Diagnostics pre-clinical services program

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

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), 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. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of diseases caused by all infectious agents other than HIV. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts.  DMID also supports 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 https://www.niaid.nih.gov/research/microbiology-and-infectious-diseases-resources .

NIAID supports nearly all stages of the in vitro diagnostic (IVD) product development pipeline from planning and design, through development, verification, and pre- and pilot manufacturing using multiple support services contracts.  The purpose of this program is to offer a comprehensive array of capabilities with the intent of providing to product developers a discrete subset of services that will propel new IVD products toward regulatory clearance. This resource is intended to be applied to any/multiple product(s) at any/multiple stage(s) requiring access to services in support of IVD development need rather than to carry a single IVD product candidate through the entire product development pathway. These services are intended to help a wide variety of investigators (including academics and start-up or mature companies) in a number of scientific areas to obtain critical data needed to attract additional funding, gain prospective partnerships (either for further development or to support r5clinical validation studies), fulfill regulatory requirements, and complete necessary studies to satisfy regulatory requirements.

The development and introduction of new IVD products to detect, identify, and characterize potential agents of bioterrorism, antimicrobial-resistant pathogens, emerging and re-emerging infectious pathogens, as well as infectious pathogens prevalent in resource-limited countries remain 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 IVD product development support for promising assay technologies that emerge from academia, as well as start-up or mature biotech companies. The suite of services will encompass those activities commonly associated with the development of IVD tests for infectious disease required for FDA 510(k) clearance, PMA approval, and EUA or pre-EUA authorization.

Since the rapid diagnosis of infectious disease-causing pathogens and/or toxins is crucial for implementing proper treatment and patient management, the commercial development of new diagnostics is a high priority. For that purpose, this solicitation includes services to support the development of new diagnostics for infectious disease-causing pathogens and/or toxins. 

NIAID anticipates awarding one or more Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that best meet the overall qualifications for fulfilling the technical requirements of the Task Areas listed in this solicitation. Contracts may be awarded to organizations that propose the full suite of services (i.e., fulfill all Task Areas) or to organizations that propose to provide services in one or more Task Areas.  The Government anticipates making awards to those organizations with the best qualifications in each Task Area.Organizations will be considered for contracts only in the Task Area(s) they include in the proposal.  Sample Task Orders are provided in the RFP solely to evaluate offeror responses and capabilities. Task Orders for specific tasks will be issued after award of the Parent Contract. All projects carried out under the IDIQ contract(s) must be conducted in a manner consistent with all applicable U.S. federal regulations or international regulatory authorities, and the DHHS, NIH, NIAID, and DMID policies and guidelines for the conduct and oversight of research involving human subjects.

Purpose and Objectives:

Contracts awarded from this solicitation shall provide the capacity and capability for a broad range of services necessary for IVD product development support for promising assays and platforms to detect, identify, and characterize human infectious agents.  Services include expanding the breadth and depth of diagnostic knowledge in all areas of infectious, immunologic, and allergic diseases and developing flexible domestic and international research capacities and capabilities to respond appropriately and when needed rapidly to mount an effective response to emerging and re-emerging disease threats both domestic and foreign on a local or global scale. The new IDIQ contract awards will support tasks in the following areas:

• Product Development Processes and Documentation (Task Area A)
• Recombinant Proteins and Monoclonal Antibodies (Task Area B)
• Biochemical Reagents: Nucleic Acids and Oligonucleotides (Task Area C)
• Clinical Specimens and Bacterial Isolates (Task Area D)
• Next-Gen Sequencing, Immunoassays, Nucleic Acid Amplification Assays (Task Area E)
• Pre-Pilot and Pilot-Scale GMP Manufacturing Services (Task Area F)

Project requirements

Under the award of the IDIQ contract(s) the future contractor(s) would support a comprehensive array of capabilities with the intent of providing to product developers a discrete subset of services that will propel new IVD products toward regulatory clearance. These services are intended to help a wide variety of investigators (including academics and start-up or mature companies) in a number of scientific areas to obtain critical data needed to attract additional funding, gain prospective partnerships (either for further development or to support  clinical validation studies), fulfill regulatory requirements, and complete necessary studies to satisfy regulatory requirements.

Anticipated period of performance

NIAID anticipates awarding multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts to fulfill the technical requirements of the upcoming solicitation with an ordering period of seven (7) years.  The anticipated start date is on/or about­­­­­­­­­­­­­­­­ June 2023.

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) a summary list of similar work previously performed;

(2) the professional qualifications and specific experience of staff who may be assigned to the requirement;

(3) resumes for proposed key personnel, including the Principal Investigator and Project Manager, that reflect education, and previous work relevant to the proposed requirement;

(4) a general description of the facilities and other resources needed to perform the work;

(5) demonstrated ability to carry out the work;

(6) adequacy of the documented experience with, and appropriateness of plans for:

(a) receiving, formatting, storing and shipping reagents and biological agents;

(b) technology transfer processes;

(c) shipping, handling and storing recombinant proteins and nucleic acids;

(d) providing and evaluating product development plans;

(e) experience working with potential biohazards and toxic chemicals; and

(f) adequacy of the plan for training, implementation, and monitoring of safety procedures;

(7) 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 and BSL-3 facilities, as needed;

(8) 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 (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm); and Federal Guidelines for Research involving Recombinant DNA molecules at https://osp.od.nih.gov/biotechnology/biosafety-and-recombinant-dna-activities/.

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 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 set up shall be single sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information shall be marked as such.

Required Business Information:

• DUNS.
• 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/SAM/pages/public/index.jsf. 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:

electronic

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Ignacio Reyes, Contracting Officer, at Ignacio.reyes@nih.gov in MS Word or Adobe Portable Document Format (PDF).  The e-mail subject line must specify NIHAI75N93022R00008.   Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically-submitted tailored capability statements are due no later than 4PM (Eastern Prevailing Time) on January 7, 2022.

CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

Disclaimer and Important Notes

This notice does not obligate the Government to award an IDIQ contract or Task Order(s) 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 shall 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 at SAM.gov. 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).