Amend_No_1-RFP-2018-6_DIPHR_DCC_.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 12

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

001 June 26, 2018 N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6)

CODE

Office of Acquisitions NICHD Contracts Management Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health

6710B ROCKLEDGE DRIVE

BETHESDA, MD 20892-7000

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) X 9A. AMENDMENT OF SOLICITATION NO.

TO ALL POTENTIAL OFFERORS

RFP-NIH-NICHD-DIPHR-2018-6

9B. DATED (SEE ITEM 11)

June 11, 2018

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

N/A

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

() A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET

FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copy.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE: To amend RFP NIH-NICHD-DIPHR-2018-6 entitled “Multiple Study Data Coordinating Centers for Division of

Intramural Population Health Research (DIPHR)” to provide answers to questions.

DUE DATE: Until July 11, 2018, 4:00 PM Local Time (Eastern Standard Time (EST) (Unchanged).

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Theresa Koomson, Contracting Officer NICHD Contracts Management Branch, OA

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY _______________/S/________________

(Signature of Contracting Officer)

06/26/2018

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

RFP NIH-NICHD-DIPHR-2018-6

Amendment Number 01

A. As a result of this Amendment the RFP is revised as follows:

1. SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B. 4. ADVANCE

UNDERSTANDINGS is modified to include the following:

Since all awardees will be given a fair opportunity to be considered for each task order and sample task order included in this solicitation, the Government reserves the right to award all related task orders to the same Contractor(s) as a logical follow-on to the task orders already issued under the contract.

2. SECTION H– SPECIAL CONTRACT REQUIREMENTS is modified to add ARTICLE H.30.:

ARTICLE H.30. ON-RAMP

The Government intends to establish an awardee pool under the Multiple Study Data Coordinating Centers for Division of Intramural Population Health Research (DIPHR) effort. The Government will initially establish the awardee pool by competitively awarding approximately two (2) IDIQ contracts. The Government reserves the right to reopen competition at any time during the term of the contract to add additional contractors to the original pool of awardees. When reopening competition, the Government will advertise via Federal Business Opportunities (FedBizOpps) to bring the awardee pool up to a greater number of awardees. Any awardee already in the awardee pool will not recompete for an awardee pool position. The On-Ramp competitions will use the same evaluation methodology and documentation (except for any updates required to reflect changes in regulatory provisions and commercial practices and certifications) as the original competition. Once a new awardee(s) is selected, that awardee(s) will be included in the awardee pool and will compete for future task orders. The ordering period for new contractors being added to the initial awardee pool will coincide with awardees ordering period.

B. This Amendment provides answers to questions received regarding this RFP, please note that individual questions may have been combined or reworded.

Question 1:

For the web-based data coordination and management system, please advise whether or not it is anticipated for the system to directly interact with the Electronic Health Record systems.

Answer:

The web-based data management system is not required to interact directly with the EHR; the EHR data transfer must be initiated at the clinical sites, after which the DCC contractor will be responsible for verifying the dataset and producing deliverable files and documentation.

Question 2:

For the web-based data coordination and management system, please advise if the system needs to provide view and analysis capabilities for imaging files.

Answer:

This is not a requirement of the EDC system.

Question 3:

In addition to tracking of serious adverse events, please advise if the DCC needs to support reporting serious problems to FDA.

Answer:

Yes, for studies involving investigational drugs or devices, this support would be required.

Question 4:

If a commercial data entry software is proposed, does the commercial data entry software and source code need to be delivered to the government at the close-out of the task order period?

Answer:

Under I. 5. C. iii., all source code developed, modified and/or enhanced under this contract is deliverable;

thus, if commercially-available source code is not developed, modified and/or enhanced, it is not deliverable.

Similarly, under E. 7. a., all data management tools are deliverable including any data entry software; if no data entry software is developed under this contract for the creation of the final datasets or documentation, then this is not a deliverable.

Question 5:

Can the government provide the labor categories that are required to support the DIPHR DCC? Can the government provide an estimated level of effort for the IDIQ and Task Order labor requirements?

Answer:

Offerors should provide, based on their previous experience on similar projects, their best estimates for the effort needed to meet the requirements of the Statement of Work.

Question 6:

For each Task Order, please clarify whether sites have been pre-selected and have already undergone qualification and readiness reviews? Please also idenify what entity(ies) are or will be responsible for negotiating and executing site contracts.

Answer:

The study site for Task Order 1 was awarded to the University of North Carolina at Chapel Hill. The solicitation for the study sites for Task Orders 2 and 3 has been posted in a separate RFP. The RFP is located at the following link: https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-DIPHR-2018-12/listing.html

Question 7:

Can the NICHD DIPHR provide a breakdown of the estimated number of unique case report forms (CRFs) to be collected per participant in each study and substudy? Can the NICHD DIPHR provide a breakdown of the estimated number of total CRFs to be collected per participant in each study and substudy?

