SOURCES SOUGHT
99 -- BARDA Biological Animal Model and MCM Development
- Notice Date
- 12/1/2021 11:37:00 AM
- Notice Type
- Sources Sought
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- BARDA - ASPR / DAAPPO / BARDA DCMA WASHINGTON DC 20515 USA
- ZIP Code
- 20515
- Solicitation Number
- 75A50122R00008
- Response Due
- 12/16/2021 11:00:00 AM
- Archive Date
- 12/31/2021
- Point of Contact
- Andrew Sargeant, Phone: 202-868-0048, Jeffrey Brown, Phone: 202-730-8662
- E-Mail Address
-
andrew.sargeant@hhs.gov, jeffrey.brown@hhs.gov
(andrew.sargeant@hhs.gov, jeffrey.brown@hhs.gov)
- Description
- 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 theNorth 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. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Together with our industry partners, BARDA promotes the advanced development of medical countermeasures (MCM) to protect Americans and respond to 21st century health security threats. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) MCM Review (2010) recommended that PHEMCE partners provide not only financial help to medical countermeasure developers but also technical and regulatory assistance. BARDA�s Strategic Plan (2011) set a goal to provide assistance to developers through core assistance programs in critical areas including nonclinical and clinical services to obtain safety and efficacy data supporting MCM development. In May 2011, BARDA awarded multiple contracts using the Indefinite Delivery, Indefinite Quantity (IDIQ) contract mechanism to establish a Nonclinical Development Network in support of the chemical, biological, radiological, and nuclear countermeasures in BARDA's portfolio. The primary goals of the program were to 1) develop well-characterized nonclinical models of infection and/or exposure to priority CBRN threats and ensure these models meet the regulatory requirements supporting MCM product development under the Food & Drug Administration (FDA) Animal Rule; 2) develop, qualify, and validate assays to monitor responses and bridge animal data to humans; and 3) design and conduct adequate and well-controlled animal efficacy and/or immunogenicity studies intended to provide the primary evidence of effectiveness of candidate MCMs. In 2015 and 2016, the Nonclinical Development Network was expanded, and distinct networks were established addressing chemical agent threats, radiologic and nuclear agent threats, and biological agent threats, respectively.�Since 2011, over 100 task orders were issued across these threat area networks. At the time of this solicitation, the BARDA Chemical Agent Nonclinical Network and Radiological/Nuclear Agent Network are each being recompeted individually for new five-year IDIQ contracts. To meet the demands for MCM development and support an ever-increasing need for nonclinical services including those required to address 21st Century Threats and BARDA�s innovation activities, this solicitation seeks to establish a Nonclinical Services Network of laboratories providing expertise, capacity, and program management across three capability areas: Capability Area 1:�������� Animal Model Development and MCM Testing (Biological Agents) Capability Area 2:�������� Analytical Method Development, Qualification, Validation, and Testing Capability Area 3:�������� Safety and Toxicity Testing BARDA anticipates awarding multiple IDIQ contracts that provide a guaranteed minimum award to the organizations or consortiums that meet the overall qualifications needed to fulfill the technical requirements of this solicitation for each capability area.�Sample Task Orders are provided in the RFP solely to evaluate Offerors� responses and capabilities. Responses for Task Order Requests (RTORs) for specific tasks will be issued after award of the Parent Contract. Written capability statements should demonstrate your organization�s in house ability and related experience in all of the following technical requirements for the animal models to be developed under this requirement as listed below:� � � i. Describe the laboratory�s capabilities and experience with small and large animal model development for biological agents and addressing essential elements of animal models in accordance�to�the FDA Animal Rule.� ii. Document the laboratory�s experience with various biological agents, levels of biocontainment available to USG, and capability to deliver these agents via various routes of administration (i.e.�aerosol, IM, IV, etc.)� iii. Describe the laboratory�s approach to the design and conduct of adequate and well-controlled efficacy studies in animals in accordance�to�the FDA Animal Rule including supportive subject matter expert, analytical, and statistical efforts to assure objectives are met.� iv. Describe laboratory�s capability and experience with providing fit for purpose animal model and efficacy data and study reports to sponsors and/or FDA regulators including documents and data compliant with FDA-required formats and standards.� Contract Type and Anticipated Period of Performance The Government anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards under the future solicitation�with the eventual contract being administered and funded via Task Orders (TO). The Government anticipates awards will be made in the third quarter of FY2022. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN 2:00 PM. EASTERN STANDARD TIME (EST), THURSDAY, DECEMBER 16, 2021, to Andrew Sargeant, Contracting Specialist�at andrew.sargeant@hhs.gov.� 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
-
SAM.gov Permalink
(https://beta.sam.gov/opp/104f3cb9b4ba419ca0a031968f50d58e/view)
- Record
- SN06189186-F 20211203/211201230119 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |