FDA-RFP-1209563_CDMS_Software_Solicitation.pdf

SOLICITATION: FDA-RFP-1209563

NCTR COTS CDMS SOFTWARE

Food and Drug Administration (FDA)

National Center for Toxicological Research (NCTR)

Solicitation #: FDA-RFP-1209563 for

Commercial Off-the-Shelf (COTS)

Pre-Clinical Data Management System (CDMS) Software

Issued: 06/07/2019

1. NOTICE OF 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.

2. NOTICE OF REQUEST FOR PROPOSALS (RFP)

This solicitation, identified as FDA-RFP-1209563, is issued as a request for proposals (RFP) in accordance with the requirements of FAR Part 12 and 13.5.

3. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2019-02, effective May 6, 2019.

FAR provisions and clauses referenced in this RFP can be found on the following website:

https://www.acquisition.gov/browse/index/far

HHSAR provisions and clauses referenced in this RFP can be found on the following website:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

4. NOTICE OF NAICS

The associated North American Industry Classification System (NAICS) Code is 511210 – Software Publishers, with a small business size standard of $38.5 million. This requirement is solicited as a Total Small Business Set-Aside.

5. SCHEDULE OF SUPPLIES OR SERVICES AND PRICES/COSTS. Price shall be inclusive of delivery, installation and training at the NCTR at the location listed herein.

Contract Line Item

(CLIN)

Description QTY Unit Unit Price Extended Price

1 Pre-Clinical Data Collection and Management System (CDMS) software (as per the Technical Requirements/Statement of Work stated herein). Attach detailed quote which itemizes pricing for individual modules/suites/functionality.

1 EA

https://www.acquisition.gov/content/part-12-acquisition-commercial-items#i1112616 https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Option Item (FAR 52.217-9) 2 Option Year 1. Annual Maintenance Plan 1 EA

3 Option Year 2. Annual Maintenance, Plan 1 EA

4 Option Year 3. Annual Maintenance Plan 1 EA 5 Option Year 4. Annual Maintenance Plan 1 EA

TOTAL $

Offerors shall provide separate prices for the following “Optional” line items on their quote:

Quantities are estimates.

Contract Line Item

(CLIN)

Description (FAR 52.217-7) Est

QTY

Unit Unit Price Extended Price

Optional Item 1

Additional Training per day during Calendar Year 2019

10 Days

Optional Item 2

Additional Training per day during Calendar Year 2020

10 Days

Optional Item 3

Additional Training per day during Calendar Year 2021

10 Days

Optional Item 4

Additional Training per day during Calendar Year 2022

10 Days

Optional Item 5

Additional Training per day during Calendar Year 2023

10 Days

Optional Item 6

Unlimited on-site corrective maintenance per year within 3 business days of call for service where problems cannot be resolved remotely after 2 business days during Calendar Year 2019

1 EA

Optional Item 7

Unlimited on-site corrective maintenance per year within 3 business days of call for service where problems cannot be resolved remotely after 2 business days during Calendar Year 2020

1 EA

Optional Item 8

Unlimited on-site corrective maintenance per year within 3 business days of call for service where problems cannot be resolved remotely after 2 business days during Calendar Year 2021

1 EA

Optional Item 9

Unlimited on-site corrective maintenance per year within 3 business days of call for service where problems cannot be resolved remotely after 2 business days during Calendar Year 2022

1 EA

Optional Unlimited on-site corrective maintenance per 1 EA

Item 10 year within 3 business days of call for service where problems cannot be resolved remotely after 2 business days during Calendar Year 2023

Optional Item 11

Annual refresher training per day during Calendar Year 2019

5 EA

Optional Item 12

Annual refresher training per day during Calendar Year 2020

5 EA

Optional Item 13

Annual refresher training per day during Calendar Year 2021

5 EA

Optional Item 14

Annual refresher training per day during Calendar Year 2022

5 EA

Optional Item 15

Annual refresher training per day during Calendar Year 2023

5 EA

The Government anticipates awarding a Firm-Fixed Price (FFP) Contract from this solicitation.