Answer:

We are unable to provide these estimates, as each study is quite unique. They can only be determined after finalization of the protocols and manual of procedures in conjunction with the clinical sites. Typically, this is done within the first 6 – 12 months after award of the clinical site contract.

Question 8:

The Proposal states, "The Contractor shall provide hardcopy standardized forms for participants with no internet access." For paper data capture, who will be responsible for data entry - the site staff or DCC contractor?

Answer:

The DCC contractor will be responsible for data entry of hardcopy forms where necessary.

Question 9:

The RFP states that the DCC will track biospecimens from collection to participating study laboratories and https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-DIPHR-2018-12/listing.html the NICHD’s biospecimen repository. Is the DCC responsible for reconciliation activities for laboratory data that is collected at study laboratories?

Answer:

No, biospecimen analytic data will be produced under separate contracts with laboratories that are directed by the Government, and such data will be delivered directly from the laboratory Contractor (not the DCC Contractor) to the Government. The DCC Contractor shall provide tracking of the biospecimens themselves (e.g. tubes) during the period of the Contract, particularly tracking from collection at clinical sites to storage at the NICHD biospecimen repository.

Question 10:

The proposal states the DCC shall, " 8. Coordinate the purchase of materials and supplies required for the studies and provide quality control." Can the government provide additional details, or clarify which materials or supplies should be included in the proposed budget estimates?

Answer:

Such supplies may include sites’ purchasing blood collection tubes, biospecimen aliquot tubes, barcode scanners, balances, etc, as needed and appropriate to the particular Task SOW.

Question 11:

The RFP states, " At the site visit, the Contractor shall systematically review staffing, facilities, documentation, procedures, data management, and source documents." It is understood that the on-site visits will focus on data quality. Will the DCC also be responsible for clinical site monitoring including source data verification (SDV), review of site regulatory binders, IP accountability records, etc? What is the expected duration of the annual on-site reviews?

Answer:

Yes, the DCC Contractor will be responsible for all of the above, though source data verification may be required at varying rates for different Task Orders. Typically on-site visits are 1-2 days and remote monitoring has been utilized in the past as well.

Question 12:

The RFP states, "12. Provide expert services such as biostatistical, information technological, or laboratory, as required to meet the study's needs." Please clarify what additional biostatistical, IT, or laboratory services will be required? How should offerors include these expenses in their budgets?

Answer:

The Government seeks to partner with the DCC to carry out the study Tasks. Depending on the task, the Government seeks DCC PIs and staff to provide biostatistical input (e.g. to perform interim analyses or help inform study design decisions) and information technological expertise to optimize the design and implementation of the web-based data system and any electronic interface with participants (e.g. participant emails, newsletters, data collection pages, websites). Offerors should include staffing with relevant expertise and expense this labor as they deem appropriate.

Question 13:

Please clarify what the DCCs role will be in "providing treatment drugs and placebos as needed for randomized clinical trials." The RFP states the treatment and placebo must be manufactured, blinded and delivered. Will offeror also be responsible for developing and approving labels? Storing IP a depot?

Answer:

The DCC contractor will work together with the Government for developing labeling and designing the IP and labels. Storage is generally expected to take place at clinical sites.

Question 14:

Will DCC contractor be expected to only procure treatments that are already marketed? Will any interventions included in Task Order studies be under an IND?

Answer:

For the currently proposed trial in Task 2, it is expected that manufacture of placebo and overcoating (or like method) of existing medications to match the placebo will be utilized. Whether or not the study will be under IND remains to be determined, according to FDA determination.

Question 15:

The footnote mentions a "data Information Security Plan" that should be included, but there is no other reference to such a plan elsewhere in the RFP. Can you please provide guidance for completing this plan?

Answer:

Correction - this plan is not required for the RFP submission.

Question 16:

This section requires a data sharing plan be included with the proposal. Does this criterion apply to the IDIQ level proposal or just the (sample) task order proposals?

Answer:

A general approach to data sharing plans is sufficient for the proposals.

Question 17:

Attachment 3 (SOW IDIQ), section III.D.4 is very similar to III.B.2. Is this a duplicate? If not, what's the difference?

Answer:

Yes, this is a duplicate. Please disregard III.D.4.

Question 18:

Attachment 7, section II.C.2 requires staff experience with PHP-based web applications. Please, clarify the purpose of this evaluation criterion since a) no tasks in the SOWs require developing PHP code, and b) use of web-based systems does not require knowledge of the programming language used to develop the system. If the criterion is indeed required, please clarify which PHP-developed system this is for.

Answer:

This criterion is for experience and expertise WORKING with PHP-based web applications. This criterion does NOT require experience and/or expertise developing such code.

Question 19:

How many sites are anticipated for Task Orders 1?

Answer:

There is 1 clinical site for Task Order 1.

Question 20:

Please, confirm that only the currently utilized by NICHD CTDB system can be used to support Task Order 1.

