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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 10, 2015 FBO #4885
SOURCES SOUGHT

A -- Epidemiological Research Support Services for NIEHS

Notice Date

4/8/2015
 

Notice Type

Sources Sought
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
 

ZIP Code

27713
 

Solicitation Number

NIHES2015030
 

Archive Date

5/9/2015
 

Point of Contact

Velvet m Torain, Phone: 919-541-0400, Christopher J. Fisher, Phone: 919-541-0428
 

E-Mail Address

torain@niehs.nih.gov, christopher.fisher@nih.gov
(torain@niehs.nih.gov, christopher.fisher@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; 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. 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. The NAICS code for the project is 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) The small business size standard is 500 employees. Background The Epidemiology Branch (EB) addresses the mission of the NIEHS by applying and extending the tools of epidemiology to study the effects of the environment on human health. EB investigators study a wide range of health effects with potential links to environmental exposures. Studies cover outcomes across the lifespan from pregnancy and child development to chronic diseases of aging, and focus on known and potential environmental hazards. EB studies often include the collection of biological and environmental samples to measure biomarkers of exposure, susceptibility, or effect. EB's research portfolio includes large multi-purpose cohorts designed to study effects of environmental exposures, genes and gene-environment interactions, genome- and epigenome-wide association studies, more narrowly focused studies in clinical or population settings, and laboratory-based mechanistic studies and covers the range of topics represented in the eight research groups. New groups addressing additional topics in environmental health are anticipated in the near future. The current eight research groups are: Aging and Neuroepidemiology, Biomarker-based Epidemiology, Chronic Disease Epidemiology, Genetics, Environment and Respiratory Disease, Molecular and Genetic Epidemiology, Pediatric Epidemiology, Reproductive Epidemiology and Women's Health. Purpose and Objectives The NIEHS seeks capability statements from qualified small businesses to provide epidemiological, scientific, technical, data management, managerial, clerical, and statistical support to Principal Investigators (PIs) within the Epidemiology Branch, Division of Intramural Research, NIEHS. The Contractor shall assist the Government by identifying and enrolling subjects, and administering, managing, and conducting epidemiological studies designed and conducted by Epidemiology Branch PIs alone or in collaboration with other scientists inside or outside of the NIEHS. The contractor shall function in a purely supportive role carrying out specific tasks as described in task orders, and shall not engage in independent research. The Contractor shall provide field research support for a range of studies in varied settings. The contractor shall provide oversight for sample collection, processing, and storage, assist in the management of a large biorepository, facilitate collaborative studies and data sharing, provide data management services, support or carry out data analysis, provide statistical support, coordinate or carry out a variety of laboratory assays, and arrange for a wide range of professional consultations as required to carry out specific task orders. Epidemiology Branch studies are carried out throughout the US and in international settings. The Contractor will be expected to provide oversight for projects in remote locations, conducting site visits as needed and maintaining close contact with research partners throughout the world. Access to bilingual staff may be required, depending on the specific research portfolio at any given time. On occasion, the Epidemiology Branch is required to respond to national disasters or other public health issues on short notice. Thus the contractor must have the resources to begin work on short notice. The workload is variable and the Contractor must have the ability to scale up or contract as required to meet needs that change over time and with the stage of ongoing research. Experience and expertise working with diverse and challenging populations is required as is experience working with community groups and awareness of best practices for sharing research results with community groups and study participants. Success in and knowledge of best practices for recruiting diverse populations and maintaining high retention rates in long-term studies are mandatory. Project Requirements Offerors must demonstrate their ability to meet all project requirements (1) through (27) below by succinctly describing their own in-house capabilities and/or those of any proposed partners/subcontractors. The requirements are: (1)conduct pilot studies, literature reviews, computer searches, or other activities to determine capabilities of collaborating institutions, numbers of eligible study subjects, exposure information for