RELEASE DATE:  June 17, 2004

NOTICE:  NOT-AI-04-037
National Institute of Allergy and Infectious Diseases (NIAID) 

RECEIPT DATE:  September 17, 2004


The Division of AIDS (DAIDS), of the National Institute of Allergy and 
Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking 
organizations with clinical and technical expertise and facilities to advance 
the Division of AIDS (DAIDS) clinical research mission through the provision 
of flexible research management support services and activities at multiple 
levels to facilitate a complex and rapidly evolving global research agenda.  
This project is being solicited under full-and-open competition under NAICS 
541710 but this decision may be subject to change following the final review 
by the NIH Small Business Officer.  A Pre-Proposal Conference will be held to 
provide potential offerors an opportunity to participate in a discussion of 
the requirements identified in this RFP.  The date for the pre-proposal 
conference will be listed in the solicitation. The DAIDS is seeking a 
contractor to provide a set of Core Functions that will constitute a 
comprehensive Centralized Clinical Research Program Management Center to 
support multiple Phase I, II and III HIV clinical research efforts.  The 
functions designated as “Core” in the SOW provide critical oversight and 
management of clinical trial operations that are vital to the DAIDS mission 
and include centralized clinical research program management subcontract 
acquisition and management, and contract transition.  Therefore, only 
offerors that propose to perform the functions designated as “Core Functions” 
within their own organization (not subcontracted out) will be considered for 
Technical Evaluation.  A second component of the proposed contract is 
comprised of a set of “Non-Core Functions” that are highly specialized 
activities, with the emphasis being on the contractor’s ability to provide 
rapid response to requests to perform these Non-Core Functions either through 
subcontracts or assuming the additional work in-house for a variety of 
support to the Division of AIDS Network and non-Network activities.   It is 
important to note that these Non-Core Functions cannot be quantified at this 
time but rather can only be defined as a general set of clinical trials 
management activities that will be needed as the DAIDS portfolio evolves and 
the DAIDS product-development cycle continues.  All offerors responding to 
this solicitation will be provided with a uniform dollar assumption for the 
anticipated costs of subcontracting activities for Non-Core Functions.  All 
offerors will be directed to NOT provide any names or specific information 
regarding future subcontracting activities.  This critical contract will 
reside within a complex research environment and will require that the 
contractor work with a consortium of multiple clinical trial groups and DAIDS 
contractors.  The work will be primarily international in scope and conducted 
in developing countries.   Specific functions performed within this contract 
will vary and will be trial-specific.  The contractor must have the capacity 
and capability to work with DAIDS-specified grantees and contractors and must 
possess the ability and relevant scientific expertise to establish necessary 
linkages (administrative, logistical, operational, information technology, 
etc.) as required for sound research program management and clinical trials 
management.  Major Core Functions will include centralized clinical research 
program management, subcontract acquisition and management, and contract 
transition.  Major Non-Core Functions will include site management activities 
to include:  site identification/assessment activities (preparation, 
coordination, evaluation, financial management, staff recruitment, equipment 
and facilities management, and on-the-ground oversight); clinical trials 
management activities [data management, DSMB support, biostatistical support, 
laboratory and specialized studies support, medical writing and document 
generation, shipping, pharmacy support, communication support, volunteer 
recruitment and retention, and volunteer counseling and clinical trials 
compliance activities (training, regulatory activities, monitoring, quality 
assurance, safety monitoring].  The prime contractor must have the ability to 
sub-contract with a variety of expert vendors and manage those contracts.  
Offerors will be evaluated on: experience in global research program 
management, subcontracting acquisition and management, and ability to provide 
support in the form of a wide variety of tasks associated with Phase I, II 
and III clinical trials.  Past experience in conducting complex programs and 
partnering with multiple entities to provide support for a clinical trial and 
infrastructure development and staffing, ability to obtain and provide on-
the-ground staff and expertise in the conduct of clinical research in 
resource-constrained areas such as Southeast Asia, Africa, Eastern Europe; 
experience in similar projects with special emphasis on the ability to 
anticipate special conditions likely encountered among resource-constrained 
sites in developing countries; experience in working with the political and 
diplomatic demands of research management in international settings; ability 
to provide expert subcontracts for all facets of clinical trials and clinical 
research management; provision of IT support and infrastructure development 
for IT capacity in resource-constrained countries; experience in managing 
large complex clinical research programs and a large complement of 
subcontracts; location of management core of key personnel in the Washington, 
D.C. area; and willingness to partner with Contract Research Organizations 
(CROs), Site Management Organizations (SMOs), Federal entities, 
pharmaceutical companies, and Non-Governmental Organizations (NGOs).   

This is a new effort; there is no incumbent.  This new contract will be 
awarded as a cost-reimbursement, incrementally-funded type contract.  It is 
anticipated that the period of performance for this contract will be a total 
of five years with an estimated level-of-effort of 150,400 total labor hours 
per year (approximately 80 FTEs) with an unknown quantity of subcontracts at 
this time. 

RFP-NIH-NIAID-DAIDS-05-06 will be available electronically on the CMP 
Homepage on or about June 17, 2004, 
http://www.niaid.nih.gov/contract/default.htm and will be posted in the 
FedBizOpps, http://www.fedbizopps.gov/.  Only electronic copies of the 
solicitation will be available.  All information required for the submission 
of an offer will be contained in the solicitation.  Responses to this RFP 
will be due September 17, 2004.

Any responsible offeror may submit a proposal that will be considered by the 
Government. This announcement does not commit the Government to award a 
contract. No collect calls will be accepted. No facsimile transmissions will 
be accepted.  


Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD  20892-7605


Elizabeth Shanahan, Contract Specialist, Phone 301-594-6309, 
Fax 301-480-5253, Email es219j@nih.gov
Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, 
Fax 301-480-5253, Email bs92y@nih.gov

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