The CTDB system will be in place for data collection for Task Order 1 prior to award of this IDIQ. Offerors may propose moving to another system only if there is sufficient rationale for doing so.

Question 21:

The RFP states the DCC will "Conduct one in-person visit to the clinical site to ensure protocol adherence.

Two DCC staff members including the PI shall conduct the site visit. Establish and implement a written plan for site monitoring and reporting. At the site visit, the DCC shall systematically review staffing, facilities, documentation, procedures, data management, and source documents." What is the estimated length of these annual clinical site visits?

Answer:

Site visits are generally 1 – 2 days.

Question 22:

Task Order 1: if enrollment started in Spring 2018, will the current database be transferred to the DCC? Is the study database already developed? What level of transition is expected?

Answer:

The data will be collected under the CTDB system. The DCC contractor will assume responsibility for monitoring data collection and management after contract award. Transition requires simply registering for a login for access to the system.

Question 23:

Task Order 1: Can DIPHR provide a visit schema containing data elements to be collected, specifically laboratory and cognitive assessments?

Answer:

The Statement of Work for the study site RFP is attached to provide expectations regarding data elements to be collected. These are subject to change pending finalization of the protocol and manual of procedures.

Question 24:

Task Order 1: What biospecimens will participants be expected to collect at home?

Answer:

Please see the attached SOW for the clinical site RFP. Currently this includes only saliva, but this is subject to change.

Question 25:

Attachment 4 (SOW TO 1): Please, clarify if the NICHD's Clinical Trial Survey System (CTSS) will be used to track biospecimens for this study. If not, which system will be used?

Answer:

The Clinical Trials Database will be used to track biospecimens. The CTSS is the participant interface with the EDC system.

Question 26:

Attachment 4 (SOW TO 1) states that the study will use CTDB for data capture and, we assume, NICHD's Clinical Trial Survey System for specimen tracking. CTDB and CTSS are owned by NICHD and are not currently publicly available, nor has any information about their features (and lack thereof) been included in the RFP. As a consequence, only companies involved in their development can develop a sound data management technical approach for this study, as knowing the data capture systems is critical to design processes that will meet the Government requirements. Likewise, to accurately estimate the labor necessary to meet the RFP requirements it is critical to know what the systems can or can't do. Please, provide detailed user manuals and/or other documents covering topics such as: building studies and forms, entering data, creating edit checks, resolving queries, scanning and managing specimens, exporting data, etc.

Answer:

The NICHD Clinical Trials Database (CTDB, https://ctdb.nichd.nih.gov/ctdb/) is similar to any electronic data capture for data entry. Thus, any offeror with “expertise in the use and management of data collected through commercially-available electronic data capture systems comparable to the CTDB or REDCap” (Technical Evaluation Criteria, Attachment 7, II. C. 2) will be equally competitive. For studies using CTDB, the CTDB team will be responsible for building forms. A template in excel format is provided for users to complete for forms and edit checks.

The primary features of the system include the following:

• System Administration functions to control staff access to a study

• Multi-Site capabilities

• Data collection tools: single key or double-key data entry and electronic data upload per patient is also available.

• Reporting tool that allow researchers to directly export collected data.

• The Clinical Trial Survey System (CTSS), an ancillary web-based application, accessible outside the

NIH, which allows patients to remotely respond to clinical questionnaires or self-reporting instruments.

• A Bio-specimen management module that allows users to create custom locations and track the bio-specimens collected during trials.

• Quality Assurance Module that provides a workflow for third party monitoring and management of internal as well as external queries

• E-Regulatory Binder, a file management module for all the regulatory documentation.

Additional questions about CTDB to facilitate responding to the RFP are welcomed.

Question 27:

Task Order #1A:

B.#4 (follow-on to above): Please confirm that the same number/location of sites as provided in TO#1 would apply to TO#1A.

Answer:

If the corresponding clinical site task orders for the clinical site are awarded, it would only involve the same clinical site as for task order 1.

Question 28:

How many sites are anticipated for Task Orders 2?

It is anticipated to utilize 2-3 clinical sites, but this remains to be determined based on site capabilities.

Question 29:

Task Order 2: "Develop capacity for providing automated mailings for the study sites to facilitate communication with the trial participants." Will these be newsletter type mailings to update participants on trial status?

Answer:

This language refers email notifications for things like reminders for study visits or questionnaire completion, tied to the participants activity on the trial (e.g. randomization date, completion of questionnaires). An annual newsletter will also be sent.

Question 30:

Task Order 2: "Obtain the Contractor’s own Institutional Review Board approval." If the DCC does not have its own IRB, does the government anticipate additional central IRB approval will be needed? Is this in addition to NIH IRB approval?

Answer:

The DCC contractor shall coordinate all required IRB approvals; if this is not required of the DCC itself, the DCC shall manage the centralized and/or site IRBs as needed.

