RFP No. RFP-NHLBI-HV-98-14 (formerly RFP-NHLBI-HV-97-09) Central Lipid Laboratory for National Health and Nutrition Survey (NHANES IV) 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. NHLBI-HV-98-14 (formerly NHLBI-HV-97-09) Title: Central Lipid Laboratory for National Health and Nutrition Survey(NHANES IV) Issued by: Douglas W. Frye Contracting Officer NIH/NHLBI Contracts Operations Branch Rockledge 2 Building, Room 6106 6701 ROCKLEDGE DR MSC7902 BETHESDA MD 20892-7902 DATE ISSUED: October 3, 1997 DATE PROPOSAL DUE: November 24, 1997, 4:30 P.M. (EST) SMALL BUSINESS SET-ASIDE: NO 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, with 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 IMPORTANT THAT YOU IMMEDIATELY NOTIFY Douglas Frye OF THE NHLBI CONTRACTING OFFICE AT THE FOLLOWING INTERNET ADDRESS: fryed@gwgate.nhlbi.nih.gov IF YOU DO NOT NOTIFY THE CONTRACTING OFFICE, 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 November 24, 1997 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 October 24, 1997. 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 on the 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 Douglas Frye 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/ Douglas W. Frye Contracting Officer ******************************************************************** B. WORK STATEMENT WITH PROJECT INFORMATION Project Description: The National Center for Health Statistics (NCHS) conducts periodic surveys of the health and nutritional status of the United States population. All surveys done to date have included determinations of blood lipids. The NCHS is requesting that the lipid determinations for the next National Health and Nutrition Survey (NHANES IV) be done as previously under the sponsorship of the National Heart,Lung,and Blood Institute (NHLBI). Broad-based data on lipoprotein values in the United States and other populations are also needed. It is essential that the lipid measurements for NHANES IV are of the highest quality with respect to their precision and accuracy to allow comparability with previous and future surveys. The (NHLBI) has assumed responsibility for the performance of the lipid measurements in two previous NHANES surveys and the Hispanic Health and Nutrition Survey (HHANES). This project is for the acquisition of a lipid laboratory capable of providing accurate and precise lipid analyses (total cholesterol, high density lipoprotein [HDL] cholesterol, triglycerides)for NHANES IV. Purpose of the Acquisition: The purpose of this proposed acquisition is to obtain lipid measurements on the NHANES IV sample population by awarding a contract for a Central Lipid Laboratory to accurately measure (a) total cholesterol and HDL cholesterol for the entire NHANES IV sample population and (b) triglycerides for the fasting NHANES IV population and to deliver the results to NCHS for use in its NHANES IV Survey and to NHLBI for monitoring national trends in cholesterol and other lipid values by comparing the values collected in the NHANES IV with corresponding data gathered in previous surveys. The NCHS conducts periodic surveys of the health and nutritional status of the civilian, non-institutionalized population of the United States. All of these surveys to date have included determinations of blood lipids. Analyses of previous NCHS surveys have documented a decline in cholesterol levels in the United States population. The NHANES IV lipid data can be linked to the National Death Index. Continuing monitoring of cholesterol levels in the United States population will be of value in assessing national trends and the impact of the National Cholesterol Education Program (NCEP). Assessment of trends in triglycerides and HDL cholesterol also will be of value. All of these activities necessitate close monitoring of cholesterol and other lipid values in the United States population to detect any changes from present levels. Attempts will be made to correlate these changes with corresponding life style changes and obesity as well as cardiovascular morbidity and mortality. Statement of Work for Solicitation Purposes: The offeror shall furnish the necessary personnel, materials, services, and facilities and otherwise do all things necessary or incident to measure serum lipids accurately as outlined in the performance of the tasks described below. The proposal must include a plan of how the work will be carried out. 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 the Central Lipid Laboratory. General Description of the Required Objectives and the Desired Results: The objective of this contract is to obtain the services of a Central Lipid Laboratory for the accurate and precise measurements of total cholesterol, HDL cholesterol, and triglycerides from a defined subset of participants in the NHANES IV scheduled to begin October 1998, with a pilot study to begin May 1998. The offeror must be standardized for total cholesterol, HDL cholesterol and triglyceride measurements with the Centers for Disease Control and Prevention (CDC). The offeror must have rigorous quality control procedures in place and keep current with the CDC-NHLBI Lipid Standardization Program so that the new data can be compared with previous NHANES data to determine trends in the United States population. The proposed bench level staff must demonstrate experience in testing lipid profile measurements. The Central Lipid Laboratory will be required to send the data and quality control information electronically to the NCHS-designated NHANES IV Data Collection Contractor. The Principal Investigator of the Central Lipid Laboratory 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 and NCHS in developing and writing manuscripts describing the results of the study. Previous Studies: The NCHS has conducted a series of health-related surveys on the civilian, non-institutionalized population of the United States. The first survey, the National Health Examination Survey (NHES I), was conducted from 1960 to 1962. NHANES I contained a nutritional component and was conducted in 1971-1974. The survey examined persons aged 1 through 74 years. NHANES II was conducted during 1976-1980 and examined persons aged 6 months through 74 years. In 1982-1984 the HHANES was conducted to examine persons in the three major Hispanic