Solicitation_Amendment_0002.pdf

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

1. Issue Date: Tuesday, 07 Aug 2018 Close Date: Wednesday, 05 Sep 2018 1:00 PM EST

2. Solicitation Number: W81XWH-18-R-0061, See Amendment 0002 below

3. Requiring Activity: Armed Forces Research Institute of Medical Services (AFRIMS), Bangkok, Thailand

4. Contracting Office: US Army Medical Research Acquisition Activity (USAMRAA)

1504 Porter Chandler Street Fort Detrick, MD 21702

5. Point of Contact: Julie L. Burns julia.l.burns3.civ@mail.mil

6. Subject/Description:

This is a non-personal services contract to provide Clinical, Epidemiological, Administrative and Logistical Support Services for Armed Forces Research Institute of Medical Services (AFRIMS).

This combined synopsis/solicitation is issued as a request for proposal (RFP).

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-99, effective: 16 Jul 2018.

This an Unrestricted/Full and Open procurement. The relevant NAICS code is 541715 with a small business size standard of 1,000. The resulting contract is expected to be firm-fixed-price.

Questions shall be addressed to: Julie Burns via email at julia.l.burns3.civ@mail.mil no later than 1:00 p.m. EST on Monday, 13 August 2018. Answers will be posted via amendment. Questions will not be accepted by telephone.

Proposals shall be submitted electronically to julia.l.burns3.civ@mail.mil by Wednesday, 05 Sep 2018 1:00pm EST. Please include your DUNS Number and CAGE Code with your offer.

Please refer to FAR 52.212-1 “Instructions to Offerors” (page: 12) & FAR 52.212-2 “Evaluation-Commercial Items” (page 20) for details on proposal evaluation and submission.

Solicitation No. W81XWH18R0061 Solicitation Amendment 0002

The purpose of this solicitation amendment is to:

1) Change the proposal response date:

FROM: 1:00pm EST Thursday, 23 Aug 18 TO: 1:00pm EST Wednesday, 05 Sep 18

2) Update FAR 52.212-1 “Instructions to Offerors – Commercial Items” to reflect the change in proposal submission due date.

The following have been modified: (see items in yellow)

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JAN 2017)

See below Addendum to FAR 52.212-1, “Instructions to Offerors”

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation.

Each offer submitted will be evaluated separately. – NOT APPLICABLE

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers exceeding $3,500, and offers of $3,500 or less if the solicitation requires the Contractor to be registered in the System for Award Management (SAM) database.) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation ``Unique Entity Identifier'' followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) System for Award Management. Unless exempted by an addendum to this solicitation, by submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from this Solicitation. If the Offeror does not become registered in the SAM database in the time prescribed by the Contracting Officer, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror. Offerors may obtain information on registration and annual confirmation requirements via the SAM database accessed through https://www.acquisition.gov.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

ADDENDUMN TO FAR 52.212-1 “Instructions to Offerors – Commercial Items”

1. SPECIFIC REQUIREMETS. This requirement will result in a Firm-Fixed Priced (FFP) commercial service contract. Performance requirements and objectives for this contract are provided in the Performance Work Statement of this solicitation.

2. PERIOD OF PERFORMANCE:

Base period 24 Sep 2018 – 23 Sep 2019 Option period 1 24 Sep 2019 – 23 Sep 2020 Option period 2 24 Sep 2020 – 23 Sep 2021 Option Period 3 24 Sep 2021 – 23 Sep 2022 Option Period 4 24 Sep 2022 – 23 Sep 2023

3. PROPOSAL SUBMISSION INSTRUCTIONS:

a. POINT OF CONTACT (POC): Questions and proposals shall be sent via E-mail to the POC for this requirement, TO: Julia L. Burns via email at julia.l.burns3.civ@mail.mil. The Offeror is responsible for ensuring receipt by the POC.

b. PROPOSAL QUESTIONS: Questions may be submitted to the POC via email No Later than Monday, 13 August 2018 1:00 PM Eastern Time. Follow-up/additional questions will not be accepted after this date.

