Attachment3-Revised.pdf

REVISED

ALLHAT Renewal Attachment 3

Attachment 3

Additional Information Specific to Solicitation NHLBI-HV-11-18

Section B - Brief Description of Supplies or Services Page 2

Section C - Statement of Work Page 2

Section C - Reporting Requirements Page 4

Section F – Deliveries or Performance Page 7

Section L - Additional Proposal Instructions Page 10

a. Background and Overview of Study

b. Study Committees

c. Estimated Level of Effort

d. Technical Proposal Table of Contents

e. Page and Formatting Limitations

f. Travel

g. Business Proposal Table of Contents

h. Cost Proposal Worksheet

Section M - Evaluation Factors Page 12

Proposal Intent Response Sheet See Solicitation

SECTION B

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Coordinating Center will optimize scientific advancement from the ALLHAT study by using

1) the administrative, data, and analytical resources to support continued manuscript preparation and development of ancillary studies and 2) the ALLHAT governance structure to provide overall scientific leadership. The Coordinating Center will foster scientific contributions based on extensive ALLHAT resources and will expand collaborations with relevant clinical and scientific communities outside of ALLHAT, including investigators from academic institutions not recently involved in ALLHAT manuscripts or ancillary studies. Collaborations might be with scientists with interest in clinical trials, pharmacogenetics, biomarkers, epidemiology, and clinical practice as they relate to hypertension and lipid-lowering treatments. This contract provides funds to preserve key study resources, continue the passive follow-up of the ALLHAT cohort, expand access to the ALLHAT datasets, and assure open, efficient, and active use of the

ALLHAT data by the entire scientific community.

SECTION C

ARTICLE C.1. STATEMENT OF WORK

A. 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 Statement of Work set forth below.

B. The contractor shall deliver the items specified in ARTICLE C.2. to the destinations indicated in ARTICLE F.1.

C. The contractor shall work with the National Heart, Lung, and Blood Institute (NHLBI) and ALLHAT Steering Committee (SC) to accomplish scientific goals. Specifically, the contractor shall:

1. Expand the ALLHAT database as additional data become available from extended passive follow-up (via relevant administrative databases).

a. Accumulate and establish appropriate analytic data files.

b. Develop and implement procedures for updating analytic data files.

c. Establish an Information Systems Security Plan.

d. Prepare and submit manuscripts for publication.

e. Perform statistical analyses as required for publications describing ALLHAT interim data.

f. Participate with other investigators in the preparation of presentations and manuscripts.

2. Work with the ALLHAT Steering Committee, other selected experts, and NHLBI staff to develop ALLHAT scientific directions that assure optimal scientific contributions.

a. Build on to-date publications and explore new areas using data from the randomized phase of the trial and from the passive follow-up.

b. Involve appropriate consultants as leaders of relevant scientific areas.

c. Foster an environment conducive to productive interdisciplinary collaboration, including mentoring early-stage investigators from a diverse set of institutions and especially from those with no recent history of participating in ALLHAT.

1. Actively recruit new investigators from within and outside ALLHAT to participate in ancillary studies, data analysis, and publications.

2. Establish Publication and Presentation and Ancillary Study policies that ensure broad accessibility to ALLHAT data by interested investigators

3. Implement strategies for sharing of data collected in ALLHAT that are consistent with a major objective of this contract, including those that:

i. Promote use of these resources by the scientific community

ii. Provide user support for new collaborating investigators not familiar with the ALLHAT data

iii. Enable incorporation of ancillary study data into the main and limited access data sets for use by other investigators according to ALLHAT and NHLBI policies.

4. Demonstrate progress recruiting outside investigators,

d. Continue development of methods of analysis and presentation of data collected during the randomized phase of the trial and during the extended passive follow-up.

e. Apply established and new analytic methods to ALLHAT data in support of paper-writing.

3. Work with ALLHAT Steering Committee and NHLBI staff to promote awareness of the

ALLHAT scientific and administrative resources among research and clinical communities.

4. Work with ALLHAT Steering Committee and NHLBI staff to disseminate ALLHAT results to clinical and lay communities, including publications in peer reviewed journals and presentations at major scientific meetings and other relevant venues, as appropriate, and with strong emphasis on clinical implications.

