BROAD AGENCY ANNOUNCEMENT (BAA) No.
NIH-NIAID-DAIT-BAA-99-12

Ladies and Gentlemen:

You are invited to submit a proposal in accordance with the requirements of this BROAD AGENCY ANNOUNCEMENT (BAA) (NIH-NIAID-DAIT-BAA-99-12) entitled "Clinical Trials and Clinical Markers for Immunologic Diseases." The Broad Agency Announcement is authorized by Federal Acquisition Regulation (FAR) 6.102. BAAs are used by agencies to fulfill their requirements for scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on a specific system or hardware solution. Proposals received as a result of the BAA will be evaluated in accordance with evaluation criteria specified herein through a peer review process. Proposals will not be evaluated against a specific Government need, as in the case of a conventional RFP, as they are not submitted in accordance with a common work statement.

In order to be considered for an award, the proposal must, at a minimum, present a detailed technical and cost proposal for one or more of the Research Areas described in Attachment 1 of this announcement to permit meaningful evaluation and be signed by an official authorized to contractually commit the submitting organization.

It is anticipated that multiple awards will result from this announcement. It is expected that these awards will be multi-year, cost-reimbursement, completion type contracts. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The maximum period acceptable for a research proposal is five (5) years. Awards are expected to be made on or about September 1,1999. The NIAID anticipates awarding 3-5 contracts based on technical merit, available funds, and programmatic balance. Program staff estimates the total annual cost (direct and indirect costs) per contract for Research Area A will be between $300,000 and $1,000,000 and for Research Area B between $100,000 and $300,000.

Award documents will be tailored to the final negotiation with the selected offeror(s) and modified, as necessary, for the type of contractor organization, cost and/or fee arrangements, and other elements as negotiated prior to award.

The documents included with this electronic RFP package are as follows:

Attachments:

The Subdirectories are:

If you are unable to download any of the applicable documents, please contact Cyndie Cotter, Contracting Officer, by phone/fax/internet (see contract numbers/addresses below).

The attachments/documents listed above represent all the necessary information required for the submission of a proposal for this acquisition. Following proposal submission and review, additional information will be requested by the Contracting Officer during discussions (if applicable).

Although these documents contain sufficient information for you or your organization to submit a proposal, if you intend to submit a proposal in response to this RFP, IT IS ESSENTIAL THAT YOU IMMEDIATELY NOTIFY CYNDIE COTTER, CONTRACTING OFFICER, OF THE NIAID CONTRACTING OFFICE AT THE INTERNET ADDRESS LISTED BELOW. IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST, YOU WILL NOT RECEIVE NOTICE OF AMENDMENTS WHICH 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 DIRECTORY WEB SITE AND THE NIAID CONTRACT 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. See STANDARD RFP INSTRUCTIONS AND PROVISIONS, in the NIH RFP Directory Web site, for more details on the Business Proposal requirements.

The original and twenty (20) copies of your Technical Proposal and the original and five (5) copies of your Business Proposal must be received by the Contracting Officer no later than January 5,1999, at 3:30 p.m. local time at the address listed in Attachment 4, Item 3.

The "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your Technical Proposal. A copy of this form is contained in the NIH RFP Directory Web site under the FORMS, FORMATS, AND ATTACHMENTS subdirectory. It is important that you list all professional personnel and organizations named in the proposal who 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", Attachment 4, Item 8.

With the Business Proposal, please submit Form NIH-2043, "Proposal Summary and Data Record," contained in the NIH RFP Directory Web site under the FORMS, FORMATS, AND ATTACHMENTS subdirectory. Please note that in addition to telephone and fax numbers, the INTERNET addresses of both the Principal Investigator and the responsible business representative are to be included on the form.

Please note that the Representations and Certifications MUST be submitted with the offeror's proposal. This form can be found in the NIH RFP Directory Web site under the REPRESENTATIONS AND CERTIFICATIONS subdirectory.

Questions concerning any areas of uncertainty which, in your opinion, require clarification or correction, must be furnished in writing to Cyndie Cotter. Your questions should be received no later than December 7, 1998, at the address indicated in Attachment 4, Item 3. (Fax or E-mail is also acceptable) and marked "Offeror's Questions, RFP-NIH-NIAID-DAIT-BAA-99-12."  

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 ENTITLED, "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWALS OF PROPOSALS".  

