide a high level summation of its proposal.

The offeror shall make a clear statement in the Executive Summary, that the proposal is valid for not less than 180 calendar days from the proposal due date.

L.9.1.2 SECTION II: SOLICITATION DOCUMENTS

Offeror(s) shall complete the OFFER part of the Standard Form (SF) 33 format (cover page). An official having the authority to bind the firm contractually must sign the cover page. If this individual is not an officer of the company, the proposal shall be accompanied by some form of written evidence of the individual's authority to bind the company, under contract, to a particular course of action. This might include such evidence as a written delegation of said authority, signed by an officer of the company.

The Offeror(s) shall acknowledge all amendments either in block 14 of the SF33 or by signing the cover sheet of each amendment and returning them as part of this volume.

L.9.1.3 SECTION III: SECTION K (REPS AND CERTS)

The offeror shall complete the annual representations and certifications electronically through the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/. The offeror shall verify their annual representations and certifications are current, accurate, complete and applicable to this solicitation as of the date of this offer and are incorporated in this offer by reference. (Refer to SAM Annual Representations and Certifications Certification Sheet in Section K.)

The applicable NAICS code for this solicitation is 541715, with a small business size standard of 1000 employees.

In addition to submission to SAM the offeror shall complete the SAM Annual Representations and Certifications Certification Sheet and the fill-ins required by the full text clauses in Section K, and submit an electronic copy of each in Section III of the Volume I Subpart I. (Refer to SAM Annual Representations and Certifications Certification Sheet and the full-text clauses in Section K.)

The offeror shall complete and submit FAR provisions 52.204-8, 52.209-7, 52.209-11 (via 52.204-7), 52.222-22 (via 52.204-7), 52.222-25 (via 52.204-7) and the “SAM Certification” in Section K.

L.9.1.4 SECTION IV: VERIFICATION OF SECURITY CLEARANCE LEVEL

The offeror shall submit documentation verifying that they can provide contract employees that possess a secret clearance. A completed DD Form 254 will be provided at time of contract award.

L.9.2 VOLUME I, SUBPART II: MANAGEMENT APPROACH/RISK

The Offeror shall provide its approach that clearly reflects how it plans to accomplish the work identified in the PWS.

The Management Approach should address the following:

· Management structure with regard to roles and responsibilities, lines of authority, span of control, flow of information, and communication strategies amongst the contractor team, any subcontractors, requiring activities, and external organizations,

· Ability to monitor contract activities,

· Subcontract Management,

· Strategies / processes to identify and manage / mitigate risk,

· Approach to managing cost, schedule, and performance for multiple task orders,

· Recruiting and retention.

Required Attachment to Volume I: Subpart II: Management Approach/ Risk:

Attachments do not count towards the overall page limit for Subpart II.

Attachment A: Organizational Conflict of Interest (OCI) Mitigation Plan: The Offeror must present its Organizational Conflict of Interest (OCI) Mitigation Plan in response to an actual, potential, or perceived conflict of interest associated with performance of this requirement. The OCI Mitigation Plan is limited to 10 pages.

Attachment B: Human Use Documentation: The offeror shall include in their proposal, proof of an active (i.e., not expired) FWA. If a subcontractor may perform human subject research, they shall have their own active (i.e., not expired) FWA. The subcontractors FWA must be possessed by the subcontractor and they are not allowed to work under the prime contractor’s FWA. You must state clearly if a subcontractor employee will not be performing human subject research and that is why proof of an active FWA is absent.

Attachment C: Indemnification and Medical Liability Insurance (IAW with Section H- “Patient Care and Medical Liability Insurance” and FAR 52.237-7): The supporting documentation shall prove that the offeror possesses current insurance and shall show the expiration date of the policies as well as including individual and aggregate limits for each of the required area of coverage.

