ARIC JOFOC FedBizOpps Notice.doc

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS, National Institutes of Health (NIH)

b. Sponsoring organization. National Heart, Lung, and Blood Institute (NHLBI), Division of Cardiovascular Sciences, Program of Prevention and Population Studies, Epidemiology Branch

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of this acquisition is to continue the Atherosclerosis Risk in Communities (ARIC) study through October 31, 2016 for the study of long-term trends in coronary heart disease (CHD) and heart failure, and to identify novel factors related to the development and progression of cardiovascular disease. The ARIC study has been conducted since 1985 in four U.S. communities through the contracts with the University of North Carolina (Coordinating Center and Field Center), Baylor College of Medicine (Central Laboratory Center), University of Minnesota (Field Center), Johns Hopkins University (Field Center), and University of Mississippi (Field Center). This JOFOC is requesting approval to issue noncompetitive solicitations to these institutions to continue as contractors.

The Epidemiology Branch within the Prevention and Population Sciences Program, NHLBI, conducts epidemiologic studies of the incidence, prevalence, and predictors of cardiovascular risk factors and diseases. The information obtained is used to develop effective programs to control these diseases. The ARIC is the major study of risk factors for cardiovascular disease in middle-aged adults and community trends for CHD and heart failure. The study has identified, and will continue to identify, new risk factors for cardiovascular and lung diseases, describe trends of these diseases in communities, and identify the contribution of genetic and genetic-environmental factors in the development of these diseases.

b. Project background.

University of North Carolina (Coordinating Center)

N01-HC-55015

Baylor College of Medicine (Central Laboratory)

N01-HC-55016

University of North Carolina (Field Center)

N01-HC-55018

University of Minnesota (Field Center)

N01-HC-55019

The ARIC study was established by NHLBI in 1985 to monitor the trends in incidence and mortality of CHD in four U.S. communities (Washington County, MD; Forsyth County, NC; Jackson, MS; and Minneapolis, MN) and to investigate the etiology and natural history of subclinical and clinical cardiovascular disease. Accordingly, ARIC includes a Community Surveillance Component and Cohort Study Component.

As part of the community surveillance component, the four communities are investigated to determine the long-term trends in hospitalized myocardial infarction (MI) and CHD deaths in approximately 470,000 men and women aged 35-84 years. Events are investigated by review of hospital records and by query of physicians and family members, and are given standardized diagnoses. Beginning in 2005, surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) is now included.

In the cohort study component, approximately 4,000 individuals aged 45-64 years were recruited from each of the four communities under surveillance. A total of 15,792 participants (11,478 whites, 4,266 African Americans, and 48 other) received an extensive baseline examination in 1987-1989. The examination consisted of questionnaires on socio-demographic characteristics, health behaviors, and psychological factors; anthropometry and physical examination; resting electrocardiography; B-mode carotid ultrasound; a diet history assessment; pulmonary function testing; resting blood pressure; and fasting blood measurements. Three repeat examinations were conducted in 1990-1992, 1993-1995, and 1996-1998, with a response rate of 93%, 86%, and 80%, respectively. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. Retention rate remains to be high (92%). There were approximately 13,000 participants alive as of December 2008.

The advent of sophisticated molecular techniques has permitted examination of the genetic determinants of disease. Advances in genotyping and statistical methodology have enabled genome-wide scans to be used to identify putative linkages and associations for many significant risk factors. ARIC has participated in several NHLBI-sponsored studies to perform whole genome association studies. Efforts are underway to carry out targeted sequencing studies to identify susceptibility genes underlying genome-wide significant findings. The ARIC study is particularly appropriate for these analyses because of its population-based nature and random ascertainment, freeing it of many of the biases of clinically identified samples. Such studies are critical to defining risk in free-living, non-clinical populations, providing data on evolution of disease risk that cannot be obtained any other way. In addition, the ARIC study includes a large proportion of African American participants, which provides sufficient statistical power to identify determinants of racial disparities in cardiovascular risk factors and disease.

