RFP_Combined_Attachments_-_NIH-NICHD-CDBB-2019-15.pdf

Attachment 1

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

PACKAGING AND DELIVERY OF PROPOSAL FOR USE WITH THE NIH ELECTRNIC

CONTRACT PROPOSAL SUBMISSION (eCPS) WEBSITE

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012019_Technical.pdf Business Proposal: XYZ Company_NIHAI2012019_Business.pdf Excel Workbook: XYZ Company_NIHAI2012019_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

2. Font size must be 10 to 12 points.

3. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

4. Margins must be at least one-inch on all sides.

5. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

TECHNICAL PROPOSAL BUSINESS PROPOSAL

The offeror must submit one (1) electronic PDF file for the Technical Proposal with three (3) sections:

1. IDIQ Basic Proposal – Not to Exceed 20 pages

2. Task Order 1 – Not to Exceed 15 pages

3. Task Order 2 – Not to Exceed 15 pages

*The proposal should not exceed 50 pages including all three sections

The offeror must submit one (1) electronic PDF file for the Business Proposal with two (2) sections:

1. Task Order 1

2. Task Order 2

(There is no cost proposal for the IDIQ Basic Statement of Work) There is a general business proposal with other required documents.

In addition, the Offerors must include the Excel Spreadsheet with the Breakdowns of the Proposed Estimated Costs for Tasks 1 &2 separately.

It should be noted that the basic IDIQ Statement of Work does not require any costs proposed in the business proposal. Only the task orders require individual cost proposals.

*The page limitation is inclusive of all attachments but does not include: bio-sketches/resumes, references, citation bibliographies, Human Subjects Documentation, Technical Proposal Direct Cost Summary Sheet, Small Business Subcontracting Plan, Summary of Related Activities, NIST 800 53 Self-Assessment. Proposal cover sheet, Section Dividers that do not contain information other than title of Section, Title and Back Page and Table of Contents.

Pages in excess of this limitation will be removed from the proposal and will not be considered.

RFP Number: NIH-NICHD-CDBB-2019-15

Proposal Intent Response Sheet 1 Attachment #2

PROPOSAL INTENT RESPONSE SHEET

RFP No.: NIH-NICHD-CDBB-2019-15 RFP Title: “NIH Infant and Toddler Toolbox”

Please review the attached Request for Proposal. Furnish the information requested below and return this page by June 14, 2019. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

[ ] DO INTEND TO SUBMIT A PROPOSAL

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:

Company/Institute Name (print):

Address (print):

Principal Investigator’s Name (print):

Title (print):

Signature/Date:

Telephone Number and E-mail Address (print):

Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants) (print):

(Continue list on a separate page if necessary)

RETURN VIA E-MAIL TO:

Kesha Williams, Contract Specialist

Email: williamskl@mail.nih.gov and

Elizabeth J. Osinski, Contracting Officer Email: elizabeth.osinski@nih.gov mailto:williamskl@mail.nih.gov mailto:elizabeth.osinski@nih.gov

IDIQ BASE STATEMENT OF WORK ATTACHMENT 3a

DATED: 5/06/2019

Attachment 3a - IDIQ BASE STATEMENT OF WORK

NIH INFANT and TODDLER TOOLBOX NIH-NICHD-

CDBB-2019-15

1) BACKGROUND and INTRODUCTION:

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) within the National Institutes of Health has a broad mission that includes ensuring the health of infants and children and that all children have the chance to achieve their full potential for healthy and productive lives. The Child Development and Behavior Branch (CDBB) within the NICHD develops and supports research relevant to the psychological, cognitive, neurobiological, language, behavioral and educational development and health of infants through young adults. Among the CDBB published research priorities is the development of an efficient, comprehensive neurodevelopmental battery of measures from evidence-based neurocognitive research specific to typically developing infants and toddlers. This research initiative addresses this priority through the development of a neuropsychological, cognitive and social assessment battery for ages of 1 – 42 months constructed for research and clinical use.

There is a wide range of early developmental assessment or screening instruments. Standardized, reliable assessment instruments (e.g., Mullen Scales of Early Learning, Brigance Inventory of Early Development, Battelle Developmental Inventory, etc.) allow for direct evaluation of infant/child behaviors but they are time intensive (60 to 150 minutes to administer), expensive (typically from $500 to $1500 when including manipulatives and/or scoring software), require trained personnel (master's level and above) for administration, scoring, and interpreting, and often rely on outdated norms. Some of these instruments assess neurodevelopment better than others. Both clinicians and researchers rely on standardized assessment instruments when evaluating and monitoring infant and young child development but at great cost and time. Developmental screeners such as the Ages & Stages Questionnaires rely on parent responses and are primarily for identification of infants and young children who would benefit from further evaluation. Screeners are useful in clinics and pre-school settings but are not generally used for infant/young child neurodevelopment research or intervention purposes.

