RFP No. RFP-NIH-NHLBI-HV-98-13 Lipoprotein (a) [Lp(a)] Standardization Program This RFP consists of I. Streamlined Technical RFP II. Specific RFP Instructions and Provisions III. Applicable RFP REFERENCES ******************************************************************** I. Streamlined Technical RFP A. Solicitation Form/Cover Letter Purchase Authority: Public Law 95-83, as amended RFP No. NIH-NHLBI-HV-98-13 Title: Lipoprotein (a) [Lp(a)] Standardization Program Issued by: Robert A. Julia Contracting Officer NIH/NHLBI Contracts Operations Branch Rockledge 2 Building, Room 6110 6701 ROCKLEDGE DR MSC7902 BETHESDA MD 20892-7902 DATE ISSUED: December 2, 1997 DATE PROPOSAL DUE: February 17, 1998, 4:30 P.M. (EST) SMALL BUSINESS SET-ASIDE: NO (SIC CODE: 8733) Ladies and Gentlemen: The Streamlined Technical RFP portion of this RFP consists of this combined solicitation form and cover letter and four additional components, as follows: B. Work Statement with Project Information; C. Reports/Deliverables; D. Special Requirements; E. Evaluation Factors for Award, including Technical Evaluation Criteria; These components contain the technical information required for the submission of a proposal for this acquisition. In addition, there are two other sections to this specific RFP. The section entitled "Specific RFP Instructions and Provisions" contains, for example, the address for delivery of your proposal, as well as other provisions that provide specific information for this RFP. The section entitled "Applicable RFP REFERENCES" identifies those items resident on the Gopher directory that are applicable to this RFP. Although these documents contain sufficient information for you or your organization to submit a proposal, if you intend to submit a proposal in response to this RFP, IT IS ESSENTIAL THAT YOU IMMEDIATELY NOTIFY Robert Julia OF THE NHLBI CONTRACTING OFFICE AT THE FOLLOWING INTERNET ADDRESS: rj12s@nih.gov IF YOU DO NOT NOTIFY THE CONTRACTING OFFICE OF YOUR INTENT, YOU WILL NOT RECEIVE NOTICE OF AMENDMENTS TO THE RFP. HOWEVER, ALL AMENDMENTS WILL BE POSTED ON THE NIH GOPHER. The original and twenty-five (25) copies of your technical proposal and the original and six (6) copies of your business proposal must be received by the Contracting Officer no later than February 17, 1998 at 4:30 p.m. local time. Submit proposals to the address listed in the item entitled "Packaging and Delivery of Proposals" under Section II of this RFP entitled "Specific RFP Instructions and Provisions." Also, refer to that Section for the item entitled "Proposal Intent Response Sheet." Please complete this form and deliver it to the address indicated therein on or before January 6, 1998. This will allow us to expedite preparations for the peer review of proposals. You are reminded that the "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your technical proposal (a copy of this form is contained in this NIH Gopher under the FORMS, FORMATS, AND ATTACHMENTS subdirectory found in C. RFP REFERENCES). This information will be used to ensure that there will be no conflict of interest when selecting review committee members. Also, your proposal must be organized and submitted in accordance with the "Technical Proposal Table of Contents" found in Section II. NOTE: IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR DESIGNEE AT THE PLACE AND TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH FAR CLAUSE 52.215-10 ENTITLED "LATE SUBMISSIONS, MODIFICATIONS, AND WITHDRAWALS OF PROPOSALS." If you have any additional questions regarding this RFP, please contact Robert Julia through the Internet using the electronic mail address listed above, phone (301) 435-0340, or fax (301) 480-3338. COLLECT CALLS WILL NOT BE ACCEPTED. SUBMISSION OF PROPOSALS USING FAX OR ELECTRONIC MAIL IS NOT AUTHORIZED. Sincerely, /s/ Robert A. Julia Contracting Officer ******************************************************************** B. Work Statement with Project Information The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), has a requirement to reach a consensus on how to define and express Lipoprotein (a) [Lp(a)] values and to obtain a common reference material to be used to harmonize the data. The measurement of lipoprotein (a) [henceforth abbreviated as Lp(a)] is of growing clinical interest because of its potential use as a strong and independent predictor for the development of coronary and cerebrovascular diseases. This association and the possible role of Lp(a) in thrombogenesis have greatly stimulated population-based studies and basic research into the genetics, structure, function, metabolism, and disease association