SOURCES SOUGHT
A -- Longitudinal Studies for Age-Associated Conditions in a Sardinia Population Cohort (Sardinia3)
- Notice Date
- 7/2/2010
- Notice Type
- Sources Sought
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(AG)-SBSS-10-133
- Archive Date
- 8/3/2010
- Point of Contact
- Rosanne S Wilson, Phone: 301-443-4433, Suzanne Stinson, Phone: 301 443 4116
- E-Mail Address
-
wilsonr@mail.nih.gov, sstinson@mail.nih.gov
(wilsonr@mail.nih.gov, sstinson@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." BACKGROUND The National Institute on Aging (NIA) has a need for a project entitled, "Longitudinal Studies for Age-Associated Conditions in a Sardinia Population Cohort (Sardinia3). The Sardinia3 project is a continued need of the SardiNIA study under Contract No. N01AG12109 and will carry out fourth visits for the maximum number of participants that are possibly available for study. The primary study AIMS include: AIM I: Performance of all data collection activities; AIM II: Performance of data entry, verification, editing, transmittal and file management; and AIM III: The Contractor shall participate in the preparation of publications and public presentations on the results of the study, and design the studies to maintain the possibility of any future extension of the project to additional phenotypes and longitudinal studies. In keeping with its overall mission, it is incumbent on the National Institute on Aging (NIA) to discriminate epidemiological and genetic factors involved in the etiology of aging-associated deficits, in order to understand and intervene to prevent or alleviate them. An indispensable and major step forward has been the progressive development of phenotypic tests for conditions and their application to determining statistical ranges of phenotypes in "outbred" (that is, genetically relatively heterogeneous populations with considerable admixtures from outside populations added over time), to assess both comparable statistical factors and epidemiological and genetic factors in the especially favorable Sardinian population. Reports from the Baltimore Longitudinal Study on Aging (BLSA) and other population studies have identified some epidemiological and genetic risk factors for aging-associated diseases; but the majority of studies have been observational, determining the range of values for a phenotype as a function of aging. Examining the genetics of aging-associated conditions such as cardiovascular problems and osteoporosis is especially difficult because 1) they are "late-onset" conditions, affecting older individuals; and 2) they are "complex traits", with a number of genes contributing more or less to tipping the balance toward a phenotype or disease in one or another subgroup of an outbred population. Thus, traditional family genetic studies are difficult, and studies of association or linkage tend to be confounded. As one aid to analyses of factors affecting aging-associated conditions and diseases, attention has increasingly focused on the promise of "founder populations" for the simplification of complex trait analysis. Such rare populations arise from a delimited group living in a defined region - in this case, the island of Sardinia - for many centuries with minimal admixture from outside populations. The high degree of relatedness in such a population helps in modern non-parametric analyses o localize and refine the localization of those genes. The Sardinian population is one of the few that is both numerous and accessible enough, and one of the most extreme in its relative homogeneity. It can thus be studied for a wide variety of both frequent and relatively rare traits. The attractiveness of Sardinia for study is increased by the concentration on a targeted region for the studies, Ogliastra, which has a particularly isolated population of 60,000, in an area enclosed by two mountain ranges and the sea. The program examines phenotypes for which NIA expertise and test instruments are well developed, and which represent important aging-related conditions. The study has been scoring >200 dichotomized traits (smoking, etc.) and over 100 quantitative traits ("endophenotypes" or "quantitative risk-related genetic or environmental factors") that can be scored on a continuous scale. The use of quantitative traits permits the study of the entire range of allelic variation in a population. The traits of particular interest include a range of cardiovascular risk factors, anthropometric measurements, blood test values, and facets of personality. Recruitment was completed for over 6,100 subjects from a selected group of four towns in east-central Sardinia where the traits for each subject was measured. Genotyping of all participants was also completed that has provided the data for investigators to look for genetic factors associated with each trait. The infrastructure for the clinic and phenotypic testing has been stable, with stringent quality control, and the