RFP No. NIH-NIAID-DMID-98-17 Title: NIAID MALARIA RESEARCH AND REFERENCE REAGENT REPOSITORY Issued by: Judith Rubinstein Contract Specialist NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard (MSC 7610) Rockville, Maryland 20892-7610 DATE ISSUED: OCTOBER 22, 1997 PROPOSAL DATE DUE: JANUARY 23, 1998, 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-DMID-98-17) for NIAID Malaria Research and Reference Reagent Repository. The Government anticipates the award of one (1), seven (7) year, cost- reimbursement, completion type contract as a result of this RFP. The documents included with this electronic RFP package are as follows: STREAMLINED RFP Attachments: A. Background and Work Statement, dated September 10, 1997 B. Deliverables and Reporting Requirements, dated September 10, 1997 C. Evaluation Factors for Award, dated September 10, 1997 D. Specific RFP Instructions and Provisions (includes the Technical Proposal Format, and the proposal intent form) E. Applicable RFP References In addition to the directory in which you are currently located (i.e., the streamlined RFP), there are five (5) other Subdirectories in the Gopher System (under C, RFP References) which must be retrieved, in whole or in part, in order to submit a proposal (the applicable portions are explained in Attachment E). The Subdirectories are: STANDARD RFP INSTRUCTIONS AND PROVISIONS OPTIONAL RFP INSTRUCTIONS AND PROVISIONS FORMS, FORMATS AND ATTACHMENTS REPRESENTATIONS AND CERTIFICATIONS SAMPLE CONTRACT FORMAT-GENERAL If you are unable to download any of the applicable documents, please contact Judith Rubinstein, Contract Specialist, by phone/fax/Internet (see contact 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 from all offerors which comprise the Competitive Range. The Business and Technical proposals must be separate portions in the proposal package. 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 the supporting documentation must be submitted with the proposal. See Standard RFP Instructions and Provisions, in the subdirectory C, RFP References, for more detail on the Business Proposal requirements. It is recommended that any proposed annual increase in costs for inflation be limited to no more than 3% of total costs per year, which is also the maximum currently allowed by the NIH for research projects. The format and content of your Technical Proposal is detailed in the "Technical Proposal Table of Contents", in Attachment D. SEE SECTION D. 5 FOR INFORMATION ON PAGE LIMITATIONS. Your attention is further directed to the "Proposal Intent" form contained in Attachment D, Item 6. Please complete this form and return it to this office on or before DECEMBER 22, 1997. This will allow us to expedite preparations for the peer review of proposals. The original and nineteen (19) 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 23, 1997, at 4:00 p.m. local time at the address listed in Attachment D, item 4. If you have any additional questions regarding this RFP, please contact Ms. Rubinstein at the Internet electronic mail address jr205j@nih.gov, by phone at 301/496-2509, or by fax at 301/480- 5253. Collect calls will not be accepted. Amendments to the RFP will be posted on the NIH homepage. If you wish to be notified of any amendments, notify Miss Rubinstein. Sincerely, /s/ Rosemary McCabe Hamill Chief, Infectious and Allergic Diseases Contract Section Contract Management Branch National Institute of Allergy and Infectious Diseases Attachments: A - E ******************************************************************** ********************************** RFP-NIH-NIAID-DMID-98-17 STREAMLINED RFP ATTACHMENT A ---------------------------- INTRODUCTION The purpose of this contract is to support the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Malaria Research and Reference Reagent Repository (Malaria Reagent Repository), in achieving its goal of providing malaria-related reagents and resources to the scientific community. Malaria is an infectious disease caused by protozoan parasites of Plasmodium spp. (primarily P. falciparum and P. vivax). Malaria claims an estimated 2 to 3 million lives annually, and accounts for untold morbidity in the approximately 300 to 500 million people infected annually. There are no approved vaccines for malaria. Currently available drugs are losing their utility as a result of the spread of drug-resistant parasites. Research is needed to develop new tools to control this deadly disease. An important rate- limiting step in malaria research is the identification and distribution of state-of-the-art reagents and technology. The need for improved access to parasite, host and vector reagents was highlighted in recommendations of the report from the International Conference on Malaria in Africa, held in Dakar, Senegal, in January, 1997. To address this need, the NIAID will establish a Malaria Reagent Repository. This repository will acquire malaria-related research reagents, by donation and/or procurement, ensure standardization, characterization and documentation of reference reagents; and provide these materials at minimal cost to qualified investigators throughout the world. Additionally, the repository will catalog and collect information about malaria reagents and disseminate this information through print, electronic media, and workshops; enhance technology transfer through development and publication of methods; facilitate commercial development of reagents through proactive communication with biotechnology and pharmaceutical companies and other concerned organizations such as the World Health Organization. It is anticipated that the majority of acquired reagents will be donated; all other "acquisition" of reagents may be accomplished through purchase and/or services. This includes purchase orders/subcontracts for producing reagents, maintaining vector colonies, expansion of reagents (renewable reagents provided to the repository in small amounts that will require expansion), and quality control analyses of reagents. Contributors and users will include scientists from the NIH, academic and non-profit institutions, and from industry. An interim repository was established in 1997, under contract N01-AI- 75331 to Braton Biotech, Inc., to initiate the process of acquiring, expanding and distributing malaria reagents. The completion date of that contract is September 29, 1998. Because this is a relatively new program, the number of reagent samples to be stored in the Malaria Reagent Repository is anticipated to expand dramatically during the initial years of this contract. WORK STATEMENT Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the work described below. (NOTE 1 TO THE OFFEROR: THE PRIME CONTRACTOR IS RESPONSIBLE FOR ALL WORK PERFORMED UNDER THIS CONTRACT. WHILE SUBCONTRACTING IS PERMITTED, NIH ENVISIONS THAT THE REAGENT ACQUISITION EFFORTS, STORAGE AND DISTRIBUTION OF REAGENTS, AND THE MANAGEMENT OF THE REAGENT INVENTORY DESCRIBED UNDER WORK STATEMENT WILL BE PERFORMED BY THE PRIME CONTRACTOR; REAGENT PRODUCTION, AND QUALITY CONTROL OF REAGENTS MAY BE SUBCONTRACTED OUT, AS WELL AS OTHER ACTIVITIES. (NOTE 2 TO THE OFFEROR: OFFERORS INTERESTED IN RESPONDING TO THIS RFP ARE ENCOURAGED TO REQUEST A COPY OF THE 1996 "NIH AIDS RESEARCH AND REFERENCE REAGENT PROGRAM CATALOG". THE CATALOG INCLUDES EXAMPLES OF FORMS FOR: 1) REGISTRATION FOR RECEIVING REAGENTS; 2) INDEMNIFICATION AGREEMENTS; 3) ACKNOWLEDGMENT OF COMMERCIAL RIGHTS; AND 4) REQUEST FOR ORDERING REAGENTS. THE CATALOG IS AVAILABLE ON- LINE AT http://www.aidsreagent.org, OR REQUESTS FOR HARD COPY OF THE CATALOG MAY BE ADDRESSED TO: CONTRACTING OFFICER, CMB, NIAID, SOLAR BUILDING, ROOM 3C07, 6003 EXECUTIVE BOULEVARD (MSC 7610), ROCKVILLE, MARYLAND 20892-7610. AN EXAMPLE OF ON-LINE ORDERING PROCEDURES CURRENTLY USED BY AN NIAID CONTRACTOR IS AVAILABLE THROUGH THE TUBERCULOSIS RESEARCH MATERIALS REPOSITORY AT http://www.cvmbs.colostate.edu/microbiology/tb/top.htm). Specifically, the Contractor shall: 1. Establish an Ongoing Advisory Committee of Malaria Experts: The Contractor shall establish, within the first