AMENDMENT OF SOLICITATION RFP NHLBI-HB-98-04: Maintenance of NHLBI Biological Specimen Repository -------------------------------------------- 1. AMENDMENT OF SOLICITATION NO.: RFP-NHLBI-HB-98-04 2. AMENDMENT NO.: 1 3. AMENDMENT DATE: September 19, 1997 4. RFP ISSUE DATE: September 2, 1997 5. ISSUED BY: National Institutes of Health National Heart, Lung, and Blood Institute Contracts Operations Branch Rockledge Building, Room 6140 6701 Rockledge Drive MSC 7902 BETHESDA MD 20892-7902 6. NAME AND ADDRESS OF CONTRACTOR: To all recipients of RFP No. NIH-NHLBI-HB-98-04 7. This amendment revises various sections of the RFP as shown below and answers/clarifies questions/comments raised at the Preproposal Conference held on September 15, 1997. ******************************************* Revision 1: Part III. Applicable RFP References, (Attachment 6), Paragraph A. is modified to add the following paragraph: Deletion of subparagraph d) Best Buy Analysis included in STANDARD RFP INSTRUCTIONS AND PROVISIONS,under paragraph e. (10) and insertion of subparagraph d) Selection as follows: d) Selection. The Government will select an offeror or offerors as stated in the Evaluation Factors for Award, including the Technical Evaluation Criteria section of the RFP. Cost and past performance analyses, and an offeror's ability to complete the work within the Government's required schedule will also be considered, if, and as, indicated in the Evaluation Factors for Award. Such consideration of greatest value will be done in support of, not in place of, the Evaluation Factors for Award section of the RFP. ********************************* Revision No. 2: Answers/Clarifications of Questions/Comments from Preproposal Conference, September 15, 1997 Question 1: In Task 5 of the workscope it states: It is expected that 500-1,000 assays will be required per year; is it known how may of each individual assay will be required? Answer 1: Because the type and number of the tests required will depend upon the nature of the research contemplated in a given protocol (e.g., the pharmacokinetics protocol of ACTG 185), it is impossible to do any better than to come up with an estimate, as we did in the RFP. For example, the last research protocol requiring testing by the current contractor focused on Western Blot for the identification of protease-resistant TSE prion-protein in the brain tissue of infected mice. The contractor was responsible for approximately 400 of these tests. ------------------ Question 2: Please describe a panel of aliquots. Answer 2: Typically, a panel of aliquots comprises a number of biological specimens requested by an investigator and approved by the NHLBI Utilization Committee. These specimens will be identified by the Project Officer and the contractor will be required to pull such samples from their locations in the freezers, aliquot them (if necessary), and label each vial to be included in the panel with a code number since all panels are blind panels. A comprehensive description regarding preparation and shipment of panels can be found under Task 3 of the RFP. It is estimated that 50 panels, containing 100 vials each, will be required annually. ------------------ Question 3: The award date of the contract as stated in the RFP is to be June 15, 1998, the repository must be relocated by December 15, 1998 and there are 400,000 specimens that need to be shipped and inventoried. Therefore, is it possible to move the repository in the month of July 1998, well before the December 15, 1998 and the arrival of the 400,000 specimens? If July is too early, then how soon after the award can plans be made to move the repository? Answer 3: The relocation of the NHLBI repository may be implemented at any time after the award date, provided that the awardee has satisfied the DOT requirements. It is anticipated that the 400,000 specimens from REDS mentioned on page 4 of the RFP will be integrated in the repository prior to the award date. ------------------ Question 4: Why are there only 700,000 specimens in the SAS/Repository Management System (RMS) and 2.1 million specimens in a FoxPro data-base? Is the plan to maintain these 2 separate data-base inventories? If so, how are the 2 systems to be used? If not, which data-base is to be the primary one? Then, is it planned that the other is to be phased-out and its inventory transferred to the primary data-base? Please clarify. Answer 4: The 700,000 samples managed by SAS/RMS are derived from 2 contracts with the University of Southern California, the Transfusion-Transmitted Viruses Study (TTVS) and the Transfusion Safety Study (TSS). The contractor has entered all these specimens into the SAS/RMS at the request of the NHLBI. The Institute is considering utilizing the same system to manage specimens from the Retrovirus Epidemiology Donor Study (REDS) in the future. However, for the foreseeable future, all specimens other than TSS and TTVS shall be maintained in the FoxPro database. Thus, the 2 systems are to be used. ------------------ Question 5: In the previous RFP associated with the NHLBI contract, there was a specific aliquot protocol that the government wanted the contractor to follow. For example, each glass vial was suppose to be placed in a separate heat-sealed sterile plastic bag when being thawed. Is this protocol still going to be required? Answer 5: As specified on page 5 of the RFP, there are no explicit guidelines for the preparation of aliquots. The contractor is expected to observe the standards described in the 2 publications that the RFP refers to on page 5, under Task 2. ------------------ Question 6: How extensive is the documentation necessary for the contractor to provide NHLBI when training in-house staff? Answer 6: The training of personnel directly involved in the handling of specimens should be documented by citing the type and duration of the course, and the date taken for the individual in question. ------------------ Question 7: In this current RFP, NHLBI states that by the end of this contract 4 liquid nitrogen freezers and 138 mechanical -70øC freezers will exist; however, the previous solicitation stated that there would be 5 liquid nitrogen freezers and 110 mechanical -70øC. Which numbers are correct? Answer 7: The figures given in the current RFP are to be used by offerors. ------------------ Question 8: How quickly does NHLBI want the 400,000 specimens inventoried and data entered into the appropriate data-base? Answer 8: Moot question (see response to question # 1). ------------------ Question 9: Do you want a commercial kit or in house assay for the WB for spongiform? Answer 9: During the last year, investigators supported by the Institute have been utilizing an ECL-Kit marketed by Amersham to perform the Western Blot with specimens suspected to harbor TSE prion-protein. It is anticipated that this kit (or a similar product) shall be used in the future. ********************************************* 8. The hour and date specified for receipt of offers is NOT extended. If you submit a proposal, please acknowledge that your proposal is based on the original RFP and this amendment. Failure of this acknowledgment in your proposal may result in rejection of your offer. ********************************* 9A. NAME AND TITLE OF CONTRACTING OFFICER (type or print): Joann A. Ciufolo, Contracting Officer 9B. UNITED STATES OF AMERICA BY (Signature of Contracting Officer) /signed/ 9C. DATE SIGNED: September 17, 1997 .