NATIONAL HEART, LUNG, AND BLOOD INSTITUTE RFP No. RFP-NIH-NHLBI-HB-98-04 MAINTENANCE OF NHLBI BIOLOGICAL SPECIMEN REPOSITORY This RFP contains the following items: I. Streamlined Technical RFP II. Specific RFP Instructions and Provisions III. Applicable RFP References Note to Offerors: Outline numbering will be internally consistent within each of the above items, but the outline number of those documents will not necessarily be consistent with the Gopher Table of Contents outline. Brief instructions for downloading files from the NIH Gopher: Download the Gopher file into a pre-set blank document that was created using the following settings: Courier 10 CPI (12 pt.), .5 left margin, 1.2 right margin, 0 top and bottom margins. ******************************************************************** I. Streamlined Technical RFP ------------------------- A. Solicitation Form/Cover Letter ------------------------------ RFP No. NIH-NHLBI-HB-98-04 Title: Maintenance of NHLBI Biological Specimen Repository Issued by: Joann Ciufolo, Contracting Officer National Institutes of Health National Heart, Lung, & Blood Institute Contracts Operations Branch Rockledge Building, Room 6140 6701 Rockledge DR MSC 7902 BETHESDA MD 20892-7902 DATE ISSUED: September 2, 1997 DATE PROPOSAL DUE: October 17, 1997, 4:30 P.M. (EST) SMALL BUSINESS SET-ASIDE: No SIC CODE: 8731 Ladies and Gentlemen: This Streamlined Technical RFP consists of this combined solicitation form and cover letter and four additional components as follows: B. Work Statement and Project Information (Attachment 1); C. Deliverables and Reporting Requirements (Attachment 2); D. Special Requirements (Attachment 3); and E. Evaluation Factors for Award (Attachment 4) In addition, there are two other sections of this specific RFP. Section II. Specific RFP Instructions and Provisions (Attachment 5) contains the address for delivery of proposals, as well as other provisions that provide specific information for this RFP. Section III. Applicable RFP References (Attachment 6) lists those items in the RFP REFERENCES Gopher directory that apply to this RFP. If you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Joann Ciufolo of the NHLBI contracting office at the following Internet address: ciufoloj@nih.gov If you fail to notify the contracting office of your intent, you will not receive notice of amendments to the RFP. However, all amendments will be posted on the NIH Gopher. The original and twenty(25) copies of your technical proposal and the original and six (6) copies of your business proposal must be received at the required address no later than October 17, 1997, at 4:30 p.m. local time. Submit proposals to the address listed in the item entitled Packaging and Delivery of Proposals under Attachment 5 of this RFP entitled II. Specific RFP Instructions and Provisions. Also, refer to that Section for the item entitled "Proposal Intent Response Sheet." Please complete this form and deliver it to the address indicated therein on or before September 29,1997. This will allow us to expedite preparations for the peer review of proposals. Proposals must be organized and submitted in accordance with the "Technical Proposal Table of Contents" found in Attachment 5 of this document (Section II, "Specific RFP Instructions and Provisions, B. Packing and Delivery of Proposals"). You are reminded that the "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your technical proposal. A copy of this form is contained in the NIH Gopher under the FORMS, FORMATS, AND ATTACHMENTS subdirectory found in Attachment 6, III. Applicable RFP References. This information will be used to ensure that there will be no conflict of interest when selecting review committee members. NOTE: IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR DESIGNEE AT THE PLACE AND TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH PHS CLAUSE 352.215-10 ENTITLED "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWALS OF PROPOSALS," AS FOUND IN THE GOPHER FILE ENTITLED "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS." If you have any additional questions regarding this RFP, please contact Joann Ciufolo through the Internet using the electronic mail address listed above or phone (301)435-0359, facsimile (301)480-3432. Collect calls will not be accepted. Sincerely, /s/ Joann Ciufolo Contracting Officer Attachments: 1 - 6 ***************************************************************** ***************************************************************** RFP-NIH-NHLBI-HB-98-04 Attachment 1 ------------ I. Streamlined Technical RFP B. Work Statement and Project Information Background STATEMENT OF WORK FOR SOLICITATION PURPOSES ------------------------------------------- The contractor shall perform the following tasks: PHASE I - Transition ------- The contractor shall coordinate an orderly and safe transition from the current incumbent contractor site to the new location, including the transport of stored specimens, data, and all Government-furnished property. Contractor shall obtain the necessary Department of Transportation (DOT) exemption from the requirements of 46 CFR Part 64 regarding Federal hazardous material transportation law so that specimens shall be moved in the freezers in which they are stored. Relocation of the NHLBI repository from the current location (McKesson BioServices, 685 Lofstrand Lane, Rockville, MD 20850) to the new location shall be completed before December 15, 1998. At the time of repository relocation, it is estimated that 2.8 million specimens will be stored in 102 freezers and 4 liquid nitrogen tanks. In order for the frozen specimens contained in the repository to