amend_0002_sol_75N92019R0030_final.pdf

Women’s Health Initiative (WHI) RFP Solicitation # 75N92019R0030 Clinical Coordinating Center Amendment No. 2

Below are the responses to the technical and business questions received during the open comment period and after the Women’s Health Initiative Pre-Proposal Conference held on January 24, 2020.

Technical:

1. Regarding Task Area A.2 - should all retrospective SRC strokes (from 2010) be budgeted for?

Response: Yes, though it is anticipated that the retrospective strokes would be spaced evenly over the years, to reduce burden in year 1.

2. Page 30; Article H.20 – Discussions in current contract period removed the requirement for OMB review of WHI forms. Is the proposed contract period still subject to on-going OMB review?

Response: No. The 21st Century Cures Act eliminated Paperwork Reduction Act requirements (OMB review) for NIH research.

3. Page 98 – Task Area B mentions “in Clinic Visit” but this is not mentioned elsewhere - for the purpose of budget preparation, details for proposed Clinic visit are requested.

Response: This was an inadvertent error. No in-clinic visits are planned during the contract period.

4. Under Task Area B in Statement of Work– Cohort Examination: RFP states, “and testing of NHLBI-approved lab analyses (DNA extraction, RNA extraction, CVD biomarkers, glucose, insulin, Hgb.)” A complete blood count (CBC) is not listed among the NHLBI-approved lab analyses to be performed on LLS2 samples, but Hgb is specifically mentioned. Please clarify: Are we to perform a CBC on LLS2 samples? Is HbA1c being requested as a newly measured biomarker?

Response: These analyses were mentioned as a potential list of analyses. The final protocol for the LLS2 visit will be finalized by study management working in concert with NHLBI. Note that task area B budget is requested for information purposes only; that task budget will be negotiated once NHLBI decides to award that task order.

5. Statement of Work, Attachment 3, Page 3, Task Date Table: Start date of Oct 2021 for Task B – Ancillary Study funding submissions have been working under the assumption of a January 2021 start date. Can an earlier start date be considered for Task B if funded?

Response: An earlier start date for task B could be considered, but the coordinating center contract will be awarded by Jan 31, 2021, and they will need time to identify and negotiate with a subcontractor to complete the in-home visits. NHLBI anticipates that planning for task area B will begin within a month or two of CCC contract award.

6. Task D – section 14 (p 113) says that costs for task area D are not needed; this option will only be exercised if one or more NIH-sponsored supplements are awarded. Please confirm that no proposed budget is required for this task.

Response: No proposed budget is required for this task.

Clinical Coordinating Center Amendment No. 2

7. Will the following link in the Statement of Work “ https://www.nhlbi.nih.gov/grants-and-training/policies-andguidelines/nhlbi-information-techn ology-security-policies-forms-and-procedures-forcontracts .” be updated to allow public access?

Response: The links will be updated prior to potential contract award.

8. Can we please confirm the following items as not applicable to this CCC RFP?

Statement of Work

a. Section I: states this an acquisition for up to four contracts for WHI regional centers.

Response: Not applicable to Clinical Coordinating Centers.

b. Section III: discusses a companion CCC WHI contract; discusses transfer of regional center activities

Response: Not applicable to Clinical Coordinating Centers.

c. Task Area C - lists close out of Regional Center Activities in the CCC RFP Can we please confirm the following links will be made available if awarded?

Response: The listed links will be made active upon contract award.

Business:

1. We are requesting clarification on the intended period of performance, as the contract periods listed throughout the RFP are variable (please see below):

a. Page 7; Article B.3.b & Page 14; Article F.1 - Dates of contract period are listed as 2/1/21-1/31/29.

Response: The period of performance listed includes all 7 years of the potential contract along with an additional year performance.

b. Page 6; Article B.2. 4 – This mentions base and 4 option periods and does not mention the separate 2 years that will be funded as a separate task order.

Response: Article B.2. Estimated Cost- Option pertains to the first five years of task area A that will be awarded with the initial task order award. Sample cost for the final two years of task area A should be provided for planning purposes only.

c. Page 59; Section L.1.c – Type of Contract – 1. Parent award will include a 7 year ordering period, but in the following paragraph: 2. Task order 1 (1 vs A?) says 5 year (60 month) time period.

Clinical Coordinating Center Amendment No. 2

Response: The initial task order award will be for the first five (5) years of task area A.

d. Page 98 – 2.b.8.2 Task Area A planned for 80 months (6 years 8 months) but then mentions 5 years plus the final two years funded as a separate task order. Should we budget for the final two years in this proposal?

