16-223-SOL-1166125.pdf

RFQ # 16‐223‐SOL‐1166125

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-

STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR

COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION

INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY

SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A SEPARATE

WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THE SOLICITATION IS

BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-88.

Offerors must submit all questions concerning this solicitation in writing, via email to the Contract Specialist, Shirley Afable at shirley.afable@fda.hhs.gov. Questions should be received no later than 12:00PM Eastern Time, Wednesday, August 24th. All responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541512 – Computer Systems Design Services with a small business size standard of $27.5M.

This acquisition is 100% set aside for small business.

Statement of Work: SEND Explorer Plus License and Maintenance or Equal

Background The Food and Drug Administration (FDA), Office of Computational Science (OCS) requires commercial off-the-shelf (COTS) software to create graphs, tables, and listings from CDISC- SEND nonclinical data submissions. The software will be used to support review of CDISC- SEND submissions.

Objective The OCS is seeking user friendly, web-based software that is specifically designed to load and display CDISC-SEND formatted datasets without manipulation.

Contract Line Item Numbers:

CLIN 0001 – SEND Explorer Plus License with 1 year maintenance or Equal CLIN 0002 – SEND Explorer Validation Test Scripts or Equal CLIN 0003 – SEND Explorer Annual Maintenance or Equal, Option Year 1 CLIN 0004 – SEND Explorer Annual Maintenance or Equal, Option Year 2 CLIN 0005 – SEND Explorer Annual Maintenance or Equal, Option Year 3

Requirements If offeror is not proposing the brand name solution specified above, the proposed product shall meet the following salient, functional characteristics in order to be considered for award.

The software license the contractor provides:

shall have a web-based user interface and support deployment on a cloud computing cluster shall support multiple concurrent users shall work in IE 11, Chrome 50 or later, and Firefox 44 or later shall load CDISC-SEND datasets that are compliant with SENDIG v3.0 shall provide tabular views and summary views for numeric SEND domains to include o summary statistics o scatterplots for each time point o a visual indication of data points that are different from control o percentage of control calculations shall provide a severity heatmap for MA, MI, and TF domains shall support hiding columns, sorting, and filtering in tabular view shall export data to Excel shall provide support for comments, supplemental qualifiers, and related records shall provide single animal detail view which can be accessed from tabular views by hyperlink that show results from multiple user-selected study endpoints across domains for the selected animal, and provide scatter plots to compare findings for the selected animal to others in the study shall provide a way to combine multiple studies into visualizations, including a correlations matrix for comparing numeric findings, scatter plots to compare an endpoint between studies across a time course, and a visualization to identify patterns in histopathology findings across studies

Period of Performance The period of performance begins with the date of award for twelve (12) months, and three (3), one (1) year options on maintenance.

Deliverables SEND Explorer Plus License with 1 year maintenance SEND Explorer Validation Test Scripts SEND Explorer Annual Maintenance All deliverables are to be delivered to the Government Technical Point of Contact - TBD

Timeline for Deliverables Software license and software should be delivered 30 calendar days from award Annual maintenance should be deliver 5 calendar days from exercise option award

Section 508 Standard Requirements Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards.

This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 provisions apply to the content identified in this SOW:

§ 1194.21 Software applications and operating systems.

§ 1194.22 Web-based intranet and internet information and applications.

§ 1194.31 Functional performance criteria.

§ 1194.41 Information, documentation, and support.