be moved without removal from the freezers in which they are stored, a Department of Transportation (DOT) special exemption is necessary. See 49 CFR Ch.1, Subpart B--Exemptions 107.203 for application instructions. Without approval of an exemption, all specimens would have to be removed from the freezers and placed in certified hazardous material shipping containers. Approximately 90 days is required to obtain such an exemption. Therefore, offerors should submit a request to the Department of Transportation for an exemption following notification by the Contracting Officer that such application should be requested. *****NOTE TO OFFERORS (1)***** A plan for the transition phase must be included in the proposal. The plan shall cover the physical relocation of the freezers, transfer of computer data, files, and existing materials and supplies. For this purpose, prior to the move, the contractor shall have access to the current repository facilities in order to inspect freezers, files, computer resources, and any other equipment, materials and supplies that must be moved. Therefore, as a separate and distinct part of the technical and business proposals, the offeror shall provide a detailed plan which describes: (1) how 2.8 million specimens contained in 102 Government-owned freezers and 4 liquid nitrogen chests will be moved and (2) the time and costs associated with such a move. To receive a list of Government-furnished freezers and a floor plan of the existing repository space, interested parties should submit a request to the Contracting Officer via Internet message (ciufoloj@nih.gov) or via facsimile at 301-480-3432.****** ****************************************** PHASE II Repository Maintenance ---------------------------------- Task 1 - Maintain Serum, Plasma, and Cell Repository ------ The contractor shall provide facilities and equipment to receive, store, aliquot, and distribute potentially hazardous biologics such as serum, plasma, and cells from individuals infected with AIDS virus and hepatitis viruses. The facilities must provide aseptic and/or sterile conditions as appropriate (Biosafety Level 2 Containment). The specimens shall be maintained by the contractor in freezers at temperatures between -70 degrees and -80 degrees centigrade. Freezers shall be located in an air-conditioned facility with temperatures maintained between 20 degrees and 25 degrees centigrade (60 degrees to 77 degrees F) when freezers are in operation. The contractor shall supply uninterruptible power to accommodate the refrigerators/freezers and other equipment. Freezers shall be connected to a central alarm system monitored twenty-four hours per day. The contractor shall provide an automated temperature monitoring system composed of individual temperature probes monitored 24 hours a day and controlled by a master computer, and a plan to ensure that necessary personnel are notified in the event of freezer malfunction. Emergency standby freezers shall be available in case of mechanical failure of any portion of storage space. In addition, alternative emergency freezer cooling systems such as a liquid nitrogen system or dry ice must be available. The contractor must have backup electric generators capable of operating all storage equipment for at least 48 hours in the event of utility company power failure. Backup generators must be tested monthly. Cell specimens (or tissues) shall be maintained at liquid nitrogen gas phase, in special liquid nitrogen chests. In order to accommodate the estimated increase of the number of specimens/vials contained in the repository and the replacement of obsolete freezers, the contractor shall purchase approximately six freezers per year, using contract funds. The estimated increase in vials will result from the splitting of specimens and arrival of new specimens. *****NOTE TO OFFERORS (2)***** The existing NHLBI biological specimen repository is stored in 83 Government-owned freezers and 4 liquid nitrogen chests with a total capacity of 1,833 cubic feet. The addition of 19 freezers is estimated before December 15, 1998 (the date by which the relocation of the repository is required) for the following purposes: Receipt of approximately 400,000 specimens from a large NHLBI study will require the addition of 11 freezers, 7 freezers will be added to accommodate estimated growth of the repository, and replacement of one obsolete freezer. At the time of contract award, it is projected that 2.8 million specimens will be contained in 102 freezers and 4 liquid nitrogen chests. These freezers shall be furnished to the offeror selected for award.********** ******************************* Task 2 - Preparing Aliquots from Selected Specimens * ------ The contractor shall provide laboratory facilities and personnel for dividing the serum or plasma samples into aliquots. All requests for samples are reviewed by the NHLBI. Once an original specimen is identified for distribution, it is thawed and divided into aliquots, one of which is sent to the investigator, and the remaining aliquots refrozen for later use. It is estimated that approximately 1,000 specimens shall be divided into 10,000 aliquots annually. Thus, the size of the repository increases regularly as original specimens are divided and distributed and new specimens are added to the repository. The handling of all biological specimens and Government-owned property under this contract shall be in accordance with all applicable local, state, and federal regulations. In addition, in order to provide safety controls for protection to the life and health of employees and other persons, the contractor shall consult, comply with, and include in all applicable subcontracts, the following standards, as appropriate: 1) Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Centers for Disease Control (CDC) and the NIH, DHHS Pub. No. (CDC) 93-8395. 