Response: For planning purposes only provide sample budget for the final 2 years of task area A.

e. Timeline listed in SOW attachment 3 – Does not include final 2 years at all. Task D (in table) is listed as starting October 2020.

Response: With your proposal cost for the first five (5) years of task area A will be required for potential negotiations.

2. Will the link to the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet.”

in the Statement of Work be provided?

Response: The estimated cost breakdown spreadsheet link is located in Section J of the solicitation.

Listed below is the link to the WHI Pre-Proposal Conference recording held on Friday January 24, 2020:

https://nih.webex.com/recordingservice/sites/nih/recording/play/7dace369989e4881ab2967c67611d3

6a

(If your unable to play the web link, please attempt on any of the following browsers; Google Chrome, Mozilla Firefox, and Microsoft Edge.)

https://nih.webex.com/recordingservice/sites/nih/recording/play/7dace369989e4881ab2967c67611d36a https://nih.webex.com/recordingservice/sites/nih/recording/play/7dace369989e4881ab2967c67611d36a

WHI: 2020 and Beyond Pre-Proposal Conference

Shari Eason Ludlam Program Director, Epidemiology Branch

Division of Cardiovascular Science National Heart, Lung, and Blood Institute

Daveta H. Brown and Cornelius Moore Office of Acquisition

National Heart, Lung, and Blood Institute National Institute of Health

January 24, 2020

Program Background Task Areas and Timelines Approach to Cohort Studies Contract Vehicle Proposal Submission Award Process

Agenda

Women’s Health Initiative Participants

Shared with permission

Hormone Therapy Trials:

Coronary Heart Disease and Fractures Adverse effect for Breast Cancer?

(16,608 E+P; 10,739 E-Alone)

Calcium/Vitamin D Trial:

Fractures and Colorectal Cancer

Dietary Modification Trial:

Breast and Colorectal Cancers Coronary Heart Disease

93,676

Observational Study

48,835

36,282

Co nt ro lle d

Tr ia ls

O bs er va ti on al S tu dy

27,347

N=161,808; Clinical Sites = 41

WHI Components 1992-2005

N = 93,515 (2010) Regional sites = 5

Long Life Study (exam in 2012-13; estimate 4200 in 2021-22)

22,301*

8,000

O bs er va tio na l S tu dy

Current WHI Components

Medical Records Cohort N = 16,300 (2018)

*Self-report followed by documentation and central adjudication+CMS+NDI

**Self-report+CMS+NDI (except cancer fully documented)

Clinical Trials

NHLBI Approach to Cohort Studies

Roger VL et al, Am J. Epidemiol 2015;181(6):363-367

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

Oct- Dec

Jan- Mar

Apr- Jun

Jul- Sept

RCs Task A Task B If awarded Task C Task D If awarded

CCC

Task A Task B If awarded planning, staff training visits Task C Task D If awarded

10/1/2024- 9/30/2025

10/1/2024- 9/30/2025

10/1/2025- 9/30/2026WHI Timeline

10/1/2021- 9/30/2022

10/1/2020- 9/30/2021

10/1/2022- 9/30/2023

10/1/2023- 9/30/2024

10/1/2023- 9/30/2024

WHI Task Areas and Timeline

FAR 16.504

“An Indefinite-quantity contract provides for an indefinite quantity, within stated limits, of supplies or services during a fixed period. The government places orders for individual requirements. Quantity limits may be stated as number of units or as dollar values.”

Indefinite Delivery Indefinite Quantity (IDIQ)

Parent IDIQ contract Minimum & Maximum Value Ordering Period

FAR 52.216-18

Statement of Work Task Area A – Core Operations Task Area B – Cohort Examination Task Area C – Study Closeout or Transfer to a new entity Task Area D – NIH Supplemental Funding

Task Orders

IDIQ cont.

Part IV, Section L – item 2: Instructions To Offeror Technical Proposal

Technical Proposal Instructions Statement of Work Technical Evaluation Criteria

Business Proposal Years 1-5: One (1) 12 month Base period and four (4) 12 month option period (Task Area A) Negotiated and awarded with the first task order award

Planning Purposes Year 6: Sample cost for one (1) 12 month option period (Task Area A) Year 7: Sample cost for one (1) eight month option period (Task Area A) Samples costs for Task Areas B & C

Proposal Submission

Peer Review

Competitive Range Determination

Final Proposal Revisions

Award Notification

IDIQ Awards

WHI Award Process

Please submit all questions via FedConnect by Tuesday, January 28, 2020.

Amendment will be posted on Thursday, January 30, 2020.

Responding to all questions.

Pre-Proposal Conference presentation and recording

Questions & Comments