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".
Proposal Due Date:
November 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-00-20 entitled "Tissue-based Small Animal Model for HIV Drug Discovery." The Government anticipates that one (1) cost reimbursement, completion type contract will be awarded for a period of seven (7) years as a result of this RFP.
The government intends to make award without discussions. Accordingly offerors are advised to submit their best offer and complete proposal information by the closing date of the RFP. The government reserves the right to hold negotiations if necessary.
This RFP will utilize the National Institute of Allergy and Infectious Diseases' (NIAID) Contract Review ON-Line (CRON) system. Offerors must submit their proposals ELECTRONICALLY. In addition to your electronic submission, Offerors must submit one unbound signed original HARDCOPY plus one additional unbound copy of both the technical and business proposal.
(Note: Documents unavailable in appropriate electronic format may be provided in hard copy. If electronic version is not provided, ten (10) paper copies of SOPs, other pertinent manuals, non-scannable figures or data, letters of collaboration/intent and/or other attachments are to be provided. See Attachment F for details.)
NIAID'S CRON system will save Offerors the paper and postage costs which the mailing of multiple copies of a standard RFP proposal imposes on the Offeror. This approach will also allow us to conduct technical review based on electronic availability of proposals which will save money that would otherwise be spent shipping proposals out to reviewers and for travel and per diem to bring in reviewers for the Technical Review meetings. We hope this will prove to be convenient to Offerors, technical reviewers and the Government. Adequate security for electronic transmission is provided by using a dedicated server with access restricted through passwords.
You must submit your electronic proposal (via the Internet) and the unbound signed original hardcopy plus one unbound copy (to the address listed in Attachment F), for receipt no later than November 1, 1999, at 4 p.m. local time. Please note that the electronic copy of your proposal will need to be submitted in Adobe Acrobat portable document format (PDF). An official authorized to bind your organization must sign the hardcopy of your proposal.
Please note and adhere to the page limitations set forth in Attachment F. The narrative portion regarding the technical plan, including objectives, approach, methods and schedule, is limited to 50 pages.
The documents included with this electronic RFP package are as follows:
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 Carl Henn, by phone, fax or e-mail numbers/address listed above.
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 via fax or e-mail on or before October 4, 1999. This will allow us to expedite preparations for the electronic submission and review of proposals.
IF YOU INTEND TO SUBMIT A PROPOSAL, IT IS ESSENTIAL THAT YOU SUBMIT THE PROPOSAL INTENT FORM. IF YOU FAIL TO SUBMIT THE FORM, YOU WILL NOT RECEIVE ADDITIONAL INSTRUCTIONS NECESSARY TO SUBMIT THE ELECTRONIC COPY OF YOUR PROPOSAL.
Questions concerning any areas of uncertainty which, in your opinion, require clarification or correction must be furnished in writing to Carl Henn at the Internet electronic mail address ch24v@nih.gov or by fax at 301/480-5253. Your questions should be received no later than October 8, 1999, and marked "Offeror's Questions, RFP-NIH-NIAID-00-20."
If you have any additional questions or concerns regarding this RFP, or the electronic transmission of proposals, please contact the above listed contract specialist. Collect calls will NOT be accepted.
Sincerely,
/s/
Carl R. Henn
Contracting Officer
Contract Management Branch
National Institute of Allergy
and Infectious Diseases, NIH
The National Institute of Allergy and Infectious Diseases (NIAID) supports a comprehensive portfolio of contract resources to discover and develop novel therapeutic agents for the prevention and treatment of infections caused by Human Immunodeficiency Virus-1 (HIV-1), AIDS-associated opportunistic pathogens, and other infectious agents. Animal model resources constitute one element of this drug discovery and development program. The purpose of the present RFC is the competition of a small animal model that can be used to evaluate potential therapeutics for HIV-1 infection.
The current contract is awarded to the J. David Gladstone Foundation, San Francisco, CA (contract number N01-AI-65309). The animal model being used is an immunodeficient mouse engrafted with human fetal thymus and liver (SCID-hu thy/liv) and infected with well-characterized isolates of HIV-1. The types of agents tested over the last 3 years include low molecular weight organic molecules, oligonucleotides, engineered viruses, and biologics. Recent experience with the SCID-hu thy/liv model has demonstrated its superiority over other small animal models for the evaluation of potential HIV-1 therapeutics since it is tissue-based, as is HIV-1 infection, and uses HIV-1 as the viral target. For these reasons, the present solicitation is for the SCID-hu thy/liv model.
WORK STATEMENT
Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment, and facilities needed to perform the work described below.
[GENERAL NOTE TO OFFEROR: Attachment (1) to this work statement, entitled "Protection of Proprietary Data", sets forth an intended Advance Understanding for this effort. Attachment (2) to this work statement provides an example of a typical "Screening Agreement" which may be signed between the NIAID and suppliers of certain compounds to be utilized during the conduct of this effort. The Offeror is responsible for reading and understanding the content and intent of these documents as regards this proposed contract.]