2) Occupational Safety and Health Administration (OSHA), Publication 29 CFR Part 1910.1030, Occupational Exposure to Blood Borne Pathogens, Final Rule. *********************** Task 3 -Prepare and Ship Panels of Aliquots or Specimens * ------ The Project Officer receives and reviews requests from investigators for specimens or panels of aliquots. When a request is approved, the NHLBI Project Officer will design panels of aliquots or specimens on the basis of the investigator's experimental needs. On the basis of that design, the Project Officer will provide to the contractor the information needed to prepare and ship each panel. It is estimated that preparation and shipment of approximately 50 panels, containing 100 vials each, will be required annually. A list identifying the specimens to be included in a panel will be provided to the contractor. The contractor shall prepare the panels as required by the Project Officer. Shipments will require preparation of the panel, packing the panel in dry ice, packaging the panel in insulated boxes, and express shipment (usually by air) to the final destination (specifically, the approved investigator). The contractor shall ship all vials C.O.D.; transportation and postage costs are to be paid by the recipients from point of carrier receipt. The contractor shall verify receipt of the panel by the investigator both in writing and by phone. Packaging and shipment shall meet standards for biologically hazardous materials (see publication prepared by the International Air Transport Association (IATA), Dangerous Goods Regulations, 37th edition, 1996 or current edition). ********************************* Task 4 - Add Specimens to the Repository * ------ The contractor shall inventory, prepare for storage, package, and label, as necessary, specimens to be added to the repository. The project officer will specify the dates of arrival of such specimens, the number of specimens, and the means of packaging, labeling and storing these samples as well as the type, number and location of freezers to be relocated to the contractor's site. It is essential that shipments be coordinated by the contractor so that personnel will be available to receive the arriving packages and transport shipment to the NHLBI repository for storage at the required temperature. ******************************** Task 5 - Performance of Virologic and Serologic Assays * ------ The contractor shall provide the capability to perform (in-house or through a subcontractor) serologic and virologic assays for the evaluation and validation of candidate blood screening tests for the detection of transfusion-associated agents. For this purpose, laboratory biosafety level 2 shall be required, as well as laboratory personnel with specific training in handling pathogenic agents. Laboratory personnel, safety practices, and techniques shall be supplemented by appropriate facility design and engineering features, safety equipment, and management practices. The contractor shall ensure that persons working with these infectious agents are aware of potential hazards and strictly adhere to standard microbiological practices and techniques. Costs for these assays will be negotiated and the contract amount increased as the need arises. The human pathogens for which blood screening tests are being developed or improved and, therefore, are likely to be involved in future assay evaluation and validation procedures, include hepatitis viruses, human retroviruses, and agents of transmissible spongiform encephalopathies. Among the serologic and virologic test formats that the contractor is expected to perform are enzyme immunoassays, polymerase chain reactions, immunoblotting, and in situ hybridization. It is expected that 500 - 1,000 assays will be required per year. ******************************* Task 6 - Inventory Control ------ The contractor shall update and maintain a computerized inventory control data base using a desktop personal computer system to track and assist in the coordination of the activities under this contract. At the time of contract award, the FoxPro data base will contain information on approximately 2.1 million specimens. This will provide inventory and management information to reflect activities of the repository, i.e., location of specimens, aliquoting of specimens, preparation of panels, and addition of new specimens. In addition, the SAS/Repository Management System (RMS) inventory and management data base shall reflect activities on approximately 700,000 specimens including location of specimens, aliquoting of specimens, preparation of panels, addition of new specimens, and results of assays performed by outside investigators using NHLBI specimens. The SAS software and license shall be provided to the contractor by the Government. ****************************** Task 7 - Ensure an Orderly Transition of the NHLBI Biological ------ Specimen Repository to a Successor Contractor In the event there is a recompetition of the subject contract and an organization other than the incumbent is selected for contract award, incumbent shall assist in ensuring an orderly and safe transition of the repository from the current location at (address of repository at time of relocation) to any successor of this contract. This shall include providing repository access to the new contractor at mutually agreed upon times. *********** * SPECIAL TRAINING REQUIREMENTS: ----------------------------- Repository