HIV VACCINE PRODUCTION
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Request for Proposal No.: |
NIH-NIAID-DAIDS-99-21 |
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Issue Date: |
October 15, 1998 |
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Issued By: |
Lawrence M. Butler, Contracting Officer |
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Point of Contact: |
Dawn Kotzen, Contract Specialist |
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Purchase Authority: |
Public Law 92-218 as amended |
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Small Business Set-Aside: |
No, SIC Code 8731 |
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Just In Time: |
No |
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Offer Expiration Date: |
Offers will be valid for 120 days unless a different period is specified by the Offeror on the form entitled "Proposal Summary and Data Record, NIH 2043." |
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Proposal Due Date: |
February 1, 1999, 4:00 P.M EST |
Ladies and Gentlemen:
You are invited to submit a proposal in accordance with the requirements of this RFP (NIH-NIAID-DAIDS 99-21) entitled "HIV VACCINE PRODUCTION." The Government anticipates that multiple Indefinite Delivery/Indefinite Quantity contracts will be awarded and requirements for specific services will be issued through the use of task orders, which may be incrementally funded. The period of these contracts will be of a seven (7) year duration.
The documents included with this electronic RFP package are as follows:
Attachments:
In addition to the information provided in this document (i.e., The Streamlined RFP), there are five (5) other referenced documents in the Streamlined RFP References that must be retrieved, in whole or in part, in order to submit a proposal. The applicable portions of these referenced documents are explained in Attachment E, Applicable RFP References of this RFP.
If you are unable to download any of the applicable documents, please contact Dawn Kotzen, Contract Specialist, by phone/fax/Internet. (See contact numbers/addresses below.)
The information contained in this electronic RFP represents all the necessary information required for the submission of a proposal for this acquisition. Following proposal submission and review, the Contracting Officer during discussions will request additional information (if applicable).
Although sufficient information for you or your organization to submit a proposal is provided, if you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Dawn Kotzen, Contract Specialist, of the NIAID Contracting Office at the Internet address listed below. If you fail to notify the Contracting Office of your interest, you will not receive notice of amendments that may be issued for this RFP, and this could impact your proposal preparation. However, please note that all amendments will be posted on the NIH RFP Home Page and the NIAID Contract Management Branch (CMB) Home Page.
The Business and Technical proposals must be separate from one another in the proposal package, as the peer review panel will only receive the Technical Proposal. The Business Proposal must be signed by an authorized official of your organization, and must contain a detailed breakdown of costs by year for each cost category/element. The basis for all costs must be explained and supporting documentation must be submitted with the proposal. (See "STANDARD RFP INSTRUCTIONS AND PROVISIONS," in the NIH RFP Home Page, for more detail on the Business Proposal requirement.)
The original and twenty (20) copies of your Technical Proposal and the original and 5 copies of your Business Proposal must be received by this office no later than February 1, 1999, at 4:00 p.m. local time at the address listed in Attachment D.
Your attention is further directed to the "Proposal Intent Response Sheet" contained in Attachment D of this document. Please complete this form and return it to this office on or before December 15, 1998. This will allow us to expedite preparations for the peer review of proposals.
The "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your Technical Proposal. It is important that you list all professional personnel and organizations named in the proposal that have any role in the proposed work, including: staff of the primary organization (offeror), subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be indicated for every person named. You may use additional sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. This information will be used to ensure that there will be no conflict of interest when selecting review committee members.
Finally, your technical proposal must be organized and submitted in accordance with the "Technical Proposal Table of Contents" contained in Attachment D of this document.
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 the PHS CLAUSE 352.215-10, "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWALS OF PROPOSALS."
Questions concerning any areas of uncertainty which, in your opinion, require clarification or correction must be furnished in writing to Dawn Kotzen, Contract Specialist at the Internet electronic mail address dk28a@nih.gov, or by fax at 301/402-0972. Dawn Kotzen, Contract Specialist can be reached at 301/496-3699. Collect calls will NOT be accepted.
Sincerely,
/s/
Lawrence M. Butler
Contracting Officer
AIDS Contract Section
Contracts Management Branch
National Institute of Allergy
and Infectious Diseases, NIH
Attachments: A - E
BACKGROUND, INTRODUCTION AND WORK STATEMENT
BACKGROUND
The development of a vaccine to prevent the spread of HIV infection has been identified by the NIAID as a goal of the highest priority. While advances in immunology and molecular biology continue to offer an ever expanding array of approaches to the development of new candidates, the limited capacity to move promising concepts through the development process presents a substantial barrier to the full achievement of this potential. Limited industry involvement in key areas, especially international (non-clade B) vaccines, calls for a non-traditional, more active and developmentally oriented response by NIH and NIAID to meet the public health threat of the AIDS epidemic. Resources that could rapidly and efficiently close development and production gaps would greatly enhance the capacity to respond to emerging needs identified by NIAID and its advisory groups. The HIV Vaccine Production Contract will support applied research that is not adequately being pursued by industry and will further develop leads derived from investigator-initiated research.
The Contract will facilitate developmental HIV vaccine research by performing tasks in three areas. Offerors may submit proposals for one or more of the Parts A-C of this solicitation.
INTRODUCTIONThe objective of the Contract is to provide to the NIAID with a full range of developmental resources to bring an HIV vaccine concept from the laboratory to initial human testing. It is envisioned that the ability to encourage and to support the development of multiple approaches will result in a shared knowledge base from which the best vaccine prototypes will emerge.
PART A: VACCINE PRODUCTION
The first area of work will require a product development team with the expertise to develop candidate vaccines including scale-up and production of GLP/GMP lots suitable for human use and to perform the necessary characterization tests required for release of vaccines for clinical use. In some cases, a Task Order may support work on well-developed products that need only final steps in production, formulation and/or filling. Other Task Orders may involve very early and iterative steps in the development process and require several years of effort.
Under Part A, various Categories of vaccine concepts will be developed based on (a) Synthetic peptides, (b) Recombinant subunits, (c) DNA vaccines, (d) Vector based vaccines, (e) Whole killed/virus-like particles, or (f) Live attenuated virus. Offerors may submit proposals based on scale-up and production of any one or more vaccine Categories.
PART B: SAFETY AND IMMUNOGENICITY TESTING
The second activity area to be supported under the contract is the testing of vaccine preparations as required prior to initial clinical evaluation. This includes testing candidate products for safety and immunogenicity (both cellular and humoral) in small animals and, if appropriate, in non-human primates.
PART C: FDA SUBMISSIONS
The third area to be supported by the contract is the development for a series of specific vaccines of the Master File, Investigator's Brochure, and compilation of an Investigational New Drug Application (IND) including a vaccine trial protocol (provided by the clinical trials group) appropriate for submission to CBER, FDA for an IND.
CONTRACT TYPE:
It is anticipated that multiple awards will be made for each part of this Indefinite Quantity Contract. The Contract will be in effect for seven (7) years. An indefinite quantity contract provides for an indefinite quantity, within stated limits, of supplies or services to be furnished during a fixed period, with deliveries or performance to be scheduled by placing orders with the contractor. Task order requests will be issued to the prequalified pool of contractors for parts A, B or C based on the specific requirements of the task order.
In response to this RFP, potential Offerors may submit proposals for one or more of the three Parts described above. Within Part A, Offerors may submit proposals for any one or more of the vaccine concept Categories. Proposals will undergo peer review based on the evaluation criteria and awards will be made to the most qualified proposals. Each Offeror awarded a contract under a given Part or Category, will receive a guaranteed minimum dollar award over the term of the Contract (offers that qualify for more than one part will receive only one contract). The guaranteed minimum dollar awards for Contractors will be determined by the following scale:
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Contract Part - |
Minimum Award |
|---|---|
| Part A - | $200,000 |
| Part B - | $100,000 |
| Part C - | $ 50,000 |
Offerors that receive awards for more than one Part will be eligible for Minimum Awards for each Part. Offerors that receive awards for one or more vaccine Categories under Part A will be eligible for a single Part A minimum award. It is anticipated that the maximum total funding under the Contract for all parts will be between $5 – 10 million per year.
When a need is established for any of the products or services to be provided under the Contract, a task order request for either Parts A, B, or C will be submitted to all Contractor(s) that received awards under that Part (see Attachment D, Specific RFP Instructions and Provisions). Contractor(s) will submit a detailed proposal with milestones to perform the work stated in the Task Order request together with a detailed budget proposal within the time allotted for proposal submission (time allowed for proposal preparation in response to a task order request will vary depending on the task). Specifics with regard to deliverables and reporting requirements will be negotiated and included into the successful offeror's task order.
STATEMENT OF WORK
WORK STATEMENT for the HIV Vaccine Production Contract.
Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government under the terms of the contract, directly or through subcontractors and/or consultants, as needed to undertake targeted research essential to translating basic research concepts into prototype vaccine products, under the direction of NIAID staff and as recommended by existing and ad hoc NIAID advisory groups.
This Statement of Work will be divided into three Parts: A) Vaccine production, B) Safety and immunogenicity testing, and C) FDA submissions. Each Contractor will be responsible for one or more of the three Parts. Contractors for each Part will fully and formally cooperate with the relevant other Part A, B or C Contractors and with the Project Officer.
[GENERAL NOTE: All clinical trials involving these vaccine products will be performed under an IND held by the NIH or the vaccine sponsor and will include IRB approval and informed consent to limit liability of the manufacturer.]
[NOTE #1 TO OFFERORS: Because the Parts A,B,C of this solicitation are not highly related, single institutions may not have the expertise and facilities required to perform all requirements in the Statement of Work. Thus it is acceptable for an Offeror to submit a proposal for Part A, B or C or any combination of the three. See evaluation criteria (Attachment C). Each Part will be independently evaluated so that the Offeror will only be evaluated based on the specific Part(s) for which it applies. Lack of expertise in one Part will not affect the evaluation of other Parts.
Separate review committees will likely be involved in the review of Parts A, B and C. Therefore, responses should be packaged as separate, stand-alone entities for each of these. Offerors for Part A should have a separate section for each category, addressing the evaluation criteria and other requirements (methods, staff, experience, allocated facilities, etc.) separately for each. Each category will be evaluated (scored) individually so that a Part A Offeror will be graded and determined to be Qualified/Not Qualified for each category independently based on the quality of the proposal for each category. The submission format should allow all the information needed to evaluate each category to be dissected free of that which pertains to other categories. If a phase-up period is anticipated, this should be addressed via a timetable for each Part A category, as the time frames could be quite different. There can be core sections which are the same for all categories but which are referenced specifically under the section for each category. An overall summary section may also be included which sums up the total facilities, staff, and resources proposed in order to judge total capacity proposed.
If the Offeror wishes to include in his proposal Parts, Categories or specific tasks for which he does not have direct expertise, then the Offeror may propose a subcontract in order to fulfill the requirements of activities in Parts A, B or C. The Contractor shall be directly responsible for all work performed under the contract, including work done by any subcontractor. The Offeror shall describe in the technical proposal, areas of responsibility of any subcontractor as they pertain to the Work Statement in the same detail as their own proposal.
To perform activities in Part A of this RFP, a highly qualified and experienced product development team consisting of Research Scientists and Technicians is required. The Principal Investigator will be responsible for overall management and productivity of the entire conduct of activities in Part A for a given Category. Offerors must be experienced and meet all requirements for GLP/GMP production.
To perform activities in Part B of this RFP, Offerors should have extensive experience in the preclinical safety and immunogenicity testing of GMP products intended for human use. Offerors must meet all requirements for GLP and/or GMP.
To perform activities in Part C of this RFP, Offerors should have extensive experience in assembling and filing all documents and records necessary for successful filing of vaccine submissions to FDA.
In responding to this RFP, Offerors should describe in detail the responsibilities and level of effort of all proposed personnel who will be assigned to the contract. In addition, Offerors should describe an administrative framework showing clear lines of authority. Documentation should be provided on the qualifications, experience, education, competence, and availability of the Principal Investigator, Research, Technical and Administrative Support staff; the extent to which outside consultants shall be used as well as assurance of their availability. If a subcontractor is proposed, similar technical information should also be provided as part of the Technical Proposal. Cost details should also be provided by the subcontractor.
Technical proposals must describe specifically how the offeror will fulfill each of the items in the Statement of Work below.
The technical proposal should include:
For Part A, the technical proposal should be based on the production of a vaccine as proposed in NOTE #A-8 TO OFFEROR.]
Specifically, the Contractor(s) shall:
PART A: VACCINE PRODUCTION.
[NOTE #A-2 TO OFFEROR: Such products may incorporate multiple components (e.g., geographic variants of HIV, various HIV gene products, immunomodulatory cytokines or the corresponding genes, third party adjuvants, delivery systems, etc.).]
[NOTE #A-3 TO OFFEROR: This activity may require direct collaboration with the vaccine inventor.]
[NOTE #A-4 TO OFFEROR: Destination sites and special shipping requirements will be designated by the Project Officer.]
At various steps during the manufacture of a vaccine the product must be characterized. Prior to use of a vaccine in clinical studies the manufactured vaccine will need to undergo final lot release testing. As described in the regulations for General Biological Product Standards (21 CFR 610) the following tests must be performed for each lot of vaccine.
[NOTE #A-5 TO OFFEROR: Stability testing will be required at various points during the production process. There is no single stability-indicating assay or parameter for all biological products. Therefore, manufacturers should propose on a case-by-case basis stability-indicating profiles for their products which provide assurance that changes in identity, purity and potency of the product will be detected.]
[NOTE #A-6 TO OFFEROR: This may include information contained in master production and control records, batch production and control records, standard operating procedures (SOP) and laboratory records. This information will be requested when required by the FDA and should be submitted within 3 weeks from the time the Project Officer makes the request.]
Six months before the end of the awarded Contract, the Contractor shall define and implement an orderly transition of data, specimens and products to any successor Contractor or to the Government, subject to Project Officer direction, and shall deliver, if requested by the Project Officer and by the completion date of the Contract, the following items: original data, reagents, stored specimens (and any necessary information related thereto), Government-owned equipment and property.
[NOTE #A-7 TO OFFERORS: A single Task Order may include any or all of the above requirements. For example, a Task Order may be limited to the vaccine or reagent formulation (including adjuvant and excipients), vialing, labeling, packaging, storage and/or shipment of premanufactured products.]
[NOTE #A-8 TO OFFERORS: The number and types of products to be developed under Part A cannot be specified at this time. For the purposes of responding to this RFP, the Offeror should describe in some detail its experience with the development/optimization of a specific vaccine, preferably a biologic product, regardless of the applicability of that particular product to an HIV vaccine.
The intent of this description is to demonstrate to the reviewers of the RFP the capabilities and problem solving experience of the Offeror during early developmental phases. The Offeror should demonstrate understanding of the approach and document capacity for production and scale-up under cGMP.
Since it is not expected that any one Offeror will have the capacity to produce every category of vaccine, the Offeror may submit a proposal for any one or more of the vaccine categories in Part A. Each Offeror will be evaluated based on the specific category(s) of vaccine for which they apply. Therefore, the Offeror is requested to propose a detailed plan for producing a pilot lot through the final form to be delivered for clinical trials of any one or all of the following six vaccines. Submit a plan for each vaccine category for which you are applying.
b) Recombinant subunits – 10,000 doses of rGP120, formulated with alum adjuvant at 200 ug/dose. Assume that the HIV strain is a primary NSI strain.
c) DNA vaccine - 10,000 doses of a plasmid DNA vaccine containing a 2000 bp insert of HIV sequence, at 100 ug/dose. Assume that the vector is pcDNA3 with a CMV promoter, and yields of DNA from laboratory-scale lots are known and present no unusual problems.
d) Vector based vaccine. Live recombinant vaccinia - 10,000 doses of recombinant vaccinia expressing an HIV env gene from one promoter and an HIV gag gene from another, to be delivered at 10E7 pfu/dose. Assume that The HIV inserts are stable, and the recombinant vector has shown good growth properties in a variety of standard mammalian cell substrates.
e) Whole killed vaccine. – 10,000 doses of inactivated whole HIV-1 virus at 100 ug p24/dose.
f) Live attenuated virus – 1000 doses at 100 TCID50/dose of a triple deletion attenuated HIV. Assume that the parent strain is a known primary NSI isolate.
For each vaccine concept, the Offeror should propose production, purification and characterization methods and a timeline for obtaining completion of each pilot lot, with sufficient data generated for IND submission. Potential pitfalls and back-up plans should be included. Offeror should include a statement of its maximum capacity for production of each vaccine lot. Include cost estimates in the form of a detailed budget proposal for performing all the activities (Part A, 1-10) listed in the Statement of Work above. Include cost documentation which would include payroll records for proposed personnel.
When the need arises to issue a task order request under the contract, prequalified contractor(s) will be requested to submit a detailed production plan and cost proposal for that specific task.
These vaccines cover a range of complexity and difficulty which is anticipated to be realistic for HIV vaccines which may be requested under the Contract. Award of the Contract, however, does not commit the Government to approve any of the protocols outlined in the proposal. The Project Officer will determine whether and which pilot lot production projects are actually undertaken.]
PART B: SAFETY AND IMMUNOGENICITY TESTING.
Test candidate products for safety and immunogenicity (both cellular and humoral) in small animals and, if necessary, in non-human primates, and other appropriate tests, including reproductive toxicology. Perform all such tests as are required for approval of a vaccine product for human administration. Testing must be sufficient to meet requirements for IND filing.
[NOTE #B-1 TO OFFERORS: Documentation of experience in preclinical safety and evaluation of immune response testing should be provided. It is anticipated that the contractor will have the capacity to perform testing for each type of vaccine candidate covered by the contract, including each of the six general vaccine Categories. Offeror should outline in detail the tests and procedures it will use to qualify each type of vaccine product for human administration. (NOTE: Standards for the evaluation of live attenuated HIV are still under development. Therefore, Offerors are not required to propose a plan for that vaccine Category at this time.) Provide an appropriate model for determining the cellular and humoral immunogenicity of an HIV vaccine in small animals and, if necessary, in non-human primates. Offeror(s) may propose subcontracts for any specific testing procedure (e.g., primate studies).
Documentation of available equipment and access to an AAALAC-accredited (or equivalent) animal facility and the capacity for testing the safety and immunogenicity of products should be included. Document a history of having performed the requested studies in compliance with Good Laboratory Practices (GLP).
For the purposes of providing a cost proposal, Offeror(s) should provide a detailed budget based on the preclinical safety and immunogenicity evaluation of one DNA vaccine product. Assume that tumorigenicity studies are not required. Include documentation for personnel costs and all specific animal, supply, and equipment costs.]
The preclinical studies shall be designed to assess the immune response including seroconversion rates, antibody levels, and cell mediated immune responses in vaccinated animals.
b. Preclinical safety evaluations shall include but are not limited to the following.
Preclinical studies shall include dose-ranging and dose escalation studies of systemic toxicity as well as toxicity to potential target organs, including hematopoietic and immune systems.
2) Local reactogenicity.
Local site reactivity studies to include detailed clinical observations and histological evaluation of tissue of the injection site or other visible lesions from biopsies or term necropsy samples.
3) Genetic toxicity.
In the case of DNA and vector-borne vaccines the pivotal GLP preclinical study shall focus on assessment for the potential of the nucleic acid vaccine to recombine with endogenous host DNA sequences and integrate into cell chromosomes. Studies designed to address the potential for integration shall use the most sensitive methods available.
4) Tumorigenicity studies.
Tumorigenicity studies may be appropriate under certain conditions, such as if the preclinical genetic testing demonstrates evidence of integration activity and/or broad tissue distribution. Such studies shall be performed when necessary.
5) Reproductive toxicity studies.
Reproductive toxicity studies must be performed prior to the use of these vaccines in pregnant women. Such studies shall include but are not limited to fertility, general reproductive performance, teratology and developmental toxicity.
6) All other safety tests as may be required for a particular vaccine type.
The use of adjuvants and/or facilitators for the administration of a vaccine will necessitate specific preclinical evaluation procedures to ensure the safety of the candidate formulation to include but not limited to the evaluations listed in #2 above.
In addition, the contractor shall:
Six months before the end of the awarded Contract, the Contractor shall define and implement an orderly transition of data, specimens and products to any successor Contractor or to the Government, subject to Project Officer direction, and shall deliver, if requested by the Project Officer and by the completion date of the Contract, the following Items: original data, reagents, stored specimens (and any necessary information related thereto), Government-owned equipment and property.
[NOTE #B-2 TO OFFERORS. Specific requirements listed in the Statement of Work are not meant to limit the scope or specifics of preclinical vaccine testing. Such testing will include all of the tests required to qualify a vaccine product for human administration.]
[NOTE #B-3 TO OFFERORS. In addition to the CFR, the FDA also provides "Points to Consider" (PTC) Documents. Testing should be conducted consistent with these guidelines. Examples of relevant guidelines include:
These documents, as well as additional guidelines relating to testing and manufacture, are available from the Division of Congressional and Public Affairs. To receive copies call 888-223-7329 then dial 999 to get a list of documents and their number. Consumer information number is 301-827-2000. On the internet go to www.cber.fda.gov.]
PART C: FDA SUBMISSIONS
Develop, in consultation with the Project Officer, vaccine sponsors, and other contractors the Master File, Investigator's Brochure, and/or final vaccine trial protocol appropriate for submission to CBER, FDA as part of an Investigational New Drug Application (IND).
[NOTE #C-1 TO OFFERORS: It is anticipated that the Contractor will not hold the IND for any human trials to be conducted. The IND will be held by either the organization that holds proprietary rights to the product, or by the Division of AIDS, NIAID. However, the Contractor may be requested to work directly with the FDA for Masterfile and IND submission. For this proposal, the Offeror should provide evidence of its previous experience with submissions to CBER.
Offeror should also demonstrate its capacity to obtain, store, collate and arrange data and information and to keep all information secure.]
Specifically, the Contractor shall perform the following tasks:
[NOTE # C-2 TO OFFEROR(S): The technical proposal should include a detailed list of required documents and a plan for the production of the Investigator's Brochure, Masterfile, IND proposal and all other documents required by the FDA for a new vaccine. It should contain provisions for cross-filing to other IND's. It should also include a plan for coordinating with vaccine manufacturers and Contractors performing preclinical safety and immunogenicity studies in order to assure that all requirements are met for providing the records and information necessary for filing the FDA submissions. It is anticipated that the protocol for the IND clinical evaluation will be provided by the Vaccine Clinical Trials Group. This proposal should not include provisions for monitoring clinical investigations after the IND has been filed.
For the purpose of preparing the cost proposal, Offeror(s) should assume that 5 vaccine products per year will be submitted to the FDA. The budget should include documentation for personnel costs plus expected direct costs for the preparation of submissions.]
RFP-NIH-NIAID-DAIDS-99-21
October 15, 1998
REPORTING REQUIREMENTS AND DELIVERABLES
In addition to those reports required by the Statement of Work and other terms of the Contract the Contractor shall prepare and submit the following reports in the manner stated below. Reports will be required for Contractors with active Task Orders throughout the period of work.
Upon the completion of each milestone as indicated in the Task Order, the Contractor shall submit three (3) copies of a milestone report as described below. Two (2) copies should be submitted to the Project Officer and one (1) copy to the Contracting Officer. The milestone report should be factual and concise and consist of the following:
1) A title page containing:
2) Reports shall include, but are not limited to the following information:
By the fifteenth (15) working day of the month following the end of each quarter, the Contractor shall submit three (3) copies of a quarterly progress report as described below. Two (2) copies should be submitted to the Project Officer and one (1) copy to the Contracting Officer. The quarterly report should be factual and concise and consist of the following:
1) A title page containing:
2) Reports shall include, but are not limited to the following information:
3) A quarterly report is not due when an annual report is due.
On or before the last day of the Contract year, the Contractor shall submit three (3) copies of an annual report. Two (2) copies shall be submitted to the Project Officer and one (1) copy shall be submitted to the Contracting Officer. The annual report shall summarize progress for the entire contract year, following the same format as for the quarterly reports, and shall take the place of the fourth quarterly report. In addition, it should include abstracts, manuscripts in progress or submitted, and publications resulting from the performance of work under the contract. An annual report is not required when the final report is due.
The contractor shall submit three (3) copies of each Task Order final report, two (2) copies to the Project Officer and one (1) copy to the Contracting Officer, which will summarize the results of the each completed Task Order. This report will be in sufficient detail to explain comprehensively the results achieved and will be submitted no later than the completion date of the Task Order.
The final report shall contain:
1) Title Page as described above in paragraph I.1)a.
2) Introduction covering the purpose and scope of the active Task Order.
3) Description of the overall progress of the active Task Order. Descriptions shall include pertinent data in tables or graphs as appropriate to present significant results achieved, conclusions resulting from analysis, and a scientific evaluation of the data accrued under the active task.
4) Copies of any abstracts, manuscripts, and publications.
1) The Contractor, at the request of the Project Officer, shall deliver to the Government or its designee by the completion date of the Task Order, the following items:
PART A:
(a) Test lots of vaccine products, as they are produced.
(b) cGMP quality pilot lots of candidate vaccine products and adjuvants, as they are produced.
(c) All vaccine candidates and adjuvants in various stages of production at termination of the contract with detailed information on them.
(d) A compete listing of accurate and updated information on design, development and production including activities of the Contractor, computerized data files, original data and any necessary information related thereto.
(e) A complete list of accurate and updated information on activities of subcontracts.
(f) Labeled and inventoried paper files.
(g) Government-owned equipment and property.
PART B:
(b)All vaccine products, adjuvants, etc. remaining from these studies.
PART C:
(a) All files pertaining to the contract at the request of the Project Officer.
(b) Copies of all FDA submissions.
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Type of Report | No. of Copies | Address |
|---|---|---|---|
|
|
Milestone |
2 |
Project Officer, |
| Quarterly | 2 | PRB, VPRP, NIAID, NIH | |
|
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Annual | 2 | Solar Bldg., Rm. 2A38 |
| Final | 2 | 6003 Executive Blvd., MSC 7620 | |
| Bethesda, MD 20892-7620 |
|
|
Milestone |
1 |
Contract Officer, |
|
|
Quarterly |
1 |
CMB, DEA, NIAID, NIH |
|
|
Annual |
1 |
Solar Bldg., Rm. 3C05 |
|
|
Final |
1 |
6003 Executive Blvd., MSC 7610 |
|
|
|
|
Bethesda, MD 20892-7610 |
RFP-NIH-NIAID-DAIDS-99-21
October 15, 1998
EVALUATION FACTORS FOR AWARD
Part A, Part B and Part C will be evaluated separately. Evaluation scores for one Part will not affect the evaluation of a separate Part. An Offeror must specify for which Part(s) it wishes to be evaluated.
(This section will be scored independently for each vaccine category.)
1. GENERAL
The technical proposal will receive paramount consideration in the selection of the Contractor(s) for this acquisition. The evaluation will be based on the documented capabilities of the prospective Contractor(s) 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 thoroughness and feasibility of the technical approach taken. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.
Listed below are mandatory qualification criteria and technical evaluation criteria. The mandatory qualification criteria establish conditions that MUST be met in order for your proposal to be considered any further for award.
The technical evaluation criteria are used by the special emphasis panel when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Proposals will be judged solely on the written material provided by the Offerors.
* A 10-POINT PREFERENCE WILL BE GIVEN TO SMALL BUSINESS THAT MEET THE CRITERIA FOR SELECTION.
2. MANDATORY QUALIFICATION CRITERIA.
The following mandatory qualification criteria establish conditions that MUST be met at the time of receipt of the final revised proposal by the Contracting Officer in order for the proposal to be considered for award:
3. TECHNICAL EVALUATION CRITERIA (to be used to evaluate proposed work for each vaccine category separately).
Overall understanding of the project, and adequacy and feasibility of plans to address all items in the Work Statement. This includes the detailed description of specific tasks to be performed, methods to be used, and discussion of problems likely to occur and plans for addressing them.
Vaccine development and production:
Adequacy of the technical approach for preparing experimental vaccines, as requested in the Statement of Work (Note #A-8), including soundness of sample protocol, adequacy of scale-up and production under GLP/cGMP procedures, packaging and formulation, safety, logistics, and coordination. (30 points)
Plan for performance of vaccine lot characterization tests (lot release testing):
Technical approach for assessing potency, safety, sterility, purity, identity, quantity and stability including logistics, coordination and preparations for IND submissions. (10 points)
Documented expertise and proficiency of the Principal Investigator in development and pilot lot production of vaccines for use in human clinical trials and in managing a project of comparable size and complexity. (15 points)
Documented expertise and proficiency of other professional and technical staff in development and production of vaccine products. (10 points)
Previous institutional expertise and proven track record in vaccine production. (10 points)
Availability of adequate facilities, equipment and resources necessary to safely and efficiently accomplish the work described in the Statement of Work. Adequacy of detailed floor plan, indicating space to be committed for performance of this project.
Availability of facilities and equipment suitable for GLP/cGMP production of vaccine products. (15 points)
Dedicated capacity for production of these products in a timely manner. (10 points)
TOTAL POINTS: 100
1. GENERAL
The technical proposal will receive paramount consideration in the selection of the Contractor(s) for this acquisition. The evaluation will be based on the documented capabilities of the prospective Contractor(s) 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 thoroughness and feasibility of the technical approach taken. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.
Listed below are mandatory qualification criteria and technical evaluation criteria. The mandatory qualification criteria establishes conditions that MUST be met in order for your proposal to be considered any further for award.
The technical evaluation criteria are used by the special emphasis panel when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Proposals will be judged solely on the written material provided by the Offerors.
* A 10-POINT PREFERENCE WILL BE GIVEN TO SMALL BUSINESS THAT MEET THE CRITERIA FOR SELECTION.
2. MANDATORY QUALIFICATION CRITERIA.
The following mandatory qualification criteria establish conditions that MUST be met at the time of receipt of the final revised proposal by the Contracting Officer in order for the proposal to be considered any further for award:
3. TECHNICAL EVALUATION CRITERIA
Overall understanding of the project and adequacy and feasibility of plans to address all items in the Work Statement. This includes the detailed description of specific tasks to be performed, methods and resources to be used, and the discussion of problems likely to occur and plans for addressing them.
Technical approach for safety and immunogenicity testing of each of the 5 Categories of vaccine (excluding live-attenuated) requested in the Statement of Work including logistics, coordination and preparation for IND submission.
Documented expertise and proficiency of the Principal Investigator, in the performance of safety and immunogenicity testing suitable for vaccines destined for human trials and in managing a project of comparable size and complexity. (20 points)
Documented experience and capabilities of other professional and technical staff in the performance of safety and immunogenicity testing. (10 points)
Previous institutional expertise and proven track record in the evaluation of vaccines suitable for human trials. (10 points)
Availability of adequate facilities, equipment and resources necessary to safely and efficiently accomplish the work described in the Statement of Work. Adequacy of detailed floor plan, indicating space to be committed for performance of this project. Adequacy of animal facilities. (15 points)
Capacity to perform required testing in a timely and efficient manner (resources dedicated to this project). (5 points)
TOTAL POINTS: 100
1. GENERAL
The technical proposal will receive paramount consideration in the selection of the Contractor(s) for this acquisition. The evaluation will be based on the documented capabilities of the prospective Contractor(s) 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 thoroughness and feasibility of the technical approach taken. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.
The technical evaluation criteria are used by the special emphasis panel when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Proposals will be judged solely on the written material provided by the Offerors.
* A 10-POINT PREFERENCE WILL BE GIVEN TO SMALL BUSINESS THAT MEET THE CRITERIA FOR SELCTION.
2. TECHNICAL EVALUATION CRITERIA
Overall understanding of the project, and adequacy and feasibility of plans to address all items in the Work Statement. This includes the detailed description of specific tasks to be performed, methods to be used, and discussion of problems likely to occur and plans for addressing them.
Technical approach for obtaining all required data and documentation and for producing all documents required by the FDA for a new vaccine (see NOTE #C-2). (25 points)
Technical approach for coordinating with vaccine manufacturers and with Contractors performing preclinical safety and immunogenicity studies and with NIAID staff in order to assure that all requirements are met for producing and providing records and information necessary for filing the FDA submissions. (25 points)
Documented expertise and proficiency of the professional and technical staff in the preparation of final protocols to be submitted to the CBER, FDA for Investigational New Drug review. (20 points)
Institutional expertise and track record in the successful completion, submission and approval of new drug applications. (20 points)
Documented availability of adequate facilities, equipment and resources necessary to accomplish the work described in the Statement of Work with an appropriate plan for management of privileged, proprietary, and confidential information.
RFP-NIH-NIAID-DAIDS-99-21
October 15, 1998
NOTICE TO OFFERORS: This attachment contains proposal instructions and information that are specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. References to additional, more general information, and forms regarding proposal preparation are contained in Attachment E, "Applicable RFP References." If there is any conflict between the instructions given in this Attachment D and any of the "Applicable RFP References" in Attachment E, the instructions contained in this Attachment D take precedence.
It is anticipated that multiple awards will be made from this solicitation and that the awards will be made on/about August 1, 1999.
It is anticipated that the awards from this solicitation will be Indefinite Quantity type contracts with a 7 year performance period, and that Task Order Procedures will be used.
Indefinite-Quantity Contract - FAR 16.504 defines an indefinite-quantity contract as a contract that provides for an indefinite quantity, within stated limits, of supplies or services to be furnished during a fixed period, with deliveries or performance to be scheduled by placing orders with the contractor.
Under an indefinite-quantity contract, the Government's agreement to order the minimum quantity provides the consideration necessary to bind the contractor to furnish additional quantities which the Government may, but is not required to, order.
Task and delivery order contracting is authorized for use with indefinite-quantity contracts as described in FAR 16.504.
Task Order Contract - FAR 16.501-1 defines a task order contract as a contract for services that does not procure or specify a firm quantity of services (other than a minimum or maximum quantity) and that provides for the issuance of orders for the performance of tasks during the period of the contract.
FAIR OPPORTUNITY TO BE CONSIDERED PROCESS
When the government develops a task order requirement, it will prepare a "Task Order Request" (TOR) for the purpose of soliciting proposals and selecting the most advantageous offer from among the multiple contract awardees.
Normally, each awardee will receive an opportunity to submit a proposal for those task order requests solicited under parts A, B, or C, for which they received a contract. However, the Contracting Officer need not contact each of the multiple awardees before selecting a task order source if the Contracting Officer has sufficient information available to ensure that each awardee receives a fair opportunity to be considered for the task order. For example, if the Government issues a task order request for a specific vaccine under Part A, Vaccine Production, for which one of the contract holders under that part is the supplier of the vaccine being requested for production under the task order request, then only that contract holder would be eligible to submit a proposal in response to that particular task order request.
Further, awardees need not be given an opportunity to be considered for a particular order in excess of $2,500 if the Contracting Officer determines that:
(ii) Only one such contractor is capable of providing such supplies or services at the level of quality required because the supplies or services ordered are unique or highly specialized;
(iii) The task order needs to be issued on a sole-source basis in the interest of economy and efficiency as a logical follow-on to a task order already issued under the contract, provided that all awardees which were qualified under the specific Part A, B, or C for which the task order request covers were given a fair opportunity to be considered for the original task order request solicited under that part; or
(iv) It is necessary to award the task order to a specific contractor to satisfy the minimum guarantee provision in its contract.
In providing services under the contract, the following procedures shall apply to the award of task orders.
All work required under the contract shall be authorized through the execution of a bilateral modification to the contract. Each modification will obligate the necessary funds to complete the task order and will include the work statement of the task order as an attachment. Task orders may be issued at any time within the contract period.
Subject to the exceptions described under "Fair Opportunity To Be Considered Process" above, when the Government elects to fill a requirement that is estimated to exceed $2,500, the Contracting Officer shall provide a TOR to the awardees that received contracts for the particular Part for which responses are being solicited. A TOR shall, at a minimum, include a Statement of Work, evaluation factors, specific reporting requirements, deliverables and delivery schedule, the relevant importance of technical and cost factors, and any special instructions.
Business proposals shall include direct and indirect costs necessary for performing the proposed task. Task order proposals shall generally be limited to a total of 20 pages, including attachments.
Within the time allowed for proposal preparation (time allowed for proposal preparation and submission will vary depending on the task) which will be designated in the task order request, Contractors shall submit their proposals in response to a task order request, which shall include, but not necessarily be limited to the following information:
(i) A statement of the contractor’s clear understanding of the task requirements;
(ii) A statement of technical and managerial resources and expertise the contractor can provide to satisfy the requirement;
(iii) An approach to perform the work;
(iv) The labor category necessary, and the numbers of hours for each labor category necessary, and an explanation of the rationale for determining hours;
(v) Resumes with identification of the actual personnel proposed for the work;
(vi) A schedule of performance identifying major milestones, deliverables and deliver date, and task completion; and
(vii) an itemization of all costs, both direct and indirect, (i.e. personnel, fringe benefits, equipment, travel, supplies, other direct costs, overhead, etc.) necessary to complete the work.
The Government will evaluate proposals and conduct negotiations as necessary. Task orders will be awarded to the contractor whose proposal is determined to be the most advantageous to the Government based on the technical and price factors specified in the TOR. The Government reserves the right to make an award on the most favorable initial proposal without discussion.
The Contracting Officer is the only individual authorized to issue a TOR or award a task order under the contract. Unless specifically authorized by the Contracting Officer, the contractor shall not commence work on a requirement until a modification to the contract has been fully executed.
It is anticipated that task orders will be awarded within 30 calendar days from receipt of task order proposals. Each task order shall, at a minimum, contain the following information:
Offerors are required to propose hourly ceiling rates for each labor classification in their response to this solicitation, RFP-NIAID-DAIDS-99-21, with cost-reimbursable contract line items proposed for other elements of cost (i.e. fringe benefits, supplies, travel, equipment, other direct costs, indirect costs, fee, etc.). Contracts that are issued to successful offerors will include an advance understanding that will fix hourly rates for each year of the contract. A 3% annual allowance for salary increases will be allowed for each of the subsequent years 2-7. The subsequent negotiation of each task order request issued to successful contractors eligible to submit a proposal under a task order request for which they qualify will focus on the number of hours proposed for each labor category and the estimated costs required for all other elements.
No protest under FAR Subpart 323.1 is authorized in connection with the issuance or proposed issuance of a task order under the contract except for a protest on the grounds that the order increases the scope, period, or maximum value of the contract. Task orders awarded under the contract are not subject to the competition requirements of FAR Part 6.
For those concerns other than small business concerns, subcontracting plans will be required when the cumulative dollar amount for tasks issued against the contract exceed $500,000 in accordance with P.L. 95-507. The small, small disadvantaged, and women owned business subcontracting plans will have to reflect goals that allow the maximum practicable subcontracting opportunities retroactive to day one of the effective date of the contract. As subsequent tasks may be issued against the contract once small, small disadvantaged, and women owned business subcontracting goals have been established, the subcontracting goals will be subject to modification with each subsequent task.
In response to this RFP, potential Offerors may submit proposals for one or more of the three Parts described in the Statement of Work (SOW). Within Part A, Offerors may submit proposals for any one or more of the vaccine concept Categories. Proposals will undergo peer review based on the evaluation criteria and awards will be made to the most qualified proposals. Each Offeror awarded a contract under a given Part or Category, will receive a guaranteed minimum dollar award over the term of the Contract (offerors that qualify for more than one part will receive only one contract). The guaranteed minimum dollar awards for Contractors will be determined by the following scale:
Contract Part - Minimum Award
Part A - $200,000
Part B - $100,000
Part C - $50,000
Offerors that receive awards for more than one Part will be eligible for Minimum Awards for each Part. Offerors that receive awards for one or more vaccine Categories under Part A will be eligible for a single Part A minimum award. It is anticipated that the maximum total funding under the Contract for all parts will be between $5 – 10 million per year.
The minimum guarantee may be obligated incrementally, on an annual basis, in order to minimize the funding required for each contract year.
The restrictions set forth in FAR Clause 52.219-14, Limitation on Subcontracting, will apply to each individual order issued under a task or delivery order contract. The section applicable to this solicitation is FAR Clause 52.219-14(a)(1) and states "Services (except construction). At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.
The clause at FAR 52.216-22, Indefinite Quantity, permits orders issued during the effective period of the contract, and not completed within that period, to be completed within the time specified in the order. The time specified in such orders, however, will not extend unreasonably beyond the contract expiration date.
Dr. James F. O'Donnell
Ombudsman for R&D Task and Delivery Order Contracts
c/o Ms. Zaiga Tums, Director, Division of
Acquisition Policy and Evaluation, OCM
Building 6100, Room 6C01
Bethesda, Maryland 20892-7540
Note: The following information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS (FEB 1998), FAR 52.219-1:
a. The standard industrial classification (SIC) code for this acquisition is 8731.
(1) The small business size standard is $5,000,000.
(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 $5,000,000.
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.
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), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:
Hand-Carried Address:
Lawrence M. Butler
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852
Mailing address (U.S.) Postal Service
Lawrence M. Butler
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.
b. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.
Your proposal shall be organized in accordance with the guidance provided in "Standard RFP Instructions and Provisions." Shipment and marking shall be as indicated below.
EXTERNAL PACKAGE MARKING
In addition to the address cited below, mark each package as follows:
NUMBER OF COPIES
The number of copies required of each part of your proposal are as specified below.
TECHNICAL PROPOSAL: ORIGINAL AND 20 COPIES
BUSINESS PROPOSAL: ORIGINAL AND 5 COPIES
NOTE: The original proposal must be readily accessible for date stamping.
COPIES TO
If hand-delivered or delivery service
Lawrence M. Butler
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852
If using U.S. Postal Service
Lawrence M. Butler
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.
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," in accordance with PHSAR 352.215-10, Late Proposals, Modifications of Proposals and Withdrawals of Proposals (NOV 1986).
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 that 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, Item F.6., of the STANDARD RFP INSTRUCTIONS AND PROVISIONS, General Instructions.)
(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration, and other agencies at the Federal, State, and local levels (Federal, State and local regulatory/enforcement agencies.)
(b) Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officers, determines to be reasonably necessary. If compliance with such additional safety measures results in an increase or decrease in the cost or time required of performance of any part of work under the contract, an equitable adjustment will be made in accordance with the applicable "Changes" Clause as set forth in the contract.
(c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contact and all violations for which the Contractor has been cited by any Federal, State, or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal, State, or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.
(e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.
RFP No.: NIH-NIAID-DAIDS-99-21
RFP Title: "HIV VACCINE PRODUCTION"
Please review the attached Request for Proposals. Furnish the information requested below and return this page by December 15, 1998. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.
[ ] DO INTEND TO SUBMIT A PROPOSAL
[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:
Company/Institution Name: ______________________________________
Address: _______________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
Project Director's Name: ________________________________________
Title: _________________________________________________________
Signature/Date: ________________________________________________
Telephone Number and E-mail Address: ___________________________
Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants):
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
(Continue list on a separate page if necessary)
RETURN TO:
CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
Attn: Dawn Kotzen
RFP-NIH-NIAID-DAIDS-99-21
FAX# 301/402-0972
Email dk28a@nih.gov
(NOTE: Instructions to offerors are indicated in parentheses or as footnotes.)
1. TECHNICAL PROPOSAL COVER SHEET .............................. Page 1
2. TECHNICAL PROPOSAL TABLE OF CONTENTS ................ Page 2
3. SUMMARY OF OBJECTIVES AND METHODS (Abstract)*... Page 3
4. TECHNICAL PLAN (Refer to Technical Proposal Instructions located in the Standard RFP Instructions and Provisions.)
a. STATEMENT OF WORK
1. Objectives ........................................ Page 4
2. Approach ......................................... _____
3. Methods ........................................... _____
4. Schedule ........................................... _____
b. PERSONNEL (List by name, title, department and organization, and detail each person's qualifications and role in the Project.) Provide narrative for:
1. Principal Investigator/Project Director
2. Other Investigators
3. Additional Personnel, (e.g., technical support, subcontractors, consultants)
(Note: For key personnel, include 2 page biosketch/resume and the form entitled "Summary of Current and Proposed Activities" under Item 5. below.)-- Page ____
c. FACILITIES/RESOURCES AND DIRECT COSTS (List/describe all equipment, facilities and other resources available for this project; attach "Technical Proposal Cost Information" form, and marked laboratory/clinical space floor plan.)-- Page ____
d. OTHER CONSIDERATIONS (Provide brief narrative of any unique arrangements, safety procedures in place, animal welfare issues, human subject and minority and gender issues, etc.)-- Page ____
5. OTHER SUPPORT (A "Summary of Current and Proposed Activities" for all Key Personnel must be provided; this form is located in FORMS, FORMATS, ATTACHMENTS) -- Page ____
6. HUMAN SUBJECTS, PARTICIPATION OF CHILDREN AND MINORITY AND GENDER ISSUES NOT OTHERWISE ADDRESSED (IF APPLICABLE) -- Page ____
7. VERTEBRATE ANIMALS (IF APPLICABLE) -- Page ____
8. "Technical Proposal Cost Information" summary spreadsheet -- Page ____
9. LITERATURE CITED -- Page ____
10. APPENDICES (Protocols, policy manuals, etc. for above Technical Plan; list each Appendix; Appendices must be clear and legible, and easily located.)
* 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, institution, and Principal Investigator on the abstract.
RFP-NIH-NIAID-DAIDS-99-21
October 15, 1998
This section identifies the items found in the RFP Web directory entitled RFP REFERENCES that are applicable to this RFP.
Note: A Subcontracting Plan is not due with the initial proposal. The Contracting Officer will notify offerors if a plan becomes due.
Applicable to Business Proposal
To Become Contract Attachments
Other-to be submitted as directed by Contracting Officer
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