Specifically, the Contractor shall:
1. Evaluate potential HIV-1 therapeutics, alone and in combination, for efficacy in blocking or reducing HIV-1 replication and for toxicity in an in vitro model system of infection. The in vitro model system shall consist of:
human peripheral blood lymphocytes.
a diverse panel of well characterized primary isolates and molecular clones of HIV-1 that replicate both in vitro and in the animal model (see related requirement in point 2 below).
Evaluation capabilities of the in vitro system shall include, but are not limited to, quantitative determinations of efficacy and cytotoxicity.
The contractor shall perform approximately 10 in vitro evaluations of single therapies per year and approximately 3 evaluations of combination therapies per year. The in vitro system shall be available for efficacy and cytotoxicity testing at the time of award.
[NOTE 1 TO OFFEROR: Each evaluation includes: (i) one assay for efficacy of each test candidate, using sufficient numbers of concentrations to generate dose-response relationships and containing positive and negative controls; and (ii) one assay for cytotoxicity at each point in the dose-response curve. Types of agents to be tested include but are not limited to: low molecular weight organic molecules, biologics, and engineered viruses.]
2. Evaluate potential HIV-1 therapeutics, alone and in combination, for efficacy and toxicity, in an in vivo animal model consisting of:
SCID mice engrafted with human fetal thymus and liver tissue.
a diverse panel of well characterized primary isolates and molecular clones of HIV-1 that replicate both in vitro and in the animal model. The viruses that comprise the panel shall represent a spectrum with regard to replication kinetics and ability to cause pathogenic effects in the SCID-hu thy/liv system.
Evaluation capabilities of the animal model shall include, but not be limited to, the following:
quantitative determinations of effects of the therapy on virus replication.
quantitative determinations of effects of the therapy on thymocyte depletion and subset distribution.
measurement of toxicity. Blood chemistries, hematologic measures, body weight, and other indicators of general health are appropriate tests. Necropsy/pathology support shall be available as needed.
limited pharmacokinetic determinations. Offerors will be required only to have the capability of collecting and preparing blood, cell, and tissue samples for shipment to another site for analysis.
Up to 1200 SCID-hu thy/liv mice (50 mice per experiment) and 125 unengrafted SCID mice will be needed for evaluations of single and combination therapies per year. The Contractor shall be capable of providing up to 100 SCID-hu thy/liv mice per month, in groups of 50 animals engrafted with tissue from a single donor. The in vivo system shall be available for efficacy and toxicity testing at the time of award.
The Project Officer will select the specific therapies to be studied, with input from the contractor. Protocols shall be submitted in writing to the Project Officer for written approval prior to the initiation of the evaluation. Details of protocol design will vary with the therapy tested and will be determined by the contractor, the Project Officer, and when appropriate, the supplier of the agent.
[NOTE 2 TO OFFEROR: Each evaluation in the animal model includes: i) one assay for therapeutic efficacy of each test candidate, in which multiple dose levels of the test candidate are employed and positive and negative controls are included, and ii) assessment of toxicity in the same animals, or in the absence of preliminary information on toxicity, in uninfected SCID mice. Types of agents to be tested include but are not limited to: low molecular weight organic molecules, biologics, engineered viruses, and agents that affect thymus function.
The Offeror should discuss the types of therapies appropriately evaluated in the model and demonstrate the suitability and feasibility of using the model for those types of studies.
The Offeror should describe in detail his/her technical approach for evaluating therapies by providing a sample protocol. This protocol should include a description of the experimental design (sequence in which various types of studies will be carried out, number of arms per study, number of animals per group, number of doses to be explored, potential routes of administration, etc.) and a description of the methods to be used to carry out evaluations; to quality assure/control viral stocks, tissue donors, and engrafted mice; and to analyze the data. A rationale for the design, based on statistical considerations, should be provided as well as a discussion of potential logistical problems and possible solutions.]
3. Quality assure/control viral stocks, donor tissue, and SCID-hu thy/liv mice. If any of the components of the model are provided by a Subcontractor, quality assurance/control standards of the Subcontractor shall be subject to the same evaluation as those of the prime Contractor and are the responsibility of the prime Contractor.
4. Further characterize and/or modify the proposed animal model to enhance its usefulness in the evaluation of therapies and/or develop other animal models and in vitro models as specified by the Project Officer.
[NOTE 3 TO OFFEROR: The Offeror should include a brief description of how the proposed in vivo model could be modified or further developed to provide additional information about potential effects (positive or negative) of therapies or to extend the spectrum of potential therapies that could be evaluated in the model. ]
5. At the specific request of the Project Officer, provision shall be made to collect samples of animal tissues and/or fluids from Contractor studies and prepare such samples for shipment to another site for analysis. Up to 5 shipments of samples may be requested per year.
