RFP No. NIH-NIAID-DMID-96-11 Title: "MATERNAL IMMUNIZATION FOR THE PREVENTION OF INFECTIOUS DISEASES IN NEONATES AND INFANTS" Issued by: Carl R. Henn Contracting Officer NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, Maryland 20982-7610 DATE ISSUED: AUGUST 24, 1995 PROPOSAL DATE DUE: JANUARY 12, 1996, 4:00 P.M. (EST) Ladies and Gentlemen: The National Institute of Allergy and Infectious Diseases (NIAID) invites interested parties to submit competitive offers for evaluation leading to the award of a contract for "Maternal Immunization for the Prevention of Infectious Diseases in Neonates and Infants." The Government contemplates the award of one (1), five (5) year, cost-reimbursement, level of effort type contract as a result of this RFP. Listed below are the four attachments of this Electronic RFP package. These documents represent all the necessary information required for the submission of a proposal for this acquisition. Following proposal submission and review, additional information will be requested by the Contracting Officer from all offerors who comprise the competitive range. IMPORTANT NOTE: All proposals submitted in response to this RFP must contain a completed copy of the Representations and Certifications. Offerors may obtain a copy of this document via the NIH Gopher (go to the "Instructions for Proposal Submission" directory, and then to the "Forms Required for Proposal Submission" sub-directory), or by contacting Sara Southard at the internet address listed below. Although these documents contain sufficient information for 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 SARA SOUTHARD OF THE NIAID CONTRACTING OFFICE AT THE FOLLOWING INTERNET ADDRESS: ss63e@nih.gov IF YOU DO NOT NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST, YOU WILL NOT RECEIVE NOTIFICATION OF AMENDMENTS ISSUED TO THE RFP. HOWEVER, ALL AMENDMENT WILL BE POSTED ON THE NIH GOPHER AND/OR GRANT LINE SYSTEMS. The documents included with this electronic RFP package are as follows: 1. Introduction, Background and Work Statement, dated August 2, 1995 (Attachment A). 2. Reporting Requirements, dated August 2, 1995 (Attachment B). 3. Evaluation Factors for Award, dated August 2, 1995 (Attachment C). 4. Proposal Instructions and Information, dated August 2, 1995 (Attachment D) In addition to the information listed above, a listing of the applicable Government clauses/provisions, sample contract format, and terms and conditions which will be incorporated into the eventual contract document may be obtained either through accessing the NIH Gopher system or by sending a request to Sara Southard, Contract Specialist, using the internet electronic mail address listed above. The original and twenty (20) copies of your technical proposal and the original and five (5) copies of your business proposal must be received by the Contracting Officer no later than January 12, 1996, at 4:00 p.m. local time at the address listed in Attachment D, Item 7. 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 directory entitled "Instructions for Proposal Submission."). New policies require submission of more detailed information than has been previously required. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work, including: staff of the primary organization (offeror), subcontractors, and collaborating organizations; and consultants. Organizational affiliation(s) must be indicated for every person named. You may use additional sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. This information will be used to ensure that there will be no conflict of interest when selecting review committee members. Your attention is further directed to the "Proposal Intent" form contained in the Gopher sub-directory entitled "Forms Required for Proposal Submission." Please complete this form and return it to this office by December 16, 1995. Funds are not presently available for this requirement. The Government's obligation under a resulting contract is contingent upon availability of appropriated funds from which payment for contract purposes can be made. If you have any additional questions regarding this RFP, please contact Sara M. Southard through the internet using the electronic mail address listed above or by phone 301/402-6289, or fax 301/480-5253. Sincerely, /s/ Carl R. Henn Contracting Officer Contract Management Branch National Institute of Allergy and Infectious Diseases Attachments: A-D ***************************************************************** ***************************************************************** RFP-NIH-NIAID-DMID-96-11 ATTACHMENT A 8/2/95 MATERNAL IMMUNIZATION FOR THE PREVENTION OF INFECTIOUS DISEASES IN NEONATES AND INFANTS WORK STATEMENT ______________ INTRODUCTION ------------ The objective of this project is to further evaluate maternal immunization as a prevention strategy for infectious diseases in neonates and infants. The work in this contract encompasses Phase I and Phase II clinical trials of candidate vaccines of various types, and related vaccine biology studies. It is anticipated that one contract will be awarded to interested parties having the expertise and capability of undertaking maternal immunization studies in a clinical setting. BACKGROUND ---------- The capacity to evaluate new and improved vaccine candidates in an efficient and expeditious manner is an essential element of the efforts of the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID). The Institute has supported efforts to evaluate control measures for infectious diseases during past decades, including maternal immunization studies. Passively acquired humoral immunity for protection of neonates and young infants against a wide variety of bacterial and viral pathogens is extremely important. Within the infant itself, humoral immunity develops early in ontogeny but is relatively inefficient. By birth the infant is capable