NIAID/Division of AIDS: Regulatory Support Center
Introduction:
This Research and Development (R&D) Sources Sought notice was originally published on February 27, 2019 under HHS-NIH-NIAID-RDSS-75N93019R00004, with a response date of March 14, 2019 by 3:00 PM (Local Time). We have revised the R&D Sources Sought notice to include the additional required activities that were left off of the original notice. If you have previously submitted a Capability Statement, you must resubmit in response to this notice. If you have not previously submitted a Capability Statement, you may submit in response to this notice.
This is a 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:
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The mission of Division of AIDS, AIDS (DAIDS), NIAID, is to bring an end to the HIV/AIDS epidemic by increasing the basic knowledge of the pathogenesis and transmission of HIV, to support the advancement of therapies for HIV infection and its complications, and to support the development of HIV/AIDS vaccines and other prevention measures. NIAID/DAIDS, henceforth referred to as DAIDS, supports extramural Clinical Trials Networks, investigator-initiated clinical trials, and partners with other Government and private organizations, in order to accomplish DAIDS's scientific objectives. Through grants and contracts, DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines, and other preventive modalities.
The DAIDS global clinical trial portfolio includes approximately 440 active protocols, 73 active INDs, 300+ network study sites in 22 countries, and collaborations with 60 pharmaceutical companies. This contract provides comprehensive clinical regulatory support services for all DAIDS-supported network and non-network clinical trials. As the Investigational New Drug (IND) Application Sponsor for a large number of DAIDS-funded clinical trials, DAIDS is required to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and ICH E6(R2) International Conference on Harmonisation-Good Clinical Practices (ICH-GCP).
In order to provide regulatory support services for the aforementioned DAIDS clinical trials portfolio, a restricted competition (small business set-aside) was held, which resulted in the award of a to Technical Resources International, Inc., 6500 Rock Spring Drive, Suite 650, Bethesda, MD 20817. A cost-plus-award fee, term form contract was awarded on April 15, 2017, to deliver 48.45 full time equivalents (FTEs) per year, with term options to extend the period of performance, for a total period of seven years, through April 14, 2024, and quantity options for increased level of effort for unanticipated increases in demand. The total value of the contract is $79,104,240 including the Base Period and all Options.
This contract provides regulatory expertise and support to operate and manage the NIAID/Division of AIDS (DAIDS) Regulatory Support Center (RSC), to provide a wide range of clinical research activities and programs for DAIDS, including the delivery of regulatory support services for unanticipated DAIDS clinical research projects that may be required in response to emerging needs or public health emergencies. The DAIDS RSC provides comprehensive regulatory support to: 1) perform DAIDS-funded and DAIDS-sponsored domestic and international clinical trial research; 2) provide training in key functions of clinical trial research to DAIDS staff, investigators, and collaborators; and 3) maintain all contract-associated data and records in the DAIDS Enterprise System (DAIDS-ES) and NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information.
The contract was awarded based on the assumptions that the Contractor would be providing regulatory support services in compliance with the current regulatory requirements existing at that time. However, since the award of the contract in April 2017, data from many of the clinical trials are now being submitted as part of marketing applications, to both the U.S. Food and Drug Administration (FDA) and other regulatory authorities around the world [e.g., the EMA, and the South African Health Products Regulatory Authority (SAHPRA)], which requires that DAIDS be compliant with requirements for multiple regulatory agencies. Further, DAIDS is required to address any current and future findings resulting from regulatory agency inspections for all submitted clinical trials, in order ensure that DAIDS meets all current as well as evolving national, international, ICH-GCP, and country-specific regulatory requirements. Finally, the number of pending and on-going clinical trials has increased by more than was expected from the time the solicitation for this contract award was published. The foregoing has led to an increase in the volume of regulatory support services required, which has resulted in the need to increase the number of FTEs that will be needed to carry out work under the contract over the next 4.5 years (see Project Requirements below).
