Funding-IN
VITRO ASSESSMENTS FOR ANTIMICROBIAL ACTIVITY; January 22, 2010
Agency
Department of Health and Human Services
Description
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's Division of Microbiology and Infectious Diseases (DMID)
has a requirement for developing and providing in vitro assays in order to
advance the development of therapeutics for infectious diseases.
Description
NIAID's role in developing medical products to counter emerging, re-emerging
and other infectious diseases, as well as agents of bioterrorism, is part of a
larger national strategy, involving multiple governmental agencies. As such,
NIAID supports integrated efforts in basic and applied research, product
development, and technology development based on national priorities for
medical products. Since 2001, NIAID has established a comprehensive
infrastructure with extensive resources that support all levels of biodefense research. With this solid framework of research
and product development resources for biodefense in
place, NIAID is now transitioning this infrastructure to provide the
flexibility required to meet the challenges of emerging, re-emerging and other
infectious diseases in addition to biodefense.
The use of in vitro assays helps advance our
understanding of infectious diseases as well as the development of therapeutics
and vaccines. Therefore, DMID is committed to developing and providing in vitro
assays to benefit the research community and public health.
For the most part, in vitro assay services
and other research resources are currently provided through multiple,
specialized programs. DMID now seeks to adopt an integrated approach to the
provision of services and resources by creating unified, comprehensive,
coordinated programs. This strategy is being employed to: advance science by
promoting cross-fertilization across and within disciplines and approaches;
serve the research community more conveniently; achieve efficient use of
resources through economy of scale and avoidance of duplication; and provide
the flexibility needed to respond to changing priorities. Accordingly, DMID is
establishing the In Vitro Assessments for Antimicrobial Activity program, which
will utilize the Indefinite Delivery, Indefinite Quantity (IDIQ) contract
mechanism.
Under IDIQ contracts, base contract awards
are made to multiple offerors that successfully
propose a general approach to the technical requirements of the solicitation,
providing a guaranteed minimum award. Task Orders for specific tasks requiring
specialized expertise are competitively solicited and funded within the program
Contractor pool. DMID is replacing multiple pathogen or class specific
solicitations with one broad IDIQ solicitation for multiple contracts to cover
all areas of current and potential future interests.
The work under this acquisition has been
broken into five Parts. Work under Parts A, B and D require Biosafety
Levels (BSL) 1 through 3, and compliance with Select Agent Regulations through
the Centers for Disease Control (CDC) and/or the United States Department of
Agriculture (USDA) (42 CFR Part 73, 7 CFR Part 331, and/or 9 CFR Part 121). For
offerors submitting proposals for more than one Part,
separate Technical and Business Proposals are required for each Part. Offerors may not submit more than one proposal per Part A,
B, C, D or E.
1. Part A - Bacteria and Fungi - Will support
the development and use of in vitro assays for routine screening of products
against a wide range of bacterial and fungal pathogens, to include all bacteria
and fungi on the NIAID Category A, B and C Priority Pathogens list (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm)
and other bacterial and fungal pathogens that cause disease in humans.
2. Part B - Viruses - Will support the
development and use of in vitro assays for routine screening products against a
wide range of viral pathogens, to include all viruses on the NIAID Category A,
B and C Priority Pathogens list, and other viral pathogens that cause disease
in humans.
3. Part C - Parasites and Vectors - Will
support the development and use of in vitro assays for routine screening of
products against a wide range of parasitic pathogens, to include all parasites
and vectors on the NIAID Category A, B and C Priority Pathogens list, and other
parasitic pathogens that cause disease in humans. This Part also includes
screening against cell lines from insect and other arthropod vectors.
4. Part D - Toxins - Will support the
development and use of in vitro assays for routine screening of products
against a wide range of toxins, to include all toxins on the NIAID Category A,
B, and C Priority Pathogens list.
5. Part E - Central Data Management System -
Will support the development, implementation, operation, and maintenance of a
Central Data Management System to support all activities conducted under Parts
A, B, C and D. In order to qualify for work under Part E, Contractors must also
qualify for one or more of Parts A-D. Offerors
submitting a proposal under Parts A, B, C and/or D DO NOT have to submit a
proposal for Part E.
For the purposes of this acquisition:
• Assays - in vitro procedures for determining the concentration, purity,
and/or biological activity of a substance by measuring its effect on an organism,
tissue, cell, enzyme or receptor preparation.
• Products - broadly defined and include therapeutic substances targeting the
host or the pathogen.
• Pathogens - bacteria, viruses, parasites, toxins and fungi, including NIAID
Category A, B and C Priority Pathogens.
• Toxins - microbial toxins as they relate to human disease,
and other toxins on the NIAID Category A, B and C Priority Pathogens list (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm).
• Vectors - insects or other arthropods that carry pathogens from infected to
uninfected hosts.
• Pathogens of interest - must be pathogens which cause disease in humans;
however surrogate human pathogens may be used for diseases where human
pathogens cannot be studied.
• Reagents - biochemical, genomic, molecular, cellular, and immunologic
materials integral to research on these pathogens, toxins and vectors.
The following factors will be considered when
evaluating proposals:
• adequacy and appropriateness of the general technical approach for in vitro
assays, to include protocol and assay development, conduct of product
susceptibility studies; soundness, feasibility and completeness of the
technical approach to pathogen production and characterization.
• adequacy, appropriateness and relevance of
expertise, experience, qualifications, and availability of the key professional
and technical staff with a project of similar size, scope, and complexity.
• availability of adequate, accredited facilities, with biocontainment
appropriate for the pathogens proposed; availability and appropriateness of
equipment and other resources necessary for the proposed in vitro assays
including IT systems, data management, and capabilities for the receipt,
storage, shipping and inventory of products, pathogens, specimens, and
reagents; and adequacy of institutional biosafety
program.
It is anticipated that multiple IDIQ base
contracts will be awarded for a 7-year period of performance beginning on or
about September 10, 2010.
Any responsible offeror
may submit a proposal which will be considered by the Agency. This RFP will be
available electronically on/about September 18, 2009, 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.
Announcement Number: NIAID-DMID-NIHAI2009066
Closing Date:
Jan
22, 2010 4:00 pm Eastern
Link to Full Announcement
Contact Information
Harry L Brubaker,
Contract Specialist
Phone: 301-496-0612
Fax: 301-480-4675
Yvette R Brown,
Contracting Officer
Phone: 301-496-0612
Fax: 301-480-4675