The universities named above have been the contractors for this research since 1985. The initial contracts were awarded in 1985 under full and open competition with performance periods through August 1993. Since then, the contracts for the Coordinating Center, the four Field Centers, and the Central Laboratory have been extended three times non-competitively to continue the community surveillance, cohort morbidity and mortality follow-up, laboratory analyses, and scientific publication of results through January 31, 2012. The justifications for the sole-source awards included: 1) These contractors have unique capabilities as a result of the established relationship with one anther and the cohorts to which they have access; 2) Continuation with these contractors was the only means to consistently evaluate community trends and maintain and follow the cohort participants; and 3) Transfer of this work to new contractors would result in substantial cost duplication and unacceptable delays, and would threaten the validity of the results. The previous approved JOFOC for the three actions are attached (Attachment 1).

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. The Atherosclerosis Risk in Communities study

b. Project description.

This initiative, which will support a 6-year follow-on of the Atherosclerosis Risk in Communities study, has five objectives:

1) Re-examine the ARIC cohort to characterize heart failure stages in the community, identify genetic and environmental factors leading to ventricular dysfunction and vascular stiffness, and assess longitudinal changes in pulmonary function and identify determinants of its decline;

2) Continue cohort follow-up for cardiovascular events, including CHD, heart failure, stroke, and atrial fibrillation; and for the study of risk factors related to progression of subclinical to clinical CVD;

3) Enhance the ARIC study with cardiovascular outcomes research to assess quality and outcomes of medical care for heart failure and heart failure risk factors;

4) Continue community surveillance to monitor long-term trends in hospitalized MI, CHD deaths, and heart failure (inpatient and outpatient); and

5) Provide a platform for ancillary studies, training for new investigators, and data sharing.

These objectives require continued surveillance of the entire community residents aged 35 years and older. Trends in incidence of cardiovascular disease are difficult and expensive to obtain, are not available on a national basis, but are critical in monitoring a primary mission of NHLBI to reduce the burden of the disease in the population. Continued monitoring of the trends through this well established infrastructure is most cost effective and should provide a reliable and primary data source for assessing the impact of prevention and medical treatment of this disorder.

These objectives also require re-examination of approximately 9,100 participants and follow-up of the originally surviving cohort for cardiovascular events and medical care received. The study will utilize the extensive risk factors, diseases, and disease treatment information documented in past examinations of the ARIC cohort. Since the etiologies of cardiovascular, lung and blood diseases are often multi-factorial and cumulative over the life span, epidemiologic studies are most informative when assessment of risk factor burden is both detailed and prolonged.

Additionally, the objectives require the widest possible use of data and research opportunities from ARIC, which exceed the expertise and abilities of any single research team. Extensive ongoing collaborations with outside investigators will expand the scientific areas under investigation. ARIC DNA, non-DNA laboratory samples and phenotypic data will be made available under procedures providing equal access, protections of participant confidentiality, and conservation of scarce resources. This sharing of data and materials enhances ARIC as a national resource for epidemiologic and genetic investigations of cardiovascular, lung and blood disease risk.

The Statement of work for the Coordinating Center, Field Centers, and Central Laboratory Center are attached (Attachment 2).

· Requirement type.

( Research & development (R&D) ( R & D support services

( Support services (non-R&D) ( Supplies/equipment

( Information technology (IT) ( Construction ( Architect-engineer (A & E) services ( Design-build ( Other (specify): ____________________

· Type of action.

( New requirement ( Follow-on ( Other (specify): ______________________

· Proposed contract/order type.

( Firm-fixed-price ( Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ ( Cost-plus-fixed-fee ( Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): _Base with Options ( Time and materials ( Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ ( Other (specify): ___________ ( Completion Form ( Term form

· Acquisition identification number.

Coordinating Center:

RFP NHLBI-HC-11-05

Field Centers:

RFP NHLBI-HC-11-06

Central Laboratory Center:

RFP NHLBI-HC-11-07

c. Total estimated dollar value and performance/delivery period.

