NIH-NICHD-DIPHR-2018-12_Amendment_1_Population_Health_Research_Support_v2.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1

1. CONTRACT ID CODE

N/A

2. AMENDMENT/MODIFICATION NUMBER

3 EFFECTIVE DATE

07/06/2018

4 REQUISITION/PURCHASE REQUISITION NUMBER , 5. PROJECT NUMBER (If applicable) N/A N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE I Office of Acquisitions Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health 6710B Rockledge Dr., First Floor, MSC 7000 Bethesda, Maryland 20892

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

X

TO THE PROSPECTIVE OFFEROR

NIH-NICHD-DIPHR-2018-12

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE I FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offers must acknowledge receipt of this amendment at the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning one ( l ) copy of the amendment; and with the offer submitted, (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A, THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A,

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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. IMPORT ANT: Contractor D is not [gj is required to sign this document and return ___ 1 copies to the issuing office.

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

15B. CONTRACTORIOFFEROR 15C. DATE SIGNED

(Signature of person authorized to sign)

Previous edition unusable

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

16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of Contracting Officer)

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

PAGE OF PAGES

1 7

June 25, 20l8

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

PURPOSE: To amend RFP NIH-NICHD-DIPHR-2018-12, entitled, “Population Health Research Support” by 1.) Revising the Period of Performance in ARTICLE B.2.

PRICES/COSTS b. to "The costs set forth in this ARTICLE will cover the contract period September 28, 2018 through September 27, 2025.", 2.) listing prospective offerors' questions and responses to the questions and 3.) additional questions will be accepted until July 9, 2018, 2:00 PM Local Time (Eastern Standard Time (EST).

The responses to the additional questions will be addressed on a forthcoming amendment.

DUE DATE: Until July 25, 2018, 3:00 PM Local Time (Eastern Standard Time (EST) (Unchanged).

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 1 0A, as heretofore changed, remains unchanged and in full force and effect.

07/06/20I8

Jacquelin Jones

RFP No.: NIH-NICHD-DIPHR-2018-12

POPULATION HEALTH RESEARCH SUPPORT

OFFERORS TECHNICAL QUESTIONS AND RESPONSES

1) The recruitment plan I assume is for overall study. Therefore each site will be responsible for part of it. Am I right?

Response; For Task order 1, yes, the total 2770 is the trial overall and sites will contribute a proportion of this expected overall total. The plan is for individual sites to provide roughly equal proportions (we expect either two or three sites to be awarded the TO1). However, proportions by site are expected to be adjusted based on sites’ particular capabilities.

2) Is the 15-page limit inclusive of TA1 and TA2 or is it 15 pages per Task Order?

Response: The IDIQ base proposal is limited to 25 pages. The Task Order 1-Task Order 1E series proposal is limited to 15 total pages. The Task order 2-Task order 2C series proposal is limited to 15 total pages.

3) For TA1 of the 2770 subjects expected how many are each site expected to enroll for each option?

Response: The response to this question is explained in question #1.

4) Should we assume monitoring will be done by an external group or internally?

Response: The sites will be responsible for monitoring and reporting adverse events, as well as developing and maintaining institutional review board approvals for the studies. A data coordinating center operated under a separate contract with the Government will assist with regulatory management and monitoring and will provide monitoring of data quality.

5) During Task Order 1, are any biological samples collected from partners? If so, what type, frequency, and will there be any special processing required?

Response: No biospecimen collection from male partners is expected at this time.

6) During Task Order 1, can you please clarify frequency of urine collection from female participants?

Response: We anticipate urine collection at screening for purposes of pregnancy testing; the remaining sample amount may be stored. Additional longitudinal urine collection is not planned at this time.

7) Can dental assessments be done by a licensed dental hygienist with referral to a dentist, as needed?

Response: This could be considered with justification of comparable, relevant capabilities/quality.

8) Can you please confirm if the following study timeline is correct?

a. Task 1 Base: 9 Months of prep and training (start 9/28/18)

b. Task 1A: 12 months to recruit Stage 1 subjects (860 total subjects) (start 6/28/19)

c. Task 1B: 12 months to recruit Stage 2 (year 1) subjects (764 total subjects) (starts

6/28/20)

d. Task 1C: 12 months to recruit Stage 2 (year 2) subjects (764 total subjects) (starts

6/28/21)

e. Task 1D: 6 months to recruit Stage 2 (year 3) subjects (382 total subjects) (starts 6/28/22)

f. Task 1E: 9 months of close-out (12/28/22) Response: The length of the time periods and the total recruitment numbers (across all sites) above are correct; the dates are subject to change based on award date.

