Amendment 1 - RFP-NIHAI2010032.pdf

Amendment #1 to RFP-NIAID-DAIT-NIHAI2010032 NIAID Division of Allergy, Immunology and Transplantation: Clinical Site Monitoring Center

Amendment to Solicitation No.: RFP-NIAID-DAIT-NIHAI2010032

Amendment No.: 1 (1st posting)

Issue Date: January 10, 2011

Effective Date:

Proposal Due Date:

January 10, 2011

February 22, 2011 at 3:00 P.M. local time

Issued By: David T. Lisle Contracting Officer

NIH/NIAID

Office of Acquisitions 6700 B Rockledge Drive Room 3112 Bethesda, Maryland 20892-7612

Point of Contact: MyLinh Pham, Contract Specialist phamm@exchange.nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals HAS NOT been extended. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to this Amendment # 1 for additional Questions & Answers.

Question 1: In regards to Option #3 Provision of Accessibility to a DAIT-WIDE CLINICAL RESEARCH INFORMATION SYSTEM. If this is implemented in year 3 of the contract period of performance our IT specialist would like to know if we are actually developing this Division-wide information system or if this system is already developed?

Response to Question 1: In the event that a DAIT-wide information system with multi-directional flows of key information between the Division and their collaborators is developed and implemented by DAIT during the contract period of performance, the Clinical Site Monitoring Center (CSMC) contractor would be responsible for:

• In collaboration with the DAIT-wide information system management and collaborators. establishing the provision of direct, automated access from their contract-generated data, report and other materials, stored in the CSMC Management and Reporting System to the DAIT-wide information system

• In collaboration with the DAIT-wide information system management and collaborators, developing/deploying accessibility mechanisms required to achieve direct, automated access from CSMC information system(s) to the DAIT-wide information system, in accordance with specification(s) that would be provided by the DAIT Contracting Officer Technical Representative. (COTR).

Question 2: Would our IT specialist be helping with the accessibility mechanisms for automated access?

Response to Question 2: Yes, please refer to prior answer.

Question 3: It would be useful information to a bidder to know what commercial off-the-shelf (COTS) system is currently being used, since this might be the system that the bidder would propose in order to make a transition smoother. Could DAIT please provide the name of the COTS system currently being used to manage this information.

Response to Question 3: The NIAID did not make information about any systems currently being used by contractors to fulfill any portion of this requirement available in the subject solicitation because the NIAID has no intent of transferring any current systems for use under the anticipated new contract award. All offerors must propose a system that meets the requirements of the solicitation without regard to any systems currently in use.

The central intent of requiring commercial and off-the-shelf software is to avoid the risks and costs associated with interfacing with and migrating data from proprietary, undocumented, and/or unsupported systems. Within the context of the RFP, "commercially available" refers to hardware and software that:

• Is pre-packaged and off-the-shelf (i.e. not developed specifically or solely for use under the CSMC contract)

• Can be purchased or licensed from one or more vendors with a pre-existing presence in the marketplace

• Is available to, and used by, other governmental and private industry users

• Is regularly updated with bug fixes and enhancements

• Has maintenance and support available from the vendor and/or third-parties.

If the cost of licenses and maintenance are included the CSMC contract, they should be transferrable to the Government.

Amendment #1 to RFP-NIAID-DAIT-NIHAI2010032