The proposed performance period for this follow-on is projected to be from November 1, 2010 to October 31, 2016. The decision to award the ARIC follow-on early was made for two major reasons. First, the ARIC follow-on includes a clinical exam with a focus on heart failure among approximately 9,100 cohort participants in support of the NHLBI mission to identify and reduce heart failure. Because the ARIC study has not conducted a clinical exam for more than 10 years, awarding the ARIC renewal early would allow sufficient time for study protocol development, OMB clearance, additional staff recruitments, and central training. A second very important reason is to take advantage of the timing for the award of a large ARIC ancillary (grant) study titled "ARIC Neurocognitive Study" (HL96812, HL96814, HL96899, HL96902, HL06917) that plans to conduct a clinical exam in 2011-2012 with a focus on cognitive function assessment.

4. Identification of the statutory authority permitting other than full and open competition.

( This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

( This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

( This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

University of North Carolina (Field Center) Bank of America Center

137 E. Franklin Street Mail Station 8030

Chapel Hill, NC 27514-4145

University of Johns Hopkins (Field Center) 2024 E. Monument, Suite 2-600 Baltimore, MD 21205

University of Minnesota (Field Center) 1300 South Second Street

Minneapolis, MN 55454-1087 University of Mississippi (Field Center) 2500 North State Street Jackson, MS 39216-4500 University of North Carolina (Coordinating Center)

Bank of America Center

137 E. Franklin Street Mail Station 8030

Chapel Hill, NC 27514-4145

Baylor College of Medicine (Central Laboratory Center)

6565 Fannin Street

Mail Station A601

Houston, TX 77030

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

An important mission of the NHLBI, includes assessing cardiovascular incidence and its causes and identification of preventive methods. The ARIC Study is a major NHLBI effort to identify and describe risk factors, including genetic factors, for cardiovascular and lung diseases. The results are expected to improve individuals at risk and the development of approaches for both individual and community prevention. Continuation of the main components of ARIC by the current contractors is required to maintain consistency in the evaluation of the study communities and participants. Transfer of the work to a new contractor would result in substantial cost duplications and unacceptable delays in accomplishing the Government's goals. It would also threaten the study's ability to achieve its research objectives. As set forth in more detail below, each of the respective contractor’s follow-on performance is critical to the success of this program. It is therefore recommended that this acquisition be non-competitively negotiated with the existing contractors. There are several specific reasons for this recommendation pertaining to each type of work:

Field Centers (Contracts Nos. N01-HC-55018 through N01-HC-55021)

a) Continuation with the current contractors is the only means to consistently evaluate community trends and maintain and follow the participant cohort. It is imperative that the follow-on continue to study the same communities and cohort in order to have trend and prediction data in the communities and individuals. "Continuity of the participant/research relationship reduces participant concerns regarding credibility..." as documented in the International Journal of Nursing Practice article on the "Principles of recruitment and retention in clinical trials" (2003; 9: 338-346). This article also noted that "The interpersonal skills of the personnel responsible for approaching potential participants are important factors in determining whether agreement to participate is forthcoming." Further, because study participants identify and are familiar with the study's clinic staff at the current centers that recruited them, transfer of responsibility for maintaining the cohort would result in a loss of participant trust and markedly decreased participation. This familiarity with the clinic staff at the four sites greatly enhances participation. Maintaining the cohort's participation is a key to the success of the research. Follow-up losses would threaten the study's ability to achieve its research objectives by reducing statistical power and creating response biases, which affect the generalizability and the accuracy of time-trend analyses.

b) Transfer of this work to new contractors would result in substantial cost duplication and unacceptable delays, and would threaten the validity of the results. The new surveillance period, which would begin on the first day of the follow-on contract period, requires that the Field Centers be operational from the start. A new contractor would need at least 12 months to gain familiarity with software, hardware, the dataset, assume management of new data, and quality assurance for all study components and procedures. Project transfer to a new contractor would cause interruption of ongoing surveillance activities as well as increased costs from disrupting scheduled data collection cycles.

