Dynamics of Health Aging and Body Composition (Health ABC) Research

The National Institutes of Health (NIH), National Institute on Aging (NIA), intends to negotiate, under authority of FAR 6.302-1, on a noncompetitive, sole source basis, with the University of California, San Francisco (UCSF) for the project entitled, "Dynamics of Health Aging and Body Composition (Health ABC) Research Study". This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statement/proposals received within fifteen days after date of publication of this synopsis will be considered by the government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This effort will be for a one (1) year base period and four (4) one year option periods. The Dynamics of Health Aging and Body Composition (Health ABC) Research Study is in accordance with the authority 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2). The proposed contractor is thus uniquely qualified, alone possessing all the elements critical for performing the tasks detailed in the Statement of Work, including access to participants enrolled in the Health ABC study and availability of the required resources for study. Further, all critical study components have been developed, implemented, field-tested, and refined by the proposed Contractor in collaboration with the NIA over the course of the Health ABC study. No other Contractors could provide a comparable service in a timely and cost-efficient manner. In addition, successful follow-up with participants requires continued and regular contact that has been established and maintained by the proposed contractor. It is essential for optimal performance of this contract that there be no disruption in work performance and that smooth continuation of the Health ABC project be maintained as can be provided by the incumbent, UCSF. If another contractor were to be awarded the proposed contract, it would seriously compromise the infrastructure, integrity and scientific productivity of the Health ABC project; such as loss of scientific leadership and staff with intimate operational knowledge of the Heath ABC study and duplication of costs associated with purchasing a new data management system. The current data management system has proprietary software which is of limited access. The University of California, San Francisco thus has the unique capability to provide the required services to NIA for the Dynamics of Health Aging and Body Composition (Health ABC) Research Study. The Health ABC requirement (1) must be performed at sites located in Memphis, TN and Pittsburgh, PA to use original Health ABC Study participants for the purpose of maintaining participant cooperation and study follow-up success; (2) has limited data access due to the UCSF being the sole proprietor of specific version of the data management system; and (3) must comply with Section 508 of the Rehabilitation Act or the Electronic and Information Technology Accessibility Standards pertaining to all of 36 CFR 1194.21 and 1194.22. The UCSF developed the data management system and it houses other studies including the Health ABC project. Although, the data developed for this study is Government owned. Therefore, the transfer of the data management system to another contractor (other than incumbent) would be disruptive to the project requiring start up time to become familiar with over fourteen years of invaluable and irreplaceable data, cause unacceptable delays to the Health ABC project and require duplication of cost to purchase and develop a system. In summary, inherent risk of loss of over fourteen years of data collection, unacceptable delays, and duplication of costs to the Government in completing the project make competition unfeasible for this study. Background and Purpose of Dynamics of Health Aging and Body Composition (Health ABC) Research Study: The Health ABC Study represents an extension of the current study under contract number N01AG62106. The Health ABC study is continued follow-up of the Health ABC cohort by means of clinic examinations, home examinations, and medical and death records abstraction. The primary aims of the requirement are to perform data collection activities; perform data entry, verification, editing, dataset preparation, documentation, and website maintenance; and participate in the scientific direction of the study, coordination of all communication and meetings, preparation of publications and public presentations on the results of the study. Although, the Health ABC study represents a new contract action, the work to be performed is essentially unchanged, using the same equipment and procedures as in the latter years of the current Health ABC study contract. The Health ABC cohort was recruited to capture the course of disablement in persons who came into old age at the relative zenith of their health and function. Participants at baseline were free of functional limitation, defined as inability to walk up a flight of stairs and/or to walk a quarter of a mile without difficulty. At baseline, the Health ABC cohort included 3,075 men and women aged 70-79 in 1997-98. Forty-six percent of the women and 37 percent of the men were African-American. The original goal of the study was to understand how change in body composition and weight-related health conditions contributed to and affected incident functional limitation. Over fourteen years of follow-up, the study has tracked functional status through examinations and telephone interviews. Health ABC has maintained an emphasis on key comorbid health conditions (as ascertained by self-report, hospital discharge diagnosis, and through physiologic testing) as modifiers of health. Thus far, the study investigators have been able to identify how body composition changes and affects strength. These observations have made fundamental contributions to understanding the prevalence and prognosis of sarcopenia. This clinical research study was designed to investigate risk factors for sarcopenia (loss of muscle mass and strength) in healthier old people and the functional consequences of such changes. The study is unique for the breadth of the measurements of body composition longitudinally and the depth of the measurements that include computerized tomography of the abdomen and thigh in addition to anthropometry and dual-energy x-ray absorptiometry. Few other studies have been established with such complete characterization for older persons. The focus of the Health ABC study has shifted as the participants aged. Questions regarding onset of early disability dominated the first few years of data analysis and Health ABC is recognized as one of the key studies of the health effects of overweight and obesity. The role of fatty infiltration into muscle was a prominent finding as this related to metabolic and functional health. The middle years of the study have been more focused on trajectories of individual health conditions: pulmonary disease (augmented by a grant), congestive heart failure, cognitive dysfunction (enhanced by the "Cognitive Vitality" sub-study begun in Year 3 of the study and by grants to junior investigators at UCSF and at University of Pittsburgh), and diabetes (also augmented by grant support to an investigator at UCSF). Analyses of longitudinal trends are now underway with a focus on hospitalization as a key event in the loss of function and in change in body composition. Health ABC investigators have also been active in genomics analysis. The Health ABC cohort now has been completely genotyped with a million SNP markers thanks to a grant obtained by collaborators at Wake Forest University. The availability of expanded genetics data has led to an influx of new investigators involved in Health ABC. For the past fourteen years, Health ABC has had a stable infrastructure for the clinics and coordinating center which has resulted in exceptional data quality and minimal loss to follow-up of the study participants. The focus of this requirement for Health ABC is to continue follow-up in the remaining living cohort members for five additional years with a focus on two major areas: FOCUS 1: Clinic or home examination of all living Health ABC cohort members will be conducted to assess the role of body composition and other novel traits in the onset or worsening of extreme disability or frailty. FOCUS 2: Continued longitudinal follow-up via health and death records abstraction and adjudication will allow for collection of important outcomes such as hip fracture, stroke, cardiovascular events, and cause of death. This proposed acquisition was previously publicized under sources sought notices HHS-NIH-NIDA(AG)-RDSS-11-158 and HHS-NIH-NIDA(AG)-SBSS-11-158. The estimated contract award date will be on or about February 15, 2012.