If you have any additional questions regarding this RFP, please contact Cynthia Cotter at the Internet electronic mail address cc41w@nih.gov, by phone at 301/402-0641, or by fax at 301/402-0972. Collect calls will NOT be accepted.  

Sincerely,

Rosemary McCabe Hamill
Chief, Infectious and Allergic
Diseases Contract Section
Contract Management Branch
National Institute of Allergy
and Infectious Diseases

Attachments: A-E

08/14/98

The purpose of this Broad Agency Announcement is to solicit proposals for research which will increase clinical application of knowledge gained from basic research on immunologic diseases. The general Research Areas are:

1. Clinical trials of immunomodulation in immunologic diseases that are unlikely to be conducted without Government support. Trials can be either a pilot or Phase I/II trial to assess safety and determine if an intervention shows promising effects which warrant further evaluation, or an appropriately controlled pivotal (Phase II/III) trial to determine efficacy. These trials must include evaluation of immunologic and other relevant parameters in order to study the mechanisms underlying the intervention and mechanisms of disease pathogenesis.
2. Development of immunologic or other markers which can be used in immunologic diseases for measuring disease activity or risk, therapeutic effect, or as diagnostic criteria. These studies shall use new technologies and approaches to develop and validate reliable and reproducible assays of relevant molecules or cells.

A single offeror may submit proposals for either or both of the general Research Areas. If proposals for both Areas are submitted, they must be separate and complete, containing both the technical and business proposals. Proposals in each Research Area will be scored separately and a merit order ranking will be determined for each Area. It is anticipated that a total of approximately five awards will be made for the two Research Areas, dependent upon the availability of funds and programmatic priorities. It is anticipated that awards for Research Area A will range between $300,000 and $1,000,000, per year and that awards for Research Area B will range between $100,000 and $300,000 per year. The duration of awards will be for five years or less.

The Division of Allergy, Immunology and Transplantation (DAIT) promotes and supports a broad range of research aimed at the elucidation of the immune mechanisms underlying disease and the translation of this basic knowledge to clinical applications that will benefit individuals affected by any immunologic disease (including autoimmune diseases, primary immunodeficiency diseases, allergy and asthma, and graft rejection in solid organ and cell transplantation). The ultimate goal of this research, and at the core of NIAID's mission, is effective and specific diagnosis, treatment and prevention of these diseases. Gaps in both knowledge and in research effort exist which represent opportunities for the NIAID to contribute to progress in this area.

Immune system-mediated inflammation and tissue damage are the cause of autoimmune diseases, graft rejection in solid organ and cell transplantation, asthma, and allergic diseases. In autoimmune disease, the immune system responds to the body's own tissues and/or proteins. In graft rejection in solid organ and cell transplantation, the immune system attacks foreign (allogeneic) molecules on the transplanted tissues. In asthma and allergy, the pathologic cascade begins with the production of an antibody called IgE to various allergens. An increased understanding of immune system function and regulation offers the possibility of intervening in these diseases by modulating one or another step in the pathogenic immune response (immunomodulation). It is hoped that such interventions will be more effective and less toxic than currently available therapies because one would be targeting particular molecules or cells. Ideally, immunomodulation would be disease specific, target basic pathogenic mechanisms, result in prolonged symptomatic improvement, improve the ultimate outcome, and have no major side effects. A large number of immunomodulatory agents are being developed and tested using a number of approaches. These include: correction of cytokine imbalance, induction of unresponsiveness in pathogenic T lymphocytes via the antigen receptor, induction of unresponsiveness via inhibition of co-stimulatory molecules, and inhibition of inflammatory cytokines.

Another group of immune system diseases, the primary immunodeficiency diseases, are a heterogeneous group of disorders all of which are characterized by an immune system dysfunction that is responsible for clinical features such as increased susceptibility to infection and abnormal inflammatory responses. There are more than 70 such diseases and the morbidity, mortality, medical and social costs for severely affected individuals and their families are extremely high. Many of these diseases are caused by genetic defects and several of the defective genes have recently been identified and cloned. Curative intervention for these diseases will involve the successful development of technology for gene transfer to correct the defect.