groups in the United States: Mexican-Americans in the Southwest; Cuban-Americans in the Miami, Florida, area; and Puerto Ricans in the metropolitan New York City area. NHANES III was conducted during 1987-1994, and examined persons aged greater than 2 months with no upper age boundary. The sample size of NHANES III was increased to include larger numbers of African-Americans, Hispanics, and other minorities as well as to perform reliable analysis beyond age and sex breakdowns and to make estimates for the poor, elderly, or populations at high risk of disease development. Each of these surveys has consisted of household interviews, medical and dietary histories, extensive physical examinations, various physiological measurements, and laboratory tests on blood and urine. Data from these surveys provide information on the prevalence of certain diseases and health conditions, to monitor health and nutritional status of the population over time, to identify public health problems, and to identify interrelationships among health and nutritional variables. The cardiovascular components of the NHANES studies have been funded by NHBLI through an Inter-Agency Agreement. The lipid measurements in all but NHANES I have been performed in Central Lipid Laboratories funded by NHLBI contracts. NHANES II included lipid/lipoprotein levels for persons 20 years of age and older. NHANES III obtained lipid levels on persons aged 6 and over. Two 3-year examination cycles were completed in NHANES III with measurement of apolipoprotein AI and B in the first cycle and measurement of lipoprotein (a) in the second. NHANES III had enhanced statistical and analytic power to perform more detailed analyses of the relationship of lipid/lipoprotein levels to other variables such as smoking level, alcohol consumption, body mass index, and exercise level in addition to the usual demographic variables. NHANES IV 1998-2004: Planning is currently underway for NHANES IV to begin collecting data in late 1998 with a pilot study to begin May 1998. The entire survey is expected to involve about 40,000 sample persons. The survey will be a nationally representative sample of adults and children greater than 2 months of age. Children age 2 years and younger will not be included in the lipid determinations. Analyses of the data from previous NHANES have documented a consistent decline in mean serum total cholesterol levels in United States adults aged 20 through 74 years over the time period 1960 through 1991 with more than half of the decline occurring during the time period 1976 through 1991 (Johnson et al JAMA 269:3002, 1993; Sempos et al JAMA 269:3009, 1993; Sempos et al JAMA 262:45, 1989). This decline occurred across the entire distribution of serum cholesterol levels and in all age-sex groups. HDL cholesterol has increased slightly, very low density lipoprotein (VLDL) cholesterol has not changed, and low density lipoprotein (LDL) cholesterol has decreased indicating that the decline in total cholesterol levels is due to a decrease in LDL cholesterol. Measuring lipid levels in the NHANES IV will provide a unique opportunity to study the total cholesterol, HDL cholesterol, and triglyceride levels in a representative sample of children and adults in the United States to determine if the previously observed decline in total cholesterol in adults is continuing and to determine if similar changes are occurring in children. In addition, NHANES IV will provide the opportunity to examine trends in African-Americans, Hispanics, and other minorities. Detailed Description of the Technical Requirements: The objective of this RFP is to obtain the services of a CDC standardized lipid laboratory to measure total cholesterol, HDL cholesterol and triglycerides as the Central Lipid Laboratory for NHANES IV. The Central Lipid Laboratory must be capable of providing accurate and precise lipid analyses for NHANES IV so that the results can be compared with those from previous NCHS surveys to determine national trends. The offeror must demonstrate familiarity with lipid measurements as performed in earlier NHANES studies and present comparisons between their proposed methods and those used in NHANES III. Offerors should provide the scientific basis for the work proposed and details of the proposed protocols. In addition, offerors must be ready to start measurements immediately when the contract is awarded since NCHS may begin the pilot study prior to the start of this contract. The offeror must address in the proposal the three phases of the contract: a pilot phase of about five months scheduled to begin spring of 1998; the full survey phase expected to begin October 1998 lasting six years; and a closing phase lasting about seven months. In the pilot phase the Central Lipid Laboratory will measure lipid levels in about 250 samples collected over 1-2 months, prepare a Manual of Operations providing details of all its methods including quality control procedures, and evaluate the lipid measurements in the pilot study with NCHS and the NHLBI Project Officer. In the full survey phase it is expected that there will be a total of 22,200 samples for measuring total cholesterol and HDL cholesterol with triglyceride measurement in half of these (11,100 samples). In the closing phase the Central Lipid Laboratory will be expected to assay any remaining samples or repeat measurements as required. In addition, the Principal Investigator of the Central Lipid Laboratory will be expected to work with the NHLBI and NCHS in preparation of manuscripts and should plan to travel to Bethesda, MD for writing and consulting with NHLBI and NCHS. In all three phases the Central Lipid Laboratory will send the data and quality control information electronically to the NHANES IV Data Collection Contractor. For proposal purposes, offerors should assume an annual site visit for discussion of results and program progress with NHLBI and NCHS. The physical examinations and blood drawing done on NHANES IV participants will be accomplished by NCHS in mobile examination centers or in the homes of sample persons. These centers are equipped with centrifuges adequate for the preparation of serum and the ability to freeze the serum. The frozen serum for lipid analyses will be shipped weekly to the Central Lipid