6. Communicate effectively with the Project Officer.
Establish a means of electronic communication with the Project Officer sufficient to support daily exchange of e-mail and the submission of data files and reports to the Project Officer when requested.
Provide periodic updates of project status via telephone, fax, or e-mail.
Submit draft protocols and reports in accordance with the Reporting Requirements and Deliverables section incorporated into this contract.
Meet with the Project Officer onsite once a year to discuss contract data and progress.
7. Maintain a safe worksite, in accordance with the Safety and Health Clause incorporated in this contract, the Offeror's Safety and Health Plan, and all applicable Federal, State, and Local health and safety regulations. The Offeror shall possess and follow a Safety and Health Plan for compliance with all relevant Federal, State, and Local guidelines and regulations regarding exposure to hazardous chemicals drugs and potentially harmful and/or infectious biological materials. The plan shall include discussions of such topics as training and monitoring of personnel, the use of protective garments and equipment by personnel, and protocols for dealing with chemical and biological spills and accidents. A copy of the plan shall be submitted an appendix to the Technical Proposal. The Safety and Health Clause of this solicitation should be consulted for additional information.
8. Ensure an orderly transition of contract-related materials to a successor Contractor or to the Government.
Six months prior to the expiration date of this contract a transition plan shall be submitted to the Project Officer for approval.
All original data and selected contract-purchased, Government-titled equipment shall be delivered by the expiration date of this contract to a location(s) specified by the Project Officer.
[NOTE 4 TO OFFEROR: For the purpose of evaluating the personnel and the organizational capabilities of the Offeror, technical proposals shall describe and document the following:
any prior personal experience of the PI and/or team members using the SCID-hu thy/liv model, i.e. performing evaluations of antiviral compounds, immune-based or other therapies; conducting pharmacologic and toxicologic studies; modifying models or developing new models; and conducting basic research on the immunopathogenesis of HIV-1.
qualifications and specific assignment of each proposed member of the research team (include resumes/CVs); how members will interact according to lines of authority (provide an administrative framework in flow chart format); the decision making authority of the Principal Investigator in relation to the rest of the organization;
specific levels of effort proposed for each individual and availability in relation to other commitments (complete the attachment entitled "SUMMARY OF RELATED ACTIVITIES");
procedures for initiation and completion of this contract's projects in a timely manner (describe how projects in general are prioritized within the organization and the level of priority this contract will receive);
all instrumentation, equipment, and laboratory space to be used to fulfill the Work Statement requirements (include a floor plan; indicate what equipment and resources are under the control of the Principal Investigator and which are to be shared; if shared, indicate who is responsible for controlling access and how determination of priority usage is made; include documentation of accreditation or certification of the facility if applicable).]
WORK STATEMENT ATTACHMENT (1)
PROTECTION OF PROPRIETARY DATA
Information and data provided to or generated by the Contractor under this contract shall be treated confidentially and protected by an Advance Understanding to be included in the resulting contract and worded as follows:
"Because there is a likelihood that the Contractor will be utilizing and evaluating materials provided to the Government by a third party Supplier, it is essential to include provisions that will protect the proprietary rights of the Supplier. These materials generally are supplied to the Government under conditions outlined in NIAID’s standard Screening Agreement or other appropriate documents. The Contractor shall be bound by the same terms and conditions as the Government in these agreements, with respect to the proprietary and confidential nature of the information provided by the Supplier.
All information provided by the Supplier or Project Officer should be assumed to be confidential unless specifically identified as non-confidential in writing by the Project Officer. Confidential information may not be revealed without written permission. All materials supplied to the Contractor and all test results similarly are to be considered confidential. All materials supplied to the Contractor shall be utilized solely for contract-related research purposes and no unauthorized use or distribution of these materials will be permitted.
Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted for review by the NIAID Project Officer before submission for public presentation or publication. Contract support shall be acknowledged in all such publications. A "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information. The Project Officer will review all manuscripts/abstracts in a period of time not to exceed 60 calendar days from receipt, and will either agree to the publication/ disclosure, recommend changes and, as applicable, refer the document to the Supplier of the compound for their review. When the Supplier does not consent to publication of the manuscript or abstract, the Project Officer shall notify the Contractor and the NIAID Contracting Officer. The Project Officer is responsible for ensuring that all parties adhere to the terms and conditions of any existing Screening Agreement or Material Transfer Agreement between NIAID and the Supplier. NIAID will use its best efforts to assist and expedite the review process by the Supplier.
Should patents arise from this contract, they will be subject to federal law governing inventions. Every patent applicant (individual or institutional) is required to provide the Government with a non-exclusive, irrevocable, paid-up license to the invention."
WORK STATEMENT ATTACHMENT (2)
Screening Agreement for Submitting Products to the Division of Acquired Immuno-deficiency Syndrome (AIDS), National Institute of Allergy and Infectious Diseases, hereafter referred to as the DIVISION,
by_______________________________________, hereafter referred to as the SUPPLIER.
1. The SUPPLIER may supply products, patented or un-patented, to the DIVISION which may proceed to screen and test for possible treatment for AIDS and associated opportunistic infections including tuberculosis. These products are to be used for screening and testing as anti-viral, anti-bacterial, anti-fungal, anti-parasitic, immunomodulating, and biological modifying agents with potential for the treatment of AIDS and associated infections, and for no other purpose.
Using protocols evaluated and approved mutually by the DIVISION and the SUPPLIER, the products will be screened by one or more of the DIVISION's contract testing laboratories, or in any other testing laboratories which may from time to time be added to the DIVISION's portfolio but in any event will not be placed in the laboratories of any company in the pharmaceutical or chemical industries without the SUPPLIER's written permission.
2. In order to facilitate records keeping and handling of confidential materials, the DIVISION utilizes the following procedures:
The SUPPLIER shall forward to the DIVISION the products to be tested together with data sheets in duplicate for each product, giving pertinent available data as to chemical constitution, solubility, toxicity, previous biological efficacy and any precautions which need to be followed in handling, storing, and shipping.
It is clearly understood that no data about the products and the results of the testing will be kept in files open to the public either by the DIVISION, the testing laboratories, or the data processing activities. Only those employees directly engaged in the operation of the DIVISION will have access to the files of information regarding source and nature of confidential materials and results of testing, except as required pursuant to the Freedom of Information Act, 5 U.S.C.552.
Whenever possible the SUPPLIER will be given the choice of the DIVISION's contract testing laboratories, although at present there is no preference; and it is understood that the DIVISION reserves the right to send the SUPPLIER's products to another screening contractor if the need arises. It is furthermore understood that the contracts between the DIVISION and the testing laboratories will contain provisions to safe guard the SUPPLIER's rights under this Agreement.
Because the DIVISION's screening effort will be accomplished in collaboration with the DIVISION's scientific staff and academic collaborators, as well as the SUPPLIER's own staff, the DIVISION will work in concert to assure rapid ongoing communications of screening data to the SUPPLIER, and the SUPPLIER will in turn use its best efforts to keep the DIVISION informed on the SUPPLIER's own ongoing concomitant studies.
3. Although the SUPPLIER recognizes that the interchange of information is generally desirable in the field of treatment for AIDS, it is mutually understood that the SUPPLIER, in voluntarily supplying appropriately marked information deemed proprietary, including product and information regarding this product hereunder, is entitled to protection for any such technical information it may furnish.
It is understood and agreed to, subject to applicable law, that the SUPPLIER shall retain all rights to those compounds or products in which the SUPPLIER has a proprietary interest. The SUPPLIER understands that contractors have the right to elect to retain title to inventions made under NIAID-supported contracts [37 CFR 401.14(b)]. The SUPPLIER deserves the right to reach an agreement with these contractors concerning the disposition of these intellectual property rights. The DIVISION agrees to notify the SUPPLIER of the names of the contractors prior to submitting compounds or products to them. Subject notwithstanding, to the provision that, with respect only to those drugs which have been determined by means of the various screening and testing processes to possess such significant activity (strong potential to be scheduled for clinical trial by the DIVISION, using mutually approved protocols), the Government shall have a royalty-free, irrevocable, nonexclusive license for clinical trials under any patent which the SUPPLIER may have or obtain on such compound or product or on a process for use of such compound or product, to manufacture and/or use by or for the Government the invention(s) claimed by the patent(s) only for medical research purposes related to or connected with the treatment of AIDS and associated infections including tuberculosis.
The DIVISION agrees that the publication of biological data on products provided by the SUPPLIER is worthwhile and shall be encouraged. Specifically:
1.With regard to screening results on compounds in which the SUPPLIER has a proprietary interest, and that the DIVISION deems significant for the research on therapies for AIDS and associated infections including tuberculosis, the SUPPLIER agrees that the DIVISION may publish or otherwise publicly disclose such results after a period of 6 months from the date of final reporting of screening and testing results to the SUPPLIER in order for patent applications to be filed. The DIVISION will consult with the SUPPLIER prior to publication within this period on screening and testing results.
2. For all other compounds, the SUPPLIER will consult with the DIVISION prior to publishing screening data along with the available biological and physical data; such consent shall not be unreasonably withheld.
3. In no case will the DIVISION publish information identifying the SUPPLIER as the source of the compound without written approval.