c) Comparability of measurements over time would be difficult to achieve with new contractors. Senior investigators involved with ARIC have spent over 20 years developing the protocols for performing this study. New investigators would not have the experience to achieve comparability in measurements, which is essential in the study of trends. In addition, maintaining comparability across centers is important to the study. The investigators have become familiar with each other's operations, during the course of 24 years of meetings, site visits, and conference calls.

d) Surveillance procedures such as abstraction and review of hospital records, query of physicians and family members, and classification of conditions, etc. have been carefully standardized, and require extensive training and experience not readily available even in other research settings. Clinical examination procedures such as blood-drawing, taking of blood pressure, ankle-brachial measurement, anthropometry, etc. have been also standardized to be comparable with past examinations. Project transfer to a new contractor would entail many months of delay to identify, recruit, and train new staff as well as increased costs from disrupting scheduled data collection cycles.

e) These contracts have developed protocols and manuals of operation that will be modified based on the study objectives for the next contract period. Familiarity with these procedures and manuals will create great efficiency during the next contract period. A new contractor would need a period of at least 12 months to gain familiarity with software, hardware and the data set, assumes management of new data, support clinical examination operations, and provide quality assurance for all study components.

f) On-going data analyses and publication efforts would be interrupted. The net result would be unacceptable delays and cost duplications, postponing availability and reporting of the final study results.

Coordinating Center (Contract No. N01-HC-55015)

a) The current Coordinating Center has established an extensive set of systems for managing the study data and communicating with investigators. These systems have provided for efficient operations since study inception. A new Coordinating Center would result in unacceptable delays, inefficiency, and increased costs. New systems would be costly and require orientation of all of the ARIC investigators and Project Office staff, numbering upwards of 120 people. This is based on the experience of the first set of contracts and preparation for the first examination and the start of community surveillance, which had an 18-month protocol development and training period.

b) The new surveillance period, which begins on the first day of the extended contract period, requires that the Coordinating Center be operational from the start. A new contractor would need a period of at least 12 months to gain familiarity with software, hardware and the dataset, assume management of new data, support clinical examination operations and community surveillance, and provide quality assurance for all study components. In addition, the Coordinating Center would have to become familiar with the operations of each of the collaborating centers, including the Field Centers and the Central Laboratory, in order to function. This would require site visits; establishing new communication interfaces; establishing new tracking systems and archiving systems for data and samples; establishing a new quality control monitoring system; and other oversight responsibilities.

c) The current Coordinating Center assists investigators by analyzing data from the extremely complex ARIC dataset. A change in the Coordinating Center would result in delays in many ongoing data analyses and publication efforts by approximately 12 months. This would be due to the need for new staff to gain familiarity with the dataset, establish new data analysis programs, and manuscript preparation oversight.

d) The current Coordinating Center has created numerous systems to streamline the study, many dependent on individuals employed at the center. Project transfer to a new contractor would cause method biases in data analysis and entail months of delay to identify, recruit, and train new staff as well as increased costs from disrupting scheduled data collection cycles.

Central Laboratory Center (Contract No. NO1-HC-55016)

a) Transfer and cataloging of the stored serum, plasma, urine and DNA aliquots would entail both added costs and the hazards of sample thawing and damaging, and identification errors.

b) The ARIC Central Laboratory measures changes in risk factors that may be major determinants of development of cardiovascular disease such as CHD, hypertension, and diabetes. It is essential to ARIC's primary goals that any changes observed in these determinants be real and not attributable to methodological errors. Because real changes in these factors may be small over the study period, undetected methodological errors would falsely be attributed to changes in the determinants of cardiovascular disease.

c) The Laboratory has succeeded to date in maintaining strict measurement comparability through use of specially prepared in-house standard materials and other quality control efforts not ordinarily undertaken even in other research settings. Such comparability could not be assured with a shift to a new contractor using new staff unfamiliar with procedural details, new standard control materials, new equipment, and new senior scientists.

