RFP No.NIH-NIAID-DAIDS-98-03 Title: NIH-AIDS RESEARCH AND REFERENCE REAGENT PROGRAM Issued by: Bruce E. Anderson Contracting Officer NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard (MSC 7610) Bethesda, Maryland 20892-7610 DATE ISSUED: JANUARY 28, 1997 PROPOSAL DATE DUE: APRIL 28, 1997, 4:30 P.M. (EST) Ladies and Gentlemen: You are invited to submit a proposal in accordance with the requirements of this RFP (NIH-NIAID-DAIDS-98-03) for the NIH-AIDS RESEARCH AND REFERENCE REAGENT PROGRAM. The Government anticipates the award of ONE (1), SEVEN (7) YEAR, cost-reimbursement, level-of-effort 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 January 28, 1997 including Appendices A-1 and A-2 B. Deliverables and Reporting Requirements, dated January 28, 1997 C. Evaluation Factors for Award, dated January 28, 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 which you are currently in (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 Bruce Anderson, Contracting Officer, by phone/fax/Internet (see contact numbers/addresses below). Offerors interested in responding to this RFP are encouraged to request a hard copy of the 1996 þNIH AIDS Research and Reference Reagent Program Catalogþ and a copy of a recent newsletter ("Courier"). The catalog includes a current listing of reagents in the AIDS Reagent Program, and includes forms for: 1) registration for receiving reagents in 1996; 2) indemnification agreements; 3) acknowledgment of commercial rights; and 4) request for ordering reagents. Requests for Catalog and newsletter should be addressed to: Bruce E. Anderson, Contracting Officer, CMB, NIAID, Solar Building, Room 3C07, 6003 Executive Boulevard (MSC 7610), Rockville, Maryland 20892-7610.) 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, but supporting documentation need NOT be submitted with the proposal (COST AND PRICING DOCUMENTATION WILL BE REQUESTED AFTER THE COMPETITIVE RANGE IS ESTABLISHED). REFERENCES FOR EVALUATION OF PAST PERFORMANCE SHOULD BE SUBMITTED IN THE BUSINESS PROPOSAL (SEE ATTACHMENT C, EVALUATION CRITERIA, FOR MORE INFORMATION). See Standard RFP Instructions and Provisions, in the subdirectory C. RFP References, for more detail on the BUSINESS PROPOSAL requirements. DUE TO THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES' CURRENT BUDGET RESTRICTIONS, 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. FINAL INFLATION INCREASES WILL BE SUBJECT TO THE NEGOTIATION PROCESS TAKING INTO CONSIDERATION THE MOST CURRENT CONSUMER PRICE INDEX (CPI). With the Business Proposal, please submit Form NIH-2043, "Proposal Summary and Data Record," contained in the NIH Gopher under the FORMS, FORMATS, AND ATTACHMENTS subdirectory found in C. RFP REFERENCES. Note that in addition to telephone and fax numbers, the INTERNET addresses of both the Principal Investigator and the responsible business representative are to be included on the form. The format and content of your TECHNICAL PROPOSAL is detailed in the þTechnical Proposal Table of Contentsþ, in Attachment D. BE ADVISED THAT THE NARRATIVE FOR THE WORK STATEMENT, RESOURCES/OTHER CONSIDERATIONS, AND PERSONNEL, ARE NOT TO EXCEED 75 PAGES. 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 C. RFP REFERENCES). New policies require submission of more detailed information than has been previously required. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work, including: staff of the primary organization (offeror), subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be indicated for every person named. You may use additional sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. This information will be used to ensure that there will be no conflict of interest when selecting review committee members. Your attention is further directed to the "Proposal Intent" form contained in Attachment D, item 11. Please complete this form and return it to this office on or before MARCH 28, 1997. This will allow us to expedite preparations for the peer review of proposals. Funds are NOT presently available for this requirement. The Government's obligation under a resulting contract is contingent upon availability of appropriated funds from which payment for contract purposes can be made. If you intend to submit a proposal in response to this RFP, IT IS ESSENTIAL THAT YOU IMMEDIATELY NOTIFY MR. BRUCE ANDERSON, CONTRACTING OFFICER, OF THE NIAID CONTRACTING OFFICE AT THE FOLLOWING INTERNET ADDRESS: ba9i@nih.gov IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST, YOU WILL NOT RECEIVE ANY NOTIFICATION OF AMENDMENTS ISSUED TO THE RFP. HOWEVER, ALL AMENDMENTS WILL BE POSTED ON THE NIH GOPHER AND/OR NIH HOME PAGE. The original and fifteen (15) 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 APRIL 28, 1997, at 4:30 p.m. local time at the address listed in Attachment D, item 7. Questions concerning any areas of uncertainty which in your opinion require clarification or correction, must be furnished in writing to Mr. Bruce Anderson. Your questions should be received no later than FEBRUARY 28, 1997, at the address indicated in Attachment D, item 5 (Fax or E-mail communication is preferred) and marked "Offeror's Questions, RFP-NIH-NIAID-DAIDS-98-03." If you have any additional questions regarding this RFP, please contact Mr. Anderson at the Internet electronic mail address: ba9i@nih.gov, by phone at 301/496-8371, or by fax at 301/402-0972. Collect calls will NOT be accepted. Sincerely, /s/ Brenda J. Velez Chief, AIDS Clinical Research Contract Section Contract Management Branch National Institute of Allergy and Infectious Diseases Attachments: A - E ********************************************************* RFP-NIH-NIAID-DAIDS-98-03 STREAMLINED RFP ------------------- ATTACHMENT A - INTRODUCTION AND STATEMENT OF WORK (January 28, 1997) INTRODUCTION --------------------- The purpose of this contract is to support the National Institutes of Health (NIH) AIDS Research and Reference Reagent Program (AIDS Reagent Program), in achieving its goal of providing novel AIDS-related reagents and resources to the scientific community. An important rate-limiting step in basic research is the identification and distribution of state-of-the-art reagents and technology. To address this need, the National Institute of Allergy and Infectious Diseases (NIAID) supports the AIDS Reagent Program. Since its establishment in 1988, the AIDS Reagent Program has evolved from a small bank of research materials to a large unique resource of many reagents for research on HIV/AIDS and related opportunistic infectious agents. It acquires state-of-the- art HIV/AIDS-related research and reference reagents; produces these reagents, standardized panels, and protocols; and then provides these reagents at minimal cost to qualified investigators throughout the world. Additionally, the reagent program collects information about AIDS-related reagents and standards and disseminates this information through print, electronic media, and workshops; enhances technology transfer through development and publication of methods; facilitates commercial development of reagents through proactive communication with biotechnology and pharmaceutical companies; and participates as an AIDS Collaborating Center of the World Health Organization. Contributors and users include scientists from the NIH, academic and non-profit institutions, and from industry. The success of the Program is evident in the expanding network of users. Over 900 scientists from 33 countries in North and South America, Europe, Asia, Africa, and Australia have registered and obtained reagents from the Program. During the past four years, over 30,000 reagents have been distributed. More than 1,200 scientific publications have referenced the use of reagents obtained from the Program. Approximately 25% of activities of the Reagent Program involve other government-sponsored activities (e.g., participants may be collaborators in NIAID cooperative agreements, ACTG investigators, and NIAID contractors). The Reagent Program is a major provider of reagents to AIDS investigators worldwide. The Reagent Program also provides technical assistance in