In some immunologic diseases, immune responses are altered before the appearance of clinical manifestations, allowing identification of those at risk and providing the opportunity for prevention. For example, the risk of developing insulin-dependent diabetes mellitus can be predicted with a high degree of accuracy in healthy relatives of diabetic patients by measuring the appearance of autoantibodies to specific antigens. Such markers are not available for other autoimmune diseases. In addition, many autoimmune diseases have fluctuating clinical courses, dictating large numbers of patients and/or long follow-up periods for evaluation of new therapies. Furthermore, immunologic interventions might be effective only at specific stages of disease. Therefore, the ability to define persons at risk, diagnose disease, determine disease activity, and determine the response to therapy are extremely important for effective immune intervention.

In December 1996, the NIAID convened a workshop at which leading basic and clinical immunologists discussed the role the Institute should play in supporting clinical trials for immune system mediated diseases including current and projected clinical trials. It was considered likely that clinical trials of many new immunologic interventions would be supported by the pharmaceutical/biotechnology industry. However, gaps in both knowledge and in research effort were identified which represent opportunities for the NIAID to contribute to progress in this area. These gaps/opportunities were also identified by a number of focus groups conducted by the NIAID. Two of these gaps/opportunities are the focus of this Broad Agency Announcement.

One such gap/opportunity is the evaluation of potentially beneficial immunotherapeutic interventions in clinical trials that would probably not be supported by industry. Several circumstances were identified that would lead to lack of industry support including: 1) new uses for agents which are off-patent and are produced and sold generically; 2) clinical trials of combination therapy with multiple agents from different companies where the control groups use each agent alone and, therefore, provide head-to-head comparisons; and 3) orphan diseases (e.g., systemic lupus erythematosus and primary immunodeficiency diseases) which have a limited commercial market.

A second gap/opportunity is the development of immunologic or other markers which can be used for measuring disease activity, therapeutic effect, the risk of developing disease, or as diagnostic criteria. Particularly needed are new technologies and approaches to develop and validate reliable and reproducible assays of relevant molecules or cells. These tests would greatly increase our ability to diagnose or predict disease, to intervene at the optimal time, and to evaluate clinical responses to new agents.

Offerors shall submit proposals for one or both of the Research Areas listed below. The NIAID reserves the right to make awards in one or both of these Research Areas. For the purposes of this solicitation, immunologic diseases include autoimmune diseases, asthma and allergic diseases, primary immunodeficiency diseases, and graft rejection in solid organ and cell transplantation. Diseases that involve the immune system but are caused by an infectious agent (e.g., AIDS, Lyme Disease) are specifically excluded, as are observation trials and epidemiological studies.

RESEARCH AREA A. CLINICAL TRIALS OF IMMUNOMODULATION IN IMMUNOLOGIC DISEASES UNLIKELY TO BE CONDUCTED WITHOUT GOVERNMENT SUPPORT. For this solicitation, immunomodulation is defined as an agent or intervention which affects the immune system. Clinical trials can be either a pilot or Phase I/II trial to assess safety and determine if an intervention shows promising effects which warrant further evaluation, or an appropriately controlled pivotal (Phase II/III) trial to determine efficacy.

Proposals submitted for this Research Area must include items 1. - 5. listed below in order to ensure a complete review of each proposal. Items 6. - 8. listed below are required to be received prior to contract award.

1. The Protocol-A detailed final protocol which includes (at a minimum) all of the following: a) background and rationale including all relevant laboratory and animal studies, toxicity data, and pilot or other previous clinical trials if available; b) study objectives; c) protocol design including definition of the study populations and eligibility criteria; a plan for recruitment, retention and follow-up of the study participants; and detailed procedures for screening, intervention, masking, randomization, study product management, adverse event monitoring, and laboratory monitoring; d) definition of endpoints, both primary and secondary; e) statistical methods and analyses to be employed; f) description of the clinical sites and their capabilities; g) organizational structure, administrative management procedures, and ability to provide the environment and services necessary to conduct clinical trials; h) an independent committee which monitors patient safety, data, and quality assurance; i) human subject considerations including children, gender and ethnic diversity, protection of human subjects, and risks and benefits; j) protocol time line and schedules; k) references; and l)model consent forms.

2. Investigator's Brochure or Package Insert-For investigational agents, the Investigator's Brochure for each agent must be provided. For an approved agent, the package insert must be provided.

3. Personnel-Documentation of the training, experience, and expertise of the Principal Investigator and all other personnel participating in the proposal.