9) Task 1-Will the hsCRP POC equipment be provided, or will this need to be purchased?

Response: The sites will purchase the hsCRP POC equipment; which device is purchased across sites will be coordinated by the data coordinating center to ensure consistency across sites.

10) Should the technical methods for recruiting all these samples be described in the “Statement of Work” described on p. 64, and within the 25-page limits (p.98)?

Response: All technical details regarding biospecimen collection and recruitment strategies should be succinctly provided within the page limits.

11) Or are they examples of projects that could be requested in the future?

Response: The non-sample tasks will be awarded with the initiation of this contract and the sample tasks may occur in the near future. They also serve as examples of potential work later in the future.

12) Will citations count toward the page limit?

Response: No, please include a citation list in an appendix.

13) For Task 1 participants, does ovulation induction include the use of gonadotropins?

a. Please confirm that inclusion for Task 1 is ovulation induction and/or IUI (i.e., subjects can have OI without IUI, can have IUI without OI, or can have OI and IUI) Response: Yes, gonadotropins are allowed as part of ‘ovulation induction.’ Yes, OI/IUI includes subjects having either or both treatments.

14) Who counts as Key Personnel?

The RFP stipulates that “resumes” must be provided for all key personnel. Is a standard resume acceptable, or must it be in the NIH biosketch format?

Response: Key personnel are Principal Investigators, PIs, of the IDIQ base and Principal Investigators, PIs, and Study Coordinators of each individual Task Orders. NIH biosketches are preferred for research staff (investigators and research support staff), though standard resumes may be expected for administrative staff, as appropriate.

15) Is it permissible to have someone other than the PI for the IDIQ be designated as the PI for a Task Order? What documentation would be necessary for this plan?

Response: Yes, it is expected that expertise required for different tasks may come from different PIs across task orders, which may be different than the PI of the IDIQ overall. All PIs would qualify as key personnel and their information should be included (e.g.

biosketch).

16) Can sub-contractors be reimbursed on a per-patient basis, or do the sub-contract budgets need to be effort-based?

Response: We would like to see the budget as effort-based for comparability, but we are open to utilizing per-patient base subcontracts.

17) Will the research centers be scientific partners in setting the research strategy/focus/projects?

Response: Research centers will be awarded contracts to fulfill the requirements of a Statement of Work written by NICHD.

18) Are there period of performance duration we should assume for each of the TA2 Options?

Response: The periods of performance for the task order #2 series are as follows:

• Task Order 2 – 14 months (8 months of prep and training starting ~09/28/18;

recruitment of at least 600 pregnant women and at least 400 of their partners/co-parents)

• Task Order 2A – 10 months to recruit at least 1000 pregnant women and at least 670 of their partners/co-parents and conduct ongoing assessments of women and their partners recruited under this task and TA2, as well as infants once deliveries begin

• Task Order 2B – 12 months (4 months to recruit remaining ~400 pregnant women and ~268 partners/co-parents, and the entire period to conduct ongoing assessments of these women and their partners, as well as those recruited under preceding tasks and infants following delivery)

• Task Order 2C – 12 months to complete study assessments of women and their partners recruited under previous tasks, as well as their infants, and to wrap up study completion tasks

19) For TA2 of the 2000 subjects expected how many are each site expected to enroll for each option?

Response: Offerors may propose enrollment of the 2000 participants at a single site or up to 4 sites depending what is needed for participant diversity and for enrollment of all participants within the time frame of the study.

20) For TA2 is a psychiatrist required to participate and collect study data (psychiatric diagnostic interviews) or is this a standard study interview to be administered by study staff?

Response: A clinician or psychiatrist is not required to administer the assessments.

Structured diagnostic interviews may also be administered by trained lay interviewers.

21) For Task 2, what samples will need to be collected at delivery?

Response: As stated in the Table in Section 3 of Attachment 7 Additional Technical Proposal Instructions, cord blood, as well as blood and urine from mothers, will be collected at delivery.