The NIH Toolbox has been a successful trans-NIH Neuroscience Blueprint project that resulted in a battery of assessment tools for use in persons 3 years to 85 years of age, allowing for assessment of neurological and behavioral function over time. The NIH Toolbox was developed as a standard measure that can be used across diverse study designs and settings while addressing common domains of study (i.e., Cognition, Emotion, Motor, Sensation). Within each domain, subdomains are included. The Cognition Domain has been found to be particularly useful by many researchers and clinicians. The Cognition domain includes measures of attention, memory, executive function, language, and processing speed. All of the items in the Cognition domain require child responses to a variety of tasks administered through a digital tablet (i.e., iPAD). Unfortunately, the NIH Toolbox did not extend below 3 years of age to newborn, a time when rapid development is occurring and when neurodevelopmental assessment is vital for identifying functional areas for which early intervention is crucial.

There is a great need across many biomedical and biobehavioral disciplines for a standard measure of infant and toddler neurodevelopment that is efficient to administer, low in cost, useful in both clinic and research (especially in resource poor settings) and yet captures multiple domains of neurodevelopment.

One of the most widely used direct child assessment is the Bayley Scales of Infant Development (Bayley) both within the United States and throughout the world. A recent PubMed search yields 1,148 publications that have included the Bayley Scales and no doubt many more since PubMed only searches for mention of the Bayley in the abstract and/or title of a publication. A search in the NIH RePORT shows over 104 currently funded grants using the Bayley Scales in 2016 alone, and over 700 funded projects using the Bayley scales between 2010 and 2017. Yet, common criticisms of the Bayley and similar direct assessment batteries, include high cost, the fact that it is a cumbersome assessment tool, requires intensive training of a professional to administer, and is impractical for clinical or low resource setting use. Despite these strong criticisms of the Bayley Scales, it continues to be used because there is no other standardized direct developmental assessment of infants and young children that is inexpensive, easy to administer within a relatively brief time frame, and able to capture multiple domains of neurodevelopment across this age range. For this reason, it is proposed that the NICHD develop such an assessment tool with a focus on assessment of neurodevelopment from infancy through 3 years, 6 months of age.

2) SCOPE:

The purpose of this contract is to develop and nationally norm (in both English and Spanish-speaking US populations) the NIH Infant and Toddler Toolbox (aka the “NIH Baby Toolbox” [NBT]) for research and clinical use in children between 1- to 42-months of age that will include both direct child assessment as well as parent/ legal guardian report, although direct assessment is preferred whenever possible. It will be designed from existing validated tasks and protocols that have been used and accepted in cognitive development research and cognitive, social, and behavioral neuroscience fields. It must be inexpensive to obtain, easy to administer (e.g., not requiring highly trained professionals to administer; not requiring multiple boxes of tangible stimuli) within a relatively brief time frame, and able to capture multiple domains of neurodevelopment across the ages of 1 to 42-months, thus extending the combined assessment reach of the NBT plus NIH Toolbox over nearly the entire lifespan.

Domains to be included, but not limited to those, are cognition, social functioning, language (receptive and expressive), numeracy, self-regulation, executive function and potentially motor development. The battery shall be developed for use with a digital tablet format and will include currently used technology such as eye-tracking and measurement such as reaction times and speed of habituation. No new tasks will be developed de novo. All tasks for assessment shall be drawn from existing batteries or published scientific literature, although extant batteries may be adapted for digital tablet format (with appropriate copyright permissions). Items for parent/legal guardian report will be drawn from existing instruments. All NBT data collection shall be completed using a digital tablet and enable, at minimum, battery scoring and preliminary analysis (e.g., identifying performance ranges relative to norms of the assessed individual) via the digital tablet, with capability for secure data transmission to other computers for data aggregation and further analyses as well as individual results printing for the clinical user Recruitment and retention of typically developing infants and toddlers, and their parent or guardian, will be representative of the U.S. population, including both preferred-language-English and preferred-language-Spanish speakers (and other languages as deemed necessary), so as to allow for representative developmental norms. The proposed battery will be piloted in a limited sample for feasibility testing and battery, technology, and protocol refinement, and then normed on typically developing infants and toddlers representative of the U.S. population (e.g., sex/gender, SES, race, ethnicity, rural- vs. urban-residing) with additional data showing the battery’s ability to discriminate and assess atypical development. The complete battery will be made available for assessment in both English and Spanish and will be normed in both infants and toddlers from homes where the primary language spoken is either English or Spanish; (i.e., sufficient numbers of both English-speaking and Spanish-speaking) populations will be assessed so as to provide statistical confidence of norms in both populations.