Question 31:

Task Order 2: Can NICHD DIPHR provide the number of clinical sites anticipated under Task Order 2?

Answer:

It is anticipated to utilize 2-3 clinical sites, but this remains to be determined based on site capabilities.

Question 32:

Attachment 5 (SOW TO 2), section IV.5 requires that the DMS "Incorporate electronic Case Report Forms (CRF) and a Manual of Procedures (MOP)." Does this mean that the MOP needs to be accessible through the DMS, that it has to be configured per the procedures described in the MOP, or something else?

Answer:

The MOP document should be kept up to date and available through the centralized, web-based DMS.

Question 33:

Attachment 5a (SOW TO 2E), section 4.4 states that a final study report must be developed, and that it shall include the "results obtained for the entire task order period of performance". Is this the final clinical study report or a final task order report? If this is the final clinical study report and task order 2E is separate from the preceding ones, there is an inconsistency because only the last part of the study would have been conducted in this task order. Please, clarify.

Answer:

The final study report shall describe the Task Order 2E work per the scope of the task, to include a report of the work performed during closeout, documentation of data management procedures, and work results obtained. The final dataset and analyses described in 4.2 and 4.3 pertain to the entire clinical study.

Question 34:

Task Order #2:

IV. #8: Can NIH/NICHD advise on the number of sites for which the contractor will need to obtain IRB approval? And, is it expected that the contractor will collect/review and request site updates of essential regulatory documents prior to assisting in the IRB submissions?

Answer:

It is anticipated to utilize 2-3 clinical sites, but this remains to be determined based on site capabilities. Also, subcontracts may be executed within these sites. The DCC will assist the sites with the development and updating of the necessary documentation and manage the approval documents obtained by the sites.

Question 35:

Task Order 2: Can DIPHR provide a visit schema containing data elements to be collected, specifically laboratory and cognitive assessments?

Broad schematics of the current concepts for data collection are below; for clarification, TO2-TOE do not include cognitive assessments.

1) Active followup:

2) Passive followup:

Question 36:

Task Order 2B, 2C, and 2D:

IV.#4: All 4 Task Orders requests the ‘coordination and implementation of Study Site Visits’. Can NIH/NICHD advise on the number of sites that will need to be visited and locations? And, is only one visit being requested as in Task Orders #1?

Answer:

Location are yet to be determined; we expect 2-3 clinical sites in Task Order 2 which shall be visited annually.

Question 37:

While we patiently await SAM to finalize the re-registration of our company (via the recent notarized letter requirement), please send me a copy of the above referenced attachment.

The Representations, Certifications, and Other Statements of Offerors is provided in the RFP at Attachment 12.

Question 38:

Please correct me if I am wrong, but I am reading this as 2 IDIQ awards for the opportunity to then take on 12 listed Task Order studies? Or is it 2 IDIQ awards who will then have the right to bid on a grand total of the 12 TO’s listed in RFP? Thanks for the clarification.

Answer:

The Government anticipates that it will award approximately two (2) IDIQ contracts. The offerors receiving an award of the IDIQ contract will then be considered for Task Order 1, Task Order 2 and Task Order 3 awards. The IDIQ selected contractors will have the opportunity to propose on future DIPHR DCC work.

Question 39:

Given the complexity of this solicitation, would the Government consider granting an extension to the submission due date?

Answer:

The RFP submission due date will not be extended.

Question 40:

Please confirm if the Past Performance Requirements (page 70 of the RFP) require a list of the last three contracts completed and a list of the last three current (active) contracts.

Answer:

The Past Performance Requirements require a list of the last 3 contracts completed… and the last 3 contracts awarded and currently being performed…

Question 41:

Is there an incumbent contractor currently supporting these activities for the DIPHR? If so, please clarify what activities and level of effort will be required from offerors for transition activities?

Answer:

EMMES Corporation is the DCC for the current ongoing DIPHR studies. No transition activities are expected.

Question 42:

Does the government intend to issue awards by complete Task Order, that is, a Task Order award will be inclusive of all sub-task orders (eg., Task Order 1 award will include 1, 1a, and 1b)?

Answer:

No, the sample task orders will not be awarded concurrently with the IDIQ contracts.

Question 43:

The additional business proposal instructions state, "3. Business Proposal: a. All offerors must submit one (1) Business Proposal with four (4) sections." Is it acceptable to provide cost estimates for each Task Order, or does the government require the cost estimates for each Task Order to also be broken down into sub-Task Order components?

Correction, the Business Proposal has three (3) sections not four (4). Cost estimates must be provided for each task order and each sample task order.

Question 44:

Section M.5 requires a data sharing plan be submitted with the proposal. Attachment 4 indicates that the plan is expected to be 3 pages long. Considering that the (sample) Task Order responses are limited to 10 pages, we suggest that these plans be excluded from the page count for the responses.

Answer:

The data sharing plan shall be excluded from the page limitation.