of Lp(a). These studies have created a demand for the rapid devel- opment of commercially available immunoassays for the measure- ment of Lp(a) in human plasma. However, many problems have been identified with the immunochemical measurement of Lp(a) due to the complexity and heterogeneity of the protein structure of Lp(a) and the homology of apo(a) with plasminogen. There has been inadequate standardization of the various Lp(a) assays and there are no generally accepted reference materials and methods. Also, there is no consensus on how to express plasma Lp(a) values; some assays express Lp(a) as total lipoprotein mass, whereas others use total protein mass. Often there is no reference to population-based reference values. Additionally, none of the existing assays have been evaluated to establish what exactly is being measured, i.e., Lp(a), free apo(a), or apo(a) associated with triglyceride-rich lipoproteins. In addition, it has not been determined whether the antibodies employed in the assays are equally immunoreactive with all the various forms of apo(a). All these factors make it very difficult to compare data among the published reports or assess the impact of findings on the severity of disease. Therefore, we propose making a contract award to one laboratory to develop a standardization strategy to harmonize Lp(a) measurements and to devise a suitable reference material to calibrate assays and minimize biases. a. Objectives of the solicitation and background information Lp(a), a cholesterol-rich lipoprotein, is characterized by a unique glycoprotein, apo(a), that is linked through disulfide bonds to apo B-100. Apo(a) is heterogeneous in size and displays a striking homology to the structure of plasminogen. Apo(a) is distinguished by the presence of a variable number of the kringle 4 like repeat sequences. The number of repeats varies and is under genetic control giving rise to different sizes of apo(a) that range from 300-800 Kda. Plasma levels of Lp(a) are largely genetically determined and are relatively insensitive to diet and most drug manipulations. There tends to be an inverse relationship between apo(a) size and plasma Lp(a) concentration. Since its discovery in 1963 by Kare Berg, numerous case control and prospective studies (with the exception of two studies) have demonstrated that increased concentrations of Lp(a) are asso- ciated with a considerably heightened risk of heart attacks and strokes. Additionally, Lp(a) has also been identified as a risk factor for preclinical atherosclerosis, for the development of accelerated coronary arterial disease in transplant recipients, and for cardiovascular disease in hemodialysis patients. Moreover, mice expressing the human apo(a) cDNA develop fatty streaks when placed on a high fat diet. Lp(a) may have both athero- and thrombogenic roles, the former through its LDL-like characteristic and the latter through the plasminogen-like properties of apo(a). All these findings have resulted in an increased interest in the measurement of Lp(a). However, because of the complexity and heterogeneity of the protein structure of Lp(a) and the homology of apo(a) to plasminogen, the immunochemical measurement of Lp(a) has been very difficult. Originally, Lp(a) was identified by following diffusion in agarose gels. Presently, several different techniques have been developed, such as radial and electroimmunodiffusion, radioim- munoassay, enzyme-linked immunosorbent assay, immunonephelo- metric assay, and fluorescent assay. Each of these methods has its advantages and disadvantages, and no single method can be considered ideal. The accuracy and standardization of these immunoassays depend on the availability of a suitable primary standard, a reference material, and a calibrator. These materials are necessary to permit comparisons between laboratories and as of yet are not available. It is thus important that investigators reach a consensus on how to define and express Lp(a) values and that a common reference material be used to harmonize the data. Therefore, we propose to award a contract to one laboratory to develop a standardized method for Lp(a) measurements and to devise and produce refer- ence material to calibrate assays and minimize biases. The objectives of the overall program are as follows: * To develop or optimize currently existing Lp(a) assays with regard to antibody specificity and sensitivity to various Lp(a) isoform sizes. * To produce and characterize a primary reference material for Lp(a) with values expressed in terms of Lp(a) lipoprotein mass (g/L), Lp(a) protein mass (g/L), Lp(a) protein concentration (nmol/L), and