NIH-NIAID-DAIDS-98-15 (PRESOLICITATION DRAFT FOR INFORMATION AND COMMENT) Title: Master Contract for Targeted HIV Vaccine and Related Biomedical Prevention Research Date Posted: July 9, 1997 Comments Due: August 26, 1997 Contact: Kristiane Cooper Phone: 301/496-7288 Ladies and Gentlemen: The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), has developed a Work Statement to meet its goal of rapidly developing vaccine and other interventions to prevent the spread of HIV infection. DAIDS anticipates awarding a contract to an organization with experience in both vaccine development and research management skills. This presolicitation notice is intended to develop and/or identify potential interested sources, explain this complex requirement and to provide potential offerors with an overview of objectives prior to the submission of proposals in response to the future solicitation. Feedback is solicited regarding the feasibility of awarding one "master contract" under which an organization would be responsible for the diverse areas of work described in the Draft Work Statement below. The documents included with this electronic "solicitation for information or planning purposes" are as follows: - Introduction, Background and Draft Work Statement dated July 9, 1997 (Attachment A) - Proposal Evaluation Criteria dated July 9, 1997 (Attachment B) Please submit questions or comments (in writing through e-mail or fax) to Kristiane Cooper not later than August 26, 1997 (e-mail address: kc116y@nih.gov, fax number: 301/402-0972) (please note the date change). Your special attention is invited to the questions and issues raised by the Work Statement (Attachment A). It is anticipated that the solicitation will be released in the Fall 1997. The RFP-Available notice will be announced in the Commerce Business Daily and NIH Guide for Grants and Contracts prior to issuance, and the RFP will be available electronically at this site. Sincerely, /s/ Toni A. Kuhn, Chief AIDS Preclinical Research Contract Section Contract Management Branch National Institute of Allergy and Infectious Diseases Attachment A: Draft Work Statement Attachment B: Proposal Evaluation Criteria FAR references: FAR 5.204, Presolicitation notices FAR 5.205, Special situations, paragraph (c) Special notices FAR 15.404, Presolicitation notices and conferences FAR 15.405, Solicitations for information or planning purposes FAR 52.215-3, Solicitation for Information or Planning Purposes ******************************************************************** ATTACHMENT A NIH-NIAID-DAIDS-98-15 (DRAFT) INTRODUCTION, BACKGROUND AND WORK STATEMENT FAR 52.215-3 SOLICITATION FOR INFORMATION OR PLANNING PURPOSES (APR 1984) (a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as provided in subsection 31.205-18, Bid and proposal (B&P) costs, of the Federal Regulation. (b) This solicitation is issued for the purpose of explaining the complexities of the proposed project to potential offerors and receiving comments regarding the feasibility of the proposed work statement. The draft Work Statement below contains "NOTES TO OFFERORS" that are provided to give potential offerors insight into preparing proposals in response to the future solicitation, especially in developing cost estimates. NIAID's preference is to make an award to one organization that would act as a master contractor with responsibility for all work statement requirements. However, it is recognized that the requirements of the Work Statement are quite diverse and that there may be no single organization with expertise and facilities to perform all requirements in house, or that might be willing to assume such a responsibility. It is the Government's intent to provide the opportunity for offerors to take advantage of their strengths and propose subcontracting for other aspects of the work. As stated in one of the Work Statement "notes to offerors," it has not been specified which work activities must be performed by a prime contractor or which under subcontract. It is requested that potential offerors or other interested parties address the following statements/questions. Please send your comments to Kristiane Cooper by e-mail at "kc116y@nih.gov" or fax 301/402-0972, and submit them not later than August 26, 1997. 1. Please provide specific comments on the prospect of one offeror's ability to successfully perform the work described herein (with subcontracting) given the diversity of the Work Statement requirements. Describe changes or improvements that could be made to the structure of the Work Statement to increase the likelihood of successful performance or its feasibility. 2. Please comment on potential conflict of interest issues that may be involved in the technical evaluation of subcontract proposals solicited by the Master Contractor. 