Request for Proposal No.: |
NIH-NIAID-DAIT-99-26 |
Issue Date: |
December 10, 1998 |
Issued By: |
Carl Henn, Senior Contracting Officer |
Point of Contact: |
Jacqueline C. Holden, Contracting Officer |
Purchase Authority: |
Public Law 92-218 as amended |
Small Business Set-Aside: |
No, SIC Code 8999 |
Just In Time: |
No |
Offer Expiration Date: |
Offers will be valid for 180 days unless a different period is specified by the Offeror on the form entitled "Proposal Summary and Data Record, NIH 2043." |
Proposal Due Date: |
April 9, 1999, 4:00 P.M EST |
Ladies and Gentlemen:
You are invited to submit a proposal in accordance with the requirements of this RFP (NIH-NIAID-DAIT-99-26) entitled "Statistical and Clinical Coordinating Center (SACCC)." The Government anticipates that one Requirements type contract will be awarded and requirements for specific services will be issued through the use of task orders, which may be incrementally funded. The performance period of this contract will be nine (9) years.
The documents included with this electronic RFP package are as follows:
Attachments:
In addition to the information provided in this document (i.e., The Streamlined RFP), there are five (5) other documents contained in the Streamlined RFP References section that must be retrieved, in whole or in part, in order to submit a proposal. The applicable portions of these referenced documents are explained in Attachment E, Applicable RFP References of this RFP.
If you are unable to download any of the applicable documents, please contact Jacqueline C. Holden, Contracting Officer, by phone/fax/Internet (See contact numbers/addresses below.)
The information contained in this electronic RFP represents all the necessary information required for the submission of a proposal for this acquisition. Following proposal submission and review, the Contracting Officer during discussions will request additional information (if applicable).
Although sufficient information for proposal preparation is provided herein, if you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Jacqueline C. Holden, Contracting Officer, of the NIAID Contracting Office at the Internet address or phone number listed below. If you fail to notify the Contracting Office of your interest, you will not receive notice of amendments that may be issued for this RFP, and this could impact your proposal preparation. However, please note that all amendments will be posted on the NIH RFP Home Page and the NIAID Contracts Management Branch (CMB) Home Page.
The Business and Technical proposals must be separate from one another in the proposal package, as the peer review panel will only receive the Technical Proposal. The Business Proposal must be signed by an authorized official of your organization, and must contain a detailed breakdown of costs by year for each cost category/element. The basis for all costs must be explained and supporting documentation must be submitted with the proposal. (See "STANDARD RFP INSTRUCTIONS AND PROVISIONS," in the NIH RFP Home Page, for more detail on the Business Proposal requirement.)
Within this web based RFP we have included a template cost spreadsheet in Microsoft Excel. Offerors are requested to complete this spreadsheet and include it with their business proposal. This spreadsheet can replace the cost sheets that you ordinarily provide. It is our hope that this spreadsheet will provide you with a useful tool, allow us to more easily understand your cost proposal, and eliminate our need to recreate your spreadsheets. This spreadsheet template is a new approach, and we would appreciate any feedback you could give us about it.
The original and twenty (20) copies of your Technical Proposal and the original and 5 copies of your Business Proposal must be received by this office no later than April 9, 1999, at 4:00 p.m. local time at the address listed in Attachment D.
Your attention is further directed to the "Proposal Intent Response Sheet" contained in Attachment D of this document. Please complete this form and return it to this office on or before March 1, 1999. This will allow us to expedite preparations for the peer review of proposals.
The "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your Technical Proposal. It is important that you list all professional personnel and organizations named in the proposal that have any role in the proposed work, including: staff of the primary organization (offeror), subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be indicated for every person named. You may use additional sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. This information will be used to ensure that there will be no conflict of interest when selecting review committee members.
Finally, your technical proposal must be organized and submitted in accordance with the "Technical Proposal Table of Contents" contained in Attachment D of this document.
NOTE: If your proposal is not received by the Contracting Officer or designee at the place and time specified, then it will be considered late and handled in accordance with the PHS CLAUSE 352.215-10, "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWALS OF PROPOSALS."
Questions concerning any areas of uncertainty which, in your opinion, require clarification or correction must be furnished in writing to Jacqueline C. Holden, Contracting Officer at the Internet electronic mail address jh55b@nih.gov, or by fax at 301-402-0972. Jacqueline C. Holden, Contracting Officer can be reached at 301-496-7119. Collect calls will NOT be accepted.
Sincerely,
/s/
Carl Henn
Senior Contracting Officer
Contract Management Branch
National Institute of Allergy
and Infectious Diseases, NIH
Attachments: A - E
STATISTICAL AND CLINICAL COORDINATING CENTER (SACCC)
I. INTRODUCTION
To address the present needs of the Government, the Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, is requesting proposals to establish and manage a Statistical and Clinical Coordinating Center to provide support for two major research programs: the NIAID Collaborative Network for Clinical Research on Immune Tolerance, to be established in FY 2000, and the NIAID Autoimmunity Centers of Excellence, to be established in FY 1999. These research programs will: (1) design and conduct clinical trials to evaluate the safety, toxicity and efficacy of tolerogenic and immunomodulatory approaches for the treatment of multiple immune-mediated diseases; and (2) design and conduct studies of the underlying mechanisms of immunomodulatory agents, and of the induction, maintenance and loss of immune tolerance, as an integral part of the clinical trials undertaken.