handling and shipping of infectious materials . The current five year contract with McKesson Bioservices Corporation (formerly Ogden Bioservices Corporation), Rockville, MD, expires in January 1998. The purpose of this solicitation is to re-compete this effort. WORK STATEMENT _________________________ Independently and not as an agent of the Government, the Contractor shall exert its best efforts to 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 GOVERNMENT MUST HAVE DIRECT OVERSIGHT OF THIS CONTRACT IN ORDER TO ENSURE QUALITY CONTROL AND SAFE HANDLING AND DISTRIBUTION OF THE REAGENTS, MANY OF WHICH ARE BIOHAZARDOUS AND INFECTIOUS (INCLUDING HIV). THE PRIME CONTRACTOR IS RESPONSIBLE FOR ALL WORK PERFORMED UNDER THIS CONTRACT. WHILE SUBCONTRACTING IS PERMITTED, THE REAGENT ACQUISITION EFFORTS, STORAGE AND DISTRIBUTION OF REAGENTS, AND THE MANAGEMENT OF THE AIDS REAGENT PROGRAM DESCRIBED UNDER THE WORK STATEMENT MUST 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 OFFEROR): OFFERORS INTERESTED IN RESPONDING TO THIS RFP ARE ENCOURAGED TO REQUEST A HARD COPY OF THE 1996 "NIH AIDS RESEARCH AND REFERENCE REAGENT PROGRAM CATALOG" AND A COPY OF A RECENT NEWSLETTER ("COURIER"). THE CATALOG INCLUDES A CURRENT LISTING OF REAGENTS IN THE AIDS REAGENT PROGRAM, AND INCLUDES FORMS FOR: 1) REGISTRATION FOR RECEIVING REAGENTS IN 1996; 2) INDEMNIFICATION AGREEMENTS; 3) ACKNOWLEDGMENT OF COMMERCIAL RIGHTS; AND 4) REQUEST FOR ORDERING REAGENTS. REQUESTS FOR CATALOG AND NEWSLETTER SHOULD BE ADDRESSED TO: BRUCE E. ANDERSON CONTRACTING OFFICER, CMB, NIAID, SOLAR BUILDING, ROOM 3C07, 6003 EXECUTIVE BOULEVARD (MSC 7610), ROCKVILLE, MARYLAND 20892- 7610.) Specifically, the Contractor shall: 1. IDENTIFY, ACQUIRE, AND PRODUCE/EXPAND (AS NECESSARY) REAGENTS: The Contractor shall actively and independently identify novel reagents that are not readily available, and prioritize their acquisition based upon the needs of the AIDS research community, availability and cost. The Contractor shall acquire reagents after receiving approval by the Project Officer. The acquisition of reagents, including radioactive reagents (either by purchase or donation) shall be an ongoing endeavor. Reagents purchased shall be acquired through a competitive process whenever practicable in accordance with FAR Part 13 Small Purchase Procedures and also in accordance with the prior consent requirements of FAR Part 44. The contractor shall keep proper documentation on file supporting: (1) the price reasonableness for all acquisitions; and (2) the criteria for evaluation and selection of all sources for reagent acquisitions. The Contractor shall produce reagents as needed after receiving approval by the Project Officer. Production of reagents includes expansion of renewable reagents, e.g., includes cell lines, viruses, microorganisms and recombinant DNA. For the purposes of this contract, reagents include but are not limited to the following biological materials: HIV and other related viruses, uninfected and infected and/or genetically manipulated prokaryotic/eukaryotic cell lines, DNA libraries, DNA clones, body fluids and cells, proteins and synthetic peptides, monoclonal and polyclonal antibodies, and opportunistic infectious agents associated with HIV infections. Reagents also refer to but are not limited to antiviral and antiinfective drugs and therapeutics, chemicals that modulate the immune system, and other materials used to treat HIV or opportunistic infections associated with AIDS. The Contractor may be requested to acquire/distribute specialized animal models (e.g. transgenic mice) to be used as a live source of reagents for investigators (no housing of animals required). The list provided above is for illustrative purposes and is not comprehensive. (NOTE 3 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 FROM DOMESTIC AND INTERNATIONAL SOURCES, AND THE OFFEROR'S KNOWLEDGE, EXPERIENCE AND QUALIFICATIONS TO DO SO SHOULD BE SUBMITTED AS PART OF THE TECHNICAL PROPOSAL. AS AN INDICATION OF THE OFFERORþS KNOWLEDGE OF THE FIELD, OUTLINE WHAT REAGENTS NEED TO BE ACQUIRED AND HOW YOU WOULD PREPARE TO DO THIS; PRIORITIZE THE MOST IMPORTANT ACQUISITIONS. BASED UPON EXPERIENCE GAINED UNDER THE CURRENT AIDS REAGENT PROGRAM CONTRACT, IT IS SOMEWHAT DIFFICULT TO PREDICT OR IDENTIFY IN ADVANCE THE TYPES AND AMOUNTS OF REAGENTS, AND THE NUMBERS OF EXPANSIONS, QUALITY CONTROL ANALYSES OF REAGENTS THAT WILL BE REQUIRED DURING THIS CONTRACT TERM. THEREFORE, BASED UPON HISTORICAL EXPERIENCE, AND FOR THE PURPOSES OF PREPARING A BUDGET, THE GOVERNMENT ESTIMATES THE FOLLOWING PROJECTED REAGENT ACQUISITION EXPENSES: $546,770 (YEAR 1), $4,190,000 (TOTAL FOR SEVEN YEARS-THIS INCLUDES 3% INFLATIONARY ADJUSTMENTS). THIS AMOUNT INCLUDES REAGENT PURCHASE, PRODUCTION/EXPANSION, AND QUALITY CONTROL OF REAGENTS. IN THE PAST, 87% OF THE ACQUIRED REAGENTS WERE DONATED BY INVESTIGATORS (50% OF WHICH WERE EXPANDED WITH CONTRACT FUNDS); ALL OTHER "ACQUISITION" OF REAGENTS WAS ACCOMPLISHED THROUGH PURCHASE AND/OR SERVICES. THE ACQUISITION EFFORT THEREFORE INCLUDES SOLICITATION OF DONATIONS, PURCHASE ORDERS/ SUBCONTRACTS FOR PRODUCING REAGENTS, AND EXPANSION OF REAGENTS (RENEWABLE REAGENTS PROVIDED TO THE AIDS REAGENT PROGRAM IN SMALL AMOUNTS WILL REQUIRE EXPANSION). FOR ANY PROPOSED SUBCONTRACTOR (OR SUBCONTRACTORS) TO PRODUCE/EXPAND REAGENTS SIMILAR TECHNICAL INFORMATION SHOULD 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 SHOULD ALSO BE PROVIDED BY THE SUBCONTRACTOR AND SUBMITTED WITH THE BUSINESS PROPOSAL.) (NOTE 4 TO THE OFFEROR: 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.) (NOTE 5 TO THE OFFEROR: IF THE OFFEROR IS A COMMERCIAL FIRM SELLING OR DISTRIBUTING AIDS-RELATED REAGENTS, THE OFFEROR SHOULD ADDRESS IN DETAIL IN THE TECHNICAL PROPOSAL HOW POTENTIAL CONFLICTS OF INTEREST WILL BE RESOLVED BETWEEN COMMERCIAL ACQUISITION AND DISTRIBUTION OF REAGENTS AND AIDS REAGENT PROGRAM ACQUISITION AND DISTRIBUTION OF SIMILAR REAGENTS. FOR EXAMPLE, THE OFFEROR MUST ADDRESS HOW THE OFFEROR WILL IDENTIFY AND OBTAIN POTENTIALLY COMMERCIALLY VALUABLE REAGENTS FOR AIDS REAGENT PROGRAM DISTRIBUTION INSTEAD OF FOR THE OFFEROR'S COMMERCIAL USE.) 2. PROVIDE FOR QUALITY CONTROL OF REAGENTS: The Contractor shall provide for quality control of reagents. Quality control includes assay and evaluation of reagents. Assays shall include but are not limited to sterility, stability, solubility, neutralization and infectivity assays, HPLC, restriction enzyme analysis, polymerase chain reactions, immunoblotting, IN SITU hybridizations, tritiated thymidine incorporation, and biological activity. The number and types of assays to be performed will require the prior approval by the Project Officer. The Contractor shall anticipate assays for, but not limited to the following: a. Biological reagents, including but not limited to body fluids, cells, tissues, cell lines, lysates, nucleic acids, viruses, protein and peptide preparations including antibodies. b. Chemical reagents, including but not limited to nucleoside analogs, chemicals and other compounds or natural products which may be used for developing therapies, and topical microbicides against HIV or opportunistic pathogens associated with AIDS. . (NOTE 6 TO THE OFFEROR: THE OFFEROR MUST DESCRIBE A PLAN FOR HOW THE QUALITY AND ACTIVITY OF THE ACQUIRED REAGENTS WILL BE VERIFIED.) (NOTE 7 TO THE OFFEROR: THE OFFEROR SHOULD SUBMIT, WITH THE TECHNICAL PROPOSAL, DOCUMENTATION DEMONSTRATING: KNOWLEDGE, EXPERIENCE AND COMPETENCE IN THE QUALITY CONTROL ANALYSES OF BIOLOGICAL AND CHEMICAL REAGENTS. FOR ANY PROPOSED SUBCONTRACTOR (OR SUBCONTRACTORS) SIMILAR TECHNICAL INFORMATION SHOULD 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 SHOULD ALSO BE PROVIDED BY THE SUBCONTRACTOR AND SUBMITTED WITH THE BUSINESS PROPOSAL. UNDER THE CURRENT CONTRACT APPROXIMATELY 10% OF THE REAGENT ACQUISITION EXPANSIONS ARE FOR THE QUALITY CONTROL OF REAGENTS.) 