6. DESCRIPTION OF REQUIREMENT/STATEMENT OF WORK (SOW):

The Food and Drug Administration/National Center for Toxicological Research (FDA/NCTR) is a world-renowned scientific research facility established in 1971 in Jefferson, AR. The mission of NCTR is to support FDA in advancing regulatory science and to engage globally to encourage the implementation of science-based standards. NCTR conducts collaborative peer-reviewed research to support and promote public-health. Recent research includes:

• expediting the translation of laboratory findings to the clinic and regulatory application

• identifying adverse effects earlier in product development and understand the risks and benefits of nanomaterials used in FDA-regulated products

• providing strategies to reduce and rapidly detect contaminants in FDA-regulated products

• using biomarkers—biological indicators of disease—to foster precision medicine

• accelerating FDA's capability to manage and analyze research data using bioinformatics

• reducing costly and dangerous surgeries by expanding minimally invasive imaging capabilities.

The NCTR has a requirement to purchase a Commercial-off-the-Shelf (COTS) software that will replace an in-house-developed, pre-clinical data (e.g. dosing, clinical observations, animal weights, feed consumption, etc.) collection and management system (CDMS) that was introduced in 1998.

Multiple stakeholders will interact with this system in different ways (ex. different modules or via separate applications), so the system needs to fit various scenarios and must be role-based. The overall goal is to have a comprehensive system with increased functionality that can capture and report on animal data from in-life portions of the study through pathology and study closure (archiving).

The CDMS software shall meet the following minimum requirements:

6.1. IT Requirements. The software shall:

a. Be hosted on premises at the NCTR Data Center on servers owned and operated by FDA. (i.e. no cloud services).

b. Be compatible with and store data and audit information on Oracle Database Version 12 or later. Oracle database licenses will be provided by FDA.

c. Be able to use Personal Identity Verification (PIV) badge for access to system.

d. Be capable of being hosted on virtual servers running either Red Hat Enterprise Linux v7 or later or Microsoft Windows Server 2012 R2 or later. Operating system licenses will be provided by FDA.

e. Be compatible with Citrix 7.15 or later.

f. If solution is a web application, shall be compatible with at least two of the following browsers: Microsoft Internet Explorer 11, Google Chrome version 66.0.3359.170 and later, Mozilla Firefox 63.0.1 (64 bit) or later.

g. Client software shall be compatible with Windows 10 and 2012 Remote Desktop Services (RDS).

h. Provide role-based access control and be able to add, modify and delete users/roles.

i. Provide logging and audit functions.

j. Compatible with single sign on and Windows Active Directory.

k. Supply all software patches, updates or upgrades electronically via secure file transfer protocol (ftp) or similar technology.

l. Be approved for the Master Approved Technologies List (MAT) and subsequent

Software Acquisition Approval (SAA) upon award.

m. Be compliant with Section 508 and vendor shall provide a voluntary product accessibility template (VPAT).

n. Have the capacity to support at least 75 concurrent users.

o. Be able to export data in the SEND (Standard for the Exchange of Non-Clinical Data) format

p. Provide license for a pre-production environment to allow for testing database and operating system patches. This will not be accessible by end customers.

q. Functionality to replace paper forms with electronic forms that can be automated and approved through an electronic approval chain.

r. Interface and function with existing equipment:

1) Hamilton 500 and 600 series syringe (dosing) pumps

2) Arlyn Series 3200 platform scales 36”x36”

3) Chip reader: DAS-7007R round wireless IPT/IPTT reader system

4) Mettler Toledo scales: XS16001L and Xs205DU

5) Barcode scanner: Intermec SR30 with USB cable and Intermec 1800 plus

6) Thin clients: HP T610

Software must not affect the performance of any connected equipment such as:

1) Alfa Wassermann Vet Axcel

2) Horiba Pentra 60C+

3) Bio/Data PAP-8

s. Be able to control the automated animal dose dispensing system (e.g. Hamilton dosing pumps) in use at NCTR. The current process entails measuring the weight of the animal on a scale connected to the system. The system then translates the body weight into a desired volume of dose, taking into consideration the mL of dose required per kg of body weight of the animal entered in the study definition. Following this, the system controls directly a syringe pump to deliver the right volume upon the pressing of a button by the animal technician. The system must be able to control the syringe pumps in a fashion that does not degrade the intrinsically high accuracy and precision of the hardware.

t. Include a standard manufacturer’s warranty of at least six months.

