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SIMIAN VACCINE EVALUATION UNITS

Solicitation Number: RFP-NIAID-DAIDS-NIHAI2012138
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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RFP-NIAID-DAIDS-NIHAI2012138
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Award
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Added: May 21, 2012 3:03 pm
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS (DAIDS), has a requirement for the provision of support services for the NIAID/DAIDS clinical research portfolio.


The development of HIV vaccines and other prevention strategies relies on the use of nonhuman primates in preclinical studies to advance the development of effective AIDS vaccine candidates and to advance development of effective topical microbicides and other prevention modalities or immune-based therapies. The NIAID Simian Vaccine Evaluation Unit (SVEU) contracts shall provide nonhuman primate resources that primarily support preclinical evaluation of AIDS vaccines. The SVEUs conduct studies in support of vaccines being developed by a wide range of investigators. These studies complement NIAID-supported basic vaccine research and vaccine evaluation studies funded through R01 (investigator-initiated research) grants, HIVRAD (HIV Vaccine Research and Design Program) grants, IPCAVD (Integrated Preclinical-Clinical AIDS Vaccine Development) grants, and NHP Consortium awards. The SVEUs also perform studies of candidate vaccines offered by companies or other researchers.


The SVEUs will use state-of-the-art techniques and technologies in evaluating promising AIDS prevention strategies in nonhuman primate models and will incorporate new and improved techniques and technologies into the studies conducted throughout the contract period.


This is a recompetition of existing contracts entitled "Simian Vaccine Evaluation Units (SVEUs)" (contract number HHSN266200600005C with Advanced BioScience Laboratory, Inc., Rockville, Maryland, contract number HHSN266200600006C with the University of Washington, Seattle, Washington, and contract number HHSN266200600007C with BioQual, Inc., Rockville, Maryland.


NIAID anticipates awarding two to four Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts to the organizations that best meet the overall qualifications needed to fulfill the technical requirements outlined in the Statement of Work. The base contracts will be awarded on or about May 1, 2013 for a period of 7 years, through April 30, 2020.


Offerors must be capable to perform all work in Task Areas 1: Core Activities: Administrative and Technical Support, Task Area 2: Maintenance of Nonhuman Primates, and Task Area 3: Conduct of Studies in Nonhuman Primates, or the work in Task Area 4: Operation of a Nonhuman Primate Breeding Colony.


Offerors should be capable of maintaining full and continuous accreditation of animal facilities by AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) [http://www.aaalac.org/accreditation/index.cfm], Office of Laboratory Animal Welfare (OLAW) Assurance [http://grants.nih.gov/grants/olaw/olaw.htm], and compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, including environmental enrichment http://grants.nih.gov/grants/olaw/references/phspol.htm.


In addition, offerors must have the capability to house from 200 to 400 nonhuman primates undergoing study in BSL-2/3 facilities (a BSL-2 facility with BSL-3 controls) for both Simian immunodeficiency virus and Simian Human immunodeficiency virus (SIV/SHIV) infected animals. In addition, offerors must demonstrate the capability to house 20-100 nonhuman primates being held for study in BSL 2 facilities (as described http://www.cdc,giv/biosafety/publications/bmb15/).


Facilities requirements for Task Area 2 include BSL-2 and BSL-2/3 housing (including quarantine space) to accommodate nonhuman primates owned by the Government but not yet ready or needed for studies. For Task Area 3, BSL-2/3 facilities (including quarantine space) will be required for performance of studies.


Facilities requirements for Task Area 4 include small group housing to accommodate a maximum of 550 nonhuman primates over the 7 year period.


Below is a general description of the Task Areas:


Task Area 1 - Core Activities: Administrative and Technical Support: Under this Task Area the Contractor shall support work that will be performed on a regular, on-going basis including (i) general administration and financial management; (ii) project planning (iii) coordination of activities across all nonhuman primate activities awarded to an SVEU unit under Task Areas 2 and 3; (iv) receipt, storage and shipment of vaccines, virus stocks, study samples including cells, tissues, mucosal secretions, blood, sera, and plasma; (v) reporting and maintenance of data; and (vi) transition activities.


Task Area 2 - Maintenance of Nonhuman Primates: Under this Task Area the Contractor shall provide support to obtain, transport, quarantine, house, care and maintain nonhuman primates that are not yet on study under Task Area 3.


Task Area 3 - Conduct of Studies in Nonhuman Primates: Under this Task Area the Contractor shall (i) initiate Contracting Officer Representative (COR)-approved studies; (ii) obtain, transport, and provide for quarantine of nonhuman primates for specific studies, as needed; (iii) provide housing, care and maintenance of nonhuman primates; and (iv) conduct studies as described in the scope of the Task Orders. Studies under this Task Area may include:


• immunogenicity and/or efficacy of candidate vaccines such as larger-scale studies of vaccines that have already demonstrated promise in nonhuman primates and immunogenicity testing of candidate HIV vaccines (or immunogenicity and efficacy of SIV vaccines which parallel HIV vaccines in approach) in anticipation of Phase I human clinical trials;
• in vivo titrations of virus stocks and infection of nonhuman primates to generate or evaluate virus stocks;
• route of immunization or route of infection, or other preliminary studies needed for subsequent vaccine study;
• efficacy of passively administered antibodies, microbicides, and other anti-viral substances;
• pilot studies of antiviral drugs and/or immunotherapy regimens;
• pilot studies of new vaccines;
• comparative studies of vaccines and/or adjuvants from multiple sources; and
• studies with topically administered microbicides or other antiviral substances to block infection of non-human primates with virus administered vaginally or by other mucosal routes.


Task Area 4 - Operation of a Nonhuman Primate Breeding Colony: Under this Task Area, the Contractor shall provide support for the operation and maintenance of a Specific Pathogen, Free (SPF) Indian-origin Rhesus macaque (Macaca mulatta) breeding colony dedicated to the support of NIAID research studies primarily conducted under the SVEU.


Immediately upon award of the base contract, the Government intends to award Task Orders in Task Area 1, Core Activities: Administrative and Technical Support, Task Area 2, Maintenance of Nonhuman Primates, Task Area 3, Conduct of Studies in Nonhuman Primates and Task Area 4, Operation of a Nonhuman Primate Breeding Colony.


Task Area 1, Core Activities: Administrative and Technical Support:


• Up to three Task Orders will be awarded as term/level of effort type Task Order for a period of 1 year with options to extend the period of the Task Orders on an annual basis for a maximum period of performance of 7 years. It is anticipated that up to 3 Task Orders will be issued to up to 3 separate contractors. The performance requirement will be the delivery of 1.30 full time equivalents per year.


Task Area 2, Maintenance of Non-human Primates:


• Up to three (3) Task Orders will be issued for maintenance of 20 nonhuman primates in BSL2/3 facilities. These Task Orders will be awarded as severable term form Task Order including a performance requirement for delivery of 0.27 full time equivalents (FTEs) plus 7,300 animal days (20 nonhuman primates for 365 days) per per year. The Task Orders will be awarded for a 1 year period with options to extend the period of the Task Orders annually for a maximum performance period of 7 years. In addition, options to purchase additional animals when existing nonhuman primates supported by this Task are used for studies conducted under Task Area 3 will be included in the Task Order. The purpose of the Options is to replenish the number of nonhuman primates in order to keep availability of the nonhuman primates at 20 on a continual basis. If an option is exercised, the contractor shall be required to purchase five (5) nonhuman primates. These options may be exercised up to five (5) times per year. It is anticipated that up to 3 Task Orders will be issued to up to 3 separate contractors.


• One (1) Task Order will be issued for maintenance of 50 nonhuman primates in a BSL2 facility. This Task Order will be awarded as severable term form Task Order including a performance requirement for delivery of 0.05 FTE plus 18,250 animal days (50 nonhuman primates for 365 days) per year. The Task Order will be awarded for a 1 year period with options to extend the Task Order annually for a maximum performance period of 3 years. It is anticipated that 1 Task Order will be issued to 1 contractor.


• Future Task Orders will be issued as the need for maintenance of additional nonhuman primates arises.


Task Area 3, Conduct of Studies in Non-human Primates


• Five (5) Task Orders will be awarded for the completion of monitoring/follow-up studies of previously challenged nonhuman primates. These Task Orders will be awarded as nonseverable completion form Task Order including a performance requirement for completion of the monitoring/follow-up studies and submission of a final study report. These studies will have a period of performance of approximately 6 to 12 months each. It is anticipated that 5 Task Orders will be issued to up to 3 separate contractors.


• In addition, it is anticipated that six (6) to twelve (12) Task Orders will be issued per year for Task Area 3, Conduct of Studies in Nonhuman Primates, as nonseverable completion form Task Order with a performance requirement for completion of studies and delivery of a final study report.


Task Area 4, Operation of a Nonhuman Primate Breeding Colony


• One (1) Task Order will be issued to provide support for appropriate housing, care and maintenance of 550 SPF non-human primates per year including breeding harems to achieve a production rate of 60-100 live births per year. This Task Order will be awarded as a severable term form Task Order including a performance requirement for delivery of 0.50 FTEs and 200,750 animal days per year (550 nonhuman primates for 365 days). The Task Order will be awarded for a 1 year period with options to extend the Task Order annually for a maximum performance period of 7 years. It is anticipated that 1 Task Order will be issued to 1 contractor.


Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically on/about June 4, 2012, and may be accessed through Federal Business Opportunities website: http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

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Solicitation 1

Type:
Solicitation
Posted Date:
June 6, 2012
Description: Please find solicitation package attached

Amendment 1

Type:
Mod/Amendment
Posted Date:
July 24, 2012
Amendment 1.pdf (280.70 Kb)
Description: The purpose of this amendment is to: 1) answer questions from potential offerors regarding the solicitation; 2) to revise Attachment 1, Packaging and Delivery of the Proposal to revise the page limitation; 3) to modify Attachment 2: Proposal Intent Response Sheet to change the due date for Proposal Intent Response Sheets; 4) to set a suggested deadline for submission of questions; and 5) to amend several Attachments to correct typographical errors in the referenced Attachment Numbers and to make changes as a result of questions from potential offerors. The revised Attachments include Attachment 3: Statement of Work for the Base Contract, Attachment 13, Statement of Work for Sample Task Order #003-7, Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Stock Generation and in vivo Titration, revise Attachment 14, Sample Statement of Work For Task Order #003-8, Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, and Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions.

Amendment 2

Type:
Mod/Amendment
Posted Date:
August 2, 2012
Description: The purpose of this amendment is to answer questions from potential offerors regarding the solicitation.

Amendment 3

Type:
Mod/Amendment
Posted Date:
August 15, 2012
Amendment 3.pdf (231.86 Kb)
Description: The purpose of this amendment is to:
1) Revise the titles and scope of Attachment 7, Statement of Work for Task Order #003-1,
Attachment 8, Statement of Work for Task Order #003-2, and Attachment 9, Statement of
Work for Task Order #003-3, to clarify that the scope of each Task Order is to reimmunize
and challenge nonhuman primates which are separate non-severable tasks (revised
Attachments 7, 8 and 9);
2) Revise Attachment 16: Additional Technical Proposal Instructions, Format for
Technical Proposal, and Table of Contents, Technical Proposal – Table of Contents
section, the paragraph entitled Task Area 3, Conduct of Studies in Nonhuman Primates,
to reduce the number of Task Orders to be issued upon award from 5 to 4 and to clarify
that the purpose of the four Task Orders is for reimmunization and challenge studies;
3) Revise Attachment 17: Additional Business Proposal Instructions and Uniform Cost
Assumptions, Section 3 – Uniform Cost Assumptions, paragraph 1, Technical Cost
Assumptions, the paragraph entitled Task Area 3, Conduct of Studies in Nonhuman
Primates, to reduce the number of Task Orders to be issued upon award from 5 to 4 and
to clarify that the purpose of the four Task Orders is for reimmunization and challenge
studies. Paragraph d, is revised to change the title to “Task Order for Reimmunization
and Challenge of Nonhuman Primates”. Paragraph d.1, the title is revised to read “Task
AMENDMENT #3, RFP NIAID‐DAIDS‐NIHAI2012138 2
Order for reimmunization and challenge of animals for Protocol #P160 and #P162 Cost
Assumptions”. Paragraph d.2., the title is revised to read “Task Order for
reimmunization and challenge of animals for Protocol #P165 (GeoVax DNA/MVA) Cost
Assumptions”. Paragraph d.3., the title is revised to read ““Task Order for
reimmunization and challenge of animals for Protocol #P168 (NYVAC/ALVAC) Cost
Assumptions”. Paragraph d.4., “Task Order for follow-up of animals for Protocol #P173
Cost Assumptions” is deleted in its entirety; and,
4) Delete in its entirety Attachment 10: Statement of Work for Task Order #003-4, [TASK
AREA 3: CONDUCT OF STUDIES IN NONHUMAN PRIMATES: CONTINUATION OF STUDY
#P173]. Attachment 10 will not be replaced and the remaining Attachments will not be
renumbered.
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Office of Acquisitions
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Callie Prassinos
Phone: 3014960612
Fax: 3014804675
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Michelle L. Scala,
Contracting Officer
Phone: 3014960612
Fax: 3014804675