United States - AIDS Reagent Program

Description

Added: Jun 04, 2019 10:38 am

Anticipated Period of Performance
The anticipated period of performance is October 15, 2019 through January 14, 2021, with 2 term options to extend services for an additional 15 months period, starting on October 15, 2019, through January 14, 2021 (if all term options are exercised) as follows:

Term Option from October 15, 2019 through October 14, 2020.
Term Option form October 15, 2020 through January 14, 2021.
Anticipated award date: October 15, 2019
The NAICS Code is 541715 with a size standard of 1,000 employees.
 
Introduction
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports the identification, acquisition, production, maintenance, characterization, authentication, and distribution of quality-assured, state-of-the-art biological and chemical reagents to the HIV research community of investigators with the purpose of advancing HIV/AIDS research, which is a high priority for NIH and NIAID. Furthermore, the contract provides support for technology transfer and execution of material transfer agreements prior to release of reagents to the community, and transition activities.
Since the establishment of the AIDS Reagent Program (ARP), it has evolved from a small bank of research materials to a unique and versatile worldwide resource, offering over 10,000 critical reagents not otherwise readily available to the HIV research community. The ARP acquires, stores, develops, and produces state-of-the-art reagents and provides these reagents at no cost to over 3,200 qualified investigators located in 65 countries throughout the world. Most of these reagents were donated by individual researchers or organizations for the purposes of sharing with the research community, as required by NIH Grants Policy. Additionally, the ARP serves as an important resource for information about HIV-related reagents and disseminates this information through its comprehensive website.
In order to provide support services as mentioned above, an unrestricted competition was held, which resulted in the award of a Cost-Plus-Fixed Fee, term form contract with term and quantity options, to Fisher BioServices, Inc., 14665 Rothgeb Drive, Rockville, Maryland 20850. The award was made on July 15, 2012, with term options to extend the period of performance, for a total period of seven years, through July 14, 2019, and quantity options for increased level of effort for unanticipated increases in demand. The total value of the contract was $25,288,024 including the Base Period and all Options.
Description
This is an acquisition for the services described herein for a period of 15 months and to deliver to the Government 23,994 direct labor hours during this period. The anticipated period of performance is October 15, 2019 through January 14, 2021, with 2 term options as follows:
Term Option from October 15, 2019 through October 14, 2020 and Term Option from October 15, 2020 through January 14, 2021.
Project requirements:
Specifically, the Contractor will be responsible for:
1. Acquisition, procurement, maintenance, production, and expansion of HIV-related biological and chemical reagents
2. Providing a system for user registration and rapid order processing, packaging, and shipping of HIV-related reagents to the research community in the U.S. and other countries, in compliance with required shipping regulations, permits and authorizations as well as following reagent-specific GLP or GMP shipping requirements, for the purpose of advancing basic and preclinical HIV research
3. Supporting authentication and characterization of biological and chemical reagents following quality control and quality assurance procedures
4. Supporting technology transfer and execution of material transfer agreements prior to release of reagents to the community
5. Establishing and implementing a process for receipt, processing, inventory placement, and storage of each reagent, and maintaining detailed records for each reagent in the inventory
6. Maintaining an internal searchable database consisting of a detailed inventory of reagents, ordering and shipping information, and registered users
7. Maintaining a public searchable website to allow requests for user registration and online ordering of reagents
8. Initial and final transition activities, including transfer of stored reagents and materials, data files and software systems related to program activities, communications and correspondence files, and government furnished property.
Examples of the range of reagents to be procured, acquired, authenticated, produced, and/or expanded include:
• Infectious viruses, including HIV and related viruses
• Other infectious agents and pathogens including NIAID Category A-C Priority Pathogens that require BSL-2/3 facilities. NOTE: work that requires BSL-4 level facilities will not be supported.
• Uninfected and/or infected cell lines including genetically manipulated prokaryotic/eukaryotic cell lines
• Plasmid DNA clones, including HIV proviral clones
• Body fluids, tissues, cells, and cell lysates
• DNA and RNA oligonucleotides
• Proteins and synthetic peptides
• Monoclonal and polyclonal antibodies
• Antiviral and anti-infective compounds and natural products, including approved drugs
• Chemicals, including small molecule libraries
• Agents that monitor and modulate the immune system
• Vaccines, vaccine candidates, and vaccine adjuvants
• Diagnostic tools and kits for detection and measurement of pathogens
(A complete catalog of the current reagent offerings can be found on the ARP website: www.aidsreagent.org.)
The NIAID intends to negotiate, under the authority of FAR Part 6.302-1 and HHSAR Part 306.302-1, on a sole source basis with Fisher BioServices, Inc., to modify the existing contract to provide additional level of effort to deliver to the Government 23,994 direct labor hours from October 15, 2019 through January 14, 2021 as follows:

• Term Option (19,195 direct labor hours) beginning October 15, 2019 through October 14, 2020
• Term Option (4,799 direct labor hours) beginning October 15, 2020 through January 14, 2021
The ARP must be continued and the current contractor, Fisher BioServices, Inc. (Fisher) is in a unique position to take this work on, for the following reasons:
• Fisher has been operating this resource with consistent performance since its inception and has historical knowledge about the inventory of over 13,000 reagents that cannot be found elsewhere. This knowledge is only partially captured in available database files, and it will take significant time to organize and document relevant information to allow another contractor to carry out the Government's requirements; this will be impossible under the current timeline.
• Over the past 30 years, Fisher has negotiated with thousands of donors and vendors to acquire and distribute critical HIV/AIDS reagents and execute technology transfer agreements to protect intellectual property. Requiring another contractor to renegotiate these donor agreements would be impossible under the current timeline.
• Fisher previously implemented several additional cost-saving measures for shipping that could not be duplicated under the current timeline.
• Fisher has established registered user agreements for more than 3,000 individuals worldwide that are not transferrable to a new contractor. Requiring another contractor to establish new user agreements would be impossible under the current timeline.
• Fisher has established functional relationships and effective communication pathways with thousands of internal and external stakeholders to establish processes and Standard Operating Procedures (SOPs) that are critical to meeting the Government's needs. Requiring another contractor to establish new communication pathways would be impossible under the current timeline.
• Fisher has a completely trained staff available immediately with already established processes and Standard Operating Procedures (SOPs) in place, thus minimizing both cost and time impact that would be required if a new contractor had to develop new processes and SOPs, and train staff on the new processes. There would be a highly negative business and time impact to the Government if a new contractor had to be integrated, requiring several additional months of new communications required to introduce a new entity to this extensive and complex resource to meet the compressed current timeline.
• NIAID's requirement is urgent and interruption in services would be detrimental to the AIDS Reagent Program. There will be a significant loss to the research community if the ARP were to come to a halt and reagents are suddenly not available to complete work funded by grants and contract from NIH and other federal and international agencies. Fisher is capable of meeting the Government's need within the compressed time period.
This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement. All capability statements received within fifteen days from the date of the publication of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
This proposed acquisition was previously published under a Research and Development Sources Sought Notice that was posted on the Federal Business Opportunities website on May 10, 2019 as notice number HHS-NIH-NIAID-RDSS-75N93019R00016.

Opportunity closing date

19 June 2019

Value of contract

to be confirmed