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Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

Solicitation Number: RFP-NIAID-DMID-NIHAI2013180
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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RFP-NIAID-DMID-NIHAI2013180
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Solicitation
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Added: Oct 29, 2013 4:22 pm Modified: Nov 22, 2013 5:07 pmTrack Changes



Type of Requirement:   Re-competition


 


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, 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.


 


Description


Research 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.


 


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/.


 


Questions regarding this solicitation should be directed to only the primary or secondary points of contact whose information is provided in this solicitation.  Contact with Government personnel other than the primary or secondary points of contact is strictly prohibited.

Added: Dec 24, 2013 1:40 pm

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AMENDMENT 1 to RFP-NIAID-DMID-NIHAI2013180


“Statistical and Data Coordinating Center (SDCC) for


Clinical Research in Infectious Diseases”


 


Posted to FedBizOpps.gov on Tuesday, December 24, 2013.


 


Summary of Changes


 


Amendment 1 makes the following changes to Solicitation RFP-NIAID-DMID-NIHAI2013180 (which was originally posted to https://www.fbo.gov/ on November 22, 2013):


 


Change Location:  Cover Page.  


Description:  Establishes a deadline for NIAID Contract Specialist’s receipt of offerors’ questions of Monday, January 13, 2013.


 


Change Location:  ARTICLE B.3.  ESTIMATED COST – OPTION


Description:  Lines added to option schedule table so as to include Option 12 for contingency extension of services which, if exercised, could add a total of no more than six(6) months to the Contract’s overall Period of Performance under FAR Clause 52.217-8.


 


Change Location:  ARTICLE I.3.  ADDITIONAL CONTRACT CLAUSES


Description:  Removes bracketed text under Items 4 and 5.  Inclusion of this text in original posting of this RFP was an oversight.  Bracketed text should have been deleted prior to the November 22, 2013 posting of this RFP at https://www.fbo.gov/ .


 


Change Location:  ATTACHMENT 3:  STATEMENT OF WORK, last page.


Description:  In light of Option 12-related information added under this amendment to ARTICLE B.3.  ESTIMATED COST – OPTION (see above) and to ATTACHMENT 7 (see below), and in interest of maintaining consistency through the RFP, this amendment also adds a brief reference to Option 12 in ATTACHMENT 3:  STATEMENT OF WORK.


 


Change Location:  ATTACHMENT 7:  ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS, page 5 of 6.


Description:  Updates text related to Option 12:  Option to Extend Services so as to include assumption according to which offerors’ should prepare their price proposal for Option 12.  

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Solicitation 1

Type:
Solicitation
Posted Date:
November 22, 2013
Description: Solicitation
Description: Attachments

Solicitation 2

Type:
Solicitation
Posted Date:
December 24, 2013
Description: RFP SDCC (amended 12-24-13)
Description: ATTACHMENTS 1-8 (amended 12-24-13)
Description: Amendment 1 Summary of Changes
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Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
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The place of performance is currently unknown.

United States
:
Frank Vidergar,
Contract Specialist
Phone: 301-402-1490
Fax: 301-402-4675
:
Aileene Mitchell Ford,
Contracting Officer
Phone: 301-496-7288
Fax: 301-402-4675