3. PROVIDE STORAGE, PROCESSING FACILITIES AND RESOURCES: The Contractor shall provide facilities and equipment to receive, weigh and store potentially hazardous reagents and maintain their activity or viability (Biosafety Level 2 Containment). The facilities must provide aseptic and/or sterile conditions as appropriate. Drugs which may be destined for pre-clinical use, as specified by Project Officer, will be stored in a room separate from infectious biologics. The Contractor shall provide appropriate storage for radioactive material per 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 AIDS Reagent Program 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 AIDS Reagent Program. 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 must 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 must be tested monthly. (NOTE 8 TO THE OFFEROR: THE NUMBER OF REAGENT SAMPLES STORED IN THE AIDS REAGENT PROGRAM HAS GROWN FROM APPROXIMATELY 55,000 SAMPLES IN 1992 TO 127,000 SAMPLES IN 1996. THESE SAMPLES INCLUDE 2,500 UNIQUE REAGENTS OF WHICH 1,000 REAGENTS ARE AVAILABLE FOR PUBLIC DISTRIBUTION. IT IS ANTICIPATED THAT NEW REAGENTS WILL ENTER THE PROGRAM ON A REGULAR BASIS, AT AN ESTIMATED RATE OF 30-50 REAGENTS (500- 2000 REAGENTS SAMPLES) RECEIVED MONTHLY FROM DOMESTIC AND INTERNATIONAL SUPPLIERS DURING EACH YEAR OF THIS CONTRACT. THE OFFEROR SHOULD ANTICIPATE A 15% INCREASE ANNUALLY IN THE NUMBER OF REAGENTS SAMPLES STORED IN THE AIDS REAGENT PROGRAM TO AN ESTIMATED TOTAL OF 385,000 SAMPLES DURING THE TERM OF THE CONTRACT. CURRENTLY, THE AIDS REAGENT PROGRAM HAS 300 CUBIC FEET OF LOW-TEMPERATURE STORAGE SPACE. IT IS ESTIMATED THAT THE CONTRACT WILL REQUIRE EXPANSION OF LOW- TEMPERATURE STORAGE SPACE TO ABOUT 500 CUBIC FEET BY THE END OF THIS CONTRACT. SEE ALSO ATTACHMENT A-1 TO THE WORK STATEMENT FOR A LIST OF GOVERNMENT FURNISHED PROPERTY, AND DETAILS ON REAGENTS SAMPLES STORED AT DIFFERENT TEMPERATURES. THE OFFEROR SHOULD PROVIDE IN THE TECHNICAL PROPOSAL A PLAN FOR STORAGE AND PROCESSING OF REAGENTS, FLOOR PLAN OF THE PROPOSED FACILITY AND LIST EQUIPMENT AND RESOURCES DEDICATED TO THE PROJECT.) c. Provide protective garments, equipment and sufficient monitoring to assure safe handling of toxic and potentially hazardous materials, including radioactive 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 SHOULD INCLUDE A SAFETY AND HEALTH PLAN IN THE TECHNICAL PROPOSAL AND INCLUDE A COPY OF OFFEROR'S SAFETY AND HEALTH OPERATING PROCEDURES MANUAL. STANDARD OPERATING PROCEDURES FOR THE SAFE HANDLING, STORAGE, AND SHIPPING OF THE TYPES OF REAGENTS LISTED IN THE 1996 CATALOG, INCLUDING THE RADIOACTIVE REAGENTS, SHALL BE PROVIDED. THE OFFEROR SHOULD INCLUDE IN THE TECHNICAL PROPOSAL: EVIDENCE OF ADEQUATE TRAINING OF PERSONNEL HANDLING INFECTIOUS AGENTS INCLUDING HIV AND OPPORTUNISTIC PATHOGENS ASSOCIATED WITH HIV INFECTION, RADIOACTIVE SUBSTANCES, DEALING WITH ACCIDENTS, AND MONITORING FOR INFECTION, AS WELL AS THE ABILITY TO IDENTIFY SAFETY STANDARDS APPLICABLE TO PARTICULAR REAGENTS LIKELY TO BE ACQUIRED.) d. Provide facilities to weigh 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, including radioactive materials. e. Provide a separate, locked, storage space (i.e., safe, approximately 15 cubic foot) at the appropriate temperature for hallucinogens, narcotics and any other reagent designated by the Drug Enforcement Administration as a dangerous and/or controlled substance compound. f. Maintain 24 hour security that provide a secure environment for employees and materials within the facility. g. Provide an automated temperature monitoring system composed of individual temperature probes monitored 24 hours a day and controlled by a master computer, 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 SHOULD DESCRIBE AN ACTION PLAN FOR IDENTIFYING MALFUNCTIONS, A PROCESS TO TEST CAPABILITY, AND A PROCESS FOR TRANSFER OF REAGENTS FROM MALFUNCTIONING REFRIGERATORS/FREEZERS.) h. The personnel assigned to this project must be bonded prior to beginning work on this contract. 4. 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 form letters to be used for refusal or acceptance of reagent requests. 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 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. (NOTE 11 TO THE OFFEROR: SAMPLES OF CURRENT INDEMNIFICATION AGREEMENTS FOR BIOHAZARDOUS REAGENTS ARE IN THE HARD COPY OF THE 1996 CATALOG). 5. SHIP AND RECEIVE REAGENTS: a. Ship and receive reagents, ensuring the assumption of shipping costs by the recipient whenever possible. b. The Contractor shall ship available reagents within 7 working days from the date requests are received. (NOTE 12 TO THE OFFEROR: FOR THE PURPOSES OF PREPARING A BUDGET, ASSUME THAT APPROXIMATELY 700 REAGENTS WILL BE SHIPPED MONTHLY FROM THE AIDS REAGENT PROGRAM, INVOLVING APPROXIMATELY 170 SHIPMENTS, OF WHICH 15% MAY BE TO OVERSEAS LOCATIONS IN INDUSTRIALIZED AND DEVELOPING COUNTRIES. THE OFFEROR SHOULD ANTICIPATE APPROXIMATELY 25 INCOMING SHIPMENTS OF REAGENTS PER MONTH INCLUDING THOSE FROM OVERSEAS.) c. 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. d. Provide for safe packaging, shipping and distribution of reagents and drugs approved by the Project Officer to eligible research investigators in the U.S. and abroad so that such shipments are coordinated for timely receipt. e. Obtain the appropriate licenses and permits required by local, state and Federal authorities for the safe import, storage and distribution of reagents and drugs. Additionally, the Contractor shall obtain the appropriate interstate, intrastate and foreign import/export shipping licenses and permits for transporting biohazardous/radioactive reagents and drugs. (NOTE 13 TO THE OFFEROR: THE OFFEROR SHOULD DEMONSTRATE KNOWLEDGE AND EXPERIENCE IN PACKAGING/SHIPPING BIOHAZARDOUS AND ETIOLOGIC AGENTS NATIONALLY AND INTERNATIONALLY. THE OFFEROR SHOULD ALSO DEMONSTRATE KNOWLEDGE AND EXPERIENCE IN PROCURING THE APPROPRIATE IMPORT/EXPORT LICENSES AND PERMITS. THE OFFEROR SHOULD DESCRIBE: (A) A PLAN FOR PACKAGING AND SHIPPING OF REAGENT REQUESTS, AND RECEIVING INCOMING REAGENTS; AND (B) LIST EQUIPMENT, RESOURCES AND FACILITIES DEDICATED TO THE PROJECT.) f. Provide 24-hour, seven days a week availability of personnel to pick up and store incoming shipments of reagents from a specified airport or other contract site in a timely manner in order to assure that reagents are maintained at necessary temperature until placed in the AIDS Reagent Program. Because the incoming shipments usually represent a substantial financial investment, it is essential that shipments be coordinated by the Contractor so that personnel will be available to receive the arriving package whenever delivered and transport shipment to the AIDS Reagent Program for storage at the required temperature. All shipments when received should be maintained for stability and viability by providing the necessary temperature in transit from the airport or other site to the AIDS Reagent Program. g. Coordinate all shipments so that viability, biological activity or purity of the reagents will not be adversely affected. Send notification by World Wide Web/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. (NOTE 14 TO THE OFFEROR: THE OFFEROR SHOULD DESCRIBE A PLAN FOR HOW THE INCOMING REAGENTS WILL BE DELIVERED TO THE AIDS REAGENT PROGRAM IN A TIMELY MANNER. FOR SHIPMENTS OUT OF THE AIDS REAGENT PROGRAM, THE OFFEROR SHALL ESTABLISH A MECHANISM FOR BEING NOTIFIED BY REQUESTER OF DATE REAGENTS WERE RECEIVED AND CONDITION OF REAGENTS UPON RECEIPT. THE OFFEROR SHOULD INCLUDE DETAILS OF PROPOSED NOTIFICATION MECHANISM/PLAN IN THE TECHNICAL PROPOSAL.) h. Use shipping containers for reagents which will 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. 