study site selection; convene focus groups when appropriate; prepare, pretest, evaluate and produce data collection forms, including computer-assisted telephone questionnaires, web-based data collection platforms and capabilities, and in-person questionnaires; ensure adequacy of inclusion of women, minorities, children and other under-served groups in research projects, where applicable and appropriate; (2)arrange and provide support for meetings and teleconferences of relevant individuals, collaborators, consultants, etc. to aid in study design, logistics, or analysis; arrange and provide support for monitoring, oversight, or advisory boards for specific studies; (3)prepare training programs, procedure manuals, manuals of operation, and other required materials for abstractors, interviewers and other study personnel; (4)provide commercial quality graphics support for field study print materials, study communications with participants, and public websites for recruitment, publicity, and general information dissemination; (5)arrange, provide support, and prepare materials for IRB submissions and continuing reviews, OMB approvals, and Certificates of Confidentiality; (6)coordinate collection, handling, transport, storage and analysis of biological, clinical, agricultural, industrial, dietary, and environmental samples in field studies; arrange for shipping and delivery of samples to laboratories for analysis or to facilities for long term storage; (7)assemble death certificates, medical records, industrial hygiene data, geocoding data, dietary/food frequency histories, reproductive histories, occupational histories, environmental monitoring data, etc. and have records evaluated and coded by appropriate posologists, pathologists, industrial hygienists, clinicians, or other relevant experts and abstractors; (8)depending on study design, recruit or trace study subjects, locate them, and obtain any necessary consent for interview and performance of relevant industrial or environmental measurements, biologic specimen collection, physical or other examination; conduct determination of vital status, assessment of disease status, exposures, genetic susceptibility or other information collection as necessary for the study; (9)conduct study protocol training for abstractors, interviewers, coders, phlebotomists and others who will acquire and assemble data; abstract, microfilm, photocopy, scan or obtain computer-based (electronic) or paper records (clinical or office medical records, hospital charts, vital records, employment records, etc.); (10)interview subjects or surrogates using mail, telephone, computer-assisted, web-based or in-person interviews, evaluating the state-of-the-art for technology-dependent techniques where appropriate and cost-effective, and arrange through licensing or subcontract to use the appropriate technique; (11)arrange for clinical diagnostic studies, laboratory or other clinical evaluation of subjects, and for industrial, agricultural, dietary, or environmental measurements; (12)staff and run a local contractor site laboratory for receipt, inventory, processing, aliquotting, bar-code labelling, shipping, storage of frozen, refrigerated or ambient samples; (13)staff and run a local contractor site laboratory facility for DNA extraction; identify quality facilities for DNA extraction in large scale studies and for genotyping and other "omic" services (e.g. epigenomics, metabolomics, microbiomics); (14)identify appropriate analysis laboratories, evaluate quality assurance/quality control of ongoing laboratory analyses, establish databases for the results of laboratory analyses, coordinate data processing needs for laboratory results for a wide range of studies; (15)assist with monitoring the availability, and manage the use of stored biologic samples from previous historical Epidemiology Branch studies; (16)enter coded information into suitable computer databases integrating quality assurance and quality control of all data collection systems; (17)design, staff and run a FIPS 199 categorization ‘Moderate' computing center under appropriate NIST, DHHS/NIH, FISMA, OMB, and IRB guidelines, with state-of-the-art, secure on-site, off-site and/or cloud storage where appropriate, secure archival / backup storage and retrieval, software, hardware, high-speed internet access, staff desktop computers, and technical IT staffing sufficient for management of a system incorporating existing Epidemiology Branch study data files, new studies, data management, freezer monitoring, laboratory inventory, telephone and web-assisted interviewing, call center(s) and associated technologies, study management systems, archival data storage, analysis programming including genetic/bioinformatics programming, with protections for PII and PHI, and appropriate risk management and risk mitigation systems in place; (18)design, develop, test, maintain, and host NIEHS EB study websites, adhering to relevant federal government policies and guidance regarding website design and management including but not limited to compliance with Section 508, local NIEHS policies, HHS guidance and standards, OMB guidance, and the Privacy Act; (19)perform data linkages with National Death Index, vital statistics, cancer registries, Medicare data, and other national registries and databases; (20)provide reproducible epidemiologic, statistical, genetic, bioinformatics, descriptive and other analyses specified by the EB investigator; (21)produce publication-quality graphics, tables, and figures as required for scientific publication of study analyses and findings; (22)provide records management: document each step of a study and maintain, in an orderly and accessible manner, all relevant material so that any aspect of the study may be reviewed and evaluated by the EB staff with little or no prior notice; (23)according to study protocols, provide professional communication materials and interactions with study participants, including letters, newsletters, reports of individual and summary results of tests performed, etc.; (24)develop and maintain study websites for study data collection and transmission with data integrity and protection of personal identifiers; (25)develop and maintain public, commercial quality study websites for study participants and the public for dissemination of study findings, vignettes, study contact information, study-related resources, etc.; (26)maintain staff or identify consultants with expertise in industrial hygiene/occupational exposure coding, medical record abstraction and coding, medication coding, language translation, etc.; and (27)develop and manage subcontracts for any clinical, data management, programming, field study operations, interviewing, laboratory analyses or other specialized procedures or knowledge not possessed by Contractor staff. ANTICIPATED PERIOD OF PERFORMANCE AND STAFFING The anticipated start date of the award is June 14. 2016. The planned total period of performance is ten (10) years. It is estimated that the total level of effort required is approximately 100,440 direct labor hours per year. GOVERNMENT FURNISHED EQUIPMENT AND MATERIALS The Contractor shall provide space for receipt, processing, and short term storage of biospecimens. Such a facility must be within 15 minutes' drive of NIEHS, in the proximity of RTP, so that the Government can have ready access to these samples and to facilitate transfer of samples to the NIEHS biorepository. In this case, the Government may furnish initial startup refrigerators, freezers and other needed equipment. The Contractor shall maintain this equipment and provide appropriate backup and security in case of equipment failures. The contractor must supply its own computer network and such computer equipment and software as required to fully support the research efforts described above and carry out the work described above items 1-27. CAPABILITY STATEMENT Interested small businesses must submit supporting documentation that clearly demonstrates how they and/or their partners are capable of meeting the 27 Project Requirements described above. Respondents should consider linking each project requirement with a description of their (a) current in-house or partnered capabilities to perform the work as evidenced by a description of staff expertise, experience and training; and (b) a representative list of ongoing or prior completed sponsored studies that are similar to the Project Requirements. Respondents should explicitly list their expertise with multi-site, national and international trials, and their operational plan for establishing a site presence on short notice. Capability statements shall be submitted in Adobe pdf or MS Word format and not exceed 30 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using 12-point font size. The cover page must indicate the respondent's 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. Capability Statements must be submitted electronically April 24, 2015, 3:00 PM, EST to the email address of the Primary and Secondary Points of Contact listed below. All responses received by the specified date and time will be acknowledged by one of the Points of Contact listed below. Please submit any questions in writing to the e-mail address listed above for either Ms. Velvet Torain or Mr. Christopher Fisher no later than April 20, 2015 at 2:00 PM, EST. DISCLAIMER AND IMPORTANT NOTICES 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 small business 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 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 future solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in a respondent's response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Small businesses that believe they possess the necessary capabilities to meet these requirements are encouraged to contact the Primary Point of Contact listed above.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIHES2015030/listing.html)
 

Place of Performance

Address: National Institue of Environmental Health Sciences (NIEHS), Epidemiological Branch, RTP, North Carolina, 27709, United States

Zip Code: 27709
 

Record

SN03693531-W 20150410/150408235247-fafd7ade64b83d707a184ad0e7a7cab5 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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