Invoicing Instructions The Contractor shall submit one invoice upon delivery of the SEND Explorer Plus License and SEND Explorer Validation Test Scripts to the address in the manner specified below:

THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO

THE ADDRESS SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration

10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments 301-827-3742 or 866-807-3742 fdavendorpaymentsteam@fda.gov

INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE

REQUIREMENTS SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND

52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER – CENTRAL

CONTRACTOR REGISTRATION) AND/OR OTHER APPLICABLE FAR CLAUSES

SPECIFIED HEREIN. TO CONSTITUTE A PROPER INVOICE, THE INVOICE MUST BE

SUBMITTED ON COMPANY LETTERHEAD AND INCLUDE EACH OF THE

FOLLOWING:

(I) NAME AND ADDRESS OF THE CONTRACTOR;

(II) INVOICE DATE AND INVOICE NUMBER;

(III) PURCHASE ORDER/AWARD NUMBER;

(IV) DESCRIPTION, QUANTITY, UNIT OF MEASURE, UNIT PRICE, AND EXTENDED

PRICE SUPPLIES DELIVERED OR SERVICES PERFORMED, INCLUDING: (a) PERIOD OF PERFORMANCE FOR WHICH COSTS ARE CLAIMED; (b) ITEMIZED TRAVEL COSTS, INCLUDING ORIGIN AND DESTINATION; AND (c) ANY OTHER SUPPORTING

INFORMATION NECESSARY TO CLARIFY QUESTIONABLE EXPENDITURES;

(V) SHIPPING NUMBER AND DATE OF SHIPMENT, INCLUDING THE BILL OF

LADING NUMBER AND WEIGHT OF SHIPMENT IF SHIPPED ON GOVERNMENT BILL

OF LADING;

(VI) TERMS OF ANY DISCOUNT FOR PROMPT PAYMENT OFFERED;

(VII) NAME AND ADDRESS OF OFFICIAL TO WHOM PAYMENT IS TO BE SENT

(MUST BE THE SAME AS THAT IN THE PURCHASE ORDER/AWARD, OR IN A

PROPER NOTICE OF ASSIGNMENT)

(VIII) NAME, TITLE, AND PHONE NUMBER OF PERSON TO NOTIFY IN EVENT OF

DEFECTIVE INVOICE;

(IX) TAXPAYER IDENTIFICATION NUMBER (TIN);

(X) ELECTRONIC FUNDS TRANSFER (EFT) BANKING INFORMATION, INCLUDING

ROUTING TRANSIT NUMBER OF THE FINANCIAL INSTITUTION RECEIVING

PAYMENT AND THE NUMBER OF THE ACCOUNT INTO WHICH FUNDS ARE TO BE

DEPOSITED;

(XI) NAME AND TELEPHONE NUMBER OF THE FDA CONTRACTING OFFICER

REPRESENTATIVE (COR) OR OTHER PROGRAM CENTER/OFFICE POINT OF

CONTACT, AS REFERENCED ON THE PURCHASE ORDER; AND

(XII) ANY OTHER INFORMATION OR DOCUMENTATION REQUIRED BY THE

PURCHASE ORDER/AWARD.

AN ELECTRONIC INVOICE IS ACCEPTABLE IF SUBMITTED IN ADOBE ACROBAT

(PDF) FORMAT. ALL ITEMS LISTED IN (I) THROUGH (XII) OF THIS CLAUSE MUST BE

INCLUDED IN THE ELECTRONIC INVOICE. ELECTRONIC INVOICES MUST BE ON

COMPANY LETTERHEAD AND MUST CONTAIN NO INK CHANGES AND BE LEGIBLE

FOR PRINTING.

QUESTIONS REGARDING INVOICE PAYMENTS SHOULD BE DIRECTED TO THE FDA

PAYMENT OFFICE AT A TELEPHONE NUMBER PROVIDED ABOVE.

Provisions and Clauses:

The following provisions and clauses apply to this acquisition and are hereby incorporated by reference. All FAR provisions and clauses may be viewed at http://acquisition.gov/comp/far/index.html. All Health and Human Services Acquisition Regulation clauses may be viewed at: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

Provisions:

52.211-6 Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

52.212-1, Instructions to Offerors – Commercial Items (Oct 2015)

52.212-3, Offeror Representations and Certifications – Commercial Items (Apr 2016) The Offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certifications electronically via the System for Award Management (SAM) website accessed through http://www.acquisition.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (r) of this provision and provide a written submission.