Question 45:

The section states "Offerors must address the following human subjects protections issues if this contract will be for research involving human subjects…" The information required is extensive and detailed. 1) is this information required for the overall IDIQ only, or is it required for each task order? 2) If required, especially for task orders, may this information be provided separately from the limited page count?

Answer:

The human subjects information is required for the overall IDIQ only. This information shall be excluded from the page limitation.

Question 46:

Is completing Attachment 14 sufficient to satisfy the requirements of RFP section L.2.b.4.a?

Answer:

No, Attachment 14 is not applicable to Human Subjects. See pages 84-94 for the required Human Subjects materials.

Question 47:

Please confirm that Attachment 13 is a required Technical Proposal attachment. It seems odd to have price information included in the technical proposal.

Answer:

Yes, this is a required attachment.

Question 48:

Will the Task Order and Sample Task Order reviewers have access to the IDIQ section? If so, is it acceptable to cross-reference the IDIQ response in the Task Order sections? If the above is acceptable, being able to use more pages for the IDIQ and less for the Task Orders would simplify review, as many processes will be the same across task orders and can therefore be developed in detail in the IDIQ.

Unlike grants, all reviewers on the panel will evaluate all proposals required by the solicitation. It is acceptable for Offerors to reference details that were already addressed; however, we recommend repeating information that is required for each SOW rather than referencing another proposal, as the evaluation can be more difficult for the reviewers. Also, when making reference it may be helpful to cite the section where it was already included.

Question 49:

Attachment 1, section II.B. Page limitations: Because the SOW of Task Order 1 is very similar to the SOW of Sample Task Orders 1A and 1B, we would normally describe our technical approach under Task Order 1 and we would then cross-reference it under the sample task orders. Therefore, we would not use the 10 pages for 1A and 1B but we would appreciate if we could use them for Task Order 1. In other words, we would prefer to have a 30-page limit for the combination of Task Order 1, Sample Task Order 1A and Sample Task Order 1B. The same comment applies to Task Order 2 and Sample Task Orders 2A to 2E (i.e., 60 pages total), and for Task Order 3 and Sample Task Orders 3A to 3C (40 pages total).

Variations in the page limitations for the individual task orders are acceptable; however, the technical proposal shall not exceed 150 pages total.

1 STATEMENT OF WORK - IDIQ ATTACHMENT 1

STATEMENT OF WORK

IDIQ CONTRACT

SPROUTS: Development of Eating Behaviors in Early Childhood

I. GENERAL DESCRIPTION OF THE REQUIRED OBJECTIVES AND DESIRED

RESULTS

A. Background:

The Division of Intramural Population Health Research (DIPHR) at the Eunice Kennedy Shriver National Institute of Child Health & Human Development designs and conducts original epidemiological, behavioral, and biostatistical research encompassing several research domains such as human reproduction and development, pregnancy and related complications, pediatric and adolescent health and behaviors, and methodologic research relevant for our mission.

DIPHR comprises three intramural research branches: Health Behavior, Epidemiology, and Biostatistics & Bioinformatics, whose mission is to design and implement original research with the potential for high impact findings for public health. DIPHR resides within the Intramural Research Program within the National Institutes of Health. Investigators within DIPHR design and lead original research studies that are subjected to a comprehensive review process including approval by the NICHD director before funding. Once approved for funding, DIPHR conducts research studies by soliciting, negotiating, awarding and administrating contracts with external sites to perform the approved initiatives. The purpose of this solicitation is to award a contract to perform the approved research study described below. NICHD intramural investigators develop a comprehensive statistical analysis plan to address the specific aims. NICHD will also provide a web-based data management platform for data collection and management. A separate solicitation with a Data Coordinating Center (DCC) will procure services to perform data management and quality control.

Scientific background: The interaction of environmental and individual factors is believed to underlie the rapid rise in excess weight in the United States over the last generation. Here, as in other developed countries, the obesogenic food environment is dominated by highly processed, energy-dense, palatable, accessible, affordable and marketed food products of minimal nutritional value (i.e., “discretionary foods”), which readily encourage intake in excess of energetic needs. Food reward sensitivity, the neurologic reward response to food stimuli, has emerged as an individual trait that may impact susceptibility to environmental influences on dietary intake and body weight. Food reward sensitivity is purported to drive hedonic eating, which is motivated by the pleasurable experience of eating independent of energy requirements.

However, critical knowledge gaps remain regarding the development of food reward sensitivity in early childhood and the roles of parental food reward sensitivity, the degree of exposure to highly rewarding foods, and other modifiable family feeding practices that shape the child’s food environment. Better understanding of the influences on child food reward sensitivity and its impact on child diet and growth will elucidate the relative importance of individual and environmental factors on eating behaviors and related health indicators, and provide critical knowledge to guide future intervention to advance the development of healthful eating habits.