six months following award, a committee composed of scientists knowledgeable in a broad range of malaria research areas, including but not limited to, molecular biology, immunology, drug and vaccine development, clinical studies and vector biology, which will provide advice to the Contractor and to NIAID on the needs of the scientific community for research reagents, and on prioritization of acquisitions. Membership of the advisory committee will be determined by the Contractor, after approval by the Project Officer, and the Contractor will be responsible for the organization of regular meetings of the committee. (NOTE 3 TO THE OFFEROR: AS AN INDICATION OF THE OFFEROR'S KNOWLEDGE OF THE FIELD, A DESCRIPTION OF THE AREAS OF EXPERTISE THAT WOULD BE COVERED BY MEMBERS OF THE ADVISORY COMMITTEE MUST BE INCLUDED WITH THE TECHNICAL PROPOSAL. INDIVIDUALS WHO MIGHT SERVE ON THIS COMMITTEE SHOULD NOT BE NAMED, HOWEVER.) The advisory committee will meet semiannually in the Bethesda, MD area; one of these meetings will occur in conjunction with the annual spring meeting of the NIAID International Centers for Tropical Disease Research. (NOTE 4 TO THE OFFEROR: TRAVEL AND PER DIEM FOR ADVISORY COMMITTEE MEMBERS AND APPROPRIATE REPRESENTATIVES FROM THE CONTRACTOR MUST BE INCLUDED IN THE COST ESTIMATE.) 2. Acquire, and Produce/Expand (as necessary) Reagents: The Contractor shall acquire reagents after receiving approval by the Project Officer. The Contractor shall actively and independently identify novel reagents that are not readily available, prioritize their acquisition based on the need of the malaria research community as reflected by recommendations of the advisory committee, availability and cost. The acquisition of new reagents, either by purchase or donation, shall be an ongoing endeavor throughout the term of the contract. The Contractor shall ensure that Reagent donors assign their reagent to a release category designating whether it may be used for commercial purposes, and if so, under what conditions. The Contractor shall keep proper documentation on file supporting: (1) the price reasonableness for all acquisitions; (2) the criteria for evaluation and selection of all sources for reagent acquisitions; and, (3) the procurement of appropriate technology transfer agreements. The handling and transportation of all reagents and Government-owned property under this Contract shall be in accordance with all applicable local, state and Federal regulations including safety controls and standards. (See Attachment A.2 to the Work Statement for details on health and safety standards.) The Contractor shall produce reagents as needed after receiving approval by Project Officer. Production of reagents includes expansion of renewable reagents, including cell lines, parasites and recombinant DNA. For the purposes of this contract, reagents may include but are not limited to the following biological materials: - Plasmodium parasites of various human and rodent species and strains, including cloned and uncloned isolates as well as genetically manipulated parasites; - Plasmodium DNA libraries, DNA clones, expression vectors, and oligonucleotide probes; - Human body fluids and cells, including those obtained from individuals living in malaria endemic regions; - Proteins and synthetic peptides; - Polyclonal and monoclonal antibodies, or hybridoma cell lines; - Specimens or DNA from principal malaria vector species, including the Anopheles gambiae complex. The list provided above is for illustrative purposes and is not comprehensive. (NOTE 5 TO THE OFFEROR: THE SELECTED CONTRACTOR WILL CONTINUE TO IDENTIFY AND RECOMMEND NEW SOURCES OF REAGENTS THROUGHOUT THE TERM OF THIS CONTRACT. A DETAILED PLAN FOR IDENTIFYING, PRIORITIZING AND ACQUIRING REAGENTS IN EACH OF THE GENERAL CATEGORIES LISTED ABOVE FROM DOMESTIC AND INTERNATIONAL SOURCES, AS WELL AS THE OFFEROR'S KNOWLEDGE, EXPERIENCE AND QUALIFICATIONS, MUST BE SUBMITTED AS PART OF THE TECHNICAL PROPOSAL. BECAUSE THIS IS A RELATIVELY NEW EFFORT, IT MAY THEREFORE BE DIFFICULT TO PREDICT OR IDENTIFY IN ADVANCE THE TYPES AND AMOUNTS OF REAGENTS, AND THE NUMBERS OF EXPANSIONS, QUALITY CONTROL ANALYSES OF REAGENTS, ETC., THAT WILL BE REQUIRED DURING THIS CONTRACT TERM. OFFERORS ARE DIRECTED TO USE THE FOLLOWING NORMALIZED COSTS IN PROPOSING REAGENT ACQUISITION COSTS: $300,000 IN YEAR 1; $400,000 IN YEAR 2; $500,000 IN YEAR 3; $515,000 IN YEAR 4; $530,000 IN YEAR 5; $546,000 IN YEAR 6; AND, $562,000 IN YEAR 7. IN ADDITION, THE OFFEROR SHOULD ASSUME THAT SUPPORT OF THE MAINTENANCE OF ANY MOSQUITO COLONIES UNDER THIS CONTRACT WILL NOT BEGIN UNTIL YEAR 3 OF THE CONTRACT. FOR ANY PROPOSED SUBCONTRACTOR (OR SUBCONTRACTORS) TO PRODUCE/EXPAND REAGENTS, SIMILAR TECHNICAL INFORMATION SHALL BE PROVIDED AS PART OF THE PROPOSAL AS THAT REQUIRED FROM THE PRIME CONTRACTOR, I.E., TECHNICAL APPROACH, METHODS, KNOWLEDGE, EXPERIENCE, PERSONNEL QUALIFICATIONS, FACILITIES, RESOURCES, ETC. COST DETAILS SHALL ALSO BE PROVIDED BY THE SUBCONTRACTOR AND SUBMITTED WITH THE BUSINESS PROPOSAL.) (NOTE 6 TO THE OFFEROR: IF THE OFFEROR IS A COMMERCIAL FIRM, THE OFFEROR MUST ADDRESS IN DETAIL IN THE TECHNICAL PROPOSAL HOW POTENTIAL CONFLICTS OF INTEREST WILL BE RESOLVED BETWEEN COMMERCIAL ACQUISITION AND DISTRIBUTION OF REAGENTS AND MALARIA REAGENT REPOSITORY ACQUISITION AND DISTRIBUTION OF SIMILAR REAGENTS. FOR EXAMPLE, THE OFFEROR MUST ADDRESS HOW THE OFFEROR WILL IDENTIFY AND OBTAIN POTENTIALLY COMMERCIALLY VALUABLE REAGENTS FOR MALARIA REAGENT REPOSITORY DISTRIBUTION INSTEAD OF FOR THE OFFEROR'S COMMERCIAL USE.) 3. Quality Control of Reagents: The Contractor shall provide a plan describing the methods which will be utilized for evaluation of the quality and activity of reagents, and the facilities available for doing so. The number and types of assays to be performed will require the prior approval by the Project Officer. It is anticipated that those reagents to be made available as reference standards will require more extensive characterization than others. The Contractor shall perform as needed assays including, but not limited to, the following: a. For parasites - sterility, culture viability, gametocyte production, DNA fingerprinting, in vivo infectivity (rodent species), drug sensitivity (human species) b. For nucleic acids - concentration, purity, restriction enzyme analysis, size distribution (genomic DNA) c. For human materials - sterility, presence of blood- borne pathogens, including HIV and hepatitis B, immunoblotting (human sera/plasma) d. For proteins/peptides - sterility, stability, protein concentration, carbohydrate and DNA content, endotoxin content, pH and conductance, identity and purity (proteins: PAGE analysis; peptides: HPLC, mass spectroscopy, amino acid analysis, N- terminal sequencing), antigenicity (antibody reactivity by immunoblotting and ELISA for vaccine antigens) e. For antibodies - sterility, stability, protein concentration, endotoxin level, immunologic activity (immunoblotting, ELISA) f. For cell lines - viability, sterility, contamination with adventitious infectious agents including mycoplasma, identity testing (e.g. specificity of antigen reactivity) g. For mosquito vectors - verification of species or strain identity by entomological markers, chromosomal markers and/or PCR; malaria infection status of wild-caught specimens (NOTE 7 TO THE OFFEROR: THE OFFEROR SHALL SUBMIT, WITH THE TECHNICAL PROPOSAL, DOCUMENTATION DEMONSTRATING: KNOWLEDGE, EXPERIENCE AND COMPETENCE IN THE QUALITY CONTROL ANALYSES OF THE ABOVE-MENTIONED REAGENTS. FOR ANY PROPOSED SUBCONTRACTOR (OR SUBCONTRACTORS) SIMILAR TECHNICAL INFORMATION SHALL BE PROVIDED WITHIN THE PROPOSAL AS THAT REQUIRED FROM THE PRIME CONTRACTOR, I.E., TECHNICAL APPROACH, METHODS, KNOWLEDGE, EXPERIENCE, PERSONNEL QUALIFICATIONS, FACILITIES, RESOURCES, ETC. COST DETAILS SHALL ALSO BE PROVIDED BY THE SUBCONTRACTOR AND SUBMITTED WITH THE BUSINESS PROPOSAL.) 