The purpose of this nine (9)-year contract is to: (1) provide statistical leadership and clinical trial design expertise for the development, implementation and analysis of clinical trials and studies of underlying mechanisms; (2) establish and administer a reliable, efficient and responsive system for the collection, storage, management, quality assurance and reporting of study data, including systems of patient registration and randomization for Phase I, II and III clinical trials; (3) conduct clinical site monitoring and training in protocol implementation, as well as data collection, management, quality control and reporting requirements; (4) provide support for regulatory and technical functions and requirements associated with Investigational New Drug (IND) Applications, including adverse event reporting; (5) prepare interim and final analyses of study data; (6) coordinate, provide administrative support, and prepare reports and analyses for review by an independent Data and Safety Monitoring Board; and (7) provide for the distribution of study products.
II. BACKGROUND
Accelerating research on tolerogenic and immunomodulatory approaches for the treatment of immune system diseases is a major priority of the NIAID Division of Allergy, Immunology and Transplantation. As part of the Institute's recent efforts to move this field of investigation forward, a series of activities were initiated in the fall of 1997. A long-range, comprehensive research plan was developed and, in February 1998, was reviewed by a panel of experts in basic and clinical immunology from academia and industry. The Expert panel strongly endorsed the overall approach, scope and timeliness of the plan. In April 1998, the NIAID convened a second expert panel to review ethical issues in the design, implementation and monitoring of clinical trials of transplant tolerance. Copies of the NIAID Plan for Research on Immune Tolerance, the Report of the NIAID Expert Panel on Immune Tolerance, and the Recommendations of the NIAID Expert Panel on Ethical Issues in Clinical Trials of Transplant Tolerance are located on the NIAID web site: /publications/immune/bookcover.htm
NIAID COLLABORATIVE NETWORK FOR CLINICAL RESEARCH ON IMMUNE TOLERANCE
The Collaborative Network for Clinical Research on Immune Tolerance is a major program emanating from this recent scientific planning process and will fund a consortium of scientific and clinical investigators focused on: evaluating promising tolerogenic approaches to treat a broad range of immune system diseases; conducting investigations of the mechanisms underlying the induction, maintenance and loss of immune tolerance; and developing and validating assays to measure the induction, maintenance and loss of tolerance. The Request for Proposals (RFP) for the Collaborative Network encompasses four (4) different components.
Part A of the solicitation, to be awarded in FY 2000, encompasses clinical trials and mechanistic studies in kidney and islet transplantation.
Parts B, C and D of the solicitation are Task Orders that may be issued by the Government based on scientific needs and opportunities and the availability of funds.
Part B expands the Collaborative Network to include the development and validation of tolerance assays.
Part C expands the Collaborative Network to include clinical trials and mechanistic studies in asthma and allergic diseases.
Part D expands the Collaborative Network to include clinical trials and mechanistic studies in autoimmune diseases.
Overall scientific leadership and direction for the Collaborative Network will be carried out by an Executive Committee, composed of the Network Project Director, other scientific and clinical investigators, NIAID scientific staff, a representative of the Juvenile Diabetes Foundation International, and the Project Director for the Statistical and Clinical Coordinating Center. The Network Executive Committee will be responsible for: (1) the development and ongoing review and modification of the scientific agenda; (2) the establishment and implementation of procedures for the development, review and evaluation of concepts for clinical trials and mechanistic studies, including evaluation/selection criteria to be used; (3) setting priorities among proposed concepts; (4) monitoring and evaluating progress; (5) allocating resources; and (6) assessing the need for redirection in scientific focus and implementing necessary changes to redirect resources in order to accommodate new knowledge and changing opportunities.
A copy of NIH-NIAID-DAIT-00-07, the RFP for the Collaborative Network for Clinical Research on Immune Tolerance, will be available shortly on the NIAID homepage at URL: /contract. One contract for the Collaborative Network will be awarded for a period of seven (7) years.
NIAID AUTOIMMUNITY CENTERS OF EXCELLENCE
In May 1998, the NIAID Division of Allergy, Immunology and Transplantation issued a Request for Applications RFA AI-98-010 to establish Autoimmunity Centers of Excellence, with co-sponsorship by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and the NIH Office of Research on Women's Health. The major goal of this cooperative research program is to establish an integrated network of centers to carry out a multidisciplinary program of basic, pre-clinical and clinical research focused on tolerance induction and immune modulation to treat and prevent autoimmune disease. Each Center will include a clinical component, incorporating multiple clinical specialists, to conduct pilot clinical trials of the safety, toxicity and potential efficacy of promising tolerogenic and immunomodulatory therapies for multiple autoimmune diseases, and to conduct studies of the mechanisms of action of tolerogenic and immunomodulatory interventions. Each Center will also include two or more basic and/or pre-clinical research components focused on elucidation of the basic mechanisms of autoimmunity, self-tolerance and immune modulation. It is anticipated that three (3) awards will be made for a total project period of four (4) years, with August 1999 as the earliest award date. It is also anticipated that each Center will include multiple clinical sites to participate in the design and implementation of pilot clinical trials. This RFA is available on the WWW at URL: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-98-010.html.
Overall scientific leadership and direction for the Autoimmunity Centers of Excellence will be carried out by a Steering Committee, composed of Center basic and clinical investigators, NIAID scientific staff, and the Project Director for the Statistical and Clinical Coordinating Center. The Autoimmunity Center Steering Committee will be responsible for: (1) the development and ongoing review and modification of the scientific agenda; (2) the establishment and implementation of procedures for the development, review and evaluation of concepts for clinical trials and mechanistic studies, including evaluation/selection criteria to be used; (3) setting priorities among proposed concepts; (4) monitoring and evaluating progress; (5) allocating resources; and (6) assessing the need for redirection in scientific focus and implementing necessary changes to redirect resources in order to accommodate new knowledge and changing opportunities.
