Inactive
Notice ID:75N93024R00002
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:...
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. Background The National Institute of Allergy and Infectious Diseases (NIAID), an Institute of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. Within this remit, the NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of infectious diseases. DMID support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through research grants and contracts. DMID also provides an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services. These services are provided through Indefinite Delivery, Indefinite Quantity (IDIQ) contracts. In order to meet the demands for interventional agent product development, NIAID awarded eight (8) IDIQ contracts (HHSN272201800001I to -8I) in 2018 that provided preclinical product development capabilities in five technical Task Areas including product development planning, medicinal chemistry, manufacturing, non-infected animal studies, and ADMET (Absorption, Distribution, Metabolism, Excretion, Toxicity). The purpose of the current solicitation is to continue the medicinal chemistry and manufacturing parts of this valuable NIAID resource with the intent of supporting product development services that will propel new products forward. The other services provided by the 2018 IDIQ contracts will be subject of a separate solicitation and those services are not part of this solicitation. Purpose and Objectives The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remains a public health priority. To assist in filling these public health gaps, the NIAID requires a nontraditional, proactive, and product development-oriented program to provide preclinical development support for promising therapeutic candidates that emerge from academia, the private sector, or other sources. The full suite of services, of which the services in this solicitation are a part, will encompass those activities commonly associated with the development of interventional products for infectious disease required for New Drug Application (NDA), Biologic License Applications (BLA) and/or Investigational New Drug (IND) applications. Consequently, NIAID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in this solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, or consultants. Chemistry underpins all stages of product development by providing the materials required at each stage of development for studies supporting advancement to the next stage of development. The Interventional Agents Chemistry Services resource is intended for case-by-case support of diverse interventional agent product candidates rather than for carrying a single program through multiple stages of the preclinical development pathway. These services are intended to help a large number and variety of investigators to obtain critical data needed to attract additional funding, gain prospective partnerships (either for further development or to support clinical trials), fulfill regulatory requirements, and complete necessary studies to satisfy regulatory requirements. Investigators work with NIAID program officers to access the services through an online request portal. Through these interactions the program officers develop requirements in conjunction with the investigators that reflect the program development needs at the time. These requirements become the basis of the Statement of Work (SOW) of a Request for Task Order Proposal (RTOP) which is issued as a solicitation to all awardees (the contractor “pool”) of the Task Area to which the RTOP is issued. Contractors in the pool then submit technical and cost proposals against the work in the RTOP and these proposals are evaluated by the responsible NIAID staff. The proposal determined to be the best value to the government is awarded, provided funds are available. Contractors in the pool are not involved in the development of the requirements, however, they may receive inquiries from the Contracting Officer (CO), in the form of a Request for Information (RFI) in regard to technical capabilities in some cases. For the purposes of this contract an Interventional Agent is a chemical or biological agent for control of an infectious disease caused by a pathogen or toxin (e.g., botulinum toxin). The provided services shall be directed at the following: Diseases caused by pathogens and toxins on the NIAID Emerging Infectious Diseases/Pathogens list (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) Emerging and re-emerging infectious diseases Antimicrobial resistant and multi-drug resistant infections Other bacterial infections Fungal infections Viral infections Parasitic diseases. NIAID anticipates awarding multiple Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that demonstrate capability to fulfill the technical requirements of at least one (1) of the technical Task Areas listed below plus required Task Area A. A contract may be awarded to an organization proposing to fulfill either or both of the technical Task Areas plus Task Area A. The Government anticipates making awards to those organizations with the best qualifications in each Task Area. Subpar evaluation in one technical Task Area will not exclude the organization from or negatively impact consideration for award in another Task Area. Organizations will be considered for contracts only in the Task Area(s) they include in the proposal. Task areas and the scope of each are as follows: Task Area A – Contract Kick-Off Meeting Task Area A will support the planning and participating in the parent contract kick-off meeting. Task Area B – Non-GMP Chemistry Task Area B will support activities required for the route optimization, process development, and synthesis of a synthetic intermediate, lead, or preclinical candidate, and may include acquisition or purchase of compounds from a third-party source, such as a commercial vendor. Activities under this Task Area include technology transfer of synthesis schemes and procedures between third party facilities and contractors as specified in each Task Order. Task Area C – GMP Manufacturing, Formulation, Fill and Finish Task Area C will support the formulation development for clinical or advanced preclinical studies; current Good Manufacturing Practices (cGMP)-compliant synthesis of Drug Substance (DS), cGMP-compliant manufacturing of Drug Product (DP) consistent with relevant FDA guidelines; provision of all required documentation including documentation required for IND filing; product release testing required for human clinical use; and DP stability testing required during clinical trials. The Contractor shall be responsible for directing and ensuring the successful technology transfer of all materials, assays, methods and procedures as required for the successful performance of the activities. The focus of this task area will be for discrete small molecule drugs, including those derived from fermentation. Biological drugs and complex or poorly defined mixtures are excluded. Project requirements NIAID recognizes that a single organization or institution may not have the full spectrum of expertise or facilities required to perform all activities set forth in the aggregate of Task Areas A, B and C in the SOW. However, the Offeror shall be able to perform all work delineated in each individual Task Area to which the Offeror proposes. All offerors must propose to Task Area A and at least one Task Area from Task Areas B and C. Offerors will only be considered for award in the Task Areas to which the Offeror proposes. Contractors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, or consultants. In such cases, the Contractor shall remain responsible for all work performed, project planning, initiation, implementation, management, and communication. The Contractor is responsible for evaluation, selection, and management of any subcontractors, consultants or partners and for all deliverables specified in this contract and each awarded Task Order. Anticipated period of performance This is an IDIQ Contract with a seven year ordering period. The anticipated start date is on/or about May 1, 2025. Capability statement / information sought Interested Contractors must submit a capability statement describing their company’s experience and ability to perform this effort that includes the following: (1) Current in-house capability and capacity to perform the work; (2) A summary list of similar work previously performed. (3) The professional qualifications and specific experience of staff who may be assigned to the requirement. (4) A general description of the facilities and other resources needed to perform the work; (5) Experience with: (a) Receiving, formatting, storing and shipping compounds. (b) Technology transfer of chemical and analytical methods and protocols. (c) Shipping, handling and storing compounds and formulated drugs. (d) Working in accordance with cGMP. (6) Demonstrated ability to perform work in accordance with Recommendations for the Safe Handling of Cytotoxic Drugs, NIH Publication No. 92-2621 and the NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication No. 81-2385. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: UEI. Company Name. Company Address. Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address). Number of Copies: Please submit one (1) electronic copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Miranda Adams, Contracting Officer, at miranda.adams@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify 75N93024R00002. Facsimile responses will not be accepted.