Contractor Tax Liability or Felony Conviction The Consolidated and Further Continuing Appropriations Act, 2015 Pub. L 113-235, Division E, Sections 744 and 745 prohibits covered agencies from using funds to enter into contracts with corporations that have unpaid federal tax delinquencies or certain felony convictions unless certain conditions are met.

The Offeror represents that – It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal or State law within the preceding 24 months.

It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.

52.203-98, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (DEVIATION 2015-02)

(a) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), Government agencies are not permitted to use funds appropriated (or otherwise made available) under that or any other Act for contracts with an entity that requires employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The prohibition in paragraph (a) of this provision does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(c) Representation. By submission of its offer, the Offeror represents that it does not require employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

Clauses:

52.212-4, Contract Terms and Conditions – Commercial Items (May 2015) 52.212-5, Contract Terms and Conditions Required to Implement Statues of Executive Orders – Commercial Items (Mar 2016)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) 52.209-6, Protecting the Government’s Interests when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) 52.219-28, Post Award Small Business Program Representation (Jul 2013) 52.222-3, Convict Labor (Jun 2013) 52.222-19, Child Labor – Cooperation with Authorities and Remedies (Feb 2016) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-26, Equal Opportunity (Apr 2015)

52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) 52.222-50, Combating Trafficking in Persons (Mar 2015) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.232-33, Payment by Electronic Funds Transfer – System for Award Management (Jul 2013)

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

52.222-41, Service Contract Labor Standards (May 2014) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xiv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph

(d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

Due Date for Quotations Offerors shall submit their quotations so that FDA receives them not later than 1:00PM Eastern Time on September 2, 2016. Fax quotations shall not be accepted. E-mail quotations shall be accepted at shirley.afable@fda.hhs.gov. Please reference the RFQ number in the subject line of email communications. Offerors quotations shall not be deemed received by the Government until the quotation is entered in the email inbox set forth above.

Quotations shall be sent to the Food and Drug Administration, Office of Acquisitions and Grant Services, Attn: Shirley Afable, 5630 Fishers Lane, Room 2086, Rockville, MD 20857. All offerors should ensure the RFQ number is visible on the outermost packaging.

Addendum to FAR 52.212-1, Quotation Preparation Instructions:

1) Price Quotation: The Offeror shall submit an original copy of their completed pricing quotation. The pricing quotation shall be separate from any other portion of the quotation.

The Offeror shall propose a firm-fixed-price for the CLINs listed in the Objective section.

The Offeror should also include a completed Contractor Tax Liability or Felony Conviction representation. Price quotations shall remain valid for a period of 90 days from the date quotations are due.

2) Technical Quotation: The technical quotation shall be limited to no more than 5 pages, to address the following:

The Offeror shall demonstrate its full understanding of the requirements and task to be performed. Offerors that submit “equal to” quotes must ensure that the proposed solution has the same or “equal to” capabilities as stated under the Requirement section. The Offeror shall also describe any assumptions relied upon in developing the proposed approach.

ACCEPTANCE OF TERMS AND CONDITIONS (ADDENDUM TO FAR 52.212-1 (B) (11)):

THIS IS AN OPEN-MARKET SOLICITATION FOR SERVICES AS DEFINED HEREIN.

THE GOVERNMENT INTENDS TO AWARD A PURCHASE ORDER AS A RESULT OF

THIS SOLICITATION THAT WILL INCLUDE THE CLAUSES SET FORTH HEREIN.

THE QUOTATION SHOULD INCLUDE ONE OF THE FOLLOWING STATEMENTS:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:

Offeror shall list exception(s) and rationale for the exception(s)

Note: This procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price.

However, the terms and conditions stated herein will be included in any resultant Purchase Order, not the terms and conditions of the offerors FSS or GWAC contract, and the statement required above shall be included in the quotation.

Quotation Evaluation The Government is conducting this source selection using low-price-technically-acceptable (LPTA) methodology. The Government will issue the order to the Offeror whose proposed product meets all Government requirements and whose overall price is lowest.