Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases
Added: Aug 15, 2013 2:34 pm
SOURCES SOUGHT NOTICE Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases Contract RFP-NIAID-DMID-NIHAI2013180 Sources Sought Reference Number: RFP-NIAID-DMID-NIHAI2013180 Type of Requirement Follow-on (Contract No.: HHSN272200800013C) Place of Performance Place of performance is unknown at this time. Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, MD, 20892-7612 Sources Sought Notice Information Introduction This 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. 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 (HHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, medical devices and diagnostics, which are funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, device and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center clinical research and Phase 0 through 4 clinical trials evaluating bacterial, viral and parasitic vaccines, therapeutics, and other biologics, drugs, medical devices, and approaches as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, examples include: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines, medical devices and therapeutics for a wide variety of emerging and re-emerging infectious diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx), which includes NIAID Category A-C Priority Pathogens to meet critical public health needs. Purpose and Objectives The U.S. Government has a requirement for the establishment and management of a Statistical and Data Coordinating Center (SDCC) to support DMID's extramural clinical research programs. Project Requirements The project requirements of the SDCC include: statistical design and analysis expertise; computerized systems for the collection, storage, management, reporting and quality control of study data; assistance in the preparation of study-related materials; a system for the tracking of clinical specimens; data collection and management user training; clinical site capability assessment for data collection and management; project/site management; and, a data repository for completed DMID-sponsored clinical studies. Anticipated Period of Performance The Government anticipates making one (1) contract award. It is anticipated that the duration of the contract will be a maximum of seven (7) years. Capability Statement / Information Sought Sources are expected to have the expertise, personnel, and facilities to meet the requirements stated herein. Tailored Capability Statements submitted as a result of this notice should demonstrate the prospective offerors' qualifications and experience, specifically providing evidence as to their capability to perform the requirements herein, with particular attention to the following technical areas:· Ability to carry out statistical design and analysis functions for Phase 0-4 clinical trials evaluating therapeutics, vaccines and devices for a wide variety of infectious diseases.· Ability to collect, manage, store and ensure quality of clinical and laboratory data.· Ability to design, manage and update clinical study-related materials.· Ability to design, manage, update and ensure secure access to a clinical study website.· Ability to coordinate and collaborate with clinical research support services contractors to facilitate study implementation and assess study progress.· Ability to provide training and technical assistance to participating clinical study sites.· Ability to design and manage an electronic specimen tracking system.· Ability to provide study/trial-specific project management. Technical Plan/Approach: appropriateness and adequacy of the plans for conducting all the activities described above. 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. It is estimated that 41.50 Full-Time Equivalents (FTEs), with each FTE working 2,080 hours per year, including subcontractor and consultant personnel, will be required. Facilities/Resources/IT Security: adequacy, appropriateness of the facilities and resources dedicated to the project and security against catastrophic loss of data or important software. 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 (3) other projects of similar size and complexity. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five (5) pages in length, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information must be marked as such. Required Business Information: DUNS.Company Name.Company Address.Company Primary Point of Contact: name, phone number, and e-mail address.Company Secondary Point of Contact: name, phone number, and e-mail address. Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system? If so, please identify the agency that approved the system.Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (formerly the Central Contractor Registration [CCR]), located at https://www.sam.gov/portal/public/SAM/. This indication should be clearly marked on the first page of your Capability Statement (preferably placed beneath the eligible small business concern's name and address). Number of Copies: Please submit one (1) electronic copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Frank Vidergar, Contract Specialist, at vidergarf@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify RFP-NIAID-DMID-NIHAI2013180. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 11:00 AM (Eastern Time) on Monday, September 2, 2013. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Responses to this notice will be reviewed by NIH personnel only, and will be held in a confidential manner. 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. 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(s).
RFP-NIAID-DMID-NIHAI2013180 Department of Health and Human Services National Institutes of Health
8/15/13, 2:34 PM Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases
Added: Oct 29, 2013 4:22 pm
Type of Requirement: Re-competition 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 Microbiology and Infectious Diseases (DMID), has a requirement for a Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases, described below.DescriptionResearch supported and conducted by the NIAID, NIH, DHHS, strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID DMID supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, medical devices and diagnostics, which are funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, device and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center clinical research and Phase 0 through 4 clinical trials evaluating bacterial, viral and parasitic vaccines, therapeutics, and other biologics, drugs, medical devices, and approaches as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies. Examples include: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines, medical devices and therapeutics for a wide variety of emerging and re-emerging infectious diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx), which includes NIAID Category A-C Priority Pathogens to meet critical public health needs. NIAID is conducting an acquisition for the establishment and management of a Statistical and Data Coordinating Center to support DMID's extramural clinical research programs through the provision of: statistical design and analysis expertise; computerized systems for the collection, storage, management, reporting and quality control of study data; assistance in the preparation of study-related materials; a system for the tracking of clinical specimens; data collection and management user training; clinical site capability assessment for data collection and management; project/site management; and, a data repository for completed DMID-sponsored clinical studies. This requirement will be conducted as a Total Small Business Set-Aside.It is anticipated that one (1) cost-reimbursement, Level-of-Effort type contract will be awarded for a one-year Base period and six (6), one-year term Option periods with the period of performance beginning on or about December 1, 2014. It is estimated that 41.40 Full-Time Equivalents (FTEs) per year, including subcontractor and consultant personnel, will be required. This information is furnished to potential offerors for information purposes only and is not to be considered restrictive for proposal purposes.Any responsible offeror may submit a proposal to be considered by NIAID in response to the posting of an Request for Proposal (RFP). The RFP is anticipated to be posted electronically on or about November 18, 2013, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. Directions for proposal submission will be included in the RFP. In order to be eligible for award of a contract, registration under North American Industry Classification System (NAICS) code 541712--Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) is required. The small business size standard is 500 employees. To register, go to https://www.sam.gov/portal/public/SAM/. This notice does not commit the Government to actually posting an RFP nor to the award of a contract. Dates listed above are approximate and are included for reference only.Contact with Government personnel, other than the following points of contact, by a potential offeror or its employees regarding this acquisition is strictly prohibited. Questions regarding this notice should be directed to the following:Primary Point of ContactFrank M. VidergarContract Specialistvidergarf@niaid.nih.govPhone - (301) 402-1490Fax - (301) 402-0972Secondary Point of ContactAileene Mitchell FordContracting Officeraileene.mitchellford@nih.govPhone - (301) 496-7288Fax - (301) 402-0972 No collect calls will be accepted.
RFP-NIAID-DMID-NIHAI2013180 Department of Health and Human Services National Institutes of Health
10/29/13, 4:22 PM