The overarching goal of this project, SPROUTS, is to investigate these research questions in the PEAS (Pregnancy Eating Attributes Study) cohort consisting of mothers and their children who

2 STATEMENT OF WORK - IDIQ ATTACHMENT 1

are currently being followed from early pregnancy to 1-year postpartum. PEAS is an ongoing observational study collecting data on numerous variables including maternal neurobehavioral factors (e.g., food reward sensitivity, self-control), eating-related psychosocial attributes (e.g., food cravings, restrained eating), infant feeding practices and dietary intake, and maternal and infant anthropometrics. SPROUTS will continue to follow these participants to examine the development of child neuro-behavioral responses to food and the association of early life exposure to discretionary foods on diet-related behavioral and health outcomes. Secondarily, the follow-up will also allow collection of biospecimens for future analyses to examine novel processes to better understand eating behavior.

B. Objectives:

This study proposes to utilize a novel and efficient design by leveraging data, resources, and the existing infrastructure of an ongoing prospective cohort study to address important research questions within a life-course approach.

The primary aims of this study are to investigate prenatal maternal, early life, and contextual influences on the development of neurobehavioral factors underlying eating behaviors in young children, and to examine the impact of these neurobehavioral factors on trajectories of child growth and diet quality.

1) Maternal influences: To investigate the associations of child neurobehavioral factors (e.g., food reinforcement, attentional bias to food cues, hedonic eating, and food acceptance) with maternal neurobehavioral factors, pregnancy diet quality, and gestational weight gain.

2) Early life influences: To examine the relationships of early life maternal feeding practices, infant eating behavior, and exposure to discretionary foods with child neurobehavioral factors, diet quality, and physical growth.

3) Contextual influences: To investigate the influence of food type (highly palatable versus normo-palatable) on child attentional bias to food cues and hedonic eating.

4) Behavior and growth: To determine the associations of child neurobehavioral factors with trajectories of diet quality and physical growth. Secondarily, to determine how parent feeding practices, the home food environment, or child self-regulation modify these associations.

A secondary aim of the study is to investigate associations of maternal neurobehavioral factors and prenatal/postpartum diet quality on maternal weight trajectory during child-rearing.

Maternal neurobehavioral factors, pregnancy diet quality, gestational weight gain, early life maternal feeding practices, infant eating behavior, and exposure to discretionary foods were obtained in PEAS at multiple time points during pregnancy through one year postpartum.

C. Scope

Participants in PEAS who remain in the study through 1-year postpartum will be invited to participate in SPROUTS.

3 STATEMENT OF WORK - IDIQ ATTACHMENT 1

The purpose of this solicitation (Task Order 1) is to contract with PEAS UNC-Chapel Hill investigators to recruit, retain, and assess PEAS participants (children, mother and co-parent when possible) from approximately child aged 3-5 years according to the specified data collection schedule. Where feasible, a brief food frequency questionnaire (Palacios 2017) will also be administered to families at approximately child aged 2 years.

Contractor will obtain informed consent for all participants, and parental permission for child participation. Data will be conducted primarily in-person or by phone/telecommunication.

NICHD intramural investigators will develop a comprehensive statistical analysis plan to address the specific aims. NICHD will also provide a web-based data management platform for data collection and management. A separate solicitation for a Data Coordinating Center (DCC) will procure services to perform data management and quality control.

II. 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 under the term of this contract as needed to perform the following work.

Specifically, the Contractor shall, as required by individual task order, perform the following work including but not limited to:

1. Maintain and update participant contact information. Establish procedures for the successful recruitment and retention of participants. Perform cohort maintenance through, for example, mailing and/or emailing, and other modes of correspondence with the cohort.

2. Participate in developing the study protocols, data forms and accompanying Manual of Procedures (MOP) under the direction of NICHD. These documents will specify the study design, target population, recruitment and retention strategies, data collection methodology, training and supervising research staff, collecting and processing data and biospecimens, quality control procedures and compliance with Internal Review Board (IRB) requirements per the statement of work. Obtain and maintain IRB approval and, if necessary, other regulatory approvals for the study protocol as required. Collaborate in the development of the required government applications (e.g., Certificates of Confidentiality, NIH clinical exemption/clearance from OMB). Assist in obtaining IRB approval or reliance agreement from the National Institutes of Health (NIH).

3. Comply with Federal Information System Management Act (FISMA) requirements.

4. Participate in telephone conference calls with the NICHD, Contracting Officer’s Representative and the DCC. A toll-free dial-in number will be provided by NICHD.

5. Provide input into the development of the web-based data management system that will support the study. Use the NICHD Clinical Trials Database (CTDB) web-based data management system for all study data collection. Where necessary, scan or directly enter data using double data entry into the web-based data management system. Ensure all study staff are adequately trained for data collection through the CTDB.

4 STATEMENT OF WORK - IDIQ ATTACHMENT 1

6. Obtain equipment for data collection according to the protocol and agreed-upon procedures.

7. Re-contact, recruit, and consent eligible mother-child dyad participants of PEAS. Recruit and consent co-parents where possible.