4. Provide Storage and Processing Facilities and Resources: The Contractor shall provide facilities and equipment to receive and store reagents, including those that are potentially hazardous, and maintain their activity or viability. The facilities must provide aseptic and/or sterile conditions, as well as biosafety containment, as appropriate. Storage facilities for all reagents must meet local, state and federal regulations. a. Provide suitable air-conditioned floor space sufficient for the installation, storage and maintenance of equipment and all items necessary for the Malaria Reagent Repository and distribution operation. b. Provide, maintain and operate facilities for the storage of bulk and packaged reagents at 2 to 8 degrees C., at -10 to -20 degrees C., at -70 to -90 degrees C., liquid nitrogen conditions; and all other items necessary for the Malaria Reagent Repository. The Contractor shall supply uninterruptible power to accommodate the refrigerators/freezers and other equipment. In addition, the Contractor shall house the units in an air-conditioned facility with the capacity to maintain a room temperature of 66 degrees to 72 degrees F, when all equipment is operational. Freezers shall be connected to a central alarm system monitored 24 hours per day. Emergency stand-by refrigerators and freezers shall be available in case of mechanical failure of storage space. The facility shall have an auxiliary electric generator capable of operating all storage equipment for at least 48 hours for back-up in the event of utility company power failure. Back-up generator shall be tested at least monthly. (NOTE 8 TO THE OFFEROR: FOR PURPOSES OF PREPARING A COST ESTIMATE, THE GOVERNMENT ESTIMATES THAT AT THE TIME OF AWARD THE MALARIA REAGENT REPOSITORY WILL CONSIST OF APPROXIMATELY 100,000 SAMPLES, WITH STORAGE REQUIREMENTS AS SHOWN IN ATTACHMENT A.1, AND THAT REAGENTS WILL BE ACCRUED AT A RATE OF APPROXIMATELY 30 RECEIVED MONTHLY FROM DOMESTIC AND INTERNATIONAL SUPPLIERS DURING EACH YEAR OF THIS CONTRACT. THE OFFEROR SHOULD ANTICIPATE A 15-20% INCREASE ANNUALLY IN THE NUMBER OF REAGENT SAMPLES STORED IN THE MALARIA REAGENT REPOSITORY TO AN ESTIMATED TOTAL OF 250,000 SAMPLES DURING THE TERM OF THE CONTRACT. THE OFFEROR SHALL PROVIDE IN THE TECHNICAL PROPOSAL A PLAN FOR STORAGE AND PROCESSING OF REAGENTS, A FLOOR PLAN OF THE PROPOSED FACILITY, AND SHALL LIST EQUIPMENT AND RESOURCES DEDICATED TO THE PROJECT.) c. Assure safe handling of toxic, radioactive, and potentially hazardous materials. Specifically, the Contractor shall comply with all applicable health and safety regulations while conducting the work set forth herein and follow the standards listed under Attachment A.2 to the Work Statement. (NOTE 9 TO THE OFFEROR: THE OFFEROR MUST INCLUDE IN THE TECHNICAL PROPOSAL: (A) EVIDENCE OF ADEQUATE TRAINING OF PERSONNEL HANDLING INFECTIOUS AGENTS INCLUDING MALARIA PARASITES, HIV, AND HEPATITIS B; (B) METHODS FOR DEALING WITH ACCIDENTS, AND MONITORING FOR INFECTION; AND (C) EVIDENCE FOR THE ABILITY TO IDENTIFY SAFETY STANDARDS APPLICABLE TO PARTICULAR REAGENTS LIKELY TO BE ACQUIRED.) d. Provide facilities to measure or dispense solid and liquid reagents into aliquots and labeled vials. Because of the nature of some of the reagents, facilities should be available for the appropriate handling of infectious agents and for hazardous materials. e. Maintain 24 hour security that provides a secure environment for employees and materials within the facility. f. Provide an automated temperature monitoring system monitored 24 hours a day, and measures to ensure that necessary personnel are notified in the event of a refrigerator/freezer malfunction. The Contractor shall be responsible for promptly repairing malfunctioning equipment or for arranging for the prompt repair. (NOTE 10 TO THE OFFEROR: THE OFFEROR SHALL DESCRIBE AN ACTION PLAN FOR IDENTIFYING MALFUNCTION, A PROCESS TO TEST CAPABILITY, AND A PROCESS FOR TRANSFER OF REAGENTS FROM MALFUNCTIONING REFRIGERATORS/FREEZERS.) 5. Obtain Approvals and Assurances Necessary to Distribute Reagents: a. Distribute reagents to approved investigators and institutions in accordance with operating procedures approved by the Project Officer. The Contractor shall consult with the Project Officer in questionable cases. b. As requested by the Project Officer, develop standard correspondence for acceptance and distribution of reagents by the repository. c. Distribute materials only to institutions which, in addition to other assurances, execute agreements to comply with the following: (1) All relevant standards for safe handling and use of the research reagents. (2) Agreement not to use the reagents in any unauthorized or unsafe way, including compliance with Protection of Human Subjects, Title 45, Code of Federal Regulations, Part 26; and Public Health Service Policy on Human Care and Use of Laboratory Animals, implementing 1996 revisions of the Guide for the Care and Use of Laboratory Animals. (3) Agreement that if commercial use is planned or commercial discoveries result through the use of a reagent, such use will occur only according to the donor-assigned release category for the reagent. (4) Agreement by reagent recipient investigators and their institutions to indemnify and hold harmless the United States, its Contractor, their suppliers, and contributors of reagents from any claims, costs, damages, or expenses. The Contractor shall secure and update/modify these agreements as required by the Project Officer. (5) State-Institution Compliance Agreement by reagent recipient investigators at public institutions that are unable to accept the terms of the Standard Indemnification Agreement stated above in c(4), the recipient institution agrees to be responsible for any claims, costs or expenses that may arise from the possession and use of reagents to the extent permitted under the law of the State. (6) Where applicable, necessary government/institutional clearance for receipt of live mosquito vectors. (NOTE 11 TO THE OFFEROR: SAMPLES OF CURRENT INDEMNIFICATION AGREEMENTS FOR BIOHAZARDOUS REAGENTS CURRENTLY USED BY NIAID ARE INCLUDED IN THE 1996 "NIH AIDS RESEARCH AND REFERENCE REAGENT PROGRAM CATALOG". ) 6. Ship and Receive Reagents: a. For reagent distribution, ensure assumption of shipping costs by the recipient whenever possible. Assumption of shipping costs for reagent distribution by the Contractor will require prior approval by the Project Officer. The Contractor shall assume shipping costs for reagent acquisition. b. Ship available reagents within 7 working days from the date requests are received, using the most economical method of transport appropriate for maintaining stability/viability of the reagent. c. Develop and maintain an electronic bulletin board that will allow reagent users and donors to interact directly. (NOTE 12 TO THE OFFEROR: FOR THE PURPOSES OF PREPARING A COST ESTIMATE, THE OFFEROR IS DIRECTED TO ASSUME THAT APPROXIMATELY 300 REAGENTS WILL BE SHIPPED MONTHLY FROM THE MALARIA REAGENT REPOSITORY, INVOLVING APPROXIMATELY 50 SHIPMENTS, OF WHICH 50% MAY BE TO OVERSEAS LOCATIONS IN INDUSTRIALIZED AND DEVELOPING COUNTRIES. THE OFFEROR SHOULD ANTICIPATE APPROXIMATELY 30 INCOMING SHIPMENTS OF REAGENTS PER MONTH, WITH 50 TO 75% COMING FROM OVERSEAS. AT THIS TIME IT IS NOT ANTICIPATED THAT RECIPIENTS WILL BE CHARGED FOR ANY REAGENT COSTS EXCEPT SHIPPING. ANY CHANGE IN THIS POLICY WILL BE MADE AT THE DISCRETION OF THE PROJECT OFFICER.) d. Provide, packaged with outgoing reagents, data sheets containing technical information, references and citations of the relevant information for safe handling and use of the reagents, and applicable safety standards. Specific safety standards for the safe handling and use of specific reagents in compliance with the guidelines/regulations shall be specified by the Contractor. e. Provide for safe packaging, shipping and distribution of reagents approved by the Project Officer to eligible research investigators in the U.S. and abroad so that such shipments are coordinated for timely receipt. f. Obtain the appropriate licenses and permits required by local, state and Federal authorities for the safe import, storage and distribution of reagents. Additionally, the Contractor