SOURCES SOUGHT
A -- Clinical Materials Serrvices
- Notice Date
- 11/17/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID-SBSS-16-NIHAI2016065
- Archive Date
- 12/22/2015
- Point of Contact
- Courtney Viebrock, Phone: 240-669-5172, George Kennedy, Phone: 240-669-5170
- E-Mail Address
-
courtney.viebrock@nih.gov, kennedyg@niaid.nih.gov
(courtney.viebrock@nih.gov, kennedyg@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION/SYNOPSIS 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 and conducted 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 of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, diagnostics and devices, which is funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, therapeutic, diagnostic and device candidates in clinical trials and clinical studies is an essential element of DMID's efforts. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase 1, Phase 2, and Phase 4 (and occasionally Phase 3) clinical trials for the evaluation of bacterial, viral and parasitic vaccines, other biologics, drugs, diagnostics and devices as preventive, therapeutic, and diagnostic measures against infectious diseases in people of all ages and risk categories. Much of this clinical research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases, including avian influenza and antimicrobial resistance, and those supporting the evaluation of safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm), BACKGROUND AND OBJECTIVES The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. In August 2008, NIAID awarded a 7-year contract to Fisher BioServices Corporation (HHSN272200800044C) to provide for the operation of a Clinical Agent and Specimen Repository (CASR) that adheres to current Good Manufacturing Practice (cGMP), for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID-sponsored clinical trials and research programs in the U.S. and abroad and ensures that all work performed is done in compliance with federal and/or local clinical trial related regulations. PROJECT REQUIREMENTS The anticipated solicitation will be for the management and operation of a cGMP-compliant clinical materials services facility including receipt, aliquoting, labeling, packaging, repackaging, shipping, acquiring, testing and disposing of clinical agents and clinical specimens. All work performed under the anticipated contract must be done in compliance with federal and/or local clinical trial related regulations. Clinical agents include investigational study products (drugs, vaccines, therapeutics, diagnostics and devices), commercial products, placebos, syringes, and other protocol/Manual of Procedures (MOP)-mandated supplies to be used in DMID-sponsored clinical trials. Clinical specimens include sera or other protocol-mandated specimens obtained from DMID-approved clinical research sites, to be distributed or tested at DMID-approved testing laboratories. Any awardee resulting from the anticipated solicitation will be transferred samples and data as part of initial transition activities. It is anticipated that on the effective date of the contract, 1,000,000 vials of specimen and 500,000 vials of product will need to be transferred. It is also anticipated that performance will require shipments to clinical trials in both domestic and foreign locales, for up to 100 trials. NIAID recognizes that a single organization or institution may not have the expertise and facilities required to perform all of the activities set forth in the Statement of Work and, consequently, that the Contractor may need to be supported to a certain extent by the expertise and resources of subcontractors to perform some of the tasks required. The Contractor shall be responsible for ALL work performed under the anticipated contract including that performed by any subcontractor(s). ANTICIPATED PERIOD OF PERFORMANCE The Government anticipates awarding one cost reimbursement, Level of Effort type award; with a one year base period of performance beginning on or around April 1, 2017. It is anticipated the award will include six (6) one-year Option Periods. The total potential period of performance, including options, will be seven years. The Government's base level of effort requirement is anticipated to be 20,325 labor hours per contract year. In addition to the base level of effort, each year of performance is anticipated to contain an option for 10,163 additional labor hours. CAPABILITY STATEMENT/INFORMATION SOUGHT Capability statements submitted by potential sources as a result of this announcement should demonstrate the respondent's qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following technical areas: Provision of clinical agent and clinical specimen repository services, including: 1. Receipt, appropriate storage, monitoring, distribution and disposition of clinical agents from product suppliers in support of DMID-sponsored clinical research; 2. Labeling, packaging and repacking of clinical agents for distribution to DMID-approved clinical research sites and DMID approved testing laboratories; 3. Receipt of all required shipping documents; 4. Validation of packaging and shipping procedures for the shipment of clinical agents under correct temperature conditions; 5. Monitoring of product inventories and expiration dates; 6. Acquisition of clinical agents and non-clinical testing; 7. Receipt, short-term storage, monitoring, distribution, and disposition of clinical specimens in support of DMID sponsored clinical research; 8. Aliquoting, labeling, of clinical specimens for distribution and testing at DMID approved testing laboratories; 9. Maintenance and operation of an electronic system for requesting services and tracking agents and specimens. 10. Ability to provide key professional and technical staff with appropriate and relevant expertise, qualifications, and experience on projects of similar size, scope, and complexity. 11. Ability to provide adequate, appropriate facilities to carry out clinical agent and clinical specimen repository activities. Past performance is considered essential. In preparing tailored Capability Statements, interested parties are asked to identify experience on projects of similar size and complexity. HOW TO SUBMIT A RESPONSE This sources sought notice requires interested parties to submit a capability statement in pdf format via the NIAID electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov/NIAID. For directions on using eCPS, go to https://ecps.nih.gov/NIAID/home/howto. PAGE LIMITATIONS: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed seven (7) 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 • 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 www.sam.gov. 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). 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 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).
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