Laboratory from two collection sites simultaneously for nearly eleven months of the year (with breaks of about three weeks during the holiday season at the end of the calendar year and about two weeks in the summer). Subordinate Tasks or Types of Work: The Central Lipid Laboratory will be responsible for performing the following tasks. Offerors must address in their proposal how this work will be carried out and describe the facilities and equipment available to do the work. While the serum specimen is in the possession of the Central Lipid Laboratory no other analyses can be performed unless approved by NHLBI and the NHANES Institutional Review Board. Required Blood Lipid Measurements: The offeror must respond to this RFP with respect to the methods to be used for analyses of total cholesterol, HDL cholesterol, and triglycerides, as well as the number and type of measurements given below. Triglycerides will only be measured in the fasting samples estimated to be half the total number of samples. The offeror should present expected values for accuracy and precision, with the description of the basis for the estimates given. The offeror must describe present and future capacity to perform this volume of work and the ability to report the results in the required time after receipt of samples. The volume of serum available for the 3-5 year old children will be 0.1 ml. For the older children and adults, 2.5 ml of serum will be available, but the offeror should propose and discuss possible methods using less than this amount. For the purposes of this proposal the offeror should assume a total of 450 participants in the pilot study, resulting in about 250 samples for lipid analysis (250 samples for total cholesterol and HDL cholesterol; 125 samples for triglyceride analysis). In the full scale NHANES IV (October 1998 through September 2004) about 40,000 people will participate. Based on past experience, only 75% are expected to be examined. Children age 2 years or less will not be included in the lipid measurements. About 80% of the remaining sample persons are expected to agree to venipuncture resulting in a total estimate of 22,200 sample persons for total cholesterol and HDL cholesterol and about half this amount for triglyceride measurement. Collection will be at about 90 locations (stands) with the average stand size being about 450 persons resulting in approximately 250 serum samples for lipid determination per stand. The estimated number of sample persons shown in the table below includes the pilot study and 3 months of the full survey for calendar year 1998 and the full survey for 1999 to 2004. In the closing phase an estimated 250 samples will be measured in the first month followed by final data analysis and transmission. The offeror will be expected to perform repeat assays in 2% of the samples. Number of Test Batteries Calendar Year 1998 1999 2000 2001 2002 2003 2004 Total Measurement: Small volume from children 3-5 years old (0.1 ml) Total Cholesterol 66 208 208 208 208 208 170 1276 HDL Cholesterol 66 208 208 208 208 208 170 1276 Regular volume from participants 6 or older (2.5 ml) Total Cholesterol 1110 3492 3492 3492 3492 3492 2854 21424 HDL Cholesterol 1110 3492 3492 3492 3492 3492 2854 21424 Triglyceride 555 1746 1746 1746 1746 1746 1427 10712 The offeror must submit a proposal that meets all of the above requirements. The offeror may propose other methods to meet the requirements providing they are sufficiently accurate and precise for the purposes of the study. The final combination of measurements to be performed under the planned contract will be determined by the Government prior to completion of negotiation. Establishment of Procedures for Use in Mobile Examination Centers: The Central Lipid Laboratory shall cooperate with the NHLBI, NCHS, and the NHANES IV Data Collection Contractor in refining the protocols for collection and processing of blood samples as well as for temporary storage in the mobile examination centers and delivery to the laboratory. In the proposal, the offeror should describe relevant experience with these procedures. Delivery/Storage: The offeror will accept delivery of specimens on a predetermined schedule supplied by NCHS. The offeror will maintain an adequate storage facility (-70 degrees C) for specimens upon receipt and for any excess specimen remaining in vials after analyzing the samples. The offeror will send excess serum to the NCHS specified repository packed on dry ice. Shipping will be by an overnight carrier as directed by NHANES IV with the NCHS account number. The timetable for sending these samples will be determined by the NHLBI Project Officer and NCHS in consultation with the Central Lipid Laboratory. For proposal purposes, the offeror should plan on sending samples six times a year and should assume that the repository will be in Rockville, MD. The offeror must describe the laboratory's back-up system for sample storage and procedures to minimize potential sample loss. The Central Lipid Laboratory should be able to store specimens for up to one year if necessary. Assay Methods: The offeror must demonstrate familiarity with the methods used in previous NHANES studies. The offeror must describe in detail the lipid measurements it proposes to use in the Central Lipid Laboratory for NHANES IV and provide evidence that these measurements are comparable to the methods used in NHANES III. The offeror must provide evidence that the laboratory has made these measurements in population studies or similar types of studies performed over several years and/or comparison with previous studies which required precise and accurate measurements of lipids and CDC standardization. Standardization and Quality Control: 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 Central Lipid Laboratory shall 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. All results must be linked to the provided NCHS sample person's six digit identification number. The offeror shall include in the proposal a detailed protocol which describes laboratory procedures, the nature of standard materials to be used in the Central Lipid Laboratory, and the record keeping for reporting results and documenting quality control information which, at a minimum, shall include: Electronic Transmission of