3) TECHNICAL REQUIREMENTS:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, facilities, and all appropriate proprietary rights, including intellectual property rights, not otherwise provided by the Government as needed to perform the Statement of Work below through the individual Task Orders (TOs) issued under this Indefinite Delivery Indefinite Quantity contract. Specifically, the Contractor shall:

1. Obtain all necessary human subjects protection and regulatory approvals per institutional and National Institutes of Health requirements.

2. Comply with FISMA requirements

3. Assist the NICHD COR in obtaining Office of Management and Budget (OMB) exemption or approval for the conduct of the study

A. Start-Up Activities:

1. The Contractor shall coordinate and implement an Initial Kick-off Meeting to include the Contracting Officer’s Representative (COR), the Contracting Officer and other Government officials. The purpose of the meeting is to meet the Contactor Staff and any subcontract staff (if applicable), for the COR to orient the Contractor about the purpose for developing the NIH Infant and Toddler Toolbox, to discuss plans for developing the assessment battery, use of a secure collaborative Web-based workspace, and determine a schedule of activities.

2. After the Initial Kick-Off meeting, the Contractor shall establish a "Program Management Team (PMT)".

The PMT will be responsible for the following:

a. Efficiently plan, implement, and manage all Task Orders (TOs) as they are awarded. The PMT shall follow NICHD established standard policies and procedures for ensuring effective and consistent communication with the Contractor, subcontractors (if applicable), consultants, the Contracting Officer's Representative (COR), and the Contracting Officer (CO).

b. The PMT shall be led by the Principal Investigator (PI) or another senior staff person who shall serve as the point of contact to the COR and is responsible to ensure effective management, quality control and government regulation compliance of all staff. The PI (or key staff) shall ensure quality control of all activities and ensure progress of projects.

c. This team shall include administrative staff capable of managing a complex operation that at a minimum includes: collaborating with multiple personnel; managing financial activities of the contract, subcontracts (if applicable), and individual tasks; creating technical/finance reports of all activities conducted and providing overall quality and required policy assurance of all project operations.

d. Provide access to research analysts, statisticians, quality control, and information technology (IT) staff capable of collaborating and key staff working on the individual Task Orders. The Contractor shall ensure consistency when overseeing the conduct of recurring NBT activities.

e. The Contractor shall develop a Draft Work Plan and provide a copy to the COR and CO for review and comment. The draft work plan shall include timelines and milestones for activities. At a minimum, the Draft Work Plan shall address the following:

i. Key staff roles and responsibilities for financial management; subcontracting; managing conflicts of interest; and satisfying reporting requirements (as listed in the “Reporting and Requirements” document). Criteria, measures and methods to objectively evaluate the effectiveness, productivity, and overall performance of all sites engaged by this contract.

ii. Processes to maintain frequent communication with the COR with respect to all activities performed.

iii. A tentative schedule of regular meetings and conference calls/webcasts with the COR.

iv. A plan to communicate to the COR revised procedures and problems in a timely fashion.

v. A summary of reporting requirements and deliverables.

vi. The Final Work Plan shall be dated and posted on the collaborative Web-based workspace's website for reference.

vii. By agreement of the CO, COR and PI, The Final Work Plan shall be modified and updated as needed to reflect newly adapted processes or activities.

B. Specific Focus Activities

1. The Contractor shall accomplish the following as specified in task order:

a. Identify the assessment measures (cognition, social functioning, language (receptive and expressive), numeracy, self-regulation and executive function) for appropriate age ranges between 1 and 42 months of age that are the best-fit extant assessment measures to be included in the NBT via the following or equally effective means:

i. Conduct a literature search and analysis of relevant cognitive, brain development, and social-emotional development infant and toddler tasks and parent/ legal guardian questionnaires or surveys relevant to the goals of the NBT, including those tasks available in English, Spanish, or both. Identify preliminarily tasks/questionnaires that may be best for inclusion in the NBT and the specific ages/ranges key to establishing the desired normative data tables, and

ii. Coordinate and implement a meeting of developmental cognition, brain development, early social development and early learning experts to obtain input on the neurocognitive domains and tasks most important to include in the NBT and the key developmental inflection points to create normed data around. Relevant NIH staff, including the NIH Baby Toolbox-Steering Committee (NBT-SC) and any others identified by the COR, shall also be invited to this meeting. A science writer must be provided to record and collate notes and summarize the discussions held at the meeting.