personnel involved in tasks 2, 3, 4, and 5 shall have specific training in handling pathogenic agents and dealing with potential hazards of the pathogens likely to be involved in the operation of the repository. ******************************************************************** ******************************************************************** PROJECT INFORMATION ------------------- Background: The initial contract to maintain the NHLBI biological specimen repository was awarded October 15, 1975, for receiving, storing and distributing specimens from the TTV study. This contract was subsequently recompeted in 1982, in 1987, and in 1991 respectively. The NHLBI plans to add to the repository additional collections of biological specimens which have been or will be established during epidemiologic and clinical studies presently supported or to be supported by the Institute. Since then, the NHLBI has initiated a number of multi-institutional prospective studies including the epidemiology of transfusion-associated AIDS [the Transfusion Safety Study (TSS)], sero-epidemiology of other human retroviruses in blood donors (REDS), pulmonary consequences of HIV infection, clinical studies of tissue plasminogen activator therapy in myocardial infarctions (TIMI trial), cooperative study of Sickle Cell Disease, and the NHLBI/NIAID/NICHD passive immunotherapy clinical trial with HIV-positive pregnant women. In these studies, specimens of blood components (plasma, serum, and cellular materials) are being collected and preserved for future use. Objective: This initiative relates to an ongoing project which is part of the Safety of Blood Therapy subprogram of the Blood Resources program through which the Division of Blood Diseases and Resources supports research on the development of methods to detect various transfusion-transmitted viruses to ensure the safety of blood, blood components, and blood derivatives. The objective of this project is to provide biological specimens to the scientific community for use in a variety of research projects. Research may center around evaluation of more sensitive tests for HIV, evaluation of newly identified agents, the study of hemostatic changes during and immediately after myocardial infarction, evaluation of hemostatic differences between patients whose vessels remain patent after thrombolytic therapy and those who suffer reclosure, studies on the etiology of thrombotic thrombocytopenia purpura, etc. ******************************************************************** ******************************************************************** RFP-NIH-NHLBI-HB-98-04 ATTACHMENT 2 ------------ I. Streamlined Technical RFP C. Deliverables and Reporting Requirements --------------------------------------- TECHNICAL PROGRESS REPORTS -------------------------- In addition to the required reports set forth elsewhere, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. The Contractor shall submit to the Contracting Officer and to the Project Officer technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the Project Officer. These shall be brief and factual and prepared in accordance with the following format: 1. Quarterly Progress Report: This report shall include descriptive information on activities in the repository during the reporting period. The reporting period consists of the first full three months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. This report shall include the following: a. the number of vials stored on the first and last days of the reporting period; b. the number of vials prepared during the reporting period; c. a list of panels prepared and shipped during the reporting period including, for each panel: 1) number of specimens (vials), 2) date of shipment, 3) date of receipt of shipment, and 4) problems with any shipment; d. maintenance problems encountered and corrective actions taken; e. needs for replacement or repair of government-furnished equipment; and 2. Final Report: Cumulative information for period of performance of all information included in quarterly progress reports. DELIVERY SCHEDULE ----------------- Copies of the technical progress reports shall be submitted as follows: Item Description; Quantity; Delivery Schedule 1. Quarterly Progress Report; 2 copies to the Project Officer (PO), 1 copy to the Contracting Officer (CO); quarterly during period of performance. 2. Final Report; 2 copies to the Project Officer (PO), 1 copy to the Contracting Officer (CO); on or before expiration of contract. 3. All stored biological specimens, data files, computerized listings of accurate and updated information on inventory, data bases, original data, and any necessary information related thereto; all contract related;(to be determined); on or before expiration of contract. 4. Labeled and inventoried paper files; all contract related;(to be determined); on or before expiration of contract. 