ARRA SPRINT FedBizOpps-Final.pdf

RECOVERY - The National Heart, Lung, and Blood Institute (NHLBI), with three (3) funding partners, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute on Aging (NIA), provides notice to the public and potential Offerors, of the contracts identified below and a requirement to augment its clinical study named Systolic Blood Pressure Intervention Trial (SPRINT), with stimulus funding.

The availability of funds via the American Recovery and Reinvestment Act (ARRA) of 2009 affords an opportunity for within-scope modifications of these five SPRINT contractors to reach their ultimate target recruitment goals. NHLBI has named this ARRA funded project “SPRINT-Senior” which will also have two (2) components, SPRINT-Senior-MAIN and SPRINT-Senior-MIND. The ARRA funding will allow an increase in the original sample size of SPRINT from 7,500 to between 9,000 and 10,000 by adding 1,500 to 2,500 participants who are 75 years of age or older.

The following SPRINT contractors will activate SPRINT-Senior. Their activities will be initiated via the Changes clause of FAR 52.243-2. that is in these contracts, and via subsequent contract modifications. These contracts were awarded on September 14, 2009.

Contractor Role Contract Number

• Wake Forest University

Health Sciences

Coordinating Center HHSN268200900040C

• Case Western Reserve University

Clinical Center Network HHSN268200900049C

• University of Alabama at Birmingham

Clinical Center Network HHSN268200900047C

• University of Utah

Clinical Center Network HHSN268200900046C

• Wake Forest University Health Sciences

Clinical Center Network

HHSN268200900048C

BACKGROUND AND SIGNIFICANCE OF SPRINT

The Systolic Blood Pressure Intervention Trial – SPRINT – is a nine-year multicenter randomized clinical trial to determine whether treating systolic blood pressure (SBP) to a lower goal than currently recommended will reduce the risk of cardiovascular disease, chronic kidney disease, or age-related cognitive decline. Current clinical guidelines recommend an SBP level of less than 140 mm Hg for healthy adults and 130 mm Hg for adults with kidney disease or diabetes. SPRINT will evaluate the potential benefits (or possible risks) of a therapeutic strategy of maintaining systolic blood pressure at less than 120 mm Hg for adults who are at risk for heart disease or kidney disease. Because two existing strategies are being compared, this is a comparative effectiveness research (CER) clinical trial.

A SPRINT sub-study, Memory and Cognition IN Decreased Hypertension – SPRINT-MIND – will evaluate whether the rate of age-related cognitive decline, a predictor of dementia, is affected by the strategy of the lower systolic goal. The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute on Aging (NIA) are jointly funding SPRINT-MIND.

By combining the expertise and resources of four institutes, the NIH is maximizing its efforts to develop the scientific evidence to determine the best treatment goal for over 900 million adults worldwide who have high blood pressure. One out of every three adult Americans has hypertension. Because SPRINT tests the effectiveness of a medical strategy to reach specific blood pressure goals and does not compare specific drugs to each other, it is unlikely that such a trial would be conducted by private industry. SPRINT has been noted as an NIH signature project and an important CER study for a common and potentially costly condition.

RATIONALE

The results from this work will enable economic efficiency by providing outcome information on participants in SPRINT and SPRINT-MIND. The results of these SPRINT studies will increase economic efficiency because they will either lead to a reduction in the use of unnecessary medical interventions and clinical visits, or will lead to prevention of costly cases of cardiovascular and kidney-related deaths and hospitalizations, and possibly delay or prevent the onset of costly cases of dementia. In addition, the results of this trial will increase our ability to care for the one in three adult Americans with hypertension and is an outstanding example of CER since two strategies of treatment for hypertension are being compared. Moreover, the datasets that are produced for SPRINT, SPRINT-MIND, and SPRINT-Senior will constitute invaluable resources for existing and future researchers to investigate the link between hypertension and cardiovascular, kidney, and neurological outcomes.

In summary, if additional resources are available, we believe that adding 1500-2500 elderly participants to SPRINT could provide very useful scientific and public health information on a large and growing segment of our population, while preserving the objectives of the SPRINT study with respect to the younger segments of our population. No previous large scale trial has examined the impact of treating SBP in the elderly to <120 mmHg versus <140 mmHg. SPRINT and SPRINT-Senior could impact the treatment and prevention of heart failure, stroke, chronic kidney disease, and possibly of dementia worldwide — all of which are health issues of growing importance.

OBJECTIVE AND ENDPOINTS

Objectives:

1. To determine whether a systolic blood pressure goal of <120mmHg versus <140 mmHg in participants ≥ age 75 with hypertension or pre-hypertension, who are also at higher risk due to additional CVD risk factors, will reduce cardiovascular disease events by 25%.

2. To determine in the stage 3 CKD elderly subgroup whether treating to a lower SBP goal than currently recommended will reduce CVD events and the progression of renal disease by 25%.

3. To determine whether treating to a lower SBP goal in the elderly will reduce the rate of

a) probable dementia by 30% if the dementia incident rate is 3.0% per year,

b) age-related incidence of cognitive decline,

c) brain volume loss as assessed by MRI, and/or

d) incidence of structural central nervous system abnormalities.

4. To determine the safety of aggressive SBP lowering in the elderly.

Endpoints:

1. Primary endpoint: Cardiovascular disease events - CVD mortality, non-fatal MI, non-fatal CVA, hospitalization for heart failure

2. Secondary endpoints:

a. All-cause mortality

b. Combined CVD events and ≥50% decrease in estimated glomerular filtration rate (eGFR) or new onset of end stage renal disease (ESRD)

c. New onset of probable dementia

d. Incidence of cognitive decline

e. Rate of age-related decline in brain volume

f. Incidence of white matter abnormalities

REQUIREMENTS

Coordinating Center (CC) Activities

The CC Contractor shall perform the following tasks:

1. Develop/adopt operational and analytical methodology; provide administrative guidance, oversight, and support for SPRINT as a whole, the SPRINT-MIND substudy, and applicable substudies.

2. Perform protocol and manual of operations activities, including:

a. Coordinate protocol writing activities, including protocol drafting and finalization, collaboratively with the Clinical Center Networks (CCNs), the central units, and the Project Office. The approved protocol, and all revisions thereto, shall be incorporated into the contract by reference without further action by the Contracting Officer. References to the SPRINT protocol also include the SPRINT-MIND substudy. The protocol shall include the following and other important information:

1) Scientific rationale for proposed study design for SPRINT, SPRINT-MIND, and other applicable substudies.

2) Participant selection, recruitment, and follow-up (including any special considerations for enrollment of up to 50% stage 3 chronic kidney disease (CKD) participants; inclusion/exclusion criteria)

3) Interventions (including procedures for medication adjustments)

4) Participant safety and confidentiality

5) Clinical outcome measures (cardiovascular, renal, and central nervous system [CNS])

6) Cognitive functioning, health-related quality of life, and cost-effectiveness outcome measures

7) Statistical design and considerations

8) Quality control

9) Data management and training

10) Plan for measuring and maximizing patient adherence and retention

11) Dissemination plan, including publication process

12) Study organization and timetable

13) Model informed consent document (including adequately addressing data and specimen sharing)

b. Develop and distribute study forms and a manual of operations, which includes detailed descriptions of patient recruitment, selection, randomization, adherence, and retention; study interventions and measurements; procedures for staff training; proper collection of data and coordination of the study;

pilot testing of forms; and all other operational aspects of the study. Provide the protocol and manual of operations (MOP) to the NHLBI, the CCN, central units, and all participating clinical sites; distribute updates as necessary in a timely manner. As part of the MOP activities, assume responsibility for developing, pre-testing, reproducing, and distributing appropriate case report forms (data forms) and reporting tables and figures. The MOP, and all revisions thereto, shall be incorporated by reference without further action by the Contracting Officer.

3. Assume responsibility for the statistical design of the study and provide biostatistical support for protocol development, including power and sample size calculations and simulations; for randomizing study subjects; for study monitoring; and for the management and analysis of study data.

4. Design and implement a plan for randomizing approximately 9,000 to 10,000 patients into SPRINT and approximately 2,800 patients into the SPRINT-MIND substudy, accessible to all clinical sites participating in enrollment within the CCNs, on a rapid basis and according to the timing specified in the SPRINT protocol.

The randomization plan should include provisions for monitoring and correcting problems.

5. Design a plan to ensure standardized quality data gathering and management for assessment of study outcomes. This plan should include a data entry system for use at clinical sites, procedures for data transmission, and provisions for training appropriate CCN staff in data collection, entry, and transmission.