Both the Collaborative Network and the Autoimmunity Centers will design policies and procedures for the development and review of concepts for proposed clinical trials and mechanistic studies, and for the development and review of proposed clinical trials and mechanistic studies. All such policies and procedures shall be subject to review and approval by the Government. In addition, proposed concepts for clinical trials and mechanistic studies, as well as proposed clinical trials and detailed research plans for mechanistic studies, shall be subject to review and approval by NIAID staff and, when necessary, by external advisors selected by the NIAID to provide advice and assistance in the monitoring of these research programs.
Additional Information on the Scope and Requirements of This Solicitation
The NIAID Collaborative Network for Clinical Research on Immune Tolerance will be supported through the contract mechanism for a period of seven (7) years, beginning in early FY 2000. The Statistical and Clinical Coordinating Center shall provide support for the NIAID Collaborative Network for Clinical Research on Immune Tolerance for a total period of nine (9) years.
III. CONTRACT TYPE
The Government contemplates awarding one (1) requirements type contract for accomplishing the tasks outlined in the Work Statement listed below. It is anticipated that a nine-year contract will be awarded.
A Requirements contract, as defined by FAR 16.503, provides for filling all actual purchase requirements of designated Government activities for supplies or services during a specified contract period, with deliveries or performance to be scheduled by placing orders with the Contractor. This method of contracting is used when the Government anticipates recurring requirements, but cannot determine in advance the precise quantities of supplies or services needed during the contract period of performance. It permits the Government flexibility in both quantities and delivery scheduling. It also assures that all of the Government's actual purchase requirements consistent with the Work Statement will be performed by the Contractor.
Orders of specified services/tasks will be issued after requirements materialize. When a need is established for any of the services under this contract's work statement, a Task Order Request will be submitted to the Contractor. A single Task Order Request may include any or all of the requirements listed in the Work Statement.
IV. TASK ORDER ACTIVITIES: PARTS B, C AND D
The Task Order activities specified below in Parts B, C and D of this solicitation pertain solely to the NIAID-JDFI Collaborative Network for Clinical Research on Immune Tolerance. All SACCC functions and requirements for the NIAID Autoimmunity Centers of Excellence are provided for in Part A of this solicitation.
Part B of this solicitation expands the activities of the SACCC to provide support to the Network for the development and validation of tolerance assays.
Part C expands the activities of the SACCC to provide support for clinical trials and mechanistic studies of tolerogenic approaches for the treatment of asthma and allergic diseases.
Part D expands the activities of the SACCC to provide support for clinical trials and mechanistic studies of tolerogenic approaches for the treatment of autoimmune diseases.
Offerors submitting a proposal under this solicitation must prepare a proposal that includes the required work outlined in Part A AND the required work outlined below in the Task Orders for Parts B, C and D. Proposals for Part A alone or Parts B, C and D alone will not be accepted for review or considered for award. Offerors shall submit separate cost estimates for the Task Order activities specified in Part C and Part D of this solicitation for the first year only based on the same scope and level of effort required for Part A of the solicitation with respect to scientific, technical, regulatory and administrative staff, anticipated number and phase of clinical trials, anticipated number of mechanistic studies and sites, as well as number of clinical trial sites and study participants. In addition, offerors shall submit a separate cost estimate for the Task Order activities specified in Part B of this solicitation for the estimated first-year costs associated with SACCC support for tolerance assay development in conjunction with Parts A, C and D. The cost estimate for Part B should not exceed twenty-five (25) percent of the total estimate for Parts A, C and D combined.
Issuance of Task Orders for Parts B, C and D will be solely at the discretion of the Government and will be based on technical merit, need, and the availability of funds during the nine-year period of performance. If the Government decides to issue a Task Order, the Contractor will be provided with a detailed work statement. The Contractor shall submit a complete Technical Proposal addressing the requirements set forth in the Task Order work statement, as well as a Business Proposal, for review and evaluation by the Government (time allowed for proposal preparation in response to a task order request will vary depending on the task). The technical merit of all such proposals will be reviewed by NIAID and selected members of the NIAID Advisory Committee for Research on Immune Tolerance. The Government anticipates that the task orders under this contract will be awarded on a cost-reimbursement basis, however other pricing arrangements may be used if deemed appropriate.
Technical Proposals shall include individual plans for incorporating into the SACCC the requirements specified for Parts B, C, and D below. Each plan (for Part B, C, and D) shall address the following components of this expansion:
THE GOVERNMENT ANTICIPATES THAT DESCRIPTIONS OF APPROXIMATELY 5-7 PAGES EACH FOR PARTS B, C, AND D WILL BE ADEQUATE TO ADDRESS THIS REQUIREMENT.
V. STATEMENT OF WORK: PART A
Part A of this solicitation encompasses the establishment of the Statistical and Clinical Coordinating Center and the provision of statistical, clinical coordination, technical, regulatory, and administrative support for clinical trials and mechanistic studies in kidney and islet transplantation undertaken by the NIAID Collaborative Network for Clinical Research on Immune Tolerance (hereafter referred to as the Network), and for pilot clinical trials and mechanistic studies in multiple autoimmune diseases undertaken by the NIAID Autoimmunity Centers of Excellence (hereafter referred to as the Centers).
Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government under the terms of this contract, as needed to perform the work set forth below.
Best available current data indicate that Contractor support shall be provided for: (i) pilot clinical trials to be initiated by both the Network and the Centers in FY 2000; (ii) the Network will initiate four pilot clinical trials in kidney and islet transplantation in FY 2000, involving 12-15 Network clinical sites and approximately 100 total study participants; (iii) in the second and subsequent years of the Network contract, approximately three efficacy trials in kidney and islet transplantation will be initiated per year, involving a total of 30 Network sites and a total of 500-700 study participants; (iv) in the second and subsequent years of the Network contract, approximately four new pilot clinical trials will be initiated, involving a total of 12-15 Network clinical sites and approximately 100 total study participants; (v) in FY 2000, the Centers will initiate four single-site pilot clinical trials involving approximately 100 total study participants, and two multi-site clinical trials involving a total of six clinical sites and 100 study participants; (vi) in the second and subsequent years of the Center program, three single-site pilot clinical trials will be initiated each year, involving approximately 100 total study participants, and three multi-site clinical trials per year, involving approximately three hundred (300) total study participants and a total of ten clinical sites.
Best available current data indicate that Contractor support shall be provided for: (i) five Network sites will be involved in the design and conduct of mechanistic studies in FY 2000, and eight Network sites will be involved in the design and conduct of mechanistic studies in the second and subsequent years of the Network contract; (ii) at least one and often two mechanistic studies will be conducted in conjunction with Network pilot clinical trials, and at least two and often three or four mechanistic studies will be conducted in conjunction with Network efficacy clinical trials; (iii) for the Center program, three sites will be involved in the design and conduct of mechanistic studies throughout the life of this research program; (iv) at least one and often two mechanistic studies will be conducted in conjunction with Center single-site pilot clinical trials, and at least two and often three mechanistic studies will be conducted in conjunction with Center multi-site clinical trials.
Best available current data indicate that Contractor will conduct: (i) one-day site establishment visits to12-15 Network sites in FY 2000; (ii) in the second and subsequent years of the Network contract, one-day site establishment visits a total of 20 additional Network sites; (iii) interim site visits to all Network sites at least annually; (iv) one-day site establishment visits to 9 Center sites in FY 2000; (v) in the second and subsequent years of the Center program, site establishment visits to a total of 10 additional Center sites; and (vi) interim site visits for all Center sites at least annually. In addition, Network sites may include foreign institutions and, therefore, Offerors shall have the flexibility to subcontract clinical site monitoring and training requirements in these instances.
Contractor support will include:
PART B: TASK ORDER EXPANSION OF THE STATISTICAL AND CLINICAL COORDINATING CENTER DEVELOPMENT AND VALIDATION OF TOLERANCE ASSAYS
BACKGROUND
Research leading to the development of improved treatments for autoimmune diseases, asthma and allergic diseases and transplant rejection is a major component of the mission of NIAID's Division of Allergy, Immunology and Transplantation. The Task Order activities specified below for Part B of this solicitation will expand the scope of the SACCC to include statistical, clinical, technical, coordination and administrative support for the Network with respect to the development of standardized assays and reliable markers of immune tolerance in kidney and islet transplantation, autoimmune diseases and/or asthma and allergic diseases.
The current lack of validated markers of immune tolerance has significant implications for the rational design of tolerogenic treatment protocols and the appropriate monitoring of study participants. The development of immune/surrogate markers of in vivo tolerance in humans is critical to advancing the application of tolerance induction therapeutic regimens. Sensitive indicators and/or predictors of early induction or loss of tolerance will facilitate clinical trials by expanding the universe of informed treatment options, including re-treatment to induce tolerance or standard therapy.
The development of useful immune/surrogate markers involves complex issues surrounding the selection, validation, quantitation, standardization, and population application of tolerance "biomarkers", and the design of clinical protocols to control the four major sources of variability which may confound clinical application: biological diversity, sampling diversity, variability of detection procedures, and validation against acknowledged disease endpoints. In addition, putative immune/surrogate endpoints should be biologically plausible, measurable by standardized and reliable assays, represent early events in the causal pathway, and exhibit dose-responses. Perhaps most importantly, immune/surrogate markers should be capable of measuring the effect of the intervention on clinical outcome. The identification and validation of a biomarker as a valid immune/surrogate marker for tolerance is a stepwise process involving smaller "transitional" studies and larger second-generation trials in which both primary outcome and putative surrogates are measured. Transitional studies are used to move new markers from the laboratory into evaluation in humans, and are designed to address specific questions of assay validity, treatment/marker associations, marker/disease associations, and inter- and intra-individual variability. Promising markers need to be further developed and then tested in current and future clinical trials in transplantation, autoimmune disease and asthma and allergic disease to definitively address the issues of optimal representation, and to test the adequacy of markers to capture the effect of treatment on clinical outcome. Unfortunately, clinical studies frequently lack the statistical power to allow definitive conclusions about the value of potential immune/surrogate markers or are terminated before sufficient evidence can be accumulated. The choice of surrogate markers will differ by disease and by tolerogenic approach and additional research is needed to identify the most useful markers for monitoring the course of specific types of immune modulation and tolerance induction.
