VendorQuestions_OCI RESPONSE

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I. AFFILIATED NETWORK

1. In Section 1.2 Scope, the SOW states that “The Government anticipates that the contractor will monitor a maximum of 10,000 websites annually” – is this the full extent of websites to monitor for this project? – does this number include or exclude network affiliate websites?

FDA RESPONSE:

Monitoring activities will be limited to 10,000 websites annually, and will include affiliate websites. Monitoring activities will be directed by OCI.

2. SOW Section 1.5.2, The solicitation states “The contractor shall attempt to document the size and scope of the operation, including any affiliate network.” Please confirm that the Government means by “affiliate network” an affiliate marketing company (e.g., affiliate.com) that provides distribution of advertising revenues.

FDA RESPONSE:

While companies that engage in affiliate marketing may become subject to monitoring by FDA (on a case-by-case basis).

An "affiliate network" or "affiliated network" (for purposes of this solicitation) 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.

3. In order to identify affiliate websites, should the contractor have the ability to machine query websites?

FDA RESPONSE

There are a variety of methods which can be utilized to identify affiliate websites (which the contractor should provide their proposed solution in their technical proposal). The contractor is expected to possess experience in this arena, and to determine (on a case-by-case basis) the most appropriate way to document an affiliate network.

II. PROJECT MANAGEMENT PLAN / STAFFING PLAN

1. Please confirm that we need to submit a PMP and COI statement along with the Proposal.

FDA RESPONSE:

A draft PMP and COI is due along with Proposals. Revisions to the draft PMP is due one week after award of contract.

2. Please provide detailed information on what is expected for the staffing plan.

FDA RESPONSE:

The proposed staffing plan consists of individuals with technical skills necessary to accomplish the work required and contains an organization chart with roles and responsibilities that are clearly defined. The proposed labor mix and level of effort that is likely to be effective and efficient. If individuals with the requisite experience are not currently in the employ of the Offeror, the Offeror has provided a detailed and realistic plan explaining how it intends to hire personnel with the requisite experience prior to the performance start date. The staffing plan explains how the Offeror will able to add personnel to support work under the general labor hour CLIN. The staffing Plan shall:

a. Define the composition of the overall work group (labor mix);

b. Provide a proposed organization chart that defines roles and responsibilities and reporting chains

c. Include an estimated LOE for each task, broken down by labor category (DO NOT INCLUDE PRICING INFORMATION);

d. Explain how the Offeror will be able to add personnel to support work under the general labor hour CLIN.

3. Please provide detailed information on what is expected for the project plan.

FDA RESPONSE:

PMP would include information on scope schedule and budget and may specifically include the following:

· Work Breakdown Structure (WBS)

A WBS that identifies the scope of the project and the activities the project entails. The level of WBS detail will be determined during the planning process for each task.

· Schedule.

The Project Schedule shall include the activity durations, major milestones, and if appropriate, planned resources.

· Cost Plan.

The project Cost Plan should be based on the project scope as defined in the Work Breakdown Structure.

The results of additional planning activities, including risk identification may be documented in the PMP.

III. PRICING AND LEVEL OF EFFORT QUESTIONS

1. With regard to the requirement to provide status updates every 6 hours (including hours outside or normal 9am-5p EST) about the completion of the monitoring and/or analysis about activities or circumstances that affect National Security and/or significant public health and safety issues, how many occurrences of this type were experienced over the past two years and what is the typical duration of the event? This historical information will assist in the planning of resources and the resulting price impact.

FDA RESPONSE

Approximately 2 events occurred over the past 24 months. The duration of the event (as it would relate to this contract) was approximately 8 hours.

2. What percentage of hours outside of normal business hours (9 am to 5 pm) should the offeror include in their pricing estimate? Are Contractor personnel required to be on call for non-working hours?

FDA RESPONSE:

This is a business decision. OCI does not anticipate emergency requests outside of normal business hours to occur on a regular basis. Additionally, the vendor should possess enough experience to be able to self-estimate the estimated level of effort required.