shall obtain the appropriate interstate, intrastate and foreign import/export shipping licenses and permits for transporting biohazardous reagents, including live mosquito vectors or their eggs. (NOTE 13 TO THE OFFEROR: THE OFFEROR SHOULD DEMONSTRATE KNOWLEDGE AND EXPERIENCE IN PACKAGING/SHIPPING BIOHAZARDOUS AND ETIOLOGIC AGENTS NATIONALLY AND INTERNATIONALLY. THE OFFEROR SHALL ALSO DEMONSTRATE KNOWLEDGE AND EXPERIENCE IN PROCURING THE APPROPRIATE IMPORT/EXPORT LICENSES AND PERMITS. THE OFFEROR SHALL DESCRIBE: (A) A PLAN FOR PACKAGING AND SHIPPING OF REAGENT REQUESTS, AND RECEIVING INCOMING REAGENTS; AND (B) A LIST OF EQUIPMENT, RESOURCES AND FACILITIES DEDICATED TO THE PROJECT.) g. Provide a plan for how the incoming reagents shall be delivered to the Malaria Reagent Repository in a timely manner, including 24-hour, seven days a week availability of personnel to pick up and store incoming shipments of reagents, as well as maintenance of stability and viability by providing the necessary temperature in transit from the pick-up site to the Malaria Reagent Repository. h. Coordinate all shipments so that viability, biological activity or purity of the reagents will not be adversely affected. Send notification by electronic mail/facsimile/telegram to all foreign investigators to coordinate shipping and receiving of frozen and refrigerated reagents. Advise domestic investigators in the most suitable manner of shipments and arrival dates. Establish a mechanism for being notified by the requester of the date reagents were received and the condition of reagents upon receipt. i. Use shipping containers for reagents which shall comply with current domestic and international transport regulations and pertinent International Air Transport Association/International Civil Aviation Organization Dangerous Goods regulations. The shipping containers must provide a sufficient margin of safety for maintaining appropriate environmental safeguards and desired refrigeration levels for specific products in transit, depending on the mode of transportation employed. j. Implement a mechanism to invoice investigators for reagent distribution fees and shipping charges. The Contractor shall be responsible for collecting contract generated revenues and shipping costs. 7. Disseminate Public Information Concerning Reagent Availability: a. Promote awareness of the Malaria Reagent Repository's services throughout the scientific community using electronic and print media and, as determined by the Project Officer, presentations at scientific meetings, symposia and workshops. These shall include presentations annually at the NIAID International Centers for Tropical Disease Research meeting, to be held in conjunction with the meeting of the advisory committee to be held in the Bethesda, MD. b. Provide HTML copy to publish and periodically update the Malaria Reagent Repository information on the NIAID Home Page on the World Wide Web, including but not limited to the Malaria Reagent Repository catalog, articles on new reagents, protocols, and NIH initiatives. These shall be of quality comparable to the information currently available on the NIAID Home Page. c. Develop and maintain an electronic World Wide Web-based reagent ordering/donating system. Contractor shall seek to have links established from relevant sites on the World Wide Web to the web site describing the repository. (NOTE 14 TO THE OFFEROR: THE OFFEROR MUST DESCRIBE A PLAN TO PROVIDE MALARIA REAGENT REPOSITORY INFORMATION ON THE WORLD WIDE WEB AND DESCRIBE HOW THE OFFEROR WILL KEEP CURRENT WITH THE ADVANCING TECHNOLOGY OF THE WORLD WIDE WEB.) d. With approval of the Project Officer, prepare camera-ready hard copy of a catalog of available reagents. The Government may print these catalogs, or the Project Officer and the Contracting Officer may direct the Contractor to arrange for printing through the contract. The catalog shall be prepared annually with a publication date of January of each year. The first catalog shall be published in June 1999. It is anticipated that approximately 1,000 copies will be printed and distributed annually. The Contractor shall distribute the catalogs to the scientific community using a mailing list to be provided by NIAID, and to others on request. (NOTE 15 TO THE OFFEROR: FOR THE PURPOSES OF PREPARING A COST ESTIMATE, ASSUME THAT THE CONTRACTOR WILL PAY FOR PRINTING AND DISTRIBUTING THE CATALOGS.) e. Publish descriptions of the Malaria Reagent Repository in relevant scientific journals as determined by the Project Officer. (NOTE 16 TO THE OFFEROR: THE OFFEROR SHALL INDICATE IN THE TECHNICAL PROPOSAL HOW THE EDITORIAL AND TECHNICAL SUPPORT FOR THE ABOVE PUBLICATIONS WILL BE PROVIDED BY THE CONTRACTOR'S STAFF, OR IF SUCH SERVICES WILL BE ACQUIRED BY A SUBCONTRACT. IF A SUBCONTRACT IS PROPOSED, THE OFFEROR SHALL PROVIDE THE QUALIFICATIONS OF THE SUBCONTRACTOR WITH THE TECHNICAL PROPOSAL, AND THE COSTS IN THE BUSINESS PROPOSAL.) 8. Provide Necessary Malaria Reagent Repository Program Support: a. Support collaborative efforts of the Division of Microbiology and Infectious Diseases, NIAID, to develop/evaluate and expand access to reagents, including but not limited to reference standards and panels of reagents. b. Periodically evaluate services provided by the Malaria Reagent Repository, including the status and use of reagents, and other services provided by the contract. c. Provide other related services within the scope of this contract as may be deemed necessary by the Project Officer. 9. Provide Support for Sponsored Workshops and Training: Under the guidance of the Project Officer, the Contractor shall sponsor workshops and training opportunities relevant to: development of reagents and/or protocols; coordination of the Malaria Reagent Repository and other programs within NIAID's malaria research portfolio; promotion of technology transfer; and promotion of compliance with relevant regulations, including but not limited to handling and shipping of infectious agents, and use of human or animal subjects. The Contractor shall provide support for invited participants, including travel and per diem expenses and honoraria, as directed by the Project Officer. (NOTE 17 TO THE OFFEROR: FOR THE PURPOSES OF PREPARING A COST ESTIMATE, ASSUME TWO, ONE-DAY WORKSHOPS ANNUALLY, FOR 15 INVITEES TO BE HELD IN THE BETHESDA, MD, AREA.) 10. Provide an Inventory and Distribution Database and Management System: Maintain an on-going computerized inventory and distribution database and processing system on an IBM/IBM compatible system which will track and assist in the coordination of the activities under this contract. (NOTE 18 TO THE OFFEROR: THIS CONTRACT SHALL NOT SUPPORT THE PURCHASE OF GENERAL PURPOSE ADP EQUIPMENT. THE OFFEROR MUST PROVIDE A PLAN TO MAINTAIN AND UPGRADE AN INVENTORY AND DISTRIBUTION DATABASE USING AN APPROPRIATE MENU-DRIVEN COMMERCIALLY AVAILABLE RELATIONAL DATABASE MANAGEMENT SYSTEM. THIS SYSTEM SHOULD INCLUDE MODULES TO: TRACK INDIVIDUAL INVESTIGATORS' REAGENT ACQUISITION AND RECEIPT; SUPPORT PRODUCTION OF STANDARD REPORTS, SUCH AS RECEIVING AND SHIPPING; TRACK PUBLICATIONS BY REGISTRANTS ACKNOWLEDGING THE NIAID MALARIA REAGENT REPOSITORY AS A SOURCE OF REAGENTS; AND, SUPPORT SPECIALIZED REPORTS INCLUDING THE REAGENT INVENTORY, INVESTIGATOR AFFILIATIONS AND MAILING LISTS. THE OFFEROR MUST PROPOSE APPROPRIATE COMPUTER HARDWARE AND SOFTWARE FOR THIS REQUIREMENT, AND A PLAN FOR MAINTENANCE, DATA INPUT AND DATA BACK- UP.) a. Keep records for each reagent, including but not limited to the following: the source/donor of the reagent; a description of the reagent; category of reagent (e.g. not of human origin, human derived, biohazardous, donor assigned category for commercial use); lot number; date of receipt; quality control information; storage conditions; solubility of the reagent when appropriate; storage location; restrictions, if any, on disposition and uses; how dispensed and to whom; when the reagent was shipped; and documentation from the recipient that the reagent was received. b. Have the capability to read and generate bar coded labels for 1.8 ml reagent vials in different formats including numeric, alpha numeric and colored bar codes. Software and hardware for maintaining these records shall be provided by the Contractor. c. Ensure protection against the loss of data by the duplication of data base files and programs for storage outside of the Malaria Reagent Repository. The system in its entirety shall be completely documented and capable of being transferred to the Government without interruption. d. Provide for the security and safety of data on the reagents and information related to the evaluation and use of the reagents. All information regarding the evaluation of the reagents shall be proprietary and treated as such. The Project Officer shall be responsible for determining the level of information regarding a particular reagent that will be made available for dissemination and to whom the information will be made available. 