Immune-Mediated Diseases Clinical Products Center
Added: Jun 30, 2017 4:03 pm
IntroductionThis is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. THE NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 EMPLOYEES.Background 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.A, 7-year contract was awarded to Eminent Services Corporation in Frederick, Maryland to establish the “DAIT Clinical Products Center” (Contract No. HHSN272201200001C). This contract provides DAIT with centralized services for the receipt, storage, packaging/repackaging, manufacture of placebo, preparation of serial dilutions, labeling, distribution, inventory and disposal of study products for clinical trials conducted by DAIT.Purpose and ObjectivesThe purpose of this contract is to continue these services for DAIT-supported, investigator-initiated clinical trials conducted under cooperative agreement grants, as well as other DAIT-funded clinical research programs. On a limited, as-needed basis, additional NIAID sponsored trials may be added as well.Project requirementsIt 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 Options 1-6 – additional Years 2 through 7) to be approximately 3.85 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 5% over the base requirement which can be exercised up to 5 times per contract year. Anticipated period of performanceThe period of performance will commence in early Fiscal Year 2019 for a period of one year, with six optional annual extensions.Capability statement / information soughtPotential sources must demonstrate and document the following in their capability statements:The Contractor shall establish and manage the CPC to provide support for clinical research programs and individual research projects, to include the following:1. establish, operate, manage, and maintain a system for the receipt, storage, inventory, packaging/repackaging, quality assurance, distribution and disposal of study products for clinical trials conducted by DAIT and other NIAID-support clinical research programs and projects, including: (i) receipt and storage of study products; (ii) inventory control and quality assurance; (iii) manufacture of placebo and preparation of serial dilutions; (iv) shipment and distribution of study products; (v) pharmaceutical services; (vi) the provision of security/safety procedures; (vii) processing and disposal of returned clinical products; (viii) the development and implementation of Standard Operating Procedures; and (ix) compliance with audits by Regulatory Health Authorities and independent audits by DAIT-designated entities. 2. operate, manage, maintain and update a centralized CPC Data Management and Reporting System.3. coordinate and collaborate with other DAIT clinical research support contractors.4. develop and implement of a Quality Assurance/Quality Control Plan.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.The following three Mandatory Qualification Criteria (MQC) will be required at the time of receipt of the Original Proposal and must be addressed in any capability statement received in response to this notice: 1) Offerors must have a permit to purchase and distribute drug products; 2) staff must include a licensed pharmacist able to purchase and distribute drug products and; 3) offerors must currently have or have had within the past 12 months the appropriate permits and/or licenses to import and export drug products.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. Written capability statements should be received by the Contracting Officer on or before 3:00 PM EST, July 14, 2017. Please reference the solicitation number on all related correspondence. No collect calls will be accepted.
NIAID-DAIT-NIHAI2017096 Department of Health and Human Services National Institutes of Health
6/30/17, 4:03 PM Immune-Mediated Diseases Clinical Products Center
Added: Aug 14, 2017 10:59 am
IntroductionThe 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 Allergy, Immunology, and Transplantation (DAIT) has a requirement for a clinical products center that will obtain, store, and deliver investigational agents to the appropriate clinical trials sites and personnel for DAIT-supported clinical trials, primarily those conducted by the Immune Tolerance Network (ITN). The center will be a central location for the receipt, storage, repackaging, labeling, and distribution of study products in accordance with federal regulations governing investigational agents.DescriptionResearch supported and conducted by NIAID, NIH, DHHS, strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. 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.In FY 2012 a 7-year contract was awarded to Eminent Services Corporation in Frederick, Maryland to establish the "Clinical Distribution Center" (Contract No. HHSN272201200001C). This contract provides DAIT with centralized services for the receipt, storage, packaging/repackaging, manufacture of placebo, preparation of serial dilutions, labeling, distribution, inventory and disposal of study products for clinical trials conducted by DAIT.The purpose of this contract is to continue these services for DAIT and expand the scope of services provided to include DAIT and NIAID-supported, investigator-initiated clinical trials conducted under cooperative agreement grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis.The following three Mandatory Qualification Criteria (MQC) must be met at the time of receipt of the Original Proposal;1.) Offerors must have a permit to purchase and distribute drug products; 2.) staff must include a licensed pharmacist able to purchase and distribute drug products and; 3.) offerors must currently have or have had within the past 12 months the appropriate permits and/or licenses to import and export drug products.TECHNICAL EVALUATION CRITERIA:CRITERIA WEIGHT1: TECHNICAL PLAN/APPROACH 602: SCIENTIFIC AND TECHNICAL PERSONNEL 203: FACILITIES, EQUIPMENT AND OTHER RESOURCES 104: PROJECT MANAGEMENT 10TOTAL POSSIBLE WEIGHT: 100It 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 Options 1-6 - Years 2 through 7) to be approximately 3.85 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 5% over the base requirement which can be exercised up to 5 times per contract year.Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about August 31, 2017, 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.nih.gov and then click on "How to Submit." 
NIAID-DAIT-NIHAI2017096 Department of Health and Human Services National Institutes of Health
8/14/17, 10:59 AM