3. The draft Proposal Evaluation Criteria are stated in Attachment B. As is apparent, higher weight would be assigned to the technical approach for developing vaccine(s) under Activity 1, in comparison to the other Activity areas. This would be the case whether that work was proposed for the prime or a subcontractor. Please feel free to comment on these criteria, including the Mandatory Qualification Criteria. 4. General comments related to any aspect of this Draft are welcome. Comments and responses to our questions will be considered prior to issuance of the solicitation. ********************************************************** DRAFT WORK STATEMENT FOR THE MASTER CONTRACT FOR TARGETED HIV VACCINE AND RELATED BIOMEDICAL PREVENTION RESEARCH INTRODUCTION The objective of this Contract is to provide to the NIAID the capability to rapidly mobilize appropriate resources to address critical scientific gaps or emerging areas of importance in preclinical and clinical HIV vaccine and other biomedical prevention research. The Contract will also provide the NIAID with the full scope of developmental resources to bring a concept from the laboratory to initial human testing. It is envisioned that the ability to encourage and to support the development of multiple approaches will result in a shared knowledge base from which the best vaccine/prevention intervention prototypes will emerge. BACKGROUND The development of vaccine and other interventions to prevent the spread of HIV infection is a national goal of the highest priority. While advances in immunology and molecular biology continue to offer an ever expanding array of approaches to the development of new candidates, the limited capacity to move promising concepts through the development process presents a substantial barrier to the full achievement of this potential. A lack of industry involvement in key areas, such as non-Clade B vaccines and microbicides, calls for a non-traditional, more active and developmentally oriented response by NIH and NIAID to meet the public health threat of the AIDS epidemic. Resources that could rapidly and efficiently close research gaps would greatly enhance the NIAID's capacity to respond to emerging needs identified by NIAID and its advisory groups. The Master Contract for Targeted HIV Vaccine and Related Biomedical Prevention Research will support applied research that is not adequately being pursued by industry and will further assist in the development of vaccine/ prevention concepts from investigator initiated research. It is anticipated that NIAID will rely on advisory groups, including the AIDS Vaccine Research Committee (AVRC) for guidance in identifying emerging opportunities and in selecting areas of emphasis for the Master Contractor to pursue. A Steering Committee, formed by NIAID to include experts not involved with the operation of the Contract, will evaluate and prioritize projects to be undertaken. Upon determination of a specific need that is appropriate to be fulfilled by the Contract, the NIAID will issue a Vaccine/Prevention Development Requirement (V/PDR) to the Master Contractor. This action will initiate work on a project. Regular reports of the activities of the Master Contract will be provided to the chartered AIDS Research Advisory Committee (ARAC) and to the AVRC. This Contract will facilitate developmental HIV vaccine/prevention research by performing work in two areas: 1) process development and cGMP production of pilot lots of candidate HIV vaccines and 2) a rapid response mechanism for funding other high priority, targeted development research. Both of these major activities will require the Master Contractor to interact extensively with NIAID staff, provide and update timelines, manage data and coordinate all activities, including those of subcontractors, in accordance with projected schedules. The most important technical capacity of the contractor(s) is expertise in vaccine development, especially biologicals. For this first area, the Contractor will identify and assemble a process development team with the expertise to move candidate products from initial construction to production of pilot lots suitable for human use. NIAID will establish the priorities for the targeted research by issuing individual V/PDRs which will focus on development and evaluation of specific products. In some cases, a V/PDR may support work on a well- developed product that needs only final steps in production and formulation. Other V/PDRs may involve very early and iterative steps in the development process and may require several years of effort. For other targeted development research, the Master Contractor, under the direction of NIAID, would provide specific reagents and systems for