SOURCES SOUGHT
A -- Sexually Transmitted Infections Clinical Trials Group
- Notice Date
- 10/25/2011
- 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, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID-SBSS-DMID-NIHAI2011122
- Point of Contact
- John Outen, Phone: 301-451-7460, George Kennedy, Phone: 301-451-2607
- E-Mail Address
-
outenj@niaid.nih.gov, kennedyg@niaid.nih.gov
(outenj@niaid.nih.gov, kennedyg@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice for a Research and Development (R&D) requirement. 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. 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. Interested parties are expected to review this notice to familiarize yourself with the requirements of this project; failure to do so will be at your firm's own risk. Background: This is not a Request for Proposal (RFP). This National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) project is for the renewal of the following contracts: • Sexually Transmitted Infections Clinical Trials Group (STI CTG) University of Alabama at Birmingham (Contract N01AI40073) • Sexually Transmitted Infections Clinical Trials Group (STICTG) University of California, San Francisco (Contract N0AI40074) These contracts were awarded on a competitive basis for a seven year period. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Institutes of Allergy and Infectious Diseases (NIAID). For more project details please see Purpose and Objectives section of this notice below. Interested parties are expected to review this notice to familiarize yourself with the requirements of this project; failure to do so will be at your firm's own risk. Purpose and Objectives: The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small business concerns including 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 that are interested in and capable of 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. As a result of this SBSS Notice, the NIAID may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Small Business Sources Sought Notice or the NIAID's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. If a RFP is issued, the NIAID anticipates that one or two awards may result from the issuance of the RFP. The specific purpose of this project is as follows: NIAID is recompeting the Sexually Transmitted Infections Clinical Trials Group (STI CTG) research program to continue to provide DMID with the infrastructure necessary for the design and conduct of clinical trials and clinical studies focused on the screening, diagnosis, treatment, prevention and control of STIs. The NIAID awarded the Sexually Transmitted Diseases Clinical Trials Unit (STD CTU) contract in 1997 to the University of North Carolina (Contract N01AI75329), and the Sexually Transmitted Infections Clinical Trials Group (STI CTG) contracts in 2003 to the University of Alabama at Birmingham (Contract N01AI40073) and the University of California, San Francisco (Contract N0AI40074), with the goal of providing clinical trial capability for the evaluation of diagnostics, therapeutics, vaccines and microbicides for the control and prevention of STIs. (Note: the Sexually Transmitted Diseases Clinical Trials Unit will not be recompeted) DMID anticipates awarding an Indefinite Delivery/Indefinite Quantity (ID/IQ) contract to fulfill the technical requirements of this solicitation in the two task area's listed below. Sample Task Orders will be provided in the RFP for the evaluation of offeror responses and capabilities. TASK AREA 1 A. Administrative and overall clinical operations support B. Concept proposal development C. Protocol development D. Identification of Clinical Populations TASK AREA 2 A. Clinical trial/study implementation and conduct in single or multiple sites. B. Clinical trial/study specific meetings and teleconferences support C. Clinical trial/study close-out and final study reporting D. Coordination and Collaboration with DMID Staff, contractors and other government entities. Anticipated Period of Performance: The anticipated ordering period for this IDIQ will be seven years. The anticipated start date is on/or about September 20, 2012. Capability Statement/Information Sought: Sources are expected to have the expertise, personnel, and facilities to meet 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 establish and maintain a collaborative, integrated, and iterative program focused on the conduct of clinical trials for sexually transmitted infections. 2. The ability to design, develop, conduct, and analyze clinical research studies and trials, carrying out 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. 3. 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. 4. The availability, adequacy and suitability of the 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 GCP, NIH, NIAID and DMID policies and procedures and the scope and requirements of the RFP. 5. 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. 6. The ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities. 7. The ability to organize and/or manage a Scientific Advisory Group. 8. 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 contractors 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 and Delivery Point: Please submit one (1) electric copy of your response to the following e-mail address: outenj@niaid.nih.gov All capability Statement sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to John Outen, Contracting Officer, at outenj@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-NIHAI2011122. Facsimile responses will not be accepted. 4. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:30PM (Eastern Prevailing Time) on 11/9/2011. 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. Facsimile responses will not be accepted. In conclusion, 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. 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: John Outen, Contract Specialist Ph: 301-451-7460 Email: outenj@niaid.nih.gov George Kennedy, Team Lead Ph: 301-451-2607 Email: kennedyg@mail.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID-SBSS-DMID-NIHAI2011122/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN02612264-W 20111027/111025233918-b0e0684b542a901a46bbc2238f4723f7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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