This Sources Sought 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 increase the quantity of FTEs to be delivered to the Government through the remainder of the current contract, beginning on October 15, 2019 of Option 2/Contract Year 3, thereby increasing the effort available to support the increase in volume of regulatory support services required. These additional regulatory support resources are needed, in order to: provide regulatory support services in compliance with regulatory requirements for multiple regulatory agencies, which have evolved since the award of the contract; address current and future regulatory findings, in order to be in compliance with evolving requirements from the various regulatory agencies; and support an increase in the number of submissions to regulatory authorities. These additional needs are compounded by the increase in number of pending and on-going clinical trials for which regulatory support services are required.
Project requirements:
Specifically, the Contractor will be responsible for the following activities: 1) Assisting with the development of SOPs, quality assurance quality control plans, training, meetings with Health Authorities; 2) Reviewing document for regulatory compliance and preparing and filing new regulatory (such as INDs); 3) Safety and Pharmacovigilance activities including safety reporting; 4) Database and website operation and maintenance; 5) Tracking all protocol registration materials; 6) Maintaining clinical and study related information in the NIAID Clinical Research Management system; 7) Assisting with preparing, negotiating, and finalizing Clinical Trial Agreements; 8) Assisting with human subjects protection related issues and ClinicalTrials.gov requirements; and 9) Assisting with technical regulatory and administrative review of clinical documents (such as protocols and consent forms).
Specifically, the Contractor will be responsible for the following additional activities:
1. Establish a fully validated, centralized electronic Trial Master File (eTMF) for clinical trial protocols funded by DAIDS/for which DAIDS is Sponsor.
2. Conduct two-way safety data reconciliation with the Data Management Centers.
3. Support pharmacovigilance activities, to include trend analysis and signal detection, using advanced analytics.
4. Support DAIDS's compliance as study product manufacturer and regulatory Sponsor.
5. Provide technical and administrative support services for DAIDS policies and inspection-related activities.
The NIAID intends to modify the existing contract with Technical Resources International, Inc., to provide an increase to the required Level of Effort under the base requirement (Options 2-6) as follows:
• An increase of 18 FTEs (from 48.45 FTEs to 66.45 FTEs) in Option 2/Year 3 (beginning October 15, 2019)
• An increase 13 FTEs (from 48.45 FTEs to 61.45 FTEs) in Option 3/Year 4
• An increase 16 FTEs (from 48.45 FTEs to 64.45 FTEs) in Option 4/Year 5
• An increase 16 FTEs (from 48.45 FTEs to 64.45 FTEs) in Option 5/Year 6
• An increase 15 FTEs (from 48.45 FTEs to 63.45 FTEs) in Option 6/Year 7
A Total Increase of 78 FTEs (Options 2-6/Contract Years 3-7)
Anticipated period of performance:
The increase in FTEs is anticipated to be applied to the term options (Options 2-6/Contract Years 3-7), beginning October 15, 2019 through April 14, 2024, of the current contract.
Other important considerations:
Work under this contract will be performed in the U.S. and internationally, and would apply to all DAIDS-sponsored and/or DAIDS-funded clinical trials.
Capability statement / information sought:
Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability statements should clearly convey information regarding the respondent's capabilities, including: (1) 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 a 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 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 institute, 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 (Local Time), March 29, 2019. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Robert Corno, Contracting Officer, at cornorj@niaid.nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS-NIH-NIAID-RDSS-75N93019R00013. Facsimile responses will not be accepted.
Common Cut-off Date:
Electronically submitted, tailored capability statements are due not later than 3:00 PM (Local Time), on March 29, 2019. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE ACCEPTED AFTER THE DUE DATE.
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.
The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses:
Contracting Officer: Robert Corno
Email Address: cornorj@niaid.nih.gov
Contracting Officer: John 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.
Robert J. Corno, Contracting Officer, Phone 2406695151, Email cornorj@niaid.nih.gov - John Manouelian, Contracting Officer, Phone 2406695152, Email manouelj@niaid.nih.gov