6.2. Data Quality and Integrity Requirements. The software shall:

a. Be able to demonstrate and function with the attributes of data quality and integrity ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, + Consistent, Complete, Enduring and Available) throughout the data lifecycle (e.g. data acquisition, data review, data processing, data reporting, data storage, data retrieval, data destruction).

b. Be Title 21 CFR Part 11 compliant.

c. Reduce/remove need for manual entry of data where at all possible.

d. Record all equipment being used and each piece of equipment must be validated via prompting from the system prior to use (e.g. taring balances, ensuring dosing pumps are dosing correct volumes) before each session to ensure data quality).

e. Operate and guide those collecting data and function in a consistent manner: 1) Consistent (statistically valid) rounding methodology throughout 2) Consistent use of terminology (clinical observations, glossary of terms, etc.); 3) Consistent units of measure (e.g. grams, kilograms, centimeters); 4) Consistent Study Day 1, Gestation Day 1, and Postnatal Day 1

f. Identify data as a “Live Entry” (entered at the time of the action/observation), “Retroactive Entry” (currently changed via a manual data collection form) or “Edited Entry” (an entry that has been changed, added, excluded from data analysis, or otherwise removed)

g. Be able to assign unique identification to test systems (animals) so that no two test systems can ever have the same identification. The same identification should be used throughout the test systems’ life (in-life through pathology). This will ensure historical data can always be accessed. System must allow tattoo, ear clip, toe clip, etc., identification to be entered if such duplicate identification is deemed necessary.

h. Be able to assign unique identification to individual studies (Study = 1 Protocol, 1 Study, 1 Report) so that no two studies can ever have the same identification. Ensure historical data can always be accessed and that study/protocol number remains consistent throughout the study. Example: Concept Number, Protocol Number, Study Number.

i. Protocol/Study number shall agree with the Institutional Animal Care and Use Committee (IACUC)-approved protocol number

j. Retain all entered data (Original Entry) in a human readable, readily available, uneditable audit trail. Edited entries must identify: the person making the edit, the date the edit is made, the time the edit is made, and the reason for the edit (e.g. justification). The system shall not obscure or overwrite Original Entries when changes (including edits, additions, exclusions or deletions) are made

k. Maintain System version control, updates, and configuration changes (including those changes to the computer clock/date) in a human readable, viewable and printable Audit Trail.

l. Incorporate a weighing algorithm capable of averaging multiple weights collected while the animal is in the balance to reduce the impact of movement. The system must also: 1) generate an automatic flag if the weight of the animal deviates in excess of a pre-determined percentage (or standard deviation) of the previous weight recorded in the system; 2) allow the technician to repeat the weighing session if he/she determines that a mistake occurred (e.g. wrong animal selected); a justification for an incorrect weight must be entered.

6.3. Study Definition/Design Requirements. The software shall:

a. Be capable of supporting a multiple number of simultaneously conducted studies.

System shall also contain support for: any commonly used species and strains (rats, mice, non- human primates, etc.), studies with small numbers of animals up to thousands of animals allocated across multiple dose groups.

b. Contain the capability (e.g. modules, features, etc.) for different types of studies:

Breeding (Colony), InLife, Multigenerational (Reproductive), and Phototoxicity Studies (optional)

c. Include valid tables for Species/Strain, Animal Actions, Animal Status, Cage Actions, Clinical Observations, Reason for Removal, Disposition (e.g. defining transfer from weaning to next phase of study), Units Codes (e.g. grams, kilograms, etc.), Operator function roles, Valid Equipment, Equipment Type or similar nomenclature. These tables should be read/write/delete and contain an audit trail.

d. Contain a “preparation table” or similar feature, for dose water, feed, and gavage dosing.

This is defined during study definition/design. The software shall also have the ability to run a report by a particular chemical to see historical use and data.

e. Once study definition/design setup has been completed, be able to build a Study Definition Form with all associated information and allow for electronic signing using the digital certificate contained in the user PIV card. This will ensure that the study definition is approved by the Primary Investigator and other associated staff.

f. Contain capability for multigenerational studies to enter and track: date-mating; multiple staggered loads based on mating period, and multiple birth dates. Should also include:

dam/sire tracking, plug info, litter info, etc.

g. Be able to define "allowable" litter occurrence GDs (gestational day range), (enter # pups born (alive/dead) & collect group pup weights by sex or entire litter. The system must also be able to track an animal that has been reassigned a new cage # during the study.

h. Be capable of noting confirmation of mating; collection of in vivo body weights and weight of dam after littering; collect litter data including the number of live and dead pups; assign and collect pup data (e.g. weights, developmental landmarks) by litter, group sex, or individual

i. Contain multiple dosing algorithms to fit study definition/design (e.g. Single, Multiple, and Aliquot dosing per day).