preclinical and clinical vaccine evaluation. To accomplish "Other Targeted Developmental Research," the Master Contractor will establish a peer review process, which adhere to DHHS/NIH extramural policy, fund research through competitively solicited subcontracts, receive data, and monitor technical and administrative progress of all work (e.g., to create novel reagents or utilize animal models for concept testing). Examples of a V/PDR include, but not limited to: o reagent production, including, but not limited to: - new cell lines [e.g., certified cell lines with additional coreceptors that conform to FDA guidelines for vaccine production], - monoclonal antibodies [e.g., the development or large-scale production of selected antibodies for macaque forms of lymphocyte antigens], - production of working quantities of antigens as reagents, o adjuvant development (testing of adjuvants with various candidate vaccines to determine if newly described immune responses are preferentially induced), o improved animal models (development, validation, production), - production and titration of challenge stocks for animal evaluations, o virological or immunological assay development (improvement, refinement) and standardization, o unique assay services or high throughput data generation by central laboratories not otherwise available to the NIAID. 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, directly or though subcontractors and/or consultants, as needed to undertake targeted research essential to translating basic research concepts into prototype vaccine/prevention biomedical products, under the direction of NIAID staff and as recommended by existing and ad hoc NIAID advisory groups. The Master Contractor shall also solicit and award subcontracts, through a competitive award process, to provide for some requirements that may lie outside the scientific expertise and capability of the Master Contractor. GENERAL OBJECTIVES: ACTIVITY 1. PROCESS DEVELOPMENT AND PILOT LOT PRODUCTION Construct, optimize, develop specific vaccine/prevention candidate and prototype products and produce pilot lots of promising candidate vaccine/prevention candidates, appropriate for clinical testing in human volunteers. ACTIVITY 2. PROVIDE A RAPID RESPONSE MECHANISM FOR FUNDING HIGH PRIORITY, TARGETED DEVELOPMENTAL RESEARCH Furnish resources to address gaps or emerging areas of importance in preclinical and clinical HIV vaccine/prevention research, using a competitive process to solicit and award subcontracts to accomplish any of a diverse array of scientific support activities. ACTIVITY 3. NEGOTIATE, IMPLEMENT AND ADMINISTER SUBCONTRACTS (awarded under[2] above, which adhere to DHHS/NIH extramural policy). [NOTE #1 TO OFFEROR: No single institution may have the expertise and facilities required to perform all requirements in the Statement of Work. Thus, it is acceptable for the Contractor to propose a subcontract in order to fulfill some requirements of activities 13. In the draft evaluation criteria (Attachment B) for this draft work statement, greater weight is given to expertise and experience required in work related to activity 1 than in activities 2 & 3. There is no requirement concerning which specific activity must be performed by the prime contractor and which under subcontract. To perform activity 1, a highly qualified and experienced process development team consisting of Research Scientists and Technicians is required. Activity 2 will require management and coordination by a highly qualified scientific administrator and experienced consultants. Activity 3, will also require a Management/Administrative Staff experienced in the scientific administration and financial analysis, administration and management of complex research projects. The Principal Investigator will be responsible for overall management and productivity of the entire project. The Offeror should describe in detail the responsibilities and level of effort of all proposed personnel who will be assigned to the contract and should describe an administrative framework showing clear lines of authority. Documentation should be provided on the qualifications, experience, education, competence, and availability of the Principal Investigator, Research, Technical and Administrative Support staffs; the extent to which outside consultants shall be used, as well as, assurance of their availability. If a subcontractor is proposed, for activities 1, 2, or 3, similar technical information should also be provided as part of the Technical Proposal; cost details should also be provided by the subcontractor.] SPECIFIC OBJECTIVES: ACTIVITY 1. PROCESS DEVELOPMENT AND PILOT LOT PRODUCTION Construct, optimize, and develop specific vaccine/prevention candidate and prototype products, upon receipt of a V/PDR issued by NIAID. At the direction of the Project Officer and the Contracting Officer, produce pilot lots of promising vaccine/prevention candidates appropriate for Phase I and Phase II human clinical trials. Specifically, the Contractor shall: A. Develop, produce, and characterize test lots of specific candidate products. (Such products may incorporate multiple components, e.g., geographic variants of HIV, various HIV gene products, immunodulatory cytokines or the corresponding genes) B. Optimize expression in systems suitable for vaccine production. C. Formulate (including adjuvant and excipients), vial, label, store and ship test lots of candidate products, as directed by the Project Officer. D. Test candidate products for identity, stability, toxicity and for comparative immunogenicity (both cellular and humoral) in small animals and, if requested, in non-human primates. [NOTE #2 TO OFFEROR: The number and types of products to be developed under Activity 1 A.-D. cannot be specified at this time. The Offeror should describe in some detail experience with the development/optimization of a specific vaccine, preferably a biologic product, regardless of the applicability of that particular product to an HIV vaccine. Documentation of available equipment and access to an AAALAC-accredited (or equivalent) animal facility and the capacity for testing the safety and immunogenicity of products should be included. The intent of this description is to demonstrate the capabilities and problem-solving experience of the Offeror during early developmental phases.] E. Consult and coordinate with the product developer(s), if the product was not developed in prior activities under this Master Contract. F. Develop detailed production plan and budgets for manufacture of pilot lots of candidate vaccine/prevention products, prior to undertaking cGMP production. G. Prepare, where applicable, master stocks or cell banks. H. Assure that facilities and all planned procedures are certified by the FDA prior to cGMP production. I. Produce and/or procure candidate vaccines (including characterization, testing [general safety, sterility, purity, potency, identity, immunogenicity and other appropriate tests, including reproductive toxicology], formulation [including adjuvanting], vialing, labeling, storing and shipping) for clinical evaluation in human trials. These products shall be prepared in cGMP facilities and by methods that meet FDA standards for products appropriate for human clinical trials as described in the Code of Federal Regulations, Title 21, Chapter I, Parts 58, 210 & 211, and 600-640 [April 1994] and the Guidelines on Sterile Drug Products Produced by Aseptic Processing [June 1987]. [NOTE #3 TO OFFEROR: The research team proposed to fulfill these requirements (E-I) should be experienced in vaccine development and pilot lot production, including filling, labeling, storing and shipping of products suitable for testing in human clinical trials. The team should have composite expertise in, but not limited to, the following technologies: lyophilization, tissue culture systems, bacterial and/or viral expression systems, fermentation (including 500-liter fermenters), protein purification, synthetic peptides as vaccines. Appropriate certification of the facilities, including those of any proposed subcontractors, should be included in the proposal.] [NOTE #4 TO OFFEROR: The number and types of products to be produced under Activity 1, pilot lot production, cannot be specified at this time. The Offeror should demonstrate understanding of the approach and document capacity for production and scale-up under cGMP. Therefore, for the purpose of technical evaluation of capabilities, the Offeror is requested to propose a detailed plan for producing pilot lots of each of the following three vaccines: 1) peptide vaccine -- 5,000 doses of a linear 15-mer, conjugated to tetanus toxoid, to be formulated with Freund incomplete adjuvant, at 200 mg of peptide/dose. The Offeror can assume the peptide sequence is established and presents no particular problems in yield, or to subsequent purification. 2) DNA vaccine -- 10,000 doses of a plasmid containing a 2000 bp insert of HIV sequence, at 100 mg/dose The Offeror can assume the vector is pcDNA3 with a CMV promoter, and yields of DNA from laboratory-scale lots are known and present no unusual problems. 