FDA Online Standards Search & Retrieval System

The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns, 8(a), Small Businesses (SB), Woman-Owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, and Service-Disabled Veteran-Owned Small Businesses (SDVOSB). The Food and Drug Administration (FDA) intends to provide maximum practicable opportunities in its acquisitions to small businesses. The FDA is conducting market survey to assess the availability of small business firms as defined by NAICS Code 541990 to acquire an online information retrieval system that provides instantaneous access to industry specifications and standards. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that a procurement will be accomplished. The FDA welcomes responses from all interested parties. The FDA does not intend to make a selection decision or award a contract/order on the basis of responses nor otherwise pay for the preparation of any information submitted of FDA's use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this Sources Sought with any interested parties. However, the FDA reserves the right to contact vendors if additional information is required. Background: (DRAFT) As an Agency, the Food and Drug Administration has a rich history in its use and support of standards for regulatory purposes. Several Centers in the Agency rely on standards to facilitate areas across the total product life cycles of the areas under its regulatory jurisdictions. Since, 1997 and in accordance with FDAMA of 1997, the Food and Drug Administration (FDA) established a consensus standards program recognizing all relevant medical devices standards and acquiring an annual license agreement to have full electronic access to published medical device standards. This access includes the full versions of all relevant related standards (as listed below), download capability, and continual updating of the database to provide the most current versions of standards to FDA scientists and regulatory staff for the purpose of executing FDA's regulatory responsibilities. Objective: (DRAFT) The objective of this contract is to acquire an online information retrieval system that provides instantaneous access to industry specifications and standards to serve the regulatory needs of the Agency where standards are utilized. Scope: (DRAFT) The system must contain expeditious and sophisticated research capabilities, as well as a comprehensive index that allows various types of searching and management reports, with the ability to identify specific documents then view the actual document pages. The documents must be viewable online in electronic-based PDF or HTML format, must be fully printable, and must be provided in a licensing agreement which will permit authorized downloading and temporary storage. Specific Requirements: (DRAFT) 1. Internet Access to Government and Commercial Standards The system shall provide access to the following active commercial standard documents including an index with complete and unlimited access to full-text images in PDF and/or scanned images: - AAMI Collection - Association for the Advancement of Medical Instrumentation - ADA Collection - Americans with Disabilities Act - ANSI Collection - American National Standards Institute - ASA Collection - Acoustical Society of America - ASME Collection - American Society of Mechanical Engineers - ASQ Collection - American Society for Quality - ASTM Collection with Redlines - American Society for Testing and Materials - BSI Health & Safety Segment (Active and Historical) - British Standards Institution - CLSI Collection - Clinical & Laboratory Standards Institute - IEC Collection - International Electrotechnical Commission - INCITS Collection - International Committee for Information Technology Standards - ISA Network - International Society of Automation - ISO Collection - International Organization of Standardization - OLA Collection - Public Library Division of the Oregon Library Association - PDA Collection - Parenteral Drug Association - RESNA Collection - Rehabilitation Engineering and Assistive Technology Society of North America - VC (ASC Z80) Collection - Verified Carbon Standard - UL Collection - Underwriters Laboratories that includes: o UL 50 o UL 50E o UL 94 o UL 746C o UL 796 o UL 991 o UL 1012 o UL 1310 o UL 1642 o UL 1977 o UL 2054 o UL 2089 o UL 4200A o UL 122 o UL 2900-1 o UL 2900-2-1 o UL 2900-2-2 o UL 1998 o UL 60601-1 o UL 5500 - ISPE GAMP 5 Guides - International Society for Pharmaceutical Engineering / Good Automated Manufacturing Practice: o GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems o GAMP Good Practice Guide: Electronic Data Archiving o GAMP Good Practice Guide: Testing of GxP Systems o GAMP Good Practice Guide: Global Information Systems o GAMP Good Practice Guide: IT Infrastructure Control and Compliance o GAMP Good Practice Guide: Validation of Laboratory Computerized Systems o GAMP Good Practice Guide: Risk-Based Approach to Electronic Records & Signatures o GAMP Good Practice Guide: Legacy Systems o GAMP Good Practice Guide: Validation of Process Controls Systems o GAMP Good Practice Guide: Calibration Management - ISPE Baseline Guides - International Society for Pharmaceutical Engineering o Volume 6: Biopharmaceuticals Bound / Electronic Set o Volume 5: Commissioning and Qualification Bound / Electronic Set o Volume 4: Water and Steam Systems Bound / Electronic Set o Volume 3: Sterile Manufacturing Facilities o Volume 1, 2nd Edition: Active Pharmaceutical Ingredients o Revision to Bulk Pharmaceutical Chemicals In addition, the ASTM Standards must be viewable in PDF format to allow users the ability to compare additions, deletions, and other changes between the active and previous versions. The system shall provide the capability to link from industry standards referenced in internal documents directly to the PDF document. The Contractor shall provide access to all listed standards through one site via provided username and password or IP authentication. 2. Index and Reports (DRAFT) The system shall provide a single index to the standard collections listed above, with access to full-text images in PDF format. The index must be able to provide the following: Summary that provides specific information regarding the standard document. Document preview or snapshot of the actual document when available. Ability to view and/or change view of available line item results in index. Ability to print index results or export for reporting. 3. Product Functionality (DRAFT) The system must provide the following research capabilities or methods: All commercial industry standards listed above must be included in the same system using the same search engine. Searching by document number or portion of a document number, including alpha prefixes and decimal points. Keywords must be searchable from the index in the title of the document, scope, intended use, keyword paragraphs or summaries, and/or abstracts. Searching by Preparing Organization. Each search query must provide the user with a results list. The results list must identify the document number, Standards Developing Organization, and the document title. The system must have an update notification feature to alert users that documents have been updated. The system must provide the following usage reporting methods: Provide usage data on the standards reviewed or downloaded from the most frequent to the least frequent upon request by FDA. Capture usage data for all FDA staff using the database starting from the beginning of the license agreement. This data shall be captured using a first-time registration function whereby the user identifies which Center/Office/Division of FDA they are from and their full name. This data shall then be connected to the staff IP address. From the capture of this information, the Government shall be able to query the system to determine how different parts of the Agency are using the database to best serve its needs. 4. Document Images/Text (DRAFT) The system must provide the following: All non-Government commercial standards must be licensed by the issuing Standards Developing Organization to allow image viewing and printing of the standard in hardcopy format. Document images must include full English translation. Documents must be updated in near real-time. System must identify recently updated documents and provide at a minimum, a history of previously published standards that were superseded. Documents must be provided via electronic media. Hardcopy delivery of documents will not be considered. If a Standards Developing Organization requires Digital Rights Management (DRM) restrictions, the encryption software shall be made available at no additional charge to allow for viewing of the PDF documents. Note: DRM is currently required for AWS. General Instructions Contractors that believe they possess the ability to provide the required services must submit documentation of their ability to meet each of the characteristics listed above to the Contracting Officer (i.e., brochure, information on equipment that meets specifications, etc.). The capability statement must also include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code. Capability statements that do not provide sufficient information for assessment will be considered non-responsive. When submitting the information, please reference the Solicitation Number 19-223-SOL-00025. Responses shall be submitted via email to Tony Wimbush at Anthony.wimbush@fda.hhs.gov by 4:00 PM on April 12, 2019.