PART B: WORK STATEMENT
Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment and facilities, not otherwise provided by the Government under the terms of this contract, as needed to:
Expand the SACCC to provide statistical, clinical, regulatory, technical and administrative expertise to the Network for the development and validation of tolerance assays for kidney and islet transplantation, asthma and allergic diseases, and autoimmune diseases. Network requirements in this area include: (i) further development of existing experimental immune system surrogate markers for the induction, maintenance and loss of tolerance; (ii) identification and testing of new immune system surrogate markers; and (iii) refinement of existing assays and the development and validation of new assays to establish broadly applicable, standardized measures of immune tolerance. The Contractor shall provide expertise and assistance to the Network in the following areas:
PART C: TASK ORDER EXPANSION OF THE STATISTICAL AND CLINICAL COORDINATING CENTER ASTHMA AND ALLERGIC DISEASES
BACKGROUND
Research leading to the development of improved treatments for asthma and allergic diseases is a major component of the mission of NIAID's Division of Allergy, Immunology and Transplantation. The activities specified in the Task Order for Part C of this solicitation will expand the scope of the SACCC to include statistical, clinical, regulatory, technical, coordination and administrative support for Network clinical trials and mechanistic studies of tolerogenic approaches for the treatment of asthma and allergic diseases.
Asthma and allergic diseases are attractive models for the development of new approaches to alter the human immune response. These diseases are increasing in prevalence and account for high medical and social costs. Despite the availability of proven therapies and many new agents in development, even the most effective pharmacotherapies have serious limitations. Some data suggest that either reduced allergen exposure, or conventional allergen immunotherapy, can block the development and/or exacerbations of asthma. However, there are obstacles to translating these findings into clinical practice, perhaps because present approaches to environmental control do not sufficiently reduce allergen levels, and because conventional immunotherapy causes only weak modulation of the human immune response. The most promising approach is to develop new methods of inhibiting allergic immune responses and/or inducing tolerance to allergens.
The development of new approaches would be enhanced by the many widely available, well standardized and clinically validated tests, including blood studies, skin tests, and pulmonary function tests, that can be used to characterize allergic responses from the immunological and physiological perspectives. Moreover, it may soon be possible to enhance the identification and stratification of at-risk individuals based on the discovery of genes that predispose to asthma and atopy.
Allergen immunotherapy was developed empirically ~80 years ago, and relatively little effort has been made to develop more robust and long-lasting allergen immunotherapies, based on fundamental principles of immunology. However, concerns about the efficacy of conventional immunotherapy have stimulated research into new approaches to tolerize to allergen. A variety of avenues are being explored and build on the fact that many clinically important allergens have been identified, purified, cloned, epitope-mapped, produced as biologically active recombinant proteins, and administered safely by mucosal and cutaneous routes. With these reagents, the timing, dose, route, and molecular form for the allergen can be tightly controlled. Approaches that combine non-antigen-specific methods (e.g., second signal blockade and cytokine modulation) and antigen-specific tolerance induction regimens appear very promising in animal models and are close to entering Phase I and/or Phase II clinical studies in humans. Among these are: (1) "DNA vaccines" comprised of plasmid DNA encoding recombinant allergens, which induce long-lasting allergen-specific tolerance in mice; (2) immunostimulatory oligonucleotides, small sequences of bacterial DNA that drive the Th1 immune responses when co-administered with protein allergens; (3) T cell costimulatory blockade in conjunction with allergen challenge; (4) peptide vaccines representing T cell epitopes of allergen (5) immunization with Mycobacterium vaccae, which non-specifically drives Th1 immune responses; (6) monoclonal antibodies to IgE, which deplete plasma IgE and down-regulate mast cells and basophil receptors for IgE; and (7) co-administration of allergen and cytokines.
PART C: WORK STATEMENT
Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment and facilities, not otherwise provided by the Government under the terms of this contract, as needed to:
Expand the SACCC to provide statistical, clinical, regulatory, technical and administrative expertise to the Network for clinical trials and mechanistic studies of tolerogenic approaches for the treatment of asthma and allergic diseases. The Contractor shall provide expertise and assistance to the Network in the following areas:
PART D: TASK ORDER EXPANSION OF THE STATISTICAL AND CLINICAL COORDINATING CENTER AUTOIMMUNE DISEASES
BACKGROUND
Research leading to the development of improved treatments for autoimmune diseases is a major component of the mission of NIAID's Division of Allergy, Immunology and Transplantation. The activities specified in the Task Order for Part D of this solicitation will expand the scope of the SACCC to include statistical, clinical, regulatory, technical, coordination and administrative support for Network clinical trials and mechanistic studies in autoimmune diseases.
Efforts to induce tolerance in autoimmunity have focused primarily on the oral administration of antigens. Oral administration of both high and low dose antigen results in a phenomenon termed "oral tolerance" in which the immune response to subsequent systemic administration of antigen is blocked. Oral tolerance can be induced in animal models and is now being evaluated in human diseases. However, the encouraging responses in animal studies have not been duplicated in recent clinical trials of rheumatoid arthritis and multiple sclerosis. There are a number of promising tolerogenic approaches other than oral tolerance that can be pursued in immune-mediated diabetes and other autoimmune diseases. These include: costimulatory blockade; anti-cytokine monoclonal antibodies; hematopoietic stem cell and bone marrow transplantation; and gene transfer-based therapies for cytokine modulation. The rationale for pursuing clinical trials in autoimmunity is supported by promising pre-clinical studies as well as the availability of tolerogenic reagents and molecules.
