SOURCES SOUGHT
A -- NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS)
- Notice Date
- 12/2/2010
- 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
- HHS-NIH-NIAID(AI)-SBSS-10-035
- Archive Date
- 12/31/2010
- Point of Contact
- Craig D. Heggestad, Phone: 301-496-0612, Michelle L. Scala, Phone: 301-496-0612
- E-Mail Address
-
heggestadcd@niaid.nih.gov, mscala@niaid.nih.gov
(heggestadcd@niaid.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; women-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 of infectious, immunologic, and allergic diseases that threaten millions of human lives. Through a variety of grants and contracts, the NIAID Division of AIDS (DAIDS) sponsors basic, pre-clinical and clinical research, including Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. NIAID/DAIDS currently funds more than 300 clinical trials in over 50 countries at more than 1,000 domestic and international clinical research sites. Over the past five years, more than 600 discrete tasks have been executed to support the DAIDS clinical research portfolio, including support services to over 200 clinical research sites in over 50 countries. The current contract for this work is entitled "HIV Clinical Research Support Services" and is with Pharmaceutical Product Development, Inc. 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. Project Requirements Offerors should have the qualifications, experience and capability to perform this requirement for more than 200 clinical research sites at both domestic and foreign sites, with particular attention to the appropriateness and adequacy of organizational experience for performing clinical research support functions for HIV/AIDS and other infectious diseases that are of relevance to HIV infection and at risk populations. The Contractor will provide a wide variety of support services including but not limited to: • Clinical research site capacity, including support services for clinical research site assessments, study specific site readiness, and recruitment and employment of clinical research site personnel • Clinical research development, implementation, management and coordination • Clinical research compliance, including training and clinical research site and study monitoring/auditing • Coordination and collaboration with other NIAID/DAIDS clinical research support contractors and grantees • Development and implementation of Quality Assurance/Quality Control procedures • Project management functions, including the development and implementation of an Integrated Master project plan Anticipated Period of Performance The performance requirement will be for the delivery of 49.6 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Year 2 through Year 7), which may be unilaterally exercised by the Government. The option periods may extend the term of the contract beyond the base period for up to 7 years. In addition, the Government may exercise options to accommodate significant increases in work to be provided for the base period and option periods. Should the Government elect to exercise these options in any year of the contract, the Contractor shall provide resources for the unanticipated increase in work volume for 3.0 additional FTEs for each option exercised. The Government may exercise an option up to two times in any year of the contract. Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondents capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; Interested contractors 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; (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/co-PI, 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. Each response should include the following Business Information: a. DUNS b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought. f. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. g. 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 be registered in CCR which is located at http://www.ccr.gov/ 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 tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than 4:00 PM, December 16, 2010. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Craig Heggestad, Contract Specialist. He can be emailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID (AI)-SBSS-10-035. A paper copy can be sent via regular mail at the address provided below. If sending a paper copy, please send an original and one copy. Craig Heggestad Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700 B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 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 Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. Respondents will be added to the prospective offerors list for any subsequent solicitation. 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. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Craig Heggestad Email Address: heggestadcd@niaid.nih.gov Contracting Officer: Michelle L. Scala Email Address: mscala@niaid.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID(AI)-SBSS-10-035/listing.html)
- Place of Performance
- Address: Place of Performance is unknown at this time, United States
- Record
- SN02337158-W 20101204/101202234126-45bd5e7756173bd786f825783f26bc38 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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