data are of correspondingly high quality. The sample cohort numbers over half of the population of the region aged 14-102; they are native-born, and at least 96 percent are known to have all grandparents born in the same province. The group include 4,933 phenotyped sib pairs, 4,266 phenotyped parent-child pairs, >4,069 phenotyped cousin pairs, and >6,459 phenotyped avuncular pairs. This sample is large enough and well enough phenotyped to show that even in this founder population, the variance for individual traits is comparable to that in outbred populations; and it is large enough and interrelated enough to infer highly significant estimates of genetic heritability for traits. With this cohort, full-genome scans with batteries of single-nucleotide markers were carried out, along with second visits to the testing center for repeated tests and additional tests related to bone-density and frailty; and third visits will be done within the tenure of the out-years of SardiNIA2, aiming at longitudinal data to supplement the cross-sectional data provided by first visits. A critical step in longitudinal studies would record data from a fourth visit of participants (Aim I); and transfer of the data (Aim II) would provide them for later use in a range of studies, A subsidiary Aim III would be to design the studies to maintain the option to study additional phenotypes. The study is designed to permit the estimation of individual trajectories of quantitative traits, which requires the measure of at least three points in time to avoid the bias resulting from "regression to the mean". A further advantage is that, by collecting multiple measurements over time, one can improve the power of mapping studies. Specifically, by modeling the repeated measures of each trait, one can focus on the long-term component of the trait for each individual. Based on the proposed studies, the information recovered could facilitate ulterior analyses of age-related trends and the molecular nature of gene variations that are significant factors for traits of particular interest; and a platform for the possible extension of studies to other phenotypes and further longitudinal studies. PURPOSE AND OBJECTIVES The Contractor shall extend the studies of aging-associated conditions in the especially favorable Sardinian population with longitudinal assays of traits, in order to sustain the later analysis of genetic factors involved in trait values and/or rates of change of values of a trait, and to move toward the identification of alleles that confer significant risk for extreme values of individual traits of interest in health and disease. The specific Objective is to extend the longitudinal study of trends in quantitative trait values with a fourth clinic visit for the participants in the study. The Contractor shall be responsible for coordination of the data collection, including recruitment and scheduling of study participants, administration and scoring of tests for each trait and data entry and transfer. The Contractor shall provide maintenance of equipment; provide personnel, supervising their performance in the administration and scoring of the tests; and be responsible for computer entry and data transfer of the test data to the Contracting Officer's Technical Representative. In addition, the Contractor shall be responsible for properly protecting all information used, gathered, or developed as a result of the Statement of Work (SOW). The Contractor shall establish and implement appropriate administrative, technical, and physical safeguards to ensure the security and confidentiality of sensitive Government information, data, and/or equipment. There are three goals for the proposed efforts to satisfy the Objective fully, consonant with the three AIMS: 1) Determine values for the specified range of phenotypes, including specified new traits, in the established cohort from the founder population of Sardinia, completing a fourth visit for the maximum of the 6,000+ initial recruits possibly available for the Tasks in SOW; 2) Provide the data (values) for all traits in electronic form and reports as specified, in order to support derived analyses and publications; and 3) Design the studies to maintain the option for later expansion of successful efforts to additional phenotypes and outcome studies in the founder population. PROJECT REQUIREMENTS A. Recruitment of Subjects and Staff, the Contractor shall develop a route to the projected goals for recruitment of subjects, including males and females from the established cohort of 6,000+ individuals; and the staff plan for the efforts, including staff recruitment and the identification of personnel to be trained in sonography and testing before studies of subjects are initiated. Phone contact shall facilitate scheduling; and as in the initial visits, the first subjects contacted for recruitment shall be those who have been identified as index cases with cardiovascular