PART D: WORK STATEMENT
Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment and facilities, not otherwise provided by the Government under the terms of this contract, as needed to:
Expand the SACCC to provide statistical, clinical, regulatory, technical and administrative expertise to the Network for clinical trials and mechanistic studies of tolerogenic approaches for the treatment of autoimmune diseases. The Contractor shall provide expertise and assistance to the Network in the following areas:
RFP-NIH-NIAID-DAIT-99-26
December 10, 1998
DELIVERABLES AND REPORTING REQUIREMENTS
The Contractor shall submit to the Contracting Officer and to the Project Officer technical progress reports covering the work accomplished during each reporting period. These reports shall be brief and factual and prepared in accordance with the format specified below.
Every two months, the Contractor shall submit a report for each open clinical protocol sponsored by the Network and a separate report for each open clinical protocol sponsored by the Centers, summarizing:
Three copies of the Bimonthly Accrual and Site Registration Reports shall be provided to the NIAID Project Officer; additionally, one copy of the report on Network-sponsored open clinical protocols shall be provided to the Chair of the Network Executive Committee and one copy of the report on Center-sponsored open clinical protocols shall be provided to the Chair of the Center Steering Committee.
The Contractor shall submit a report on all adverse experiences for each Network-sponsored open clinical protocol and each Center-sponsored open clinical protocol, including copies of adverse experience report forms. Three copies shall be provided to the NIAID Project Officer.
Every three months, the Contractor shall submit a report summarizing the status of the following, with a separate report prepared for Network activities and a separate report prepared for Center activities:
Three (3) copies of both reports shall be provided to the NIAID Project Officer; additionally, one copy of the Network report shall be provided to the Chair of the Network Executive Committee, and one copy of the Center report shall be provided to the Chair of the Center Steering Committee.
On a quarterly basis, the Contractor shall submit separate reports summarizing the status of proposed, interim and final analyses of the results of clinical trials and mechanistic studies sponsored by the Network and the Centers. This shall include:
Three (3) copies of the Quarterly Statistical Reports shall be provided to the NIAID Contracting Officer.
Quarterly and at the completion of each Center study, the Contractor shall submit a summation of the work performed and the results obtained. This report shall be in sufficient detail to explain comprehensively the tasks accomplished and the results achieved, and shall summarize data analyses performed in text, tabular and graphical form. This report shall include but not be limited to a summary of all relevant descriptive information for all clinical sites combined, as well as for each site individually (e.g., accrual data, attrition, number of forms received, number of data edits, clinical site monitoring reports, adverse events, safety information, etc.
On an annual basis, the Contractor shall submit a report summarizing the results of the entire contract work for the period covered, with separate reports prepared for the requirements of this contract with respect to the activities of the Network and the Centers as specified below. These Annual Reports shall be in sufficient detail to explain comprehensively the results achieved. Annual Reports shall be submitted thirty (30) days prior the anniversary date. Three (3) copies of these reports shall be provided to the NIAID Project Officer.
RFP-NIH-NIAID-DAIT-99-26
December 10, 1998
EVALUATION FACTORS FOR AWARD
Selection of an offeror for contract award will be based on an evaluation of proposals against two factors. The factors in order of importance are technical and cost. Although technical factors are of paramount consideration in the award of the contract, cost/price are also important to the overall contract award decision. In accordance with FAR 15.305, proposals will be subject to a cost realism analysis by the Government. Offerors are advised that award will be made to the offeror whose proposal provides the best overall value to the Government.
The evaluation will be based on the demonstrated capabilities of the prospective contractor in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Proposals will be judged solely on the written materials provided by the Offeror.
PART A
Demonstrated expertise, appropriate training, experience and availability of the statistical, clinical, regulatory, technical and administrative staff required to plan and implement the requirements of this project as described in the work statement.
Proposed scientific, clinical, regulatory, technical and administrative leadership of the SACCC. This shall include the documented training, expertise, experience, leadership/management skills and availability of the Project Director and the surrounding leadership of the SACCC to successfully plan and manage the project.
Documented training, expertise, experience and availability of the proposed other professional, technical and administrative staff, documented ability to perform their roles in carrying out the requirements of this project, expertise and experience in similar projects, and their time commitment.
Documented training, expertise, experience and availability of proposed subcontractor(s), their documented capability to perform the requirements of this project, experience in similar projects, and their time commitment.
Documented availability and adequacy of facilities, equipment and resources necessary to carry out all phases of this project.
PARTS B, C, AND D
PARTS B, C AND D: Feasibility will be assessed relative to: (1) additional statistical, clinical, regulatory, technical and/or administrative expertise required; (2) integration of data into the centralized database for Collaborative Network clinical trials and mechanistic studies; (3) pro- posed changed in the administrative/organizational structure of the SACCC; and (4) statistical and clinical trial design features and considerations of importance for each Part.
PART B = Points: 5
Feasibility of the proposed plan and approach to expand the SACCC to incorporate support for the Network relative to research focused on the development and validation of tolerance assays.
PART C = Points: 5
Feasibility of the proposed plan and approach to expand the SACCC to incorporate support for the Network for clinical trials and mechanistic studies in asthma and allergic diseases.
PART D = Points: 5
Feasibility of the proposed plan and approach to expand the SACCC to incorporate support for the Network for clinical trials and mechanistic studies in autoimmune diseases.
TOTAL POINTS = 100
RFP-NIH-NIAID-DAIT-99-26
December 10, 1998
NOTICE TO OFFERORS: This attachment contains proposal instructions and information that are specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. References to additional, more general information, and forms regarding proposal preparation are contained in "Applicable RFP References," Attachment E. If there is any conflict between the instructions given in this Attachment D and any of the "Applicable RFP References" in Attachment E, the instructions contained in this Attachment D take precedence.
