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FBO DAILY ISSUE OF JUNE 18, 2009 FBO #2761
SOURCES SOUGHT

D -- FDA Advisory Committee Tracking and Reporting System - EPLC Documentation - Step 2 of the SOP - Introduction of the SOP - Step 1 ADB SOP - Step 3 of the SOP - Standard Development Enviornment - Labor Categories - BRD - Draft Statement of Work - Step 4 of the SOP

Notice Date

6/16/2009
 

Notice Type

Sources Sought
 

NAICS

541512 — Computer Systems Design Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

1058466
 

Archive Date

6/25/2009
 

Point of Contact

Brenda K Lee, Phone: 301-827-7036, Ted L Weitzman, Phone: 301-827-7178
 

E-Mail Address

brenda.lee@fda.hhs.gov, ted.weitzman@fda.hhs.gov
(brenda.lee@fda.hhs.gov, ted.weitzman@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Attachment 5b Step 4 SOP Attachment 1 Statement of Work Attachment 3 Attachment 5a Attachment 4 Attachment 5b Step 3 SOP Attachment 5b Step 1 SOP Attachment 5b Attachment 5b Step 2 SOP Attachment 2 This is a SOURCES SOUGHT NOTICE to determine the availability and capability of qualified small businesses (including certified 8(a), Small Disadvantaged, HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses). The NAICS Code is 541512. The small business size standard is 25M. The U.S Food and Drug Administration has a need to establish a modern, state-of-the-art, fully-electronic system that creates, coordinated, integrated, streamlined, consistent, reliable, and accurate operations for the management FDA Advisory Committee processes. This requirement is to design, develop, and implement a FDA Advisory Committee Tracking and Reporting System (FACTRS). The system will accommodate all FDA Advisory Committee business processes. This includes functionality that incorporates electronic records management, workflow, and process automation. Records management consists of document creation, check-in, routing, review, signoff, storage, and retrieval. Document review shall include options to edit, version, and return submitted review documents and options to communicate within the system to the reviewer any specific comments on deficiencies in submissions. Automation shall include the generation of reports, and the auto-population of forms and template documents. The system shall provide electronic notifications to staff of necessary review actions and deadlines, and shall allow for electronic signature. FACTRS shall serve as a data driven system which reduce data and business process redundancies and allow for both complex ad hoc and standard data quarries. FACTRS must integrate with other FDA legacy and enterprise solutions to obtain necessary information to manage the program, such as personnel information on Advisory Committee members or internet access for public submissions of nominations to the Agency. The system shall offer access to information for all operational units involved in Advisory Committee management which is currently unavailable. It shall allow the Agency to respond to inquiries, required reporting, and unanticipated requests for data in a timelier manner and with the reduced risk of inconsistent and inaccurate data reporting. FACTRS shall provide a structured, electronic system with access to data that would support the research of current business processes and drive ongoing advancements in the management of the FDA Advisory Committee program at all levels of the organization. The work shall be built on appropriate existing legacy or enterprise systems components that provide the functionalities described above to meet the business needs of FDA’s Advisory Committee program. System Design and Development support is required to produce systems and business application software that integrate hardware, software, data, network and other technologies consistent with FDA IT Standards. Review and analyze the requirements, gathered to date and update to be accurate and comprehensive and provide analysis for stage gate review. FDA is seeking senior and mid level analyst, developer and documentation specialist expertise to perform the FACTRS application design, development, and system unit testing in accordance to FDA IT Standards with the Appian Business Process Management System (BPMS) the primary development tool. It is required to follow the HHS Enterprise Performance Life Cycle (EPLC) framework which consists of ten life cycle phases. The EPLC is a mechanism that assures that systems under development meet the established requirements and support the FDA mission functions. It provides a structured approach to managing information systems projects, beginning with the planning processes and ending with the implementation. It is required to review the Systems Requirements Specification (SRS), update as appropriate, and conduct a successful requirements analysis stage gate before proceeding to the design phase. Within each phase, activities, responsibilities, reviews, and deliverables are defined. Exit criteria are established for each phase and stage gate reviews are conducted through the IT governance process to ensure that the project’s management quality, soundness, and technical feasibility remain acceptable and the project is ready and approved to move forward to the next phase. The scope primarily involves the design and development phases, but limited work in other phases will be performed. This will be a web-based environment primarily based on, but not limited to: Appian BPMS software, Java and JavaScript code, Oracle 10g database server, Microsoft Exchange mail server, Adobe PDF fillable forms. System and Data Integration – Application shall be integrated with other ongoing projects in the Agency, sharing data and/or code between projects such as, but not limited to: Common Electronic Document Room (cEDR), Automated Employee Process System (AEP), Commissioner Fellowship, Advanced Submission Tracking and Retrieval (FASTAR), AIMS, and CASPER. The work shall adhere to FDA’s Enterprise Architecture (EA) and Architecture Review Team (ARM) standards, and incorporate them to meet future requirements resulting from government initiatives, migration to new data standards and changes to internal OIT requirements. Provide all resources to accomplish knowledge transfer for thorough understanding of all FACTRS system components with the intention that those mentored can support the FACTRS system independent of the design/development contractor. Perform maintenance and technical support related to testing, problem determination, remedy, and configuration management. It is required to have key personnel that have Appian development experience and able to provide Appian development expertise. It is anticipated that travel may be required to attend conferences and symposiums to provide interface and attain knowledge necessary for the performance of the requirements. Earned Value Management (EVM) system is required to manage this project that is in compliance with the guidelines ANSI/EIA Standard 748. The qualities and operating characteristics of earned value management systems are described in American National Standards Institute (ANSI)/Electronic Industries Alliance (EIA) Standard-748-A-1998, Earned Value Management Systems. A copy of the standard is available from Global Engineering Documents (1-800-854-7179). Stage Gate Reviews are required at the end of each phase to provide for independent review and approval of key elements of the IT project’s development or operation. Stage Gate Reviews consist of an independent confirmation by IT governance organization that all documents and contract deliverables are satisfactorily produced and adequately met all exit criteria for the phase to permit advancement to the next phase. It is required to produce all required documentation and perform all activities necessary to complete the phase as identified in the Enterprise Performance Life Cycle Framework (EPLC). In addition, be responsible for providing documentation of known issues and plans to mitigate the risks, if any, and facilitate the preparation and execution of the stage gate. The anticipated period of performance is a base period plus 3 one year option periods. The NAICS Code is 541512. The small business size standard is 25M. Interested small business offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Response must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform the requirement as described above in sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above in compliance with FAR 52.219-14 (“Limitations of Subcontracting”). Failure to definitively address each aspect of the requirement will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to ten pages, and must include: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS XXXX (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system.Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, and a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. The government is interested in comments on the Statement of Work. Responses to this announcement will not be returned, nor there any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA, OAGS may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. STATEMENT OF WORK COMMENTS SHOULD BE PROVIDED SEPARATELY FROM THE CAPABILITY STATEMENTS. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT AND STATEMENT OF WORK COMMENTS VIA E-MAIL to Brenda K. Lee at brenda.lee@fda.hhs.gov no later than June 24, 2009 4:00 PM Eastern Time for consideration.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1058466/listing.html)
 

Place of Performance

Address: Contractor's Site, Rockville, Maryland, 20857, United States

Zip Code: 20857
 

Record

SN01845749-W 20090618/090616235109-35b445f170884159e8face29eb188d97 (fbodaily.com)
 

Source

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

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