3. What is the annual average level of effort, in terms of FTEs?

FDA RESPONSE:

Since this is the first undertaking by FDA, we do not have data associated with this.

4. In reference to Section 1.4, does the FDA require 365days/24hour/7days a week support for this contract?

FDA RESPONSE

No

5. How many FTE currently support the FDA/OCI monitoring effort of 300 websites per month, and do government employees or contractors supply this support

FDA RESPONSE

Present monitoring efforts are spread out among various components of FDA; current support levels are unknown and change on a regular basis.

IV. REPORTS

A. QUANTITY OF REPORTS

1. If Data Form Reports (Section 1.5.3., p. 4) (DELIVERABLE 3) are limited to 1000, how can they also include a “lists of rogue Internet websites identified via monitoring” which is suppose to cover 10,000 websites (SOW, Section 1.2 SCOPE, p.2)?

FDA RESPONSE

Good point, the maximum number of data reports should match the maximum number of websites to be monitored on an annual basis. FDA has changed the maximum amount of data reports from 1,000 to 10,000.

2. The SOW states that “The contractor shall provide a maximum of 10,000 initial data reports of analysis (which may include other associated attachments [i.e., spreadsheets, etc.]) ( p. 5 first full paragraph) under the scope of this contract” However, there will need to be reporting on

a. Section 1.9 (p7) the analysis of the “findings of each request” made by the FDA-OCI, FDA RESPONSE

Changed to section 1.5.4- The Analysis reports of Findings are considered supplemental information to the initial data reports. FDA will determine when it is necessary for the contractor to provide the analysis reports. OCI staff does not anticipate needing more than 5,000 supplemental analysis reports annually.

b. The 10,000 Initial Data Report Form reports, FDA RESPONSE:

The 10,000 covers: Internet Landscape changes, Recidivist Activities by Previously-Warned Entities, Identification of Affiliated Networks, National Incident Reports, Analysis Reports of Findings, Straw Purchase Reports, Investigative Test Purchase Reports.

c. Monthly Status Reports (Section 1.5.2., p.4)

FDA RESPONSE

This is separate from the 10,000 Data Reports. No More than 12 per year.

3. The solicitation mentions that the contractor shall monitor up to 10,000 web sites annually. What is the preferred frequency with which each of these sites needs to be reviewed?

FDA RESPONSE:

OCI will dictate the frequency level and continued monitoring of websites.

4. Are the 10,000 sites a combination of “proactively identified” and “reactive” sites? About what portion are “proactive” and what portion are “reactive”? Does the FDA provide an initial list of “sites of interest” as part of the 10,000 sites?

FDA RESPONSE:

OCI will determine which sites require monitoring by the vendor, and to what degree. The vendor will be "proactively" identifying violative websites only at the request of OCI. Primarily, the vendor will be developing & analyzing information obtained / provided by OCI to the vendor.

5. In reference to Volume 1 Section 1.5.3, please define the number of Data Form reports (on an as-needed basis) that contractor will be required to fulfill on a weekly/monthly basis.

FDA RESPONSE OCI can not predict the number of incidents which will occur that would require a Data Form report. However, as noted above, the number of Data Form reports will count towards the 10,000 reports which may be created under this contract.

B. CONTENT OF REPORTS

1. Does the FDA require website link analysis to be included in its reports?

FDA RESPONSE

This would be determined on a case-by-case basis.

2. Please provide a description of the other types of OCI requests that would require the contractor to complete an Analysis Report as described in SOW 1.9 (now 1.5.4).

FDA RESPONSE

The Analysis Reports will be utilized by OCI to review the size and scope of the alleged illegal activities. Analysis Reports will typically contain detailed information regarding the website(s) operated by the perpetrator(s).

C. PURPOSE OF REPORTS

1. Could these reports potentially be used as evidence in court?

FDA RESPONSE

OCI does not anticipate utilizing any of the reports in formal judicial proceedings.

V. INCUMBENT CONTRACTOR / HISTORY OF INTERNET MONITORING EFFORTS

1. Are there incumbent contractors performing this work and, if so:

FDA RESPONSE: No

2. Who (Government and/or Contractors) are currently performing this work? If contractors, who are they?

FDA RESPONSE

No known contractors performing work for OCI at the present time.