6. DISSEMINATE PUBLIC INFORMATION CONCERNING REAGENT AVAILABILITY: a. Promote awareness of the AIDS Reagent Program's services throughout the scientific community using electronic and print media, and as determined by the Project Officer, leased booths or poster presentations at scientific meetings, symposia and workshops. World Wide Web-based advertisements shall include links to all relevant pages. (NOTE 15 TO THE OFFEROR: THE OFFEROR SHOULD ANTICIPATE MAKING TWO PRESENTATIONS ANNUALLY AT SCIENTIFIC MEETINGS. FOR THE PURPOSE OF PREPARING A BUDGET ASSUME ONE MEETING IN WASHINGTON D.C. METROPOLITAN AREA AND OTHER IN SAN FRANCISCO, CALIFORNIA. THE OFFEROR SHOULD OUTLINE THEIR EXPERIENCE IN INTERACTIONS WITH THE AIDS RESEARCH COMMUNITY, BIOTECHNOLOGY AND PHARMACEUTICAL COMPANIES (WORLDWIDE), TECHNOLOGY TRANSFER OFFICIALS, AND THE DIVISION OF AIDS, INCLUDING SPONSORING WORKSHOPS AND AWARENESS-PROMOTING ACTIVITIES.) b. Provide HTML copy to publish and periodically update the AIDS Reagent Program information on the NIAID Home Page on the World Wide Web including but not limited to the AIDS Reagent Program catalog, a newsletter (the "Courier"), articles on new reagents, protocols, and NIH initiatives. These should 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, LISTSERV news groups and an electronic bulletin board. (NOTE 16 TO THE OFFEROR: CURRENTLY A FOLIO INFOBASE IS ACCESSED VIA A NIAID FILE SERVER AND IS ACCESSIBLE TO USERS ON THE WORLD WIDE WEB. THE INFOBASE WAS CREATED WITH FOLIO VIEWS 3.1 (FOLIO CORPORATION, 2155 NORTH FREEDOM BLVD., SUITE 150, PROVO, UT). THE OFFEROR SHOULD DESCRIBE A PLAN TO CONTINUE TO PROVIDE AIDS REAGENT PROGRAM INFORMATION ON THE WORLD WIDE WEB AND 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 January 1999, and shall be of quality comparable to the January 1998 catalog. It is anticipated that approximately 4,000 copies will be printed and distributed annually. The Contractor shall distribute the catalogs to the scientific community on the AIDS Reagent Program mailing list (approximately 3,000 copies), and to others on request. e. With approval of Project Officer, publish three to four hard copy editions of a newsletter ("Courier"), including information on new reagents, protocols, and NIH research initiatives. It is anticipated that approximately 4,000 copies will be published with each edition. The Contractor shall distribute catalog updates/newsletters to the scientific community on the AIDS Reagent Program mailing list and to others on request. f. Publish descriptions of portions of the AIDS Reagent Program collection in relevant scientific journals as determined by the Project Officer. (NOTE 17 TO THE OFFEROR: THE OFFEROR SHOULD INDICATE IN THE TECHNICAL PROPOSAL HOW THE EDITORIAL AND TECHNICAL SUPPORT FOR THE ABOVE PUBLICATIONS WILL BE PROVIDED BY THE CONTRACTOR'S STAFF. IF A SUBCONTRACT IS PROPOSED, THE OFFEROR SHOULD PROVIDE THE CRITERIA FOR SELECTION OF THE SUBCONTRACTOR WITH THE TECHNICAL PROPOSAL, AND THE COSTS IN THE BUSINESS PROPOSAL.) 7. PROVIDE NECESSARY AIDS REAGENT PROGRAM SUPPORT: a. Support collaborative efforts of the Division of AIDS to develop/evaluate and expand access to reagents, including but not limited to reference standards and panels of reagents, such as PCR standards, DNA libraries, drug resistant viral isolates, antibodies, and drugs. b. Periodically evaluate services provided by the AIDS Reagent Program, including the status and use of reagents, and other services provided by the contract. c. The Contractor shall provide other related services within the scope of this contract as may be deemed necessary by the Project Officer. 8. PROVIDE SUPPORT FOR THE AIDS REAGENT PROGRAM SPONSORED WORKSHOPS: Under the guidance of the Project Officer, the AIDS Reagent Program shall sponsor workshops: to develop reagents and/or protocols; to prioritize reagent acquisitions; to promote technology transfer; and to promote compliance with regulations for packaging and shipping of infectious substances. The Contractor shall provide support for invited participants, including travel and per diem expenses and honoraria. (NOTE 18 TO THE OFFEROR: FOR THE PURPOSES OF PREPARING A BUDGET, ASSUME TWO, ONE-DAY WORKSHOPS ANNUALLY, FOR 10 INVITEES TO BE HELD IN THE WASHINGTON, D.C. AREA.) 9. PROVIDE AN INVENTORY AND DISTRIBUTION DATABASE AND MANAGEMENT SYSTEM: Provide and 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 19 TO THE OFFEROR: THIS CONTRACT SHALL NOT SUPPORT THE PURCHASE OF GENERAL PURPOSE ADP EQUIPMENT. THE OFFEROR SHOULD ASSUME THAT THE GOVERNMENT WILL PROVIDE TO THE NEW CONTRACTOR THE EXISTING DATA BASE AND MANAGEMENT SYSTEM, THE AIDS REAGENT MANAGEMENT SYSTEM CONTAINING INFORMATION ON REAGENT INVENTORY, INCLUDING ACTIVITIES OF THE AIDS REAGENT PROGRAM, ALONG WITH NECESSARY DOCUMENTATION. THE AIDS REAGENT MANAGEMENT SYSTEM CURRENTLY RESIDES ON AN IBM COMPATIBLE 486 COMPUTER, IS WRITTEN IN FOXPRO FOR DOS 2.6 (FOX SOFTWARE INC., PERRYSBURG, OH 43551), A MENU-DRIVEN COMMERCIALLY AVAILABLE RELATIONAL DATABASE MANAGEMENT SYSTEM. A MAJOR COMPONENT OF THE SYSTEM IS THE MODULE TO TRACK INDIVIDUAL INVESTIGATORS' REAGENT ACQUISITION AND RECEIPT. OTHER MODULES SUPPORT PRODUCTION OF STANDARD REPORTS, SUCH AS RECEIVING AND SHIPPING. MORE SPECIALIZED REPORTS INCLUDING THE REAGENT INVENTORY, INVESTIGATOR AFFILIATIONS AND MAILING LISTS ARE ALSO AVAILABLE THROUGH THIS DATABASE. THE AIDS REAGENT MANAGEMENT SYSTEM AND COMPUTER FILES WILL BE TRANSFERRED TO THE NEW CONTRACTOR, WITHOUT ANY COMPUTERS. THE OFFEROR SHOULD 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, radioactive, 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 AIDS Reagent Program. 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. 10. 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. (NOTE 20 TO THE OFFEROR: FOR THE PURPOSE OF PREPARING A BUDGET, ASSUME A MINIMUM OF 12 VISITS PER YEAR TO 6003 EXECUTIVE BOULEVARD, ROCKVILLE, MD 20892, TO MEET WITH THE PROJECT OFFICER.) 11. ENSURE AN ORDERLY TRANSITION OF THE AIDS REAGENT PROGRAM TO A SUCCESSOR CONTRACTOR: a. The Contractor shall coordinate an orderly and safe transition from the current incumbent Contractor to the new awardee, 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 current AIDS Reagent Program with the current Contractor and begin operation of the AIDS Reagent Program within 90 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 expiration date of this contract, the following items: 1) preserved reagent samples; 2) data files and program comprising the AIDS Reagent 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 21 TO THE OFFEROR: THE OFFEROR SHOULD INCLUDE TWO (2) "TRANSITION" PLANS" IN THE TECHNICAL PROPOSAL (AND COSTS IN THE BUSINESS PROPOSAL): 1) IN THE EVENT AN ORGANIZATION OTHER THAN THE CURRENT CONTRACTOR IS SELECTED, THE CURRENT INCUMBENT CONTRACTOR SHALL BEGIN TO MOVE THE AIDS REAGENT PROGRAM 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 ON OR ABOUT NOVEMBER 20, 1997; IT IS ESTIMATED THAT THIS WILL BE ACCOMPLISHED NO LATER THAN 90 CALENDAR DAYS FROM THE AWARD OF THE "NEW" CONTRACT; THEREFORE, THE OFFEROR SHOULD PROVIDE, IN THE TECHNICAL PROPOSAL, A TRANSITION PLAN FOR COORDINATING BETWEEN THE INCUMBENT CONTRACTOR AND THE OFFEROR THAT WILL 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 AIDS REAGENT MANAGEMENT SYSTEM; 2) PROVIDE WITH THE TECHNICAL PROPOSAL A PLAN FOR MOVEMENT OF THE AIDS REAGENT PROGRAM AT THE CONCLUSION OF "THIS" CONTRACT TO A NEW SITE; INCLUDE COSTS IN THE BUSINESS PROPOSAL FOR THIS MOVE.) (NOTE 22 TO THE OFFEROR: THE OFFEROR SHOULD FURNISH ITS PROPOSED STANDARD OPERATING PROCEDURES RELATING TO THE CONDUCT OF THIS CONTRACT AS PART OF THE TECHNICAL PROPOSAL.) ***************************************************************** ATTACHMENT A-1 LIST OF GOVERNMENT FURNISHED PROPERTY ______________________________________ Dates Purchased: 1. Equipment: (i) LKB Gamma Counter, Model 1272-001. 10/88 (ii) LKB Rackbeta Liquid Scintillation Counter, 10/88 Model 1209-005. (iii) Cryo-Frig -90 degree Centigrade Freezer, 05/90 Model C2090-DNS (20 cu.ft.). (iv) American Scientific Upright Refrigerator, 11/88 Model LR234-ANK (22.5 cu.ft.) (v) American Scientific Refrigerator/Freezer, 11/88 Model GCS141-A0A (10.9 cu.ft./3.1 cu.ft.). (vi) Taylor Wharton Liquid Nitrogen Tank, 01/93 Model 33KCT (33,000 vial capacity) The above listed new equipment provided to the AIDS Reagent Program is under preventive maintenance contract and is in good working condition. 2. Computer Software: (i) AIDS Reagent Management System: 38 information files, approximately 18 Megabytes; 253 programming files, approximately 8.5 Megabytes. (ii) Annual catalog of reagents: 170 files, 4.0 Megabytes; data sheets, 689 files, 14 Megabytes. (iii) One Folio file (.nfo) of catalog information, approximately 7.9 Megabytes. (iv) Thirty Folio Search and Replace (FSR) files, approximately 188 Megabytes. 