b. Finalize the assessment measures to be used in the NBT. All identified tasks shall be drawn from existing batteries or published scientific literature, although extant batteries may be adapted for digital tablet format (with appropriate copyright permissions). Items for parent/legal guardian report shall be drawn from existing, validated instruments. Provide to the COR, the CO, and the NIH Infant and Toddler Toolbox Steering Committee (NBT-SC) for approval, a description of the final tasks/questionnaires and how they will be implemented in a tablet format.

c. For copyrighted or intellectual property protected tests, acquire and abide by copyright or intellectual property permissions necessary for inclusion in and/or translation to a digital format for the NBT.

d. Create an NBT External Advisory Committee (EAC) to the PI comprised of outside experts, not affiliated with the Contract, who shall advise the PI and contractor staff on key issues, decisions, challenges, and product development throughout the entire Contract period.

e. Identify a digital tablet platform with the technological capabilities necessary to complete all NBT assessments (e.g., via eye-tracking and measurement such as speed of habituation), including presenting stimuli, collecting and storing all data (including data such as gaze location and duration, reaction times), analyze and transmit data, as well as produce researcher and clinician reports available on the tablet screen and/or via a print function as to an individual’s performance relative to NBT-established norms. In the event that an adequate tablet device cannot be identified for the implementation of the NIH Infant and Toddler Toolbox, the COR and CO will direct the Contractor to identify an alternative electronic system that will meet the goals of producing a safe, cost-effective, efficient and automated direct assessment tool for use in infants and toddlers.

f. Program the NBT software necessary for data collection, analysis, data transmission, and results reporting. All NBT data collection shall be completed using the digital tablet and enable, at minimum, battery/assessment scoring and preliminary analysis (e.g., identifying performance ranges relative to norms of the assessed individual) via the digital tablet, with capability for secure data transmission to other computers for data aggregation and further analyses, as well as individual results printing for the NBT user.

g. Establish policies and practices for data collection, transmission, and management in accordance with Government regulations and policies, and a centralized resource for data collection, data cleaning, analyses, archiving and back-up, and data sharing. This data resource must also provide project staff and/or consultants with design and statistical expertise for the life of the project. This resource must have the necessary computer, networking, data storage and statistical expertise to successfully manage the large amounts of data, data transmission/importing, and complex analyses anticipated for contract activities, as well as the necessary data security/protection capabilities in place. Together with the PI and PMT and in consultation with the NBT Advisory Committee, this data resource should establish a Data Safety Monitoring Plan, that is reviewed and approved by the COR, the CO and NBT-SC before any human data collection begins.

h. Establish a digital Data Code Book, detailing the nature and data type of all data fields, including any changes to data collection or coding. This Data Code Book must be available for review throughout the life of the award by the COR, the CO and NBT-SC and other Government officials, as well as the Contractor’s Advisory Committee as requested.

i. In consultation with the data resource (above, in 1.g.) and the External Advisory Committee, establish inclusion and exclusion plans for the pilot and norming tasks, as well as target numbers (of subjects) for each cell of the testing.

j. Identify recruitment strategy(s) and sources for pilot and norming testing of NBT. Also identify the need for multiple field sites for testing. Obtain IRB human testing approval for both planned pilot and norms testing of NBT.

2. The Contractor will accomplish the following as specified in task order:

a. Recruit and consent required number of participant parent/child dyads for pilot and norms testing.

b. Pilot the NBT tasks with typically developing infants and young children at the relevant ages;

adjust testing protocols as necessary with the approval of the COR and CO.

c. The proposed battery shall be piloted in a limited sample for feasibility testing and battery, technology, and protocol refinement, and then normed on typically developing infants and toddlers representative of the U.S. population (e.g., sex/gender, SES, race, ethnicity, rural- vs.

urban-residing) with additional data showing the battery’s ability to discriminate and assess atypical development.

d. The complete battery shall be made available for assessment in both English and Spanish and shall be normed in both infants and toddlers from homes where the primary language spoken is either English or Spanish (i.e., sufficient numbers of both English-speaking and Spanish-speaking homes); populations shall be assessed so as to provide statistical confidence of norms in both populations.

e. Develop a User Manual for the NBT, detailing specific measures and data points to be collected, as well as settings and requisite environmental or physical characteristics (i.e., placement of the tablet) for optimal data collection. Also, to be included are a Trouble-shooting section and “help-desk” contact information (e.g., phone, email, online real-time chat) with an audit trail of all help-desk contacts including a description of both problem and solution(s). This audit trail should be formative, facilitating the “Trouble-shooting” section of the User Manual and programming improvements.

f. Establish validity and reliability of NBT tasks/questionnaires within appropriate age ranges.