5. Government-owned equipment and property; all contract related;(to be determined); on or before expiration of contract. ********************************* Deliverables shall be sent to the following addresses: Project Officer --------------- Blood Resources Program Division of Blood Diseases & Resources National Heart, Lung, & Blood Institute 6701 Rockledge Drive, MSC 7950, Room 10146 Bethesda, MD 20892-7950 Shipping, Deliveries and Couriers: 6701 Rockledge Drive Rockledge Two, 10th Floor, Room 10146 Bethesda, MD 20817 AND Contracting Officer ------------------- BDR Contracts Section Contracts Operations Branch National Heart, Lung, & Blood Institute 6701 Rockledge Drive, MSC 7902, Room 6140 Bethesda, MD 20892-7902 Shipping, Deliveries and Couriers: 6701 Rockledge Drive Rockledge Two, 6th Floor, Room 6140 Bethesda, MD 20817 ******************************************************************** ******************************************************************** RFP-NIH-NHLBI-HB-98-04 ATTACHMENT 3 ------------ I. Streamlined Technical RFP D. Special Requirements 1. EQUIPMENT The Government does not plan to purchase any major equipment (except for additional freezers to accommodate growth of the repository and replacement of Government-furnished freezers in lieu of repair if cost effective) nor to support alteration or renovation of space to complete the objectives of the contract. Thus, items of equipment and functional space or facilities necessary to perform the contract must be furnished by the offeror and available for use during the course of the contract. Items typically required in addition to housing for the freezers are listed below: a. Autoclaves b. Microbiological laboratory c. Laminar flow hoods d. Low temperature freezers e. Centrifuges f. Refrigerators g. Packaging and shipping area h. Computer equipment and software 2. BIOHAZARD CONTAINMENT Standard precautions for biohazard containment must be observed in the work proposed. See HHS Publication No. (NIH) 88-8395, entitled "Biosafety in Microbiological and Biomedical Laboratories", 2nd Edition, May 1988. 3. GOVERNMENT FURNISHED MATERIALS AND FACILITIES; GOVERNMENT PROPERTY The Government will initially provide approximately 102 freezers and 4 liquid nitrogen chests with a total capacity of 2,500 cubic feet. In general, approximately 80 percent of the total capacity of the Government-owned freezers will be occupied with specimens. The contractor shall be responsible for the maintenance of all Government-furnished equipment. The Government will furnish computerized repository specimen inventory records and data files. In addition, SAS software and license will be provided to the contractor by the Government. 4. SAFETY AND HEALTH The NHLBI Blood Specimen Repository contains material potentially infected with hepatitis B virus, the agent of non-A, non-B hepatitis, human immunodeficiency virus (HIV), and human T-cell leukemia virus type I (HTLV-I). Biosafety Level 2 practices, containment equipment, and facilities are recommended for all activities utilizing body fluids and tissues potentially infected with these viruses. These recommended precautions are described in HHS Publication No. 88-8395, Biosafety in Microbiological and Biomedical Laboratories. PHS 352.223-70 will be included in the contract. 5. PACKAGING, MARKING, AND SHIPPING All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. The contractor shall guarantee that all required materials shall be delivered in immediately useable and acceptable condition. (Refer to IATA publication "Dangerous Goods Regulations", 37th edition, 1996 or current edition.) ******************************************************************** ******************************************************************** RFP-NIH-NHLBI-HB-98-04 ATTACHMENT 4 ------------ I. Streamlined Technical RFP E. Evaluation Factors for Award, with Technical Evaluation Criteria EVALUATION FACTORS FOR AWARD ---------------------------- 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 and/or past performance, in that order of importance may become the determining factor(s) in the award decision. In any event, the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered; but the technical proposal will be the basis for the award decision, if possible. 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. 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. Offeror's past performance will be evaluated after establishment of the competitive range. Cost will be used as a selection factor if technical ability cannot be used as the basis for award decision. Listed below are the technical evaluation criteria used by the technical evaluation committee when reviewing technical proposals. EVALUATION CRITERIA: ------------------- 1. Adequacy and availability of facilities and equipment. 30% --- Documented ability to provide essential facilities and equipment in the required time frame to perform the proposed work. These include appropriate repository space and equipment; adequate facility design and engineering features to achieve biohazard containment (laboratory biosafety level 2); and computer equipment and software as specified in the Statement of Work. 2. Managerial coordination plans. 30% --- An effective plan to coordinate the various aspects of the storage, preparation of aliquots, shipment of biological specimens, and conduct of required serologic and virologic assays. This plan must also include logistics for receiving, processing, and storing incoming shipments. In addition, a plan for compliance with all safety guidelines and regulations, including training and monitoring of personnel must be provided. A plan to move the repository, including existing freezers and specimens, within the required time frame and without damage must be included. 3. Qualifications, experience, and 30% availability of proposed personnel. --- Documented technical and administrative competence, experience, and availability of a Principal Investigator to oversee the operation of the NHLBI repository. Documented availability of experienced repository and laboratory personnel necessary to successfully perform proposed roles. Repository personnel directly involved in the handling of specimens must have documented training in handling pathogenic agents and dealing with potential hazards of the pathogens likely to be involved in the operation of the repository. 4. Ability to perform serologic and virologic assays. 