VI. SECURITY CLEARANCE / BACKGROUND INVESTIGATION QUESTIONS

1. Paragraph 6.6, Public Trust Positions, states that a favorably adjudicated Single Scope Background Investigation (SSBI) conducted by DoD/DSS or other Federal Agencies will be accepted. Does this mean that contractor personnel with an active DoD/DSS Secret or higher security clearance meet the Level 6 FDA requirements?

FDA RESPONSE

OMB and FDA's Physical Security team will determine equivalency after a contract is awarded and the awarded company is going through the security clearance validations / procedures.

2. Reference Paragraph 6.11 of the SOW requires a physical security plan to be submitted with the contractor’s proposal. Which volume of the proposal includes this plan, what is its page limit, and how does it impact proposal page count?

FDA RESPONSE –

This would be considered "supporting documentation" and will not be apart of the 25 page limit for the Technical Proposal. The security plan should not exceed 3 pages.

VII. TRAVEL

1. Reference Paragraph 6-18, Cost Reimbursable Travel Expenses. This paragraph states that the Contractor shall invoice and be reimbursed for all travel costs associated and allowable and allocable to the CAERS contract. What is the CAERS contract?

FDA RESPONSE –

Administrative error CAERs does not apply to this effort.

2. Is there any long distance travel envisioned in the performance of this contract? Should offerors assume a budget for long distance and local travel in the Pricing proposal?

FDA RESPONSE

OCI does not anticipate any long-distance travel as part of the performance under this contract.

VIII. CLARIFICATIONS / DEFINITIONS

A. "ANCHOR SITE"

What is the definition of an Anchor Site?

FDA RESPONSE:

For purposes of his solicitation, an "Anchor Site" is defined as a website that is crucial to the operation of a network of affiliate websites. An "Anchor Site" may be a website that (1) processes all of the payments for a network; and/or (2) processes the orders for a network; and/or (3) provides customer service for a network.

B. "INTERNET MONITORING"

1. Is it an FDA priority in this program to comprehensively monitor the Internet, which requires an automated approach such as automated linguistic analysis?

FDA RESPONSE:

This is a business decision. The SOW is written in a way to give the vendor flexibility to propose an innovative approach to this requirement.

2. There is discussion in the RFP about proactively and reactively monitoring domestically and internationally. Are these only for English language sites or do we have to consider foreign languages? If so, what are the languages the contractor should focus on?

FDA RESPONSE:

While this contract will focus on English-language sites, it is expected that the vendor will encounter sites containing foreign language. OCI does not expect the vendor to provide translation services, but does expect the vendor to analyze the relationship to any foreign-language sites to the remainder of the operation.

3. In order to effectively find illicit activities and monitor proactively, the contractor may have to reach out to external data sources. Is the FDA going to cover the cost of these external data sources?

FDA RESPONSE:

The onus is on the contractor to propose an acceptable technical approach to this requirement. FDA / OCI staff may approve external data sources costs if they find it in the best interest of the Government to accept and approve the proposed costs.

4. Is the use of online search engines such as “Google and Yahoo” as the primary Discovery and monitoring tool for this effort acceptable to support this contract?

FDA RESPONSE

The vendor should already possess the skills and equipment necessary to successfully perform the functions required under this solicitation.

C. "STRAW PURCHASES"

1. How many straw purchases (section 1.6) does the government anticipate the contractor will make?

FDA RESPONSE:

D. "FRAUDULENT PRODUCTS"

1. Will FDA establish the criteria for fraudulent products or is it FDA’s expectation that the Contractor establish the criteria?

FDA RESPONSE:

OCI will establish all criteria, E. "PRIORITY DIESEASES"

1. What are the PRIORITY diseases for which prompt recognition of illegal disease benefit claims are a necessity?

FDA RESPONSE

Priorities change on a regular basis within the FDA based on a variety of issues. As such, OCI will provide an initial "priority" list to the vendor at the initiation of the contract. The list is subject to change at any time.