11. Meet with the Project Officer: The Contractor's key personnel, including the Principal Investigator, shall meet with the Project Officer at periodic intervals to be scheduled after contract award, to review the project and discuss the work to be performed. It is estimated that a minimum of 4 visits per year will be necessary to 6003 Executive Boulevard, Rockville, MD 20852, to meet with the Project Officer. 12. Ensure an orderly transition of the Malaria Reagent Repository to a successor Contractor: a. The Contractor shall coordinate an orderly and safe transition from the interim Contractor, and an orderly transition to the successor of this contract, including the movement of stored reagent samples, data, and all Government furnished property to a subsequent Contractor or to the Government. The Contractor shall safely and effectively coordinate the transfer of the contents of the reagents maintained by the current NIAID Contractor and begin operation of the Malaria Reagent Repository within 60 calendar days from the award of the new contract. The Contractor, subject to Project Officer approval, shall deliver to the Government or its designee by the completion date of this contract, the following items: 1) preserved reagent samples; 2) data files and program comprising the Malaria Reagent Repository management system; 3) computerized listings of accurate and updated information on reagent inventory, data files, data bases, original data and any necessary information related thereto; 4) labeled and inventoried paper files; and 5) Government owned equipment and property. b. The Contractor shall commence operation in accordance with approved Standard Operating Procedures. (NOTE 19 TO THE OFFEROR: THE OFFEROR SHALL INCLUDE A "TRANSITION" PLAN IN THE TECHNICAL PROPOSAL (AND COSTS IN THE BUSINESS PROPOSAL). IN THE EVENT AN ORGANIZATION OTHER THAN THE CURRENT CONTRACTOR IS SELECTED, THE RECIPIENT OF THIS NEW AWARD WILL WORK WITH THE CURRENT CONTRACTOR TO MOVE THE MALARIA REAGENT REPOSITORY COLLECTION (CURRENTLY LOCATED IN ROCKVILLE, MD), AND ALL GOVERNMENT FURNISHED PROPERTY LISTED UNDER ATTACHMENT A.1. TO THE STATEMENT OF WORK, TO THE NEW SITE. IT IS ESTIMATED THAT THIS TRANSITION WILL BEGIN WITHIN 14 CALENDAR DAYS OF THE AWARD AND WILL BE ACCOMPLISHED NO LATER THAN 30 CALENDAR DAYS FROM THE AWARD OF THE NEW CONTRACT. THEREFORE, THE OFFEROR SHALL PROVIDE, IN THE TECHNICAL PROPOSAL, A TRANSITION PLAN FOR COORDINATING BETWEEN THE INCUMBENT CONTRACTOR AND THE OFFEROR THAT SHALL INCLUDE ALL TASKS ASSOCIATED WITH THIS RELOCATION EFFORT AND THE MANNER OF OPERATIONS BY THE OFFEROR DURING THE TRANSITION PERIOD. INCLUDE ANY PROPOSED TRAINING TIME ASSOCIATED WITH TRANSFER AND OPERATION OF THE CURRENT MALARIA REAGENT MANAGEMENT SYSTEM. INCLUDE ALL COSTS WITH THE BUSINESS PROPOSAL ONLY.) (NOTE 20 TO THE OFFEROR: THE OFFEROR SHOULD FURNISH ITS PROPOSED STANDARD OPERATING PROCEDURES RELATING TO THE CONDUCT OF THIS CONTRACT AS AN ATTACHMENT TO THE TECHNICAL PROPOSAL.) (GENERAL NOTE TO THE OFFEROR: See Attachment D, Item 5 for information on page limitations.) -_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_- _-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_- ATTACHMENT A.1 LIST OF GOVERNMENT FURNISHED PROPERTY 1. Equipment: Dates Purchased 2 -85 C chest freezers with inventory rack system 1997 2 -35 C chest freezers with inventory rack system 1997 1 liquid nitrogen vapor phase freezer with inventory rack system 1997 5 liquid nitrogen dry shippers 1997 2. Computer Software: Windows based inventory database system 3. Reagents: Majority of the approximately 100,000 reagent samples will be stored in 1.0 or 2.0 ml Nunc tube type vials as follows: Storage Temperature Storage Space Number of Samples (degrees Centigrade) (cubic foot) -35 30 80,000 -85 50 15,000 Liquid Nitrogen 5,000 Total 100,000 -_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_- _-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_- ATTACHMENT A.2 SAFETY CONTROLS AND STANDARDS A. In order to provide safety controls for protection to the life and health of employees and other persons; for prevention of damage to all property; and for avoidance of work interruptions in the performance of the contract; the Contractor and any subcontractors shall comply with the following standards or subsequent issues, and any supplements. In addition, the Contractor shall comply with all applicable Federal, state and local laws, codes, ordinances and regulations, including obtaining of all required licenses and permits in connection with biological and hazardous materials. (1) Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Centers for Disease Control (CDC) and the NIH, HHS Pub. No. (CDC) 93-8395. (2) NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication No. 81-2385. (3) Occupational Safety and Health Administration (OSHA) Publications: (I) 29 CFR Part 1910.1030, Occupational Exposure to Blood Borne Pathogens; Final Rule; and (ii) 29 CFR Part 1910, Occupational Exposure in Laboratories; Final Rule. The above, 1 and 2, may be obtained from: Division of Safety Office of Research Services National Institutes of Health Building 31 - Room 1C02 Bethesda, Maryland 20892 OSHA Publications listed above (item 3) may be obtained by contacting US Government Publication Office at (202) 783-3238. B. The contractor, or subcontractor, shall identify any particular safety standards that are not referenced above as applicable to a particular reagent, and after approval by the Project Officer, communicate that information to the recipient of the reagent. -_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_- ******************************************************************** ********************************** RFP-NIH-NIAID-DMID-98-17 ATTACHMENT B REPORTING REQUIREMENTS AND DELIVERABLES -------------------------------------------------------------------- The Contractor shall submit to the Contracting Officer and to the Project officer technical progress reports covering the work accomplished during each reporting period as stated below: A. Quarterly Reports By the fifteenth working day after completion of each quarter, the Contractor shall submit 3 copies of a report of work performed in the previous quarter. Each quarterly report shall consist of: 1. A cover page containing: (a) Contract number and title; (b) Period of performance being reported; (c) Contractor's name and address; (d) Author(s); and (e) Date of submission 2. Information which shall include a brief summary of the work performed during the reporting period but not be limited to the following: (a) An inventory report of the quantity and types of each reagent stored as of the last day of each quarter; (b) A list of reagents assayed during the quarter, and type of assay and results of the assay; (c) A summary of reagents shipped which will have the following information for each reagent: (i) Quantity of the reagent, (ii) Date of shipment, (iii) Date of receipt of shipment, (iv) Name and address of the recipient, (v) Problems associated with any shipment (d) A summary of reagents that were acquired during the quarter which will list the following information for each: (i) Quantity of reagent, (ii) Source of reagent, (iii) Description of reagent, (iv) Quality control information, and (v) Restrictions on disposition and use. (vi) Unit and total cost of reagent. (e) Cumulative list of publications by registrants acknowledging the NIAID Malaria Reagent Repository as a source of reagents. (f) Feedback on reagents use. (g) Maintenance problems encountered and corrective action taken. (h) Need for replacement or repair of Government furnished equipment. (i) Description of current technical or administrative problems encountered, their resolution or the proposed corrective action. B. Final Report The Contractor shall submit 3 copies of the final report which documents and summarizes the results of the entire contract for the period of performance. This report will provide a final inventory and contain a cover page described in A.I. above and the information required in A.2. above. 