Answers to Contractor submitted questions will be provided via solicitation amendment. Questions shall be submitted in MS Word (only) in the following format; Solicitation Section, page number, and question (e.g. PWS Section 4.1, page 38, question). No tables please.

c. PROPOSAL DUE DATE: No Later Than: Wednesday, 05 Sep 2018 1:00 PM Eastern Time.

d. ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission should include two (2) separate parts: (1) Non-Cost/Price proposal (i.e. Technical Approach, Experience and Past Performance) and (2) Cost/Price proposal. A signed SF 1449 and your non-cost/price proposal shall be submitted in MS Word or searchable PDF format. The cost/price proposal shall include proposed pricing filled out for CLINs 0001, 1001, 2001, 3001, and 4001 as well as supplemental excel pricing sheet (Attachment #3).

4. PROPOSAL CONTENT & FORMAT INSTRUCTIONS.

a. ADMINISTRATIVE FORMAT INSTRUCTIONS:

(1) PAGE LIMITS: Proposals are limited to 8 single-sided pages. Pages should be numbered consecutively throughout the document and not by sections. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation.

The following sections are NOT subject to page limits:

(a) Cover/title Page

(b) Contractor POCs

(c) Excel Pricing Sheet (Attachment 3)

(d) Signed Proposal with pricing

(e) Fill out and submit the following:

- FAR 52.209-11

- FAR 52.212-3 and 52.212-3 Alt 1

- FAR 52.219-28

(f) Resume(s) and letter(s) of Intent/commitment for proposed Key Personnel (Deliverable 6)

The following sections are limited to 8 single-side pages:

(a) Technical Approach

(b) Experience

(c) Past Performance

(2) FORMATTING: Proposal content shall be no smaller than Arial font 12 pitch. Exhibits, graphics, charts, captions, etc., shall be no smaller than Arial font 10 pitch.

b. NON-COST/PRICE PROPOSAL CONTENT & INSTRUCTIONS The Offeror’s non-cost/price proposal shall clearly reflect the Offeror’s approach to execute and comply with the performance requirements identified in the PWS and is to be clear and concise. The level of effort proposed must be consistent with the proposed solution outlined in your non-cost/price proposal (i.e. Technical Approach). If you intend to use any labor categories that you feel are consistent in duties with the level of effort, but are titled differently, in accordance with your cost accounting procedures, you must cross map those labor categories to the Government’s PWS to ensure your proposal receives a proper evaluation. Any use of subject matter experts (SME) or other labor categories shall be explained in full as to why an existing labor category/rate is impractical to use or the proposal shall be deemed noncompliant.

Contract POC(s) The Offeror shall include on the cover page/title page of the proposal the proposed POCs. The Offeror shall provide a POC authorized to hold discussions/negotiations with the Government who has the full authority to bind the Offeror to a contract. The Offeror shall also provide a POC for the Contract Manager. Information required includes: First name, last name, title, e-mail address, phone number, mailing address, and level of authority.

(1) TECHNICAL APPROACH: The Offeror shall submit a written technical approach which effectively demonstrates:

Offeror’s clear understanding of the all the tasks and how the approach is likely to yield the required results within the required time frame

Offeror’s methodology that will be used in accomplishing any resultant award

Offeror’s overall ability to perform support services in the Philippines

Offeror’s approach to which the technical approach will yield success and to which manages or reduces (cost, technical or scheduled risk) to the Government

Offeror’s Management Plan, that describes the following:

* Management Approach - Management Approach that describes policies and procedures in accordance with industry practices for project management, administration, execution, and tracking as well as policies and procedures specific to conduct this type of support services in the Philippines as well as timely submission of deliverables.

* Staffing Plan – Staffing Plan that describes the staffing strategy that will be used to manage task completion, including the role of the Program/Contract Manager. The Offerors described staffing strategy for supporting this effort and a cross-reference of proposed position(s) to task(s).

(2) EXPERIENCE: The Offeror shall submit written Experience which effectively demonstrates the:

Demonstrated relevant corporate experience (for this purpose, experience refers to what an

Offeror has done, not how well it was accomplished) identical to, similar to or related to performing services contained in the PWS. Offeror’s relevant experience shall support and substantiate that the organization (to include subcontractors and business partners, if applicable), have current capabilities for assuring successful task completion.

