MODIFICATION
A -- NIAID/Division of AIDS: Regulatory Support Center
- Notice Date
- 1/22/2016
- Notice Type
- Modification/Amendment
- 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
- NIAID-DAIDS-NIHAI2015049
- Archive Date
- 2/20/2016
- Point of Contact
- Ashley Virts, Phone: 240-669-5154, John Manouelian, Phone: 240-669-5152
- E-Mail Address
-
virtsa@mail.nih.gov, manouelj@mail.nih.gov
(virtsa@mail.nih.gov, manouelj@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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 has a requirement for regulatory and technical support services for DAIDS-supported clinical trials and clinical research and to meet evolving regulatory and scientific needs. Description The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to bring an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the advancement of therapies for HIV infection and its complications, and supporting 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 to accomplish the Division'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. This contract will be used primarily to support DAIDS activities. However, this contract may be used to support other NIAID programs as necessary to help accomplish our mission. DAIDS acts as study sponsor for clinical trials that meet the requirements to be conducted under Health Authority (HA) oversight (U.S. Food and Drug Administration [FDA] and others as appropriate), of Investigational New Drug (IND) studies, as well as those studies that do not meet these requirements (non-IND). As of May 2015, there are 61 active INDs containing 117 protocols (86 active), and 1342 clinical research sites (718 domestic, 624 international) with trials being conducted in 64 (22 active) different countries. As the IND sponsor for a large number of DAIDS-supported clinical trials, there is an established requirement for DAIDS to provide regulatory support for these clinical trials to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Parts 11, 50, 54, 56, 312, and 314 and Title 45 CFR Part 46. Clinical trials must also be conducted in accordance with the International Conference on Harmonisation (ICH) Guidelines: E2A Clinical Safety Data Management and E6 Good Clinical Practices (GCP), and country-specific regulatory requirements. In order to provide regulatory support services for DAIDS clinical research and clinical trials, on April 15, 2010, a seven-year contract [Contract No. HHSN272201000013C] was awarded to Technical Resources International, Inc. to operate the Regulatory Support Center (RSC). The purpose of this solicitation is to continue clinical regulatory and technical support services for DAIDS-supported clinical trials and clinical research and to meet evolving regulatory and scientific needs. The purpose of the proposed contract is to provide regulatory expertise and support to operate and manage the Division of AIDS (DAIDS) Regulatory Support Center (RSC) to provide a wide range of clinical research activities and programs for DAIDS. 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. Specifically, the contractor shall: 1. Assist NIAID with developing SOPs, quality assurance/quality control (QA/QC) plans, training, meetings with Health Authorities and other stakeholders, and other general tasks such as providing administrative support. 2. Review documents for regulatory compliance, and prepare and file new regulatory filings [such as Investigation New Drug Applications (INDs)] and amendments to existing regulatory filings, in compliance with all applicable regulations. 3. Support safety and pharmacovigilance activities including safety reporting activities for NIAID-supported studies (IND and non-IND studies as well as those under other Health Authority purview), distribution of safety reports and safety information, and other NIAID projects. 4. Database and Website support: Operate, maintain and update a public Government-labeled website to provide access to documentation and links to resources for clinical research regulatory requirements and other clinical research/trial implementation functions. Operate and maintain a collaboration website, which serves as an interactive portal for the shared development and final publication of documents used by RSC in conjunction with DAIDS. 5. Receive, process, and track all protocol registration materials supporting DAIDS IND and non-IND studies. 6. Maintain clinical study and study-related information as well as a library of documents in the NIAID-Clinical Research Management System (N-CRMS). 7. Assist DAIDS to prepare, negotiate, finalize and distribute Clinical Trial Agreements (CTAs) and other research agreements. 8. P rovide support on Human Subjects Protection (HSP)-related issues as well as for meeting ClinicalTrials.gov requirements. 9. Assist DAIDS with technical, regulatory and administrative review of clinical documents (such as protocols and sample informed consents) for scientific review committees. 10. Provide other related regulatory support, as directed by the COR. Anticipated Period of Performance It is anticipated that one (1) cost-plus-award-fee, level-of-effort (term) type contract will be awarded. The Contracting Officer has determined that a performance based contract is suitable for this acquisition. An Award Fee Plan will be included in the solicitation. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about February 15, 2017. The requirement will be for the delivery of 48.45 full time equivalents (FTEs) per year, inclusive of subcontractors and consultants, for the Base Period (Year 1) and each option period (Years 2 through 7). In addition, the Government may unilaterally exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include: Increased Level of Effort (1.0 FTE): The Government may exercise options for incremental increases in the level of effort. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. For each option quantity exercised, the Contractor shall provide an additional 1.0 FTE, inclusive of subcontractor and consultant effort. Up to two (2) Options per year may be exercised during years 1 through 7 of contract performance. Increased Level of Effort (2.0 FTEs): The Government may exercise options for incremental increases in the level of effort. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. For each option quantity exercised, the Contractor shall provide an additional 2.0 FTEs, inclusive of subcontractor and consultant effort. Up to two (2) Options per year may be exercised during years 1 through 7 of contract performance. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/abou t 02/05/2016, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit." Added: <input type="hidden" name="dnf_class_values[procurement_notice][description][1][added_on]" value="2016-01-21 16:21:33">Jan 21, 2016 4:21 pm Modified: <input type="hidden" name="dnf_class_values[procurement_notice][description][1][modified_on]" value="2016-01-22 10:50:03">Jan 22, 2016 10:50 am Track Changes
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