8. Collect mother/co-parent self-reported data by questionnaires/surveys to assess maternal and/or co-parent variables including but not limited to socio-demographic, reproductive, socio-behavioral, diet, physical activity, and other relevant behaviors and psychosocial variables and medical conditions, or as otherwise specified; questionnaires will also ascertain parent-reported child variables. The majority of data shall be collected at the in-person assessments to maximize compliance. Employ additional assessment technologies as needed.

9. Measure maternal, co-parent, and child weight and height by standardized protocols.

Such measurements shall be taken at centralized locations by trained research staff.

10. Assess child neurobehavioral variables including but not limited to attentional bias to food cues, food reinforcement, food preferences, eating in the absence of hunger, delay of gratification and executive function. Such assessments shall be conducted at in-person study visits in laboratory-controlled conditions at Contractor facilities by trained research staff.

11. The staffing plan shall include an on-site investigator with documented experience and expertise in performing relevant behavioral assessments in preschool-aged children, as evidenced by previous research funding, study leadership and publication record.

12. Attend and participate in annual investigators’ meetings at the NIH in Bethesda, MD.

13. Host annual site visits by NICHD COR and (potentially separately) by the DCC.

14. Coordinate with the DCC to assure completeness and quality of the data.

15. Submit final draft of field MOP.

16. Participate in data analysis and preparation of scientific papers with NICHD investigators.

17. Prepare and submit the Final Study Report.

STATEMENT OF WORK – TASK ORDER 1 ATTACHMENT 2

TASK ORDER 1

SPROUTS Start-up, Recruitment and Data Collection

I. Background

The government has a need to establish a cohort study, leveraging on existing historical data from the PEAS ongoing study, to recruit mother-child dyads, and co-parents where possible, and collect baseline information. Establishing this framework is critical to the successful recruitment of participants and data collection. Maternal neurobehavioral factors, pregnancy diet quality, gestational weight gain, early life maternal feeding practices, infant eating behavior, and exposure to discretionary foods were obtained in PEAS at multiple time points during pregnancy through one year postpartum.

Data collected during this task order (TO1) will include child attentional bias to food cues, delay of gratification, and anthropometrics. Child eating behaviors, food intake, parent feeding practices, home food environment, and anthropometrics will be obtained from mothers. Where possible, co-parents will be asked to complete assessments of reward-based eating, child feeding practices, impulsivity, division of responsibility for child feeding, and anthropometrics.

II. Objectives:

This task order will recruit the SPROUTS cohort, develop the Manual of Procedures, and obtain administrative approvals and finalizing data collection instruments and methods. The task will also include data collection at child age 3 years (approximate), and where feasible, will include a brief food frequency questionnaire at child age 2 years (approximate). These measures will be used to address the following hypotheses/aims:

1) Maternal influences: To investigate the associations of child attentional bias to food cues and eating behaviors (at approximately age 3 years) with maternal neurobehavioral factors, pregnancy diet quality, and gestational weight gain.

• Maternal neurobehavioral factors, pregnancy diet quality and gestational weight gain are being collected at multiple time points in PEAS

2) Early life influences: To examine the relationships of early life maternal feeding practices, infant eating behavior, and exposure to discretionary foods with child attentional bias to food cues, eating behaviors, diet quality, and BMI percentile at approximately age 3 years.

• Early life maternal feeding practices, infant eating behavior and exposure to discretionary foods are being collected in PEAS; the age 2 food frequency questionnaire will contribute to these data.

3) Contextual influences: To investigate the influence of food type (highly palatable versus normo-palatable) on child attentional bias to food cues.

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. Establish procedures for the successful recruitment and retention of participants, including maintaining/updating participant contact information. Perform cohort maintenance through, for example, mailing and/or emailing, and other modes of correspondence with the cohort.

2. Participate in developing the study protocols, data forms and accompanying Manual of Procedures (MOP) under the direction of NICHD. These documents will specify the study design, target population, recruitment and retention strategies, data collection methodology, training and supervising research staff, collecting and processing data and biospecimens, quality control procedures and compliance with Internal Review Board (IRB) requirements per the Statement of Work.

3. Prepare necessary materials for IRB and, if necessary, other regulatory approvals for the study protocol as required by the institution. Collaborate in the development of the required governmental applications (e.g., Certificates of Confidentiality, NIH clinical exemption/clearance from OMB). Assist in obtaining IRB approval (or reliance agreement) from the National Institutes of Health (NIH). Obtain and maintain IRB approval throughout the conduct of the study.

4. Comply with Federal Information System Management Act (FISMA) requirements.

5. Schedule and participate in weekly 1-hour telephone conference calls between study site key personnel, the NICHD Contracting Officer’s Representative and the DCC.

NICHD will provide a toll-free dial-in number.

