2-Synopsis.pdf

Synopsis No. 75N9602004092020

NIEHS, Office of Acquisitions

PharmaPendium

Synopsis

SYNOPSIS

General Information

Document Type: Synopsis Synopsis Number: 75N9602004092020 Posted Date: April 9, 2020 Original Response Date: April 13, 2020 Current Response Date: April 13, 2020 Set Aside: N/A NAICS Code: 511210

Contracting Office Address

NIEHS

530 Davis Drives Durham, NC 27709

Description

THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS.

The National Institute of Environmental Health Sciences (NIEHS), Research Triangle Park, NC intends to negotiate on a sole source basis with Elssevier B.V.,Radarweg 29, 1043 NX Amsterdam, The Netherlands, DUNS # 406928382; pursuant to FAR 13.106-1(b)(1)- Only One Responsible Source.

This purchase is for:

License to access the following Pharmapendium modules:

• Pharmapendium Base

• FDA Classic Collection

• Pharmacokinetics module

• Efficacy module

PharmaPendium is a commercial database that has been carefully curated and organized to provide access to comprehensive safety and regulatory data from the Food and Drug Administration (FDA) submissions on pharmaceuticals. PharmaPendium is a database product derived from data in Food and Drug Administration (FDA) and MDL Information Systems (later bought by Elsevier) Cooperative Research and Development Agreement (CRADA) in 2006 and 2007. PharmaPendium is a unique database that at its core integrates preclinical, clinical and post-market safety data from all the FDA approval packages.

An FDA drug approval package consists of medical, pharmacological and other data collected as part of the FDA's review of a pharmaceutical. Pre-1991 FDA approvals exist on microfiche while more recent approvals publically accessible on the web through the FDA Drug Label Database and Drugs@FDA. Unfortunately, the pharmacokinetic, efficacy, toxicology, and adverse event data are buried in microfiche, PDFs and webpages rendering this information inaccessible and difficult to search. As a result, FDA worked with MDL Information Systems (Elsevier) to digitize the approval packages and extract all the data elements in order to create a database that integrated the data from the preclinical, clinical and adverse event reports. As a result, PharmaPendium encompasses a suite of unique content not provided by any other vendor.

This notice of intent is not a solicitation or request for quotes. Notwithstanding, any responsible source that believes it is capable of meeting NIEHS requirement, may submit capability statement. Responses to this posting must be submitted via email to, luis.salas@nih.gov, by April 13, 2020 at 12PM EST.

A determination by the Government not to compete this quote contract action based upon responses to this notice is solely with the discretion of the Government. information received will only be considered for the purpose of determining whether to conduct a competitive procurement.

There is no solicitation package available. For any questions regarding this announcement, please contact Luis Salas at the above email address.

mailto:luis.salas@nih.gov mailto:luis.salas@nih.gov