of responding to a large number of antigens, but there is little response to others. While significant progress has been made in the development of more immunogenic bacterial and viral vaccines, prophylaxis in the vulnerable neonate and young infant remains problematic. Attempts at inducing early protection by immunizing newborns have been generally disappointing. Maternal immunization resulting in passive transfer of antibodies to the neonate provides a potentially powerful alternative strategy for protection during the vulnerable neonatal and early infant periods. Perhaps the best known example has been the worldwide impact of maternal immunization during pregnancy against tetanus. Neonatal tetanus remains a major cause of infant mortality in much of the developing world, and active maternal immunization with tetanus toxoid vaccine has been shown to be the most cost effective intervention to prevent tetanus neonatorum. Other pathogens cause significant disease incidence, mortality and morbidity in neonates and young infants. These include group B streptococci, pneumococci, B. pertussis, and respiratory viruses such as influenza and respiratory syncytial virus (RSV). H. influenzae type b (Hib) is a major cause of severe bacterial infection in infants throughout the world, and until recently, had been the most common cause of bacterial meningitis in children in the United States. The licensure of Hib polysaccharide conjugate vaccines for infants beginning at two months of age offers tremendous benefits for young infants, but infants with low levels of passive maternally-derived antibody may have a "window" of susceptibility to Hib disease. Although some Hib conjugate vaccines induce a good antibody response to the primary dose, even those vaccines will not protect infants until three months of age. In many developing countries where immunization with Hib conjugates is not routine or affordable, a high proportion of invasive disease occurs within the first six months of life. The only source of protection for these infants is maternally derived antibody. Pneumococcal infections are responsible for an estimated one million deaths annually in children under five years of age in the developing world. A substantial proportion of this pneumococcal disease occurs in infants under five months of age. Passive protection from maternally derived pneumococcal antibodies has the potential for enormous economic impact in developing countries. Group B streptococci cause significant mortality and devastating morbidity in neonates and young infants. The infant generally acquires the infection either in utero or during the birth process, and is often profoundly ill by 24 hours of age. Maternal immunization may be a highly effective prevention strategy for neonatal GBS disease. While much emphasis has been placed on bacterial pathogens, both pregnant women and young infants have been documented to be vulnerable to serious sequelae of viral infections. Mortality and serious morbidity resulting from influenza infection is common for pregnant women and for infants. Numerous studies have shown that pregnant women will generate a normal response to inactivated influenza vaccine and that a beneficial effect can be generated by the passive transfer of specific influenza antibody from mother to fetus. It is likely that passive antibody transfer following maternal vaccination would be sufficient to protect infants from developing influenza infection in the first months of life. Another potential source of protective antibodies is in the breast milk of nursing mothers. A second viral respiratory pathogen of great significance in infants and young children is RSV. The greatest vulnerability to life threatening disease caused by RSV occurs during the first six months of life. No vaccine is currently available which is safe and immunogenic in very young infants. The protective effect of RSV-specific hyperimmune globulin has been demonstrated in high risk infants. Studies have also shown that naturally acquired neutralizing antibodies against RSV will protect infants from serious lower RSV infections. However, only about 20 percent of women have titers high enough to protect their infants through the first five months of life. Immunization of pregnant women with a safe and immunogenic RSV vaccine has the potential to prevent or modify early infection with RSV in their infants. In summary, maternal immunization of the pregnant woman in the third trimester of pregnancy can increase her antibody titers and has the potential to provide her infant(s) with high levels of protective antibody that could confer protection for the first six months of life against relevant infections. This approach could eliminate that window of susceptibility of infants both in the US and the developing world to Hib, pneumococcal, GBS, pertussis and respiratory viral infections prior to the age when protective, active antibody responses from active immunization can be generated. This is a re-competition of a contract awarded to Baylor College of Medicine in 1991 (N01 AI 15126). Several Phase I and Phase II trials of potential maternal vaccines have been initiated. In the previous contract, response to several candidate vaccines (e.g. Hib conjugate vaccines, and a pneumococcal polysaccharide vaccines) were examined, and the passive transfer of specific antibodies evaluated. A maternal immunization study evaluating a decreased dose of Hib conjugate vaccine is currently underway. The contractor undertook a study evaluating the safety and immunogenicity of a RSV subunit vaccine in post-partum women and other healthy women of childbearing age. A large study evaluating immunization with Hib conjugate vaccines and pneumococcal polysaccharide vaccine in women prior to pregnancy was also undertaken in a Native American population. The Maternal Immunization Group (MIG) is intended to explore research opportunities in maternal immunization with the goal being the prevention of neonatal infectious disease. Important in the MIG is the epidemiologic surveillance of pathogens circulating in the pregnant female population and neonatal population that are of special interest to NIAID. The MIG must provide staff, expertise, a maternal and neonatal population, and facilities to test a number of candidate vaccines developed by industry and government/academic scientists. WORK STATEMENT -------------- Independently and not as an agent of the Government, the Contractor shall exert its best efforts to furnish all necessary services, qualified professional and technical personnel, materials, equipment, and facilities, not otherwise provided by the Government under the terms of this contract as needed to perform the work set forth below. Specifically, the Contractor shall: (1) Establish and maintain the facilities and staff necessary to conduct prophylactic studies on candidate vaccines in pregnant human volunteers. [NOTES TO OFFEROR: A. A well trained, committed and balanced team of staff to fulfill the requirements of this work statement is required. The PI should have an M.D. and/or Ph.D. degree and have demonstrated experience in the clinical evaluation of vaccines and capacity to organize and administer a clinical study. The team of professional personnel, including the nursing staff, should have composite expertise in pediatrics, neonatal infectious diseases, maternal immunization, obstetrics, immunology, clinical trials, host response to pathogens and vaccines, surveillance, immunodiagnostics and biostatistics. Effective nursing staff are critical to the success of vaccine trials and a designated Research Nurse Coordinator/Supervisor is desirable. Individuals to be responsible for coordination of regulatory issues should be identified. The technical personnel should be trained and experienced in performing assay and laboratory procedures. B. The NIAID Blue Ribbon Panel on Vaccine Research identified a need to train investigators in vaccine related clinical research. It is both feasible and desirable to provide training opportunities for suitable individuals through effort expended on the activities of this contract. If appropriate and relevant, the offeror is free to propose inclusion of training opportunities for international and/or domestic scientists and clinicians. C. A summary curriculum vitae of each proposed professional and technical personnel should be included in the proposal. D. The offeror should describe how an existing clinical and laboratory facility can support the various studies, or describe the establishment of such facilities or collaborations to support the various studies.] (2) Provide patients as required for Phase I and Phase II vaccine studies. The target population for the vaccines is pregnant females. Test healthy adult non-pregnant female volunteers before progressing into the target population for candidate vaccines which have not been evaluated previously in adult volunteers. [NOTES TO OFFEROR: E. It is anticipated that testing in healthy volunteers in different age groups will be performed by NIAID-supported Vaccine Evaluation Units, before progressing to the target population. However, depending on the vaccine or the study, there may be a need within the MIG for testing some candidate vaccines in seropositive or seronegative adult non-pregnant female volunteers. The anticipated number is 50 women per year.] F. For contracts dealing with clinical research, it is NIH policy that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which were published in the Federal Register of March 28, 1994 (FR 59, #59, pages 14508-14513).] (3) Conduct Phase I and Phase II clinical trials to determine vaccine safety, reactogenicity, transplacental transfer of antibody, breast milk transfer of antibody, optimal dose, timing, immunogenicity and isotyping, depending on the vaccine being tested. [NOTES TO OFFEROR: G. Examples of the vaccines to be tested include, but are not restricted to: i. Vaccines for Group B Streptococci ii. Respiratory syncytial virus vaccines iii. Haemophilus influenzae type b conjugate and polysaccharide vaccines iv. Pneumococcal polysaccharide and conjugate vaccines H. There is interest not only in passive transfer through the placenta but also secretion of specific IgA antibodies in the milk. I. Issues of interest and importance include immunization schedules, dose, and transfer of functional/neutralizing antibodies. J. The range of studies anticipated requires a minimum of 120 subjects total per year. K. Three sample protocols and consent forms should be submitted with the proposal and should demonstrate a thorough understanding of testing of the vaccines anticipated. For these protocols, particular attention should be paid to rationale for the study design and the development of optimized strategies. L. Award of the contract does not commit the Government to approve the studies outlined and protocols presented in the proposal. The Project Officer will determine which studies are actually undertaken.] M. Although Phase III studies for vaccine efficacy may be considered in the event vaccines under study warrant it, a protocol for a Phase III trial should not be submitted with this proposal, nor should the costs for such a trial be included in the budget estimations.] (4) Conduct assays for antigens and antibodies (including antibody sub-classes) to determine volunteer eligibility, their baseline antigen/antibody levels on entry into a study, their response and the infant's response to the maternally-administered candidate vaccine, and if appropriate, the infant's response to active immunization. [NOTE TO OFFEROR: N. Assays for antigens/antibodies to bacterial and viral vaccines will preferably be conducted by the contractor unless otherwise directed by the Project Officer. To ensure standardization, assays on selected sera samples may be undertaken by other contractors or employees of the Government, or by vaccine manufacturers. Should non-routine or "special" assays for antigens/antibodies be necessary, testing may be arranged by the Government, and the offeror will be asked to ship specimens to the appropriate site for assay.] (5) Collect and appropriately store sera and other body fluids from study participants. Amounts and type will depend upon individual protocols. [NOTE TO OFFEROR: O. Studies may require collection of blood by venipuncture from infants.] (6) Follow vaccinees and their infants for up to three years to document duration of antibody or immune response, resistance to infection in the event of natural infection within the community, and any potential hazards of immunization as requested by the Project Officer. [NOTES TO OFFEROR: P. It is likely that all of the studies will require this type of follow-up. Q. Consideration should be given to establishing a group to formally monitor the infants of vaccinated mothers for adverse events. This may range from a safety monitor to the establishment of a Data and Safety Monitoring Board.] (7) Initiate or maintain an etiologic surveillance system to monitor relevant bacterial and viral infections in the populations proposed for study, in order to aid in the interpretation of the volunteers' and infants response to vaccination. [NOTE TO OFFEROR: R. The pathogens of interest may change during the course of the contract. The surveillance system should be flexible to allow for these changes.] (8) Prepare protocols, consent forms and other IND information for submission to the Project Officer and local Institutional Review Board (IRB) for approval and for NIAID to submit to the FDA as part of an Investigational New Drug (IND) package. Amend as necessary after comments by the Project Officer, local IRB, the DMID Clinical and Regulatory Affairs Branch, and regulatory authorities. (9) Organize and administer the clinical and associated laboratory research activities of the contract. a. Plan, conduct, and report on the proposed clinical research and associated laboratory studies. This shall include developing the specifics of experimental design, receiving and shipping of reagents and samples, coding of patients, reagents, and samples, and coordinating all of the subcontractors' activities (if applicable). This shall also include conducting all clinical studies in compliance with DMID/NIAID policy and in coordination with the Clinical and Regulatory Affairs Branch, DMID/NIAID. b. Manage the information generated, including transmission, storage, confidentiality, retrieval, validation, analysis, and publication. c. Coordinate the preparation of all manuscripts and presentations involving data from the studies. Establish a publication policy for results of multicenter studies, if applicable. All publications shall acknowledge NIAID support and be submitted to the Project Officer for review, prior to publication. The Project Officer shall have access to all data generated with the support of this contract. d. Establish and manage laboratory facility(ies) to support the various studies. e. Supervise, coordinate, and perform the project(s) (10) Attend and participate in one 2-day meeting per year in Bethesda to discuss results and future plans. [NOTE TO OFFEROR: S. Travel, lodging and meal costs for the Principal Investigator and one co-investigator to attend this meeting should be included in the business proposal.] (11) Attend and participate in one 2 day meeting per year in Bethesda to discuss clinical trial coordination, and regulatory issues related to clinical trials. [NOTE TO OFFEROR: T. Travel, lodging and meal costs for the individual serving as the research nurse coordinator or clinical trial coordinator and one other staff member to attend this meeting should be included in the business proposal.] (12) Organize and attend one 2-day meeting per year for purposes of protocol and study development and/or evaluation. [NOTE TO OFFEROR: U. This meeting will usually be held at the contractor's site. Travel, lodging, meal and honoraria costs for five external scientific protocol/study developers/evaluators to attend this meeting should be included in the business proposal. The individuals will be invited after consultation with the Project Officer. For cost purposes, assume that two individuals will travel from Los Angeles, two will travel from Boston, and one will travel from Chicago.] (13) Report to the DMID Clinical and Regulatory Affairs Branch and to the Project Officer all adverse reactions to comply with FDA regulations. [GENERAL NOTES TO OFFEROR: V. There may be occasion over the span of the proposed contract for multi-center efforts involving other DMID contractors so that protocols can be expeditiously completed. The Project Officer will determine the necessity of this. W. Award of the contract does not commit the Government to approve ANY of the studies presented in the proposal. The Project Officer will determine which studies are actually undertaken. The Project Officer will also determine the necessity of arranging and attending meetings related to contract activities.] ***************************************************************** ***************************************************************** RFP-NIH-NIAID-DMID-96-11 ATTACHMENT B 8/2/95 REPORTING REQUIREMENTS ______________________ The Contractor shall submit to the Contracting Officer and to the Project Officer technical progress reports covering the work accomplished during each reporting period. These reports are subject to the technical inspection and requests for clarification by the Project Officer. These shall be brief and factual and prepared in accordance with the following format: A. Technical Reports In addition to those reports required by SECTION I and other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below: (1) Semi-Annual Technical Progress Reports - by the fifteenth working day of the month following the end of each six month period, the Contractor shall submit five (5) copies of a semi-annual Technical Progress Report, comprising four (4) copies to the Project Officer and one (1) copy to the Contracting Officer. Such reports shall include the following specific information: a. A cover page that lists the contract number and title, the period of performance being reported, the contractor's names and address, the author(s), and the date of submission; b. SECTION I - An introduction covering the purpose and scope of the contract effort; c. SECTION II - A description of overall progress plus a separate description for each task or other logical segment of work on which effort was expended during the report period. The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project; d. SECTION III - Substantive performance; a description of current technical or substantive performance and any problems encountered and/or which may exist along with proposed corrective action. Each clinical study should be reported separately according to the number assigned by the Project Officer. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and if behind planned progress what corrective steps are planned. e. An anticipated work plan for the following six months. f. A table reporting the numbers of women and minority subjects enrolled in each clinical trial. The table should list the total number of subjects enrolled and provide separate subtotals according to ethnic descriptions (i.e., American Indian or Alaskan Native; Asian or Pacific Islander; Black, not of Hispanic origin; Hispanic; White, not of Hispanic origin; and Other or unknown) and gender. g. Preprints, reprints, and abstracts shall be submitted along with the report. SEMI-ANNUAL TECHNICAL PROGRESS REPORTS ARE NOT DUE FOR PERIODS IN WHICH AN ANNUAL OR FINAL REPORT IS DUE. (2) Annual Reports - On the anniversary date of the contract, the Contractor shall submit eight (8) copies of an Annual Technical Progress Report, as above, comprising seven (7) copies to the Project Officer and one (1) copy to the Contracting Officer. Such reports shall detail, document, and summarize the results of the entire contract work for the period covered. These reports shall be in sufficient detail to explain comprehensively the results achieved. Also to be included in the report is a summary of work proposed for the next reporting period. Specific requirements, if any, are set forth in ARTICLES C:1, Work Statement. A one page summary of each ongoing and completed protocol shall be submitted at this time. An annual report will not be required for the period when the final report is due. Preprints and reprints of papers and abstracts not submitted in the semi-annual report shall be submitted. (3) Final Report - By the expiration date of the contract, the Contractor shall submit eight (8) copies of a comprehensive Final Report, as above, comprising seven (7) copies to the Project Officer and one (1) copy to the Contracting Officer. This final report shall detail, document and summarize the results of the entire contract work for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved. Additional specific requirements are set forth in ARTICLE C:1. Preprints and reprints not included previously submitted shall be submitted. (4) Summary of Salient Results - With the annual/final reports the Contractor shall submit a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. (5) Other Reports - The Contractor shall submit seven (7) copies of: a) a one page summary of each ongoing and completed protocol one year and thirty days after an individual IND goes into effect and b) yearly IRB approvals and supporting documents. B. If the Contractor becomes unable to deliver the reports specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons, therefore. C. Technical Report Distribution Copies of the technical reports shall be submitted as follows: Type of # of Report Copies Addressee Due Dates ______ ______ _________ _________ Semi- 4 Project Officer Semi-Annually Annual DMID, NIAID, NIH (Dates to be Progress Solar Building, Room ____ specified 6003 Executive Blvd. MSC 7630 in contract) Bethesda, MD 20892-7630 Semi- 1 Contracting Officer Same as above Annual CMB, NIAID, NIH Progress Solar Building, Room 3C07 6003 Executive Blvd. MSC 7610 Bethesda, MD 20892-7610 Annual 7 Same as P.O. above Annually (Dates to be specified in contract) Annual 1 Same as C.O. above Same as above Final 7 Same as P.O. above Expiration date Final 1 Same as C.O. above Same as above ***************************************************************** ***************************************************************** RFP-NIH-NIAID-DMID-96-11 ATTACHMENT C 8/2/95 EVALUATION FACTORS FOR AWARD ____________________________ A. GENERAL The technical proposal will receive paramount consideration in the selection of the contractor for this acquisition. The evaluation will be based on the demonstrated capabilities of the prospective contractors in relation to the needs of the project as set forth in the RFP. The merit of each proposal will be evaluated carefully, based on responsiveness to the RFP and thoroughness and feasibility of the technical approach taken. Offerors must submit information sufficient to evaluate their 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. B. COMPARATIVE IMPORTANCE OF PROPOSALS You are advised that paramount consideration shall be given to the evaluation of the technical proposals, but not to the exclusion of cost considerations. While high competency is sought, capabilities that exceed those needed for successful performance of the contract work/statement are not requested. 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 will become paramount. In any event, the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered. C. MANDATORY QUALIFICATIONS FOR FACILITIES Prior to award the offeror must document the adequacy and suitability of facilities for performing all of the requirements of the Work Statement. D. TECHNICAL EVALUATION CRITERIA Proposals submitted in response to this RFP will be evaluated based on the following factors which are listed and weighted in order of their relative importance. Proposals will be judged solely on the written material provided by the offeror. Criterion Element Weight 1. TECHNICAL APPROACH ..................................... 80 Documented technical adequacy and feasibility of the proposed plans for Phase I and Phase II studies on candidate vaccines, epidemiologic surveillance for vaccine-relevant pathogens, performance of assays and laboratory procedures. Adequacy, suitability and availability of necessary populations as documented in the proposal and demonstrated ability to recruit, retain and follow appropriate samples of the study populations. a) Phase I and II trials: This includes the comprehensive approach for evaluating the vaccines cited as relevant examples in the Work Statement, suitability and originality of the sample clinical protocols, demonstrated ability to recruit, retain and follow appropriate populations, strategies for follow-up of vaccinees, appropriateness of consent forms and data collection forms, and handling of data, as required in the protocols and as requested in the Work Statement................... ........................ 50 b) Associated laboratory studies: This includes plans for transporting and storing clinical specimens, performing assays on sera and other body fluids, and for other relevant laboratory procedures as required in the protocols and as requested in the Work Statement................... ........................ 20 c) Epidemiologic surveillance: This includes the proposed methods and approaches for collecting focused epidemiologic data to support trials of vaccines, and evaluating risk factors for infection......................................... ........................ 10 2. PERSONNEL.............................................. 20 Documented adequacy and relevance of expertise, experience, education, and availability of personnel who will be assigned to perform the requirements. The PI should have an M.D. and/or Ph.D. degree and should provide documented evidence of experience in the clinical evaluation of vaccines in child-bearing aged women and pregnant women, and capacity to organize and administer a clinical study. The team of professional personnel, including the nursing staff, should have composite expertise in pediatrics, neonatal infectious diseases, maternal immunization, obstetrics, immunology, clinical trials, host response to pathogens and vaccines, surveillance, immunodiagnostics and biostatistics. The technical personnel should have documented training and experience in performing assay and laboratory procedures. The support staff should possess the requisite experience to perform their clerical and administrative duties. TOTAL POSSIBLE POINTS...................................... 100 E. EVALUATION OF MINORITY GROUP AND GENDER REPRESENTATION (NIH 3185) (JUL 1994) This research project involves human subjects. NIH Policy requires that woman and members of minority groups and their subpopulations must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification is provided with respect to the health of the subjects or the purpose of the research. Where inclusion of women and minority populations is not feasible, a detailed rationale and justification for exclusion of one or both groups from the study population must be submitted with the technical proposal. The NIH will review the exclusion rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research. If the rationale is not considered acceptable by the Government and you are included in the competitive range, you will be afforded the opportunity to further discuss and/or clarify your position during discussions or include women and minorities in your best and final (BAFO). If your exclusion position is still considered unacceptable by the Government after discussions, your proposal may not be considered further for award. ***************************************************************** ***************************************************************** RFP-NIH-NIAID-DMID-96-11 ATTACHMENT D 8/2/95 PROPOSAL INSTRUCTIONS AND INFORMATION _____________________________________ NOTICE TO OFFERORS: This attachment contains proposal instructions and information which is specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. Additional, more general, information and forms regarding proposal preparation are contained in the NIH Gopher directory entitled "Instructions for Proposal Submission." 1. 52.216-1 TYPE OF CONTRACT (APR 1984) The Government contemplates award of a cost-reimbursement contract resulting from this solicitation. 2. SIC CODE AND SMALL BUSINESS SIZE STANDARD (NIH 3150) (JUN 1988) (a) The standard industrial classification (SIC) code for this acquisition is 8733. (b) (1) The small business size standard is $3.5 million dollars. (2) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees. (c) This requirement is NOT Set-Aside for Small Business. However, the Federal Acquisition Regulation (FAR) requires in every solicitation (except for foreign acquisitions) the inclusion of the Standard Industrial Classification (SIC) Code and corresponding size standard which best describes the nature of the requirement in the solicitation. 3. NUMBER AND TYPE OF AWARD(S) (NIH 2980) (APR 1984) It is anticipated that 1 award will be made from this solicitation and that award will be made on or about September 30, 1996. Further, it is anticipated that the award from this solicitation will be a multiple-year cost reimbursement type contract with a term of 5 years, and that incremental funding will be used. (Also, see Incremental Funding Provision in this Section.) 4. ESTIMATE OF EFFORT (NIH 2985) (APR 1984) To assist you in the preparation of your proposal, the Government considers the total effort to perform this contract to be approximately 35.5 person years. This number is furnished for your information only and is not to be considered restrictive for proposal purposes. As further assistance, it is estimated that the above total labor effort is constituted as follows: Labor Percentages of Effort Category Yr1 Yr2 Yr3 Yr4 Yr5 -------- --- --- --- --- --- Prin. Invest. 30% 30% 30% 30% 30% Investigators 250% 250% 250% 250% 250% RNs 200% 200% 200% 200% 200% Technical & Support 230% 230% 230% 230% 230% _____ _____ _____ _____ _____ Subtotal 710% 710% 710% 710% 710% (Based on a 12-month work year) 5. COMPARATIVE IMPORTANCE OF PROPOSALS (NIH 3171) (JUL 1994) You are advised that paramount consideration shall be given to the evaluation of technical proposals. However, the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered. 6. 52.233-2 SERVICE OF PROTEST (NOV 1988) (a) Protests, as defined in Section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General Accounting Office (GAO) or the General Services Administration Board of Contract Appeals (GSBCA), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgement of receipt from: Mr. Lewis Pollack Hand-Carried Address: NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard Rockville, Maryland 20852 Mailing Address: NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, Maryland 20892-7610 (b) The copy of any protest shall be received in the office designated above on the same day a protest is filed with the GSBCA or within one day of filing a protest with the GAO. 7. PACKAGING AND DELIVERY OF THE PROPOSAL (NIH 2995) (JUL 1994) Shipment and marking shall be as indicated below: External Package Marking: _________________________ In addition to the address cited below, mark each package as follows: "RFP No. NIH-NIAID-DMID-96-11" "TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY" PLEASE READ THE FOLLOWING INFORMATION CAREFULLY: Number of Copies: ________________ Technical Proposal: Original and 20 copies. Business Proposal: Original and 5 copies. If hand delivered or delivery service ------------------------------------- NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard Rockville, Maryland 20852 If using U.S. Postal Service ---------------------------- NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, Maryland 20982-7610 * THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the Rockville, Maryland address. Any package sent to the Rockville address via this service will be held at a local post office for pick-up. THE GOVERNMENT IS NOT RESPONSIBLE FOR PICKING UP ANY MAIL AT A LOCAL POST OFFICE. If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal". 8. EVALUATION OF PROPOSALS (NIH 3125) (JUL 1986) The Government will evaluate Proposals in accordance with the evaluation criteria set forth in Attachment C (Proposal Evaluation Criteria) of this RFP document. 9. PHSAR 352.280-1(a) NOTICE TO OFFERORS OF REQUIREMENTS OF 45 CFR PART 46, PROTECTION OF HUMAN SUBJECTS (SEP 1985) (a) Copies of the Department of Health and Human Services (Department) regulations for the protection of human subjects, 45 CFR Part 46, are available from the Office for Protection from Research Risks (OPRR), National Institutes of Health, Bethesda, Maryland 20892. The regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the Department. (b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention of interaction with the individual, or (2) identifiable private information. The regulations extend to the use of human organ, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR Part 46. (c) Activities in which the only involvement of human subjects will be in one or more of the categories set forth in 45 CFR 46.101(b)(1-6) are exempt from coverage. (d) Inappropriate designations of the non-involvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal. The Public Health Service will make a final determination of whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the proposal. In doubtful cases, prior consultation with OPRR, (telephone: 301-496-7163), is recommended. (e) In accordance with 45 CFR Part 46, prospective Contractors being considered for award shall be required to file with OPRR an acceptable Assurance of Compliance with the regulations, specifying review procedures and assigning responsibilities for the protection of human subjects. The initial and continuing review of a research project by an institutional review board shall assure that the rights and welfare of the human subjects involved are adequately protected, that the risks to the subjects are reasonable in relation to the potential benefits, if any, to the subjects and the importance of the knowledge to be gained, and that informed consent will be obtained by methods that are adequate and appropriate. Prospective Contractors proposing research that involves human subjects shall be contacted by OPRR and given detailed instructions for establishing an institutional review board and filing and Assurance of Compliance. (f) It is recommended that OPRR be consulted for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. 10. PHSAR 352.280-2(a) NOTICE TO OFFERORS OF REQUIREMENT FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS (SEP 1985) The PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions establishes a number of requirements for research activities involving animals. Before a PHS award may be made to an applicant organization, the organization shall file, with the Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), PHS, a written Animal Welfare Assurance which commits the organization to comply with the provisions of the PHS Policy on Humane Care and use of Laboratory Animals by Awardee Institutions, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources. In accordance with the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, applicant organizations must establish a committee, qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities and procedures. No PHS award involving the use of animals shall be made unless the Animal Welfare Assurance has been approved by OPRR. Prior to award, the contracting officer will notify Contractor(s) selected for projects that involve live vertebrate animals that an Animal Welfare Assurance is required. The contracting officer will request that OPRR negotiate an acceptable Animal Welfare Assurance with those Contractor(s). For further information, OPRR may be contacted at NIH, Bethesda, Maryland 20892 (301-496-7163). 11. PRIVACY ACT (NIH 3131) (JUL 1994) The Privacy Act of 1974 (P.L. 93-579) requires that a Federal agency advise each individual whom it asks to supply information, the authority which authorizes the solicitation, whether disclosure is voluntary or mandatory, the principal purpose or purposes for which the information is intended to be used, the uses outside the agency which may be made of the information, and the effects on the individual, if any, of not providing all or any part of the requested information. The NIH is requesting the information called for in this RFP pursuant to the authority provided by Sec. 301(g) of the Public Health Services Act, as amended, and P.L. 92-218, as amended. Providing the information requested is entirely voluntary. The collection of this information is for the purposes of conducting an accurate, fair, and adequate review prior to a discussion as to whether to award a contract. Failure to provide any or all of the requested information may result in a less than adequate review. In addition, the Privacy Act of 1974 (P.L. 93-579, Sec. 7) requires that the following information be provided when individuals are requested to disclose their social security number. Provision of the social security number is voluntary. Social security numbers are requested for the purpose of accurate and efficient identification, referral, review and management of NIH contracting programs. Authority for requesting this information is provided by Section 305 and Title IV of the PHS Act, as amended. The information provided by you may be routinely disclosed for the following purposes: - to the cognizant audit agency and the General Accounting Office for auditing. - to the Department of Justice as required for litigation. - to respond to congressional inquiries. - to qualified experts, not within the definition of Department employees, for opinions as a part of the review process. 12. INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH PROPOSAL INSTRUCTIONS (NIH 3475) (JUL 1994) It is the policy of NIH that woman and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), [(this was reprinted to correct typesetting errors from the Federal Register dated March 9, 1994 (FR 59 11146-11151)], and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Offerors may obtain copies from these sources or from the contact person listed in the RFP. Unless otherwise specified in this solicitation, the Government has determined that the work set forth herein does not involve a gender specific study or a single or limited number of minority population groups. Therefore, the NIH believes that the inclusion of women an minority population is appropriate for this project. (See Attachment C of this RFP for more information about evaluation factors for award.) The format for the Annual Technical Progress Report (See Technical Reporting Requirements contained in Attachment B of this RFP) shall be used in proposal preparation. 13. ADDITIONAL PROPOSAL INSTRUCTIONS A listing of additional instructions and notices required for proposal preparation is provided below. The full text versions of these provisions are contained in the NIH Gopher directory entitled "Instructions for Proposal Submission". - NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE - 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (JUN 1988) - COMMITMENT OF PUBLIC FUNDS (NIH 2455) (JUL 1986) - COMMUNICATIONS PRIOR TO CONTRACT AWARD (NIH 2345) (FEB 1990) - RELEASE OF INFORMATION (NIH 3170) (JUL 1994) - PREPARATION COSTS (NIH 3173) (JUL 1994) - PHSAR 352.215-10 LATE PROPOSALS, MODIFICATIONS OF PROPOSALS AND WITHDRAWALS OF PROPOSALS (NOV 1986) - CONTRACT CLAUSES (NIH 3120) (JUN 1986) - FORMAT AND CONTENT OF PROPOSALS (NIH 3121) (JUL 1994) - SEPARATION OF TECHNICAL AND BUSINESS PROPOSALS (NIH 3122) (JUL 1994) - ALTERNATE PROPOSALS (NIH 3123) (JUL 1994) - CONFIDENTIALITY OF PROPOSALS (NIH 3124) (JUL 1994) - USE OF THE METRIC SYSTEM OF MEASUREMENT (NIH 3126) (JUL 1994) - SELECTION OF OFFERORS (NIH 3130) (JUL 1986) - SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS SUBCONTRACTING PLAN (NIH 3135) (JUL 1986) - REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS (NIH 3165) (JUL 1994) - SALARY RATE LIMITATION INFORMATION FOR OFFERORS (NIH 3101) (OCT 1994) - TECHNICAL PROPOSAL INSTRUCTIONS (NIH 3500) (JUL 1994) - TECHNICAL DISCUSSIONS (NIH 3505) (JUL 1994) - TECHNICAL EVALUATION (NIH 3510) (JUL 1994) - ADDITIONAL TECHNICAL PROPOSAL INFORMATION (NIH 3165) (JUL 1994) - OTHER CONSIDERATIONS (NIH 3520) (JUL 1994) - COST AND PRICING DATA (NIH 3600) (JUL 1994) - QUALIFICATIONS OF THE OFFEROR (NIH 3615) (JUL 1994) - PROPERTY/EQUIPMENT/FACILITIES (NIH 3620) (JUL 1994) - ROYALTIES (NIH 3625) (JUL 1994) - FINANCIAL CAPACITY (NIH 3630) (JUL 1994) - SUBCONTRACTORS (NIH 3635) (JUL 1994) - INCREMENTAL FUNDING (NIH 3640) (JUL 1994) - REPRESENTATIONS AND CERTIFICATIONS (NIH 3645) (JUL 1994) - NOTICE TO OFFERORS - FORMS/FORMATS/ATTACHMENTS (NIH 3145) (JUL 1986)