Inactive

General Information: Document Type: Sources Sought (FDA-SSN-12022022) Release Date: December 2, 2022 Response Date: December 09, 2022 at 3.00 P.M. EST via e-mail to Ian.Weiss@fda.hhs.gov Contract Info... General Information: Document Type: Sources Sought (FDA-SSN-12022022) Release Date: December 2, 2022 Response Date: December 09, 2022 at 3.00 P.M. EST via e-mail to Ian.Weiss@fda.hhs.gov Contract Information: Ian Weiss Contract Specialist Office of Acquisition and Grants Services U.S. Food and Drug Administration Tel: 301-796-5728 Email: Ian.Weiss@fda.hhs.gov Description: CANNABIS-DERIVED PRODUCT DATA AND RELATED SERVICES 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, 541715, Research And Development In The Physical, Engineering, And Life Sciences (Except Nanotechnology And Biotechnology) (1,000 employees). 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. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** Background Implementation of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) resulted in removal of hemp from the definition of marijuana in the Controlled Substance Act (CSA). As a result, cannabis plants and derivatives containing no more than 0.3% delta-9-tetrahydrocannabinol (THC) on a dry weight basis would no longer fall under the purview of the CSA. Since the 2018 Farm Bill enactment, both the availability of and demand for cannabis-derived products (CDPs) have surged, prompting the FDA’s Cannabis Product Committee (CPC) to identify critical needs to address the Agency’s evidence gaps in the Cannabis-Derived Products Data Acceleration Plan (DAP) (available at this link: https://www.fda.gov/news-events/public-health-focus/cannabis-derived-products-data-acceleration-plan). The DAP calls for data about product problems (e.g., quality concerns), adverse events, and misinformation sources based on real world data (RWD) to help fill knowledge gaps and meet the new and emerging challenges these novel products and markets present with regard to advancing understanding of quality, safety, and surveillance, and informing development of policy, prevention, education, and outreach efforts. The above-described data and services will help address FDA’s data gaps by providing access to information about new and emerging risks and safety signals identified in consumer-reported adverse event experiences with CDPs from multiple social media platforms and other potential online data sources (including dark web, e-commerce, and special interest websites), using machine learning (ML) and natural language processing (NLP) to identify and characterize online activity that other sources do not collect. Such data and services will include analyzing the captured data, as well as providing information on the current scientific literature in general and through a health equity lens in particular to identify gaps, helping the Agency target resources appropriately in terms of potential actions to address the gaps, such as calls for research; postmarket surveillance refinement; sampling prioritization; and development of guidances, alerts, advisories, and other education and outreach. These data and services will also include summarized and FDA-cleared findings by due dates and in formats for dissemination to be determined in consultation with FDA, including but not limited to publications in peer-reviewed journals and meeting presentations/webinars, to promote engagement and participation among the state and local government, scientific, academic, consumer, industry, and public health stakeholder community. In these ways, access to these data and services will help inform surveillance and development of policy, guide prevention efforts, and target education/outreach initiatives. Scope and Objectives The scope and objective of work for this requirement are the same: to help address FDA-identified evidence gaps contributing to strengthening FDA’s surveillance and safety signal detection, prevention, education/outreach, and public health protection activities. The goals and expectations with regard to the scope and objective will include, but will not be limited to, addressing the following aims: • To collect information about new and emerging risks, and safety signals identified in online data sources (including dark web, e-commerce, and special interest websites), and in consumer-reported adverse event experiences with CDPs from multiple social media platforms, using data mining, machine learning (ML) and natural language processing (NLP) to identify and characterize online activity that other sources do not capture. • To analyze the captured data on new and emerging risks, and safety signals, as well as to provide information on the current scientific literature in general and through a health equity lens in particular (e.g., describing what user groups are targeted by CDP marketing and identifying user groups that interact with CDP online content and communities), to identify gaps, helping the Agency target resources appropriately in terms of potential actions to address the gaps, such as calls for research; postmarket surveillance refinement; sampling prioritization; and development of guidances, alerts, advisories, and other education and outreach. • To develop and deliver reports on findings by due dates and in formats to be determined in consultation with FDA, including summaries, manuscripts, and presentations/webinars synthesizing the considered data, with clearance obtained through FDA management for sharing with diverse stakeholders as determined appropriate by FDA to promote engagement and participation among the state and local government, scientific, academic, consumer, industry, and public health stakeholder community. All details of the effort can be found in the attached draft SOW. Period of Performance The period of performance is one (01) twelve (12) month base year with one (01) twelve (12) month option period. Capabilities, Technical and Past Performance Experience: Provide a capability statement describing how your company would be able to meet the requirements. Do not provide a generic capability statement. Address the Objectives and Scope. In addition, please provide 03 examples of past performance of similar size and scope. Business Status: Please provide your business size status (e.g., small business, 8(a), HUBZone, etc) and DUNS number. 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. Responses to the sources sought shall be no longer than 10 pages.