|
Request for Proposal No.: |
NIH-NIAID-DAIDS-99-02 |
|
Issue Date: |
September 3, 1998 |
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Issued By: |
Brenda Velez, Chief, ACRCS, NIAID, NIH |
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Point of Contact: |
Merilee Rahe-Stoline, Contract Specialist |
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Purchase Authority: |
Public Law 92-218 as amended |
|
Small Business Set-Aside: |
Yes, 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: |
November 6, 1998, 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-99-02) entitled "Division of AIDS Specimen Repository". The Government anticipates that one (1) cost reimbursement, completion type contract will be awarded for a period of (7) years as a result of this RFP.
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 Merilee Rahe-Stoline, 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 Merilee Rahe-Stoline, 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.)
Within this Web based RFP 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.
The original and twenty (20) copies of your Technical Proposal and the original and five (5) copies of your Business Proposal must be received by this office no later than November 6, 1998, 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 October 1, 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 Merilee Rahe-Stoline, Contract Specialist at the Internet electronic mail address mr29k@nih.gov, or by fax at 301/480-5253. Merilee Rahe-Stoline, Contract Specialist can be reached at 301/496-2508. Collect calls will NOT be accepted.
Sincerely,
/s/
Brenda Velez,Contracting Officer
AIDS Contract Section
Contracts Management Branch
National Institute of Allergy
and Infectious Diseases, NIH
Attachments: A - E
INTRODUCTION, BACKGROUND AND WORK STATEMENT
ABBREVIATIONS
AACTG - Adult AIDS Clinical Trials Group INTRODUCTION & BACKGROUND
AIDS - Acquired Immunodeficiency Syndrome
AVEG - AIDS Vaccine Evaluation Group
CDC -Centers for Disease Control and Prevention
CFR - Code of Federal Regulations
CO - Contracting Officer
CRP - Clinical Research Program
DAIDS - Division of Acquired Immunodeficiency Syndrome
DATRI - Division of AIDS Treatment Research Initiative
DEA- Division of Extramural Activities
DHHS - Department of Health and Human Services
DOD - Department of Defense
DOT- Department of Transportation
ETB - Efficacy Trials Branch
FAR - Federal Acquisition Regulation
FDA - Food and Drug Administration
FY - Fiscal Year
HATS - Heterosexual HIV Transmission Study
HHSAR - Health and Human Services Acquisition Regulation
HIV - Human Immunodeficiency Virus
HIVNET - HIV Network for Prevention Trials
ICAR - International Collaboration in AIDS Research
MACS - Multicenter AIDS Cohort Study
NARDS - National AIDS Repository Database System
NIAID - National Institute of Allergy and Infectious Diseases
NIH - National Institutes of Health
OSHA - Occupational Safety and Health Administration
PACTG - Pediatric AIDS Clinical Trials Group
PAVE - Preparation for AIDS/HIV Vaccine Evaluation
PHS - U.S. Public Health Services
PO - Project Officer
RFC - Request for Contract
RFP - Request for Proposal
SOP- Standard Operating Procedure
VPRP - Vaccine and Prevention Research Program
WIHS - Woman's Interagency HIV Study
WITS - Women and Infant Transmission Study
The mission of the Division of AIDS (DAIDS), National Institutes of Allergies and Infectious Diseases (NIAID) is to increase basic knowledge of Human Immunodeficiency Virus (HIV) disease and Acquired Immunodeficiency Syndrome (AIDS), and to promote progress in its detection, treatment, and prevention.
The importance of this mission and targeted goals assumes increasing significance as the pandemic of AIDS continues to grow. DAIDS supports a number of multi-institutional programs in epidemiologic, therapeutic, and vaccine/prevention research. DAIDS' domestic natural history studies of HIV have served to identify and characterize HIV transmission patterns in high-risk male and female populations, and included baseline epidemiological studies in the United States. Among these studies is the Multicenter AIDS Cohort Study (MACS), Women and Infants Transmission Study (WITS), Heterosexual HIV Transmission Study (HATS) and the Women's Interagency HIV Study (WIHS). A wide variety of studies on the natural history of HIV at international sites include unsolicited R01 collaborative research grants in Haiti, Uganda, and Kenya. The AIDS Vaccine Evaluation Group (AVEG) conducts phase I/II trials of candidate HIV vaccines. The HIV Network for Prevention Trials (HIVNET) has a primary role in conducting Phase III efficacy trials of preventive HIV vaccines and other HIV prevention approaches. Recently HIVNET has conducted vaccine preparation studies which include sites overseas in Haiti, India, Thailand, Zimbabwe, Malawi, Kenya, Brazil, Uganda, Senegal, Zambia, and South Africa, as well as U.S. study sites. The Adult AIDS Clinical Trials Group (AACTG) is a cooperative adult clinical trials network that conducts studies to test the efficacy of various therapeutic approaches for treating HIV infection and HIV-associated illnesses. The Pediatric AIDS Clinical Trials Group (PACTG) supports the development and implementation of phase I, II, and III studies designed to test and optimize therapies to prevent and treat HIV infection and its sequelae in infants, children and adolescents.
HIV prevention trials, clinical-related treatment trials and epidemiologic studies provide relevant baseline information in support of the basic mission of DAIDS and require a centralized, coherent, and dependable system for receiving, cataloging, storing, accessing, and distributing study subject samples derived from field projects. The variety of body fluids and tissues collected depend on the specific projects and include, but are not limited to, peripheral blood cells, sera, semen, saliva, urine, placenta and autopsy materials. These materials are a major resource for answering critical questions about HIV infection and the clinical history of HIV disease. A centralized repository ensures that samples are stored in viable condition, that samples are retrievable, and that the government facilitates the standardized utilization of these samples for research purposes.
The purpose of this contract is to provide a specimen repository for domestic and international HIV epidemiology studies, HIV vaccine trials and, other clinical and prevention research studies supported by the DAIDS in the NIAID. The DAIDS Specimen Repository contract shall serve to continue functions now facilitated by the present contractor, and expand the workscope to cover growing areas in HIV preventative and treatment trials. DAIDS maintains a specimen repository to receive and store specimens, and at the request of the NIAID, the Contractor shall prepare and ship repository specimens to various laboratories for further research. The NIAID requires state-of-the-art storage and computerized inventory management of AIDS-related specimens. The Repository was established by NIAID in 1984; the current contract will expire in August 1999. This initiative shall continue the functions served by the present Contractor and expand the workscope to cover amplified efforts of the DAIDS in the area of HIV vaccine trials and other clinical and prevention research studies.
WORK STATEMENT
DIVISION OF AIDS SPECIMEN REPOSITORY
Independently, and not as an agent of the Government, the contractor shall furnish services, qualified professional and technical personnel, material, equipment, and facilities not otherwise provided by the Government under the terms of this contract to perform the work set forth below.
[Note 1 to Offeror: In responding to this RFP, the Offeror should describe in detail the responsibilities and level of effort of all proposed personnel who will be assigned to the contract, the administrative framework showing clear lines of authority, and a detailed work plan showing proposed time schedules for achieving contract objectives and maintaining quality control over the implementation and operation of the contract. Documentation should be also provided on the qualifications, experience, education, competence, availability, and decision-making authority of the Principal Investigator, Technical, and Administrative Support Staff; the extent to which outside consultants will be used as well as assurance of the availability; and the percentage of time each staff member (including proposed subcontractors and consultants) will contribute to the project. Resumes, endorsements, and explanations of previous efforts should clearly demonstrate relevant training, experience, and specific accomplishments. Documentation should include all previous and current projects of a similar nature, including the contract number or grant number, the sponsoring agency, the Project Officer, and a description of the project. It is recognized that a single institution may not have the expertise and facilities required to perform all requirements of the Work Statement. Therefore, the Contractor may subcontract a portion of the work. If a subcontractor is proposed, similar technical information should be provided in the proposal as that required by the prime Contractor, i.e., technical approach, methods, experience, personnel qualifications, facilities, resources, etc. A detailed cost proposal should also be provided for the subcontractor(s). The relationship between the subcontractor and the prime contractor should be clearly delineated.
If the Offeror is a commercial firm selling or distributing AIDS-related reagents or products, the Offeror must address in the Technical Proposal how potential conflicts of interest will be resolved.]
In general, the Contractor shall: (1) secure, receive, catalog, process, store, and disburse clinical specimens from human immunodeficiency virus (HIV)-infected patients, cohort participants, recipients of candidate HIV vaccines and other biomedical interventions in studies sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS); (2) provide a computerized specimen inventory management system in a format identified and approved by DAIDS; (3) provide adequate cold-storage facilities for clinical specimens, and provide experienced professional personnel (formally trained in dangerous goods biosafety) to support specimen handling and repository management; (4) provide labeling and shipping procedure training and oversight to study sites; (5) report progress to the Project Officer and provide specimen availability summaries as requested by the Project Officer; (6) complete the development and the execution of a DAIDS Repository Management Plan which may include, but is not limited to: systematic effort to discard identified specimens with low research potential, reduce the numbers of duplicate specimens, discard specimens with missing key clinical data, and/or expand the freezer capacity of the repository as requested by the Project Officer; and (7) ensure an orderly and safe transition of the Repository from the incumbent Contractor, and to a successor contractor, if necessary. Transition to a successor contractor shall include all Repository data including all source codes.
Specifically, the Contractor shall:
1. Secure, receive, process as necessary, catalog, store and ship clinical specimens to and from both domestic and international DAIDS study sites, and distribute clinical specimens to other investigators at the request of the Project Officer. Currently the specimen repository supports these DAIDS studies: MACS, WITS, WIHS, HIVNET, AACTG, PACTG, AVEG, DATRI, and maintains specimens from other completed DAIDS studies such as the Jump Start Project, the HATS, and the San Francisco Men's Health Study. These specimens may include, but are not limited to, peripheral blood mononuclear cells, serum, plasma, tissue specimens, and other bodily fluids or substances such as cervical-vaginal lavage (CVL), breast milk, semen, saliva, urine, feces, mucosal, autopsy and biopsy materials, and specimen spots dried on filter paper.
(1) Title 49 CFR Part 100-199 Transportation
(2) Title 42 CFR Part 71.54 and 72.3 Etiologic Agents, Hosts and Vectors; Interstate Shipment of Etiologic Agents
(3) Title 39 CFR Part 124 Postal Services
(4) International Air Transport Association (IATA), Dangerous Goods Regulations 36th Edition 1995, and 1997 changes to the IATA Dangerous Good Regulations
(5) International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transportation of Dangerous Good by Air 1995-1996
(6) United Nations Recommendations on the Transport of Dangerous Good 8th Edition
[Note 2 to Offeror: Importing biological materials into the U.S. requires a permit from the Centers for Disease Control and Prevention (CDC). In compliance with the Code of Federal Regulations (CFR), the CDC regulates the importation of all etiologic agents and vectors of human disease (42 CFR 71.54 and 72.3). Failure to obtain the appropriate permit may result in confiscation of a shipment at the port of entry. Requests for CDC permit applications (Form 753) may be obtained by calling (404) 639-3883. These permits usually take two weeks to process and may be renewed annually. The Offeror should describe whether it possesses the appropriate licenses and permits.]
[Note 3 to Offeror: The Repository currently contains over two million specimens, collected from 45 sites. For budgeting purposes, the Offeror should expect to accrue approximately four million additional samples, collected from 70 sites, during the term of the contract. The Offeror should assume receiving on an average of approximately 27,000 samples per month in the first year with an expansion to 30,000 samples per month in the second year and up to 40,000-50,000 samples per month for years 3-7. Approximately 90% of monthly shipments are –70oC (serum/plasma, etc.) and approximately 10% of monthly shipments are -195o C (cells). The number of cell shipments is expected to increase with the certification of a large capacity liquid nitrogen shipping container which is now under development by the government. The provision of this large capacity shipper will then enable DAIDS-supported research sites to ship their large stores of cells to the Repository.]
(1) Title 29 CFR 1910.1030 OSHA Bloodborne Pathogen Standard
(2) Health & Safety Guidelines for Grantees and Contractors, NIH Guide, Vol. 24, No. 33, dated September 22, 1995
(3) Biosafety in the Laboratory: Prudent Practices for Handling and Disposal of Infectious Materials; National Academy Press, Wash., D.C.
(4) Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, HHS Pub. No. (CDC) 93-8395 published by the U.S. Government Printing Office. (Website: www.niehs.nih.gov/odhsb/biosafe/bmbl/bmbl-1.htm)
(5) Recommendations for Prevention of HIV transmission in Health Care Settings, Morbidity and Mortality Weekly Report, Vol. 36, No. 2-S, dated August 21, 1987.
(6) Agent Summary Statement for Human Immunodeficiency Virus and Report on Laboratory-Acquired Infection with Human Immunodeficiency virus, Morbidity and Mortality Weekly Report, Vol. 37, No.S-4, pp. 1-22, dated April 1, 1988.
[Note 4 to Offeror: The Offeror should provide the following in the Technical Proposal: a safety and health plan and summary of the Offeror's safety and health operating procedures manual; training certificates for key personnel from Transport of Dangerous Goods training courses; documentation of ongoing programs and plans for programs for adequate training of personnel handling infectious biological material including decontamination procedures, accident procedures and monitoring for infection; evidence of training and compliance with applicable guidelines or regulations for a Biosafety Level 2 facility; and, draft Standard Operating Procedures for acquiring, storing, and disbursing potentially hazardous biological specimens. SOP and amendments thereto shall be approved by the P.O. prior to commencement of work.]
[Note 5 to Offeror: In responding to this RFP, the Offeror shall provide an introductory Repository Management Plan. The Offerors should use their management experience to propose ideas which address issues concerning the possibility of a maximum capacity for the repository; basic points which may be used in deciding which categories of specimens might be collected, stored, or discarded; ways to effectively manage the availability/accessibility of specimens to the scientific community; and how to institute and maintain quality control standards throughout the plan. As noted in Appendix II, the AIDS Research Advisory Committee (ARAC) of the NIAID voted to approve the proposed concept of continuing the DAIDS Specimen Repository with the modification that a Management Plan be developed to address the above issues. To assist the Offeror in the development of an initial Repository Management Plan, background information is given in Appendix II. Upon award the successful Offeror's draft plan will be refined in collaboration with DAIDS research cohort groups and policy-makers.]
[Note 6 to Offeror: For purposes of describing the plan and budget, the Offeror should assume that disbursement of approximately 24,000 specimen tubes (3,000 of which are aliquots) per year will occur. Disbursement of all samples (aliquoted and non-aliquoted) will occur at a rate of approximately 2000 samples per month in the first year, 2800 samples per month in the second year and up to 3700 -6000 samples per month for years 3-7 of the contract. Approximately 85% of these monthly samples are non-aliquoted, 15% are aliquoted, and all samples are disbursed across 45 sites in the first and second years and up to 65 sites in years 3-7 of the contract.]
2. Provide and maintain a computer facility and Specimen Inventory Database Management System to track samples and activities in the Repository. This system shall be adaptable/programmable to include the capability to print and scan specimen labels that are bar-coded. (Approximately 4% of all Repository specimens stored/disbursed currently are bar-coded.)
[Note 7 to Offeror: In responding to this RFP, the Offeror should describe a plan outlining the basic steps towards implementation of computerized electronic identification system. Upon notification of the Award, the Project Officer will review and approve a proposed barcode system to be fully developed and implemented within a six-(6) month time period.]
[Note 8 to Offeror: The Offeror should assume that the Government will provide the existing hardware and database management system, namely the National AIDS Repository Database System (NARDS), to the successor Offeror. The NARDS is an inventory system for all samples that are stored at and distributed from the repository, with the ability to track sample aliquots and the freeze/thaw cycle(s) of the parent specimens. Other modules support the production of standard reports such as receiving and shipping. The NARDS currently resides on a Hewlett-Packard 9000/800 G40 with the HP-UNIX operating system and is based on the ORACLE Relational Database Management System, which is menu-driven and commercially available.]
[Note 9 to Offeror: In responding to this RFP, The Offeror may include suggestions (with specific information) regarding hardware and database management inventory system software understood to be more adaptable, comprehensive, and contemporary than the existing one.]
3. Provide facilities and resources to store/handle/package specimens.
[Note 10 to Offeror: There are 72 mechanical freezers and 31 liquid nitrogen freezers presently in use, which will transfer with the award. The new awardee will assume the cost of transfer as a contract expense. The Offeror should plan for an increase of cold storage equipment over the course of contract performance commensurate with Offeror NOTE 6.]
[Note 11 to Offeror: The Offeror should provide the following in the Technical Proposal: a floor plan of the proposed facility and a list of equipment and resources to be dedicated to the project. There should be sufficient freezer capacity to ultimately store and maintain approximately six (6) million biologic specimens by the end of the seven-year contract period. This estimate includes the two (2) million current specimens, which will transfer with the award, as well as the projected accumulation and storage of an additional four (4) million more samples over the course of the contract performance.]
[Note 12 to Offeror: See Appendix 1, the Work Statement for a detailed description of Government-owned equipment/property to be supplied to the awardee.]
4. Provide training, instruction and oversight for all aspects of interaction between the repository and study sites.
[Note 13 to Offeror: For purposes of preparing a budget, the Offeror should assume conducting up to two training meetings per year in the Bethesda, MD area as requested by the Project Officer.]
5. Report on progress, anticipated or existing problems, and discuss the work to be performed with the Project Officer.
6. Follow Reporting Requirements. (Refer to Attachment B)
7. Contractor's key personnel shall meet with the Project Officer at periodic intervals after contract award to review Repository status.
[Note 14 to Offeror: For the purpose of preparing a budget, assume a minimum of eight meetings per year between key personnel and Project Officer in the Bethesda, MD area.]
8. Ensure an orderly and safe transition of the Repository from the incumbent Contractor, at the beginning of the period of performance; and to a successor Contractor, at the end of the period of performance. Transition to a successor Contractor shall include all data files and source codes.
(1) Government-owned equipment and property;
(2) entire Repository inventory of stored specimens;
(3) National AIDS Repository Database System (NARDS);
(4) supporting hardware and software documentation including source codes;
(5) user manuals and training materials;
(6) labeled and inventoried paper files.
No later than sixty (60) days after the beginning of this contract, The Contractor shall meet with the Project Officer to present recommendations for developing and/or implementing additional Standard Operating Procedures and/or a plan for revising current Standard Operating Procedures.
(1) Government-owned equipment and property;
(2) National AIDS Repository Database System (NARDS);
(3) supporting hardware and software documentation including source codes;
(4) user manuals and training materials;
(5) labeled and inventoried paper files, and
(6) entire Repository inventory of stored specimens
[Note 15 to Offeror: The Offeror should include two "transition plans" in the Technical Proposal, and appropriate costs in the Business Proposal. (1) A transition plan for all tasks associated with the relocation of the Repository equipment, samples, and Inventory database within an estimated 60 calendar days from the award date of the new contract; and the manner of operations by the Offeror during the transition period. Include proposed training time associated with transfer, including learning the NARDS. Should the incumbent recompete and be awarded the new contract, no transition will be necessary. (2) A transition plan for movement of the Repository at the conclusion of this contract to the Government or its designee. Costs and responsibility for both (1) and (2) are to be assumed by the new awardee.]
APPENDIX 1
DETAILED DESCRIPTION OF GOVERNMENT-OWNED PROPERTY TO BE FURNISHED TO AWARDEE
| Item |
Description |
|
Model Number |
Quantity |
||
|---|---|---|---|---|---|---|
| General Repository Equipment | ||||||
| 1 |
Biological safety cabinet |
CCI |
740 |
2 |
||
| 2 |
Water baths |
Elemco |
70 |
2 |
||
| 3 |
-70° Mechanical freezer with racks |
Revco |
ULT2090EN |
28 |
||
| 4 |
-70° Mechanical freezer with racks |
Harris |
HLT19LS85 |
17 |
||
| 5 |
LN2 Freezer with racks |
MVE |
A4500 |
12 |
||
| 6 |
LN2 Freezer with racks |
MVE |
XLC-1840 |
5 |
||
| 7 |
LN2 Cryogenic shipper |
MVE |
TA-60 |
2 |
||
| 8 |
-70° Mechanical freezer with racks |
Rush |
3185 |
8 |
||
| 9 |
LN2 Cryogenic shipper |
Custom Biogenics |
DS-3 |
3 |
||
| 10 |
LN2 Cryogenic shipper |
Taylor-Wharton |
CP65 |
4 |
||
| 11 |
LN2 Freezer with racks |
Taylor-Wharton |
33K |
7 |
||
| 12 |
LN2 Bulk storage tank |
MVE |
VVXC3000NC1 |
1 |
||
| 13 |
Vacuum jacketed LN2 distribution pipe |
MVE |
none |
1 |
||
| 14 |
-70° Mechanical freezer with racks |
Harris |
HLT-36LS86 |
15 |
||
| 15 |
Plastic shipping case for LN2 shipper |
MVE |
none |
1 |
||
| 16 |
LN2 Freezer with racks |
Taylor-Wharton |
38KM21 |
7 |
||
| 17 |
DOT certified dry ice shipping container |
U.S. Army |
FSSU-21 |
15 (approx.) |
||
| 18 |
DOT certified dry ice shipping container |
U.S. Army |
FSSU-4 |
5 (approx.) |
||
|
Computer Hardware, Software and Data Communications Equipment |
||||||
| 1 |
9000/800 G40 Business Server with 128 MB RAM, 7 GB hard disk storage, DAT cartridge tape drive, CD-ROM drive, 16 port MUX, HP-IB interface |
Hewlett-Packard |
9000/G40 |
1 |
||
| 2 |
HP-Unix operating system software |
Hewlett-Packard |
v10.20 |
1 |
||
| 3 |
Oracle RDBMS software |
Oracle |
v7.3 |
1 |
||
| 4 |
CASE Designer 2000 software |
Oracle |
none |
1 |
||
| 5 |
CASE Developer 2000 software |
Oracle |
none |
1 |
||
| 6 |
ANSI C Compiler |
Hewlett-Packard |
none |
1 |
||
| 7 |
PowerMon software |
Systems Enhancement Corporation |
v1.3 |
1 |
||
| 8 |
X-Terminal |
Hewlett-Packard |
A1097C |
1 |
||
|
9 |
ENVIZEX Computer Terminal |
Hewlett-Packard |
D1196A |
4 |
||
| 10 |
ENTRIA Workstation |
Hewlett-Packard |
C3264A |
1 |
||
| 11 |
Computer Terminal |
DEC |
VT420-CA |
2 |
||
| 12 |
Uninterruptible power supply for HP |
DEC |
none |
1 |
||
| 13 |
Gateway 2000 personal computer with Pentium overdrive chip, 32 MB RAM, 200 MB and 1.6 GB HDs, dual floppy drive, CD-ROM drive, LAN card, internal fax-modem, and color monitor |
Gateway |
4DX-33 |
1 |
||
| 14 |
Compaq Presario personal computer with Pentium chip, 32 MB RAM, 4.3 GB HD, floppy drives, CD-ROM, LAN card, internal fax-modem, and color monitor |
Compaq |
Presario |
1 |
||
| 15 |
Windows 95 software |
Microsoft |
Windows 95 |
2 |
||
| 16 |
WordPerfect Suite 7 |
Corel |
v7.0 |
2 |
||
| 17 |
DBMS/Copy |
SPSS, Inc. |
v5.0 |
1 |
||
| 18 |
Smarterm Essentials |
Persoft, Inc. |
v7.0 |
2 |
||
| 19 |
Platinum DB Monitoring sw for HP G40 |
Plat.Technologies |
v3.1 |
1 |
||
| 20 |
14400 Baud external modem |
Practical Peripherals |
PM14400FXMT |
|||
| 21 |
Power surge protector |
Trippe |
Isobar 4 |
1 |
||
| 22 |
Dot matrix printer |
DEC |
LA-424 |
1 |
||
| 23 |
Printer with postscript and 4 MB RAM modules |
Hewlett-Packard |
LaserJet 4 |
1 |
||
| 24 |
External cassette tape drive for Compaq |
Iomega Ditto |
Easy 3200 |
1 |
||
| 25 |
Smart 650VA uninterruptible power supply for pc |
APC |
VS650 |
2 |
||
| 26 |
Bar Code Scanner |
American Microsystems |
5310HP4342 |
1 |
||
| 27 |
Delta Plus label printer |
Eltron |
TLP2642PSA |
1 |
||
| 28 |
Label Works software |
American Microsystems |
v2.0 |
1 |
||
| 29 |
Deskpro personal computer with 1 MB RAM, floppy drives, 40 MB hard drive, and monochrome monitor |
Compaq |
286e |
1 |
||
| 30 |
Paper copier |
Minolta |
EP-2121 |
1 |
||
| 31 |
Plain Paper Facsimile machine |
Muratec |
F-86 |
1 |
||
| 32 |
Laser Jet Color Printer |
Hewlett-Packard |
5M |
1 |
||
APPENDIX II
Background Information for Specimen Repository Management Plan*
The Management Plan will provide the framework and the principles upon which issues of capacity, specimen selection and processing, quality control and inventory management are overseen. Upon selection of the Specimen Repository Contractor, the initial draft plan submitted with the proposal may be used to expand into a fully practical Plan to provide operational and policy guidance. This full Plan, developed with input from the Project Officer, other DAIDS representatives and other ad-hoc experts or investigators, will be completed within the initial 9 months of the Contract. The Plan will be modified as necessary throughout the life of the Contract in response to changing needs and circumstances. The Plan will incorporate cross-reference to existing NIAID and DAIDS written procedures that are intended to provide capable investigators fair and equitable access to those specimens they need to conduct specified relevant research optimizing the use of valuable specimens. During development of a final and fully operational Repository Management Plan, specific attention will be devoted to the following:
Specimen Repository Collections
The DAIDS Specimen Repository is dedicated to the storage and selective retrieval of specimens collected primarily as part of prevention-related research. These include specimens from the following types of research: Clinical Phase I and II clinical vaccine trials among volunteers at low or medium risk for HIV infection; Epidemiologic studies among domestic (US) and international cohorts comprised of volunteers with behaviors putting them at high-risk of HIV infection; Clinical, epidemiologic and behavioral research studies among populations preparatory to HIV prevention/intervention trials; Natural History of HIV-infected persons and associated transmission factors.
Progress in development of potentially effective prevention modalities has resulted in recent, or pending, commencement of many Phase I studies. Evaluation of the results is likely to lead to medium or large size clinical trials. Some intervention trials will monitor volunteers repeatedly and for very long periods, both for assessments of safety and to detect, concurrently or retrospectively, dynamic changes in their immunologic or virologic status. This is especially true in vaccine trials in which not only infection (Primary Endpoint) but many Secondary Endpoints (virologic, immunologic, and clinical) will be followed concurrently or retrospective and be evaluated singly and in combinations.
Thus, a substantial percentage of specimens will have to be retained for many years. Estimates have been made that, for each full efficacy trial involving 3000 or more study participants and likely lasting 3 or more years, another 1 millions vials will be accessioned. With the prospects that several efficacy trials will be completed or nearing completion within the seven-year term of the proposed Repository Contract extension, adequate provision must be made to prevent specimen overload.
Access to Specimens by Depositors and Others
Specimens in the repository are there to be in service to the specific or general research purposes for which the investigators were funded. The specimens may be retrieved from the repository by individual investigators or multiple, collaborating investigators. Ownership of these specimens resides with the US government if the research study is funded through a government contract; and with a specific institution if awarded through a cooperative agreement with the government. The procedures through which a requester may have access to repository-stored specimens and the information required to assure that stored specimens are used to the optimum to answer relevant research questions, are spelled out in a separate 1996 document available from the Division of AIDS: "Procedures for Establishing Collaborations to Access Specimens Collected from DAIDS-Supported Studies." In brief, submissions from outside investigators are reviewed for scientific originality and likelihood that the requester has the facilities to perform the research. The actual application forms to petition for access to various DAIDS-funded projects (MACS, AVEG, HIVNET, etc.) share many features in common but do differ in the details required of requesters on specifics of the proposal.
Longevity of Stored Specimens; Priority for Retention
Indefinite expansion of specimen storage capacity may not be practical. The relevance of most preserved specimens to answer relevant scientific questions declines with time. However, specimen discard or storage reconfiguration and consolidation is very labor intensive and represents a many-fold increase in daily operating costs. The usual storage configuration of specimens in freezers does not lend itself to discard of the content of entire freezers or racks. Expansion has often been the default procedure.
In future HIV vaccine efficacy trials, it may be possible for the Protocol Team to establish, before protocol implementation, a prioritization for specimen retention. For example, a representative sample, or a complete collection of specimens demonstrating the primary endpoint (HIV infection) or demonstrating secondary endpoints. For example, a prospective plan could be made for the storage of those specimens from specific study visits to be in high-priority designated freezers, whereas other specimens of intervening intervals, or lower priority occasions, could be stored in low-priority freezers. Then, after an ample interval without retrieval of specimens from the low-priority collections, either for research associated with the original protocol or newly proposed research, the specimens remaining in the low-priority freezers could be considered subject to discard. Once specimens of known or likely scientific value have been culled from the low-priority occasion, all others may then be discarded. Such culled specimens might include infrequent specimens associated with persons whose subsequent specimens were noted to demonstrate HIV infection. Alternatively, low-priority specimens might be culled to assist in the preparation of serum panels involving (negative) controls (from persons immunized but not later infected or from unimmunized, placebo recipients).
Therefore, the potential bases for prioritization within a draft Management Plan might include the following elements:
• Prioritize across differing types of protocols according to whether they are biomedical interventions (e.g., highest priority given biomedical intervention involving dynamic host changes after vaccination or immunoglobulins, HIV exposures, chemoprophylaxis or microbicides).
• Prioritize within a protocol for specimens according to visits.
• Plan accession and storage to enable convenient vacating of space so future accession is not compromised by previous specimens of marginal or expired value.
Types of Repository Collections
A. Natural History Studies in HIV-infected Subjects (and associated transmission factors)
1. Natural History (Multi-center AIDS Cohort Study, MACS)
2. Women's Inter-Agency Transmission Study, WITS;
B. Prospective Cohort Studies: epidemiologic factors influencing HIV transmission
C. Prevention Research Clinical Trials
1. Phase I, II (lower risk populations)
Including: (past, current, and pending):
2. Phase II, III (higher risk populations)
Applicable to:
• Mothers & Infants (M-I Transmission)
• Utilizing antiretrovirals, other medications, HIV-Ig, Vaccines
• Adults (heterosexual, homosexual)
• Utilizing Behavioral, STD control and barrier/microbicides
D. Ancillary/Sub-studies of Clinical Studies
E. Panels developed for QC or New Assay Development
F. Donated Collections from Designated Collaborators (with rationale)
RFP-NIH-NIAID-DAIDS 99 - 02
SEPTEMBER 3, 1998
REPORTING REQUIREMENTS AND DELIVERABLES
In order to effectively monitor project progress, the report schedule shall be as follows: (See Post-Award Administration and Monitoring for further discussion).
The Contractor shall submit to the Contracting Officer and to the Project Officer technical progress reports covering the work accomplished during each reporting period. The exact submission schedule will be negotiated and established in the contract. The reports shall be brief, factual and prepared in accordance with the following format:
By the fifteenth day of the month following the end of each quarter, the Contractor shall submit two (2) copies of a quarterly progress report as described below. One (1) copy shall be submitted to the Project Officer and one (1) copy to the Contracting Officer. A quarterly report is not due when an annual report is due. The quarterly report should be factual, concise, and consist of the following:
A. Title page containing:
B. Reports shall include, but are not limited to the following information:
(1) A brief introduction covering the objective and scope of the contract effort.
(2) A description of the overall work accomplished during the quarter plus brief descriptions of shipping activity both into and out of the Repository, including specimen disbursement requests.
(3) A description of any technical or performance problems encountered and corrective actions planned or taken. An explanation of any differences between planned and actual progress.
(4) Selected other information as may be required by the Project Officer.
15 days after the anniversary date of the contract, the Contractor shall submit two (2) copies of an annual report. One (1) copy shall be submitted to the Project Officer and one (1) copy to the Contracting Officer. The annual report shall be factual and concise and summarize progress for the entire contract year, following the same format as for the Quarterly Progress Reports, and shall take the place of the fourth Quarterly Progress Report each year. An annual report is not required when the final report is due.
Upon request by the Project Officer, and within 5 working days of such a request, the Contractor shall provide an interim report to cover the period of the current week or latest 1 - 4 weeks, and describing:
The contractor shall submit two (2) copies of the final report, which will summarize the results of the entire contract work for the complete performance period. One (1) copy shall be submitted to the Project Officer and one (1) copy to the Contracting Officer. This report will follow the same format as for the Annual Progress Reports and shall take the place of the last Annual Progress Report. It shall be in sufficient detail to explain comprehensively the results achieved and shall be submitted no later than the completion date of the contract.
If the Contractor becomes unable to deliver the reports or other deliverables specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons therefore at the address given below.
Type of Report |
No. of Copies |
Address |
Due Dates |
|---|---|---|---|
| Quarterly |
1 |
Project Officer |
Quarterly. Dates to be Specified in Contract |
| Quarterly |
1 |
Contracting Officer |
Same as above. |
| Annual |
1 |
P.O.'s Address, above |
Annually. Dates to be Specified in Contract |
| Annual |
1 |
C.O.'s Address, above |
Same as above. |
| Final |
1 |
P.O.'s Address, above |
Contract Completion Date |
| Final |
1 |
C.O.'s Address, above |
Same as above |
RFP-NIH-NIAID-DAIDS 99-02
SEPTEMBER 3, 1998
PROPOSAL EVALUATION CRITERIA
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: technical and cost. Although technical factors are of paramount consideration in the award of the contract, cost/price are also important to the overall contract award decision.
Offerors are advised that award will be made to that offeror whose proposal provides the best overall value to the Government. In accordance with FAR 15.305, proposals 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 evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Proposals will be judged solely on the written material provided by the offeror.
The following qualification criterion established conditions that MUST be met at the time of submission of the Final Revised Proposal in order for proposals to be considered for award:
The Contractor must have available biosafety level 2 facilities of sufficient capacity for all laboratory procedures employing HIV-1 isolates.
A. Technical Approach (Total 40 points)
Technical adequacy and feasibility of the proposed technical approach for executing each of the requirements specified in the Work Statement. Understanding of the scope, purpose and complexity of the project, including recognition of potential problems and proposed solutions. Specifically:
B. Personnel Qualifications (TOTAL 40 points)
C. Corporate Experience, Facilities and Resources (TOTAL 20 points)
Documented successful experience of the Offeror in operating a biohazardous material clinical specimen repository for long-term storage and periodic disbursement of specified samples, and in using a computerized relational database inventory system.
Documented availability of adequate physical facilities, equipment, and other resources necessary to receive, catalog, store, and disburse study specimens in a manner which meets safety and security requirements, preserves specimen integrity and utility, and meets projected growth requirements. (20 points)
TOTAL: 100 POINTS
RFP-NIH-NIAID-DAIDS 99-02
September 3, 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".
It is anticipated that one (1) award will be made from this solicitation and that the awards will be made on/about August 31, 1999.
It is anticipated that the award from this solicitation will be a cost reimbursement completion type contract with a seven (7) year performance period, and that incremental funding will be used.
It is expected that one completion type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the five year total effort to be approximately 5,630%, (690% year 1). This estimate is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.
As further assistance, it is estimated that the above total labor effort is constituted as follows:
Labor Category |
Annual Effort |
Total |
|---|---|---|
| Principal Investigator |
30% |
210% |
| CO-Investigators/Project Director |
160% |
1,120% |
| Senior Analyst |
100% |
700% |
|
Other Support |
400% |
3,600% |
|
TOTAL |
690% |
5,630% |
These percentages are based on a 12 month calendar year.
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, FAR 52.219-1:
(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.
Hand-Carried Address:
Brenda Velez, Contracting Officer
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852
Mailing address (U.S.) Postal Service
Brenda Velez, Contracting Officer
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.
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:
"RFP NO. NIH-NIAID-DAIDS 99-02
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"
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
Merilee Rahe-Stoline
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852
If using U.S. Postal Service
Merilee Rahe-Stoline
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 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.
RFP No.: NIH-NIAID-DAIDS 99-02
RFP Title: "Division of AIDS Specimen Repository"
Please review the attached Request for Proposals. Furnish the information requested below and return this page by October 1, 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: Merilee Rahe-Stoline
RFP-NIH-NIAID-DAIDS 99-02
FAX# 301/480-5253
Email mr29k@nih.gov
(NOTE: Instructions to offerors are indicated in parentheses or as footnotes.)
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 in Item 6.)-- 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 ____
* 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 99-02
September 3, 1998
This section identifies the items found in the RFP Web directory entitled RFP REFERENCES that are applicable to this RFP.
Applicable to Technical Proposal
Other-to be submitted as directed by Contracting Officer
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