The data collection plan shall provide methods for avoiding bias in data collection and ascertainment of major endpoints in an unmasked study design. It is anticipated that data (including biological specimens, ECGs, and MRIs) will be transmitted from individual clinical sites and clinical investigators recruiting patients within the CCNs directly to the Coordinating Center (CC) and relevant central units (e.g., Central Laboratory, ECG Reading Center, and MRI Reading Center), and that central units will transmit data to the CC for central analysis. The data collection plan should also include a close collaboration with the CCNs for correcting problems with missing, delayed, or erroneous data.

6. Ensure that the provisions of the protocol and manual of operations are carried out by the CCNs and the clinical sites. Provide centralized training and collaborate with CCNs on provision of clinic-specific training in all aspects of study and substudy implementation, including the following: procedures for screening and eligibility determination; randomization; recruitment of study participants; measurement and promotion of participants’ adherence to treatment; provision of study treatment; data collection and follow-up procedures, including methods for ensuring patient retention. Maintain quality control (QC) at participating Clinical Center Networks (CCN), and monitor their performance status; promote interactions among the CCNs, coordinating study activities among the CCNs and central units, and ensuring uniformity of study activities at all sites; train central units in standardized protocol implementation; review and provide rapid feedback to the CCNs and central units on the quality of data submitted and proposed corrections; conduct periodic visits to each CCN in order to monitor and ensure high performance throughout the trial; report to the NHLBI Project Office on QC and related matters periodically as specified for each report in the protocol and as needed.

7. Solicit, select (with participation of the NHLBI Project Office and Steering Committee), and oversee the central units, which consist of the Drug Distribution Center (DDC) and core laboratories—Central Laboratory, ECG Reading Center, and MRI Reading Center.

a. The DDC shall plan, acquire, package, label, and dispense drugs in a timely manner according to the study protocol, and will also monitor compliance and provide data to the CC for further analyses.

b. The Central Laboratory will arrange for the collection and analysis of blood and urinary measurements, provide interpretation of laboratory measurements, collect and store biological specimens of trial participants, including plasma, and obtaining DNA for eventual analysis; the Central Laboratory will report results related to patient safety directly to the CCNs.

c. The ECG Reading Center shall collect and interpret ECGs.

d. The MRI Reading Center shall collect and interpret MRIs.

8. The core laboratories shall be responsible for developing and distributing specific measurement procedures, timely data gathering, analysis under the leadership from the CC, and providing data to the CC for central analyses. This task also includes regular monitoring of quality control measures and performance of each core unit, review of the quality of all data transmitted, and reporting these and related matters to the NHLBI Project Office. All activities of these core units will be funded by the CC.

9. Make travel arrangements and reimbursement for the Steering Committee chair and for the Data and Safety Monitoring Board (DSMB) members.

10. Coordinate, plan, make arrangements for, and participate in the meetings of the Steering Committee and its subcommittees, and of the DSMB and other meetings related to the conduct of the overall trial.

11. Facilitate communications among all organizational study components during each phase of the trial, including the Protocol Review Committee (PRC), the Data and Safety Monitoring Board (DSMB), ad hoc task forces or working groups, and trial-wide subcommittees, such as the ancillary/substudy, mortality/morbidity, operational, publications, and adherence subcommittees; prepare and distribute minutes and reports of the Steering Committee, Executive Committee, PRC, and DSMB meetings, ensuring the quality and accuracy of data collection and report content. Maintain in the central study website (see item 12 below) a repository of minutes and materials necessary to the functioning of the various committees and all other aspects of the trial. Specifically:

a. Coordinate, arrange, participate in, and provide any information necessary for regular Steering Committee meetings (at least six in-person meetings and six teleconferences during the protocol development phase; thereafter, semiannual in-person meetings and teleconferences as needed), and promptly prepare and distribute minutes of each meeting and any other correspondence necessary.

Coordinate, arrange, participate in, fund, and provide any information for any other meetings or conference calls with the CCNs and clinical investigators, as needed. Regularly prepare reports of patient screening, recruitment, status of data collection and quality control, or any other matters needed to be discussed at Steering Committee meetings or during conference calls.

b. Assume responsibility for arranging and conducting regular PRC/DSMB activities. These activities include an anticipated two meetings (one in person and one conference call) per year, plus additional conference calls as needed, for approximately 25 people (7-9 members, 4-6 investigators, and 10 Project Office staff). Provide study data in a timely fashion to the DSMB per study protocol and as requested. Fund all PRC/DSMB-related activities, including travel expenses for meetings, honoraria to members, meeting room charges, meals and refreshments.

12. Computer Systems and Websites:

a. Establish and maintain a computer system, secure study database, and software needed for the storage and analysis of all clinical trial data (including biological specimens, ECGs, and MRIs) collected from all SPRINT clinical sites. Provide for the central interpretation of substudies, such as cognitive functioning, quality of life, and costs data collected on subsamples of participants. Provide computer backup systems in the event of a primary system failure. The database shall also contain bar coding information for tracking of biological specimens. Maintain documentation of the data variables and maintenance of appropriate confidentiality and security of all computer files.

b. Plan, develop and maintain a study web site for the distribution of SPRINT and SPRINT-MIND information, documents, and forms to the CCNs. Develop a secure web-based entry system for the CCNs, clinical sites, and central units to use. In addition, develop and maintain a public web site that provides information about SPRINT and SPRINT-MIND for the lay public. All web pages designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act (http://www.access-board.gov/sec508/guide/1194.22.htm#Back).

c. During Phase I of the study, submit an updated Information Systems Security Plan as required by the NHLBI Information Systems Security Officer.

13. Monitor patient recruitment by providing weekly reports to the CCNs, the Project Office, core laboratories, and the Drug Distribution Center (DDC) during the recruitment phases, and maintain updated reports on an Internet site accessible to all units of the study. These reports shall include progress in recruitment of women and specific minorities (African Americans, Hispanics, Native Americans, and Asians).

Collaboratively with the CCNs, develop and implement recruitment monitoring procedures designed to maximize not only enrollment but eventual adherence and retention of patients, including creation of study logo, brochures, posters, incentives, checklists (e.g., “red flags” that alert staff to patients who may pose adherence or retention challenges). Develop and implement a recruitment monitoring plan that includes the responsibility for evaluating and correcting recruitment problems, including criteria for certification of new clinical sites, termination of recruitment at existing sites, and appropriate follow-up of patients enrolled from the terminated site.

14. Monitor patient adherence and retention by providing weekly reports to the CCNs and the Project Office, and maintain updated reports on an Internet site accessible to all units of the study. These reports shall include progress in adherence and retention of women and specific minorities (African Americans, Hispanics, Native Americans, and Asians). Collaboratively with the CCNs, implement an adherence and retention monitoring plan that includes the responsibility for evaluating and correcting adherence and retention problems. Organize and maintain a Recruitment, Retention and Adherence Subcommittee, comprised of CC, CCN, and NIH staff, which will track clinical sites’ performance in the areas of recruitment, adherence to treatment, and retention of study participants, and will provide feedback, support and assistance to sites in a timely way and on an ongoing basis to ensure achievement of study goals in these areas.

15. Prepare and submit a data analysis plan for the trial to the Steering Committee and NHLBI for approval as part of the protocol development phase. Analyze and present data collected during the course of the study. In Phase II, prepare study publications, reports, and other scientific manuscripts in collaboration with other study investigators and the NHLBI Project Office. Assume the development and funding of a supplement in a scientific journal for design and baseline papers. The data analysis plan specified in the protocol should include the beginning of analysis activities from the start of data collection throughout the study, and should include DSMB reports.

16. Prepare and distribute periodic technical and statistical reports to the participating CCNs, the Project Officer, the Contracting Officer, and others identified as key partners by the Project Officer.

17. At least weekly, review study activities, including progress in recruitment and certification of new clinical sites; review data to ensure the scientific validity and the protection of human subject safety and privacy.

18. Establish and conduct timely reviews by the Morbidity and Mortality Subcommittee to classify all clinical outcome events in a uniform fashion. Implement a plan for timely monitoring of adverse events (to http://www.access-board.gov/sec508/guide/1194.22.htm#Back� maximize patient safety). Monitor end point results, morbidity and mortality data, and adverse event reports for patterns of safety or toxicity that may warrant changes in the study. Provide notification and reports to the DSMB and Project Office as required by the SPRINT protocol, NHLBI policy, and the Department of Health and Human Services (DHHS), Office for the Protection from Research Risk (OHRP), and the Food and Drug Administration (FDA) guidelines.

19. Design and implement a plan for study closeout, analysis, and dissemination, including final data collection, verification, analytical support for scientific writing groups, publication of study results, and plans for the investigators’ dissemination of study results. In Phase III, analyze data and prepare study publications, reports, and other scientific manuscripts in collaboration with other study investigators and the NHLBI Project Office. In collaboration with NHLBI staff and other study investigators, finalize the dissemination plan for disseminating study results as well as educational materials and specific procedures for translating trial results into clinical practice. This plan should also include plans to effectively convey results to bodies that develop practice guidelines. This task includes study closeout and dissemination activities for SPRINT and all applicable substudies, including the SPRINT-MIND substudy.

