SOURCES SOUGHT
70 -- Access to Over the Counter (OTC) Data Dictionary Resource
- Notice Date
- 12/21/2011
- Notice Type
- Sources Sought
- NAICS
- 511210
— Software Publishers
- 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
- FDA-SOL-12-1098565
- Archive Date
- 9/21/2012
- Point of Contact
- Christine M. Rynkiewicz, , Linda Giles,
- E-Mail Address
-
christine.rynkiewicz@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov
(christine.rynkiewicz@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This Sources Sought/Request for Information (RFI) is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration (FDA) or its Centers. The purpose of this RFI is to help the FDA understand the industry best practices and technical solutions capable of providing the full range of requirements described in this RFI. The FDA will use this market research information to assess the market's capability to successfully meet the FDA's over-the-counter data dictionary requirement. Sources Sought One of the purposes of this sources sought notice is to determine the availability and capability of qualified small businesses [including Small Business Administration Certified 8(a) companies; firms in Historically Underutilized Business Zones (HUBZone); Service Disabled Veteran Owned small businesses; and Women-owned small businesses] to provide access to an over-the-counter data dictionary resource. FDA welcomes responses from all interested parties. Requirement FDA requires an enhanced resource to validate over-the-counter (OTC) product names, including newly marketed and discontinued products, has been identified. FDA is interested in procuring access to a data resource that contains OTC trade names, active ingredients, and related attributes such as the manufacturer name and therapeutic classification. The requirement shall provide FDA personnel with access to a high-quality up-to-date data resource with the ability for users to look up product information for U.S. marketed or previously marketed products. Specifically, FDA will use the resource as a look up source to validate the product names listed on adverse event reports that are submitted to FDA's Adverse Event Reporting System. Technical Requirements 1.The data resource shall provide product information for U.S. approved and unapproved marketed and discontinued products (e.g., OTC, homeopathic, prescription, dietary supplements) to include the following attributes: a.Trade name(s). b.Active ingredient(s). c.National Drug Code (NDC) and or Universal Product Code (UPC). d.Therapeutic classification(s). e.Package size. f.Available strengths. g.Dosage form. h.Route of administration. i.Manufacturer/Labeler. j.Marketing status (e.g., Discontinued). k.Marketing category (monograph, OTC, prescription, BLA, etc). l.Date of initial market entry (i.e., first recorded U.S. sales). m.Synonyms (e.g., ascorbic acid for vitamin C). n.Designation if multi-ingredient product. o.Designation if combination product (e.g., drug/device or biologic/device, or drug/biologic or drug/biologic/device). p.DEA schedule. q.Hierarchical structure to allow for grouping related products (e.g., grouping all products together by a parent name or grouping products marketed by a certain manufacturer). r.Therapeutic equivalent code (e.g., AB). s.Indications or reason for use. t.Labeling information such as Contraindications and Directions for Use is desirable, but not required. 2.The data resource shall be provided in the format of an ASCII flat file accessible through File Transfer Protocol (FTP) or other secure download site. 3.The data resource shall provide monthly updates in the format of an ASCII flat file accessible through File Transfer Protocol (FTP) or other secure download site. 4.The FDA shall have the ability load the data resource in the Oracle Thesaurus Management System (TMS) or similar structure associated with FDA's Adverse Event Reporting System 5.A description of the data collection methods to include the frequency of the updates, quality procedures and sources of data as part of the submission to allow FDA staff to appropriately evaluate. 6.Implementation of training support and materials and ongoing technical support for the data resource shall be provided. Training materials or onsite training or web-based training within two weeks of award shall be provided. Ongoing technical support shall be available by phone or by e-mail for all FDA staff during business hours (09:00 AM-5:00 PM EST). 7.Full conformance or level of conformance with Section 508 standards. Responses to this notice shall be limited to ten pages (excluding marketing literature and/or technical data sheets) and must include: 1.Organization name. 2.Telephone number and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 3.Name, title, telephone number and e-mail addresses of individuals who can verify the demonstrated technical capabilities identified in the responses. 4.Commercial pricing list or other pricing information. 5.Customary practices, including warranty, discounts, contract type under which commercial sales of the products or services are made. 6.Any questions concerning the FDA's requirements for the OTC data dictionary. 7.To ascertain if the system is commercially available, deployed and proven; a listing of other organizations that have implemented the interested party's data dictionary resource. 8.Appropriate NAICS code. 9.DUNS number, CAGE code, Tax Identification Number and company structure (corporation, LLC, partnership, joint venture, etc.). 10.Active registration in the Central Contractor Registry (CCR). 11.Identification of the available contract vehicles, such as: GSA Federal Supply Schedules (schedule/contract number and appropriate Special Item Numbers) or other GWAC vehicles by agency and contract number. 12.Please provide the size classification of your business. If you are classified as a small business, HUBZone small business, Service Disabled Veteran Owned small business, Woman-owned small business and/or 8(a) certified small business, please provide a detailed capability statement, focusing on your firm's proven ability to provide the range of requirements. Additionally, please demonstrate your firm's capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting. Acknowledgment 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 RFI with any interested parties. 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. However, FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation if issued. This announcement is Government market research and may result in revisions in both its requirements and its acquisition strategy based on industry responses. Any questions regarding this notice must be submitted in writing to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov. Respondents must submit a capability statement to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov no later than January 4, 2012, 11:00 AM Eastern Prevailing Time for consideration.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-12-1098565/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02643695-W 20111223/111221234838-006b3bf2e1a84ba08bd69216f0199fa6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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