SOLICITATION NOTICE
A -- NIAID HIV AND OTHER INFECTIOUS DISEASES CLINICAL RESEARCH SUPPORT SERVICES (CRSS)
- Notice Date
- 1/14/2011
- Notice Type
- Presolicitation
- 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
- RFP-NIAID-DAIDS-NIH-AI-2010035
- Archive Date
- 2/15/2011
- Point of Contact
- Craig D. Heggestad, Phone: 3014438175, 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
- The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS (DAIDS), has a requirement for the provision of support services for the NIAID/DAIDS clinical research portfolio. Through a variety of grants and contracts, the Division 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. Since its inception in 1987, NIAID/DAIDS has designed, developed and sponsored extramural clinical trials networks, supported investigator-initiated clinical trials, and partnered with other Government and private organizations to assist in carrying out the Division's scientific 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. Activities include clinical research site assessments, clinical research laboratory audits and the planning, coordinating, conducting and evaluation of DAIDS Regional Training Events. 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 as well as 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: a. 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 b. Clinical research development, implementation, management and coordination, including support services for preparation of study-specific documents and regulatory submissions, data management, biostatistical design and analysis, clinical research laboratory performance, clinical products receipt, distribution and inventory, volunteer recruitment, retention and counseling, and study close-out c. Clinical research compliance, including training and clinical research site and study monitoring/auditing d. Coordination and collaboration with other NIAID/DAIDS and NIAID/DMID clinical research support contractors and grantees e. Development and implementation of Quality Assurance/Quality Control procedures f. Project management functions, including the development and implementation of an Integrated Master Project Plan It is anticipated that one cost reimbursement, term type contract will be awarded for a 1-year Base Period plus six 1-year Options for a possible total period of performance of 7-years beginning on or about November 15, 2011. The performance requirement will be for the delivery of 49.6 A total level of effort of 49.6 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Years 2 through 7), which may be unilaterally exercised by the Government. 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 an option for increased level of effort, 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. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about January 31, 2011, and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/RFP-NIAID-DAIDS-NIH-AI-2010035/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institute of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, Maryland, 20892-7612, United States
- Zip Code: 20892-7612
- Zip Code: 20892-7612
- Record
- SN02361051-W 20110116/110114234522-eb3aaf1347938e7a839100fb35f8ff39 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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