Quality Control Information: Provision must be made for electronic transmission of quality control information. If desired, a program and the specifications for data output will be provided by the NCHS or its representative. See Information Technology Section below. Laboratory Log for Vials: A laboratory log book containing a record of the status of all vials upon arrival, date of receipt, deviation from protocol or from good standard operating procedures (i.e., proper labeling and packaging, account of all vials). Laboratory Log for All Handling: A laboratory log book containing a record of all handling, storage, and manipulation of vials which might affect the quantitative results report (e.g., freezing, thawing). Quality Assurance System: A quality assurance system by which excessive random or systematic errors may be detected and monitored. Specific procedures should be described for each variable being measured. All sample person lipid values must be linked to the following: 1) Analytic batch and date of analysis. 2) Quality control values. Quality control values measured as part of the batch, expected control values, identification of control materials by lot number as well as the manufacturer and date of expiration. Indicate if supplemental methods of quality control are used in conjunction with the primary quality control program to eliminate any bias. Examples are use of "blind controls," split samples, or testing a specimen a day later and comparing results. 3) Standard materials. Standard materials used and changed over time to provide long-time comparability of values. 4) Reagents. Reagents identified by batch, date, and expiration dates. All commercial reagents identified by manufacturer, lot number, and reagents' expiration dates. 5) Repeats. All repeated values and reason for test repeats recorded. Repeat tests for specimens that have been compromised in the shipping process will be done at the cost of the Government. All other repeats will be done at the cost of the Contractor. The Central Lipid Laboratory should plan to repeat 2% of the previous day's samples randomly as part of the procedures to monitor the reproducibility of results. 6) Reportable range. State reportable range of test results according to reliability of test system. Provide performance characteristics of test procedures; include linearity limits, accuracy, precision, specificity, and sensitivity. Also include reference ranges and physiologically impossible range edits. 7) Clinical Laboratory Improvement Amendments (CLIA) Certification. The laboratory must be CLIA certified. The offeror must provide in the proposal a copy of CLIA certification. If certification is other than CLIA, provide supporting documentation. 8) Analytic procedure. The principle of the analytical procedure should be written in paragraph form with a brief statement concerning type of reaction(s) involved. 9) Special safety precautions. Hazards of the procedures and special safety precautions for handling and disposal of hazardous materials are to be clearly stated. Specify any protective clothing and safety equipment required (e.g., barriers, safety glasses, gloves, clip-on monitors) as well as type of spill kit to use if necessary. Indicate how health and safety instructions are stated and displayed. Plots of Daily Quality Control: Plots of daily quality control information shall be monitored and corrective actions documented for reference by NCHS and the NHLBI Project Officer. Provisions for Controls and Standards: The Central Lipid Laboratory must continue participation in the CDC-NHLBI Lipid Standardization program. In addition, provision must be made for controls and standards for each assay performed, using one standard set of materials. In the event that standards do change, a comparability study shall be done to demonstrate the relationship of the values before and after the change in standards. 1) Controls and standards shall be identified by lot number, manufacturer, and date of expiration. 2) Confirmatory studies of commercial standards and controls performed as a routine monitoring of the laboratory's performance of the specified testing shall also be recorded and results made available. 3) Current information on lipid/lipoprotein standardization in accord with practices used by reference laboratories such as CDC shall be maintained. Reagents Evaluation: Reagents used in the study assessments shall be properly evaluated to conform to their labeled specifications, their date of expiration, their dates of use, lot number and manufacturer. The effects of changing reagents on values of controls and standards shall be monitored and documented. Procedures to guard against use of outdated reagents must be documented. Equipment Calibration: All equipment used in the study must be calibrated on a regular basis. The rationale for the selected time period must be documented. Documentation of calibration must be made on the quality control record; analytic batches must be linkable to the date of equipment calibration. Provision shall be made for periodic preventive maintenance of all instruments used in the laboratory determinations. Provision shall be made for documenting that the instruments used are maintaining a previously determined performance at each check. Technician Identifiability: The technician(s) running the samples and calibrating the machines shall be identified. This will also apply to sample preparation if it is a separate step or series of steps. Provision for Error Detection: Provision shall be made for detecting errors outside pre-determined limits and for repeating samples. Documenting Bench Performance and Drifts over Time: Provision shall be made for documenting daily bench performance and for detecting drifts over time. Checks of Consecutive Series of Runs: Complete documentation shall be made of consecutive series of runs where the run mean value is above or below an expected range of mean values. A protocol to detect trends from the target mean shall be established. Criteria for "In Control" and "Out-of-Control" Values: Criteria shall be established for "in-control" and "out-of-control" values. Specify procedures for dealing with "out-of-control" runs. Pilot Study: For planning purposes, offerors should assume that the blood for lipid