4. Research Support-An explanation of the reasons that the proposed clinical trial will not be supported by industry or other sources must be provided including available documentation. The proposal should clearly delineate costs of patient care covered by other sources (such as third party payers), and protocol-related patient care costs.

5. Mechanistic Studies-Proposals must also include one or more substudies which utilize the patients and patient materials from the trial for the evaluation of immunologic and other relevant parameters in order to study the mechanisms of disease pathogenesis, surrogate markers of disease activity and therapeutic effect, mechanisms of human immunologic function, or the immunologic mechanisms underlying the activity of the intervention. The NIAID is particularly interested in the application of new technologies and approaches in these studies. See Research Area B (below) for examples of such studies.

6. Investigational New Drug Application (INDA)-If an INDA is required, this shall be filed by the investigator and a copy of the approved INDA provided by the time of the award.

7. Clinical Trials Agreement (CTA)-If a CTA or other agreement exists between the offeror and a pharmaceutical company, a copy shall be provided.

8. Institutional Review Board (IRB) Approval-Offerors must provide documentation of approval of the protocol by the relevant IRB(s) prior to award.

RESEARCH AREA B. DEVELOPMENT OF IMMUNOLOGIC OR OTHER MARKERS WHICH CAN BE USED IN IMMUNOLOGIC DISEASES FOR MEASURING DISEASE ACTIVITY, THERAPEUTIC EFFECT, THE RISK OF DEVELOPING THE DISEASE, OR AS DIAGNOSTIC CRITERIA. The NIAID is particularly interested in studies which use new technologies and approaches to develop and validate reliable and reproducible assays of relevant molecules or cells. Examples of relevant research include, but are not limited to, the following:

o Quantitation of disease-related, autoreactive Tlymphocytes using methods such as MHC/peptide tetramers, chimeric antibodies, or very early activation antigens;

o Analysis of autoreactive T cells by PCR for expression of genes implicated in immunity or inflammation, or by FACS for cell surface markers that identify functions (e.g., cytokine receptors that distinguish TH1 from TH2 or chemokine receptors or integrins that indicate preferential patterns of homing);

o Identification and evaluation of cytokine and cytokine receptor polymorphisms and analysis for genetic linkage to disease;

o Use of high throughput technologies (e.g. chip technology using expressed sequence tags) to identify and evaluate genes activated in disease sites;

o Correlation of the above parameters with clinical disease activity and/or response to intervention;

o Comparison of samples from peripheral blood with those from sites of disease, i.e., do peripheral blood samples provide useful information; and

o Assessment for the presence of molecular evidence (e.g. using PCR probes) of potential causative environmental agents.

The areas outlined above are not intended to be all-inclusive.

SPECIAL INSTRUCTIONS TO OFFERORS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN CLINICAL RESEARCH STUDY POPULATIONS FOLLOW:

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (concerning the inclusion of women in study populations, and concerning the inclusion of minorities in study populations) which have been in effect since 1990. This policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11,March 18, 1994. A copy of this document is available in the FORMS, FORMATS, AND ATTACHMENTS directory.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address:

http://www.nih.gov/grants/guide/notice-files/not98-024.html

Offerors may obtain copies from these sources or from the contact person listed in the RFP who may also provide additional relevant information concerning the policy.

Subcontracting agreements are allowable and encouraged to accomplish the work outlined in this solicitation. The proposal shall describe in detail the research plan and contribution to the overall proposal, complete description of facilities, professional background of personnel, and cost.

Disclosures of any and all patents or patent applications of materials, reagents, animal models, or procedures filed in or outside the US by the offerors and/or listed personnel or collaborators shall be made at the time of proposal submission.

The data shall remain in the Contractor's possession, unless otherwise requested by the Project Officer. All results, methods employed, and data obtained shall be presented to the Government [Project Officer] in Technical Progress Reports as specified. The privacy of data will be maintained. It is anticipated that the work will be presented at scientific meetings and published in scientific journals. Preprints and reprints of these will be sent to the Project Officer. The only copyrights which might apply are those of the scientific journals in which these data and results may be published. Should patents arise from this contract, they will be subject to federal law governing inventions. Every patent application (individual or institutional) is required to provide the Government with a nonexclusive, irrevocable, paid-up license in the invention.