Attachment D: Liability Insurance (IAW Section H –“Standard Liability Insurance” and FAR 52.228-7): The supporting documentation shall prove that the offeror possesses current insurance and shall show the expiration date of the policies as well as the including individual and aggregate limits for each of the required areas of coverage.

L.9.3 VOLUME I, SUBPART III: TECHNICAL APPROACH/RISK FOR THE INITAL TASK ORDERS

Technical proposals will demonstrate that the offeror's proposed labor mix and level of effort are adequate to complete the tasks listed in the PWS. Additionally, the offeror shall demonstrate a thorough understanding of the technical requirements of the task order. The offeror shall demonstrate the ability to provide any products or reports as part of the task.

The page limit for Volume I, Subpart III is 20 pages (excluding resumes and information regarding GFP) and this pages limit encompasses both of the initial task orders.

Resumes: The Offeror must present resumes for all key personnel positions. Key Personnel are delineated in the initial task order PWS. Resumes should include: the individual’s name, descriptions of past/current responsibilities, relevant work experience, and any certification in the main program areas. Proposed personnel shall demonstrate sufficiently to the proposal evaluator(s) that the person proposed has the knowledge and experience relevant to accomplish the required tasks. DO NOT include Social Security Number (SSN), date of birth, home address, or personal telephone number of the person on the resume. Resumes are limited to 2 pages per key personnel and do not count towards the overall page limit of 20 pages.

Estimated level of effort in the PWS: The Government estimates that this task order will require an approximate level of effort as outlined in the PWS. Please note that the Government estimate is only put in place for Offerors to ascertain the approximate or estimated level of effort for this task and to allow Offerors to better understand the general scope of this effort. Offerors are encouraged and expected to submit a level of effort consistent with your technical approach.

Government Furnished Equipment: Offerors need to specify any Government Furnished Equipment / Information / Property, necessary to perform this task. This shall include any Contractor purchased or acquired/ Government-owned items. This attachment should include the following information: item description, quantity, and current location. Detailed Bills of Materials shall be submitted along with the proposal; noting part numbers, prices, and need dates for all required GFE. The contractor may assume that equipment typically available on a Government site will be available and does not have to be listed. Any GFE past what is typically available for contractors in an office environment, which the contractor needs to complete the work listed in the PWS, needs to be listed.

L.9.4 VOLUME I, SUBPART IV: PAST PERFORMANCE

All information required pertains to all proposed first-tier subcontractors with whom the Offeror is teaming, as well as the Offeror. The Offeror shall submit with its proposal the first tier subcontractor’s letter(s) of consent allowing the Government to disclose the subcontractors' past performance to the Offeror during negotiations.

L.9.4.1 Past Performance Information Sheets.

Past Performance has a page limit of eight pages (to include past performance information sheets).

The first four pages will be the submission of a maximum of four Past Performance Information Sheets (Section J, Attachment VI – Past Performance Information Sheet). If more than four Past Performance Information Sheets are provided, only the first four will be considered. If a Past Performance Information Sheet contains more than one page (inclusive of narrative), only the first page will be considered.

The second four pages afford the offeror four pages to cover the items highlighted under the paragraph below titled “Additional Four Pages”.

The Offeror shall submit up to four (4) Past Performance Information Sheets (Section J, Attachment VI – Past Performance Information Sheet) for contracts over the past three (3) years which are similar to the size and scope of the PWS in this solicitation. Two of the four contracts must have been held by the prime offeror.

Contracts cited must be current, or have ended not more than three years prior to the closing date of the solicitation. If the contract performance ended more than three years prior to the closing date of the solicitation it will be determined not relevant.

Each of the Past Performance Information Sheets shall be completed in its entirety. The Past Performance Information listed on each sheet shall be for services related to the services required under this solicitation. For each of the Past Performance Information Sheets submitted, the offeror shall describe the objectives achieved and detail how the effort is similar to the requirements of this solicitation (referencing the PWS in Section C). The offeror may include contracts that demonstrate the prior experience of key personnel or subcontractors/teaming partners who will be performing in support of the contract resulting from this solicitation; such contracts shall be clearly identified to show the relationship of the past performance entry to the offeror.

