SOURCES SOUGHT
A -- NIAID HIV/AIDS Scientific and Operations Support
- Notice Date
- 11/12/2014
- 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_RDSS_15_NIHAI2015030
- Archive Date
- 12/11/2014
- Point of Contact
- Robert J. Corno, Phone: 2406695151, John R. Manouelian, Phone: 2406695152
- E-Mail Address
-
robert.corno@nih.gov, manouelj@niaid.nih.gov
(robert.corno@nih.gov, manouelj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction/Synopsis This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources including small and small disadvantaged businesses to perform a potential R&D requirement. Background This Division of DAIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), project is for work related to the contract below: NIAID HIV/AIDS Scientific and Operations Support, Henry M. Jackson Foundation (Contract HHSN272200800014C) This contract was awarded on a competitive basis for a seven year period from March 1, 2008 through February 28, 2015 with the purpose of providing scientific, technical and operational expertise for NIAID HIV and AIDS research and particularly clinical research activities that are conducted as part of grant and contract awards. A term type/level of effort contract was awarded for the delivery of 77 Full Time Equivalents (FTEs) per year. The total value of the contract is $79,396,336 and includes options for extension of the term for a total performance period of 7 years and options for increases in the level of effort. A significant proportion of the work carried out by DAIDS is the oversight of the design, implementation, conduct and oversight of clinical trials and clinical studies supported through grants, contracts and interagency agreements. This includes NIAID-sponsored Phase I, II, III, IV and post-marketing trials of HIV therapeutic, vaccine and prevention clinical research. NIAID currently supports clinical research efforts through large clinical networks, individual single or multi-site grants, and partnerships with other Federal and non-Federal agencies. NIAID is currently supporting approximately 400 trials related to HIV and AIDS in various stages. These trials range from 10 to 6,000 participants and are conducted in more than 40 countries. Approximately half of the countries are resource poor. This Sources Sough 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 NIAID. Purpose and Objectives The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in 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 R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if it deemed necessary and appropriate. 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 Sources Sought Notice or the NIAID's use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. The objective of this acquisition is to continue to provide scientific, technical and operational expertise for NIAID DAIDS HIV and AIDS research and particularly clinical research activities that are conducted as part of grant and contract awards. This contract is intended to augment the capacity of services provided by existing research support contracts and provide needed flexibility and scalability. This contract will also involve daily interaction between Contractor and NIAID federal staff for time sensitive activities that require continuity, a high degree of collaborative problem solving and time sensitive decision making. The Contractor shall provide support for NIAID clinical research activities, program operations, communications, conflict of interest mitigation, non-disclosure and confidentiality issues, project management, and initial and final contract transitions. Project Requirements Offerors should have the qualifications, experience and capability to perform this requirement. The Contractor support shall be provided in the following major areas: A. Clinical Research Support B. Program Research and Operations Support C. Communications Support D. Conflict of Interest Mitigation, Non-Disclosure and Confidentiality E. Project Management F. Transition Support Services Required: A. Clinical Research Support : Includes providing advice and assistance to NIAID staff in support of: 1. Development and review of clinical study concepts and protocols 2. Clinical research site identification, assessment, preparation and training 3. Clinical site preparation team visits and follow-up visits 4. Clinical site visit scheduling and to track and manage of site visit reports and other materials necessary to document appropriate clinical, laboratory, pharmacy and data management facilities and services, staff and operating procedures. 5. Design and conduct of site and protocol-specific training 6. Preparation and filing of Investigational New Drug (IND) Applications 7. Ensure documentation of local Institutional Review Board (IRB) approval of protocols 8. Approve essential documentation, as defined by the International Conference on Harmonization ICH-E6-GCP (http://www.fda.gov/cder/guidance/959fnl.pdf) 9. Ensuring that clinical sites have a supply of study products; maintain required documentation of study products 10. Ensuring site compliance with regulatory and protocol-specific requirements including data collection and data management, pharmacy facilities and services, laboratory compliance of site and specialized laboratories 11. Ensuring safety oversight and monitoring 12. Data and Safety Monitoring Board (DSMB) activities 13. Scientific and administrative laboratory projects resulting from NIAID participation in the Global Enterprise and related partnerships 14. Designing, implementing and managing an efficient system for tracking clinical research documents and recording appropriate quality control of all documents needed for the life cycle of NIAID-sponsored clinical trials 15. Identification and response to a broad range of regulations, policies and guidelines governing the conduct of research involving human subjects in domestic and international settings 16. Evaluation and development of clinical research training programs B. Program Research and Operations Support : Includes providing advice and assistance to NIAID staff in support of: 1. Grant and contract portfolio tracking, analysis and monitoring 2. Data management systems and data quality assurance for DAIDS-supported clinical and non-clinical research programs 3. On-site scientific and technical activities conducted through cross-organization technical/scientific working groups, meetings, conferences, product reviews or project reviews. 