3. Paper Files: Ten, 4-drawer file cabinets for accumulated paperwork. Four, 5-drawer file cabinets for accumulated paperwork. 4. Journals: Five, 7'X 4'(wide) and 18" deep bookshelves stacked with scientific journals. 5. Shipping Materials: Nine, 6-ft shelving units containing packing and shipping materials. 6. Reagents: Majority of the approximately 127,000 reagents samples, including drugs, are stored in 1.0 or 2.0 ml Nunc tube type vials as follows: Storage Temperature Storage Space Number of Samples (degree Centigrade) (cubic foot) 24 21 1,200 2-8 82 7,500 -20 40 11,000 -90 94 52,000 -135 61 55,000 Total 298 cu ft 126,700 ********************************************************** ATTACHMENT A-2 SAFETY CONTROLS AND STANDARDS ___________________________ PHS 352.223-70 SAFETY AND HEALTH (APRIL 1984) 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 will 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) Recommendations for Prevention of HIV Transmission in Health-Care Settings, Morbidity and Mortality Report, August 21, 1987, Vol. 35, No. 2S. (3) Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings. Morbidity and Mortality Weekly Report, June 24, 1988, Vol. 37, No. 24. (4) Agent Summary Statement for Human Immunodeficiency Viruses (HIV); Included are GTLV-III, LAV, HIV-1, and HIV-2. Morbidity and Mortality Weekly Report, April 1, 1988, Vol. 37, No. S4. (5) Recommendations for the Safe Handling of Parentoral Antineoplastic Drugs, NIH Publication No. 83-2621. (6) NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication No. 81-2385. The above, (1) - (6), may be obtained from: Division of Safety Office of Research Services National Institutes of Health Building 31, Room 1C02 31 CENTER DR MSC 2260 BETHESDA MD 20892-2260 (7) Occuupational Safety and Health Administration (OSHA) Publications: 1) 29 CFR Part 1910.1030, Occupational Exposure to Blood Borne Pathogens, Final Rule, and; 2) 29 CFR Part 1910, Occupational Exposure to hazardous chemicals in Laboratories, Final Rule. The above 1 and 2 can be obtained from: Division of Safety Office of Research Services National Institutes of Health Building 31, Room 1C02 31 CENTER DR MSC 2260 BETHESDA MD 20892-2260 (8) Guidelines for Research Involving Recombinant DNA Molecules (49 FR 46266 or latest revision) and Administrative Practices Supplement. These may be obtained from: Office of Recombinant DNA Activities Office of Science Policy and Legislation National Institutes of Health Building 31, Room B1C34 31 CENTER DR MSC 2250 BETHESDA MD 20892-2250 (9) Procedures for the Domestic handling and Transport of Diagnostic Specimens and Etiologic Agents, National Committee for Clinical Laboratory Standards, July 17, 1985, Vol. 5. This may be obtained from National Committee for Clinical Laboratory Standards 771 East Lancaster Avenue Villanova, Pennsylvania 19085 Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer may determine to be reasonably necessary; provided, that if compliance with such additional safety measures results in a material increase in the cost or time of performance of the contract, an equitable adjustment will be made in accordance with the clause of this contract entitled "Changes." b. Prior to commencement of work, the Contractor will submit in writing its plan for complying with the safety and health provisions of this contract, and will meet with the Contracting Officer or his/her designated representative to discuss and develop a mutual understanding relative to administration of the overall safety program. c. During the performance of work under this contract, the Contractor shall comply with all procedures prescribed by the Contracting Officer for the control and safety of persons visiting the job site and will comply with such requirements to prevent accidents as may be prescribed by the Contracting Officer. d. The Contractor will maintain an accurate record of, and report to the Contracting Officer in such manner as the Contracting Officer may prescribe, all accidents and incidents resulting in death, traumatic injury, occupational disease, and/or damage to all property incident to work performed under the contract. e. The Contracting Officer shall notify (if otherwise, confirm in writing) the Contractor of any noncompliance with the provisions of this clause and corrective action to be taken. After receipt of such notice, the Contractor shall immediately take such corrective action. (Such notice, when delivered to the Contractor or its representative at the site of the work, shall be deemed sufficient for the purpose.) If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action has been taken. No part of the time lost due to any such stop order shall be the subject of claim for extension of time or for costs or damages by the Contractor. f. The Contractor shall insert the substance of this clause in each subcontract involving the use of hazardous materials or operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor. (End of clause) *********************************************************************** 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, 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 AIDS Reagent Program 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.1. above and the information required in A.2. above. 1. The final report shall be submitted by the expiration 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. C. OTHER DELIVERABLES. The Contractor, subject to the Contracting Officer, approval shall deliver to the Government or its designee by the expiration date of the Contract, the following items: (1) Preserved reagent samples; (2) AIDS Reagent Management System and documentation on the computer systems/files; (3) Computerized listing of accurate and updated information on reagent inventory, including activities of the AIDS Reagent Program, 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-DAIDS-98-03 ATTACHMENT C (January 28, 1997) EVALUATION FACTORS FOR AWARD ---------------------------- 1. GENERAL Proposals submitted in response to this solicitation will be subjected to review by an ad hoc technical review committee. 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 merit of each proposal will be evaluated carefully, based on responsiveness to the RFP and thoroughness and feasibility of the technical approach taken. Offerors must submit information sufficient to evaluate their proposal based on the detailed criteria listed below. Failure to provide the information required to evaluate the proposal may result in rejection of that proposal without further consideration. While high competency is sought, capabilities that exceed those needed for successful performance of the contract work statement are not requested. 2. COMPARATIVE IMPORTANCE OF PROPOSALS You are advised that paramount consideration shall be given to the evaluation of the technical proposals, but not to the exclusion of past performance and cost considerations. The past performance capability of the offeror and estimated cost of an offer will be considered to determine which offer provides the best or greatest overall value to the Government. Past performance will be evaluated apart from the technical evaluation and the cost/price analysis (See Item 4. below for additional past performance information). At Source Selection, the technical evaluation will count for NINETY PERCENT (90%) of the overall evaluation and past performance will count for TEN PERCENT (10%) of the overall evaluation. In cases where offers are considered to be equal based on the combined technical and past performance evaluation, the estimated cost to the Government may be the determining factor for award of a contract. In any event, the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered. 3. PROPOSAL EVALUATION CRITERIA 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 POINTS A. TECHNICAL APPROACH 55 Points The technical adequacy, feasibility, safety and effectiveness of the