It is anticipated that one (1) award will be made from this solicitation and that the award will be made on/about September 30, 1999.
It is contemplated that the award from this solicitation will be a Requirements type contract with a period of performance of nine (9) years.
Requirements Contract - FAR 16.503 defines a requirements contract as a contract that provides for filling all actual purchase requirements of designated Government activities for supplies and services during a specified contract period, with deliveries or performance to be scheduled by placing orders with the contractor.
Task Order Contract - FAR 16.501-1 defines a task order contract as a contract for services that does not procure or specify a firm quantity of services (other than a minimum or maximum quantity) and that provides for the issuance of orders for the performance of tasks during the period of the contract.
It is expected that one requirements type contract will be awarded as a result of this RFP.
To assist you in the preparation of PART A ONLY of your proposal, the Government considers the nine year total effort for PART A ONLY to be approximately 835% effort per year.
This estimate is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.
For PART A ONLY, it is estimated that the above total labor effort is constituted as follows:
Position |
Annual Level of Effort |
---|---|
SACCC Leadership |
|
Project Director | 1 @ 60% |
Sr. Administrative Asst. |
1 @ 50% |
SACCC Executive |
1 @ 100% |
Secretary |
1 @ 100% |
TOTAL |
310% |
Statistical Support |
|
---|---|
Senior Statistician |
2@ 50% |
TOTAL |
100% |
Data Collection, Management & Quality Control |
|
---|---|
Senior Programmer | 1 @ 40% |
|
2 @ 40% |
TOTAL |
120% |
Clinical Site Monitoring & Training |
|
---|---|
Clinical Site Monitor | 3 @ 30% |
TOTAL |
90% |
Regulatory Support |
|
---|---|
Regulatory Affairs | 1 @ 50% |
|
|
Administrative Assist |
1 @ 75% |
TOTAL |
125% |
Drug Distribution |
|
---|---|
Senior Coordinator | 1 @ 30% |
|
|
Technician |
2 @ 30% |
TOTAL |
90% |
All work required under the contract shall be authorized through the execution of a bilateral modification to the contract. Each modification will obligate the necessary funds to complete the task order and will include the work statement of the task order as an attachment. Task orders may be issued at any time within the contract period.
In providing services under the contract, the following procedures shall apply to the issuing of Task Order Requests (TOR) and the award of Task Orders (TO).
TASK ORDER REQUESTS
When Government identifies a specific requirement, the Contracting Officer shall provide the Contractor with a written Task Order Request (TOR). A single Task Order Request may include any or all of the activities (items) listed in the Work Statement. A Task Order Request shall, at a minimum, include a description of the required task, specific reporting requirements, deliverables and delivery schedule, any special instructions, and a proposal submission due date.
In response to the Government's Task Order Request, the Contractor shall submit their proposal that shall include, but not necessarily be limited to, the following information:
(i) A statement of the contractor's clear understanding of the task requirements;
(ii) A statement of technical and managerial resources and expertise the contractor can provide to satisfy the requirement;
(iii) An approach to perform the work,
(iv) The labor necessary to perform the proposed task, including the numbers of hours for each labor category and an explanation of the rationale for determining hours proposed;
(v) Resumes or CVs with identification of the actual personnel proposed for the work;
(vi) A schedule of performance identifying major milestones, deliverables and delivery dates, and task completion; and
(vii) An itemization of all costs, both direct and indirect, (i.e. personnel, fringe benefits, equipment, travel, supplies, other direct costs, overhead, etc.) necessary to complete the proposed task.
Each proposal submitted in response to a Task Order Request will be subject to a streamlined review by the NIAID. Costs for each task will be negotiated separately and the award of a Task Order, including specifics on deliverables and reports will be recognized through a formal bilateral modification to the contract. The Government anticipates that Task Orders under this contract will be awarded on a cost-reimbursement basis, however other pricing arrangements may be used if deemed appropriate.
The Contracting Officer is the only individual authorized to issue a Task Order Request (TOR) or award a Task Order (TO) under the contract. Unless specifically authorized by the Contracting Officer, the contractor shall not commence work on a requirement until a modification to the contract has been fully executed.
AWARD OF TASK ORDERS
It is anticipated that Task Orders will be awarded approximately 30 calendar days from receipt of task order proposals. Each Task Order shall, at a minimum, contain the following information:
No protest under FAR Subpart 323.1 is authorized in connection with the issuance or proposed issuance of a Task Order under the contract except for a protest on the grounds that the order increases the scope, period, or maximum value of the contract. Task Orders awarded under the contract are not subject to the competition requirements of FAR Part 6.
For those concerns other than small business concerns, subcontracting plans will be required when the cumulative dollar amount for tasks issued against the contract exceed $500,000 in accordance with P.L. 95-507. The small, small disadvantaged, and women owned business subcontracting plans will have to reflect goals that allow the maximum practicable subcontracting opportunities retroactive to day one of the effective date of the contract. As subsequent tasks may be issued against the contract once small, small disadvantaged, and women-owned small business subcontracting goals have been established, the subcontracting goals will be subject to modification with each subsequent task.
The restrictions set forth in FAR Clause 52.219-14, Limitation on Subcontracting, will apply to each individual order issued under a task or delivery order contract. The section applicable to this solicitation is FAR Clause 52.219-14(a)(1) and states "Services (except construction). At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.