3) live recombinant vaccinia -- 20,000 doses of recombinant vaccinia expressing an HIV env gene from one promoter and an HIV gag gene from another, to be delivered at 107 pfu/dose. The Offeror can assume the HIV inserts are stable, and the recombinant vector has shown good growth properties in a variety of standard mammalian cell substrates. For each vaccine, the Offeror should propose production and purification methods, characterization and release tests (safety, sterility, identity, purity and potency), and a timeline for obtaining completion of each pilot lot, with sufficient data generated for IND submission. Potential pitfalls and back-up plans should be included, as well as cost estimates. These three vaccines cover a range of complexity and difficulty which is anticipated to be realistic for HIV vaccines which may be requested under this Contract. Award of this Contract, however, does not commit the Government to approve any of the protocols outlined in the proposal. The Project Officer will make the final determination regarding whether and which pilot lot production projects are actually undertaken.] J. Develop, in consultation with the Project Officer and as appropriate, the Master File, and Investigator's Brochure, appropriate for submission to CBER, FDA for Investigational New Drug Application (IND). [NOTE #5 TO OFFEROR: It is not anticipated that the Master Contractor will hold the IND for any human trials to be conducted. The IND will be held by either the organization that holds proprietary rights to the product, or by the Division of AIDS, NIAID. However, the Master Contractor may be requested to assist Division of AIDS in preparation of submissions to the FDA for Masterfile and IND submission. For this proposal, the Offeror should provide evidence of previous experience with submissions to CBER.] ACTIVITY 2. PROVIDE A RAPID RESPONSE MECHANISM FOR FUNDING HIGH PRIORITY, TARGETED DEVELOPMENTAL RESEARCH The Master Contractor shall competitively solicit and award subcontracts to accomplish work described in Vaccine/Prevention Development Requirements (V/PDRs) developed by NIAID. Specifically, the Master Contractor shall: A. Prepare, for the approval of the Project Officer, a Solicitation for Proposal (SFP) request based on the V/PDR. The SFP shall be released no later than 30 days after receipt of the approved V/PDR from the NIAID. Offerors shall be given at least 60 calendar days to respond to the Solicitation. The Solicitation shall require that Offerors: 1) propose a technical plan, detailing availability of facilities, to accomplish the intent of the V/PDR; 2) document and specify the experience of levels of effort of proposed personnel to accomplish the work; 3) propose a time frame, with specific objectives and milestones, for accomplishing the intent of the V/PDR; 4) specify and justify a detailed budget; 5) be bound by the same terms as the Government to respect the privacy and confidentiality of human volunteers, to human subject, animal welfare, inclusion of women and minorities as human subjects in research involving human subjects, and conflict of interest. 6) acknowledge support from the Government contract in all abstracts, presentations, and publications; 7) submit quarterly progress reports, if awarded a subcontract. [NOTE #6 TO OFFEROR: V/PDRs are anticipated in a wide, but not unlimited, range of activities for the evaluation of vaccines, primarily that are not generated under Activity 1. In order to understand the technical content of the V/PDR and thus to assemble a competent review panel, the Offeror, should demonstrate in the proposal, access to expertise in the following areas: reagents (e.g. -- new cell lines, monoclonal antibodies, expression systems), improved animal models (development, validation, production), virus challenge stocks for use in animal evaluations, virological or immunological assay development (improvement, refinement) and standardization (also those with high throughput data generation), adjuvant development, protein structure determination, testing (toxicology, safety, efficacy) in small animals and/or primates. "Access" in this context may be supplied through consultants. The 30-day period specified for release of the SFP allows for draft revisions in consultation with the Project Officer, Contracting Officer, and the Master Contractor. The Offeror can assume that four SFPs will be issued each year requiring reviews. For the purposes of this proposal, the Offeror should assume that one V/PDR will be issued in each of the following areas: (1) measurement of HIV virus load in tissue samples; (2) construction and certification of cell lines that stably express novel co-receptors; (3) preparation of monoclonal antibodies to macaque lymphocyte surface antigens; (4) development of transgenic rodents that are more susceptible to HIV pathogenesis on the basis of a novel co-receptor. The Offeror should indicate how it would identify competent reviewers to evaluate proposals in response to each SFP that the Master Contractor would issue, and outline a plan for conducting the review.] B. Coordinate with the Contracting Officer, NIAID, and with the Scientific Review Program of the Division of Extramural Activities, NIAID, to evaluate the technical merit and feasibility of all proposals. Review of the proposals will occur no later than 30 days after the receipt deadline. [NOTE #7 TO OFFEROR: For purposes of this proposal, expect that four V/PDRs will be issued per year under Activity 2, and that two of them will generate four proposals, and two will generate ten proposals; assume that a total of six subcontracts, averaging three years in length, will be awarded each year. The Offeror should propose an appropriate staff for this activity and activity 3 below, for awarding and monitoring subcontracts.] C. Within 15 working days of review of proposals, the Master Contractor shall prepare a technical evaluation report, describing the strengths and weaknesses of each proposal, their costs, and a Source Selection Plan (SSP) (a prioritized listing) of proposals and shall include a summary of the technical merit, strengths and weaknesses of each proposal, which will be submitted to the Project Officer and the Contracting Officer. The number of subcontracts to be awarded (from each SFP) will be determined by the Project Officer, depending on the number and quality of proposals received, and on the availability of federal funds. ACTIVITY 3. NEGOTIATE, IMPLEMENT AND ADMINISTER SUBCONTRACTS The Master Contractor is responsible for appropriate scientific management, administration, and financial oversight of all subcontracts awarded. Specifically, and upon approval of the SSP, the Master Contractor shall: A. perform a detailed cost analysis of the cost and pricing data/proposal and submit the analysis and the cost and pricing data to the Contracting Officer for review and approval prior to the negotiation/award of any subcontract; B. negotiate budgets and technical issues with selected subcontractors; obtain and submit certified cost and pricing data, including a certificate of current cost and pricing data from the potential subcontractors, if appropriate according to the Federal Acquisition Regulations (FAR). The cost and pricing data must fully support and document the proposed costs; C. document the final negotiated costs for each subcontract in a Negotiation Memorandum in accordance with HHSAR 315.672 and provide a copy to the NIAID Contracting Officer along with a copy of each subcontract proposal and proposed/draft subcontract agreement (the Contracting Officer will review the Negotiation Memorandum and proposed subcontract agreement for approval/disapproval of each subcontract); D. require subcontractors to submit invoices for reimbursement of costs incurred on at least a bimonthly basis; E. receive, compile, analyze and evaluate data or progress, on a quarterly basis, achieved toward the goals and objectives for which each of the individual subcontracts was awarded. Original progress reports from the subcontracts are to be provided to the Project Officer within one week of receipt; and, F. submit Excel (or equivalent) spreadsheets on a quarterly basis which document their own and subcontractor expenditures by V/PDR and by cost category. 4. OTHER ACTIVITIES: A. Meet with Project Officer The Master Contractor will closely coordinate work with the Project Officer. Regular meetings will be scheduled at least bimonthly in the Rockville/Bethesda area and/or by conference call. B. Manage and account for intellectual property rights that pre- exist or may develop through the activities of the Master Contractor, including maintenance of security of confidential and/or proprietary data. C. Provide facilities and resources: 1. to receive, store and manipulate biohazardous materials (Biosafety Level 2 and 3 Containment) and maintain their viability. The facilities must provide aseptic and/or sterile conditions as appropriate. 2. to provide for controlled storage of samples at appropriate temperatures. (room temperature through -90C.) 3. to provide protective garments, equipment and sufficient monitoring to assure safe handling of potentially hazardous materials, including radioactive materials 4. to conduct work under this contract in accordance with all applicable and current Federal, state, and local laws, codes, ordinances and regulations, (also refer to the PHS Safety and Health provisions) D. Obtain clearance for publication. The Master Contractor shall provide advance copies of draft manuscripts (including abstracts and public presentations) resulting from this Contract, as well subcontracts, to the Project Officer and obtain clearance in writing before submitting for publication or presentation. The Master Contractor, and its subcontractors shall be bound by the same terms as the Government to respect the confidential nature of information provided by the preclinical trial investigators and the vaccine product developers. Support from the Government contract must be acknowledged in all abstracts, presentations, and publications. E. Ensure an orderly transition to a successor Contractor. By the end of the sixth year of this Contract, the Contractor shall refine and implement an orderly transition of data and specimens to a successor Contractor or to the Government, subject to Project Officer direction, and shall deliver, if requested by the Project Officer and by the completion data of the Contract, the following items: original data, reagents, stored specimens (and any necessary information related thereto), Government-owned equipment and property, and complete information and history on each subcontract. [NOTE #8 TO OFFEROR: Submit a draft transition plan with the Technical Proposal.] *************************************************************** ATTACHMENT B July 9, 1997 PROPOSAL EVALUATION CRITERIA 1. GENERAL The technical proposal will receive paramount consideration in the selection of the Contractor for this acquisition. In the event that the technical evaluation reveals that two or more Offerors are approximately equal in technical ability, then cost may become a significant factor in determining an award. In any event, the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered. The evaluation will be based on the documented capabilities of the prospective Contractors 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 requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Listed below are mandatory qualification criteria and technical evaluation criteria. The mandatory qualification criteria establishes conditions that MUST be met, at the time of receipt of Best and Final Offers (BAFO) by the Contracting Officer, in order for your proposal to be considered any further for award. The technical evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Proposals will be judged solely on the written material provided by the Offerors. 2. MANDATORY QUALIFICATION CRITERIA The following mandatory qualification criteria establish conditions that MUST be met, by the time of submission of the Best and Final Offer, in order for the proposal to be considered for award: A. The Offeror must provide documentation that they meet the requirements listed in the Code of Federal Regulations (Number 21, April 1, 1994) for an establishment engaged in the preparation of vaccines licensed for human use by the Center for Biologics Evaluation and Research (CBER). B. The Offeror must have access to biosafety level 2/3 facilities of sufficient capacity for all laboratory procedures and assays employing live HIV, SIV, or SHIV isolates. C. The Offeror must document access to an AAALAC-accredited (or equivalent) animal facility and the capacity for testing the safety and immunogenicity of manufactured products. 3. TECHNICAL EVALUATION CRITERIA WEIGHT A. Technical Approach and Management Plan 50 POINTS Adequacy of overall plans to address and coordinate all items in the Work Statement, including demonstration of thorough awareness and overall understanding of the specific activities to be performed and the approach to accomplish the activities successfully. 1. Vaccine Development and Production (Activity 1) Proposed approach for process development and pilot lot production of vaccine/prevention candidates (also refer to Note 4). (30 Points) 2. Proposed approach for responding rapidly to high priority, targeted developmental research requirements, including the solicitation, review functions (in accordance with NIH/DHHS extramural policies/ guidelines*), negotiation, award, and monitoring of subcontracts(administrative/financial) (Activity 2 & Activity 3) (20 Points) B. Personnel Experience, Qualifications and 40 POINTS Staffing Plan 1. Research personnel Documented expertise and proficiency of the professional and technical staff in vaccine development and production of pilot lots, including expertise in preparing necessary documentation for CBER, FDA for Investigational New Drug review. 2. Administrative personnel Documented relevant experience in coordinating, tracking and reporting on multiple and complex projects/subcontracts and administrative and financial monitoring. 3. Staffing Plan Adequacy of the staffing plan for the conduct of the of professional and technical staff. C. Facilities and Resources 10 POINTS Availability and adequacy of facilities, equipment and resources necessary to accomplish the work described in the Work Statement. TOTAL POINTS: 100 POINTS * DHHS/NIH guidelines will be attached to the RFP when issued _______________________________ 1(under Task activity 2 as well as by subcontracts included in the original proposal for conduct of activities 1-3.)