1. The final report shall be submitted by the completion date of the contract. 2. If the Contractor is 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 reasons therefor. 3. Type of Report No. of Due Dates Copies Addressee/Distribution Quarterly 2 Project Officer Quarterly 1 Contracting Officer CMB, NIAID Solar Building - Room 3C07 6003, Executive Boulevard Bethesda, MD 20892-7610 Final 2 Same as Project Officer above Final 1 Same as Contracting Officer above C. Other Deliverables The Contractor, subject to the Contracting Officer's approval, shall deliver to the Government or its designee by the completion date of the Contract, the following items: (1) Preserved reagent samples; (2) Malaria Reagent Repository management system and documentation on the computer systems/files; (3) Computerized listing of accurate and updated information on reagent inventory, including activities of the Malaria Reagent Repository, data files, data bases, original data and any necessary information related thereto; (4) Labeled and inventoried paper files; and (5) Government-owned equipment and property. ******************************************************************** RFP-NIH-NIAID-DMID-98-17 ATTACHMENT C PROPOSAL EVALUATION CRITERIA --------------------------------------------------- 1. GENERAL Selection of an offeror for contract award will be based on an evaluation of proposals against three factors. The factors in order of importance are: technical, cost, and past performance. Although technical factors are of paramount consideration in the award of the contract, both past performance and cost/price are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. Offerors are advised that award will be made to that offeror whose proposal provides the best overall value to the Government. The evaluation will be based on the demonstrated 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 the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. 2. TECHNICAL FACTOR Proposals submitted in response to this RFP will be evaluated based on the following factors which are listed and weighted in order of their relative importance. Proposals will be judged solely on the written material provided by the offeror. It is anticipated that one award will be made as a result of this acquisition, dependent on the availability of funds. TECHNICAL EVALUATION CRITERIA A. Technical Approach (55 Points) (i) Documented adequacy and feasibility of the proposed methods and approaches for operating a repository and reagent distribution center, including: transfer of current physical inventory, database system and Government-owned equipment from current contractor; initiation and phase-in of work; identification, prioritization, and acquisition of reagents from domestic and international sources; aliquoting, labeling and storage of reagents; selection and maintenance of computerized database system for inventory and tracking; processing of requests; and, shipment of reagents. (25 points) (ii) Documented adequacy and feasibility of the proposed methods and approaches for production, expansion, and quality control, including evaluation of the quality and activity of the reagents. (20 points) (iii) Documented adequacy and feasibility of the proposed methods and approaches for providing services for coordination of the operation of the Malaria Reagent Repository with the malaria research community, biotechnology and pharmaceutical companies (worldwide), technology transfer officials, and NIAID, including maintaining and updating inventory information on the World Wide Web, providing technical information on reagents and assays; sponsoring workshops and awareness-promoting activities, and providing training. (10 points) B. Personnel Qualifications (25 Points) Documented adequacy and suitability of the training, previous experience, and availability of the Principal Investigator and staff for conducting all aspects of the Statement of Work, including: previous experience in the operations and coordination of a biologics repository; demonstrated knowledge and research experience in microbiology in order to provide technical experience; laboratory competence and familiarity with safety regulations; and, familiarity with database management, website maintenance and meeting support. C. Facilities and Resources (20 Points) Documented availability of adequate facilities, equipment and resources necessary to safely operate, maintain and expand this Malaria Reagent Repository plus appropriate support services, including facilities to ship, receive and store hazardous and infectious agents, and maintain their activity and viability; produce and expand reagents; perform quality control functions; and, maintain a computerized database system. TOTAL 100 Points 3. PAST PERFORMANCE FACTOR The offeror's past performance will be evaluated after completion of the technical evaluation. Only those offerors comprising the competitive range will be evaluated. The Government will evaluate the quality of the offeror's past performance based on information obtained from references provided by the offeror, as well as other relevant past performance information obtained from other sources known to the Government. Evaluation of past performance will be a subjective assessment based on a consideration of all relevant facts and circumstances. The Government is seeking to determine whether the offeror has consistently demonstrated a commitment to customer satisfaction and timely delivery of services at fair and reasonable prices. The assessment of the offeror's past performance will be used as a means of evaluating the relative capability of the offeror and the other competitors. Thus, an offeror with an exceptional record of past performance may receive a more favorable evaluation than another whose record is acceptable, even though both may have acceptable technical and management proposals. Past performance will be ranked and the Government's conclusions about overall quality of the offeror's past performance may be influential in determining the relative merits of the offeror's proposal and in selecting the offeror whose proposal is considered most advantageous to the Government. By past performance, the Government means the offeror's record of conforming to specifications and to standards of good workmanship; the offeror's record of forecasting and controlling costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer. Offerors shall submit the following information as part of their business proposals (for both the offeror and proposed major subcontractors): a list of the contracts completed during the past THREE years and ALL contracts currently in progress for products or services similar to those being acquired under this RFP. Contracts listed may include those entered into with the Federal Government, agencies of state and local governments and commercial customers. Offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. Include the following information for each contract: 1. Name of Contracting Organization 2. Contract Number 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Project Officer's Name and Telephone Number ******************************************************************** RFP-NIH-NIAID-DMID-98-17 ATTACHMENT D SPECIFIC RFP INSTRUCTIONS AND PROVISIONS ----------------------------------------- NOTICE TO OFFERORS: This attachment contains proposal instructions and information which 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 Attachment E, "Applicable RFP References." 