20. Create a public use dataset, and design and implement a plan for data sharing. Prepare accompanying documentation that meets the requirements for a Limited Access Dataset. [See www.nhlbi.nih.gov/resources/deca/]

21. Provide a final report that documents and summarizes the results of the entire contract work, including recommendations and conclusions based on the experience and results obtained. The final report shall include tables, graphs, diagrams, curves, sketches, and drawings in sufficient detail to comprehensively explain the results achieved under the contract. Provide a final study dataset with documentation, as described in Section 4A, Coordinating Center Reporting Requirements and Deliverables.

22. Additional duties of the CC include:

a. Assist the NHLBI in obtaining clearances required by the Paperwork Reduction Act from the Office of Management and Budget.

b. Assist the NHLBI in obtaining Federal-wide Assurance numbers from the DHHS, OHRP for each clinic before the clinic randomizes patients into the study.

c. Prepare and provide to NHLBI a CD ROM of the study data, with detailed, clearly understandable documentation, by the contract completion date.

Clinical Center Network (CCN) Activities

The CCN Contractors perform the following tasks:

1. Provide scientific leadership and oversee 10-30 selected clinical sites for inclusion in the SPRINT Clinical Center Network (CCN) hub. Describe the site selection criteria and process and provide letters of commitment the clinical sites. Provide evidence that the number of clinical sites and participants can be recruited and can successfully implement the study protocol and related substudies, including SPRINT- MIND. Provide letters of commitment from the clinical sites. Criteria for selection shall, at a minimum, include evidence of an adequate patient population; evidence of institutional support; evidence of previous experience with clinical trials; and evidence that patients at the clinical sites are on cardiovascular or renal http://www.nhlbi.nih.gov/resources/deca/� treatment plans consistent with guidelines or standard of care. Potential clinical investigators will be identified through mailings to appropriate professional organizations or associations such as the American College of Cardiology, or other means identified during Phase I. If clinical sites will be located abroad, the CCN will be responsible for all international regulatory matters.

2. Collaborate with other CCNs, the Coordinating Center (CC) and other central units, and the Project Office in finalizing the protocol and the manual of operations (MOP), which includes detailed intervention and measurement descriptions and staff training procedures. References to the SPRINT protocol also include the SPRINT-MIND substudy. The protocol may include the following and other important information:

a. Scientific rationale for proposed study design for SPRINT, SPRINT-MIND, and other applicable substudies.

b. Participant selection, recruitment, and follow-up (including any special considerations for enrollment of up to 50% stage 3 CKD participants; inclusion/exclusion criteria)

c. Interventions (including procedures for medication adjustments)

d. Participant safety and confidentiality

e. Clinical outcome measures

f. Cognitive functioning, health-related quality of life, and cost-effectiveness outcome measures

g. Statistical design and considerations

h. Quality control

i. Data management and training

j. Plan for measuring and maximizing patient adherence and retention

k. Dissemination plan

l. Study organization and timetable

m. Model informed consent document (including adequately addressing data and specimen sharing)

3. Propose to the Steering Committee a drug treatment regimen for the stepped blood pressure strategy and for background therapy (pharmacologic and non-pharmacologic).

4. Have or develop a communication system to be used within the CCN and its associated clinical sites, including Internet capability; this system should include means of assisting the CC in facilitating data gathering links between the clinical sites, CCNs, and central units (DDC, core laboratories).

5. Have mechanisms for obtaining or obtain IRB clearance/assurances for all participating sites within the network, including an approved informed consent document.

6. Assist the CC in training and monitoring staff within the CCN in protocol implementation, and in following the MOP for standardization of protocol-directed procedures and data collection; clinical centers within the CCN will send appropriate materials (e.g., blood samples, ECGs) to the CC and applicable core laboratories (e.g., Central Laboratory, ECG Reading Center, and MRI Reading Center) in a timely fashion, as specified in the protocol and MOP; collaborate with the CC in correcting problems with missed, delayed, and erroneous data at the respective clinical sites within the CCN.

7. Recruit, randomize, manage, and follow up a minimum of 1,500 patients according to the study protocol and MOP; address recruitment shortfalls in a timely fashion; participate with the CC and other CCNs in classifying clinical events in study patients.