d) The contractor has unique qualifications needed for this work. The senior Laboratory investigators are recognized leaders in cardiovascular genetic studies and the studies of the pathogenesis of atherosclerosis. The use of any new contractors to perform the contract work would result in the loss of the unique expertise and the years of experience of the Laboratory investigators.

e) Cost duplications would result from recruiting and training new laboratory staff, reestablishing ARIC analytical procedures, and testing results for comparability with previous measurements.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Multiple discussions by the COTR and Contract Offices' staffs took place with investigators both internal and external to NHLBI scientific experts in the community that determine if other sources exist. Discussions with the ARIC Observational Studies Monitoring Board (OSMB) have taken place annually since study inception and most recently on December 3, 2008, when the OSMB specifically recommended a study continuation with the same set of the study centers (OSMB Minutes and roster, Attachment 4a). A working group of independent investigators outside of NIH was convened on July 1, 2008, to discuss future research opportunities the ARIC study. The members were also highly supportive of continuing the study based on the data resources and productivity of the investigators (Working Group on Future Research Opportunities in ARIC Minutes and roster, Attachment 4b). No performance issues were identified by either the OSMB or the Working Group. On May 5, 2009, members of the NHLBI Board of External Experts (BEE) endorsed continuation of the study (attached roster—no minutes were generated, Attachment 4c). The NHLBI Advisory Council provided their endorsement on June 10, 2009 (attached roster-no minutes were generated, Attachment 4d. A brief summary of the meeting is available at: http://www.nhlbi.nih.gov/meetings/nhlbac/Jun09sum.htm).

It was determined based on these discussions that these six contractors were best suited for this work scope both in the scientific and management aspects of the study. Therefore, a 15 day Notice of Intent was issued in FedBizOpps on October 27, 2009 (Attachment 5). No responses were received by the November, 11, 2009, the expiration date.

7.

Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

An independent government cost estimation (IGCE) has been developed based on the history with these contractors and other epidemiologic studies monitored by the Contracting Officer and COTR. The development of the IGCE also used documentation provided on current payroll and vendor quotes as submitted during the negotiations for the FY 2006 follow-on. Updated documentation will be requested for this acquisition for any “new” effort or supplies.

8.

Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

As mentioned in item 6 above, multiple discussions by the COTR and Contract Offices' staffs took place with investigators both internal and external to NHLBI prior to deciding that the current contractors should be negotiated with on a noncompetitive basis. It was determined based on these discussions that these six contractors were best suited for this work scope both in the scientific and management aspects of the study. Therefore, a 15 day FedBizOpps Notice of Intent Notice was posted in the on October 27, 2009 (Attachment 5). No responses were received by the November, 11, 2009, the expiration date.

9.

Any other facts supporting the use of other than full and open competition.

As described in FAR 6.303-2(a)(9)(ii), duplication of costs would result if award were made to other sources in purchasing new equipment, transfer and reinstallation of Government titled property, and staff identification, hiring, and training based on the ARIC study Protocols and Manuals of Operation. This estimate was derived from costs taken from the Independent Government Cost Estimate (IGCE) that was developed for the Coordinating Center, the Field Center and the Central Lab. This IGCE was developed for the ARIC renewal using current estimated costs from ARIC and other similar studies. The COTR estimated that a learning curve of one year would be required to establish four new FC’s, a new Coordinating Center and a new Central Laboratory.

10.

Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest in writing for the proposed acquisition.

11.

Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

As indicated above, a follow-on acquisition beyond this follow-on is possible and will be re-evaluated near the end of the contract period based on NHLBI review of scientific need and contractor performance. While continuation of current work will require use of the same contractors, any new work to measure components identified as new scientific opportunities will be competed as a full and open competition. This pertains to the introduction of new technologies into the study, such as a new imaging component or new laboratory measurements. For this contract follow-on, two new contracts (for an Echocardiography Reading Center and a Cardiovascular Outcomes Research Center) will be competed to measure new components defined by the study objectives.

PAGE