amend_0002_sol_75N92019R0031_final.pdf

Women’s Health Initiative (WHI) RFP Solicitation # 75N92019R0031 Regional 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. Pg. 99, Personnel

(a) are the %'s noted for PI (25%), statistical expertise (50%) and outcomes staff (200%), minimum requirements?

Response: These levels of effort are NHLBI’s estimate of the necessary requirements for task A for the regional centers.

(b) may we budget for Co-Investigators and/or other Sr/Key Personnel?

Response: You may budget for the staffing levels that can be justified as necessary to complete the elements of task A.

(c) may we budget for outside consultants?

Response: Yes, if needed to complete the elements of task A.

2. Should the budget for Task A separate the outcomes expenses from the science expenses?

Response: The elements of the budget for task A should all be grouped together. Recall that task A relates to core operations of the study (refer to statement of work) and that science is intended to be funded with ancillary grant funding (refer to the slides from the pre-proposal conference.)

3. Is it anticipated that regional centers will have funding needs related to Task B?

Response: At this time, it not anticipated, the home-based exam will be sub-contracted through the coordinating center contract. Regional center PIs will be involved with planning the content of the exam through their study management and operations tasks covered in task A.

4. Information Security - as a site, we will not be accessing, hosting, or maintaining government information. Are the contract clauses on pages 69-75 applicable?

(a) Pg. 69, Homeland Security Presidential Directive (HSPD)-12

(b) Pg. 69, Security Assessment & Authorization (SA&A)

(c) Pg. 69, System Security Plan (SSP)

Response: A determination of the applicable clauses will be made by the NHLBI Information Systems

Security Officer prior to potential contract award.

5. Controlled Unclassified Information (CUI), pages 32-33

(a) Does the data that will be generated, maintained and managed at our site meet the definition of

CUI?

Women’s Health Initiative (WHI) RFP Solicitation # 75N92019R0031 Regional Center Amendment No. 2

Response: Further information pertaining to CUI will be provided during discussions.

Business:

1. Please confirm hard copy of the proposal is not required.

Response: Hard copies of the proposal are not required. Offerors are to follow the Fedconnect

Solicitation instructions listed in Section L of the solicitation along with attachment 1 – Packaging and delivery of proposals.

2. Please confirm budget is for 12-month period plus four (4) option periods AND a separate estimate for following 2 years for Tasks A and/or B and Task C (close out).

Response: With your proposal the cost for the first five (5) years of task area A will be negotiated one

(1) 12 month base period and four (4) 12 month option periods. Sample cost for final 2 years of task area A should be provided for planning purposes only. Sample costs for task areas B & C should also be provided.

3. Per RFP page 112, we would like to confirm that subcontracting sites are allowed (and not just consultants).

Response: Yes, subcontracts are allowed. Please follow Business Proposal Instruction regarding subcontracts listed in Section L.

4. How do we access the budget templates?

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

5. Attachment 1, please confirm we will upload 3 documents (separate pdf's for Technical and Business proposals plus excel budget), via the FedConnect "Response" feature.

Response: Correct, separate files should be submitted for the technical and business proposal along with the estimated cost breakdown spreadsheet.

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