8. Develop a strategy to encourage standard of care for all participants for the treatment of cardiovascular and renal risk factors other than blood pressure, such as reporting LDL levels to both patients and non-study providers with a recommended set of actions.

9. Ensure that data files at the clinical sites are collected, maintained, and secured to ensure patient confidentiality and data integrity.

10. Provide timely data on recruitment and measurements to the CC; recruitment data should include numbers of participants screened and numbers randomized, and should be categorized by gender and race.

11. Arrange and lead meetings for CCN clinical site personnel; participate in study-wide meetings and committees, providing information and experts as needed.

12. Assist the CC in capturing major adverse drug effects in a timely fashion to maximize patient safety, and promptly report serious adverse drug events and unanticipated problems from the appropriate clinical site, through the CCN leadership, to the Project Office and the CC, according to the protocol and the MOP.

13. Ascertain and respond to clinical alerts in data measured or interpreted within the CCN, and respond to clinical alerts reported by the CC or core laboratories.

14. Participate in preparing publications in collaboration with other study investigators, the CC, and the NHLBI Project Office.

15. Provide a concise final report which will serve as a technical reference document, describing all of the phase activities.

16. Assist the clinical sites in collecting event outcome data (e.g. hospitalizations records).

17. Reimburse the clinical sites by a capitation approach for services rendered. A reasonable reimbursement fee should be proposed to be paid to the clinical sites for randomization and follow-up. Reimbursement to clinical sites for administrative costs to allow for initiation of study (obtaining IRB approval, etc.) and a fixed unit price for data forms will be negotiated as the basis for reimbursement and payment under the contract.

In general, reimbursement of capitated costs will only be made after the Coordinating Center has verified that the results for a particular participant have been transmitted to the CC or that other study-related milestones have been accomplished by the clinical site. The capitation reimbursement system will be developed during Phase I and must be approved by NHLBI. Patient test costs are normally not subject to indirect costs. Non-protocol routine patient care costs are to be assumed by third party or other normal payment procedures.

18. Establish subcontracts or equivalent agreements for the clinical sites and develop administrative procedures necessary for reimbursement of the clinical investigators for accepted data forms.

Investigators will receive a fixed fee for each completed and accepted patient randomized data form and a fixed fee for all subsequent data forms on that patient. The CCN will negotiate, administer and monitor the subcontract agreements with the clinical sites, which will be responsible for the following:

a. Obtaining IRB approval and follow any other legal and ethical requirements related to the conduct of human subjects research. If clinical sites are located abroad, this includes obtaining foreign site clearances.

b. Obtaining the participant’s informed consent.

c. Randomizing consenting participants and delivering study treatment per the randomization assignment.

d. Conducting all required procedures per the protocol, including blood draws, urinary samples, or any other additional measures as described in the protocol and manual of operations.

e. Ensuring that the study protocol and procedures are followed, including scheduling participants’ follow up and other visits as required.

f. Implementing procedures to maximize patient adherence and retention, including frequent contacts and reminders; ongoing support; encouragement of patient self-monitoring; problem-solving to address barriers; motivational enhancement; and other state-of-the-art adherence-enhancing activities.

g. Adjusting the study treatment as indicated per the guidelines reported in the study protocol and manual of operations.

h. Completing study data forms as directed and answering any data queries in a timely fashion.

Providing documentation of outcomes as directed.

i. Maintaining an up-to-date regulatory data file.

j. Making participants’ records and study files available for site visits by the CC and the NHLBI.

k. Actively participating in study management as directed, including participating in all committee meetings (whenever clinical sites staff are members of those committees).

l. Performing other duties as needed to implement and complete the study.

This is not a request for proposals. If an interested party, other than the contractors listed above, believes it can perform the requirements for SPRINT-Senior, it may submit a statement of capabilities. Responses must identify institution’s business size and associated NAICS code(s). The Statements of Capabilities should not exceed ten (10) two sided typed pages, including attachments. Submissions must be received at the following address or by email as a portable data file (PDF), no later than 4:00 pm local time, Thursday, February 11, 2010: National Institutes of Health, National Heart Lung and Blood Institute, Office of Acquisitions, Rockledge II – Room 6126, 6701 Rockledge Drive – MSC 7902, Bethesda, MD 20892-7902 (use 20817 for overnight deliveries). Questions may be directed to Paul McFarlane, Contracting Officer (301-435-0345) or pm24v@nih.gov. This notice will expire 10 calendar days from its posting.