detailed and specific plans demonstrating knowledge, experience and competence, standard operating procedures, and quality control measures proposed for operation of an AIDS Reagent Program, including: (1) Identification, prioritization, and acquisition of reagents from domestic and international sources;(15 points) (2) Production/expansion of reagents; evaluation of the quality and activity of the reagents; (10 points) (3) Coordination of the operation of the AIDS Reagent Program through interactions with the AIDS research community, biotechnology and pharmaceutical companies (worldwide), technology transfer officials, and the Division of AIDS, including sponsoring workshops and awareness- promoting activities; plan for providing editorial and publishing services for the catalog of reagents and the newsletter; plan for resolving potential conflicts of interest if a commercial organization is acquiring potentially valuable reagents for this program instead of for offeror's commercial use; (10 points) (4) Maintaining and updating internal information database systems and on the World Wide Web, to track all information that relates to the activities of the AIDS Reagent Program, including an inventory of reagents, shipment and receiving of reagents, and assay information; (10 points) (5) Effecting smooth transitions between Contractors, including providing assistance to the incumbent Contractor to ensure a safe and efficient move of the AIDS Reagent Program; and coordinating an orderly transition to the successor Contractor. Quality of the Standard Operating Procedures submitted to BEGIN operation of the AIDS Reagent Program. (10 points) B. PERSONNEL QUALIFICATIONS 25 Points (1). Documented training, experience and availability of a Principal Investigator with technical and administrative competence to operate an AIDS Reagent Program or a Project of comparable size and complexity; the proposed P.I. should have a Ph.D. or its equivalence, and postdoctoral research experience in biological sciences; demonstrated knowledge and research experience in retrovirology in order to identify and prioritize HIV/AIDS reagents and to provide technical assistance (10 points). (2). Documented training, experience and availability of other professional and support staff necessary to successfully carry out proposed roles, including editorial and demonstrated scientific writing (preferably experience in human virology and/or retroviruses) to prepare an AIDS Reagent Program catalog, a scientific newsletter and promotional literature; experience with promotion of a AIDS research service/business; laboratory competence and familiarity with safety regulations and World Wide Web site maintenance experience (15 points). C. FACILITIES AND RESOURCES 20 Points Documented availability of adequate facilities, equipment and resources necessary to safely operate, maintain and expand this AIDS Reagent Program; facilities to ship, receive and store hazardous and infectious agents, and maintain their activity and viability. The offeror offer must provide: 1) a detailed floor plan of the proposed facility which shows location of the equipment and resources; 2) information regarding ownership/lease of the facility which demonstrates availability for the duration of the proposed contract); 3) plan for compliance with all safety guidelines and regulations, including training and monitoring of personnel for exposure to infectious and hazardous reagents; and 4) logistic plan for storage, packaging and shipping of reagents nationally and internationally, including notification mechanism for date reagent received and condition of reagent upon receipt; logistic plan for receiving, processing and storing incoming reagent shipments. TOTAL 100 Points 4. 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 At SOURCE SELECTION (after the initial technical review and negotiations), past performance information from Offerors who comprise the competitive range will be evaluated using the following CUSTOMER SURVEY: **************************************************** [SAMPLE-DO NOT COMPLETE] NATIONAL INSTITUTES OF HEALTH CONTRACTOR PERFORMANCE - RFP CUSTOMER SURVEY QUESTIONNAIRE Please complete the following questionnaire and return via regular mail or fax to the attention of: (Name) (Address) (Fax Number) BASELINE INFORMATION This survey pertains to the company: Contract Number: Date of survey: Name of person completing survey: Signature of person completing survey: Your company/Agency: Your role in this contract (circle one): Contracting Officer Contract Specialist Project Officer Other Time period covered including all option periods: Contract value including all option and option periods: $ Type of Contract: Approximate percentage of work being performed (or completed) by subcontractor(s): % Subcontracting company names (where more than__ % of work was completed by the subcontractor). Company Program Manager Phone Company Program Manager Phone Company Program Manager Phone General description of products/services required under the contract: RATINGS Please answer each of the following questions with a rating that is based on objective measurable performance indicators to the maximum extent possible. Commentary to explain rating can be noted on an attachment. Assign each area a rating of 0 (Unsatisfactory), 1 (Poor), 2 (Fair), 3 (Good), 4 (Excellent), or 5 (Outstanding). Use the attached Rating Guidelines as a guidance in making these evaluations. Circle the appropriate rating. If you do not have enough personal knowledge or feedback from internal customers who directly received products and services from the contractor to make a determination on any of the performance criteria below, please circle the þN/Aþ (not applicable/no opinion) answer. QUALITY OF SERVICE 1. Compliance with contract requirements: 0 1 2 3 4 5 N/A 2. Accuracy of reports: 0 1 2 3 4 5 N/A 3. Effectiveness of personnel: 0 1 2 3 4 5 N/A 4. Technical excellence: 0 1 2 3 4 5 N/A COST CONTROL 1. Record of forecasting and controlling target costs: 0 1 2 3 4 5 N/A 2. Current, accurate and complete billings: 0 1 2 3 4 5 N/A 3. Relationship of negotiated costs to actuals: 0 1 2 3 4 5 N/A 4. Cost efficiencies: 0 1 2 3 4 5 N/A TIMELINESS OF PERFORMANCE 1. Met interim milestones: 0 1 2 3 4 5 N/A 2. Reliability: 0 1 2 3 4 5 N/A 3. Responsive to technical direction: 0 1 2 3 4 5 N/A 4. Completed on time including wrap-up and contract administration: 0 1 2 3 4 5 N/A 5. Met delivery schedules: 0 1 2 3 4 5 N/A 6. No liquidated damages assessed: Yes No (circle one) BUSINESS RELATIONS 1. Effective management, including subcontracts: 0 1 2 3 4 5 N/A 2. Reasonable/cooperative behavior: 0 1 2 3 4 5 N/A 3. Responsive to contract requirements: 0 1 2 3 4 5 N/A 4. Notification of problems: 0 1 2 3 4 5 N/A 5. Flexibility: 0 1 2 3 4 5 N/A 6. Pro-active vs reactive: 0 1 2 3 4 5 N/A 7. Effective small/small disadvantaged business subcontracting program: 0 1 2 3 4 5 N/A CUSTOMER SATISFACTION 1. The contractor is committed to customer satisfaction. Yes No (circle one) 2. Would you recommend selection of this firm again? Yes No (circle one) ADDITIONAL COMMENTS: ******************************************************************** RATING GUIDELINES Summarize contractor performance in each of the rating areas. Assign each area a rating of 0 ( UNSATISFACTORY), 1 (POOR), 2 (FAIR), 3 (GOOD), 4 (EXCELLENT), OR 5 (OUTSTANDING). Use the following instructions as guidance in making these evaluations. Ensure that this assessment is consistent with any other Agency assessments made (i.e., for payment of fee purposes). CRITERIA --------- QUALITY OF PRODUCT OR SERVICE (Compliance with contract requirements; Accuracy of reports; Effectiveness of personnel; Technical excellence) 0 Unsatisfactory: contractor is not in compliance and is jeopardizing achievement of contract objectives. 1 Poor: major problems have been encountered. 2 Fair: some problems have been encountered. 3 Good: minor inefficiencies/errors have been identified. 4 Excellent: contractor is in compliance with contract requirements and/or delivers quality products/services. 