conditions, referred by their physicians, that warrant targeted investigation. These would be followed by relatives and controls from the rest of the cohort. B. Contacting and Scheduling Participants, the Contractor shall develop an Informed Consent form in Italian for the studies and receive prior written approval by the COTR prior to submission to Institutional Review Boards. The Contractor shall be responsible for obtaining appropriate institutional review board approvals from local authorities, and for abiding by institutional review board rulings from NIA. The Contractor shall identify, recruit, and obtain informed consent for eligible volunteers. Participant recruitment shall be conducted so as to ensure a wide distribution of ages of participants, aiming at as much of the original subject cohort as possible. The Contractor shall be responsible for scheduling participants at the participating site(s). C. Tasks and phasing, TASK 1: Anthropometric measures and arterial stiffness and echographic assessments, the Contractor shall collect data using reliable anthropometric measures, non-invasive indices of arterial stiffness (pulse wave velocity; PWV, Augmentation index; AGI), a non-invasive measure for arterial intimal-medial thickness (carotid intimal-medial thickness; IMT), and non-invasive measures of renal and thyroid ultrasound shall be performed by a trained test administrator. The cardiovascular-related measurements shall include blood pressure, heart rate, weight, height, waist to hip ratio, ankle brachial pressure index, carotid and heart bruits, as well as carotid intima-media thickness, carotid pressure-strain elastic modulus, and pulse wave velocity. At the time of testing, blood and urine samples shall be collected. A report shall be provided to each participant on selected phenotypes and related data. The report shall include data from Task 1 for which there are accepted public health practices and interventions and which are clinically well-known to the physicians, i.e. cholesterol, blood pressure, general physical parameters, etc. For the arterial stiffness measurements, the report shall indicate extreme values from carotid ultrasound that would correspond to clinical guidelines for interventions, and correspondingly extreme features from renal and thyroid ultrasound that indicate possible pathology that can be further investigated with their physician. For ankle brachial pressure index, augmentation index, echocardiogram, 24 hour blood pressure monitoring, and pulse-wave velocity. The NIA will provide standardized tests that shall be used and administered according to the standardized set of instructions in manuals provided in English by the NIA, including standardized tests for augmentation index, echocardiogram, 24 hour blood pressure monitoring, ankle brachial pressure index, renal ultrasound, and thyroid ultrasound. The COTR shall work closely with the Contractor to monitor training and testing sessions of testers, to maintain consistency both during the study and with other NIA studies. The Contractor shall report to the COTR on a monthly basis by telephone or email to review subject participation and any procedural difficulties. TASK 2: Assessments of frailty and cognitive state, 1) A lower leg PQCT scan to determine trabecular and total bone density; mechanical resistance to compression; cortical bone area and density; and muscle cross-sectional area; 2) Muscle strength testing by hand-grip strength; 3) Walking speed in a 4-meter test; 4) Self-report of exhaustion and unintentional weight loss, and level of physical activity. The Contractor shall incorporate the standard EPIC food frequency questionnaire to be completed by participants at home, or administered by an interviewer during a follow-up visit for those who experience difficulty in filling out the questionnaire; 5) Brief standard cognitive performance assessment, comprising mini-mental status examination, clocks test, fluency test, and short-term memory drawing test; and 6) The contractor shall incorporate in the third visits the standard CESD (Center for Epidemiological Study of Depression) assessment of symptoms of depression to facilitate association with frailty. TASK 3: Demographic and Short Symptom Checklist (SSCL) data, Two additional test instruments, supplied by NIA in an Italian version, shall be administered to the same population cohorts screened for arterial stiffness and personality phenotypes. One instrument is a short symptom checklist for various conditions (SSCL) and the other obtains basic demographic and family structure and composition information. The tests shall be administered with the supervision of a trained test administrator/ interviewer. TASK 4: Retinal, hearing, and facial morphology assessments, The Contractor shall collect data using reliable measures of retinal features, facial and ear morphology features, and hearing. For each subject, results shall be recorded for retinal 45 degree