SOURCES SOUGHT
A -- NIAID Division of Allergy, Immunology and Transplantation: Regulatory Management Center
- Notice Date
- 4/19/2010
- 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(AI)-SBSS-10-031
- Archive Date
- 5/5/2010
- Point of Contact
- Albert Nguyen, Phone: 301-496-0612, David T Lisle, Phone: 301-451-2617
- E-Mail Address
-
nguyenal@niaid.nih.gov, dlisle@niaid.nih.gov
(nguyenal@niaid.nih.gov, dlisle@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. ALL SMALL BUSINESSES ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500. 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 better understand, treat and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research focusing on immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research programs and individual research projects to evaluate the safety and efficacy of therapeutic and preventive approaches and agents and to elucidate the underlying mechanisms of such approaches and agents. As the sponsor of Investigational New Drug Application (IND) and Investigational Device Exemption (IDE) applications for a large number of DAIT-supported clinical trials, there is an established requirement for DAIT to provide regulatory support to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Parts 50, 54, 56 and 312, and Title 45 CFR Part 46. In addition, all DAIT-supported clinical trials, including those conducted under FDA regulation, as well as IND/IDE-exempt studies and trials, must be conducted in accordance with the International Conference on Harmonization (ICH) Guidelines: E2A Clinical Safety Data Management and E6 Good Clinical Practices (GCP), as well as country-specific regulatory regulations and requirements. DAIT employs several mechanisms to provide regulatory support services for the Division's various clinical research programs, including the following: • Separate contracts have been awarded for some clinical research programs to provide a broad range of statistical, data management and clinical coordination support, including regulatory support services; • In other instances, separate grants have been awarded to provide such services for specific clinical research programs funded under cooperative agreements; and • For some clinical research programs, regulatory and other support services are provided for within the actual grant programs established to conduct clinical research in specific areas. Regulatory support to DAIT's largest clinical research program, the Collaborative Network for Clinical Research on Immune Tolerance, is provided through a seven-year contract, awarded in FY 2004 to Social and Scientific Systems, Inc., located in Silver Spring, MD (Contract No. HHSN266200400089C). This contract also provides regulatory support services for DAIT's Asthma and Allergic Diseases Cooperative Research Centers (AADCRCs). Collectively, through these various mechanisms, regulatory support services have been provided for over100 clinical trials conducted at U.S. and non-U.S. clinical sites and involving 40 INDs/IDEs for 75 different types of investigational products/devices in multiple clinical areas, including: asthma and allergic diseases, autoimmune disorders, such as type 1 diabetes and systemic lupus erythematosus, and immune-mediated rejection in solid organ, tissue and cell transplantation. For selected research programs, regulatory support has also been provided for oversight of Good Manufacturing Practices (GMP) as well as for nonclinical Good Laboratory Practices (GLP) for animal testing. The purpose of this contract is to establish a Division-wide Regulatory Management Center to: (1) centralize all regulatory support services for DAIT-funded clinical research programs, currently carried out under multiple grants and contracts, into a single contract dedicated to regulatory affairs; (2) provide regulatory support services for individual clinical trial projects conducted under investigator-initiated cooperative agreement grants within a centralized contract; and (3) provide regulatory support services for future DAIT-supported clinical research programs and individual projects. It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Year 1 and Option 1 - additional Years 2 through 10) to be approximately 5.4 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 25% over the base requirement which can be exercised up to 3 times per contract year. Options for electronic data submission to an internal DAIT-wide system as well electronic submission of IND/IDE documents to the FDA will be included. The Government estimates a 10% increase in the level of effort for each optional activity during the applicable period. The Contractor shall provide technical and administrative assistance to DAIT in carrying out the regulatory support functions listed below for both domestic and international sites. In instances where DAIT or DAIT-supported investigators serve as the IND or IDE sponsor, the Contractor shall provide the full spectrum of support services listed below. In instances where a company serves as the IND or IDE sponsor, the Contractor may be responsible for carrying out a subset of these regulatory support functions: 1. assistance in the preparation, submission and distribution of regulatory submissions, reports and other materials and in communications with Regulatory Health Authorities, including country-specific translations of regulatory submissions when necessary. 2. maintenance and management of Regulatory Health Authority submissions, reports and other materials, conduct of quality assurance checks, and preparation of status reports on Regulatory Health Authority submissions and activities. 3. assistance in implementing protocol-specific site registration requirements and conduct of training on the site registration process. 4. maintenance and management of the official (FDA-auditable) Sponsor Essential Clinical Documents (SECDs), conduct of quality assurance checks on the completeness of SECD files, and preparation of status reports on the completeness of the SECDs, noting expiration dates when applicable.. 5. electronic tracking of Safety Reports. 6. assistance in ensuring compliance with GCP, GLP and GMP requirements and conduct of training on such requirements. 7. coordination and collaboration with other DAIT contractors and grantees. 8. development and implementation of Standard Operating Procedures (SOPs) relevant to the regulatory support activities/operations. 9. participating in audits conducted by DAIT and by Regulatory Health Authorities and complying with the findings of audits and implementing corrective/remedial actions as necessary. 10. planning and implementation an Initial and a Final Transition of contract documents, reports, data and other materials. Potential sources must demonstrate and document the following in their capability statements: 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: Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. All capable small business organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by May 4, 2010. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Any proprietary information should be so marked.
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