The offeror shall comply with Governmental and Institutional health and safety regulations while conducting the work set forth. All chemicals, radioactive materials, drugs, blood, blood products, and tissues handled during this project should be considered potentially hazardous, and, thus, handled using appropriate safety measures. The offeror shall have written documentation for all of their safety procedures for handling the above-described materials, which shall be available to the Project Officer upon request. The offeror shall employ appropriately trained staff and have appropriate containment and testing facilities. A partial list of current references is provided for general information:

HHS publication #(CDC) 93-8395 "Biosafety in Microbiological and Biomedical Laboratories, Second Edition." Washington, D.C.: Government Printing Office, 1993.

Centers for Disease Control. Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other blood-borne pathogens in health-care settings. MMWR 1988; 37:377-382, 387-388.

Occupational Safety and Health Administration. Occupational exposure to blood-borne pathogens. Federal Register 1989; 54:23042-139.

DELIVERABLES AND REPORTING REQUIREMENTS

As part of the work to be performed under this contract, the Contractor shall prepare and deliver the following reports to the Project Officer, with one additional copy to the Contracting Officer. The exact submission schedule will be negotiated and established in the contract document.

A. TECHNICAL REPORTS

1. Quarterly Progress Reports

The Contractor shall submit 2 copies (as specified above) 30 calendar days following the end of each quarterly performance period. Each quarterly report shall include the following:

Quarterly Progress reports are not required for periods in which an annual or final report is due.

2. Annual/Final Reports

The Contractor shall submit two (2) copies (as specified above) of Annual and Final reports which document and summarize the results of the entire contract work for the period covered. For the final report, this shall be the entire contract period of performance. The following format shall be followed:

These reports shall be in sufficient detail to explain comprehensively the results achieved, particularly, figures and tables shall be clearly labeled to describe the data presented. Annual reports shall be submitted 30 calendar days following the anniversary date of the contract. The final report shall be submitted by the completion date of the contract. An annual report shall not be required for the period when the final report is due.

3. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (concerning the inclusion of women in study populations, and concerning the inclusion of minorities in study populations) which have been in effect since 1990. This policy contains some new provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18,1994.

A copy of this document is available in the FORMS, FORMATS, AND ATTACHMENTS directory. Unless otherwise specified in the RFP, the Government has determined that the work set forth herein does not involve a gender specific study or a single or limited number of minority population groups. Therefore, the Government believes that the inclusion of women and minority populations is appropriate for this project. (See the Technical Evaluation Criteria for more information about evaluation factors for award) The format for the "Annual Technical Progress Report" found in the FORMS, FORMATS, and ATTACHMENTS directory shall be used in proposal preparation.

4. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address:

http://www.nih.gov/grants/guide/notice-files/not98-024.html

5. Summary of Salient Results: With the Final Report, the Contractor shall submit a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

6. Scientific Publications: The Contractor shall submit one (1) copy of all scientific publications which result from this study.

B. TECHNICAL REPORT DISTRIBUTION

Copies of the technical reports shall be submitted as follows:

C. Reports submitted to the Government shall not include any identifier of subjects, i.e. volunteers, patients, involved in these studies.

D. If the Contractor becomes unable to deliver the reports specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reason therefore.

ATTACHMENT C
RFP-NIH-NIAID-DAIT-BAA-99-12
08/14/98

EVALUATION FACTORS FOR AWARD

The Government will make awards to the responsible offeror(s) whose proposals provide the best value to the Government, cost and other factors considered. For this solicitation, the technical proposal shall receive paramount consideration in the selection of the contractor(s). The evaluation will be based on the demonstrated capabilities of the prospective offerors in relation to the needs of the project as set forth herein. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP.

The estimated cost of an offer must be reasonable for the tasks to be performed, and, in accordance with FAR 15.305, will be subject to a cost realism analysis by the Government.

All technical proposals will undergo evaluation by a peer review group also known as the Special Emphasis Panel (SEP). The SEP may include both Government and non-Government evaluators. The Division of Extramural Activities, NIAID, shall be responsible for administering this review and evaluation.

The final stage of the evaluation is the establishment of an ORDER OF MERIT RANKING in which all competing proposals are ranked on the basis of their respective relevance and scientific merit evaluations. Subsequent awards depend upon the availability of funds, scientific priority, and program balance which the NIAID determines to exist at the time of award selection.

2. HUMAN SUBJECTS

This research involves human subjects. NIH Policy requires that women, members of minority groups and their subpopulations, and children must be included in the study populations of research involving human subjects, UNLESS a clear and compelling rationale and justification is provided with respect to the health of the subjects or the purpose of the research.