analyses will be collected by NCHS for four to six weeks during May to June 1998, processed into serum, and frozen for shipment to the Central Lipid Laboratory. Approximately 250 samples will be analyzed for total cholesterol and HDL cholesterol. About half of these will have triglycerides measured also. At the conclusion of the pilot study, the Central Lipid Laboratory shall provide data which document the accuracy and precision of each determination for NHLBI approval. The pilot study will provide an opportunity to evaluate the field procedures; measure inter-individual variation for the lipid measures; and with analysis of replicates, to obtain a measure of the reproducibility of the method which includes the effects of sample handling. The Central Lipid Laboratory must plan to analyze the pilot study samples and report the results to the NHLBI Project Officer, NCHS, and the NHANES IV Data Collection Contractor, documenting its performance with quality control charts as appropriate. The offeror should describe a pilot study plan to optimize the information to be gained. The offeror should include in the proposal the written protocol to be used in the pilot study. Manual of Operations: The Central Lipid Laboratory shall prepare and present to the NHLBI Project Officer a Manual of Operations in draft form within two months after contract award, and in final form for NHLBI Project Officer and NCHS approval, prior to analysis of study samples. The Manual of Operations should follow the format recommended by the National Committee for Clinical Laboratory Standards (NCCLS). A template will be provided by the government. The two-month draft must be usable as a basis for discussions with the NHLBI Project Officer and NCHS which, with pilot study results, will lead to final protocol requirements. The Manual of Operations must include detailed information on techniques and materials used for the assays and the quality control procedures: Part 1. A list of the lipid determinations to be measured on each sample in the Central Lipid Laboratory with justification for each being in terms of the criteria described above in Required Blood Lipid Measurements. The list should include the quality control data gathered during standardization and any information available on inter-individual variation. Part 2. A description of the procedures used by NCHS for collecting, processing and delivering samples to the Central Lipid Laboratory. The final draft must incorporate any changes which appear to be appropriate based on the pilot study results. Part 3. A detailed description of the analytical methods to be used, including accession, inspection and preparation of reagents, use and calibration of equipment and procedures for computer data entry. All operating instructions to laboratory personnel should be included. The final Manual of Operations must incorporate any changes resulting from pilot efforts and discussions with NHLBI and NCHS. Part 4. A complete report documenting standardization procedures. Describe the quality control program and listing specific criteria for accuracy and precision to be maintained during analysis of field samples. Part 5. A protocol for temporary excess sample storage. In preparation of their proposals, offerors should note that to the extent possible, laboratory procedures should be maintained without change throughout the analysis of field samples (over the six years of following the study participants); any necessary changes must be approved by the NHLBI Project Officer in advance. Offerors should include in their proposal evidence of ability to prepare a Manual of Operations as described above and should present a procedure for any necessary modifications. Analysis of Field Samples: Starting in October 1998, approximately 3700 samples per year will be collected by the NCHS in the mobile vans, processed into serum, and shipped to the Central Lipid Laboratory for analysis. All samples will be analyzed for total cholesterol and HDL cholesterol, and about half of these will be analyzed for triglycerides. It is anticipated that the same number of samples will be collected each of the following five years. NCHS will provide serum samples, dry ice, and labels as well as the cost of shipping of the serum to the Central Lipid Laboratory. Specimen collection, storage, and handling procedures; criteria for specimen rejection (a) Indicate specific requirements, if applicable. (b) Volume of specimen required. Indicate amount of specimen required, include both optimum and minimum. (c) Storage requirements. Clearly state specimen stability and storage requirements. (d) Specimen characteristics. List specimen characteristics that may compromise test results, e.g., hemolysis, lipemia. (e) Unacceptable specimens. Describe criteria for determining unacceptable specimens and action to be taken in handling and reporting unacceptable specimens. (f) Handling conditions. Specify specimen handling conditions including timing of collection, transport, and special equipment. (g) Limits of detection. Specify the limits of detection for each assay. Indicate if zero is a reportable value. (h) Sources of bias. Specify known sources of potential bias including interfering substances. Sample Storage: The Central Lipid Laboratory shall furnish and maintain a storage facility for specimens to be kept at -70 degrees C upon receipt and for any excess serum remaining in vials after analyzing the sample specimens. Excess serum must be shipped to the NCHS-designated central serum bank at least quarterly. Evaluation of the Performance of Each Assay Method: Performance of a method must be judged on both the practicality and reliability of the methods. In evaluating the practicality of a method, provide the following: (a) Time needed for analysis of one specimen alone. (b) Number of samples under routine conditions. Number of samples which can be analyzed per unit of time under routine conditions. (c) Maintenance time. Time in hours used for preventive maintenance, reagent preparation, calibration, trouble shooting, and total operating time. (d) Sensitivity of measurements. (e) Specificity of measurements. Information Technology Requirements: (a) Central Lipid Laboratory functions. The serum samples will be appropriately packaged in the