field photographs with a non-mydriatic retinal camera, a single photograph for each eye; for 10 photographs of frontal and 10 of side views of the head, and of hearing scored with best current practice for audiometry; TASK 5: Urine analysis and blood drawing, fractionation, sample storage, and assays, From each participant at each visit the following biological material shall be collected: 1) 10 ml of fasting morning (middle catch) urine shall be collected and stored at -80° in ten(10) 1-mL aliquots, and 2) 50 ml of blood from overnight-fasting subjects shall be drawn and fractionated to provide at least: (a) from 40 mL, fourteen (14) 1-ml aliquots of EDTA-plasma and eight (8) 1-mL aliquots of heparin-plasma, four (4) full buffy coats, and two (2) samples of red blood cells; (b) from 10 ml of blood, about 640 ug of total DNA extracted in two (2) separate aliquots. White cells shall be stored in liquid nitrogen; all other fractions shall be held temporarily at -20 C, and then stored at -80 C, in sufficient quantities to allow a range of standard assays. For each participant, the Contractor shall ship three (3) 1-ml portion of fasting urine and six (6) 1-mL portions of serum and one (1) 1-mL of plasma to the NIA in Baltimore, Maryland USA to allow for possible additional assays of some proteins, hormones, inflammatory markers, oxidative stress biomarkers, lipids or minerals. Shipments shall be made at intervals of at least every six (6) months for samples from up to 1,000 participants per shipment. Shipments shall be on dry ice, according to IATA (International Air Transport Association) http://www.iata.org/cargo/dg/ and ICAO (International Civil Aviation Organization) http://www.icao.org/, with the IATA Dangerous Goods Regulations containing all provisions mandated by ICAO and all rules universally agreed by airlines to correctly package and safely transport dangerous goods by air. Shipping containers and packaging requirements using UN specifications shall be utilized in the shipment of samples. A battery of tests to be done by the Contractor for each subject shall include: Blood sugar level, Triglycerides, HDL, LDL, Cholesterol, Insulin, Uric acid, Serum creatinine, BUN, Fibrinogen, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT), C-reactive protein, Erythrocyte sedimentation rate, Prostate-specific antigen (PSA), Adult hemoblobin (HbA), MCV, MCH, red blood cell, leukocyte and platelet counts Hemoglobin A1c, Iron, Transferrin, Ferritin, fT4, TSH, Anti-thyroperoxidase antibody, Anti-TSH receptor antibodies, IgE, and total Urine tests (pH, glucose, protein, blood, ketone bodies, bilirubin, urobilinogen, nitrites, weight, leucocytes, microalbuminuria and creatinine). D. Data transfer, the Contractor shall be responsible for the transfer of test data to the NIA, where a copy of the data shall be stored. Data shall be transmitted electronically. During year five (5) of the contract, the Contractor shall be responsible for data closeout, and throughout the studies, shall provide consultation on related features of manuscript preparation. Carotid artery images and arterial waveforms, and electronic images of kidney and thyroid ultrasound, as well as photographic images of retina and frontal and side head views, shall be recorded on disks and SuperVHS videotapes and shipped to NIA for digitization and processing. All phenotypic data generated and scored from participant testing shall be transmitted to the COTR in updated successive full versions of the database at least every 13 months (that is, within one month after the data have been recorded for a contract year). The data to be reported shall include the coded identity of all participants; and keyed to the participants, corresponding results from all test instruments (tapes for PWV and IMT tests and renal and thyroid ultrasound; assessments of frailty and cognitive state, as well as database entries for cardiac measurements and responses to the standardized test instruments for the emographic and SSCL data and audiometry measures; retinal scans and photos for facial and ear morphology analyses; and database entries of the scores of the results of blood and urine tests). E. Quality control, all tests for Tasks 1-4 shall be administered and scored according to the standardized procedures. For Task 5, standardized hospital clinical laboratory tests will be employed, and the results recorded in the database for the Project. All tests shall be double-scored and entered, where appropriate. Acceptable data shall be complete assessments with minimal missing data and free of scoring and entry errors. F. Auxiliary Activities, the Contractor shall participate in the analysis and preparation of data for publication, and in publications and public presentations of results. At six (6) month intervals, the Contractor shall participate in discussions to develop and/or contribute to ancillary study plans. Ancillary studies constitute scientific