F. "IDENTIFICATION OF ROGUE SITES"

1. Does the FDA require prioritization techniques to identify the most popular set of target rogue websites?

FDA RESPONSE:

OCI will dictate the priority each request will receive.

2. Is the discovery of new rogue website networks a priority for the FDA?

FDA RESPONSE:

This determination is made on a case-by-case basis, and is based on current investigative priorities and resources.

3. The SOW states “The contractor shall report Internet monitoring activities to FDA-OCI as the specific requests are completed by the contractor. Regarding the monitoring of websites which were the subject of previous enforcement actions by the FDA, the contractor will report any changes to the landscape to FDA-OCI within 24 hours of identifying the changes.” How many of these sites are there?

FDA RESPONSE:

Approximately 150

4. Will each report prepared in accordance with SOW 1.5.3 be limited to one specific rogue website and its affiliates? If not, please state the average number of rogue websites included in each report.

FDA RESPONSE:

Yes. A single report shall be a comprehensive report which provides all available information associated with an affiliate network.

G. "ENGAGING WITH ILLICIT SITES"

1. By engaging to simulate transactions with illicit sites, will FDA provide sovereign protection to Contractor?

FDA RESPONSE

While the contractor will be conducting purchases, they will be received by OCI personnel. The contractor will not receive or be in possession of any FDA-regulated products as part of this contract.

2. Will the contractor have to manage chain of evidence protection standards?

FDA RESPONSE:

No

3. The document discusses finding new illicit sites. Does the FDA have a set of business rules that they have been following to identify these sites. If so, will the contractor have access to these business rules or does the contractor have to build business rules from scratch?

FDA RESPONSE:

The vendor should already possess the skills and equipment necessary to successfully perform the functions required under this solicitation.

4. Are the owners of the sites that are being monitored by FDA currently aware that are being monitored and are amicable for daily crawl and monitoring activities?

Some are and some are not.

H. "LEGITIMATE PROCESS FOR SELLING FDA REGULATED PRODUCTS"

Is there a process established by FDA to legitimately sell FDA regulated products online, such as getting an FDA number that they are required to put on their website?

FDA RESPONSE:

Each FDA center has procedures and guidelines for the individual products that they regulate via inspections, issuance of certificates, and collection of fees. Regulatory Procedures may be subject to change based on legislative mandates and the relative risks that the products pose to consumers.

I. "QUALITY OF SERVICE"

How does FDA plan to verify the quality of the service being provided in terms of whether we are finding illegal sites effectively or monitoring sites effectively?

FDA RESPONSE:

OCI may conduct an independent analysis of the information provided by the vendor to determine if the vendor is providing comprehensive analysis reports. In the event OCI documents significantly different intelligence (that was also available to the vendor at the time of analysis), OCI may deem the quality of service as ineffective.

J. "SOFTWARE DEVELOPMENT LIFE CYCLE (SDLC)"

1. Is there a Software Development Life Cycle (SDLC) process that FDA follows that the contractor must follow to implement the project?

FDA RESPONSE:

SLDC procedures apply to applications and hardware that are loaded or interface on FDA's servers. Since FDA does not anticipate hosting Internet Monitoring Software / Applications and the contractor is expected to have the appropriate infrastructure in place SLDC procedures to not apply to this requirement.

K. "SOFTWARE"

1. Are there any architectural standards, frameworks, guidelines mandated by FDA that the contractor needs to follow for building the software?

FDA RESPONSE

FDA does not intend to procure services to build, develop, or design software.

2. Does a contractor have to transition any software developed at private expense prior to the contract?

FDA RESPONSE

If the vendor chooses to propose utilizing a software application to support this requirement, the FDA would expect that the software already be developed and available to the public (commercial). FDA does not intend to pay the contractor for prior software development work.

L . "TRANSITION ACTIVITIES"

1. Do the transition activities involve only operations, equipment, and any data relative to this contract?

FDA RESPONSE:

All activities shall be included in the transition plan.