3. Identify the number of sites and human subjects necessary to pilot test and norm the NBT. Recruit field sites. Obtain single IRB approval for norming data collection protocol. Begin recruitment for norming protocol. The Contractor shall as specified in task order:

a. Recruit and consent required numbers of participant parent/child dyads for pilot and normative data collection. The study sample must be representative of the U.S. population, including both, but is not limited to, preferred-language-English and preferred-language-Spanish speakers, so as to allow for representative developmental norms.

b. Engage in scientific norming of the NBT for each identified age range with typically developing infants and young children.

c. Develop tables of normed scores for each age range to be incorporated into the automated scoring system and the digital User Manual (provided on the NBT device and at the publicly visible (to subscribers, Government staff, etc.) NBT website).

4. Discuss and propose a draft plan for sustainability, including wide distribution and user support services, updating software over time, and likely/proposed method of cost recovery plus profit for post-award distribution.

5. In consultation with the NBT External Advisory Committee (and concurrence from the COR and CO), select an atypically developing infant-toddler population with a well-documented high-risk for a specific developmental condition/disorder/disease to test, in order to demonstrate the utility of the NBT for differentiating typically and atypically developing children. Design and conduct additional assessments using the NBT with this sample of at-high-risk or atypically developing children with a specific developmental condition/disorder/disease. The purpose is to determine the usefulness of the NBT for children developing atypically and to discriminate atypically from typically developing children. Include:

a. Initial piloting of the NBT with children developing atypically at specified or all age ranges.

b. Reliability and Validity analyses, specifically addressing clinician-focused concerns and the sensitivity of the NBT to identify or predict future developmental perturbations.

c. Norming for the specific developmental condition/disorder/disease for the age ranges selected/specified.

6. The Contractor Shall as specified in task order:

a. Finalize all standardization and norming of the NBT, as noted above.

b. Finalize the automated scoring system and individual testing results interpretation and the User

Manual, providing additional user guidance on interpretation of individual testing results along with appropriate citations supporting these interpretations, as noted above.

c. Finalize the data management, storage/transfer/archiving, and sharing plans for the NBT beyond the final year of award, as well as finalize the Data Code Book for deposit with the full NBT data set as noted above.

d. Finalize for approval by the COR and CO the distribution and sustainability plan for the NBT beyond the final year of the NBT award, as noted above.

7. The Contractor shall deliver the following products ad events:

a. Initial Kick Off Meeting

b. External Advisory Committee Annual & Ad Hoc Meetings

c. Monthly Progress Calls/Meetings

d. Demonstration of working Prototype, User Manual & Data Code Book

e. Annual Site Visit Meetings

f. IRB Approval & Consenting Documents for Pilot testing of NBT Prototype

g. Field Site Assessment Tester Training Materials

h. IRB Approval & Consenting Documents for the NBT Norming study

i. Final Norms Tables

j. Final Data Code Book

k. Final User Manual

l. Field Site Tester Training Materials

m. Fully Operational Final NIH Infant and Toddler Toolbox Device, Assessment Battery and Norms

Interpretive Assessment Report (generated for end-user)

n. All Final NBT Application Source Code, Algorithms and Data Sets

C. Project Management

1. The Contractor Shall as specified in task order:

a. Provide a Principal Investigator responsible for overall project management, scientific integrity and rigor, integration and coordination of the NBT effort. The PI shall recommend modifications to project requirements and timelines.

b. Provide a sound technical, scientific, and administrative infrastructure, including a PMT and Advisory Committee

c. Efficiently plan, initiate, implement and complete all projects carried out under this contract.

d. Report progress, problems and issues with the COR, and the CO within the following timeframes.

Problems within 24 hours. Progress reports as specified in the deliverables.

e. Ensure all components of this contract are compliant with applicable government policies (e.g., produce, test, and provide evidence of all products being in compliance with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L.

105-220)).

2. Subcontract Management and Reporting (if applicable)

a. Solicit, evaluate, award and manage subcontracts as needed for the successful completion of tasks required for the NBT.

b. Submit Quarterly Technical Reports on subcontractor performance and progress toward achievement of defined tasks and responsibilities within established timelines.

c. Identify and resolve problems with Subcontractor performance.

d. Ensure that all subcontractor personnel, equipment and facilities comply with all applicable regulatory requirements, e.g., Good Clinical Practice (GCP) training, and 508 accessibility [Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220)] of all materials and products, in effect throughout the contract period of performance.

e. Ensure the complete and effective transfer of technology and other products by the subcontractors to the Contractor, or to the COR and CO.

f. Perform all necessary transition and closeout functions on each subcontract.

3. Meetings and Teleconferences

a. Contract Initiation Meeting

As noted above (“A. Start-Up Activities 1.”) the Contractor shall conduct a one-day Contract Initiation Meeting with the COR, the Contracting Officer and other NIH personnel designated by the COR, to be held at a mutually (i.e., PI and COR) agreed upon site. The purpose of the Contract Kick-off Meeting shall be to orient the Contractor to NICHD contract procedures and expectations.

b. Monthly Meetings/Teleconferences as specified in task order

1) Plan and conduct meetings of the PI/designated Contract Contact and the COR, either in person or via teleconference, to review overall progress.

2) The Contractor shall plan and conduct meetings of the Contractor’s Principal Investigator/designated Contract Contact and Project Manager with the COR and CO either in person or via teleconference, to review findings (e.g., from scientific literature review, technology review, and meetings), protocols (recruitment, data coordination and management, etc.), regulatory approvals (IRB approval, copyright authorizations, etc.), the status of approved projects (human subject protocols, etc.), and to discuss any matters relevant to the scientific and financial administration of the contract and future activities.

3) The Contractor shall prepare and distribute the agenda and meeting/teleconference materials to all participants.

c. Periodic Written Reports as specified in task order

a. The Contractor shall provide a written summary (i.e., meeting date, list of participants, discussed topics, action items, and outcomes) of all meetings and teleconferences for review and acceptance by the COR, including:

i. Initial Kick off Meeting Summary Report

ii. List of Program Management Team (PMT) Roles & Responsibilities

iii. Draft & Final Work Plan

iv. Literature Assessment Selection Report, Infant & Toddler Developmental

Assessment Experts Meeting Assessment Selection Report & Final Assessment Selection Report

v. Final List of External Advisory Committee (EAC) Members

vi. External Advisory Committee Meeting Minutes Summary

vii. Monthly Progress Call/Meeting Summary

viii. Final Assessment Selection Report

ix. Digital Tablet Selection Report

x. List of Pilot Protocol & Test Sites

xi. Readiness to Advance to Next Task Order Report

xii. Reliability & Validity Assessments Report

xiii. Participant Recruitment Report

xiv. Validity Report

xv. Usability Report

xvi. Updated Data Code Book

xvii. IRB Approval & Consenting Documents for the NBT Norming study

xviii. Participant Testing Completion Report

d. Annual Site Visit as specified in task order Arrange and conduct annual site visits to be held at or near the NIH in Bethesda, MD for the COR, CO and NIH NBT Steering Committee, and other government officials, as invited by the COR, to review and discuss: project progress; problems and obstacles and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans. These site visits shall be attended by the PI, the Contractor’s business representative, and all contract key personnel (i.e., PI and significant contributors to the planned discussion content of the meeting, such as the Project Manager, assessment experts, statisticians, technology developers, etc.). The annual visit with the Advisory Committee can sequentially coincide with this annual site visit. The Contractor is responsible for:

1) Identifying a meeting location, date, and time in coordination with the COR and CO.

2) Planning and submitting the agenda to the COR two weeks before site visit.

3) Developing accessible written and oral presentation materials;

4) Arranging for the logistics associated with the site visits and for travel costs for all non-

Government site visit attendees; and

5) Preparing and submitting Annual Site Visit reports to the COR and CO.

D. Intellectual Property The Contractor shall be solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed to perform the project. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the Contractor any proprietary rights, including intellectual property rights, or any materials needed by the Contractor to perform the project. The Contractor is required to report to the U.S. government all inventions made in the performance of the project, as specified in FAR 52.227-11 (Bayh-Dole Act).

E. Final Transition As specified in task order, the Contractor shall ensure an orderly, secure, and efficient transition of contract-related materials and activities to the successor contractor or to the Government. A description of transition activities, timelines, and assigned staff shall be provided in a Draft and Final Transition Plan, which shall be reviewed and approved by the COR and CO.

The Draft and Final Transition Plan shall include the following as required by the task order:

1. Estimate of cost, time frame to complete transition and the staff required to execute a successful and timely transition.

2. Any outstanding deliverables with final delivery dates.

3. List of open actions needed to ensure completion during the transition period.

4. List of incomplete remedial site actions or open issues and plan for their resolution.

5. List of facilities and equipment support provided and any scheduled support to be provided during the transition period.

6. Provide a list of all subcontracts (if applicable) with a transition plan.

7. A list of coordination plans/activities as specified in the approved sustainability plan.

8. A cleaned and edited data set, on media and in a format determined by the COR and CO with copies of all data management tools, including data documentation, data dictionaries, data entry software and editing programs to allow reading and analysis of the data.

9. Fully documented programming (including each significant version of the programming, via the detailed annotated source programming code, and the final Data Code Book that documents all changes in data collection) for tasks/questionnaires developed.

10. All computer programs used for reading, cleaning, manipulating, graphing, and analyzing data and programs used for generating reliability, validity, scoring, standardization and norming of the NBT.

11. An audit trail of all raw data corrections, verified by COR as readable electronic copies of the original data collected from study participants from all studies conducted under this Contract, and all logs and other records related to data collection, entry, editing, analysis, and transfer, including the Data Code Book.

12. Final Report with summaries of products and analyses performed by the Contractor through all TOs issued under this IDIQ Contract.

STATEMENT OF WORK-TASK ORDER 1 ATTACHMENT 3b

Attachment 3b - STATEMENT OF WORK – TASK ORDER 1 Establish Requisite Resources for NBT Activities

I. BACKGROUND AND INTRODUCTION

There is a wide range of early developmental assessment or screening instructions. Standardized, reliable assessment instruments (e.g. Mullen Scales of Early Learning, Brigance Inventory of Early Development, Battelle Developmental Inventory, etc.) allow for direct evaluation of infant/child behaviors but they are time intensive, expensive to purchase, require highly trained personnel for administration, scoring, and interpreting, and often rely on outdated norms.

II. SCOPE

There is a wide range of early developmental assessment or screening instruments. Standardized, reliable assessment instruments (e.g., Mullen Scales of Early Learning, Brigance Inventory of Early Development, Battelle Developmental Inventory, etc.) allow for direct evaluation of infant/child behaviors but they are time intensive, expensive to purchase, require highly trained personnel for administration, scoring, and interpreting, and often rely on outdated norms. The purpose of the NIH Infant and Toddler Toolbox (aka the “NIH Baby Toolbox” [NBT]) is to develop and nationally norm an easy to administer, score, and interpret infant and toddler assessment inventory of cognition, social functioning, language (receptive and expressive), numeracy, self-regulation and executive function for research and clinical use in children between 1- to 42-months of age that will include direct child assessment (preferred measurement), supplemented as needed by parental/ legal guardian report.

Toward these goals, the purpose of this task order is to identify and establish the requisite resources that will be needed to support and build the NIH Infant and Toddler Toolbox (NBT), including resources needed to provide infrastructure and support for study conduct, data acquisition, quality and monitoring, and delivery of prototype products. Major responsibilities include identifying and selecting scientific and statistical experts for consultation, and appropriate measures and hardware to be implemented by the NBT. Also required are data quality and integrity testing and assurances, producing thorough data documentation, cleaning and verifying of data, supporting administrative and regulatory requirements, and selecting and securing NBT piloting field sites.

III. TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the following work. Specifically, the Contractor shall:

1. Obtain all necessary human subjects protection and regulatory approvals per institutional and National Institutes of Health requirements.

2. Comply with FISMA requirements

3. Assist the NICHD COR in obtaining Office of Management and Budget (OMB) exemption or approval for the conduct of the study

A. Identify Key Team/Person Roles, Team Management, Policies & Procedures, and Communication Strategies

1. Organize and execute an initial “Kick-off Meeting” within two weeks of TO award, at a mutually agreeable location, date and time, to introduce contractor staff and governmental contracts personnel, clarify contract goals, reporting requirements and schedule, and establish effective communication strategies and a collaborative Web-based workspace to facilitate communications between the Contract Officer Representative (COR), Contracting Officer (CO), and contract PI/Primary Point of Contact (PPC). This meeting can be held in-person, via the web, or some combination of both. The meeting should include as many contract staff as possible, but must include the PI and if different, the PPC, and senior contractor staff. Both the COR and CO must also be available to attend.

2. Plan a monthly phone or VOIP meeting at mutually agreed upon times and dates between the PI/PPC and COR, and whomever else the COR requests or approves of their attendance. The purpose of these meetings is to monitor and report on progress, identified challenges, and the strategies to resolve or overcome them. Within 2 business days post Kick-Off Meeting, the contractor will email their summary notes to the COR and CO for review and concurrence.