Lp(a) cholesterol (nmol/L). * To provide a secondary reference material(s) for Lp(a). * To develop an Lp(a) reference method for the transfer of Lp(a) values expressed in different terms from the primary Lp(a) standard to the secondary Lp(a) reference material(s). * If results warrant, to establish a synthetic peptide of apo(a) or recombinant apo(a) to be used as a primary stand- ard. The immunological reactivity of this synthetic peptide would have to be identical to the naturally occurring apo(a). To accomplish these objectives, the successful offeror must have rigorous quality control procedures in place; the proposed bench level staff must demonstrate experience in testing lipid profile measurements. The proposed Principal Investigator is required to be a senior scientist with experience in supervision of a laboratory involved in lipid measurements for large-scale clinical trials or epidemiologic studies and will be expected to collaborate with NHLBI in developing and writing manuscripts describing the results of the study. b. Detailed Description of the Technical Requirement and Subordinate Task or Types of Work Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, quali- fied personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work set forth below. [The proposal must include a plan of how the work will be carried out and describe the facilities and equipment available to do the work. The subcontracting of portions of the work of this program is allowable. However, offerors must identify in their proposals potential problems and propose solutions to them when such working arrangements are anticipated. Subcontractors will be held to the same standards as prime contractors.] 1. At the initiation of the program in July 1998, the Principal Investigator shall meet with NHLBI staff and possibly outside consultants to develop a strategy that will optimize the effort and time spent on this program to accomplish the standardization of Lp(a) within the specified time of 4 years. The contractor shall provide a program plan and time-line for review and approval of the Project Officer prior to proceeding to task 2. 2. The contractor shall evaluate existing Lp(a) assays to optimize reproducibility. For example, the laboratory should consider demonstrating a linear dose-response curve over a wide range of Lp(a) values and sizes, evaluate handling and storage conditions for plasma or serum samples, and select and characterize the antibodies used in each assay. An optimal assay will require specific antibodies that do not cross-react with plasminogen or apoB, recognize all apo(a) isoforms, not be influenced by the size of the different forms present in the samples, and be sensitive enough to measure the lowest range of Lp(a) levels. If necessary, the con- tractor shall develop new Lp(a) assays that fulfill all the requirements of an optimal assay. 3. The contractor shall produce and characterize a primary and secondary reference material for Lp(a). The primary reference material shall be a highly purified Lp(a) in which its protein and cholesterol content have been determined by an existing accepted reference method. Values for the primary reference material shall be expressed in terms of Lp(a) lipoprotein mass (g/L), Lp(a) protein mass (g/L), Lp(a) protein concentration (nmol/L), and Lp(a) cholesterol (nmol/L). The secondary reference material shall be a highly stable serum-based material that is assigned an accurate Lp(a) value using the pri- mary reference material as the standard. Storage methods and shelf-life must be defined and reported. If results warrant, the contractor may develop a synthetic peptide of apo(a) or recombinant apo(a) that could be used as a primary standard. The immunological reactivity of this synthetic peptide would have to be identical to the naturally occurring apo(a). 4. The contractor shall validate an Lp(a) assay method that can be used as a reference method. This reference method will be used to assign an accurate Lp(a) concentration to the secondary reference material using the primary reference material as the standard. This method must be specific, accurate, precise, stable over time, and minimally affected by isoform sizes of apo(a) and matrix effects. Project Officer approval of this validation shall be obtained prior to implementing production. 