investigations designed to address different, but complementary scientific objectives from those pursued in SardiNIA2 (for example, the choice of additional tests that could be carried out on the serum samples delivered to NIA by the Contractor). The data for major longitudinal analyses will be available from Tasks 1-5 and the cumulative data reported from up to four (4) visits for each participant, which will have measured traits at multiple points in time for specific individuals and permit the determination of trends and genetic risk factors affecting the rate of change of individual traits. The critical storage of samples and maintenance of clinic facilities and staff for Tasks 1-5, and with the transfer of data and accompanying participation of the Contractor in the analysis and preparation of data for publication, are designed to fulfill all the requirements for AIMS I and III study. REPORTS/DELIVERABLES: All reports shall be submitted in electronic form as PC-formatted computer files in Microsoft Word and Microsoft Excel and/or searchable PDF format. The following reports will be required: A. Annual Progress Reports, the Contractor shall submit to the COTR and Contracting Officer (CO) a report describing the activities during the reporting period. Each annual progress report shall include a summary of the results of the entire contract work for the period covered and the activities planned for the ensuing reporting period. An annual progress report shall not be required when the final report is due. B. Final Progress Report and Summary of Salient Results, a final report shall be submitted on or before the last day of the period of performance. This report shall include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to explain comprehensively the Tasks accomplished and the results achieved, and shall summarize data and statistical analyses performed in text, tabular and graphical form. C. Other Reports and Deliverables: Annual Technical Progress Report for Clinical Research Study Populations. The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed under this contract. The Contractor shall recruit subjects from the Sardinian population cohort already recruited to have comparable numbers of males and females. The Contractor shall submit this information in the format indicated for the Inclusion Enrollment Report. ANTICIPATED PERIOD OF PERFORMANCE. The anticipated period of performance is five 12-month performance years from 6/15/2011 through 6/14/2016. OTHER IMPORTANT CONSIDERATIONS: (1) The government is expected to use procedures in FAR Part 15, Contracting by Negotiations. The North American Industry Classification System (NAICS) Code will be 541720 ($7.0M); (2) The Contractor must perform services in Sardinia, Italy; (3) The Contractor must use the data management system developed for and used for the SardiNIA study. Because the Consiglio Nazionale Delle Ricerche is the sole proprietor of this specific version, access to this data management system is limited; and (4) The Contractor must access participants enrolled in the SardiNIA study and availability of precise testing equipment required for collecting core assessments of traits and genotyping; competency and experience with data collection manuals, forms and procedures, data entry, management, verification and quality control, transfer, and tracking systems; and study-wide policies and procedures relevant to data usage and scientific productivity of the study. It is essential the Contractor provides optimal performance of services so there will be no discontinuity in work performance and that smooth continuation of the SardiNIA2 Project be maintained in SardiNIA3. CAPABILITY STATEMENT/INFORMATION SOUGHT. a. Capability Statement - Respondents to this notice must provide, as part of their responses, a capability statement to include the following: (1) information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; (2) provide any catalog/list prices for services described in this notice; (3) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code(s); and (4) any other information that may be helpful in developing or finalizing the OPDIV's acquisition requirements. b. Information Submission Instructions - Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone and facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) RESPONSES SHOULD BE RECEIVED NO LATER THAN JULY 19, 2010 at 12:00 PM LOCAL TIME; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to wilsonr@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Rosanne S. Wilson, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
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FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-SBSS-10-133/listing.html)
- Place of Performance
- Address: Sardinia, Italy
- Record
- SN02196254-W 20100704/100702235042-99fec978d2295221fc28c85b4ffc3602 (fbodaily.com)
- Source
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