M. "GOVERNMENT OBJECTIVE"

1. What is FDA’s key objective in creating this Internet Monitoring Program (Attachment 1: SOW and other terms/conditions, Section 1.0, pp1-2.5)? We believe monitoring is an activity and the SOW does not reflect a clear program objective.

FDA RESPONSE

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The Internet Monitoring Program will support these efforts.

N. "GEOGRAPHICAL IDENTITY"

1. How specific do they want the geographical identity to be?

FDA RESPONSE:

The most specific information associated with the physical location of the operation that available to the contractor should be provided, including: country; state; city, street address(es), etc.

O. "SUB-NETWORK"

1. What is the definition of a Sub-Network?

FDA RESPONSE:

For purposes of this solicitation, a "sub-network" is defined as a network of affiliate websites (possibly segregated or contained) located within a larger network of affiliate websites.

P. "INVESTIGATIVE TEST PURCHASES"

1. When would it be deemed necessary for the Contractor to conduct an Investigative Test Purchase?

FDA RESPONSE:

OCI will advise the vendor when a test purchase is warranted, and will specifically request one be conducted.

Q. "PUBLIC SAFETY ISSUES"

1. How will “circumstances that affect National Security and/or significant public health and safety issues” be defined?

FDA RESPONSE

OCI will determine what issues fall into this category based on current events, directives, and investigative priorities.

R. "RADIATION EMITTING PRODUCTS"

SOW 1.1 paragraph 1 includes radiation-emitting products as a separate category. However, Radiation-emitting products are not listed as a separate category in the bulleted list following the SOW 1.1 paragraph 2.

FDA RESPONSE:

Information regarding Radiation emitting products has been added to the RFQ under the General Requirements sections.

IX. DELIVERABLES

1. Please provide a sentence or two on FDA media?

FDA RESPONSE:

FDA media is not an actual deliverable rather it is a vehicle for providing the deliverable. Please see the note below the deliverable table and description in the Government Furnished Property (GFP) section of the RFQ.

2. If the Offeror must ensure the software is loaded onto FDA computers, what is the process and timeline to obtain FDA approval and/or action?

FDA RESPONSE:

OCI will coordinate with the vendor to ensure all necessary software is loaded onto the computers within 60 days of award of the contract.

3. Why does the SOW updates to the Project Management Plan” under Monthly Status Reports when it is already a separate deliverable?

FDA RESPONSE:

Updates to the Project Manage plan have been deleted from the MSR section

X. GOVERNMENT FURNISHED INFORMATION / PROPERTY (GFI) / (GFP)

1. Will FDA provide lists of known harmful ingredients to vendor, to enable vendor to search for such ingredients? Will FDA provide scientific, botanical and foreign language names for known harmful ingredients? Will FDA provide vendor with lists of products and/or ingredients previously denied approval by FDA?

FDA RESPONSE:

OCI will provide direction to the vendor regarding these issues, which may include ingredient lists.

2. Will vendor have access to FDA lists of products/ingredients that have been approved by FDA?

FDA RESPONSE

OCI will direct the vendor to all publicly-available information and may, at times, provide internal information to the vendor to assist them in completing the task.

3. Will FDA be providing the targeted sites for monitoring or will this be a collaboration between FDA and the Contractor?

FDA RESPONSE:

OCI will provide the vendor with the targeted sites for monitoring (for recidivist activity).

4. Will the FDA provide a clear definition of illegal marketing? Or provide criteria for evaluating it?

FDA RESPONSE

OCI will provide direction to the vendor regarding these issues.

5. Will the contractor have access to ISPs through FDA?

FDA RESPONSE:

No

6. What storage device(s) will be provided as described in SOW 6.1 last paragraph?

FDA RESPONSE:

Since we will need information from the selected contractor to determine their storage needs, including the hardware and storage size, the type of storage device will be determined by OCI following the award of the contract.

7. The solicitation states “the work product created as a result of this contract will be stored on storage media owned and operated by the FDA.” If the Offeror has proprietary software to conduct internet monitoring does this software need to be loaded onto an FDA computer or can the Offeror use their own systems and transfer the information onto the computer?

