Attachment_3_Definitions.docx

ATTACHMENT 3: DEFINITIONS

1. An "affiliate network" or "affiliated network" is defined as the following: Any presence on the Internet (i.e., website, webpage, blog, etc.), operating in association with other presence on the Internet, which: (1) provides information about FDA-regulated products, together with links to the actual merchants / websites who sell the FDA-regulated products; (2) directly offers FDA-regulated products for sale; (3) process payments for the sale of FDA-regulated products; (4) serves any other purpose (including direct marketing, customer and/or order fulfillment services) on behalf of the organization / network.

2. "Internet monitoring" is defined as any information that is publicly available (overt, open source) such as, monitoring of websites, Internet billboards, chat rooms, social networking sites, and Internet spam activity, to gather intelligence and report identified illicit websites and networks. The contractor will participate in Reactive Monitoring – information known by the FDA and initiated at the specific request of the FDA.

3. Primarily the contractor will be proactively and reactively monitoring the open internet as directed by FDA-OCI staff in writing or verbally. Monitoring activities may change frequently based on emerging threats and trends. Therefore, the contractor must be prepared to be flexible and have the capacity to quickly modify their search efforts within 24hrs of notification. The Government anticipates that the contractor will monitor a maximum of 10,000 websites annually.

4. For the purpose of this effort, "relevant data and statistical information" is defined as the following:

a. Website domain names

b. IP address for each identified URL

c. Name server utilized for each URL

d. Mail exchange server utilized for each URL

e. “Whois” information to include IP address, Registrar, Registrant and Web host as well as historical “who-is” data

f. Geographical identification of website

g. Associated affiliate network

h. Anchor site for each identified network

i. Sub-networks identified

j. FDA-regulated product(s) offered for sale

k. Source of supply, when identified

l. Methods of payment accepted

m. Point-of-contact information identified on website; i.e., email addresses, telephone numbers; fax numbers

n. Merchant processor and merchant acquirer information, when identified

o. Results of deconfliction efforts.

5. “National Security Event” is defined as an event or outbreak affecting National Security within the jurisdiction of the FDA or pursuant to FDA’s assistance to another government agency(ies) as necessary. Such events are determined on a case-by-case basis by the COR.

6. “Public Health/Safety Issue” is defined as an event or outbreak which involves a threat to the health or safety of the citizens of the United States of a similar event occurring outside the borders of the United States in which the FDA has been requested to assist.

7. “Deconfliction” includes the sharing of limited investigative information with other relevant entities. This effort involves two types of deconfliction:

a. Internal deconfliction is the ability of the contractor to recognize information previously provided to the contractor by FDA-OCI and make a determination that the information is related

b. External deconfliction is the furnishment of investigative information to another law enforcement agency as directed by the COR. External deconfliction ensures a target of an investigation is not already under investigation by another agency. It is also possible the effort can enhance an existing investigation by combining resources.