SOURCES SOUGHT
A -- NIAID HIV AND OTHER INFECTIOUS DISEASES CLINICAL RESEARCH SUPPORT SERVICES (CRSS)
- Notice Date
- 10/27/2015
- 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, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID-SBSS-15-050
- Archive Date
- 11/27/2015
- Point of Contact
- Rosemary Gomes, Phone: 240-669-5374, Michelle L Scala, Phone: 240-669-5156
- E-Mail Address
-
Rosemary.Gomes@nih.gov, mscala@niaid.nih.gov
(Rosemary.Gomes@nih.gov, mscala@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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. THIS IS STRICLY MARKET RESEARCH. NIAID/DAIDS WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH. Background The National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) supports the advancement of therapies for HIV infection and its complications, and supports the development of HIV/AIDS vaccines and other prevention measures. DAIDS sponsors more than 150 Phase I, II, III and IV clinical trials at over 150 clinical research sites in over 17 countries to evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. Over the past five years, the incumbent has conducted more than 90 work requests to support the DAIDS clinical research portfolio in the areas of clinical research, laboratory and training. The current contract for this work is entitled "HIV Clinical Research Support Services" (CRSS) and the incumbent contractor is Westat, contract number HHSN272201200009C. Purpose and Objectives The purpose of the proposed contract is to provide a broad range of clinical research support services to the current and evolving NIAID/DAIDS-supported clinical research portfolio and other infectious diseases that are of relevance to HIV infection and at risk populations, and to assist NIAID in the development and maintenance of a strong and responsive clinical infrastructure. Primary objectives are to provide a responsive and flexible infrastructure/base for both recurring and ad hoc support services to meet the scientific/technical requirements of the DAIDS research portfolio. This contract also has the objective to serve as a gap-filling mechanism to provide urgent or unanticipated services for emerging or evolving needs and provide prompt access to subject matter experts, consultants and subcontractors. Project Requirements a. Specifically, the CRSS contract will be responsible for the following: Provide clinical site research support activities to include capacity assessment, capacity building, audits to assess compliance with Federal regulatory and in-country requirements, and targeted site training. b. Provide clinical trial support including support services for study-specific document preparation, translations, data management, biostatistical design and analysis, and project management. c. Conduct laboratory audits to include good clinical laboratory practices (GCLP), current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) to assess compliance with Federal regulatory requirements and DAIDS policy requirements and perform other related laboratory support work. d. Provide training support to include review and revision of training materials for support and management of DAIDS Learning Portal (DLP), training warehouse, and DLP help desk support. e. Coordinate and collaborate with other DAIDS grantees and clinical research support contractors in the performance of the Performance Work Statement as listed in Attachments entitled "DAIDS Extramural Clinical Trial Portfolio" and "Current NIAID/DAIDS Clinical Research Support Contracts". f. Project management and quality assurance for individual projects and for the overall contract. Anticipated period of performance It is anticipated that one (1) cost reimbursement, level-of-effort (term) performance based type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about May 15, 2017. The requirement will be for the delivery of 48.10 full time equivalents (FTEs) per year for the Base Period (Year 1) and each option period (Years 2 through 7). In addition to the above functions and services to be provided for the Base period, the Government may exercise, at its discretion, Options for additional level of effort to accommodate significant increases in work. These Options are defined as follows: Option 1 - 6: Extend the Term of the Contract: The Government may exercise options to extend the term of the contract beyond the Base period (Year 1), annually, for a total contract period of up to 7 years of the performance. The total period of performance resulting from the base period plus all potential Term Options is 7 years. Assume that the scope and types of activities as outlined for the Base Period (Year 1 of the contract) would be continued for each succeeding annual contract period. Options 7-34: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand. Up to Four (4) Options per year may be exercised during years 1 through 7 of contract performance. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1 or 2 FTEs for each option exercised. The period of performance of an Option for Increased Level of Effort will not exceed the term of the base year or Option year in which the Option is exercised. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1 or 2 FTEs for each option exercised. Other important considerations This work will take place both in the US and internationally, including remote and/or resource constrained settings. Capability statement / information sought Interested respondents must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed for being 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 Project Director, which 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; and (5) demonstrated ability to carry out the work. Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the activities set forth in the Performance Work Statement (PWS). The Respondent may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Respondent shall be responsible for all work performed under this contract including that performed by any subcontractors and consultants. The Respondent will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. 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 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 Central Contractor Registration (CCR) 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) electric 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 Rosemary Gomes, Contract Specialist, at rosemary.gomes@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-15-050. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:30 p.m., local time November 12, 2015. 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 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).
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