5 Outstanding: the contractor has demonstrated an outstanding performance level in this category that justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances when contractor performance clearly exceeds the performance levels described as "Excellent." -------------------------------------------------- COST CONTROL (Record of forecasting and controlling target costs; Current, accurate and complete billings; Relationship of negotiated costs to actuals; Cost efficiencies) 0 Unsatisfactory: Contractor is unable to manage costs effectively 1 Poor: Contractor is having major difficulty in managing costs effectively. 2 Fair: Contractor is having some problems in managing costs effectively. 3 Good: Contractor is usually effective in managing costs. 4 Excellent: Contractor is effective in managing costs and submits current, accurate, and complete billings. 5 Outstanding: The contractor has demonstrated an outstanding performance level in this category that justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances when contractor performance clearly exceeds the performance levels described as "Excellent." ----------------------------------------------- TIMELINESS OF PERFORMANCE (Met interim milestones; Reliability; Responsive to technical direction; Completed on time including wrap-up and contract administration; Met delivery schedules; No liquidated damages assessed) 0 Unsatisfactory: Contractor delays are jeopardizing performance of contract objectives. 1 Poor: Contractor is having major difficulty meeting milestones and delivery schedules 2 Fair: Contractor is having some problems meeting milestones and delivery schedules. 3 Good: Contractor is usually effective in meeting milestones and delivery schedules 4 Excellent: Contractor is effective in meeting milestones and delivery schedules. 5 Outstanding: The contractor has demonstrated an outstanding performance level in this category that justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances when contractor performance clearly exceeds the performance levels described as þExcellent.þ ------------------------------------------------------- BUSINESS RELATIONS (Effective management,including subcontracts; Reasonable/cooperative behavior; Responsive to contract requirements; Notification of problems; Flexibility; Pro-active vs reactive; Effective small/small disadvantaged business subcontracting program) 0 Unsatisfactory: Response to inquiries, technical/service/administrative issues is not effective. 1 Poor: Response to inquiries,technical/service/admin- istrative issues is marginally effective 2 Fair: Response to inquiries, technical/service/admin- istrative issues is somewhat effective. 3 Good: Response to inquiries, technical/service/admin- istrative issues is usually effective. 4 Excellent: Response to inquiries, technical/service/admin-istrative issues is effective. 5 Outstanding: The contractor has demonstrated an outstanding performance level in this category that justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances when contractor performance clearly exceeds the performance levels described as "Excellent." ********************************************************** RFP-NIH-NIAID-DAIDS-98-03 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 award will be made on or about January 20, 1998 (NOTE: award may be made by November 20, 1997, to allow for a transition period to a new contractor). It is anticipated that the award from this solicitation will be multiple-year, cost-reimbursement type level-of-effort contract with a period of performance of 7 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]. 2. LEVEL-OF-EFFORT The Government's requirement for the work set forth in the Work Statement of this solicitation is 101,920 DIRECT LABOR HOURS over the 7-year contract. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows: DIRECT LABOR HOURS* ------------------ PRINCIPAL ASSIST. P.I. INVEST. OTHER SCIENT. SUPPORT TOTALS ---------------------------------------------------------------- YEAR 1 2,080 4,160 8,320 14,560 YEAR 2 2,080 4,160 8,320 14,560 YEAR 3 2,080 4,160 8,320 14,560 YEAR 4 2,080 4,160 8,320 14,560 YEAR 5 2,080 4,160 8,320 14,560 YEAR 6 2,080 4,160 8,320 14,560 YEAR 7 2,080 4,160 8,320 14,560 --------------------------------------------------------------- TOTALS 14,560 29,120 58,240 101,920 *EFFORT IN THE ABOVE CHART WAS BASED ON 100% EFFORT (1 FULL-TIME EQUIVALENT = 2,080 HOURS PER YEAR), WHICH INCLUDES HOLIDAYS AND OTHER PAID ABSENCES. IF YOU ARE USING A DIFFERENT BASE, PLEASE STATE THE WORK-YEAR USED IN YOUR PROPOSAL. THE ABOVE LEVEL-OF- EFFORT IS THE GOVERNMENT'S ESTIMATE OF THE EFFORT THAT WILL BE NECESSARY TO SATISFACTORILY ACCOMPLISH THE OBJECTIVES OF THESE PROGRAM, AND IT WILL BE USED AS A BASIS FOR NEGOTIATIONS. YOU CAN PROPOSE DEVIATIONS FROM THIS ESTIMATED LEVEL OF EFFORT, WITH JUSTIFICATION. 3. 52.233-2 SERVICE OF PROTEST (NOV 1988) (a) 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: Mr. Bruce Anderson Hand-Carried Address: NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard Rockville, Maryland 20852 Mailing Address: NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard (MSC 7610) Bethesda, Maryland 20892-7610 (b) 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. 4. PACKAGING AND DELIVERY OF THE PROPOSAL (NIH 2995) (JUL 1994) 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-DAIDS-98-03 TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY Number of Copies: ________________ TECHNICAL PROPOSAL: ORIGINAL AND 20 COPIES BUSINESS PROPOSAL: ORIGINAL AND 5 COPIES If hand delivered or delivery service ------------------------------------- Contract Specialist Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard Rockville, Maryland 20852 If using U.S. Postal Service --------------------------- Contract Specialist Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard (MSC 7610) Bethesda, Maryland 20892-7610 * THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES 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" and handled 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 PLEASE USE THE FOLLOWING FORMAT TO ORGANIZE AND PRESENT YOUR TECHNICAL PROPOSAL-THIS WILL AID IN THE REVIEW OF THE PROPOSALS RECEIVED: SECTION # PAGE # --------- ------- I. TECHNICAL PROPOSAL COVER SHEET (Format in Section C of Gopher RFP: FORMS, FORMATS, ATTACHMENTS) II. TECHNICAL PROPOSAL TABLE OF CONTENTS III. TECHNICAL PROPOSAL* SUB-SECTIONS - THE OFFEROR SHOULD STRUCTURE THEIR PROPOSAL TO MIRROR THE WORK STATEMENT AND EVALUATION CRITERIA AS FOLLOWS (IN CASE OF ANY INCONSISTANY BETWEEN THE LANGUAGE BELOW AND THE WORK STATEMENT/EVALUATION CRITERIA IN THIS RFP, THE LATER RULE): -------- SECTION A: WORK STATEMENT (DISCUSS YOUR SPECIFIC TECHNICAL APPROACH TO): (1) IDENTIFICATION, PRIORITIZATION, AND ACQUISITION OF REAGENTS FROM DOMESTIC AND INTERNATIONAL SOURCES; [qualifications and experience in the identification, prioritization, and acquisition of reagents from domestic and international sources; outline of what reagents need to be acquired and how you would prepare to do this; prioritize the most important acquisitions] [see Work Statement Note 3]. (2) PRODUCTION/EXPANSION OF REAGENTS; EVALUATION OF THE QUALITY AND ACTIVITY OF THE REAGENTS; [plan for production/expansion of reagents, and how the quality and activity of the acquired reagents will be verified] [see Work Statement Notes 3,6,7] (3) COORDINATION OF THE OPERATION OF THE AIDS REAGENT PROGRAM THROUGH INTERACTIONS WITH THE AIDS RESEARCH COMMUNITY, BIOTECHNOLOGY AND PHARMACEUTICAL COMPANIES (WORLDWIDE), TECHNOLOGY TRANSFER OFFICIALS, AND THE DIVISION OF AIDS, INCLUDING SPONSORING WORKSHOPS AND AWARENESS-PROMOTING ACTIVITIES; [plan for interacting with the AIDS research community, sponsoring workshops and awareness-promoting activities; how the editorial and technical support for the above publications will be provided; plan for resolving potential conflicts of interest if a commercial organization is acquiring potentially valuable reagents for this program instead of for offerorþs commercial use] [see Work Statement Notes 5,16,17] (4) MAINTAINING AND UPDATING INTERNAL INFORMATION DATABASE SYSTEMS AND ON THE WORLD WIDE WEB, TO TRACK ALL INFORMATION THAT RELATES TO THE ACTIVITIES OF THE AIDS REAGENT PROGRAM, INCLUDING AN INVENTORY OF REAGENTS, SHIPMENT AND RECEIVING OF REAGENTS, AND ASSAY INFORMATION. [plan to provide an inventory and distribution database and management system;; propose appropriate computer hardware and software for this requirement, and a plan for maintenance, data input and data back-up; plan to continue to provide aids reagent program information on the world wide web and how the offeror will keep current with the advancing technology of the world wide web] [see Work Statement Note 19]. (5) EFFECTING SMOOTH TRANSITIONS BETWEEN CONTRACTORS, INCLUDING PROVIDING ASSISTANCE TO THE INCUMBENT CONTRACTOR TO ENSURE A SAFE AND EFFICIENT MOVE OF THE AIDS REAGENT PROGRAM; AND COORDINATING AN ORDERLY TRANSITION TO THE SUCCESSOR CONTRACTOR. QUALITY OF THE STANDARD OPERATING PROCEDURES SUBMITTED TO BEGIN OPERATION OF THE AIDS REAGENT PROGRAM. [Discussion of the two Transition Plans; proposed standard operating procedures relating to BEGIN operation of this contract] [see Work Statement Notes 21,22]. SECTION B: RESOURCES/OTHER CONSIDERATIONS Documented availability of adequate facilities, equipment and resources necessary to safely operate, maintain and expand this AIDS Reagent Program; facilities to ship, receive and store hazardous and infectious agents, and maintain their activity and viability. THE OFFEROR OFFER SHOULD PROVIDE: (1) A DETAILED FLOOR PLAN OF THE PROPOSED FACILITY WHICH SHOWS LOCATION OF THE EQUIPMENT AND RESOURCES TO BE DEDICATED TO THIS EFFORT; [see Work Statement Note [3]. (2) INFORMATION REGARDING OWNERSHIP/LEASE OF THE FACILITY WHICH DEMONSTRATES AVAILABILITY FOR THE DURATION OF THE PROPOSED CONTRACT; (3) PLAN FOR COMPLIANCE WITH ALL SAFETY GUIDELINES AND REGULATIONS, INCLUDING TRAINING AND MONITORING OF PERSONNEL FOR EXPOSURE TO INFECTIOUS AND HAZARDOUS REAGENTS; [submit copy of current Safety and Health Plan; evidence of adequate training of personnel handling infectious agents including hiv and opportunistic pathogens associated with hiv infection, radioactive substances, dealing with accidents, and monitoring for infection, as well as the ability to identify safety standards applicable to particular reagents likely to be acquired] [see Work Statement Note 9]. (4) LOGISTIC PLAN FOR STORAGE, PACKAGING AND SHIPPING OF REAGENTS NATIONALLY AND INTERNATIONALLY, INCLUDING NOTIFICATION MECHANISM FOR DATE REAGENT RECEIVED AND CONDITION OF REAGENT UPON RECEIPT; LOGISTIC PLAN FOR RECEIVING, PROCESSING AND STORING INCOMING REAGENT SHIPMENTS. [logistic plan for storage, packaging and shipping of reagents nationally and internationally; plan for how the incoming reagents will be delivered to the aids reagent program in a timely manner; for shipments out of the aids reagent program, plan for establishing a mechanism for being notified by requester of date reagents were received and condition of reagents upon receipt; action plan for identifying malfunction, a process to test capability, and a process for transfer of reagents from malfunctioning refrigerators/freezers; experience in procuring the appropriate import/export licenses and permits] [see Work Statement Notes 8,10,13,14]. SECTION C: PERSONNEL list personnel by name, title, department and organization, and detail each person's qualifications, role, and level- of-effort in NARRATIVE Format (ATTACH RESUMES IN SECTION D BELOW AND A FLOWCHART SHOWING ORGANIZATIONAL LINES OF AUTHORITY); identify any subcontractor/consultant personnel and provide their qualifications) (1) DOCUMENTED TRAINING, EXPERIENCE AND AVAILABILITY OF A PRINCIPAL INVESTIGATOR (2) DOCUMENTED TRAINING, EXPERIENCE AND AVAILABILITY OF OTHER PROFESSIONAL AND SUPPORT STAFF [NOTE: FOR KEY PERSONNEL, ALSO INCLUDE THE FORM ENTITLED "SUMMARY OF CURRENT AND PROPOSED ACTIVITIES" UNDER SECTION D BELOW] SECTION D: APPENDICES: (list each Appendix; Appendices should be clear and legible, and easily located) (1) Resumes and flowchart of organizational structure for this project (IT IS RECOMMENDED THAT RESUMES BE REDUCED TO NO MORE THAN 2 PAGES IN LENGTH) (2) Any policy manuals, safety manuals, SOPs for above Technical Plan); (3) "Summary of Current and Proposed Activities" (ALL key personnel should be listed on this form; it is located in the FORMS, FORMATS, ATTACHMENTS Directory found IN Section C, Gopher RFP) (4) "Technical Proposal Cost Information" form (located in Section C, Gopher RFP, FORMS, FORMATS, & ATTACHMENTS) ** Sections III.A through III.C. above MUST NOT EXCEED 75 PAGES (this does not include any appendices but only the NARRATIVE description of the Technical Plan). The front side of a page equals one page (front and back of a page equals two pages). 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 an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. ************************************************** 6. PROPOSAL INTENT RESPONSE SHEET PROPOSAL INTENT --------------- RFP No.:NIH-NIAID-DAIDS-98-03 PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY THE EARLIEST PRACTICABLE DATE. 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-DAIDS-98-03 NIH-AIDS RESEARCH AND REFERENCE REAGENT PROGRAM [] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS: ____________________________________________________ TYPED NAME AND TITLE: ________________________________________ INSTITUTION:________________________________________ SIGNATURE:________________________________________ TELEPHONE NO.:________________________________________ DATE: ________________________________________ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - COLLABORATORS/CONSULTANTS - Provide name(s) and institution(s): (Continue list on reverse if necessary) __________________________________________________________ __________________________________________________________ RETURN TO: CMB, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard (MSC 7610) Bethesda, Maryland 20892-7610 Attn: Bruce Anderson RFP NIH-NIAID-DAIDS-98-03 Fax # 301/402-0972 PLEASE RETURN BY: MARCH 28, 1996 ************************************************** RFP-NIH-NIAID-DAIDS-98-03 ATTACHMENT E III. APPLICABLE RFP REFERENCES ------------------------------- This section identifies the items located in the Gopher directory "C. 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" (item 2. below). 2. The following items are applicable from the file entitled" OPTIONAL RFP INSTRUCTIONS AND PROVISIONS": (1) LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS OF PROPOSALS, PHS 352.215-10 (2) PAST PERFORMANCE INFORMATION (SINCE PAST PERFORMANCE IS AN EVALUATION CRITERION, THIS ITEM IS APPLICABLE) (3) SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS SUBCONTRACTING PLAN (DOES NOT APPLY TO SMALL BUSINESSES) (4) FACILITIES CAPITAL COST OF MONEY (FOR COMMERCIAL ORGANIZATIONS) 3. The following items are applicable from the subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS": Applicable to TECHNICAL PROPOSAL -------------------------------- (1) Technical Proposal Cover Sheet (2) Technical Proposal Cost Information, Dec 1988 (3) Summary of Current and Proposed Activities, July 1995 Applicable to BUSINESS PROPOSAL ------------------------------- (4) Contract Pricing Proposal, SF-1411, (Rev. 10/95) (5) Proposal Summary and Data record, NIH-2043 (Rev. 6/82) (6) Business Proposal Cost Information (7) Disclosure of Lobbying Activities, OMB SF-LLL To Become CONTRACT ATTACHMENTS ------------------------------ (8) Invoice/Financing Requests Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1, JUN 1992 (9) Form NIH 2706 (Financial Report) and Instructions for Completing Form NIH 2706; note - financial reports are not always required and this will be discussed during negotiations (10) Procurement of Certain Equipment, NIH(RC)-7 OTHER - TO BE SUBMITTED AS DIRECTED BY CONTRACTING OFFICER --------------------------------------------------------- (11) Certificate of Current Cost or Pricing Data, NIH- 1397 4. The Representations and Certifications are applicable. 5. The "Sample Contract Format-General" is applicable.