FDA RESPONSE:

FDA expects that any proposed software to assist with Internet Monitoring will be hosted on the contractor's system and does not expect to load software on FDA provided equipment (laptops), unless necessary for FDA to review data / deliverables etc... The contractor shall have the appropriate infrastructure in place to do the work.

8. Please describe the specifications of the government laptops that will be provided and if the contractor may attach monitors and external hard drives to the laptops.

FDA RESPONSE

The government laptops will be accompanied by docking stations, keyboards, and a mouse. External hard drives may also be provided by OCI. The contractor may attach a monitor to the laptop at the contractor's expense.

XI. CONTRACT ADMINISTRATION QUESTIONS

A. MISCELLANEOUS ADMIN QUESTIONS

1. On what date does the FDA intend to award this contract?

FDA RESPONSE:

August 1st. This date is subject to change.

2. Would the FDA consider opening the procurement to firms other than small?

FDA RESPONSE

No. The FDA has made the determination that there are two or more capable small business vendors.

3. The RFP indicates this is a 100% Small Business Set-Aside. Can you provide the details and definition as to what constitutes the Small Business participation should an award be made i.e. 0%, 10% or 51% T&M etc.?

FDA RESPONSE:

51%

4. If the RFP must remain a small business set aside and small business lead, what is the maximum participation for a large business subcontractor?

FDA RESPONSE:

49%

5. The Combined Synopsis/Solicitation, in the first full sentence of the synopsis indicates this solicitation is “for commercial items / services” and therefore prepared in accordance with the format in Subpart 12.6 of the FAR. However, both the Classification Code and the NAICS code indicate that the project is focused on the delivery of services to the FDA in the form of internet monitoring and reporting.

FDA RESPONSE:

This is a commercial buy in accordance with 12.6 procedures. The Government anticipates more than 50% will be commercial services, hence the service NAICS code specified. The vendor has the flexibility to propose an innovative technical approach via commercial services, commercial products, or a combination thereof.

B. TECHNICAL VOLUME

1. On page 3 of the Synopsis document, FDA indicates that “Factor 1” is technical understanding and the other factors are of decreasing importance in the selection of the contractor. Is there a points rating system for this project or evaluation scale and can it be made available?

FDA RESPONSE:

Per the paragraph under Relevant Experience, "The technical proposals will be graded subjectively with final scores of "Minimally Acceptable", "Acceptable", or "Exceptional".

2. Does this page limit include any graphics or pictures that the Offeror submits to demonstrate their solution?

FDA RESPONSE:

Graphics and / or pictures to demonstrate the contractor's technical approach may be submitted as an attachment to Volume 1 but shall not exceed 10 pages.

C. PAST PERFORMANCE VOLUME

1. Only Volume 1 has a page limit of 25 pages (Synopsis, p. 2 of 7). Is there a page limit for Volume 2: Past Performance?

FDA RESPONSE:

Under the instructions section it states that the Past Performance Volume should be no more than 3 pages long (one page for each referenced contract). We also stated that the contractor should send out the Past Performance Questionnaire.

2. Does the FDA have a standard for font and font size?

FDA RESPONSE:

Times New Roman, no smaller than 11 font no bigger than 12 font.

D. KEY PERSONNEL RESUMES

1. For which positions does the Government intend the Offeror to provide resumes? Is there a page limit per resume? What information does the Government want the resume to include?

FDA RESPONSE

It is the contractor's independent business decision to propose the Labor Mix, Key Personnel, and Labor Categories.

E. PRICING

1. Is it the Government’s expectation to see the ODC / Labor build-up costs which include Overhead, G&A, Fringe, and Fees, or simply ignore the “Sample BOE” worksheet and provide the Fully-loaded labor rates?

FDA RESPONSE

All worksheets should be completed. The Government uses the BOE worksheet which includes Overhead, G&A, Fringe, and Fees to determine whether or not the proposed Fully Loaded rates are fair and reasonable.

2. With respect to the "Discount" in the pricing spreadsheet, could you tell me a bit about what that typically refers to?

"Discount" would be defined as a reduction of regular / standard prices charged for the same or similar commercial services.