1. NUMBER AND TYPE OF AWARD(S) (NIH 2980) (APR 1984) It is anticipated that one (1) award will be made from this solicitation and that the award will be made on/about September 25, 1998. It is anticipated that the award from this solicitation will be a multiple-year cost reimbursement completion type contract with a 7 year performance period, and that incremental funding will be used [see paragraph (6) of Business Proposal Instructions, in the "Standard RFP Instructions and Provisions" of the Gopher RFP]. 2. ESTIMATE OF EFFORT It is expected that a completion type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the effort to be approximately 3,800%. This estimate is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes. As further assistance, it is estimated that the above total labor effort is constituted as follows: Labor Percentages Labor Category Year 1 Year 2 Year 3-7 Total Professional - P.I. 25% 25% 25% 175% Co-investigator 75% 75% 200% 1,150% Technical 150% 150% 250% 1,550% Administrative 50% 75% 100% 625% Driver/Assistant 25% 25% 50% 300% Total 325% 350% 625% 3,800% These percentages are based on a 12 month calendar year. 3. 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: Rosemary McCabe Hamill Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard Rockville, MD 20852 Mailing address (U.S.) Postal Service Judith Rubinstein 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. 4. PACKAGING AND DELIVERY OF THE PROPOSAL (NIH 2995) (JUL 1994) Your proposal shall be organized as specified in Section C.1., "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-DMID-98-17 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 19 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 Judith Rubinstein Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard Rockville, MD 20852 If using U.S. Postal Service Judith Rubinstein 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. 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). 5. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT-ORGANIZATION OF THE TECHNICAL PROPOSAL NOTE: Offerors are requested to adhere to a limitation of 120 pages in the technical proposal (including description of any subcontracting arrangements), exclusive of appendices. Appendices shall have no page limitation. "Appendices" are defined as laboratory manuals, standard operating procedures, and copies of publications or manuscripts. All other documents will be included in the page count, except that cover pages, tables of contents, listings of figures, and indices may be used and will not be included in the page count. A transmittal letter may be used to forward proposals to the contracting officer and will not count against the page count. Type density and size must be 10 to 12 points. If constant spacing is used, there should be no more than 15 characters per inch (cpi), whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Please number each page. PLEASE USE THE FOLLOWING FORMAT TO ORGANIZE AND PRESENT YOUR TECHNICAL PROPOSAL. THIS WILL AID IN THE REVIEW OF THE PROPOSALS RECEIVED. SECTION # I. Technical Proposal Cover Sheet (Format in Section C of Gopher RFP: FORMS, FORMATS, ATTACHMENTS) II. Technical Proposal Table of Contents III. Technical Plan (Refer to Technical Proposal Instructions, Section C.1., Standard RFP Instructions and Provisions, Gopher RFP) For each subsection, offerors should structure their proposals to mirror the work statement and evaluation criteria. In case of any inconsistency between the language below and the work statement/evaluation criteria, the latter rule. A. Resources and Environment Provide evidence of availability of adequate facilities, equipment, supplies and resources to needed to safely operate, maintain and expand the Malaria Reagent Repository, including the following functions: - Shipment, receipt, storage and handling of hazardous and infectious agents, and maintenance of their activity and viability, and assurance of their safe handling. - Production, expansion and quality control of reagents - Maintenance of computerized data base system - Preparation and distribution of reagent catalog Provide description of safety procedures used in transporting and working with biohazards. B. Statement of Work This should describe the proposed methods and approaches for operating a repository and reagent distribution center, including: - Transfer of current physical inventory, database system and Government-owned equipment from the current contractor. - Initiation and phase in of work - Identification, prioritization, acquisition, receipt and distribution/shipping of reagents - Aliquoting, labeling and storage of reagents - Production, expansion and quality control of reagents - Maintenance of computerized database system for inventory and tracking - Coordination of repository operation with the malaria research community, including: -- maintaining and updating inventory information on the World Wide Web -- development and maintenance of World Wide Web-based reagent ordering/donating system -- development and maintenance of electronic bulletin board for interaction of reagent donors and users -- providing technical information on reagents and assays -- Sponsoring workshops and other awareness promoting activities, and providing training C. Personnel List all personnel for the project, including the Principal Investigator and other investigators, subcontractors, consultants/collaborators, and technical/support staff. List each by name, title, department, and organization. For each person, document his/her professional qualifications, time commitment, and knowledge of and experience in: - operations and coordination of a biologics repository - microbiology research - laboratory operations and procedures - safety regulations - database management - website maintenance - public dissemination of information - meeting planning and support IV. Summary of Current and Proposed Activities form in the FORMS, FORMATS, ATTACHMENTS Directory found in Section C, Gopher RFP) V. Technical Proposal Cost Information form (Format in Section C, Gopher RFP, FORMS, FORMATS, & ATTACHMENTS) 6. PROPOSAL INTENT RESPONSE SHEET RFP No. NIH-NIAID-DMID-98-17 NIAID MALARIA RESEARCH AND REFERENCE REAGENT REPOSITORY PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY DECEMBER 22, 1997. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION. =============================================== [ ] DO INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING: RFP No. NIH-NIAID-DMID-98-17 NIAID MALARIA RESEARCH AND REFERENCE REAGENT REPOSITORY [ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS: ____________________________________________________________________ COMPANY/INSTITUTION NAME: _________________________________________ ADDRESS: _________________________________________ _________________________________________ _________________________________________ _________________________________________ PROJECT DIRECTOR'S NAME: _________________________________________ TITLE: _________________________________________ SIGNATURE: _________________________________________ (Date) TELEPHONE NUMBER: _________________________________________ NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS (include Subcontractors and Consultants): ____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________ (Continue list on reverse if necessary) =============================================== RETURN TO: CMB, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard (MSC 7610) Bethesda, MD 20892-7610 Attn: Judith Rubinstein RFP-NIH-NIAID-DMID-98-17 _-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_- 7. SIC CODE AND SIZE STANDARD Note: The following information is to be used by the offeror in preparing its Representations and Certifications (see Section C.4 of the Gopher RFP), specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS (JAN 1997), FAR 52.219-1: The standard industrial classification (SIC) code for this acquisition is 8999. The small business size standard is $5.0 million. 