j. Contain aliquot (e.g. volumes of cream) setup for single animals and multiple animals in a cage.

k. Contain functionality to set up dosing animals in a cage with different dose levels or different compounds. Be able to also support studies that may consist of single or multiple dose administration per day and studies involving dosed feed and dosed water.

l. Be able to define first day on study as “0” or “1”, as well as capture an allocation date, start date on study, plug date, and first dose date.

m. Be able to assign animals to studies based on statistically valid weight-ordered randomization for caging and treatment groups. This should be done ensuring that no littermates or first cousins are in the same cages or treatment groups.

n. Be able to allocate to cages, animals by filial (e.g. Generation F0, F1, F3, etc.).

o. Include an event scheduler and calendar feature by room, cage, animal, dose groups, sex, sub-group, litter. Scheduling should include daily activities such as body weights, dosing activities, clinical observations, cage changes, cage or rack rotations, feeder or bottle weight collections, blood collections; sentinel and necropsy removal dates. This functionality should include completion checks for viewing what activities were completed and incomplete based on study definition/design.

p. Be able to use the study definition/design parameters for animal & cage actions defined in conjunction with the study/room calendar for actions to be performed per day and be able to generate an exception report when the required/defined actions were not performed.

q. Contain functionality for tracking animals who go on and off protocols and that move from different rooms/cages/slots.

6.4. Reporting/Data Export Requirements. The software shall:

a. Include standard reports (e.g. Animal and Cage History, Removal Reports, Dosing Reports and Cage & Animal Note) as well as customizable/ad hoc reporting capability.

Reports should be accessible during in-life portions of the study, pathology evaluation, as well as after study completion.

b. Contain ability to see historical observation throughout history of an animal.

c. Be capable of exporting the data in .CSV and SAS-compatible formats.

d. Include the ability to control and record all relevant aspects required to comply with US

National Toxicology Program specifications outlined for developmental/ reproductive toxicology studies https://ntp.niehs.nih.gov/testing/types/devrepro/index.html) and toxicology/carcinogenicity studies (https://ntp.niehs.nih.gov/testing/types/cartox/index.html).

e. Be able to report by ranges of: cage IDs, animal IDs, time-frames, and treatment groups.

f. Be able to lock down by protocol number the study definition/design, animal data collection, and any error correction modules. Can only be locked/unlocked by a specific role. This process should be fully audited.

g. Include interactive exception reports and daily activity reports that can be run after each session. The same reports can be run by protocol for a given day.

h. Contain allocation/caging reports by day or for entire study.

i. Include reports for each table and an audit trail table.

6.5. Data Collection Requirements. The software shall:

a. Include an animal room scheduling/calendar, usage, and tracking system. This feature shall be based on study definition/design setup derived from a protocol.

b. Contain ability to guide user (e.g. animal care technician) through specified actions based upon study definition/design. The system shall ensure that study activities are being completed as designed and guiding the user through the tasks that need to be completed during a given session.

c. Be able to collect pre-study animal data on the system such as: body weights, clinical observations, feed & water consumption.

d. Contain ability to capture site-specific measurements of masses (e.g. tumors and palpable mass) to monitor for growth and removal criteria to include palpable mass with mass location diagrams.

e. Capture cage allocation date, start date on study, and the first dose date.

f. Be able to reinstate adult animals and pups that were removed from the study by accident.

g. Be able to assign phenotypes/genotypes in the Dam cage before weaning.

h. Be able to collect anogenital distance measurements.

https://ntp.niehs.nih.gov/testing/types/devrepro/index.html https://ntp.niehs.nih.gov/testing/types/cartox/index.html

i. Be able to collect veterinary observations and treatments from physical and ophthalmic exams. This includes type and amount of medication administered as well as the timeframe for treatments.

j. Be able to address when a partial dose was administered and include functionality to log this action. It should also be able to enter when no dose was administered and allow the technician to re-start the animal/cage actions. (This is required when a problem occurs when the dose is drawn up (e.g. air in line). The dosing pump should function accordingly.

6.6. Pathology Requirements. The software shall:

a. Contain modules/functionality for Necropsy, Clinical Pathology, Histology, Histopathology, Vaginal Cytology, and Sperm Analysis.

b. Import in-life data to pathology data collection modules to include: animal carcass identification (CID), reason for removal, removal observations, removal weight, treatment (number and text), sex, disposition, clinical observations; allow pathology users to generate in-life reports, including daily activity and in-life removal data.

c. Include the ability to set-up necropsy data collection per protocol requirements (i.e.

protocol required tissue list dependent on receiving status, tissue review and disposition, organ weights, fixative and fixation limit).

d. Allow input of study specific Tissue List Driver.

e. Include a progressive dictionary so the glossary for each module learns as the study progresses.

f. Include ability for user to enter receiving status disposition. System configured so that receiving status (dead, moribund, terminal sacrifice, etc.) defines how the system functions for each group of animals received for sacrifice based on protocol.

g. Allow for import of digital images from gross observations and microscopic images.

h. Provide capability to streamline histology workflow in the laboratory. Histology module/functionality that allows for verification of protocol required tissues at trimming and embedding; ability to track all areas as the tissues are processed through the laboratory; ability to identify and track protocol requirements including immunohistochemistry (IHC), special stains, image analysis, etc.; ability to track tissues, blocks, slides and cases throughout laboratory. All tracking would include identity of task area, date and user.

i. Accurately capture quality control documentation. Histology module/functions should allow user to document re-embeds, recuts, wet tissue retrims, discarding slides, submitting multiple slides, reprocessing tissue and restaining slides.

j. Provide functionality to accurately capture Vaginal Cytology procedures (e.g.

documentation of collection, fixation, stain/coverslip and labeling. Reading for cycling and removal in designated cycle and live read for sperm presence).

k. Provide capability of determining where a specific animal is in the laboratory or the status of a specific study.

l. Include bi-directional interface to allow demographics (study number, CID, date of collection, test required, etc.) to be transmitted to the analyzers in real time mode.

Collate the data with CID, sex and treatment.

m. Clinical Pathology Module/functions must have ability to interface with the following analyzers: 1) Alfa Wassermann Vet Axcel; 2) Horiba Pentra 60C+; 3) Bio/Data PAP-8.

n. Allow for individual study setup to include protocol required tissues, morphologies, qualifiers and sites, microscopic correlation of gross and microscopic findings.

o. Histopathology module/functions must have standardized reports available including reports for individual animal and summaries by treatment, sex, tissue, anatomic site as well as diagnostic criteria (e.g. neoplastic, non-neoplastic), cause of death and microscopic correlation of gross and microscopic findings.

p. Support Sperm Motility and Vaginal Cytology Evaluation (SMCVC). Histopathology module/functionality must have ability to import data from IVOX Hamilton Thorne Sperm Analyzer. Vaginal Cytology system must allow for entry of manual collection and evaluation data (e.g. stage of estrus, presence of sperm for confirmation of mating).

Module must have standardized reports including individual animal reports and summaries by treatment and sex for sperm analysis and vaginal cytology data.

6.7. Installation, Validation, and Initial Training. The contractor shall:

a. Provide validation of the installed system software through a standard validation package in order to support the use of the data system for studies. The validation package provided shall include:

i. Standard System Requirements Specification

ii. Standard Requirements Traceability Matrix – Requirements to OQ Scripts

iii. Software Configuration Documentation

iv. Template Validation Plan

v. Template Operational Qualification Protocol

vi. Execution of IQ and OQ test scripts

b. Conduct onsite training sessions within 30 days after installation and validation to provide a thorough demonstration of all system/solution functions, maintenance, data administration, basic troubleshooting and hardware/software operation and software via manuals, telephone and email.

c. Provide the installation for the commercial software program; however, the contractor shall provide a minimum of five (5) days of on-site (in-person) training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. The training shall contain a brief overview of the entire system and separate training sessions related to each specific module or function (e.g. Data Collection, Study Definition/Design, Pathology, Auditing, Reporting, etc.).

d. Contain built-in and/or standardized training modules for users as well as test studies for training purposes.

e. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

6.8. Annual Maintenance Plan, Support and Training. Contractor shall:

a. Provide unlimited technical support via telephone and email within two hours during normal business hours (8 a.m. to 4 p.m. Central time, Monday thru Friday, excluding Federal holidays) and within 4 hours during all other times. This technical support shall not violate or void the terms of the warranty and shall be available to all users of the system and any associated groups (NCTR IT Staff, COR, etc.).

b. Provide guidance and assistance to FDA staff in the installation and troubleshooting of software; however, non-FDA personnel are not allowed to access FDA systems.

c. All updates and service will be performed by Government personnel with vendor assistance either in-person, via Webex/phone call, or secure screen-share application support. (Vendor will not be able to log into the system or act as an administrator on the system but can use screen-sharing protocol.)

d. Include unlimited software and updates during the coverage period(s). This shall be contained in an audit trail. Notification of software updates or planned outages must be communicated to the COR at least 30 days in advance.

6.9. Optional Items. Contractor shall provide separate pricing for the following Optional items:

a. Provide a daily price for approximately 10 days ofsupport training, via live video conference, preferably webex, focused on the users of the software (i.e. Animal Care, Pathology, etc.).

b. Provide unlimited on-site corrective maintenance/repairs (inclusive or all parts, labor, and travel costs) within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

c. Provide a daily price for up to 5 days of annual refresher and new user training via live video conference, preferably Webex.

7. DELIVERIES, ACCEPTANCE, AND PERFORMANCE DATES

FOB Point. Destination. All items shall include shipping, handling, delivery, installation, validation andtraining to:

US FDA/NCTR

3900 NCTR Rd.

Jefferson AR, 72079

Deliveries and training shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Labor Day Martin Luther King, Jr.’s Birthday Columbus Day Washington’s Birthday Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day

Inspection and Acceptance.

Supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer’s Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

Period of Performance.

Delivery of the CDMS system, installation training and validation shall occur within 180 calendar days after receipt of award (ARO). The CDMS system shall be delivered within 30 calendar days ARO. Installation must be performed by government staff with guidance from vendor. Warranty shall commence upon acceptance of the system, which shall not occur until CDMS delivery, installation, training and validation of the system is complete. The Post-warranty Annual Maintenance Plan if exercised, shall commence, upon expiration of the initial warranty period and continue for a year, which may be extended in annual increments. If/when Option Year 1 is exercised; the periods of performance for all options will be firmed via a modification. The anticipated performance period for the four (4) one-year option periods are as follows:

Option Year 1: 03/15/2020 - 03/14/2021 Option Year 2: 03/15/2021 - 03/14/2022 Option Year 3: 03/15/2022 - 03/14/2023 Option Year 4: 03/15/2023 - 03/14/2024

8. INSTRUCTIONS TO OFFERORS

The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items (OCT 2018), applies to this acquisition. Addenda to this provision are as follows:

8.1 GENERAL INFORMATION

Offerors shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure that all electronic documents submitted do not contain or otherwise use macros.

Offerors are required to submit complete proposals in response to this Request for Proposals (RFP). It is anticipated that this solicitation process will be conducted in two phases consisting of the following:

Phase I – Initial Proposals. The Government will evaluate all offers in accordance with the terms of this RFP and determine which offers are the most highly rated. The Contracting Officer may limit the number of proposals moving into Phase II to the greatest number that will permit an efficient competition among the most highly rated proposals.

Phase II (if needed) – Demonstrations. Those Offerors who are determined to be the most highly rated may be asked to participate in a demonstration of their proposed software solution. The demonstration will focus on, but will not be entirely composed of, the offeror’s proposed responses to the Government’s list of demonstration items. Each offeror will be expected to demonstrate their proposed solution within 5 hours. The demonstration process is outlined at 8.4 of this section and in Attachment 1.

8.2 PROPOSAL FORMAT

Offerors shall submit proposals consisting of three (3) separate Volumes, one for each of the following Factors:

• Factor 1: Technical Capability

• Factor 2: Past Performance

• Factor 3: Business/Pricing

Each volume shall be complete and separate from other volumes, signed by an official authorized to bind the Offeror. To permit a thorough and effective evaluation, each volume should be precise and complete, while as brief as possible. It is essential that the Offeror present information in sufficient detail so as to permit the Government to make an evaluation without further information being required from the Offeror.

All Volumes shall include:

• Cover Page (include the RFP title, RFP number and Company name)

• Table of Contents.

Electronic copies shall be submitted as follows:

• Using Microsoft Office programs (Word, Excel). If using Excel, do not hide formulas and do not protect cells.