5. In collaboration with the NHLBI Project Office and ALLHAT Steering Committee provide administrative and coordination to the ALLHAT organization.

a. Establish an organizational structure that enables scientific progress, interdisciplinary collaboration, and outreach to relevant communities outside of ALLHAT, including relevant professional organizations.

b. Implement ALLHAT policies and procedures, including those for collaboration on manuscripts.

c. Work with ALLHAT Steering Committee and NHLBI staff to involve appropriate consultants, including and especially as leaders of science-focused working groups.

d. Plan, make arrangements for, and support the meetings and teleconferences of the study committees, working groups, and an external Advisory Group.

e. Plan, make arrangements for, and provide support for meetings, teleconferences, and exploratory analyses, designed to encourage new collaborations between the current ALLHAT investigators and new investigators from a diverse set of institutions.

6. Study Website

a. Establish and maintain a website; the website shall be operational within six months of contract award.

b. Interact with the Steering Committee and the Project Office to obtain their input into the content and design.

c. Ensure that the content is up-to-date, accurate, and user friendly, and that all links are functional.

d. Promote awareness and use of the website as a dissemination and collaboration tool.

e. Ensure that all web pages designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act (http://www.accessboard.gov/sec508/guide/1194.22.htm#Back).

ARTICLE C.2. REPORTING REQUIREMENTS

In addition to the reports required by other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE F.1. DELIVERIES of this contract.

Technical Reports and Other Deliverables

1. Annual Progress Report: shall summarize activities and work performed during the period covered and describe plans for the next period. This report will complement semi-annual documents and reports presented to the NHLBI Project Office which will contain comprehensive details of study activities and progress. The report will include the following:

1) major activities by quarter of the contract year; 2) levels of effort and administrative changes; 3) summary of papers submitted, accepted, and published during the reporting period, including comparisons with the preceding period, and 4) progress in engaging new investigators and new institutions in scientific collaborations with ALLHAT.

2. Semi-annual Progress Report: will be prepared to assess progress and adjust goals as needed. As with the annual report, it will complement detailed periodic documents and will include components listed above in the annual progress report. This report is not required when the Annual Progress Report is due.

3. Final Technical Report: This report shall include a summation of the work performed and results achieved for the entire contract period of performance. The Final Report shall be submitted on or before the last day of the contract performance period and shall be in sufficient detail to serve as a reference document.

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

4. Steering Committee Meeting Minutes: Minutes of Steering Committee meetings and telephone conference calls shall be provided within 15 calendar days of the meeting.

5. Interim Data Set- The contractor shall provide a interim access data set for ALLHAT with full documentation. The data set and documentation shall be prepared in accordance with the NHLBI Data Set policy found at http://www.nhlbi.nih.gov/resources/deca/policy_new.htm.

6. Final Data Set- The final data set with full documentation is due with the Final Report. The data set and documentation shall be prepared in accordance with the NHLBI Data Set policy found at http://www.nhlbi.nih.gov/resources/deca/policy_new.htm.

7. Plan for engagement of investigators and academic institutions not previously involved with ALLHAT: Draft an engagement plan that outlines the steps needed to stimulate the interest of investigators and academic institutions in collaboration with ALLHAT, that identifies the barriers to collaboration, and proposes steps to eliminate the barriers to collaboration, and evaluates over time the success and productivity of these new collaborations. Measures of productivity may include scientific papers, ancillary studies, and grant applications using ALLHAT data. Provide the draft plan to NHLBI within 90 days of the award. Comments on the draft plan will be provided to the contractor and suggested changes incorporated 120 days after contract award. Updates and revisions of the engagement plan shall be prepared and submitted in year 2.

8. Section 508 Annual Report -The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. Instructions for completing the report are available at: http://508.hhs.gov/.

9. Information Security Training Report -The Contractor shall maintain a listing by name and title of each employee (including subcontractors) working under this contract that has completed the NIH required information security training. Any additional security training completed by Contractor/Subcontractor staff shall be included on this listing. [The listing of completed training shall be included in the first technical progress report. (See Article C.2.a.

Technical Progress Reports.) Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report.] (Reference subparagraph d. of the INFORMATION SECURITY Article in SECTION H of this contract.)