10% --- Demonstrated ability to perform, or subcontract for, virologic and serologic assays for the evaluation and validation of candidate blood screening tests for the detection of transfusion-associated agents, including enzyme immunoassays, polymerase chain reaction, immunoblotting, and in situ hybridization. For this purpose, laboratory biosafety level 2 shall be required. Laboratory personnel must have documented training in handling pathogenic agents and dealing with potential hazards of the pathogens likely to be involved in the testing of samples. Total 100% =================== ******************************************************************** THE REMAINDER OF THIS GOPHER RFP CONSISTS OF THE FOLLOWING SECTIONS: II. Specific RFP Instructions and Provisions (Attachment 5), and III. Applicable RFP References (Attachment 6) ******************************************************************** RFP-NIH-NHLBI-HB-98-04 Attachment 5 ------------ II. 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. Reference to additional, more general, information and forms regarding proposal preparation are contained in Attachment 6, III. Applicable RFP References. The following specific RFP instructions and provisions apply to this RFP: A. Proposal Intent Response Sheet (submit prior to proposal submission) B. Packaging and Delivery of Proposal C. SIC Code and Small Business Size Standard D. Number and Type of Award E. Pre-Proposal Conference F. Estimate of Effort G. Service of Protest H. Page Limits I. Safety and Health J. Government Notice for Handling Proposals K. Continued Ban on Funding of Human Embryo Research L. Technical Proposal Table of Contents ***************************************************************** ***************************************************************** A. PROPOSAL INTENT RESPONSE SHEET ------------------------------ RFP No. NIH-NHLBI-HB 98-04 TITLE OF RFP: Maintenance of NHLBI Biological Specimen Repository PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY: SEPTEMBER 29, 1997. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION. ******************************************************************** I INTEND TO SUBMIT A PROPOSAL COMPANY/INSTITUTION NAME: ADDRESS: PROJECT DIRECTOR'S NAME: TITLE: TELEPHONE NUMBER: NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS (include Subcontractors and Consultants): RETURN TO: Review Branch or FAX TO: Dr. James Scheirer NIH, NHLBI (301) 480-3541 Attention: Dr. James Scheirer Rockledge Building, Room 7220 6701 ROCKLEDGE DR MSC 7924 BETHESDA MD 20892-7924 ******************************************************************** ******************************************************************** ************************ B. PACKAGING AND DELIVERY OF PROPOSALS ----------------------------------- Your proposal shall be organized as specified in the Technical Proposal Table of Contents, below, and as described in the "Standard RFP Instructions and Provisions" found in the Gopher Directory entitled "RFP References." 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. NHLBI-HB-98-04 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 ONLY -- Original* and Twenty-five (25) COPIES BUSINESS PROPOSAL -- Original* and Six (6) COPIES COPIES TO: If hand-delivered or If using U.S. Postal delivery service: Service: Review Branch Review Branch Division of Extramural Affairs Division of Extramural Affairs National Heart, Lung, and National Institutes of Health Blood Institute National Heart, Lung, and Rockledge Building, Room 7091 Blood Institute 6701 Rockledge DR MSC 7924 6701 Rockledge DR MSC 7924 Bethesda MD 20817 Bethesda MD 20892-7924 *THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE STAMPING. NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the Bethesda, Maryland address. Any package sent to the Bethesda address via this services 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." ******************** C. SIC CODE AND SMALL BUSINESS 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 RFP References directory 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 8731. The small business size standard is 500 employees. THIS 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. ********************** D. NUMBER AND TYPE OF AWARD ------------------------ It is anticipated that a single award will be made from this solicitation and that the award will be made on/about June 15, 1998. It is anticipated that the award from this solicitation will be a multiple-year, cost reimbursement, completion type contract with a period of performance of six years, 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]. ************************ E. Pre-Proposal Conference ----------------------- A pre-proposal conference will be held with prospective offerors at: 6701 Rockledge Drive Rockledge Two, Room 9140 Bethesda, Maryland 20817 Date: September 15, 1997 Time: 10 a.m. to 11:30 am. The pre-proposal conference will be held for the purpose of providing information concerning the Government's requirements which may be helpful in the preparation of proposals and for answering any questions which you have regarding this solicitation. The success of this type of conference depends largely on the lead-time available to the Government for research in connection with questions submitted by offerors. Therefore, you are requested to submit written questions concerning any areas of uncertainty which, in your opinion, require clarification or correction, in sufficient time to be received on or before September 10, 1997. Questions should be submitted to the Contracting Officer at the address listed below: U. S. Mail: Joann A. Ciufolo, Contracting Officer BDR Contracts Section Contracts Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Rm. 6140 Bethesda, MD 20892-7902 Internet: ciufoloj@nih.gov Facsimile: 301-480-3432 Answers will be furnished simultaneously to all prospective offerors whether or not they are in attendance at the pre-proposal conference. Attendance at the pre-proposal conference is recommended; however, attendance is not a prerequisite for proposal submission and will not be considered a factor in proposal evaluation. ************************* F. 