Electronic Quality Management System (eQMS) and Electronic Trial Master File (eTMF)

AMENDMENT PURPOSE: extend the response date to July 24, 2019 5:00 pm EST, and NIAID will accept Questions through Friday, July 12, 2019 5:00 pm EST. Please submit inquiries via email to tamara.mcdermott@nih.gov. .

I. OVERVIEW: This notice is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation document will not be issued. Submit quotes on RFQ-RML-75N93019Q00001.

This solicitation is a request for quotes (RFQ). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-02 effective June 5, 2019. The associated North American Industry Classification System (NAICS) code for this procurement is 541512 Computer System Design Services with a small business size standard of $27.5 Million. This acquisition will be processed under Simplified Acquisition Procedures, FAR Subpart 13.5 - Simplified Procedures for Certain Commercial Items and is not a total small business set aside. It is anticipated that one (1) Time and Materials purchase order will be awarded.

II. STATEMENT OF NEED: The purpose of this requirement is to determine and prioritize functional and technical requirements that meet the regulatory and compliance needs of the National Institute of Allergy and Infectious Diseases (NIAID) Intramural and Extramural Divisions and to understand the technology system and tool landscape for electronic Quality Management systems (eQMS) and electronic Trial Master Files (eTMF). Specifically, NIAID is seeking:

• Commercial off-the-shelf (COTS) eQMS that can scale to support multiple divisions within NIAID.
• COTS eTMF that can scale to support multiple divisions within NIAID.
• Professional services to configure, deploy, train, validate, migrate existing documents, and support NIAID's use and adoption of the eQMS and eTMF systems.
• Ongoing support including maintaining compliance with changing regulatory requirements and mitigation of security vulnerabilities.

Reference Attachment 1 - Statement of Work (SOW) for background and project requirements.

III. PERIOD OF PERFORMANCE: It is anticipated that an award will be made on or about July 31, 2019. The base year period of performance is one year from the date of contract award plus two successive option years. The estimated total period of performance is August 1, 2019 through July 31, 2022.

IV. PLACE OF PERFORMANCE: Any onsite activities must be performed at: 5601 Fishers Lane, Rockville, MD 20851.
V. INSTRUCTIONS:
All interested vendors shall provide a quote for the requirement as outlined in the SOW. The Government may evaluate only those quotes that fully meet the requirements as outlined in the SOW and respond to the instructions and requirements of this solicitation. Vendors are required to submit a Technical Response (Volume 1), Past Performance information (Volume 2), and Price Quote (Volume 3) to Government officials for the purposes of assuring that the prospective Contractor is fully cognizant of the scope of this order and has the capability to complete all requirements. The Technical, Past Performance, and Price volumes shall be separate and complete so that evaluation of one may be accomplished independently of the other. Failure to furnish a full and complete package as instructed may result in the Vendor's response being considered non-responsive and will therefore be eliminated from further consideration and award. Quotes which merely offer to conduct a program in accordance with the requirements of the Government's scope of work will not be eligible for evaluation.

A. Transmittal and Cover Letter (Volume 1, Section 1)
The vendor's transmittal and cover letter for their technical response must contain the name, phone number, and e-mail address of the person to be contacted concerning any matter related to the solicitation. NIAID may, for example, contact that individual to schedule and make arrangements for the vendor's discussion meetings, if necessary. The Vendor will submit a signed cover letter by an authorized company representative to constitute agreement with all terms and conditions of this RFQ.

Include the following information in your response
1) DUNS number and TIN;
2) Company Name mailing address, and website address;
3) Date submitted and quote expiration date;
4) All of the above-cite information for each entity on the proposed team, if a team is proposed;
5) Type of Company (e.g., small business, 8(a), women-owned, veteran-owned, etc.) as validated via the System for Award Management (SAM). All vendors must be registered in SAM located at https://www.sam.gov/SAM/;
6) Company Point of Contact, Phone, and e-mail address.

B. Executive Summary (Volume 1, Section 2)
The vendor should provide an executive summary for the Technical Response (Volume 1). In the executive summary, the vendor should highlight the significant factors of its technical approach. The executive summary for the technical response should be no more than 1-page long. In the event that the vendor is planning to propose a teaming, mentor/protegee, or a subcontracting relationship, narrative statements must also be included for the additional organizations, as well as a clear delineation of tasks that they will be expected to support.

C. Technical Response (Volume 1, Section 3)
No price information is to be included in this volume. However, resource information such as data concerning labor hours and category, materials, subcontracts, etc. should be included in the Technical Response, if applicable, so that the Government can evaluate the Vendor's understanding of the scope of the required work. Volume 1 shall not exceed 15 pages (excluding Cover page, Table of Contents, Videos/Screenshots, Appendices, and Resumes). Vendors shall provide a Technical Response that addresses the following four evaluation criteria:
1) Technical Capabilities,
2) Management Approach,
3) Personnel Qualifications, and
4) Organization Experience

At a minimum, the vendor's Technical Response must include:
1) Written description and walkthrough, via narrative in conjunction with screenshots or video, of how the Vendor's software solution meets all software requirements specified in the SOW without the need for custom development. IN-PERSON DEMONSTRATIONS WILL NOT BE ACCEPTED.
2) Describe your technical capability and experience implementing the proposed software in situations similar to the requirements identified in Section 5 of the SOW,
3) Commercial software license(s) (and/or subscription agreement if applicable) for evaluation,
4) The proposed methods and techniques for completing each task,
5) How each task will be evaluated for full performance and acceptability of work from the vendor's viewpoint; with support,
6) Any anticipated major difficulties and problem areas, along with potential recommended approaches for their resolution, and
7) Major logistical considerations.

The Vendor must define their management and technical approach that satisfies the requirements defined in this document. Please include a (1) staffing plan and (2) resumes for key personnel and (3) a description of your current personnel resources for this, which addresses their capabilities and experience relating to the attached Statement of Work. At a minimum, this section of the response must include:
• Organizational Structure (Org chart and resource headcount required to support the requirement)
• Identification of roles and specify responsibilities for each role
• Definition of the primary skill set required for each role
• Description of resource planning processes and procedures to support the changing needs of the environment
• Description and definition of management methods and processes for all types of support activities
• Description of resource training, skills development and certification approach
• Description of management and status reporting approaches
• Resumes are required for all proposed staff. Resumes should be limited to three pages and must include the proposed labor category for the individual.

D. Past Performance (Volume 2)
The Vendor shall identify three (3) contracts/orders with the Federal Government and/or commercial customers that demonstrate recent and relevant past performance. Recent is defined as within the last three years. Relevant is defined as work similar in complexity and magnitude of the work described in this Statement of Work.

Include the following information:
• Project title
• Description of the project
• Contract number
• Contract amount and type of contract
• Government Agency/Organization
• Contracting Officer's Representative (COR) name, address, and phone number
• Contracting Officer's name, address, and phone number
• Current status, e.g., completed and/or if in progress, start and estimated completion dates
• Name of company being referenced
• SOW paragraphs that the reference applies to
• Key personnel (please highlight those individuals who worked on the relevant project(s) and are also being proposed for this effort.)
• A brief narrative of why you deem the reference to be relevant to this effort

The Government may also consider information obtained from other sources. Past performance information will be utilized to determine the quality of the contractor's past performance as it relates to the probability of success of the required effort.