10. Source Code and Object Code - Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

11. Information Security Reporting Requirements The Contractor shall submit the following reports as required by the INFORMATION SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

12. Roster of Employees Requiring Suitability Investigations - The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s).

The roster shall be submitted to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. (Reference subparagraph c.(2) of the INFORMATION SECURITY Article in SECTION H of this contract.)

13. Reporting of New and Departing Employees -The Contractor shall notify the Contracting Officer's Technical Representative (COTR) and Contracting Officer within five business days of staffing changes for positions that require suitability determinations as follows (Reference subparagraph f. of the INFORMATION SECURITY Article in SECTION H of this contract.):

(1) New Employees: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

(2) Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COTR and/or Contracting Officer upon request.

14. Contractor - Employee Non-Disclosure Agreement(s) - The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at:

http://ocio.nih.gov/security/Nondisclosure.pdf . (Reference subparagraph g.of the INFORMATION SECURITY Article in SECTION H of this contract.)

15. Self Assessment & Information Security Plan Reporting

(1) NIST SP 800-53 Self-Assessment (Reference subparagraph h. of the INFORMATION SECURITY Article in SECTION H of this contract.)

The contractor shall annually update and resubmit its Self-Assessment required by NIST SP 800-53, Recommended Security Controls for Federal Information Systems to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer [For option contracts: no later than the completion date of the period of performance/ for all other contracts: indicate due date as determined by the COTR/Contracting Officer ]. (http://csrc.nist.gov/publications - under Special Publications).

The Contractor's annual update to its Self-Assessment Questionnaire shall include similar information for any subcontractor that performs under the SOW to (1) develop a Federal information system(s) at the Contractor's/Subcontractor's facility, or (2) host and/or maintain a Federal information system(s) at the Contractor's/Subcontractor's facility.

(2) Information System Security Plan (Reference subparagraph i. of the INFORMATION SECURITY Article in SECTION H of this contract.)

The Contractor's draft ISSP submitted with its proposal shall be finalized in coordination with the COTR [insert date/no later than 90 calendar days after contract award].

Following approval of its draft ISSP, the Contractor shall update and resubmit its ISSP to the COTR every three years or when a major modification has been made to its internal system.

The Contractor shall use the current ISSP template in Appendix A of NIST SP 800-18, Guide to Developing Security Plans for Federal Information Systems.

(http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf).

The Contractor shall include similar information for any subcontractor performing under the SOW with the Contractor whenever the submission of an ISSP is required.

SECTION F – DELIVERIES OR PEFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the contract shall be deemed to occur upon performance of the work described in ARTICLE C.1. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

The items specified below, as described in SECTION C, ARTICLE C.2., will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. Destination, within

Consignees Premises (APRIL 1984), and in accordance with and by the date(s) specified below:

The following table provides an overview of deliverables and their respective delivery schedule:

Item Description Delivered to Delivery Schedule

1. Annual Progress Report

Project Officer Contracting Officer

June 15, 2012-2016

2. Semi-Annual Progress Report Project Officer

December 15, 2011-2016

3. Final Technical Report and Summary of Salient Results

Project Officer Contracting Officer

Contract Expiration Date

4 Steering Committee Meeting Minutes

Project Officer Contracting Officer

15 Days after meeting

5. Interim Data Set Project Officer

June 1, 2012 June 1, 2014

6. Final Data Set Project Officer

Contract Expiration Date

7. Plan for engagement of new investigators and academic institutions with ALLHAT

Project Officer Contracting Officer

Draft 90 days after contract award, August 1, 2011

9. Section 508 Report Project Officer Contracting Officer

June 1, 2012, 2013, 2014, 2015

10.

Source Code and Object Code

Project Officer Contracting Officer

Contract Expiration Date

10. Roster of Employees Requiring Suitability Investigations

Project Officer Contracting Officer

Within 14 days of the effective date of the contract

11. Information Security Training Report

Project Officer Contracting Officer

First Technical Report

12. Reporting New and Departing Employees

Project Officer Contracting Officer

Within 5 days of staffing change

13. Contractor -Employee Non- Disclosure Agreement(s)

Project Officer Contracting Officer

As required

14. Self Assessment and Information Security Plan

Project Officer Contracting Officer

Contract Expiration Date

15. Section 508 Annual Report Contracting Officer Annually

Copies of reports shall be sent to the following addresses:

Addressee Item Format Quantity

National Heart, Lung, and Blood Institute RKL2, Rm 6016, MSC 7902 6701 Rockledge Dr Bethesda MD 20892-7902

Project Officer National Heart, Lung, and Blood Institute RKL 2, Rm 10214 , MSC 7936 6701 Rockledge Dr Bethesda MD 20892-7936

1-4, 7-15

1-15

Electronic Copy

Electronic Copy

1 each

1 each

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

ADDITIONAL PROPOSAL INSTRUCTIONS

1. Background and Overview of Study The Antihypertensive and Lipid-Lowering to Prevent Heart Attack Trial (ALLHAT) was funded in 1993. It was a randomized, double-blind, practice-based trial designed to determine whether the incidence of major coronary heart disease (CHD) events (primary endpoint) is reduced in high-risk patients with hypertension treated with a calcium channel blocker (amlodipine), an angiotensin converting enzyme (ACE) inhibitor (lisinopril), or an alpha-blocker (doxazosin), each compared with a diuretic (chlorthalidone) as first-step therapy. The Lipid-Lowering Trial, conducted in a subset of the ALLHAT participants (N=10,355), was designed to compare open-label pravastatin with usual care for prevention of total mortality (Am J Hypertension 1996;9:342-360). Between 1994 and 1998, 42,418 participants were recruited from 623 clinics, mostly primary care, across the United States, Canada, Puerto Rico and the U.S. Virgin Islands.

After an average of 4.9 years of follow-up (3.2 for the doxazosin arm, which was terminated early), the investigators reported that the primary endpoint, a composite of fatal CHD and non-fatal myocardial infarction, did not differ across the randomized treatment comparisons – despite better metabolic profiles in participants randomized to receive the newer antihypertensive agents.

In addition, the diuretic-based therapy was superior to the alpha-blocker, ACE inhibitor and CCB-based therapies in preventing one or more major forms of cardiovascular disease, including stroke and heart failure (JAMA 2000; 283:1967-1975; JAMA 2002; 288:2981-2997; JAMA 2002;

288: 2998-3007; Hypertension 2003; 42:239-246).

The ALLHAT participants have been followed since the end of the trial in 2002 through national administrative data bases, including the National Death Index (NDI), Centers for Medicare and Medicaid Services (CMS), United States Renal Data System (USRDS), and Social Security Administration (SSA). Data through 2006 are currently being analyzed. During the combined active and passive average follow-up of nearly 9 years, about a third of participants died.

ALLHAT protocols and publications can be found at www.allhat.org .

2. Study Committees: Include the Executive Committee, Steering Committee, working groups, and external Advisory Group. Members of the Advisory Group will be selected by the NHLBI.

3. Estimated Level of Effort – 8 FTE (See Excel Workbook Posted with Solicitation)

4. Technical Proposal Table of Contents

1. Cover Page Page 1

Cover page should include: RFP Title and Number, Name of Organization, Name of Principal Investigator, Address, and Telephone Number.

2. Table of Contents Page 2

3. Abstract/Project Objectives Page 3

4. Technical Proposal Plan Page 5—35

The Technical Proposal Plan shall not exceed 30 single-sided pages or 15 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated.

5. Personnel

(1) List of All Personnel in the project including subcontractors, consultants/ collaborators, by name, title, department, and organization Page #

(2) Provide narrative of expertise and qualifications for Principal

Investigator/Project Director, other investigators and staff Page #

(3) Other Staff Page # [Note: Include a resume/CV/biosketch for PI and co-investigators in the Appendices]

6. Facilities, Equipment, and Other Resources Page # Describe all facilities, equipment and other resources available.

7. Summary of Related Activities Page #

8. Technical Proposal Plan Cost Summary Page #

9. IT System Security Plan Page #

10. Appendices Page #

5. Page and Formatting Limitations The Technical Proposal Plan, objectives, approach, methods and schedule shall not exceed 30 single-sided pages or 15 double-sided pages. Page limitation applies to item 4 on the Technical Proposal table of contents. Appendices shall include CVs for the PI and Co- Investigators, and up to 10 manuscripts that have been accepted for publication but not yet published. Each page of the technical proposal plan must be numbered sequentially.