field, labeled with a bar coded sample identification number, and shipped via Federal Express to the laboratory for analysis. Tracking data will be forwarded to the NHANES IV Data Collection Contractor for follow-up with the Central Lipid Laboratory. One file will contain the results linked to the identification number, the run number, run date and Medical Examination Center (MEC). Another file will contain the quality control data linked to the run number and date as well as the value for each quality control pool. The Central Lipid Laboratory will be responsible for utilizing an automated Laboratory Management System (LMS) for performing the following functions: (i) Importing sample transmittal information into the system. (ii) Tracking samples in process. (iii) Entering analysis results. (iv) Flagging abnormal or out of range results. Action to obtain correct results. (v) Entering quality control data. Entering quality control data including running quality control tests, random repeats, and proficiency test results. (vi) Indicating results of retesting. (vii) Providing detailed auditing information. Providing detailed auditing information including date, time, and user information for each major activity. (viii) Generating quarterly reports to NCHS. Reports to contain an itemized list of samples analyzed, a summary of quality control results, problems encountered, resolution of problems. (ix) Generating an electronic file of the analysis data in a government specified format. The LMS for performing the above functions will be provided to the Central Lipid Laboratory or the offeror can provide an overview of its existing capabilities to meet these requirements. It is preferable that the laboratory utilize the NCHS-provided LMS software. NCHS or its representative will provide training on how to use the LMS. The following minimum hardware configuration is required for the LMS: Pentium Workstation, 16 MB of RAM, Windows 95, 100 MB of free disk space, and a 28.8 modem. The modem can be provided by the government if needed. If the Central Lipid Laboratory does not use the LMS provided by NCHS, the offeror must provide a description of its current data format, its plan for converting this to the format specified by NCHS, and plans for modifying its data output structure to meet any potential change in formatting standards during the study. (b) Overview of processing requirements. The Federal Express air bill number will be used as the shipment identifier for acknowledgment of receipt and tracking of shipment information. A transmittal file listing the contents of the shipment and any relevant sample information (e.g. date, participant's age, cycle number) that is required will also be provided. The information will be sent electronically to the Central Lipid Laboratory. The offeror should provide an overview of existing laboratory capabilities to receive this information electronically. Strict control of the sample at the laboratory is critical. The offeror should have in place an automated process for tracking receipt and processing of the samples from time of receipt in the laboratory to output of the analysis data. The contractor should provide an overview of its laboratory's capabilities in this area. Accurate data entry of sample results and quality control data is of paramount importance to NHLBI and NCHS. If the offeror proposes to utilize existing software for sample processing and results capture, it must be described. The software will be required to produce an output file for transmittal to NCHS in a format provided to the Central Lipid Laboratory at least 2 months prior to the start of the contract. It is the Central Lipid Laboratory's responsibility to ensure that its output files to the NHANES IV Data Collection Contractor meet these specifications. (c) Electronic processing capabilities. The NHANES IV Data Collection Contractor will establish a toll free 800 number for receipt and transmission of electronic files. The offeror must provide an overview of the laboratory's capability to receive and transmit data electronically via TCP/IP over a wide area network or via dial-up modem. (d) Other requirements. Provide an overview of how the laboratory will meet the following other information technology requirements: (i) Confidentiality. The Central Lipid Laboratory will be subject to CDC Confidentiality and Automated Information System Security Requirements. (ii) Record storage. The Central Lipid Laboratory should maintain historical records/archives of transmissions and results to support resolution of questions or issues regarding particular samples throughout the course of the study. Data Analysis and Publication: The Central Lipid Laboratory director or principal investigator must work closely with the CDC, NHANES IV Data Collection Contractor, the NCHS, and the NHLBI during all phases of the study including protocol development and pilot testing, conduct of the field study, and preparation of manuscripts for publication. It is expected that all analysis of lipid data will be performed by NHLBI and NCHS staff. The offeror should discuss the related experience of its key personnel and their commitment to this activity. A timeline for the study is required. Proposed Phases and Period of Performance: Dates #Mo. Phase Description 5/1/98 - 9/30/98 5 I Pilot Study/Protocol Finalization 10/1/98 - 9/30/99 12 II 1st year NHANES IV Full Survey 10/1/99 - 9/30/00 12 II 2nd year NHANES IV Full Survey 10/1/00 - 9/30/01 12 II 3rd year NHANES IV Full Survey 10/1/01 - 9/30/02 12 II 4th year NHANES IV Full Survey 10/1/02 - 9/30/03 12 II 5th year NHANES IV Full Survey 10/1/03 - 9/30/04 12 II Final year NHANES IV Full Survey 10/1/04 - 4/30/05 7 III Closing C. REPORTS/DELIVERABLES Satisfactory performance of this contract shall be deemed to occur upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule. The items specified below shall be delivered f.o.b. destination in accordance with and by the date(s) specified below. Item Description Quantity Delivery Schedule (1) Data on accuracy and precision 10 copies No later than two (2) months from contract award. (2) Results of analysis of pilot 10 copies No later than study samples two (2) months after completion of the pilot tests. (3) Manual of Operations: (a) Draft 10 copies No