SOURCES SOUGHT
B -- CDC International Reagent Resource (IRR)
- Notice Date
- 4/18/2018
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2018-N-67801
- Archive Date
- 5/18/2018
- Point of Contact
- Liubov A. Kriel, Phone: 7704882856
- E-Mail Address
-
vyh1@cdc.gov
(vyh1@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction. This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NACIS code for this acquisition is 541990, All Other Professional, Scientific, and Technical Services with a size standard of $15M. Background. The National Center for Immunization and Respiratory Diseases (NCIRD) prevents disease, disability, and death through immunization and by control of respiratory and related diseases. In carrying out its mission, NCIRD: (1) provides leadership, expertise, and service in laboratory and epidemiological sciences, and in immunization program delivery; (2) conducts applied research on disease prevention and control; (3) translates research findings into public health policies and practices; (4) provides diagnostic and reference laboratory services to relevant partners; (5) conducts surveillance and research to determine disease distribution, determinants, and burden nationally and internationally; (6) responds to disease outbreaks domestically and abroad; (7) ensures that public health decisions are made objectively and based upon the highest quality of scientific data; (8) provides technical expertise, education, and training to domestic and international partners; (9) provides leadership to internal and external partners for establishing and maintaining immunization, and other prevention and control programs; (10) develops, implements, and evaluates domestic and international public health policies; (11) communicates information to increase awareness, knowledge, and understanding of public health issues domestically and internationally, and to promote effective immunization programs; (12) aligns the national center focus with the overall strategic goals of CDC; (13) synchronizes all aspects of CDC's pandemic influenza preparedness and response from strategy through implementation and evaluation; and (14) implements, coordinates, and evaluates programs across NCIRD, Office of Infectious Diseases (OID), and CDC to optimize public health impact. The National Strategy for Pandemic Influenza, issued by President Bush on November 1, 2005, has guided our nation's preparedness and response to an influenza pandemic with the intent of (1) stopping, slowing or otherwise limiting the spread of a pandemic to the United States; (2) limiting the domestic spread of a pandemic, and mitigating disease, suffering and death; and (3) sustaining infrastructure and mitigating impact to the economy and the functioning of society. Further guidance was provided in "The Implementation Plan for the National Strategy," which identified more than 300 actions for Federal departments and agencies and set clear expectations for state and local governments and other non-federal entities. It also provided guidance for all federal departments and agencies on the development of their own plans. The U.S. Department of Health and Human Services (DHHS) was charged with leading the federal pandemic preparedness, with the Centers for Disease Control and Prevention (CDC) charged with responsibility for detecting the onset of outbreaks with influenza pandemic potential, assisting with the containment of such outbreaks, delaying the introduction and transmission of pandemic viruses in the United States, and assisting State, Local and Territorial (SLTT) health authorities in the management of an influenza pandemic event. Based on these guidelines, CDC's Influenza Division sponsored the "CDC Influenza Reagent Contract (CDC-IRR)", which was a ten year contract designed to provide laboratory support to public health professionals as necessary to minimize the impact of an influenza pandemic on the health of Americans. More specifically, the CDC-IRR Contract served (a) to ensure that adequate stocks of influenza viruses, positive controls, kits, proficiency panels and other research materials were available on a routine basis to CDC and other partner researchers in order to adequately characterize circulating seasonal and novel viruses and (b) ensure the ability to quickly ramp up production and distribution activities to surge levels in the event of a pandemic or public health emergency. Based on the success of the CDC Influenza Reagent Resource Contract, currently in the ninth year of its ten year term, its collaboration with Global Health Security Agenda (GHSA), and recent success of CDC's response to the zika virus outbreak, during which CDC and CDC-partner GHSA and zika researchers benefitted from availability of reagents and research materials common and/or similar to those being made available to influenza researchers under the CDC-IRR Contract, NCIRD has determined that it would be beneficial to the public health, and appropriate under this new contract, to expand the scope of the IRR Contract beyond influenza to include additional bacterial and viral pathogens that are within the scope of its mission, including non-influenza respiratory viruses and bacteria. This contract is a critical component of CDC's efforts to ensure the availability of quality reference pathogens and other reagents to CDC and partner researchers for public health responses and also serves to enhance the CDC's ability to provide on-site technical assistance to state and local public health laboratories and commercial developers of vaccines, antiviral drugs, and diagnostic tests; in support of our common goal to minimize the impact of bacterial, viral, and respiratory diseases on the health of Americans. Purpose and Objectives. The primary objectives of this contract are: 1. to produce quality stocks of NCIRD reference viruses, bacteria, positive controls, detection kits, proficiency panels and other similar type surveillance and research reagents; 2. to ensure that these reagents, and any others critical to the performance of surveillance and other public health-related laboratory activities, are available to the CDC, its public health laboratory partners, and researchers and developers for characterization of circulating and novel viruses and bacteria; 3. to ensure the ability to ramp up acquisition, production, and distribution activities to surge levels as may be needed to meet the needs of a public health emergency. Special Notes: a. Similar work was previously provided by American Type Culture Collection under CDC Contract 200-2008-28045. b. This is a cost reimbursement requirements type contract with options which will be funded annually to meet anticipated routine needs of the government. A list of all reagents that shall be produced or acquired for inclusion with the IRR catalog during each year of the contract's performance will be provided at the soliciation stage. Additional funding could be made available to meet anticipated surge requirements (Surge Options I, II, III) of the contract. c. Deliverables: Contractor inventories shall be fully stocked by the end of Year 1, and