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 total effort to be approximately 49,000 hours. This estimate is furnished for your information only and is not to be considered restrictive for proposal purposes. Phase I: Transition 6 months (July 1998 - December 1998) Phase II: Repository Maintenance 6 months (January 1999 - June 1999) 12 months (July 1999 - June 2000) 12 months (July 2000 - June 2001) 12 months (July 2001 - June 2002) 12 months (July 2002 - June 2003) 12 months (July 2003 - June 2004) Direct labor devoted to the project must be compatible with the work proposed. Type of personnel included in the estimate are: principal investigator, laboratory technician, repository technician, computer scientist, and administrative. *************************** G. SERVICE OF PROTEST (OCT 1995) - 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) or the General Services Administration Board of Contract Appeals (GSBCA), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from: If hand-delivered or delivery service: Joann Ciufolo, Contracting Officer Contracts Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge Building, Room 6140 6701 Rockledge DR BETHESDA MD 20817 If using U.S. Postal Service: Joann Ciufolo, Contracting Officer Contracts Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge Building, Room 6140 6701 Rockledge DR MSC 7902 BETHESDA MD 20892-7902 (2) The copy of any protest shall be received in the office designated above on the same day a protest is filed with the GSBCA or within one day of filing a protest with the GAO. (3) In this procurement, you may not protest to the GSBCA because of the nature of the supplies or services being procured. *********************** (H) Page Limits The offerors shall limit their technical proposal response to 125 pages. The technical approach must be limited to 25 pages. The other portions of the proposal, including related experience, personnel, etc, must be limited to 100 pages. *********************** (I) SAFETY AND HEALTH (AUGUST 1997) - PHS 352.223-70 (a) In order to help ensure the protection of the life and health of all persons, as well as to help prevent damage to property, the Contractor shall comply with all Federal, State and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration, and other agencies at the Federal, State and local levels (Federal, State and local regulatory/enforcement agencies). (b) Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officers, determines to be reasonably necessary. If compliance with such additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, an equitable adjustment will be made in accordance with whichever applicable "Changes" Clause as set forth in this contract (FAR 52.243-1, Changes - Fixed Price; FAR 52.243-2, Changes - Cost Reimbursement; or FAR 52.243-3, changes - Time and Materials or Labor-Hours). (c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials, or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contract and all violations for which the contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. This report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action. (d) If the Contractor fails or refuses to comply promptly with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violations(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor. (e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor. *************************** (J) 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 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. If authorized in agency implementing regulations, agencies may release proposals outside the Government for evaluation, consistent with the following: (1) Decisions to release proposals outside the Government for evaluation purposes shall be made by the agency head or designee; (2) Written agreement must be obtained from the evaluator that the information (data) contained in the proposal will be used only for evaluation purposes and will not be further disclosed; (3) Any authorized restrictive legends placed on the proposal by the prospective Contractor or subcontractor or by the Government shall be applied to any reproduction or abstracted information made by the evaluator; (4) Upon completing the evaluation, all copies of the proposal, as well as any abstracts thereof, shall be returned to the Government office which initially furnished them for evaluation; and (5) All determinations to release the proposal outside the Government take into consideration requirements for avoiding organizational conflicts of interest and the competitive relationship, if any, between the prospective Contractor or subcontractor and the prospective outside evaluator. The submitter of any proposal shall be provided notice adequate to afford an opportunity to take appropriate action before release of any information (data) contained therein pursuant to a request under the Freedom of Information Act (5 U.S.C. 552); and, time permitting, the submitter should be consulted to obtain assistance in determining the eligibility of the information (data) in question as an exemption under the Act. (See also Subpart 