SOURCES SOUGHT
A -- Interventional Agents Safety and Pharmacokinetic Services
- Notice Date
- 11/6/2023 10:18:55 AM
- Notice Type
- Sources Sought
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N93024R00003
- Response Due
- 12/1/2023 12:00:00 PM
- Archive Date
- 06/01/2024
- Point of Contact
- Miranda Adams, Phone: 2406695344, Jonathan Bryan, Phone: 2406695180
- E-Mail Address
-
miranda.adams@nih.gov, jonathan.bryan@nih.gov
(miranda.adams@nih.gov, jonathan.bryan@nih.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 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 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. This solicitation concerns safety and pharmacokinetics services support provided as preclinical services. To meet the demands for interventional agent product development, NIAID awarded eight (8) contracts in 2018 that provided preclinical product development capabilities in five technical Task Areas using the Indefinite Delivery, Indefinite Quantity (IDIQ) contract mechanism (Contracts HHSN272201800001I to -8I). The purpose of the current solicitation is to ensure the product development planning, safety, toxicology, and pharmacokinetics activities of this valuable NIAID resource continue to be offered with the intent of supporting product development services that will propel new products forward. The preclinical development resource is intended to be applied on a case-by-case basis for diverse interventional agent product candidates rather than to carry a single product candidate through the entire preclinical development pathway. These services are intended to help a wide variety of investigators in several scientific areas 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. 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 high 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 and non-clinical development support for promising therapeutic candidates that emerge from academia, the private sector, or other sources. The suite of services will encompass those activities commonly associated with the development of interventional products for infectious disease required for New Drug Applications (NDA), Biologic License Applications (BLA), and/or Investigational New Drug (IND) applications. For the purposes of this contract, an Interventional Agent is a chemical or biological agent for control of diseases caused by pathogens or toxins. The provided services shall be directed at the following: Diseases caused by pathogens and toxins on the National Institute of Allergy and Infectious Diseases (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 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 F. A contract may be awarded to an organization proposing to fulfill any number or combination of the technical Task Areas plus Task Area F. 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. Sample Task Order solicitations will be provided in the RFP solely for evaluative purposes and do not represent actual work being solicited at this time. Task Order solicitations for actual work will be issued after the award of the Parent Contract. Task Area A � Product Development Planning and Education Task Area A will support products by review, evaluation, or development of Product Development Plans (PDP) or their individual components, with respect to feasibility of design, development, manufacture, assay development, stability, preparation for clinical trials to include required documents, materials, and data for IND. This Task Area also supports conducting, reviewing, and evaluating technical feasibility or regulatory compliance of planned preclinical or nonclinical studies. Task Area A supports the development of Section 508-compliant educational materials including white papers, technical reviews, technical guidance documents, classes, and workshops.�� Task Area B � Non-GLP in vitro Preclinical Safety Studies Task Area B will support the testing of candidate interventional agents in in vitro preclinical microbiological and safety studies. Task Area C � Non-GLP in vivo Preclinical Microbiological, Safety, Toxicology, and Pharmacokinetics Services Task Area C will support the preclinical safety, toxicity, and pharmacokinetic studies of interventional agent candidates in relevant small and large animal models. This activity includes all such non-GLP in vivo tests that are needed for drug development, toward the IND. The Contractor is responsible for the acquisition, housing, and care of animals, and must provide access to an Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)-accredited (or equivalent) animal facility and the capacity (appropriate cage space, etc.) as required to fulfill the required services. Task Area D � GLP Preclinical Microbiological, Safety, Toxicology, and Pharmacokinetics (PK) Services Task Area D will support the preclinical safety, toxicity, and pharmacokinetic studies of interventional agent candidates against in vitro, or relevant small and large animal models. This activity includes all such tests that are required to support clinical use in humans. Testing must be sufficient to meet requirements for IND/NDA/BLA filing and shall be performed under Good Laboratory Practice (GLP requirements (21 CFR 58). The Contractor is responsible for the acquisition, housing, and care of animals, and must provide access to an AAALAC-accredited (or equivalent) animal facility and the capacity (appropriate cage space, etc.) as required to fulfill the required services. Task Area E � Commercial Off-the-Shelf Screening for Absorption, Distribution, Metabolism, and Excretion (ADME), Safety, and Pharmacokinetics (PK) Task Area E will support the non-GLP in vitro and in vivo screening style assays for Adsorption, Distribution, Metabolism, and Excretion (ADME), Safety, and Pharmacokinetics (PK) in a fixed format requiring minimal customization or protocol development. The scope of Task Area E animal studies includes small animal PK and tolerability studies using traditional routes of administration and standard timepoints and bioanalysis. Task Area E does not include the following: (1) Good Laboratory Practice (GLP) studies of any kind; (2) Non-GLP animal studies requiring protocol development, customization, large animals or non-traditional species, non-traditional routes of administration, extended observation or data collection periods, or multiple dosing per animal. Task Area F � Contract Kick-Off Meeting Task Area F will support the planning and participating in the parent contract kick-off meeting. 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 Statement of Work. Offerors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through subcontracts, partnership or consortia agreements, and/or use of consultants. However, Offerors shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order. NIAID will issue a Request for Task Order Proposal (RTOP) after the determination of a specific need which will be articulated in a Statement of Work (SOW) included in the RTOP. Specific activities within the Task Areas will depend on requirements developed by NIAID in conjunction with the status of the individual interventional agents as part of an overall product development plan. The Offer shall develop a response including a technical proposal in which the Offer specifies the scientific approach and methods it will employ to accomplish the key components of the RTOP and a business proposal detailing the associated costs or pricing structure as appropriate to the Task Order type. Compliance with applicable parts of 21 CFR (e.g. Good Laboratory Practices, and Electronic Records) may be required as determined by needs, funding, product maturity, and timelines of the product as specified in the Task Order. For the purposes of this contract, the following definitions apply: Therapeutic - A drug (synthetic or natural product) or a biotechnology product (e.g., monoclonal antibody) intended for use in the cure, mitigation, or treatment of disease. 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 and biological agents. � � � �(b) technology transfer processes. � � � �(c) shipping, handling and storing compounds and formulated drugs. �(6) availability of adequate facilities, equipment, and resources with sufficient capacity necessary to safely and efficiently accomplish the work described in the Statement of Work in a timely manner, to include documented access to BSL-2 facilities; �(7) perform work in accordance with the following guidelines: �Biosafety in Microbiological and Biomedical Laboratories�, Centers for Disease Control and Prevention and the National Institutes of Health, Sixth Edition 2007 (hhtp://www.cdc.gov/biosafety/publications/bmbl5/index.htm); Federal Guidelines for Research involving Recombinant DNA molecules at https://osp.od.nih.gov/biotechnology/biosafety-and-recombinant-dna-activities/; and 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 75N93024R00003. Facsimile responses will not be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/31a2feb0ca05467b8a14aac236b73476/view)
- Record
- SN06877407-F 20231108/231106230132 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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