E. Price Quote (Volume 3)
The Vendor's Price Quote shall be a separate volume from the Technical Response and Past Performance. Pricing shall be Time and Materials and include all anticipated pricing to fully perform the SOW including options. As provided in Attachment 2- Pricing Sheet, the vendor must include all labor categories, fully-loaded rates (both onsite and offsite), and hours for each labor category proposed for each applicable CLIN element. All rates quoted must be valid during the contract performance period. Price quotes shall include the following:
• Separate line item prices for all elements within Contract Line Item Numbers (CLINS) 1 through 11 as reflected in Attachment 2 - Pricing Sheet.
• Identify the labor category(s) to be utilized for this effort, a description of the skills and experience per category, and the fixed loaded hourly rate(s) quoted, and any other associated pricing, for calculating the price for this effort.
• Provide estimated prices for contractor travel and/or materials. The vendor must notify NIAID in its quote if it anticipates any travel or materials associated with performance and provide a description of these prices. Travel shall be in accordance with Federal Travel Regulations. https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation-ftr
• Subcontractor rate information shall also be included, if applicable.

F. Package Submission
Quotes must be submitted via email to the Contract Specialist, Tamara McDermott, at tamara.mcdermott@nih.gov on or before Monday, July 15, 2019 5:00 pm EST. All or part of the successful vendor's quote may be incorporated in any contract resulting from this solicitation. The successful vendor's quote may be incorporated by reference. Reference Solicitation ID: RFQ-RML-75N93019Q00001 on your quote.

By submission of a quote, the vendor acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) https://www.sam.gov/portal/public/SAM/ prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. [Note: Lack of registration in the SAM will make an vendor ineligible for award].

VI. SECTION 508
Requirements for accessibility based on Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) are determined to be relevant for the following program need:

Software 1194.21 Software Applications and Operating Systems
1194.31 Functional Performance Criteria
1194.41 Information, Documentation, and Support
Web 1194.22 Web-Based Internet Information and Applications
1194.31 Functional Performance Criteria
1194.41 Information, Documentation, and Support
Web Application
1194.21 Software Applications and Operating Systems
1194.22 Web-Based Internet Information and Applications
1194.31 Functional Performance Criteria
1194.41 Information, Documentation, and Support
Telecommunications 1194.23 Telecommunications Item(s)s
1194.31 Functional Performance Criteria
1194.41 Information, Documentation, and Support
Video/Multimedia 1194.24 Video and Multimedia Item(s)s
1194.31 Functional Performance Criteria
1194.41 Information, Documentation, and Support
Self-Contained 1194.25 Self-Contained, Closed Item(s)s
1194.31 Functional Performance Criteria
1194.41 Information, Documentation, and Support
Personal Computers 1194.26 Desktop and Portable Computers
1194.31 Functional Performance Criteria
1194.41 Information, Documentation, and Support

Solicitation respondents must describe how their proposed Electronic and Information Technology (EIT) deliverables meet at least those technical provisions identified as applicable in Attachment 3 - Government Product/Service Accessibility Template (GPAT).

VII. EVALUATION:
The Government will award a purchase order resulting from this solicitation to the responsible contractor whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate quotes: technical, past performance, and price. Technical subfactors include: 1. Technical Capabilities, 2. Management Approach, 3. Personnel Qualifications, and 4. Organizational Experience. . Only quotes that are deemed to be technical acceptable will be evaluated for past performance and price. All factors for consideration are subject to verification by the Government. The Government's objective is to obtain the highest technical solution necessary to achieve project objectives with a reasonable price. Technical and past performance non-price factors, when combined, are considered more important when compared to price. In the event quotes are evaluated as technically equal in non-price factors, price will become a major consideration in selecting the successful vendor. The Government will evaluate quotes for award purposes by adding the total price for all options to the total price for the base requirement. Evaluation of options shall not obligate the Government to exercise the option(s). Responses to this solicitation may be considered for award after it has been determined that the quote adequately addresses the requirements for Section 508.

VIII. DISCUSSIONS: The Government intends to award without discussions but reserves the right to conduct discussions should it be deemed in the Government's best interest.

IX. SPECIAL NOTICE TO VENDORS
Vendors are advised that the Government may share your information with non-government personnel who are assisting with the evaluation of quotes. The exclusive responsibility for source selection will reside with the Government. By submitting your quote, you will be consenting to disclosure of your quote to non-government personnel for purposes of evaluation.