The clause at FAR 52.216-21, Requirements, permits orders issued during the effective period of the contract, and not completed within that period, to be completed within the time specified in the order. The time specified in such orders, however, will not extend unreasonably beyond the contract expiration date.
Note: The following information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS, FAR 52.219-1:
(1) The small business size standard is $5,000,000.
(2) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is $5,000,000.
Dr. James F. O'Donnell
Ombudsmen for R&D Task and Delivery Order Contract
C/o Ms. Zaiga Tums, Director, Division of
Acquisition Policy and Evaluation, OCM
Building 6100, Room 6C01
Bethesda, MD 20892-7540
Hand-Carried Address:
Brenda Velez
Contracts Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852
Mailing address (U.S.) Postal Service
Brenda Velez
Contracts Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.
Your proposal shall be organized in accordance with the guidance provided in "Standard RFP Instructions and Provisions." Shipment and marking shall be as indicated below.
EXTERNAL PACKAGE MARKING
In addition to the address cited below, mark each package as follows:
"RFP NO. NIH-NIAID-DAIT-99-26
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"
NUMBER OF COPIES
The number of copies required of each part of your proposal are as specified below.
TECHNICAL PROPOSAL: ORIGINAL AND 20 COPIES
BUSINESS PROPOSAL: ORIGINAL AND 5 COPIES
NOTE: The original proposal must be readily accessible for date stamping.
COPIES TO
If hand-delivered or delivery service
Jacqueline C. Holden
Contracts Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852
If using U.S. Postal Service
Jacqueline C. Holden
Contracts Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.
NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the Rockville, Maryland address. Any package sent to the Rockville address via this service will be held at a local post office for pick-up. THE GOVERNMENT IS NOT RESPONSIBLE FOR PICKING UP ANY MAIL AT A LOCAL POST OFFICE. If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal," in accordance with PHSAR 352.215-10, Late Proposals, Modifications of Proposals and Withdrawals of Proposals (NOV 1986).
AN OFFEROR SHALL PLACE THIS NOTICE ON TOP OF EACH COPY OF ITS TECHNICAL PROPOSAL.
"This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices that the submitter places on this proposal shall also be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be made only to the extent authorized by, and in accordance with, the procedures in HHSAR paragraph 315.608-72."
(For information regarding authorized restrictive notices, offerors should refer to the "Confidentiality of Proposals" section, Item F.6., of the STANDARD RFP INSTRUCTIONS AND PROVISIONS, General Instructions.)
(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration, and other agencies at the Federal, State, and local levels (Federal, State and local regulatory/enforcement agencies.)
(b) Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officers, determines to be reasonably necessary. If compliance with such additional safety measures results in an increase or decrease in the cost or time required of performance of any part of work under the contract, an equitable adjustment will be made in accordance with the applicable "Changes" Clause as set forth in the contract.
(c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contact and all violations for which the Contractor has been cited by any Federal, State, or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal, State, or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.
(e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.
PRIVACY ACT SYSTEM OF RECORDS
This procurement action requires the Contractor to do one or more of the following: design, develop or operate a system of records on individuals to accomplish an agency function in accordance with the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties.
The Privacy Act System of Records Notice that applies to this RFP was published in the Federal Register dated April 7, 1997, Vol. 62 No. 66, Pages 16596-16602. This notice will be incorporated into any contract resulting from this RFP. If you would like a copy, please contract the Contracting Officer identified in the cover letter to this RFP.
RFP No.: NIH-NIAID-DAIT-99-26
RFP Title: "Statistical and Clinical Coordinating Center (SACCC)"
Please review the attached Request for Proposals. Furnish the information requested below and return this page by March 1, 1999. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.
[ ] DO INTEND TO SUBMIT A PROPOSAL
[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:
Company/Institution Name: ______________________________________
Address: _______________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
Project Director's Name: ________________________________________
Title: _________________________________________________________
Signature/Date: ________________________________________________
Telephone Number and E-mail Address: ___________________________
Names of Collaborating Institutions and Investigators (include Subcontractors
and Consultants):
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
(Continue list on a separate page if necessary)
RETURN TO:
CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
Attn: Jacqueline C. Holden
RFP-NIH-NIAID-DAIT-99-26
FAX# 301-402-0972
Email jh55b@nih.gov
(NOTE: Instructions to offerors are indicated in parentheses or as footnotes.)
(Note: For key personnel, include 2 page biosketch/resume and the form entitled "Summary of Current and Proposed Activities" under Item 5. below.)-- Page ____
5. OTHER SUPPORT (A "Summary of Current and Proposed Activities" for all Key Personnel must be provided; this form is located in FORMS, FORMATS, ATTACHMENTS) -- Page ____
6. VERTEBRATE ANIMALS (IF APPLICABLE) -- Page ____
7. "Technical Proposal Cost Information" summary spreadsheet -- Page ____
8. LITERATURE CITED -- Page ____
9. APPENDICES (Protocols, policy manuals, etc. for above Technical Plan; list each Appendix; Appendices must be clear and legible, and easily located.)
* State the proposal's broad, long-term objectives and specific aims. Describe concisely the research design and methods for achieving these goals. DO NOT EXCEED ONE PAGE in providing the abstract. Identify the RFP number, institution, and Principal Investigator on the abstract.
RFP-NIH-NIAID-DAIT-99-26
December 10, 1998
This section identifies the items found in the RFP Web directory entitled RFP REFERENCES that are applicable to this RFP.
Note: A Subcontracting Plan is not due with the initial proposal. The Contracting Officer will notify offerors if a plan becomes due.
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