As soon as tests are completed and reported to the DIVISION, the SUPPLIER will receive from the DIVISION a full report including all screening data. The products scheduled for clinical trial, referred to herein, shall be designated by the DIVISION, and the aforementioned report will specify the compounds so selected. The DIVISION shall be consulted whenever the SUPPLIER desires to include screening data in a publication, and appropriate credit shall be given to the U.S. Public Health Service.
The DIVISION is confident that this agreement will lay the basis for mutually satisfactory cooperation in the field and in the treatment of AIDS and associated diseases.
In agreeing to the above, the SUPPLIER signs below, as well as the attached duplicate of this agreement, and returns both to the DIVISION for countersignature. One original will be returned for the SUPPLIER's files.
The Contractor shall submit draft protocols and technical reports during each reporting period that include, at a minimum, the information specified below (A-C). All such protocols and reports shall be submitted in electronic form, as computer files, in Microsoft Word ver. 7.0 for Windows and Microsoft Excel ver. 7.0 for Windows, with formats readable with an IBM-type personal computer. Files shall be sent by E-mail or on 3.5 inch discs by US mail or courier service. The Contractor shall prepare up to 15 draft protocols, 15 interim reports, and 2 semi-annual reports per year. All reports shall be archived on 3.5 inch discs to be surrendered to the Government at the expiration of the contract.
A. Draft Protocols
Prior to initiating each study the Contractor shall submit for the Project Officer’s approval a draft of the protocol to be utilized. The protocol shall be in table form and include:
A study number
Study design (route and timing of drug administration, number of groups and of animals per group, measures of toxicity and/or efficacy to be studied, and other elements as specified by the Project Officer)
B. Interim Reports
The Contractor shall submit individual reports detailing the results of each completed study. Each interim report shall be in a format and quality that can be sent to the original sponsor without modification by the Project Officer. Interim reports shall contain:
1. A cover page listing:
Contract title and number
Project title and number
Contractor's name and address
Date of submission
2. A summary table of data and graphical representations of same
3. An introduction describing the study
4. A discussion of materials and methods
A discussion and interpretation of the results
Individual data (body weight, implant weight, p24 values, viral load values, etc., for each mouse)
Detailed statistics
C. Semi Annual Reports
The Contractor shall submit semi-annual reports that summarize the studies completed by the Contractor in the preceding 6 month period. Semi-annual reports shall be composed of:
1. A cover page containing:
Contract title and number
Period of performance being reported
Contractor's name and address
Date of submission.
2. A table of contents
Summary tables of results from interim reports submitted during the preceding 6 month period
A table listing virus stocks prepared during the reporting period, with in vitro and in vivo titers
A discussion of technical and administrative problems encountered, their resolution or proposed corrective action; explanation of differences between planned progress and actual progress
A cumulative list of drugs or therapies studied, with report number and date of study
A cumulative list of oral presentations and published materials attributable to the contract
The final semi-annual report shall contain additionally:
a brief description of any unfinished projects
a status report on transition or shut down activities
D. Distribution
It remains the responsibility of the Contractor to assure receipt by the Government official listed below of all deliverables by the established due dates. If the Contractor is unable to deliver the items specified hereunder within the period of performance , 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.
Type
of
Deliverable
No. of
Copies
Addressee/Distribution
Due Dates
Draft Protocol
1
Project Officer
Within 2 calendar days of Project Officer’s request
Interim Report
1
1
Project Officer
Contracting Officer
Within 15 calendar days of completion of in vitro studies
or within 30 calendar days of completion of animal studies
Semi-Annual
Report
1
1
Project Officer,
Contracting Officer
Within 30 calendar days after each 6 month period from
the time of contract award
Selection of an Offeror for contract award will be based
on an evaluation of proposals against two factors. The factors in order of
importance are: (1) technical merit, and (2) cost. Although technical factors
are of paramount consideration in the award of the contract, cost/price is
also important to the overall contract award decision. Offerors are advised
that an award will be made to the Offeror whose proposal provides the best
overall value to the Government. In accordance with FAR 15.3, the award will
be subject to a cost realism analysis by the Government. The evaluation will
be based on the demonstrated capabilities of the prospective Contractors in
relation to the needs of the project as set forth in the RFP. The merits of
each proposal will be carefully evaluated. Each proposal must document the
feasibility of its plan to successfully achieve the objectives of the RFP.
Offerors must submit information sufficient to evaluate their proposals based
on the detailed criteria listed below.
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.
A. Technical Approach/Understanding the Problem 60
points
Offerors will be evaluated on the basis of a demonstrated
understanding of the objectives and needs of the proposed project in the following
areas:
Invivo model: Availability, appropriateness, and adequacy
of the components of the test system. The following elements will be considered:
virus strains; SCID-hu thy/liv mice, including capability to provide up
to 100 animals per month, in groups of 50 engrafted with tissue from a single
donor; plan for quality assurance/control of virus stocks, tissue donors,
and SCID-hu thy/liv mice; spectrum of agents and strategies that can be
tested in the model; potential of the model to identify therapies useful
for humans infected with HIV-1. (20 points)
Experimental design: in vivo model. Scientific and technical
adequacy and feasibility of the proposed experimental design and methodologies
for quantitating efficacy and toxicity of candidate therapies. (15
points)
Invitro test system: Scientific and technical adequacy
and appropriateness of components of the test system and the methodologies
proposed for quantitating efficacy and cytotoxicity. (15 points)
Model development: Scientific and technical potential of the animal model
to be developed or modified to enhance its usefulness in the evaluation
of therapies. Scoring will be based on the requested discussion of how the
Offeror could further extend or adapt the proposed model.
(10 points)
B. Personnel 30 points
Principal Investigator: Quality of recent work and relevance to the proposed
contract; demonstrated scientific leadership in the area of animal models
of HIV-1 infection; experience using the SCID-hu thy/liv model for evaluating
HIV-1 therapies; his/her time availability for the proposed work; documented
participation in similar projects; and demonstrated ability to coordinate
a team effort.
Other professional, technical, and support staff: Spectrum of expertise
offered, qualifications, experience evaluating HIV-1 therapies in vitro
and in the SCID-hu thy/liv model, and availability; documented capability
to conduct proposed studies.
C. Organizational Structure, Facilities, and Resources 10
points
Adequacy of lines of authority and responsibility
Adequacy, suitability, and availability of all necessary facilities, equipment,
and resources to conduct all the tasks in the Work Statement; adequacy of
the organization's Safety and Health Plan.
Total 100 Points
HUBZONE PARTICIPATION FACTOR
Offerors which are qualified HubZone Small Business Concerns will be evaluated
in accordance with FAR Clause 52.219-4 (January 1999).
SMALL DISADVANTAGED BUSINESS PARTICIPATION FACTOR (SUBJECTIVE ASSESSMENT)
Evaluation of the offeror's Small Disadvantaged Business Participation
Plan will be based on information obtained from the plan provided by the offeror
(with their business proposal), the realism of the proposal, other relevant
information obtained from named SDB concerns, and any information supplied by
the Offeror concerning problems encountered in SDB participation.
Evaluation of SDB Participation Plans will be a subjective assessment based
on a consideration of all relevant facts and circumstances. The Government is
seeking to determine whether the Offeror has demonstrated a commitment to use
SDB concerns for the work that it intends to perform as the prime contractor.
The assessment of the Offeror's SDB Participation Plan will be used as a means
of evaluating the relative capability and commitment of the Offeror and the
other competitors. Thus, an Offeror with an exceptional record of participation
with SDB concerns may receive a more favorable evaluation than another, whose
record is acceptable, even though both may have acceptable technical proposals.
SDB Participation will not be scored, but the Government's conclusions about
overall commitment and realism of the Offeror's SDB Participation Plan will
be influential in determining the relative merits of the Offeror's proposal
and in selecting the Offeror whose proposal is considered most advantageous
to the Government.
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".
NUMBER AND TYPE OF AWARD(S)
It is anticipated that one (1) award will be made from this solicitation
and that the award will be made on/about June 1, 2000.
It is anticipated that the award from this solicitation will be a cost reimbursement
completion type contract with a 7 year performance period, and that incremental
funding will be used.
ESTIMATE OF EFFORT
It is estimated by the Government that the total labor effort may fall
within the ranges listed below. However, this information is furnished
for the Offeror's information only and is not to be considered restrictive
for proposal purposes.
Labor Category
Estimated Effort
Professional
215% per year
Non-Professional
175% per year
SIC CODE AND SIZE STANDARD
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:
The standard industrial classification (SIC) code for this acquisition
is 8731.
(1) The small business size standard is 500 employees.
(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
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.
SERVICE OF PROTEST (AUG 1996) - FAR 52.233-2
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:
NOTE: All material sent to this office by Federal Express should be sent to
the Hand Carried Address.
The copy of any protest shall be received in the office designated above within
one day of filing a protest with the GAO.
GOVERNMENT NOTICE FOR HANDLING PROPOSALS
AN OFFEROR SHALL PLACE THIS NOTICE ON TOP OF EACH COPY OF ITS TECHNICAL
PROPOSAL.
"This proposal shall be used and disclosed for evaluation purposes
only, and a copy of this Government notice shall be applied to any reproduction
or abstract thereof. Any authorized restrictive notices 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."
The Privacy Act will not apply to this contract. No data that can be
personally identified with individuals will be collected to accomplish a Department
function as part of the requirements of the contract. Records will be filed
by organization and not by individuals, and, therefore, the Privacy Act does
not apply.
SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUG 1997)
(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 this 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.
PROPOSAL INTENT RESPONSE SHEET
RFP No.: NIH-NIAID-DAIDS-00-20
RFP Title:"Tissue-based Small Animal Model for HIV Drug Discovery"
Please review the attached Request for Proposals. Furnish the information
requested below and return this page by October 4, 1999. 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 (print): ______________________________________
Telephone Number and E-mail Address (print clearly): _____________________________________________________________
_____________________________________________________________
Names of Collaborating Institutions and Investigators (include Subcontractors
and Consultants) (print):
This section identifies the items found in the RFP Web directory entitled
RFP
REFERENCES that are applicable to this RFP.
The entire file entitled "STANDARD
RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as
otherwise may be modified by the inclusion of an item from the "OPTIONAL
RFP INSTRUCTIONS AND PROVISIONS".
ABOUT NIAID'S CONTRACT REVIEW ON-LINE (CRON) system
The National Institute of Allergy and Infectious Diseases is using RFP
NIH-NIAID-DAIDS-00-20 to test the Contract Review On-Line (CRON) system developed
by the NIAID. Proposals in response to this Request for Proposal (RFP) will
be submitted electronically over the Internet. Adequate security will be provided
by using a dedicated server with access restricted through passwords. Following
the initial phase of electronic submission by the offerors, proposals will
be forwarded to the selected technical reviewers where they will be read and
evaluated electronically. The technical review is designed so that a face-to-face
meeting is not required. Instead technical reviewers will access proposals
through the Internet. Final Revised Proposals (FRPs) will also be submitted
and reviewed electronically.
This electronic acquisition approach will save the government and, hence,
the taxpayer the costs of travel and per diem for the reviewers, and of shipping
proposals to the reviewers.
Offerors will be spared the cost of copying and shipping proposals, which
can be a significant expense. This approach should also reduce the staff time
needed to process an action through to award. We anticipate that the savings
in staff time will be much greater than the savings in postage and paper costs.
ELECTRONIC SUBMISSION INSTRUCTIONS
GENERAL --- To submit a proposal electronically under
this RFP, Offerors will need to prepare the proposal on a word processor or
spreadsheet program (for the cost portions) and convert them to Adobe Acrobat
Portable Document Format (PDF). THE TECHNICAL PROPOSAL AND BUSINESS PROPOSAL
MUST BE CONTAINED ON SEPARATE FILES. Further, to expedite the file transferring
process, the two files must be named using the following DOS naming convention:
Technical Proposal: c:\rfp____\techprop.pdf
Business Proposal: c:\rfp____\busiprop.pdf
Approximately TWO weeks prior to the due date of proposals,
all offerors will be provided with specific electronic access information and
electronic proposal transmission instructions. For this reason, it is imperative
that all offerors who are intending to submit a proposal in response to this
RFP contact the Contracting Officer identified in this RFP and complete and
submit the attached Proposal Intent Form by October 4, 1999.
NOTE: There is no limit to the size (MB) of the two electronic PDF files
to be submitted; however, the size of the technical proposal is limited to the
page limitation language outlined below. For purposes of assessing compliance
with the page count, technical proposals will be viewed using the print function
of the Adobe Acrobat Reader, Version 3.0.
ADDITIONAL SUGGESTIONS --- Do not embed sound or video (e.g., MPEG) files into
the proposal documents. The evaluation system will not incorporate a capability
to read these files. Graphics which are embedded into documents should be kept
as simple as possible. Complex graphics require longer periods for the computers
used in the evaluation system to draw, and redraw these figures and scrolling
through the document is slowed significantly. Suggestions include:
Limit colors to 256 colors at 1024 x 768 resolution; avoid color gradients.
Simplify the color palette used in creating figures.
Be aware of how large these graphics files become. Large files are discouraged.
Limit scanned images as much as possible.
PAGE LIMITS -- The narrative portion of the Technical
Proposal, (under 4. Technical plan, items a through d)is limited to fifty (50)
pages. Pages in excess of this will be removed from the proposal and will
not be read or evaluated. Offerors are encouraged to limit the overall size
of the Technical Proposal, inclusive of appendices, attachments, etc. Note that
although no page limit has been placed on the Business Proposal, offerors are
encouraged to limit its content to only those documents necessary to provide
adequate support for the proposed costs.
Type density and size must be 10 to 12 points. If constant spacing is used,
there should be no more than 15 cpi, whereas proportional spacing should provide
an average of no more than 15 cpi. There must be no more than six lines of text
within a vertical inch. Margins must be set to 1 inch around.
Technical Proposal and Business Proposal preparation instructions along with
proposal table of contents are detailed below.
TECHNICAL PROPOSAL INSTRUCTIONS
GENERAL --- The entire technical proposal, except as noted below in the
"Technical Proposal Table of Contents", is to be submitted electronically. The
STANDARD RFP INSTRUCTIONS AND PROVISIONS provide more detail on the TECHNICAL
PROPOSAL requirements.
TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT
(NOTE: Instructions to offerors are indicated in parentheses or as footnotes.)
TECHNICAL PROPOSAL TABLE OF CONTENTS ................ Page 2
SUMMARY OF OBJECTIVES AND METHODS (Abstract)*... Page 3
TECHNICAL PLAN (Refer to Technical Proposal Instructions located in
the Standard RFP Instructions and Provisions.)
STATEMENT OF WORK
a.Objectives ........................................ Page 4
b. Approach ......................................... _____
c. Methods ........................................... _____
d. Schedule ........................................... _____
PERSONNEL (List by name, title, department and organization, and detail
each person's qualifications and role in the Project.)
Provide narrative for:
e. Principal Investigator/Project Director
f. Other Investigators
g. 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.") -- Page
____
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 in Item 6.)-- Page ____
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 ____
HUMAN SUBJECTS, PARTICIPATION OF CHILDREN AND MINORITY AND GENDER
ISSUES NOT OTHERWISE ADDRESSED (IF APPLICABLE) -- Page ____
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.
** HARDCOPY SUBMISSION OF APPENDICES: The following items are excluded from
our electronic submission requirement and will not be subject to page limitations.
Offerors may provide appendices electronically or may instead submit ten (10)
paper copies of the information.
Complete SOPs; any other pertinent policy manuals; any letters of collaboration
from other investigators; non-scannable figures or data.
4. BUSINESS PROPOSAL INSTRUCTIONS
GENERAL --- THE ENTIRE BUSINESS PROPOSAL IS TO BE SUBMITTED ELECTRONICALLY.
There are no page limits with the business proposal. The STANDARD
RFP INSTRUCTIONS AND PROVISIONS provide more detail on the BUSINESS
PROPOSAL requirements.
Following proposal submission and review, additional information will be requested
by the Contracting Officer from all offerors that comprise the competitive
range. The format of your BUSINESS PROPOSAL is detailed in the "Business Proposal
Table of Contents", below.
With the Business Proposal, please submit Form NIH-2043, "Proposal Summary
and Data Record." Note that in addition to telephone and fax numbers, the
INTERNET addresses of both the Principal Investigator and the responsible
business representative are to be included on the form.
ESCALATION. Due to the National Institute of Allergy and Infectious Diseases'
current budget restrictions, it is recommended that any proposed annual
increase in costs for inflation be limited to no more than 3% of total costs
per year. Final inflation increases will be subject to the negotiation process
taking into consideration the most current consumer price index (cpi).
BUSINESS PROPOSAL TABLE OF CONTENTS
Please use the following format to organize and present your Business
Proposal:
Business
Proposal Cost Information and cost spreadsheets which include an itemized
cost element breakdown, for each year of the contract. Cost elements on
these spreadsheets include (as applicable): Direct Labor, Fringe Benefits,
Materials, Subcontracts, Travel, Equipment, ODC, Raw Materials, Purchased
Parts, Indirect Costs, Fee.
[Note: We have included a template cost
spreadsheet in Microsoft Excel. Offerors are requested to complete
this spreadsheet and include it with their business proposal. This spreadsheet
can replace the cost sheets that you ordinarily provide. It is our hope
that this spreadsheet will provide you with a useful tool, allow us to
more easily understand your cost proposal, and eliminate our need to recreate
your spreadsheets. This spreadsheet template is a new approach, and we
would appreciate any feedback you could give us about it.]
Business Plan - the business plan has the following components:
A narrative of the BASIS of costs proposed; do not provide documentation
with initial proposal
Qualification of the Offeror - This includes: General Experience, Organizational
Experience Related to the RFP, Performance History, Pertinent Contracts
and Grants
Property, Equipment, Facilities to be dedicated to this work
[Note to Offeror: Listed below are delivery instructions for the submission
of the PAPER copies of your proposal. Instructions for your electronic submission
are described above in Electronic Submission Instructions.]
Shipment and marking shall be as indicated below:
A. EXTERNAL PACKAGE MARKING:
In addition to the address cited below, mark each package as follows:
"RFP NO. NIH-NIAID-DAIDS-00-20
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"
B. NUMBER OF COPIES:
The number of copies required of each part of your proposal are as specified
below.
Technical Proposal: One (1) unbound signed original and one
unbound copy, with 10 copies of items excluded from electronic submission requirement
that you choose to provide in paper format (SOPs, PERTINENT MANUALS, NONSCANNABLE
FIGURES OR DATA, AND LETTERS OF COLLABORATION/INTENT.)
Business Proposal: One (1) unbound signed original and one unbound
copy.
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 hand
delivered (20817 zip code) address. Any package sent to this 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).