4. Preparing responses to inquiries and requests for information concerning NIAID-funded research programs and policies from a broad range of audiences, including advocacy groups, health care professionals, health care research organizations, industry, investigators, Congress, other components of the Department of Health and Human Services, and other Federal agencies 5. Development of public health policies for HIV/AIDS research in domestic and international settings 6. Developing collaborations with a broad range of organizations and groups to ensure appropriate involvement and input into NIAID-sponsored HIV and AIDS research programs 7. Research support for document development relevant to the issues that impact HIV and AIDS clinical programs, collaborations, and product development efforts. This may involve understanding clinical trial agreements, confidentiality or disclosure agreements, or strategies to facilitate private sector participation in NIAID programs 8. Assist NIAID in coordinating and the scheduling of site visits and other activities requiring travel for staff of the NIAID, DAIDS-supported contractors and DAIDS-supported investigators 9. Coordination and support of Contractor staff travel C. Communications Support : Provide advice and assistance to NIAID staff to educate, raise awareness and document the results of DAIDS-sponsored clinical and other research activities for relevant scientific and non-scientific constituencies. This includes preparation and review of written materials and presentations concerning NIAID-sponsored HIV and AIDS research projects for scientific, press, and lay audiences. These materials must comply with Federal and NIH standards when developed for web distribution (e.g., Section 508 compliant). D. Conflict of Interest Mitigation, Non-Disclosure and Confidentiality Plan : The Contractor shall implement and monitor on an ongoing basis an organizational conflict of interest and non-disclosure/confidentiality plan, conduct an annual review and report and resolve breaches of the plan, and conduct training for all staff to ensure that these issues are consistently and effectively managed. E. Project Management : The Contractor shall establish and manage an organizational structure to support contract performance. Specifically, the Contractor shall: 1. Ensure that Contractor staff are available to meet with the Project Officer or his/her designees at the offices of NIAID in Bethesda, Maryland, with short notice; for any staff on official travel, his/her "acting" shall be available. 2. Develop and conduct a standard training program for all Contractor staff covering contract purpose and scope; organizational structure and supported research programs and research support contracts; Contractor organizational and management structure; Standard Operating Procedures for internal assignment, monitoring of tasks, and mitigation of conflicts of interest, disclosure and confidentiality concerns. F. Transition : Develop and implement a plan to ensure the orderly and efficient transition of data, materials and other resources to a successor contractor or to the Government. Performance Requirement and Anticipated Period of Performance A term/level of effort type contract is anticipated. The performance requirement will be the delivery of 58 Full Time Equivalents (FTEs) during the period March 1, 2015 through August 31, 2015. An option to extend services for a 6 month period (from September 1, 2015 through February 29, 2016) is also anticipated. Capability Statement/Information Sought Capability Statements that are submitted in response to this announcement should clearly convey information regarding the respondent's 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 that 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, that 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 number 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., large business, non-profit, educational institution, small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ Responses must be submitted no later than 3:00 PM (Eastern Standard Time), November 26, 2014. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted by e-mail to Robert Corno, Contract Specialist 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_RDSS_15_NIHAI2015030. Robert Corno Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases, NIH Email Address: cornorj@niaid.nih.gov 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. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Robert Corno Email Address: cornorj@niaid.nih.gov Contracting Officer: John R. Manouelian Email Address: manouelj@mail.nih.gov 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.
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- SN03571518-W 20141114/141112234616-27dda8800248e794a64eb6e9053a0797 (fbodaily.com)
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