Loren Data's SAM Daily™

FBO DAILY ISSUE OF SEPTEMBER 10, 2005 FBO #1384
SOURCES SOUGHT

R -- Sole Source Notice-Consulting Services

Notice Date

9/8/2005
 

Notice Type

Sources Sought
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
 

ZIP Code

20892-7663
 

Solicitation Number

263-2005-Q(GO)-0139
 

Response Due

9/15/2005
 

Archive Date

9/30/2005
 

Description

The National Institutes of Health intends to negotiate on a sole source basis under FAR Part 12, Acquisition for Commercial Items, and will be made pursuant to the authority in FAR 13.5, the Test Program for Certain Commercial Items with Lorraine G. Fitzsimmons, 3502 Victory Lane, Potomac, MD 20854. The provided services are commercial in nature as defined in FAR Part 2. The total contracted dollar amount will not exceed $5 million. Ms. Fitzsimmons is the only known source capable of providing the required supplies and services. This action is under the authority of 41 U.S.C. 253(c)(1), as set forth in FAR Subpart 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirement. The requirement is to research, gather information, and prepare analyses of current issues being explored by the CRpac (Clinical Research Policy Analysis and Coordination) program, including areas such as adverse event reporting; clinical trial monitoring; regulations governing research involving human biological materials; informed consent; third parties; streamlining and standardizing policies and guidelines required for the conduct of clinical research. Plan and organize a series of workshops and national conferences regarding clinical trial design and clinical trial monitoring issues with initial emphasis on the roles and responsibilities and operating procedures of Data and Safety and Monitoring Boards (DSMB). These meetings will explore issues such as IC variability in DSMB operating policies and procedures, best practices in data review, the independence of DSMB members and statistician, and conflict of interest screening. As necessary for information gathering purposes, interact with senior policy and program staff within the individual NIH ICs, staff in federal agencies and offices that have responsibilities relative to the oversight of clinical research, including the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the federal agencies that have adopted the Common Rule, as well as patient advocacy and voluntary organizations, professional and scientific organizations, bioethics community, IRB administrators, the academic research community, the pharmaceutical and biotechnology industries, and other constituencies with a stake in the conduct of clinical research. Ms. Fitzsimmons is the only known vendor that can meet NIH?s requirements. Ms. Fitzsimmons has had she has had significant and substantive involvement with a number of ongoing activities and issues related to the initiatives of the CRpac. Specifically, Ms. Fitzsimmons has been involved with the Trans-NIH Bioethics Advisory Committee (T-NBC) and worked on several related working groups, including the review of HHS regulations governing research involving children and guidelines for the use of human biological materials in research. Given Ms. Fitzsimmons wealth of knowledge, expertise, and specialized experience regarding clinical trial monitoring, she is uniquely qualified for this contract position. Interested parties may identify their interest and capability to respond to the requirement or submit proposals to the Contract Specialist within 7 days of this notice at 3PM EST. This acquisition will be processed under FAR Part 12, Acquisition for Commercial Items, and will be made pursuant to the authority in FAR 13.5, the Test Program for Certain Commercial Items. This notice of intent is not a request for competitive proposals. A determination by the Government not to compete with this proposed purcase order based on responses to this notice is solely within the discretion of the Government. A determination by the NIH not to compete this proposed purchase order based on responses to this notice is solely within the discretion of the NIH. Information received will normally be considered solely for the purpose of determing whether to conduct a competitive procurement. Address responses to the attention of Zedekiah J. Worsham at National Institutes of Health, 6011 Executive Blvd., Room 541E, MSC 7663, Bethesda, MD 20892-7663. The NAICS code for the procurement is 541519, and the business size is $6 million.
 

Place of Performance

Address: 9000 Rockville Pike, Bethesda, MD 20892

Zip Code: 20892

Country: USA
 

Record

SN00889929-W 20050910/050908211935 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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