later than two (2) months after contract award. (b) Final 10 copies Before analysis of any study specimens. (4) Quarterly Progress Reports 10 copies To start three months after the beginning of full scale survey data collection (5) Quarterly Monitoring Reports 10 copies Within 2 weeks from CDC containing results of following receipt standardization (6) Data on study specimens, As directed Three (3) weeks replicates, and external following receipt quality assessment of specimens (7) Interim Recommendations 10 copies March 1, 1999 (8) Raw Data As directed As directed by NHANES IV Data Collection Contractor (9) Stored serum samples As directed As directed by NHANES IV Data Collection Contractor (10) Annual Report 10 copies Contract Anniversary Date (11) Final Report 10 copies Contract Expiration Date Deliverables shall be sent to the following addresses: Deliverable Address Item No./Report Quantity NHLBI: Project Officer (1)-(5),(7),(10),(11) 4 Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute National Institutes of Health 6701 ROCKLEDGE DR MSC 7956 BETHESDA MD 20892-7956 Contracting Officer (1)-(5),(7),(10),(11) 1 Contracts Operations Branch National Heart, Lung, and Blood Institute National Institutes of Health 6701 ROCKLEDGE DR MSC 7902 BETHESDA MD 20892-7902 NCHS: Planning Branch (1)-(5),(7),(10),(11) 5 Division of Health Examination Statistics National Center for Health Statistics Centers for Disease Control and Prevention 6525 BELCREST RD RM 1000 HYATTSVILLE MD 20782 Other: NHANES IV Data Collection Contractor: Westat Inc. (6),(8) As directed ROCKVILLE MD NHANES IV Serum Repository: McKesson BioServices (9) As directed ROCKVILLE MD Reporting Requirements (Contract format Article C.2 Reporting Requirements) In addition to those reports required by other terms of this contract, the Central Lipid Laboratory shall prepare and submit the following reports in the manner stated below: (1) Accuracy and precision data from the pilot study shall be furnished for NHLBI and NCHS approval prior to participation in the full study. (2) Results of analysis of each lipid measurement of pilot study samples. (3) Manual of Operations. A draft of the Central Lipid Laboratory Manual of Operations must be completed according to the NCCLS guidelines (template available) and submitted within two months after contract is awarded. The Manual must be finalized and sent for NHLBI and NCHS approval before analyzing samples from the first full scale NHANES IV study examinations which are currently scheduled to begin in October 1998. (4) Quarterly Progress Report. Beginning three months after the effective date of this contract Quarterly Progress Reports shall be submitted describing determinations, receipt and control information, major problems encountered and resolved, equipment calibration changes, changes in reagents, and summary quality control data. (5) Quarterly Monitoring Reports. Copies of the Quarterly CDC Monitoring Reports containing results of Central Lipid Laboratory standardization must be submitted within two weeks of receipt. (6) Laboratory Test Results. Submit results electronically to the NCHS NHANES IV Data Collection Contractor on a weekly basis. All results shall be submitted to the center within three (3) weeks following the receipt of the specimens. This time frame is established for pilot phase, validation assay results, and all survey data. (7) Interim Recommendations. A report must be sent six months after award of the contract. The report should recommend any suggested modifications. However, these changes should be kept to a minimum. (8) Raw data must be made available to the NHLBI Project Officer or to the NHANES IV Data Collection Contractor on request. (9) Residual serum. Periodically during the study the residual frozen serum must be delivered to the NCHS designated location. Upon completion of the contract, all remaining stored frozen samples must be delivered to the NCHS-designated location. (10) Annual Progress Reports must be provided to the NHLBI and to the NCHS. The Central Lipid Laboratory must take primary responsibility for reporting on administrative matters, staffing changes, and any problems occurring or anticipated related to its contract responsibilities, on solutions to the problems and on its quality control results and general progress in each major activity. The first report is due on the contract anniversary date. (11) Final Report. This report should 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. A draft of the final report will be due three months prior to the final report which shall be submitted on or before the last day of the contract performance period which is expected to be April 30, 2005. D. SPECIAL REQUIREMENTS 1. Government Furnished Facilities and Equipment The Government will furnish samples of serum labeled with an identification number and the age and fasting status of the examinee. The Government will ship the serum from the collection point to the Central Lipid Laboratory with dry ice. The Government will also provide the Laboratory Management Software. No Government furnished facilities are to be provided. 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 as set forth below. "FTE" as used below means Full Time Equivalent and is often expressed as percent effort. This information is furnished for the offeror's information as a guideline and is not to be considered restrictive for proposal purposes. ******By PHASE, in FTE*** Pilot Full-Scale Closing Principal Investigator/ Laboratory Director .10 .05 .10 Laboratory technician .25 .50 .15 Data Management .15 .25 .15 Secretarial/Clerical/Admin. .10 .10 .10 4. Geographic Restriction: It is to be noted that the award of a contract under this RFP shall be made only to an offeror which is located in the United States. One of the objectives of this study is to collect data on the lipid levels in the United States. Since all of the collection centers will be located in the United States, it will be necessary to limit the award to an offeror that is also located in the United States in order to prevent potential problems in the shipment of and the confidentiality of the blood samples. The need for close communication among NHLBI, CDC, NCHS and the NHANES IV Data Collection Contractor for data verification and quality assurance also will require the offeror to be located in the same country as the population to be studied. Proposals received from offerors located outside of the United States will not be considered for contract award. 