5. The contractor shall publicize the new Lp(a) standard and methodology and take or recommend appropriate steps to promulgate standardization of Lp(a) measurements in the scientific, health care, and clinical research communi- ties. At minimum, publication in a relevant, refereed scientific journal is anticipated as well as hosting of a conference to disseminate the results. A sufficient quantity of reference material must be prepared for use by the Principal Investigator's professional colleagues. Plans and recommendations must be included in the Final Technical Report to provide continued commercial availa- bility of reference materials following completion of the contract. Such plans could include production of refer- ence materials by the contractor institution, with costs to be covered by charges for samples delivered, or licensing to a commercial biochemical company. [The offeror must provide evidence in the proposal that the laboratory is currently standardized and participating in the CDC-NHLBI Lipid Standardization Program. Offeror must maintain an up-to-date CDC-NHLBI standardization status throughout the course of the study. The offeror must describe the quality control methods to be used (and those currently in use in the laboratory), including the source, preparation, storage, and use of calibrators and control pools and the methods for assuring their long-term stability, the calculation of statistics and their use in control charts, and specific actions to be taken when performance standards are not met. The successful offeror must document that it has an operating quality control program to assess and control within-run and between-run variability, accuracy, and long-term drift for all lipid measures. A laboratory log book will be required, containing a record of all handling, storage, and manipulation of samples which might affect the quantitative results report (e.g., freezing, thawing). A quality assurance system is required by which excessive random or systematic errors may be detected and monitored. Specific procedures should be described for each variable being measured. Equipment calibration and technician identifiability with sample runs should be covered.] C. REPORTS/DELIVERABLES In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE F.1. DELIVERIES of this contract: (1) Program Plan A program plan is required in task 1 at or following the meeting with the Project Officer for approval prior to starting work on task 2. [Note: The proposal should contain a draft program plan.] (2) Quarterly Technical Progress Report This report shall include a description of the activities during the reporting period, including any changes in materials and/or methods, and the activities planned for the ensuing reporting period. The first reporting period con- sists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. The first report shall be due November 16, 1998. Thereafter, reports shall be due on or before the fifteenth calendar day following each reporting period. The quarterly progress report will not be required for the periods covered by annual and final progress reports. (3) Annual Technical Progress Report This report shall include a summation of the quarterly progress reports and shall include a summation of the results of the entire contract work for the preceding year. The first report shall be due August 30, 1999. Thereafter, reports shall be due on or before the thirty-first calendar day following each year of performance, except that the annual report will not be required for the final year of the contract when the final technical progress report is due. (4) Final Report This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted on or before the last day of the contract performance period in accordance with ARTICLE F.1, DELIVERIES, of this contract. (5) Summary of Salient Results The contractor shall submit with the Final Report a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. (6) Abstracts & Manuscripts Reprints of abstracts and manuscripts shall be submitted after publication. Satisfactory performance of this contract shall be deemed to occur upon completion of the services described in ARTICLE C.1. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule: Item Description Delivered to: Delivery Schedule a. Program Plan Project Officer Within two weeks following the meeting with the Project Officer (task 1) b. Quarterly Project Officer Quarterly Progress and Contracting Report Officer c. Annual Project Officer Annually Progress and Contracting Report Officer d. Final report Project Officer Upon completion of and Contracting the contract. Officer e. Summary of Project Officer Upon completion of Salient and Contracting the contract. Results Officer f. Abstracts Project Officer Upon publication and manuscripts Copies of reports shall be sent to the following addresses: Addressee Item Quantity Project Officer (a) 1 Vascular Research Program, DHVD, NHLBI (b) 2 6701 ROCKLEDGE DR MSC 7956 (c) 2 BETHESDA MD 20892-7956 [etc.] [etc.] Contracting Officer (a) 0 Contracts Operations Branch, DEA, NHLBI (b) 1 6701 ROCKLEDGE DR MSC 7902 (c) 1 BETHESDA MD 20892-7902 [etc.] [etc.] D. Special Requirements 1. GOVERNMENT FURNISHED FACILITIES AND EQUIPMENT No government-furnished material or facilities are envisioned for this acquisition. 