Offerors are encouraged to limit the overall size of the technical proposal plan, inclusive of appendices, attachments, etc. Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be no less than ½ inch around, exclusive of headers and footers.

6. Travel

Travel should be included for two meetings per year for Executive and Steering Committee Meetings for five individuals, two meetings per year for Scientific Topics/Collaboration/ Dissemination Working Groups for three people in periods I, III, and IV and four people in periods II and IV, and one Advisory Group meeting in period III for four individuals.

Assume all meetings will be two (2) days in length. Additional individuals may be proposed with a justification.

7. Business Proposal Table of Contents Proposal Summary and Data Record, NIH-2043 ....................................Page 1 Offeror's Points of Contact ......................................................................Page 2 Breakdown of Proposed Estimated Costs (Excel Workbook) .................Page 3 A written justification of each cost element proposed ..........................Page #-# Disclosure of Lobbying Activities, OMB Form SF-LLL .........................Page #-# Qualifications of the Offeror..................................................................Page #-# General Experience

Organizational Experience Related to the RFP Performance History Pertinent Contracts Pertinent Grants Extent of Small Disadvantaged Business Participation.........................Page #-# (See Instructions to Offerors, General Instructions) Other Administrative Data.....................................................................Page #-# Representations & Certifications...........................................................Page #-# Small Business Subcontracting….………………………………………Page #-# Annual Financial Report……………………………………...…………..Page #-# Travel Policy……………………………………………………………….Page #-#

8. Cost Proposal Worksheet (See Excel Workbook Posted with Solicitation

9. Payment Method As noted in Article G.3. This contract will not be paid by Letter of Credit. The payment management system will not be utilized for this contract.

SECTION M

TECHNICAL EVALUATION CRITERIA

The evaluation criteria are used by the Special Emphasis Panel when reviewing the technical proposals. The criteria below are listed in relative importance with weights assigned for evaluation purposes.

No. Criterion Points

1 Scientific leadership and proposed areas of science: Demonstrated expertise and appropriateness of the proposed areas of science to optimize scientific advancement from ALLHAT. Documented ability to provide scientific leadership in the relevant areas of science and in statistical analysis. Appropriateness of the milestones, time lines, and products of the Program to achieve the stated goals.

2. Approach to database management: Merit of the proposed technical approaches to:

enable and foster manuscript preparation and ancillary study development; expand the data base as appropriate when new data become available; and provide high-quality performance of statistical analysis. Adequacy of plans to obtain access to data and other necessary approvals. EIT Accessibility Standards. This contract will require a number of data management activities, including the continued maintenance of a registry website. Merit of proposed plans for developing and maintaining a Section 508 study website.

No. Criterion Points

3. Capabilities: Documented expertise and experience of the principal investigator and other key personnel, including a qualified database management team. Adequacy of the proposed research team, including consultants, to accomplish the objectives of the renewal. Access to consultants with relevant expertise. Availability and adequacy of facilities and resources necessary to meet the objectives, including institutional commitment to the ALLHAT trial.

4. Administrative leadership and documented ability to foster collaboration:

Documented plans to engage current ALLHAT community. Adequacy of plans to foster collaborations with investigators and a diverse set of research institutions outside of ALLHAT, including policies and procedures to accomplish the collaborations. Documented ability and adequacy of plans to provide administrative support to accomplish the collaborative Program objectives.

Total: 100

OTHER EVALUATION CRITERIA

Past Performance – Past performance will be evaluated based on one or more sources of information including but not limited to past performance questionnaires and other information contained in various Government databases or other sources. The evaluation will be performed on all offerors prior to the technical evaluation. Past performance will be considered by the extent of the offeror’s ability to meet project quality, performance, and schedule, and will consider noted concerns and areas of improvement.

SDB - Offerors will be required to submit a Small Disadvantaged Business (SDB) Participation Plan as part of their business proposal for this RFP. Evaluation of the Plan will be performed by the Contracting Officer only on those offerors being considered for award. The evaluation will be made based on a consideration of all relevant facts and circumstances. It will not be based on absolute standards of acceptable performance.

Cost – An analysis of the offeror’s cost proposal will be conducted as part of the evaluation to determine whether costs are realistic, complete and reasonable.