When inclusion of women, minority populations, and/or children is not feasible, a detailed rationale and justification for exclusion of one or more groups from the study population must be submitted with the technical proposal. The Government will review the rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research. If the rationale is not considered acceptable, you may be afforded the opportunity to further discuss and/or clarify your position during discussions, or to include the missing population in your Final Proposal Revision (FPR). If your exclusion position is still considered unacceptable by the Government after discussions, your proposal may not be considered further for award.

3. MANDATORY EVALUATION CRITERIA

The following mandatory evaluation criteria establish conditions that MUST be met prior to contract award in order for the proposal to be considered for award:

4. TECHNICAL EVALUATION CRITERIA

Proposals shall be evaluated in accordance with the following technical evaluation criteria, which are weighted in the order of their relative importance, with a maximum total score of 100 points. Proposals will be judged solely on the written material provided by the offeror. Separate Order of Merit Rankings will be determined for each of the two general Research Areas.

CRITERIA:

1. SCIENTIFIC AND TECHNICAL MERIT (50 Points)

B. PERSONNEL AND EXPERIENCE (35 Points)

C. FACILITIES AND RESOURCES (15 Points)

Documented availability and proposed utilization of sufficient and appropriate space, equipment, physical resources, and patient populations and/or patient materials necessary to conduct and support the proposed research.

1. SIC CODE AND SIZE STANDARD

(a) The standard industrial classification (SIC) code for this acquisition is 8733.  

(b) (1) The small business size standard is $5M.  

(c) This requirement is NOT Set-Aside for Small Business. However, the Federal Acquisition Regulation (FAR) requires in every solicitation (except for foreign acquisitions) the inclusion of the Standard Industrial Classification (SIC) Code and corresponding size standard which best describes the nature of the requirement in the solicitation.

2. PROPOSAL INTENT RESPONSE SHEET

RFP No.: NIH-NIAID-DAIT-BAA-99-12

RFP Title: CLINICAL TRIALS AND CLINICAL MARKERS FOR IMMUNOLOGIC DISEASES

PLEASE REVIEW THE ATTACHED ANNOUNCEMENT. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY December 7, 1998. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.

[ ] DO INTEND TO SUBMIT A PROPOSAL UNDER:

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:

____________________________________________________
____________________________________________________

Address: _______________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________

Project Director's Name: ________________________________________

Title: _________________________________________________________

Signature/Date: ________________________________________________

Telephone Number and E-mail Address: ___________________________

________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________

RETURN TO:

CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
Attn: Cyndie Cotter
RFP NIH-NIAID-DAIT-BAA-99-12
Fax # 301/402-0972 

PLEASE RETURN BY December 7, 1998  

3. PACKAGING AND DELIVERY OF THE PROPOSAL

In addition to the address cited below, mark each package as follows:

"RFP NO. NIH-NIAID-DAIT-BAA-99-12
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

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

If hand-delivered or delivery service:

Contract Specialist
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

If using U.S. Postal Service

Contract Specialist
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

4. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

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 which 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."

5. NUMBER AND TYPE OF AWARD(S)

It is anticipated that approximately five (5) awards will be made from this solicitation and that these awards will be made on or about September 1, 1999.

The cost for each contract will vary based on the category of the research proposed, methodology, duration, organization, etc. Negotiations are anticipated with those offerors whose proposals, following scientific review, are judged to be especially meritorious, and which offer the greatest contribution to NIAID's immunology research program. The Government reserves the right to make awards without any discussions. The Government also reserves the right to limit the number of awards due to budget restraints, and to reject any or all proposals received. The NIAID anticipates awarding 3-5 contracts based on technical merit and available funds. Program staff estimates the total annual cost per contract (direct and indirect costs) for Research Area A will be between $300,000 and $1,000,000 and for Research Area B between 100,000 and $300,000; however, exceptional proposals outside of this range will be considered.

6. SERVICE OF PROTEST (AUG 1996) - FAR 52.233-2

(1) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Hand-Carried Address:

Contracting Officer
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

Mailing address (U.S.) Postal Service

Contracting Officer
Contract 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.

(2) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

7. SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUG 1997)

(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 this 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.

8. TECHNICAL PROPOSAL TABLE OF CONTENTS