2. PACKAGING, MARKING, AND SHIPPING The contractor shall guarantee that all required materials shall be delivered in immediately useable and acceptable condition. 3. ESTIMATE OF EFFORT It is expected that a completion type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the effort to be approximately 1.2 FTE for the first year, increasing to 2 FTE in the final year. This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes. Labor Category Yr 1 Yr 2 Yr 3 Yr 4 Principal Inv. 40% 40% 40% 50% Laboratory Tech 55% 110% 110% 100% Secty/Cler/Admin. 25% 20% 20% 50% Total: 120% 170% 170% 200% 4. Geographic Restriction: award of a contract under this RFP will be made only to an offeror located in the United States. E. EVALUATION FACTORS FOR AWARD, WITH TECHNICAL EVALUATION CRITERIA Proposals submitted in response to this solicitation will be reviewed by a peer group of scientists, conducted by Review Branch, Division of Extramural Affairs, NHLBI, and subsequently by a review group within the NHLBI. Factors to be considered in evaluating the proposals are listed below. The technical proposal will receive paramount consideration in the selection of the contractor for this acquisition. Estimated costs must be reasonable for the tasks to be performed. In the event that the technical evaluation reveals that two or more offerors are approximately equal in technical ability, then the estimated cost of performance may become paramount. The evaluation will be based on the demonstrated capabilities of the prospective contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully, based on responsiveness to the RFP and the thoroughness and feasibility of the technical approach taken. The Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered. Offerors must submit information sufficient to evaluate their proposals 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. Listed below are evaluation criteria. The evaluation criteria are used by the technical evaluation groups to evaluate the technical proposals and are listed in the order of relative importance with weights assigned for evaluation purposes. No. Criterion Points 1. Technical approach and planning 35 Adequacy of plans, approaches, and proposed procedures for accomplishing the tasks listed in the Statement of Work, including draft protocols, quality control procedures, and scientific basis and logistics for carrying out the work for the proposed program. This also includes the adequacy of plans for future maintenance, distribution, and commercial availability of primary and secondary standards for Lp(a) following completion of the contract work. 2. Qualifications of staff 30 Adequacy of expertise, experience, and time commitment of pro- posed personnel, as documented in verifiable resumes or curricula vitarum, to perform the statement of work and present the results in appropriate refereed forums. 3. Corporate Experience 25 The organizational experience and history of the offeror in the area of lipoprotein characterization methodologies relevant to the statement of work. Offeror's laboratory must currently be participating in the CDC-NHLBI Lipid Standardization Program; have documented, verifiable prior experience in successfully performing lipid determinations in human serum or plasma as part of a population study or clinical trial; and demonstrate capability of performing the required lipoprotein analyses for this program as well as adequacy of quality control procedures. 4. Corporate facilities and resources 10 Availability of adequate facilities, equipment, and admin- istrative support for accomplishing the statement of work. Total: 100 ******************************************************************** THE REMAINDER OF THIS GOPHER RFP CONSISTS OF THE FOLLOWING SECTIONS: II. Specific RFP Instructions and Provisions, and III. Applicable RFP References ******************************************************************** II. Specific RFP Instructions and Provisions The following specific RFP instructions and provisions apply to this RFP: (a) Proposal Intent Response Sheet (submit prior to proposal submission) (b) Packaging and Delivery of Proposal (c) Privacy Act System of Records (found in Section I & in Section C of contract) (d) SIC Code and Small Business Size Standard (e) Number and Type of Award (f) Estimate of Effort (g) Service of Protest (h) Page Limits (i) Government Notice for Handling Proposals (j) Technical Proposal Table of Contents ******************************************************************** (a) PROPOSAL INTENT RESPONSE SHEET RFP No.: RFP-NIH-NHLBI-HV-98-13 TITLE OF RFP: Lipoprotein (a) [Lp(a)] Standardization Program PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY January 6, 1998. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION. ******************************************************************** I INTEND TO SUBMIT A PROPOSAL COMPANY/INSTITUTION NAME: ADDRESS: PROJECT DIRECTOR'S NAME: TITLE: TELEPHONE NUMBER: NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS (include Subcontractors and Consultants): RETURN TO: Review Branch or FAX TO: Dr. James Scheirer NIH, NHLBI (301) 480-3541 Attention: Dr. James Scheirer Rockledge Building, Room 7220 6701 ROCKLEDGE DR MSC 7924 BETHESDA MD 20892-7924 ******************************************************************** (b) PACKAGING AND DELIVERY OF PROPOSALS Your proposal shall be organized as specified in the Technical Proposal Table of Contents, below, and as described in the "Standard RFP Instructions and Provisions" found in the Gopher Directory entitled "RFP References." Shipment and marking shall be as indicated below. EXTERNAL PACKAGE MARKING: In addition to the address cited below, mark each package as follows: RFP NO. RFP-NIH-NHLBI-HV-98-13. TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY NUMBER OF COPIES The number of copies required of each part of your proposal is as specified below. TECHNICAL PROPOSAL ONLY -- ORIGINAL* AND Twenty-five (25) COPIES BUSINESS PROPOSAL -- ORIGINAL* AND Six (6) COPIES COPIES TO: If hand-delivered or If using U.S. Postal delivery service: Service: Review Branch Review Branch Division of Extramural Affairs Division of Extramural Affairs National Heart, Lung, and National Institutes of Health Blood Institute National Heart, Lung, and Rockledge 2 Building, Room 7091 Blood Institute 6701 Rockledge Dr MSC 7924 6701 ROCKLEDGE DR MSC 7924 Bethesda MD 20892-7924 BETHESDA MD 20892-7924 *THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE STAMPING. NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the office for receipt of proposals. Any package sent via this service will be processed by the NIH Mail Room and delivered with regular mail on an expedited basis. The Review Branch or the Contracting Officer will not be able to pick up any mail at the NIH Mail Room. If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal." (c) PRIVACY ACT SYSTEM OF RECORDS This acquisition will NOT require a contractor to do one or more of the following: design, develop, or operate a system of records on individuals to accomplish an agency function in accordance with the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. (d) SIC CODE AND SMALL BUSINESS SIZE STANDARD Note: The following information is to be used by the offeror in preparing its Representations and Certifications (see the RFP References directory of the Gopher RFP), specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS (OCT 1995),FAR 52.219-1: The standard industrial classification (SIC) code for this acquisition is 8733. The small business size standard is $5 million per year. (e) NUMBER AND TYPE OF AWARD It is anticipated that a single award will be made from this solicitation and that the award will be made on/about July 30, 1998. It is anticipated that the award from this solicitation will be a multiple-year cost reimbursement type completion contract with a period of performance of July 30, 1998 through July 29, 2002, and that incremental funding will be used [see paragraph 5)(b), (c), or (d) of Business Proposal Instructions, in the "Standard RFP Instructions and Provisions" of the Gopher RFP]. (f) ESTIMATE OF EFFORT It is expected that a completion type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the effort to be approximately as set forth in Part I, Section D.3. (g) SERVICE OF PROTEST (AUG 1996)--FAR 52.233-2 (1) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from: Robert A. Julia, Contracting Officer Contracts Operations Branch National Heart, Lung, and Blood Institute Rockledge 2, Room 6110 6701 ROCKLEDGE DR MSC 7902 BETHESDA MD 20892-7902 (2) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (h) Page Limits The offerors shall limit their response to 125 pages. The technical approach must be limited to 25 pages. The other portions of the proposal, including related experience, personnel, etc., must be limited to 100 pages. (i) GOVERNMENT NOTICE FOR