SOLICITATION NOTICE
A -- Non-Human Primate Major Histocompatibility Complex Allele Discovery and Typing Technology Development
- Notice Date
- 2/23/2015
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- BAANIAID-DAIT-NIHAI2015033
- Archive Date
- 7/22/2015
- Point of Contact
- Anuj Patel, Phone: 240-669-5142, Liem T. Nguyen, Phone: 301-496-0612
- E-Mail Address
-
patelap2@niaid.nih.gov, lnguyen@niaid.nih.gov
(patelap2@niaid.nih.gov, lnguyen@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- ATTACHMENT 11: PRESOLICITATION NOTICE Nonhuman Primate Major Histocompatibility Complex Allele Discovery and Typing Technology Development BAA NIAID-DAIT-NIHAI2015033 Presolicitation Notice Information Introduction 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 Allergy, Immunology, and Transplantation intends to issue a Broad Agency Announcement entitled "Nonhuman Primate Major Histocompatibility Complex Allele Discovery and Typing Technology Development." Description NHPs approximate human physiology, immunology, and genetics more closely than other animals. Therefore, they are often the preferred models to: 1) evaluate the safety and efficacy of candidate vaccines against human pathogens; 2) develop and evaluate immune-based therapeutic strategies to prevent graft rejection and graft versus host disease in cell, tissue, and organ transplantation; and 3) study the pathogenesis of infectious and immune-mediated diseases and evaluate novel immune-based therapies. To support these continuing research efforts NIAID announces the re-competition of the NHP Major Histocompatibility Complex (MHC) Gene Discovery and Typing Technology Development Program. The objectives of this program are to facilitate and extend the immunological and infectious disease research conducted with these important models by providing detailed knowledge of NHP MHC and killer cell immunoglobulin-like receptor (KIR) genes, loci, and alleles through gene discovery and tissue expression studies; and by developing and providing readily accessible means or methods to genotype individual research animals for the complete set of MHC or KIR alleles, or for select alleles, for the optimum design of experiments and genetic management of colonies. The most commonly used NHP species in immunological and infectious disease research are the Old World NHPs, including the cynomolgus or long-tailed macaque (Macaca fascicularis), the rhesus macaque (Macaca mulatta), the baboon (multiple Papio species), sooty mangabey (Cercocebus atys) and the pigtail macaque (Macaca nemestrina). For purposes of this solicitation, NHP is used to denote the Old World monkey Macaca sp., unless otherwise noted. As in humans, the MHC region is the most polymorphic of the NHP genome, with a high degree of genetic diversity across the population. The MHC region includes MHC Class I and Class II genes, which encode cell surface proteins that serve a critical role in the adaptive immune response. NHP MHC Class I and Class II orthologs from Old World macaques exist for most of the human MHC genes. However, a striking difference between the human and the macaque species is that the NHP MHC Class I loci have undergone multiple duplication and expansion events resulting in a significantly greater number of expressed MHC Class I A and B genes per animal than in humans. Transcription levels of different NHP MHC Class I genes can vary widely. In addition, the numbers of MHC Class I A and B loci can differ significantly among animals within a population. The NHP MHC Class II region also has been subject to more gene duplication and expansion than its human counterpart. Studies of multiple macaque species reveal similarly increased MHC genomic complexity over that of humans and great apes. Recent progress has been made in characterizing the NHP MHC Class I and Class II region genomic organization in rhesus macaques. This knowledge of the genomic structure from multiple haplotypes and species of NHPs may help resolve the MHC organization and facilitate future gene discovery efforts. Although much progress has been made towards MHC Class I allele discovery for the Indian rhesus macaque, continued and more refined gene, locus, and allele analysis and discovery work is still needed for this and most other macaque species and subspecies. Further MHC Class II discovery efforts are also needed in these species. It is also necessary to establish allele or haplotype frequencies within individual colonies or sources (i.e., country origin) of animals used by the research community. In addition to gene discovery, studies are needed to describe differential expression of MHC genes in cells and/or tissues germane to immunology, infectious disease and transplant researchers under relevant physiological conditions, such as inflammation, or under iatrogenic conditions such as immunosuppression. In contrast to the progress made on MHC characterization in NHPs, much less is known about the related killer cell immunoglobulin-like receptors (KIR). The KIR system in NHPs is more complex than the MHC, containing more genes, more alleles, and a large degree of haplotype diversity. More detailed genetic characterization of the KIR system, including allele discovery, is important for understanding KIR/MHC interactions by researchers in the transplant and especially infectious disease communities. The inchoate state of NHP KIR databases and nomenclature remains a significant obstacle to progress in this area. An effort to standardize NHP KIR nomenclature, possibly leading to official assignment of KIR allele names, would be valuable and establish a framework for future characterization efforts. Identification of the complete set of MHC alleles present in an animal has historically required technically challenging and time- and labor-intensive methods and provided no certainty that all alleles or loci within an individual were detected. Furthermore, the availability of defined genotyping methods or resources for typing of individual alleles is quite limited compared to the large number of alleles already identified. Development of, and access to, high-throughput technologies for MHC and/or KIR allele genotyping and/or haplotype determination are required to accelerate immunological studies in NHP species. Historically, the variety of DNA-based methods have included: reference strand conformational analysis (RSCA), denaturing gradient gel electrophoresis (DGGE), sequence-specific polymerase chain reaction (PCR-SSP), sequence-specific oligonucleotide probes (SSOP) and MHC-linked microsatellites, or short tandem repeats (STRs). The level and accuracy of information provided and the potential limitations differ by technique. A variety of DNA-based technologies is required for the diverse needs of the NHP research community, including methods for specific allele genotyping, haplotyping, and complete MHC and/or KIR genotyping. Affordable methods that are easily upgraded as new allelic or haplotype information becomes available are needed. For those methods not provided through resource services, they need to be relatively high-throughput and easily translatable to laboratories conducting NHP research. Recent advances have been made by the previous awardees to refine and streamline NHP MHC genotyping, and the continued evolution of sequencing technology will allow for further improvements. This solicitation to re-compete the NHP MHC Gene Discovery and Typing Development Program will continue and expand upon the initial program goals to advance the detailed knowledge base of NHP MHC genetic loci, alleles, and haplotypes, and their frequencies; expand discovery and characterization of NHP KIR genes, alleles, haplotypes, and frequencies; and develop robust, high-throughput genotyping and haplotyping methods. Offers submitted in response to this BAA must present detailed technical and business proposals designed to meet the Research and Technical Objectives described. The Statement of Work, including the specific technical requirements and performance specifications, is developed and proposed by the offeror, not the Government. Proposals are NOT evaluated against each other since they are not submitted in accordance with a common Statement of Work issued by the Government. Instead, Research and Technical Objectives are provided in the BAA that describe the research areas in which the Government is interested. Proposals received in response to the BAA are evaluated in accordance with Evaluation Factors for Award specified in Section M. The NIAID will assess whether the work proposed should be redirected, removed, and/or whether schedule or budget adjustments should be made. As a result, during discussions with offerors, the NIAID reserves the right to modify or delete proposed milestones, decision points, research plans, process, schedule, budget or product. The selection of proposals for award is based upon the evaluation factors, importance to the agency programs (programmatic balance), and fund availability. It is anticipated that one to two cost reimbursement, completion type contracts will be awarded for a five (5)-year period of performance beginning on or about April 1, 2016. NIAID estimates that the average annual total cost (direct and indirect costs combined) is $1.0M for all contract awards made under this announcement. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed five (5) years. Any responsible offeror may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about March 4, 2015, and may be accessed through FedBizOpps 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. For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."
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