• Adobe PDF:

o Combine individual files (if applicable) into a single PDF per Volume, i.e. Volume 1 –

Technical Capability shall be submitted with the original Word documents and also with all Word files consolidated (if applicable) into a single pdf file. Submit Volume 2 and 3 in the same manner.

o PDF must be unlocked, unprotected, and fully searchable for specific text (i.e. not a scanned document with non-renderable text that will not allow word search functions).

The Government will evaluate technical proposals in accordance with the technical evaluation factors as described in Section 9 – Basis of Award & Evaluation.

8.3 PROPOSAL INSTRUCTIONS

The Technical Proposal shall not contain reference to cost in any section.

The Technical Proposal shall not exceed 30 pages. The Cover Page and Table of Contents are not included in the page limit.

Factor 1: Technical Capability

Offerors must provide a narrative description which includes sufficient technical information necessary for the Government to conclusively determine that the offered items/services meet or exceed each of the requirements identified herein. Proposals shall thoroughly address the following, at a minimum:

A. IT (hosting, compatability, capabilities, functionality) B. Data Quality and Integrity C. Study Definition/Design D. Reporting/Data Export E. Data Collection F. Pathology

As the NCTR’s current software system is integrated throughout and integral to the Center’s operations, the Offeror shall discuss their approach to implementing the COTS CDMS solution to support the NCTR’s functions as described herein. The Offeror shall demonstrate the offeror’s understanding of the project and the challenges that the offeror envisions, as well as proposed strategies for overcoming those challenges. Since many users utilize the software’s different functions, the Offeror’s narrative shall also discuss the degree of convertibility and adaptability of the proposed solution across different technological and methodological scenarios. Offerors shall identify and clearly detail any exceptions taken to the Technical requirements identified herein and the rationale thereto.

The offeror shall submit a written Accessibility Conformance Report (ACR) addressing the level of conformance of the delivered items to the 508 standards identified in clause 352.239-74. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). To be considered for award, the ACR must be complete, and submitted according to the instructions provided by ITIC.

NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

Offerors shall submit the following information for MAT List approval:

• Version/Model number of the proposed software.

• Description of what your software does (if the software contains a suite of procusts, please provide the function of each product contained within the suite.

• Website URL for Software

Factor 2: Past Performance

The purpose of this Past Performance section is for the Offeror to demonstrate/discuss how well the Offeror performed and how well the offered product met the requirement on similar contracts/projects; therefore, the Offeror shall submit a list of contracts similar in scope and size to the requirement described in the Statement of Work, describe the successfulness of the product, provide information regarding any problems that arose during the project and how they were addressed by the Offeror so the Government can assess overall performance. For each reference include period of performance, contract/project description and how it is relevant to current requirement, dollar value, Organization or company name, point of contact name, POC email address and telephone number for each contact. Provide this information for recent (within the last 3 years) and relevant (type of software solution provided) contracts/projects.

Include information regarding clients you have served that are toxicity testing facilities who submit data to regulatory agencies or where the data is required to demonstrate the attributes of quality data such as Attributable, Legible, Contemporaneous, Original, Accurate, Consistent, Complete, Enduring and Available (ALCOA+).

http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/policy/accessibility

Past Performance information will be used to determine the likelihood of success in meeting the FDA’s requirements as indicated by the Offeror’s record of past performance.

Offerors are advised that the contact information for the contractual and technical points of contact must be accurate. The Government intends to contact the Offerors’ previous customers/clients to conduct phone interviews. As such, offerors are encouraged to inform their references that the Government may contact them for the assessment of the offeror’s past performance as well as how well the solution performed to meet requirements.

Factor 3: Business/Pricing

This Volume shall include the following sections:

A. Administrative Data. This section shall include the following information:

• Name, title, and signature of person authorized to sign the proposal.

• Name, title and contact information of person(s) authorized to negotiate with the government.

• Your proposal must stipulate that it is predicated upon all the terms and conditions of this RFP. In addition, it must contain a statement to the effect that it is firm for a period of at least 120 days from the date of receipt by the Government.

• Any other special considerations involved in the instant acquisition and any. This section can be used to identify and clearly detail any exceptions taken to the RFP and the rationale thereto.

B. Pricing. The price proposed shall represent the offeror’s response to the schedule of supplies/services above. Offerors shall complete the pricing table provided herein and also provide a detailed vendor quote in your own format.

C. Reps and Certs. The Representations and Certifications included at FAR 52.212-3 are required by public law, procurement regulations, or procurement policy. If the offeror has completed the annual representations and certifications electronically, include a copy.