maintained thereafter in accordance with current government priorities. The contractor's reagent catalog composition and inventory levels shall be reviewed on at least an annual basis as part of their acquisition, production, and inventory management plans, and may be adjusted as required to meet the current anticipated needs of the program. d. Surge Options I, II, and III: Surge options provide for 25%, 50% and 75% increases above the basic award. In the event that surge options are exercised in response to a public health emergency, the government may require expedited delivery of surge quantities as may be needed to meet an imminent threat to public health. Project Requirements. The contractor will produce or otherwise acquire, characterize, store and distribute CDC-furnished NCIRD pathogens and other reagents, including ancillary reagents critical to the performance of CDC-developed assays, and associated with influenza, non-influenza respiratory viruses and bacteria, and other vaccine preventable bacterial diseases. This includes live and inactivated viruses, bacteria, nucleic acids, antisera, proteins, cell lines, hybridomas, monoclonal antibodies. The purpose of IRR reagents is to assist in characterization of viral and bacterial pathogens as part of CDC surveillance activities; to aid in the development, evaluation, validation and testing of diagnostic products; to support vaccine development; and to support other research activities that increase awareness, knowledge, and understanding of the public health issues related to these pathogens. The IRR inventory of viruses, bacteria and other reagents will be regularly updated during contract performance to ensure that the catalog reflects current circulating or novel pathogen strains relevant to the ongoing surveillance and research activities of CDC and its partner laboratories. All reagents produced by the contractor or its subcontractors shall be in accordance with the format and quality specifications as described in Quality Specifications that will be provided at the solicitation stage. These reagents will be added to the IRR's existing inventory of over 200,000 vials of viruses, antigens, antisera, cell lines, monoclonal antibodies, plasmids, and other genetic materials, and over 4,000 RT-PCR typing kits and panels. All IRR reagents will be manufactured according to a recognized national or international quality standard such as ISO 9001, US current good manufacturing practices, or comparable standards. Manufacturing batch records documenting all production processes and quality control testing for every lot shall be maintained by the contractor and available for CDC review upon request. Contract deliverables include Influenza Real-time RT-PCR kits that are regulated by the Food and Drug Administration (FDA) as in vitro diagnostic reagents. The government will perform an annual review of contractor facilities to ensure that they conform to the requirements of Food and Drug Administration's Quality System Regulations/Medical Device Good Manufacturing Practices; see 21 CFR Part 820. Upon approval from CDC, IRR reagents that have met all required quality specifications will be made available to registered persons and institutions through an electronic "storefront" website, www.internationalreagentresource.org. to be provided by the government and maintained by the contractor. The contractor will receive and process reagent order requests from the IRR website via their internal ERP system and manage all shipping logistics to recipient laboratories. In fiscal year 2016, the IRR shipped around 13,000 reagents in 1,675 shipments, 88 percent of which were to domestic states and territories. Anticipated period of performance. The period of performance will be 10 years from date of award. Other Important Considerations. To be considered for award of this contract, the technical proposal submission must demonstrate at a minimum that the offeror is USDA-approved BSL3 Enhanced; or, a USDA-approved BSL3 teamed with an USDA-approved BSL 3 Enhanced Laboratory for purposes of this acquisition. In addition, Select Agent registration is required. Capability Statement/Information Sought. PAGE LIMIT 8 PAGES. Interested offerors should submit a capability statement specifically addressing the criteria listed below ONLY. Capability statements that address requirements other than what is identified below will not be reviewed. a. Your opinion about the difficulty and or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; b. Your staff expertise, including your availability, experience, formal training, and any other training; c. Your current in house capability and capacity to perform the work; d. Your prior completed projects of a similar nature; e. Your corporate experience and management capability. Provide any examples of prior completed Government contracts, reference, and other related information. Information Submission Instructions: Please include a cover page with the following business information. The cover page does not count against the page limit for the capability statement. a. DUNS Number: b. Organization Name and Address: c. Do you have a Government-approved accounting system? If so, please identify the agency that approved this system. d. Business Size and Type of Business (e. g., small business, 8(a), woman owned, veteran owned, etc.) pursuant to the applicable NAICS code 541620, size standards which is $14 millions. e. Technical point of contact including name, title, address, telephone number, and email address of the individual(s) who can verify the demonstrated capabilities identified in the response. f. Contract's point of contact including name, title, address, telephone number, and email address. g. In your opinion, can this work fit under a GSA Schedule? If so, which GSA Schedule? Please provide the schedule number. Page Limitation: Capability Statements shall be limited to EIGHT (8) (including references, appendices, charts, illustrations, diagrams, and or resumes) single-spaced pages including cover page. Pages shall be formatted as follows: MS Word, 8 ½ x 11, 12 pitch, Times New Roman font with one (1) inch margins. Response Due Date: Submit capability statements via email to Liubov A. Kriel, Contract Specialist at vyh1@cdc.gov. Should you have any questions concerning this sources sought, please direct your questions in writing to the Contracting Specialist Liubov A. Kriel at vyh1@cdc.gov. The government will not respond to oral questions. Responses must be submitted no later than 10:00 am, Eastern Standard Time (EST) by Thursday, May 3, 2018. Capability statements will NOT be accepted after the due date. No telephonic or facsimile responses will be accepted. The Government will not provide feedback on capability statements and we will not return capability statements received. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2018-N-67801/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN04893647-W 20180420/180418230837-a37512b94b128c9e0db77237f7c68857 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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