SOURCES SOUGHT
A -- VACCINE AND TREATMENT EVALUATION UNITS (VTEU)
- Notice Date
- 3/29/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIAID-DMID-NIHAI2012144
- Archive Date
- 4/28/2012
- Point of Contact
- Edward Shane Ryan, Phone: 301-451-3692, Aileene Mitchell Ford, Phone: 301-496-7288
- E-Mail Address
-
ryanes@niaid.nih.gov, aileene.mitchellford@nih.gov
(ryanes@niaid.nih.gov, aileene.mitchellford@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice Information 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." The information from this market research will help the DMID, NIAID, NIH, and DHHS, plan their acquisition strategy. Please be sure to indicate if you have a GSA schedule contract, a contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC. A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government. 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 infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) (www.niaid.nih.gov/dmid/clinresearch) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic, clinical, and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that are funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, diagnostics and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of the NIAID. One key NIAID program that has been carrying out these studies since the 1960's is the Vaccine and Treatment Evaluation Units (VTEU). Approximately 40 clinical trials and clinical studies have been conducted during the past three years under current contracts. (HHSN272200800002C, HHSN272200800003C, HHSN272200800004C, HHSN272200800005C, HHSN272200800006C, HHSN272200800007C, HHSN272200800008C, and HHSN272200800057C; all due to expire on or about October 31, 2014.) Several of these clinical trials/studies were performed in a compressed time frame to address emergent public health research needs, for example the 2009 H1N1 influenza pandemic. Purpose and Objectives The purpose of the proposed solicitation is to provide for the recompetition of the VTEU, to continue designing and conducting a broad range of clinical studies and clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. These studies have and will continue to include IDE, IND and non-IND trials, many Phase I first in man clinical trials, and Phase II proof-of-concept trials. The VTEUs have and will continue to undertake a variety of other studies, which include targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. In addition to conducting clinical trials, the VTEUs are responsible for identifying new concepts for clinical trials. These concepts have and will continue to include new methods to utilize currently available vaccine, diagnostics, and treatments; clinical trials of promising investigational products; and clinical studies conducted to better characterize responses to vaccines. The VTEUs work with DMID protocol teams and other collaborators to develop concepts, proposed by the VTEUs or other sources, into clinical protocols. The VTEUs also provide expert consultation to DMID in areas of infectious disease clinical research. Finally, the VTEUs have an important role in responding to emerging public health needs at the direction of the NIAID. The objective of the VTEUs is to support the conduct of clinical studies and clinical trials related to infectious diseases in a variety of domestic and international populations. Examples of studies that will be conducted include Phase 0 through Phase IV clinical trials, clinical trials for devices and diagnostics, clinical studies, sample collection, sample analysis, surveillance, and epidemiology studies. In addition and in order to carry out clinical studies and clinical trials spanning as wide a variety of infectious diseases as possible, the VTEUs will be required to have the ability to conduct studies in international populations. To this end, for any contract awards made the contractor(s) MUST document and have the ability to access at least 200 subjects per year from an international population in a resource poor setting (low and middle income countries as defined by the World Bank (see: http://data.worldbank.org/about/country-classifications/country-and-lending-groups) that includes healthy volunteers from birth to mature adults, pregnant women and subjects with endemic diseases for the specific international location. The NIAID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts to organizations that meet the overall qualifications needed to fulfill the technical requirements of the proposed solicitation. Task orders for specific tasks will be issued after the award of the IDIQ contract. All projects carried out under this contract must be conducted in a manner consistent with all applicable Federal regulations and the DMID, NIAID, NIH and DHHS policies and guidelines for the conduct and oversight of research involving human subjects. The anticipated start date is on/or about September 13, 2013 with an ordering period of seven years. Capability Statement/Information Sought Sources are expected to have the expertise, personnel, and facilities to meet the stated requirements of this project. Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas: 1. The ability to design, develop, conduct, and analyze clinical research studies and trials spanning a wide variety of infectious diseases, carrying out concept and protocol development, implementation and management activities in compliance with NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf). Include a discussion regarding ability to receive, package, distribute and track study products, as well as collect and process clinical specimens. 2. The ability to access the number and type of populations, both general and specialized, required to serve as study participants, and ability to recruit and retain such study participants. In addition to an ability to access a variety of populations in the United States, sources must demonstrate the ability to conduct studies in international populations and demonstrate access to at least 200 subjects per year from an international population in a resource poor setting, as described in the Purpose and Objectives section above. 3. The availability, adequacy and suitability of the inpatient and outpatient clinical research facilities, equipment and other resources of the Offeror and all proposed subcontractors for the conduct of clinical trials, clinical studies and other evaluations and analyses in accordance with Federal regulatory requirements and guidelines, including cGCP, NIH, NIAID and DMID policies and procedures.. 4. The ability to provide adequate scientific and technical personnel who have expertise with Good Clinical Practices, food and drug law (21 CFR312), and other regulatory requirements governing the conduct of research involving human subjects, including a Principal Investigator with an active physician's licensure in the United States. 5. The ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities, which could entail multiple, large-scale clinical trials running in parallel. 6. Ability to identify domestic and international clinical sites and manage by subcontracting, if necessary. How to Submit a Response 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed five pages, excluding resumes, describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) the capability to provide the required level of effort on a continuing and emerging needs basis; (4) resumes for proposed key personnel, which reflect education, and previous work relevant to the proposed requirement; (5) a general description of the facilities and other resources needed to perform the work. All proprietary information should be marked as such. Tailored capability statements should also include an indication of current certified small business status; 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). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. If there are any responsible offerors who have proven experience and meet the capabilities cited to perform the requirement, they may submit experience, capabilities and qualifications as outlined above which will be considered by the NIH. This notice of intent is not a request for competitive proposals. However, all information received within fourteen (14) days after date of publication of this synopsis will be considered by the Government. 2. Required Business Information: • DUNS. • Company Name. • Company Address. • Company Point of Contact, Phone and Email address • Current GSA Schedules 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 Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp 3. Number of Copies: Please submit one (1) electric copy of your response to the following e-mail address: All capability Statement sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to E. Shane Ryan, Contract Specialist, at ryanes@niaid.nih.gov in MS Word, WordPerfect or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-DMID-NIHAI2012144. Facsimile responses will not be accepted. 4. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 1:00PM (Eastern Prevailing Time) on 04/13/2012. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. All responses must be received at NIAID by the specified due date and time in order to be considered. 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. 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)." Points of Contact: Inquiries concerning this Notice may be direct to: Shane Ryan, Contract Specialist Ph: 301-451-3692 Email: ryanes@niaid.nih.gov Aileene Mitchell Ford, Team Lead Ph: 301-496-7288 Email: aileene.mitchellford@nih.gov
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