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. 8. 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. (For information regarding authorized restrictive notices, offerors should refer to the "Confidentiality of Proposals" section of the STANDARD RFP INSTRUCTIONS AND PROVISIONS subdirectory of the RFP REFERENCES directory of the Gopher RFP.). 9. NOTICE OF PLANNING MEETING FOR THE NIAID MALARIA RESEARCH AND REFERENCE REAGENT REPOSITORY This is a scientific meeting to assist the Government in directing the work of the interim repository and to aid the Government in directing the new award. The meeting is not a pre-proposal conference. However, interested parties may attend. Dates and Times: November 24, 1997, 9:00 A.M. - 5:30 P.M. November 25, 1997, 9:00 A.M. - 12:15 P.M. Location: Solar Building, Room 1A01 6003 Executive Boulevard Rockville, MD 20852 Topics likely to be discussed: - Background on "Multilateral Initiative on Malaria" - Related NIAID activities - Purpose of the repository - Description of the interim and full malaria repositories - Description of the DAIDS repository (a model for the malaria repository) - Reagent acquisition Interest groups will be formed which will address issues such as the following: - Drug development - Medical entomology - Vaccine development - Criteria for prioritization of reagent acquisition/development - Minimum requirements for reagent characterization upon donation to the repository - Minimum requirements for QA/QC for different types of reagents - Distribution mechanism for field-acquired reagents - How to handle proprietary concerns - How to deal with ethical issues regarding use of human tissues - Training/technology transfer If you plan to attend please contact Judith Rubinstein. Phone: 301-496-2509 FAX: 301-480-5253 e-mail: jr205j@nih.gov 10. The following clause will be included in any contract issued under this RFP. RECIPIENTS REIMBURSEMENT PROCEDURES During the course of this contract, the Contracting Officer or the duly designated representative will notify the contractor to make certain shipments directly to specified U.S. Government Recipients, Contractors, Government Agencies, or other private organizations and the Contractor shall make such shipments as directed. The Contractor shall bill recipients directly for the items provided. The charges for the cost of these items shall be based upon the current price list for the items as specified by the Government. Revised price lists will be issued by the Government when appropriate. The Contractor shall keep an accurate account of all payments received from recipients separate from other fiscal aspects of the contract. The Contractor shall record as credits on monthly invoices to the Government, all payments received from the Government Grantees/Contractors/Government Agencies/or other private organizations. The income from recipients must be credited to the Government in the billing period actually received. Thus, the Contractor shall bill the Government directly for payment of contract costs received and shall subtract as a credit all payments received from recipients. The actual collections from sales shall be offset against the gross billing leaving a new amount due on the invoice. The designated Project Officer may direct from time to time that shipments be made entirely at Government expense. The Contractor shall account for the contract related income separately in accordance with its own double entry accounting system. The Contractor shall submit to the Government a monthly or Quarterly Summary Sheet of Sales with the Progress Report. The administration of the contract related income shall be subject to the terms of this contract, including specifically and without limitation, the Audit-Negotiation clause (FAR 52.215-2) and the applicable cost principles of the Federal Acquisition Regulation. The Contractor shall use the following procedures for collection of delinquent accounts: Step 1 - Accounts 30 days past due: a copy of the invoice shall be sent to the recipient with a notation that the account is overdue and request payment. Step 2 - Accounts 60 days past due: the Contractor shall notify the Project Officer. When the completion (final) invoice is submitted on this contract, a listing of all outstanding recipient invoices shall be provided along with details as to what disposition is expected on each. If the amount of revenues generated by the sale of research substances exceed the total cost of performance plus fixed fee (if any), the excess shall be refunded to the Government in accordance with the Contracting Officer s instructions. If revenues are received after submission of the completion voucher, you shall forward a check to the National Institutes of Health in the amount of the revenues received. Such check shall be made out to the Department of Health and Human Services (address to be provided). Note: At this time, charges will consist solely of shipping costs and can be recouped by shipping COD, using the recipient's Overnight service account or other appropriate mechanism. The requirements of this clause would go into effect when the government provides the price list referenced above. ******************************************************************** RFP-NIH-NIAID-DMID-98-17 ATTACHMENT E APPLICABLE RFP REFERENCES ------------------------- This section identifies the items found in the Gopher directory entitled RFP REFERENCES that are applicable to this RFP. 1. The entire file entitled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as otherwise may be modified by the inclusion of an item from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS". 2. The following items are applicable from the file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS": a. LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS OF PROPOSALS, PHS 352.215-10 b. HUMAN SUBJECTS NOTICE TO OFFERORS OF REQUIREMENTS OF 45 CFR PART 46, PROTECTION OF HUMAN SUBJECTS (SEPTEMBER 1985) (Applies to collection and use of reagents.) c . CARE OF LIVE VERTEBRATE ANIMALS d. SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS SUBCONTRACTING PLAN (does not apply to small business) Note: A Subcontracting Plan is not due with the initial proposal. The Contracting Officer will notify offerors if a plan becomes due. e. PAST PERFORMANCE INFORMATION (Since past performance is an evaluation criterion, this item is applicable.) f. FACILITIES CAPITAL COST OF MONEY (for commercial organizations) 3. The following items/files are applicable from the subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS": Applicable to Technical Proposal a. Technical Proposal Cover Sheet b. Technical Proposal Cost Information, Dec. 1988 c. Summary of Current and Proposed Activities, July 1995 d. Technical Proposal Table of Contents, July 1995 Applicable to Business Proposal e. Contract Pricing Proposal, SF 1411, (Rev. 10/95) f. Proposal Summary and Data Record, NIH-2043 (Rev. 9/96) g. Business Proposal Cost Information h. Disclosure of Lobbying Activities, OMB Form SF-LLL, Dec. 1989 To Become Contract Attachments i. Invoice/Financing Requests Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1, May 1997. j. Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16), Apr. 1984. k. Form NIH 2706 (Financial Report) and Instructions for Completing Form NIH 2706 Note: Financial reports are not always required. This will be discussed during negotiations. l. Protection of Human Subjects Assurance Identification/Certification/Declaration, Optional Form 310, (Rev. 1/95). Other-to be submitted as directed by Contracting Officer m. Certificate of Current Cost or Pricing Data, NIH-1397. n. Subcontracting Plan Format 4. The Representations And Certifications are applicable. 5. The "Sample Contract Format-General" is applicable.