Each Past Performance Information Sheet may include one or more task orders if they are under a single IDIQ contracts. Otherwise, contracts should be limited to one per sheet. Sheets should list applicable task orders and not just the IDIQ base contract number.

Each Past Performance Information Sheet shall identify no more than one Point of Contact (POC) and if more than one POC is provided for any Past Performance Information Sheet, only the first POC will be considered. The Government may contact the POCs listed on the Past Performance Information Sheets. POCs must be either Government personnel (civil service or military) or employees of private sector clients with whom you have provided services. Information provided by or for POCs who work directly for your company, or indirectly (i.e., in a prime/ subcontractor or mentor/protégé relationship, etc.), will be determined not relevant. The Government may contact the POCs listed on the Past Performance Information Sheets.

Additional Four Pages: Any and all contracts (to include any contract or contracts listed on a Past Performance Information Sheet) terminated for cause in whole or in part during the past three (3) years (to include those currently in the process of such termination) are considered relevant. Please provide a brief background, issues with contract performance, any cure notices or show cause letters received and description of any corrective action taken. The second four pages afford the offeror four pages to cover these items.

In addition to the Past Performance Information Sheets, the Government reserves the right to use alternative resources to gather past performance information.

L.9.4.2. Subcontracting Concerns

If Past Performance is submitted for a contract under which the offeror (or proposed subcontractor, partner, mentor, protégé, parent company, sister company, etc.) provided services as a subcontractor, partner, mentor, protégé, parent company, sister company, etc., the Past Performance Information Sheet shall clearly describe the corporate relationships among those who provided the services, citing key responsibilities for each, to include identifying the specific services provided (in terms of numbers and types of personnel, locations, etc) and nature of services provided (e.g., consulting services, subject matter expertise). If the submission does not clearly detail the specific responsibilities and relationship under a contract, it will be determined not relevant.

If a subcontracting, teaming, partnering, mentoring or other relationship is proposed, the offeror shall submit written consent from the subcontractor, partner, etc. to disclose their Past Performance information to the contractor. If such consent is not provided as part of the submission, the Past Performance of the subcontractor, partner, etc., it will be determined not relevant.

If neither the offeror nor its subcontractor(s), teaming partner(s), etc. possess relevant past performance, the offeror shall submit a statement affirming that they possess no relevant Past Performance.

L.9.4.5. VOLUME I: SUBPART V: SMALL BUSINESS PARTICIPATION PLAN

Small Business Participation Plan has a page limit of 20 pages excluding attachments.

All offerors are required to submit a small business participation plan. If applicable (for other than small business concern offerors under the assigned NAICS code herein), the offeror shall submit a subcontracting plan in accordance with FAR Clause 52.219-9 ALT II DEV and DFARS Clause 252.219-7003 DEV. The subcontracting plan requirement is not applicable to small business concerns qualified as such under the NAICS code assigned to this solicitation. Master subcontracting plans can be included as an attachment to the subcontracting plan and will not count towards the page count.

L.9.5. VOLUME II: PRICE/COST

VOLUME II, SUBPART I: PRICE PROPOSAL FOR THE INITIAL FFP TASK ORDER

Offerors are cautioned that their proposed price should be consistent with the proposed technical approach and reflective of the effort required by the solicitation. Unrealistically low proposed prices may be grounds for eliminating a proposal from the competition on the basis that the offeror does not understand the requirement.

The initial FFP task order PWS contains the Government’s estimated amounts for travel. The offeror shall use this amount in the construction of their price proposal. The amounts are unburdened and may be burdened by the offeror in accordance with their accounting system.

Offerors should provide a spreadsheet (Microsoft Excel) that outlines the level of effort (number of hours per FTE), unburdened (direct) labor rate and fully burdened labor rate for each FTE being proposed.