24.2, Freedom of Information Act.) ************************* (K) CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH Section 512 of the Fiscal Year 1997 Appropriations Act contains language identical to that contained in the Fiscal Year 1996 Balanced Budget Down Payments Act I (P.L. 104-99) that prohibits NIH from using appropriated funds to support human embryo research. Contract funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk or injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289G(B)). The term, human embryo or embryos, include any organism, not protected as a human subject under 45 CFR 46 as of the date of the Act, that is derived by fertilization, partenogenesis, cloning, or any other means from one or more human gametes. ********************** (L) TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT ------------------------------------------- RFP-NIH-NHLBI-HB-98-04 (Note: Instructions to offerors are indicated in parentheses or as footnotes.) TECHNICAL PROPOSAL TABLE OF CONTENTS ------------------------------------ Page Numbers 1. Technical Proposal Cover Sheet..(Format found in Section C of Gopher:FORMS,FORMATS,ATTACHMENTS)............................ 2. Technical Proposal Table of Contents (THIS DOCUMENT).......... 3. Summary of Objective and Methods (Abstract)*,**................ 4. Technical Plan (Refer to Technical Proposal Instructions, Section C.1., Standard RFP Instructions and Provisions, Gopher RFP)**......................................................... a. Statement of Work 1. Objective ..........(Items a.1 through a.4 ............. 2. Approach ........... are not to exceed 25 pages)........ 3. Methods ................................................ 4. Schedule ............................................... b. Personnel *** 1. List of All Personnel on the Project, including Subcontractors, Consultants/Collaborators, by Name, Title, and Organization 2. Principal Investigator/Project Director 3. Other Key Staff 4. Additional Personnel c. Resources and Facilities d. Other Considerations (use specifically titled subparagraphs, as applicable) 5. Other Support ................................................ (Refer to "Summary of Current and Proposed Activities" in the FORMS, FORMATS, ATTACHMENTS Directory found in the RFP References directory of the Gopher RFP) 6. Technical Proposal Cost Information ......................... (Format in Gopher RFP, RFP References, FORMS, FORMATS,& ATTACHMENTS) 7. Literature Cited.............................................. 8. Appendices ................................................... * State the proposal's broad, long-term objectives and specific aims. Describe concisely the research design and methods for achieving these goals. DO NOT EXCEED one page in providing the abstract. Identify the RFP Number, Organization, and Principal Investigator on the abstract. ** Type density and size must be 10 to 12 points. If constant spacing is used, there should be no more than 15 CPI, whereas proportional spacing should provide and average of no more than 15 CPI. There must be no more than six lines of text within a vertical inch. *** An individual resume should not exceed two pages. ******************************************************************** ******************************************************************** RFP-NIH-NHLBI-HB-98-04 Attachment 6 ------------ III. Applicable RFP References ------------------------- This file or section identifies the items in the RFP References Gopher directory that are applicable to this RFP. A. 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". B. The following items are applicable from the Gopher file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS": 1. Late Proposals, Modifications of Proposals, and Withdrawals of Proposals, PHS 352.215-10. 2. Small Business and Small Disadvantaged Business Subcontracting Plan. Note: A subcontracting plan is not due with the initial proposal. The Contracting Officer will notify offerors if a plan becomes due. 3. Past Performance Information. Since past performance will be evaluated as part of the source selection if technical proposals are equal and a decision cannot then be made on the basis of cost, this item is applicable. 4. Facilities Capital Cost of Money. C. The following items/files are applicable from the subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS": Applicable to TECHNICAL PROPOSAL -------------------------------- 1. Technical Proposal Cost Information 2. Summary of Current and Proposed Activities 3. Technical Proposal Table of Contents (See above) 4. Technical Proposal Cover Sheet Applicable to BUSINESS PROPOSAL ------------------------------- 5. Contract Pricing Proposal, SF 1411 6. Proposal Summary and Data Record, NIH-2043 7. Disclosure of Lobbying Activities, OMB Form SF-LLL 8. Business Proposal Cost Information To Become CONTRACT ATTACHMENTS ------------------------------ 9. Invoice/Financing Requests Instructions for NIH Cost- Reimbursement Type Contracts, NIH(RC)-1, Jun. 1992. 10. Form NIH 2706 (Financial Report) and Instructions for Completing Form NIH 2706. 11. Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16), Apr. 1984. Others to be submitted as directed by Contracting Officer --------------------------------------------------------- 12. Certificate of Current Cost or Pricing Data, NIH-1397. D. The Representations and Certifications are applicable and must be submitted with the offeror's business proposal. E. The "Sample Contract Format-General" is applicable. ******************************************************************** ******************************************************************** .