X. QUESTIONS: If you have questions regarding this requirement, please submit inquires immediately, but no later than Monday, July 1, 2019 5:00 PM EST, via email to the Contract Specialist, Tamara McDermott, at tamara.mcdermott@nih.gov. The Government will issue an amendment to the RFQ responding to questions, if needed.

XI. SMALL BUSINESS SUBCONTRACTING PLAN
[Applicable to Large Businesses only.] NIAID highly encourages small business participation. FAR clause 52.219-9 requires a small business subcontracting plan in order to be eligible for contract award if subcontracting possibilities exist. This requirement does not apply to small business or small disadvantaged business vendors. Attachment 4 - Small Business Subcontracting Plan is provided as an outline that meets the minimal requirements of section 8(d) of the Small Business Act, as amended, and implemented by the Federal Acquisition Regulations (FAR) Subpart 19.7. This outline is not intended to replace any existing corporate master plan, which is more extensive. Assistance is available for locating small and small disadvantaged business sources by contacting NIAID's Small Business Specialist. For contact information, please send an inquiry to the Contract Specialist, Tamara McDermott.

XII. INVOICING
Invoices shall be submitted on a monthly basis.

XIII. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
A COR will be specified upon award and will represent the Government for purpose of this order. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.
The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements.
The Government may unilaterally change its COR designation.

XIV. PROVISIONS & CLAUSES
Vendors must complete annual representations and certifications on-line at http://www.sam.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Oct 2018).

The Contractor shall comply with the following Federal Acquisition Regulation (FAR) provisions and clauses, which are incorporated by reference, to implement provisions of law or Executive Orders applicable to acquisitions of commercial items. The full text versions may be accessed electronically at: https://www.acquisition.gov/far/.
FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements - Representation (Jan 2017)
FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. (Jan 2017)
FAR 52.204-9 Personal Identity Verification of Contractor Personnel (Jan 2011)
FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)
FAR 52.212-4 Contract Terms and Conditions - Commercial Items (Oct 2018)
ALTERNATE I (Jan 2017)
FAR 52.216-31 Time-and-Materials/Labor-Hour Proposal Requirements-Commercial Item Acquisition (Feb 2007)
FAR 52.227-14 Rights in Data - General (May 2014)
FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)
FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

The following additional Health and Human Services Acquisition Regulations (HHSAR) provisions and clauses are applicable to this requirement:
HHSAR 352.203-70 Anti-Lobbying (December 18, 2015)
HHSAR 352.208-70 Printing and Duplication (December 18, 2015)
HHSAR 352.219-70 Mentor-Protégé Program (December 18, 2015)
HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)
HHSAR 352.224-71 Confidential Information (December 18, 2015)
HHSAR 352.231-70 Salary Rate Limitation (December 18, 2015)
HHSAR 352.237-75 Key Personnel (December 18, 2015)
HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)
HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)
Copies of the above-referenced clauses are available from http://www.hhs.gov/policies/hhsar/ or upon request, either by telephone or fax.

The following additional FAR provisions and clauses are applicable to this requirement and provided in full text as Attachment 5 - Full Text Provisions and Clauses:
FAR 52.212-1 Instruction to Offerors - Commercial Items (Oct 2018) Amended
FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (May 2019)
FAR 52.217-5 Evaluation of Options (Jul 1990)
FAR 52.217-7 Option for Increased Quantity - Separately Priced Line Item (Mar 1989)
FAR 52.217-8 Option to Extend Services (Nov 1999)
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

XV. LIST OF ATTACHMENTS
Attachment 1 - STATEMENT OF WORK
Attachment 2 - Pricing Sheet
Attachment 3 - Government Product Accessibility Template (GPAT)
Attachment 4 - Small Business Subcontracting Plan Template
Attachment 5 - Full Text Provisions and Clauses

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