Demonstrated experience shall reflect (a) Appropriate mix and balance of education and training of team members AND proposed Key Personnel, (b) provide evidence that the organization has current capabilities for assuring performance with , and (c) Quality and effectiveness insofar as the allocation of personnel and resources. For any individual proposed to fill the Key Personnel position, you are to submit resume(s) and a letter(s) of intent/commitment (Deliverable 6). Resumes shall include a list of relevant training, education, and license/certifications.

Demonstrated experience for proposed Key Personnel is recommended have experience in human subject’s protection and extensive clinical trial experience, and shall be a currently licensed Physician with the ability to practice medicine in Philippines.

Demonstrated experience for proposed co-Investigator(s) shall be currently licensed Physician with ability to practice medicine in the Philippines.

(3) PAST PERFORMANCE REFERENCES: The Offeror shall submit no more than 2 references of relevant contracts within the past three years for its own performance. The contracts may be past or current as long as the performance did not end more than three years ago and the contracts may have been with Federal, State and/or City agencies and commercial customers.

(a) PAST PERFORMANCE REFERENCE CONTENT: It is the Offeror’s responsibility to provide valid, current and verifiable references. References must include:

Name of the Organization that will be providing the reference, Name of the POC, POC Telephone Number, POC Email address, Contract Number, Period of Performance, and Scope of Work

(b) INFORMATION FROM OTHER SOURCES: The Government may consider information obtained through other sources.

c. PRICE PROPOSAL CONTENT

Offerors’ price proposals shall include proposal price assumptions and include the following documents:

SF 1449

Labor - The Offer shall submit a signed SF 1449 and include proposed pricing for the following CLINs:

CLIN 0001

CLIN 1001

CLIN 2001

CLIN 3001

CLIN 4001

ODCs - The Offer shall propose Government estimated pricing for all Other Direct Costs (ODCs) as follows:

CLIN 0002 - $26,760.00

CLIN 1001 - $27,060.00

CLIN 2001 - $27,360.00

CLIN 3001 - $27,360.00

CLIN 4001 - $27,960.00

Excel Pricing Sheet (Attachment 3) The Offeror shall fill out and submit with proposal package. The Offeror shall indicate which labor categories will be performed by a subcontractor(s) along with the subcontractor company name, DUNS, Cage Code, and address.

Contractor shall ensure mathematical computations are correct.

The “estimated” labor category is as follows:

Labor Category Est Hours per Year Quantity Principal Investigator Physician (Key

672 1

Personnel) Co-Investigator 576 3 Registered Nurse 1920 2 Registered Medical Technologist

Administrative Support Staff

Health Care Support Staff

Estimated level of effort The contractor shall accomplish the required tasks by employing and utilizing qualified personnel with appropriate combinations of education, training, experience, and/or overlapping capabilities.

The Government estimates this order requires an approximate level of effort, as outlined above, to accomplish the tasks identified 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; however, this is not to be construed as either mandatory or necessarily the best technical approach. It is only in place as a reference to allow Offerors to better understand the general scope of this effort from the Government’s perspective. The Government is seeking the best solution for this performance based acquisition which uses the level of effort and labor mix your company has determined is appropriate to accomplish the tasks/objectives contained in this requirement. Offerors are not bound to propose these labor categories or quantities, rather offerors are expected to provide their best solution citing the labor mix and quantity required to accomplish the tasks. If Offerors have determined either the following labor categories or overall level of effort provided are not their best technical solution, Offerors are strongly encouraged and expected to submit a level of effort consistent with all of the cost/price and non-cost/price aspects of its approach.

Contractor Manpower Reporting shall be Not Separately Priced (NSP)

CLIN 0003 - NSP

CLIN 1003 - NSP

CLIN 2003 - NSP

CLIN 3003 - NSP

CLIN 4004 - NSP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the AFIRMS via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

https://cmra.army.mil. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2018.

Contractors may direct questions to the applicable help desk at: usarmy.pentagon.hqda-asa-mra.mbx.samr-fm-cmra@mail.mil.

d. ADDITIONAL INFORMATION

Alternate Proposals Alternate proposals will not be evaluated by the Government.

Prime and subcontractor An offeror shall NOT submit a proposal as a Prime contractor and also be proposed as a subcontractor on another prime contractor‘s proposal, responding to this RFP, UNLESS they are proposed as a subcontractor under multiple Offeror’s submitting a proposal to this RFP.

(End of provision)