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. It is to be noted that the award of a contract under this RFP will be made only to an offeror which is located in the United States. 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. a. Prior Experience: 30 points Laboratory must currently be participating in the CDC-NHLBI Lipid Standardization Program and have documented, verifiable prior experience in successfully performing lipid determinations in human serum or plasma as part of a population study or clinical trial. Capability of performing the required lipid analyses for this program as well as adequacy of quality control procedures. b. Competence of Proposed Staff: 30 points Adequacy of proposed staff possessing strong qualifications, experience in handling samples and performing lipid measurements of this kind. Capability and experience in developing a Manual of Operations and in advising field center personnel in blood collection techniques. c. Technical Approach: 30 points Adequacy of proposed plan for performing the required work. Adequacy of draft protocols and quality control procedures. Adequacy of scientific basis and logistical aspects for carrying out the work for the proposed program. Plan to perform measurements in a timely manner and send results to the NHANES IV Data Collection Contractor. d. Facilities: 10 points Adequacy of facilities and supportive environment including space and equipment for the work proposed, including the capability of transmitting and receiving data electronically to/from the NHANES IV Data Collection Contractor and adequacy of facilities to store blood specimens, together with evidence of institutional support for participation in a long-term collaborative program. ******************************************************************** 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. NHLBI-HV-98-14 TITLE OF RFP: Central lipid Laboratory for National Health and Nutrition Survey (NHANES IV) PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY OCTOBER 24, 1997. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION. ******************************************************************** I INTEND TO SUBMIT A PROPOSAL COMPANY/INSTITUTION NAME: ADDRESS: PROJECT DIRECTOR'S NAME: TITLE: TELEPHONE NUMBER: NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS (include Subcontractors and Consultants): RETURN TO: Review Branch or FAX TO: Dr. James Scheirer NIH, NHLBI (301) 480-3541 Attention: Dr. James Scheirer Rockledge Building, Room 7220 6701 ROCKLEDGE DR MSC 7924 BETHESDA MD 20892-7924 ******************************************************************** (b) PACKAGING AND DELIVERY OF PROPOSALS Your proposal shall be organized as specified in the Technical Proposal Table of Contents, below, and as described in the "Standard RFP Instructions and Provisions" found in the Gopher Directory entitled "RFP References." Shipment and marking shall be as indicated below. EXTERNAL PACKAGE MARKING: In addition to the address cited below, mark each package as follows: RFP NO. NHLBI-HV-98-14. 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 BETHESDA MD 20892-7924 *THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE STAMPING. NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the Bethesda, Maryland address. Any package sent to the Bethesda address via this 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." (c) PRIVACY ACT SYSTEM OF RECORDS This acquisition will 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. Violation of the Act may involve the imposition of criminal penalties. The Privacy Act System of Records Notice applicable to this project is number 09-25-0126. It was published in the Federal Register dated January 20, 1995, Vol. 60, No. 13, Pages 4264-4265. This notice will be incorporated into any resultant contract. If you would like a copy, please contact the Contracting officer identified in the cover letter to this RFP. (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 8071. 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 May 1, 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 May 1, 1998 through April 30, 2005 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. (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: Douglas W. Frye, Contracting Officer Contracts Operations Branch National Heart, Lung, and Blood Institute Rockledge 2, Room 6106 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) 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.) ******************************************************************** (i) TECHNICAL PROPOSAL TABLE OF CONTENTS RFP-NHLBI-HV-98-14 (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. Statement of Work 1. Objective .....(Items a.1 through a.4..... are not to exceed 25 pages) 2. Approach .......... 3. Methods ........... 4. Schedule .......... b. Personnel *** 1. List of All Personnel on the Project, including Subcontractors, Consultants/Collaborators, by Name, Title, and Organization 2. Principal Investigator/Project Director 3. Other Key Staff 4. Additional Personnel c. Resources and Facilities d. Other Considerations (use specifically titled subparagraphs, as applicable) 5. Other Support . . . . . . . . . . . . . . . . . . . . . . . . . 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 7. Technical Proposal Cost Information . . . . . . . . . . . . . . 6 (Format in Gopher RFP, RFP References, FORMS, FORMATS, & ATTACHMENTS) 8. Literature Cited. . . . . . . . . . . . . . . . . . . . . . . . 7 9. Appendices. . . . . . . . . . . . . . . . . . . . . . . . . . . 8 * 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. 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, May 1997. 11. Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16), Apr. 1984. 12. Instructions for Completing NIH 2706 (financial Report) OTHERS TO BE SUBMITTED AS DIRECTED BY CONTRACTING OFFICER 13. Certificate of Current Cost or Pricing Data, NIH-1397. 14. 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. ******************************************************************** .