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FBO DAILY ISSUE OF APRIL 04, 2004 FBO #0860
SOURCES SOUGHT

R -- FDA Electronic Submissions Gateway

Notice Date

4/2/2004
 

Notice Type

Sources Sought
 

NAICS

541512 — Computer Systems Design Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
 

ZIP Code

20857
 

Solicitation Number

Reference-Number-223-04-5504
 

Response Due

4/20/2004
 

Archive Date

5/5/2004
 

Point of Contact

Katharine Minker, Contract Specialist, Phone (301) 827-7155, Fax (301) 827-7151, - Katharine Minker, Contract Specialist, Phone (301) 827-7155, Fax (301) 827-7151,
 

E-Mail Address

kminker@oc.fda.gov, kminker@oc.fda.gov
 

Description

Sources Sought Synopsis for FDA Electronic Submissions Gateway This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. This is not a request for a formal proposal. The anticipated NAICS Code for this acquisition is 541512 with a size standard of $21M. This synopsis seeks to identify contractors that can provide the services described below. The FDA anticipates award of a firm fixed price contract with a 15-month period of performance and a start date of no later than 09/01/2004. The major objectives to be accomplished under this contract are: 1) to determine system requirements; 2) to design the target architecture and 3) to support implementation contract procurement for the receipt and processing of PDUFA related regulatory application submissions through the use of a single point of entry. In addition, the target architecture must provide for an extensible and scalable design such that additional non-PDUFA needs can be readily accommodated. In 1997, the Food and Drug Administration Modernization Act (FDAMA) required that FDA move towards the goal of a paperless submission and review environment. The regulatory reform initiatives in FDAMA and Prescription Drug User Fee Act (PDUFA II) mandated that CBER & CDER have the capability to receive all PDUFA-related regulatory submissions electronically by the year 2002. More recently, PDUFA III has established the following goals in relation to Electronic Applications and Submissions (Section XII): FDA will implement a common solution in CBER, CDER, ORA and OC for the secure exchange of content including secure e-mail, electronic signatures, and secure submission of, and access to application components. FDA will deliver a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment. This will support CBER, CDER, OC and ORA. The system should automate the current electronic submission processes such as checking the content of electronic submissions for completeness and electronically acknowledging submissions. FDA will provide a specification format for the electronic submission of the Common Technical Document (eCTD), and provide an electronic review system for this new format that will be used by CBER, CDER and ORA reviewers. Implementation should include training to ensure successful deployment. This project will serve as the foundation for automation of other types of electronic submissions. The review software will be made available to the public. Where common business needs exist, CBER, CDER, ORA and OC will use the same software applications, such as eCTD software, and COTS solutions. FDA receives electronic submissions including IND, BLA, NDA, and IDE regulatory applications as well as their associated correspondence and other types of submissions defined by business units. While many of these are received online, this project will support a unified FDA business solution. With the increasing number of electronic submissions and the initial release of the Electronic Common Technical Document (eCTD), it is critical to automate and standardize the receipt and processing of these submissions. The objective of the E-Submissions Gateway is to enable the receipt of guidance-compliant electronic submissions over the Internet and to integrate the processing of these submissions with the CBER and CDER environments (as well as extending to other FDA Center/Office needs). This will enable the FDA to address (if not meet) the PDUFA III Electronic Applications and Submissions Goals of: A single point of entry for the receipt and processing of all electronic submissions in a highly secure environment, Automating the current electronic processes such as checking the content of the electronic submission for completeness and electronically acknowledging submissions, Supporting the electronic submission of the eCTD. The electronic submission process is defined as the receipt, acknowledgment (to the applicant/sponsor), routing, and notification (to a receiving Center) of the receipt of an electronic submission. ?Receipt? means transfer of a submission from a transaction partner?s system to temporary storage in the FDA Gateway. ?Acknowledgment? to the sender which includes a detailed submission log confirming what was sent from a transaction partner?s system and received by the Gateway. ?Routing? refers to delivering a submission (and corresponding log files) to a Center-level storage area and initiating a manual or automated load process (if established) to place a submission into a Center receiving system (e.g. CBER EDR, CDER EDR). ?Notification? of a submission?s arrival is made to those responsible for the Center receiving system. These steps comprise the whole scope of electronic submission delivery. Part of this task is the replacement of the current Gateway functionality. The Gateway currently routes Individual Case Safety Reports (ICSRs) to the Adverse Event Reporting System (AERS) in CDER and CBER for processing. The other element of this task is the integration of the receipt, acknowledgment, routing and notification procedures that need to be incorporated to fully automate the electronic submission process. The solution will have an impact on the current electronic submission receipt and processing. A Word file will be posted to this website with graphics that show a high-level ?Concept of Operations? indicating how the FDA Electronic Submissions Gateway provides support to internal and external stakeholders, and another that details the conceptual structure of the Gateway itself. Potential contractors need to demonstrate the following capabilities to meet the requirements of the FDA's Electronic Submissions Gateway project. The contractor should describe the adherence to system development life-cycle best practices and their ability to meet the Capability Maturity Model (CMM) Level 2 requirements. Describe your understanding of the FDA electronic submission models and guidance, and expertise with needed software tools. The contractor should provide information on past and present performance in areas of systems life cycle development and technical integration for corporate/enterprise level systems and programs in a government environment. The contractor should also describe their capabilities in complying with the government's security certification and accreditation requirements. The contractor should describe their ability to meet the following high-level goals that have been considered in the Gateway architectural design: Enable transaction partners to submit guidance-compliant regulatory submissions (e.g. eCTD, Adverse Event Reports, eBLA and eIND) electronically to the FDA. Expedite the submission of electronic submissions from transaction partners to the FDA using the Internet. Provide a secure central point of receipt of electronic submissions for the Agency and the ability to route submissions to Center level holding areas in an automated fashion. Support standards developed by the International Conference on Harmonization (ICH) Provide seamless support for FDA electronic submission business processes. Ensure confidentiality and integrity of e-submissions. Enable audit trail capability and the generation of transmission logs for Agency ? Industry transactions. Provide a reliable e-submissions environment (e.g. available 99.5% 24x7x365). Provide a scalable and high performance environment. Support continuity of operations. Maximize the use of commercial-off-the-shelf (COTS) components. Be based upon open standards. Interested parties shall submit a capability statement not to exceed 10 pages, in Microsoft Word, no later than April 20, 2004 to the Contract Specialist via email at kminker@oc.fda.gov Note: Responses must reference Request for Information (RFI) number 223-04-5504. Request for copies of the RFP or other documents relating to this requirement will not be addressed. No questions will be answered concerning this requirement until AFTER the RFP has been released. Any questions received (via any medium including E-mail, Mail, Phone or Fax) before the RFP is released will be deleted/not addressed. There is no additional information available at this time about this requirement.
 

Place of Performance

Address: Rockville MD

Country: USA
 

Record

SN00558963-W 20040404/040402211813 (fbodaily.com)
 

Source

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

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