Notice_of_Intent_to_Sole_Source_1216906.docx

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services intends to award a sole source, firm fixed-price contract to the American Society of Health System Pharmacists, Inc. to provide access to AHFS Pharmacologic-Therapeutic Classification System data for The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) office. The proposed simplified acquisition action is for supplies and services for which the Government intends to solicit and negotiate with only one source in accordance with FAR 13.106-1(b).

Any businesses with the availability and capability to provide a service contract with the breath and depth of information that the American Society of Health System Pharmacists, Inc. can provide shall submit a capability statement. At a minimum the contractor shall provide a subscription service that meets the technical specifications outlined below:

· Contractor shall deliver the data to FDA in electronic files suitable for incorporation into a relational database.

· Contractor shall make any updates to the data available to FDA during the term of the license

· Contractor will provide drug product Pharmacologic-Therapeutic Classification data that will contain the following information:

· Therapeutic classification system definition and its hierarchical structure

· Therapeutic classification associated with corresponding monographs by generic name

· Therapeutic classification associated with generic drug names, tradenames and synonyms with corresponding monographs

· Mapping of NDC code to the therapeutic classification system

· Mapping of RxNorm Semantic Clinical Drug Form concept unique identifier to the therapeutic classification

Interested parties may identify their interests and capabilities to respond to the requirement prior to the response date of this notice. At a minimum, respondents shall provide capability statements that include:

· Business name, bio, DUNS number, business address, business website, point of contact information, phone number, and email address

· Business socio-economic status (i.e. SB, 8(a), VOSB, SDVOSB, HubZone, SDB, WOSB, etc.)

· Descriptive literature, brochures, marketing material, etc. detailing the nature of the products and services. This information shall provide sufficient technical information for the Government to conclusively determine that the offered products and services meet the technical requirements

· Past performance information for the sale of the same or substantially similar products and services including date of service, description, dollar value, client name, POC address, phone number and email

· If applicable, identification of the offeror’s GSA Schedule contract number and SINs which are applicable to the requirement

FDA will consider all responses received prior to the closing date of this notice and will use responses in determining whether it is necessary to use full and open competition for this requirement. A determination by the Government not to compete this proposed simplified acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive requirement. This request for capability information does not constitute a request for proposals or any other solicitation. The FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. 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. However, FDA reserves the right to contact vendors if additional information is required.

U.S. Food and Drug Administration

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