HANDLING PROPOSALS AN OFFEROR SHALL PLACE THIS NOTICE ON TOP OF EACH COPY OF ITS TECHNICAL PROPOSAL. This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices which the submitter places on this proposal shall also be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be made only to the extent authorized by, and in accordance with, the procedures in HHSAR paragraph 315.608-72. (For information regarding authorized restrictive notices, offerors should refer to the "Confidentiality of Proposals" section of the STANDARD RFP INSTRUCTIONS AND PROVISIONS subdirectory of the RFP REFERENCES directory of the Gopher RFP.) ******************************************************************** (j) TECHNICAL PROPOSAL TABLE OF CONTENTS RFP NIH-NHLBI-HV-98-13 (Note: Instructions to offerors are indicated in parentheses or as footnotes.) TECHNICAL PROPOSAL TABLE OF CONTENTS* Page Numbers 1. Technical Proposal Cover Sheet (Format found in RFP References Section of Gopher RFP; FORMS,FORMATS,ATTACHMENTS). . . . . . . . . . . . . . . . . 1 2. Technical Proposal Table of Contents (THIS DOCUMENT). . . . . . 2 3. Abstract ** . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4. Offeror's Technical Plan for Accomplishing Statement of Work. . 4 a. Personnel *** 1. List of All Personnel on the Project, including Subcontractors, Consultants/Collaborators, by Name, Title, and Organization 2. Principal Investigator/Project Director 3. Other Key Staff 4. Additional Personnel b. Statement of Work 1. Objective .....(Items b.1 through b.4..... are not to exceed 25 pages) 2. Approach .......... 3. Methods ........... 4. Schedule .......... c. Resources and Facilities d. Other Considerations (use specifically titled subparagraphs, as applicable) 5. Other Support . . . . . . . . . . . . . . . . . . . . . . . . . 5 (Refer to "Summary of Current and Proposed Activities" in the FORMS, FORMATS, ATTACHMENTS Directory found in the RFP References directory of the Gopher RFP) 6. Human Subjects Issues Not Otherwise Addressed . . . . . . . . . 6 7. Technical Proposal Cost Information . . . . . . . . . . . . . . 7 (Format in Gopher RFP, RFP References, FORMS, FORMATS, & ATTACHMENTS) 8. Literature Cited. . . . . . . . . . . . . . . . . . . . . . . . 8 9. Appendices. . . . . . . . . . . . . . . . . . . . . . . . . . . 9 * 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. ** State the proposal's broad, long-term objectives and specific aims. Describe concisely the research design and methods for achieving these goals. DO NOT EXCEED one page in providing the abstract. Identify the RFP Number, Organization, and Principal Investigator on the abstract. *** An individual resume should not exceed two pages. ******************************************************************** III. Applicable RFP REFERENCES This file or section identifies the items in the RFP REFERENCES Gopher directory that are applicable to this RFP. A. The entire file entitled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as otherwise may be modified by the inclusion of an item from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS." B. The following items are applicable from the Gopher file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS": 1. Facilities Capital Cost of Money 2. Human Subjects 3. Past Performance Information: Since elements of past performance are contained in the Evaluation Factors for Award, this item is applicable. 4. Small Business and Small Disadvantaged Business Subcontracting Plan C. The following items/files are applicable from the subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS": APPLICABLE TO TECHNICAL PROPOSAL 1. Technical Proposal Cost Information 2. Summary of Current and Proposed Activities 3. Technical Proposal Table of Contents (See above) 4. Technical Proposal Cover Sheet 5. Protection of Human Subjects, OF 310 APPLICABLE TO BUSINESS PROPOSAL 6. Contract Pricing Proposal, SF 1411 7. Proposal Summary and Data Record, NIH-2043 8. Disclosure of Lobbying Activities, OMB Form SF-LLL 9. Business Proposal Cost Information TO BECOME CONTRACT ATTACHMENTS 10. Invoice/Financing Request Instructions for NIH Cost- Reimbursement Type Contracts, NIH(RC)-1, Jun. 1992. 11. Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16), Apr. 1984. OTHERS TO BE SUBMITTED AS DIRECTED BY CONTRACTING OFFICER 12. Certificate of Current Cost or Pricing Data, NIH-1397. 13. Small, Small Disadvantaged, and Women-Owned Small Business Model Subcontracting Plan Outline D. The Representations and Certifications are applicable and must be submitted with the offeror's business proposal. E. The "Sample Contract Format--General" is applicable.