Indicate in the Business Proposal that the electronic Representations and Certifications information is current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated. Include the company’s DUNS and TIN numbers with the Business Proposal submission.

D. A statement acknowledging any Amendments made available on FBO.

The government is not responsible for locating or securing any information which is not identified in the proposal; however, the Government reserves the right to obtain information for use in the evaluation from all sources including sources outside of the Government.

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) FedBizOpps for information relevant to this solicitation, e.g., questions and answers, amendments, etc.

Proprietary and/or confidential information shall be clearly marked.

8.4 DEMONSTRATIONS

8.4.1. Description of the Demonstration Process: Selected Offerors may be asked to provide a demonstration of the proposed software solution via live video conference (preferably Webex).

Offerors shall address the items (scenarios) listed in Attachment 1 “CDMS Software Demonstration Instructions.”

8.4.2. Schedule for Demonstrations (“Demos”): The scheduling of Offeror demonstrations will begin after the initial proposal evaluation and determination of the most highly rated offers.

The presentations will be scheduled as tightly as possible; the duration of the entire presentation process will depend on the number of offers. The order of demonstrations will be determined by random selection by the Contracting Officer.

8.4.3. Form of Demonstrations. Offerors shall conduct their demonstration via live video conference (preferably Webex). Submission of videotapes or other forms of media containing the presentation for evaluation, in lieu of the oral presentation, may not be authorized and such technical proposals may be rejected.

8.4.4. Documentation: The Government may record the webex of each offeror's Demonstration. These recordings will be used by the Government, as necessary, during evaluations.

8.4.5. Demonstration Procedure & Time Limit: Each offeror will be given a maximum of five

(5) hours for their demonstration; the five (5) hour time limit for the Demonstration will begin after opening remarks by the Government. Offerors shall demonstrate according to the provided instructions only. If a Demonstration shows all of the provided scenarios before the allotted time is completed, then the Demonstration shall be concluded.

After completion of the Demonstrations, the Government may request clarification of any of the points addressed which are unclear and may ask for elaboration by the Offeror on any point which was not adequately supported in the Demonstration. Any such interchange between the Offeror and the Government will be for clarification only and will not constitute Discussions.

9. BASIS OF AWARD & EVALUATION CRITERIA

The provision at FAR 52.212-2, Evaluation—Commercial Items (OCT 2014), applies to this acquisition. Paragraph (a) and (b) of this provision are tailored as follows:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Technical Capability

2. Past Performance

3. Price

4. Demonstrations (if needed)

Technical Capability and Past Performance are relatively equal, but when combined are significantly more important than price when determining the best overall value to the Government though price remains an important factor. If the Government determines non-price factors to be essentially equal among competing offerors, price becomes more important as a discriminating factor. The Government is more concerned with obtaining superior performance capability rather than lowest overall price. However, the Government will not make an award at a significantly higher overall price to achieve only slightly superior performance.

The Government's determination of technical capability in no way relinquishes the Awardee's contractual obligation to ensure the supplies meet the FDA’s stated need.

In Phase I, Proposals will be evaluated from a technical, past performance and price standpoint. The Government intends to make a determination of which are most highly rated proposals and exclude the lower rated proposals from further consideration. If required, The government may choose to conduct Phase II and invite the vendors with the most highly rated proposals to provide demonstrations of their software.

If demonstrations are conducted, the FDA will assess the, performance of the software for its overall functionality, user-friendliness, and conformance to the requirements in the Statement of Work and Demonstration requirements.

If demonstrations are conducted, Technical Capability, Past Performance and Demonstrations are relatively equal, but when combined are significantly more important than price when determining the best overall value to the Government though price remains an important factor. If the Government determines non-price factors to be essentially equal among competing offerors, price becomes more important as a discriminating factor. The Government is more concerned with obtaining superior performance capability rather than lowest overall price. However, the Government will not make an award at a significantly higher overall price to achieve only slightly superior performance.

Offerors are advised that the Government intends to evaluate proposals and make award without discussions; however, the Government reserves the right to request additional information or conduct discussions at any time. The Government also reserves the right to require and assess Demonstrations as part of process of determining which Offer is the most highly rated and which is the best solution for meeting the FDA’s need.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

10. The Provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items (Oct 2018) applies to this acquisition.

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u)) of this provision.

(a) Definitions. As used in this provision— “Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest-level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation”, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C.

395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote…