Loren Data's SAM Daily™

FBO DAILY ISSUE OF JUNE 25, 2009 FBO #2768
SOURCES SOUGHT

A -- Clinical Support Services

Notice Date

6/23/2009
 

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 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-09-058
 

Archive Date

7/22/2009
 

Point of Contact

Rosanne S Wilson, Phone: 301-443-4433, Teresa A. Baughman, Phone: (301) 443-1193
 

E-Mail Address

wilsonr@mail.nih.gov, baughmat@nida.nih.gov
(wilsonr@mail.nih.gov, baughmat@nida.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) Intramural Research Program (IRP) in Baltimore conducts human subject research in compliance with state and federal regulatory guidelines. In 1999 a significant addition to the mission was added to encompass interventional clinical trials and additional observational studies, in addition to the existing Baltimore Longitudinal Study of Aging (BLSA), the longest continuous study of normative aging in the world. The expansion also included the implementation of a parallel, integrated, community-based approach to the study of normative aging identified as the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) program which is conducted in Baltimore neighborhoods onboard three Medical Research Vehicles (MRVs) within the Baltimore area. Accrual of this program's participant population began in October 2000. Successful methodologies have been developed that promote participation in clinical research among individuals from groups that have been traditionally under-represented in such research and who bear a disproportionate burden of age-associated disease and disability. These projects have been undertaken as a unified clinical trials program within the Clinical Research Branch (CRB) in the NIA IRP to maximize efficiency in terms of staff cost and cross training, provide a common support infrastructure including but not limited to clinical laboratory support and medical records, and to provide uniformly applied common testing approaches required by the science for the spectrum of normative aging research trials under development. In order to continue the expanded research agenda to include longitudinal, observational and interventional studies, the NIA obtained sufficient space to house the combined clinical research programs with provisions for performance of inpatient care, an outpatient clinic and support functions in a Clinical Research Unit. This space, occupying 24,000 SF, is located on the 5th floor of Harbor Hospital in Baltimore, Maryland. The research program includes the scientific disciplines of biochemistry, cellular and molecular biology, genetics, physiology, immunology, neuroscience, neurogenetics, behavioral sciences (psychology, cognition, psychophysiology), epidemiology, statistics, and clinical research and the medical disciplines of neurobiology, immunology, endocrinology, cardiology, rheumatology, hematology, oncology, and gerontology. Medical problems associated with aging are pursued in depth using the tools of modern laboratory and clinical research. Clinical investigative initiatives include seven primary areas in addition to the current BLSA and HANDLS longitudinal normative aging studies. The areas of clinical research study and/or interventional trials include: Endocrinology (diabetes mellitus, therapeutic effects of hormone replacement and growth hormone, hormones and receptors), Rheumatology (Osteoporosis, Osteoarthritis, Rheumatoid arthritis, body composition, biomarkers and metabolic pathways in inflammatory states)Cardiology (atherosclerosis, arterial stiffness, coronary artery restenosis, neovascularization), Clinical Pharmacology (pharmacokinetics, pharmacodynamics, mechanisms of drug action), Neurology (dementias, neuromuscular diseases, Parkinson's disease and early markers of Alzheimer's Disease), Immunology/Infectious Disease (vaccine strategies, pneumococcal infection, T-cell function enhancement, chemokine biology and immunosensesence) Genetics (gene therapy, genomic characterization studies) and Hematology-Oncology (anemia assessment and lymphoma and solid tumor treatment with early phase trials using new agents such as anti-angiogenesis agents, novel immune enhancement and pharmacologic approaches with available agents and for symptom control). Some participants will receive standard or conventional treatment in conjunction with research-related interventions as appropriate for the underlying disease process under study. The current number of research studies is 81 with 26 of these involving Clinical trials. The types of Research Protocols include 1) screening, 2) training, 3) natural history (disease progression, sample data collection, recruiting; and sample data collection, not recruiting), 4) Pharmacokinetic dynamics and 5) Clinical Trials (Phase 0, I.II, III, and IV). Facilities within this program include seven research laboratories, a Clinical Core Laboratory, three Medical Research Vehicles, a 3T MRI unit, the NIA Clinical Research Unit which is comprised of 10-bed inpatient unit, outpatient testing facilities as well as a licensed Pharmacy, a 4-bed Cytapheresis Unit, a Protocol Office, and a Medical Records Department. Support and coordination of the NIA Clinical Research Unit is under the CRB. The NIA Clinical Director, who serves as the Branch Chief, plans, manages and supports the conduct of intramural clinical research focused on the cause, diagnosis, prevention and treatment of age-associated diseases and fosters the translation of advances in basic science into clinical applications. The Clinical Director also holds the responsibility for ensuring the quality and safety of clinical trials within the Institute. To that end, the NIA Protocol Office, under the NIA Clinical Director, is charged with establishing standards and providing regulatory support for the Program. The Branch: (1) provides the infrastructure needed to promote high quality clinical research and ensure patient safety, including; protocol review, clinic infrastructure, nursing and physician support, clinical informatics, data and safety management; (2) monitors and maintains quality assurance of the intramural clinical research program; (3) develops and implements clinical program priorities, allocates clinical resources; (4) integrates the established research themes and projects with clinical relevance from various IRP laboratories and branches; (5) evaluates program effectiveness and represents the IRP in management and scientific decision-making meetings within the Institute; (6) coordinates the credentialing of health care providers within the Institute; (7) coordinates and provides clinical research training for NIA staff and fellows; and (8) develops novel approaches for carrying out translational research in an efficient and cost-effective manner. Purpose and Objectives. The mission of the CRB is to provide a model for age-associated research programs by providing infrastructure for, and performance of cutting edge clinical research within a coordinated multi-disciplinary environment. The expanded clinical research program will continue to develop translational clinical research emphasizing aging and age-associated diseases. Translational studies represent the practical application of basic laboratory discoveries to the clinical setting, and as such, require an efficient synergism between those conducting basic research and those framing and conducting the clinical investigation. Successful translation of basic research requires coordination of the efforts by laboratory investigators, statisticians, physician-scientists, clinicians, and other patient-care providers. Strong linkages between the bench and the Clinical Research Unit enhance the likelihood of success for this bench to bedside approach. The BLSA is ongoing. The objective is to continue to collect viable and useful longitudinal data on aging participants so that it may be used to expand the understanding of normative aging. The central focus of the research is to understand age-related changes in physiology and the ability to adapt to environmental stress. This understanding is then applied to developing insight about the pathophysiology of age-related diseases. The program seeks to understand the changes associated with healthy aging and to define the criteria for evaluating when a change becomes pathologic. Thus, not only are the common age-related diseases under study (e.g., Alzheimer's Disease, Parkinson's Disease, stroke, atherosclerosis, osteoarthritis, diabetes, cancer), but the determinants of healthy aging are also being defined. HANDLS is designed to evaluate normative age-related health disparities in minority and socio-economically diverse populations by going out into communities and collecting research data onboard three MRVs. The focal point of the HANDLS research program is on investigations specific to understanding the possible biomedical and behavioral basis of health disparities and designing effective preventive and therapeutic interventions for this population. Project requirements. The Contractor will have the benefit and responsibility of working in concert with Federal managers, principal investigators and employees who have developed and currently work on these protocols. It is estimated that approximately 700 research participants will be seen per year at the stationary facility and approximately 1200 will be seen at the mobile research facility. The Contractor will provide all required support to execute these protocols, to include, but not limited to, recruitment and retention of participants, medical records processing and storage, IT management, testing (physical, psychological and physiological), biological sample storage and archiving, emergency medical care if needed, transportation, MRV support, scheduling, participant compensation, participant education, quality assurance, safety, protocol management, Institutional Review Boards as required, a licensed research pharmacy, laboratory support and staff support for approximately 120 FTEs to include unit orientation, training, travel, and etc. The Contractor may be required to subcontract for specific services as needed. The Contractor will be required to assess its own procedures on a continuous basis and develop improved patient handling and testing procedures designed to (a) improve the viability of data collected (b) improve cost efficiency of operations and (c) increase volume of participants that can be safely processed. Anticipated period of performance. The anticipated period of performance is one 12-month base year from 4/1/10 through 3/31/11 with four 12-month option years thereafter. Capability statement. NIA is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this research effort. At a minimum prospective Offerors must document capabilities in the following areas. (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. We ask that the capability statement use 12 font minimum, 8 ½ by 11 paper size, not exceed 20 single sided in length (including reference material). Electronic format can be Microsoft Word, Adobe PDF, or Microsoft Power Point including attachments, resumes, charts, etc. Organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary. Please provide your DUNS number, organization name, address, technical and administrative points of contact (including names, titles, addresses, telephone and fax numbers, and e-mail addresses), and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code. Please identify your size classification relative to North American Industry Classification System (NAICS) code of 541712 (500 employees Size Standard) which is being contemplated for this requirement. Include a statement whether or not you are a small business; HUBZone small business; service-disabled, veteran-owned small businesses; 8(a) small business; women-owned small business; or small disadvantaged business in order to assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. An electronic copy of the capability statement must be received at the following e-mail addresses no later than July 7, 2009 (fill in two weeks from posting date). Telephone and facsimile responses will not be accepted. Rosanne Wilson, Contracting Officer wilsonr@mail.nih.gov 301-443-4433 With an e-mail copy (cc) to Teresa Baughman, Contracting Officer baughmat@mail.nih.gov 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

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-SBSS-09-058/listing.html)
 

Place of Performance

Address: Harbor Hospital, Baltimore, Maryland, 21225, United States

Zip Code: 21225
 

Record

SN01853320-W 20090625/090623235848-6222567e1cf00b609e4878512d3ad667 (fbodaily.com)
 

Source

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

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