6. Provide input into the development of the web-based data management system, the NICHD Clinical Trials Database (CTDB), that will support the study. Ensure all study staff are adequately trained for data collection through the CTDB. Use the CTDB for all study data collection; where exceptions to the use of the CTDB for direct data collection, scan or directly enter data using double data entry into the

CTDB.

7. Obtain equipment for data collection (e.g., eye-trackers, data collection computer tablets) according to the protocol and agreed-upon procedures.

8. Re-contact, recruit, and consent a target of 260 (200 minimum) eligible mother-child dyad participants of PEAS.

9. At approximately child age 3 years, assess the following variables using measures including but not limited to those delineated in the table below. Data shall be collected at the in-person assessments to the extent possible to maximize compliance. Employ additional assessment technologies (e.g., phone interviews) and strategies as needed to collect the required data given considerations for participant burden, staffing requirements, etc. Specific procedures will be developed in collaboration with UNC investigators under the direction of NICHD after award. Comparable measures may be substituted if determined to be preferable; assessments will be finalized in collaboration with UNC investigators under the direction of NICHD after award.

Respondent Construct Assessment Child Attentional bias to food cues Laboratory measure using eye-tracker

Delay of gratification Laboratory measure- “marshmallow task” (Mischel 1989)

Height and weight Standard protocol at in-person assessment Parent Child food intake Two non-consecutive parent proxy 24-hour diet recalls Child eating behaviors Children’s Eating Behavior Questionnaire

(CEBQ) (Wardle 2001) Problematic Child Mealtime Behaviors subscale of the Meals in Our Household Questionnaire (MHQ) (Anderson 2012)

Parent reward-based eating Reward-based Eating Drive Scale (Mason 2017)

Parent feeding practices Comprehensive Feeding Practices Questionnaire (CFPQ) (Musher-Eizenman 2007), OR Caregiver Feeding Styles Questionnaire (Hughes 2005)

Home food environment Home Food Inventory (Fulkerson 2008)- to be completed by parent at home

Mother’s weight Standard protocol at in-person assessment

Co-parent (opt-in)

Parent reward-based eating Reward-based Eating Drive Scale (Mason 2017)

Parent feeding practices Comprehensive Feeding Practices Questionnaire (CFPQ) (Musher-Eizenman 2007), OR Caregiver Feeding Styles Questionnaire (Hughes 2005)

Co-parent height and weight Standard protocol at in-person assessment Impulsivity Barratt Impulsivity Scale (abbreviated)

(Spinella 2007) Division of responsibility for child feeding

Measure to be determined

10. Where feasible, administer a brief child food frequency questionnaire to mothers at approximately child aged 2 years.

11. Attend and participate in annual Investigators’ Meetings at the NIH in Bethesda, MD.

12. Host an annual site visits by NICHD and (potentially separately) by the DCC.

13. Monitor the study’s progress using the reports generated by the CTDB to ensure completeness and quality of the data. Take timely corrective action as needed.

14. Submit quarterly and final task order report.

15. Participate in data analysis and preparation of scientific papers with NICHD investigators.

1 STATEMENT OF WORK – SAMPLE TASK 2

ATTACHMENT 3

SAMPLE TASK ORDER 2

SPROUTS age 4 assessment

I. Background

The government has a need to establish a cohort study, leveraging on existing historical data from the PEAS ongoing study, to recruit mother-child dyads and collect baseline information. Establishing this framework is critical to the successful recruitment of participants and data collection. Maternal neurobehavioral factors, pregnancy diet quality, gestational weight gain, early life maternal feeding practices, infant eating behavior, and exposure to discretionary foods were obtained in PEAS at multiple time points during pregnancy through one year postpartum.

Data collected during this task order (TO2) will include child eating in the absence of hunger (EAH), executive function, and anthropometrics. Child eating behaviors, food intake, parent feeding practices, home food environment, and anthropometrics will be obtained from mothers.

II. Objectives:

This task order will conduct assessments of SPROUTS participants at approximately child age 4 years. These measures will be used to address the following hypotheses/aims:

1) Maternal influences: To investigate the associations of child EAH and eating behaviors (at approximately age 4 years) with maternal neurobehavioral factors, pregnancy diet quality, and gestational weight gain.

• Maternal neurobehavioral factors, pregnancy diet quality and gestational weight gain are being collected at multiple time points in PEAS

2) Early life influences: To examine the relationships of early life maternal feeding practices, infant eating behavior, and exposure to discretionary foods with child EAH, eating behaviors, diet quality, and BMI percentile at approximately age 4 years.

• Early life maternal feeding practices, infant eating behavior and exposure to discretionary foods are being collected in PEAS; the age 2 food frequency questionnaire will contribute to these data.

3) Contextual influences: To investigate the influence of food type (highly palatable versus normo-palatable) on child EAH.

2 STATEMENT OF WORK – SAMPLE TASK 2

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…