22) For Task 2, what processing will be expected for samples at all time periods?

Response: Task Order 2 requires processing blood into plasma, buffy coat, and red blood cells (RBC) immediately after collection, as well as recording and storing those samples until they are shipped to the NICHD repository. Other tasks might include processing blood into serum, processing urine, and other preparation of biosample materials for storage to preserve biomarkers. Specific details will be discussed with awardees in collaboration with NICHD as part of the development of the final Manual of Procedures

(MOP).

23) For Task 2, is there an estimated duration for the interviews and collection of data at each time period?

Response: At baseline: mother and co-parents – 3 hours each

At second and third trimester assessments – 1.5 hours each At delivery – 1.5 hours At 6- and 12-month follow-ups – 3 hours each

24) For task 2, will people who score high on the RAPPER analysis need psychiatric evaluations by a psychiatrist or will this be done by study personnel? If psychiatric, should a psychiatrist be key personnel?

Response: RAPPER (Real-time Assessment of Pregnancy and Parenting Environment for Research), an assessment platform that will be developed by the study’s Data Coordinating Center, will record participants’ experiences related to pregnancy, mental health symptoms, and health-related behaviors. Evaluations of participants who score high on RAPPER assessments of symptoms do not need to be done by a psychiatrist, but the offeror could propose to do so. (Please refer to the response to question #7).

POPULATION HEALTH RESEARCH SUPPORT

OFFERORS BUSINESS QUESTIONS AND RESPONSES

1) Article B.2. b on page 4 states the contract period is September 28, 2018 to September 27, 2018.

Article F.1 on page 10 lists the period of performance as September 28, 2018 to September 27, 2025. Can you confirm if the period of performance is a 1-year base period with six option years or if this is a 7-year IDIQ?

Response: The correct Period of Performance is September 28, 2018 to September 27, 2025.

An amendment will be posted to the RFP correcting the Period of Performance.

2) Past Performance Information on p 61 and Qualification of the Offeror on p 88 reference providing information about pertinent contracts and grants. Can you please confirm that cooperative agreements will also be acceptable past performance examples/references?Response:

Only Pertinent contracts and grants will be acceptable past performance example.

Cooperative agreements will not be considered as past performance for this solicitation.

3) Should we assume a 9/28/18 start date for the Base and Tasks 1-2?

Response: The September 28, 2018 is an anticipated date and can be used in assumptions for your budget proposal.

4) ARTICLE B.2 PRICES/COSTS - The costs set forth in this ARTICLE will cover the contract period September 28, 2018 through September 27, 2018.

- a. What are the dates of the contract period?

Response: The correct Period of Performance is September 28, 2018 to September 27, 2025.

The solicitation will be amended.

5) How does payment work?

- a. Is the institution paid per subject completion, annually, or quarterly?

Response: The invoice process is discussed in Section G – Contract Administration Data, ARTICLE G.5. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND

CONTRACT FINANCIAL REPORT. All invoices are to be submitted monthly.

6) In Attachment 7, the RFP refers to separate parts of the technical proposal for the IDIQ and study tasks for a total of 40 pages, and in Attachment 1 it references a total page count of 25 pages.

Response: The IDIQ base proposal is limited to 25 pages. The Task Order 1-Task Order 1E series proposal is limited to 15 total pages. The Task order 2-Task order 2C series proposal is limited to 15 total pages.

7) Will the preferred format of the requested proposal be separated into separate sections for IDIQ and study tasks?

Response: Yes. Please separate your sections for the IDIQ Technical and business proposals and the study tasks technical and business proposals.

8) Can you confirm if there is a page limit for the business proposal?

Response: The total page count of the Business proposal shall not exceed 25 single-space pages. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section.

9) Should separate budgets be submitted for the IDIQ and study tasks?

Response: Separate budgets should be submitted for all task orders only.

10) Is a separate budget and budget justification required for each sample task (e.g. 1A, 1B, etc.)?

Response: Yes.

11) Are the studies described in Attachment 4 (Sample Task Order 1, 1A – 1E, p. 112 – 133) and Attachment 5 (Sample Order 2, 2A – 2C, p. 134 – 154) the required deliverables for this contract?

Response: Attachments 4 and 5 describe the individual task orders with their specific deliverables; however, there are also deliverables described in Attachment 3 for the overall IDIQ contract.