3. Establish the Program Management Team (PMT) and core NBT staff.

Provide the COR with a listing of PMT persons and their roles. Likely members of the PMT and core NBT staff will include, but are not limited to:

a. Identify Principal Investigator (PI)/Primary Point of Contact (PPC)

b. Identify staff roles/responsibilities (including, but not limited to):

i. administrative staff capable of managing a complex operation

ii. financial manager

iii. information technology (IT) staff with computer tablet expertise

iv. statistician(s) & methodologist(s)

v. data management staff

vi. library information and research analyst(s)

vii. scientific experts (e.g., infant/toddler developmental clinical assessment expert(s))

viii. planned consultant(s), as needed

ix. subcontractor(s), as needed

4. Draft a Work Plan describing all planned activities needed to accomplish the goals of Task Order 1 and their timelines, including requisite minimum staffing. Include a risk assessment (i.e., possible/anticipated challenges), likely solution strategies, and how/whether timeline and budget would be affected. The Draft Work Plan is due to COR and CO/CS within 15 days of Task Order Award, with final Work Plan due upon approval of negotiated draft.

B. Identify and select existing assessments/batteries to be used in the NBT

There are many possible strategies to identify the “best-fit” extant assessments and measures to be incorporated into the NBT. The following two frequently implemented strategies, used together, have successfully been used in similar task selection projects such as the NIH Toolbox, but the Contractor is not limited to these strategies:

1. Conduct an extensive published literature search for extant measures or batteries that are widely accepted in the scientific field and/or are validated assessments of the required domain(s) with equivalent versions in both English and Spanish. Provide COR with Assessment Selection Report resulting from literature search.

2. Coordinate and implement a meeting of developmental cognition, brain development, early social development and early learning experts to identify the best assessments that can meet the requirements for use in the NBT. Provide COR with Assessment Selection Report resulting from expert meeting.

3. Once all assessment measures search efforts have been completed, the Contractor shall establish a final streamlined list of the selected measures to be incorporated into the NBT, paired to the domain being assessed, and provide this list to the COR. Once these measures have been established, the Contractor shall secure and abide by any required copyright/trademark permissions for incorporation of the assessment into the NBT.

C. Establish an External Advisory Committee (EAC) that will meet no less than annually throughout the life of the NBT contract; the first meeting must be held in-person, thereafter it can be held in any manner the EAC and Contractor deem most efficient or cost-effective.

1. Identify & recruit a minimum of 5 external advisors with relevant yet diverse expertise to offer guidance and insight throughout the entire project. A list of EAC members, and their affiliations will be provided to the COR for review and approval, and provide updates as needed. The EAC will report their deliberations and recommendations in writing to the PI/PPC, who in turn will share a written (or e-doc) copy and discuss these with the COR within 30 days after the meeting.

2. Convene the first annual EAC meeting (in-person meeting mandatory) within six months of this TO award. The PI/PPC and Program Manager are required to attend all EAC meetings;

COR attendance must be invited and accommodated, but attendance is not required.

3. Establish the purpose, procedures/practices (e.g., voting procedures), & processes (e.g., frequency of meetings, meeting format) of the EAC and member responsibilities (per federal policies/requirements); identify EAC Chairperson (must not be contractor staff; will serve as primary contact for communications with contractor and COR outside of regularly scheduled meetings, convenes meetings, signs-off on meeting summaries, etc.)

D. Identify the digital platform for NBT and move all selected assessments onto the digital tablet platform

1. Survey potential digital tablets and already-available attachments to enable assessments

2. Identify the best-fit digital tablet with or without attachments to enable the requisite testing and measurement/data acquisition. (Considerations should include, but are not limited to ease of programming, functionality, product life (duration), durability, flexibility to adapt as needed, secure data transmission capabilities, cost, single-charge battery capacity, etc.) Provide the COR with a brief written Digital Tablet Selection Report detailing devices considered and justification for final device selection.

3. Adapt and install assessments for digital tablet format.

4. Conduct prototype performance testing and debugging (QA, integration and functional testing, etc.) and modify prototype as needed to improve performance. Prototype performance must meet or exceed 80% reliability (i.e., successfully execute NBT testing stimuli presentation and subject response measurement without glitch or failure 80% of the time the prototype assessments are in active use).

5. Conduct formative usability testing of prototype with a sample (N>10) characteristic of likely users who are naive to the NBT and adjust prototype accordingly. Usability ratings of all components must reach “satisfied/good” or better in >75% of those surveyed.

6. Establish a user support service for end users of the NBT in the pilot and norming studies, with the goal of formatively establishing product support services for users in the NBT distribution phase, post contract.

7. Create an NBT User Manual (with a troubleshooting section and user support contact information) for use in the pilot and norming studies at field sites. Collect and track formative user data to improve user support services. Provide User Manual to COR at first Annual Site Visit Meeting.

E. Establish a centralized resource for data management

1. Develop and implement a comprehensive Data Management Plan (DMP) less than 4 pages in length, addressing all essential aspects of data management and documentation including description of roles and responsibilities; the context and methodology for data collection including expected data types and annotated data collection instruments; documentation procedures of all files, variables, naming conventions,…