QA_FDA OCI Internet Monitoring Services_75F40124Q00348.pdf

QUESTION # DOCUMENT SECTION PAGE # SOLICITATION TEXT QUESTION ANSWER

Attachment A:

SOW

3.0 Requirements; 4a.

Contractor Requirements

2 D. The Contractor shall possess an archive of research data that contains at least five (5) years of web artifacts about illegal sales of FDA regulated products. These data can be leveraged to provide historical context when creating reports for OCI requests.

What is defined as “research data” and is this in reference to publicly available data or to non-public data as well? If not publicly available, how would Quoters obtain this research data? Will this research data be transitioned from the incumbent contractor?

Research data is any open souce publicly available information that has been acquired while investigating vendors suspected of illegally selling/marketing FDA regulated products.

Attachment A:

SOW

3.0 Requirements; 4a.

Contractor Requirements

2 F. 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.

This type of monitoring is typically procured as a subscription service. Regarding monitoring of websites as an automated service, can we request an FFP line item for providing this service?

The proposed solution shall be priced as firm fixed price and included in the total annual firm fixed price amount.

Attachment B:

Pricing Worksheet

Summary Tab 1 N/A Please confirm that the Awardee would invoice based on the total annual fixed price amount.

Yes, the awardee would invoice based on the total fixed price amount. Please note under section xi. of Attachment_C_SOL_RFQ, "The contractor may propose an invoicing and payment plan that the Government may consider. If no formal plan proposed, invoicing and payment will occur at the end of services rendered. "

Attachment B:

Pricing Worksheet

Deliverable Schedule Costs

Tab 2 N/A Please confirm that the unit pricing is used for evaluation purposes only and that the Awardee would not need to bill by unit price.

Confirmed. See response to question 3 for additional information regarding invoicing.

Attachment B:

Pricing Worksheet

Deliverable Schedule Costs

Tab 2 N/A Please confirm that when completing the price for each deliverables, that Quoters should multiply their unit price by the maximum amount for each. If not the maximum, will you provide historical volumes for each deliverable to help in developing our price?

Confirmed. The total evaluated price will be the unit price multiplied by the maximum amount.

Attachment B:

Pricing Worksheet

Labor Category Prices;

and, Labor Category Descriptions

Tab 3 & 4 N/A Please confirm that Quoters can propose other labor categories - outside of those provided in the solicitation - as needed based on their solution.

Yes, but quoters must provide a description of each added labor category that differs from those that are identified.

Attachment C:

SOL_RFQ #

7540124Q00348 iv 1 The associated North American Industry Classification System (NAICS) Code is 541519 Other Computer Related Services with a small business size standard of $34 million.

The solicitation is for full and open competition.

Can you please clarify if this is meant for small businesses only or if the intent for this solicitation to be full/open to include large businesses?

Per section iv. of Attachment_C_SOL_RFQ, the solicitation is for full and open competition.

Attachment C:

SOL_RFQ #

7540124Q00348 viii.d (Advisory Down- Select Notification)

2 Quoters who are rated most highly in Phase I will be advised to proceed to Phase II of the quote submission process.

How will the "most highly rated" quoters be determined (e.g., must have high confidence rating, number of quoters, etc.)?

Per Attachment C, section viii.d, "The Government will determine the appropriate number of Quoters for Phase II that is most beneficial to the Government. However, the Government’s advice will be a recommendation only, and those Quoters who are advised not to proceed may elect to continue their participation in the procurement." THe evaluation criteria for Phase 1 is provided under Attachment C, section ix.

Attachment C:

SOL_RFQ #

7540124Q00348 ix.i (Basis of Award);

and, ix.ii (Volume III: Tab B: Price Quote Instructions)

5; 13 Page 5: The Government will evaluate the quote for award purposes by adding the total price for all options (including the option to extend services) to the total price for the basic requirement.

Page 13: The price quote will be evaluated inclusive of optional line items (CLINS) and optional periods of performance based on the total proposed value.

Page 5 states that the total price for evaluation will include the option to extend services, although this is not specifically mentioned in the evaluation criteria on page 13.

Additionally, Attachment B does not include a place to include pricing for the "option to extend services", which presumably refers to the possible 6-month extension in FAR 52.217-8 (p20).

1. Can FDA please clarify what periods will be included in the price evaluation (just the stated option periods or the additional 6-month option to extend)?

2. If the 6-month extension is included in the evaluation, can FDA please clarify how this pricing should be provided?

The total evaluated price will NOT include the option to extend services; FAR clause 52.217-8. See amended Attachment C.

Attachment C:

SOL_RFQ_Amendment1 xi.ii (Factor 1:

Relevant Experience (Phase I))

6 The Quoters shall provide a total of three (3) separate Relevant Experience contracts where each contract is similar to the requirements in the Attachment_A_SOW in terms of type, scope, complexity, and dollar value, as defined below, in which the Quoters is the Prime/subcontractor or team lead in a teaming arrangement that can be ongoing or have been completed within the last three (3) years. Each narrative shall describe the work performed solely by the Quoters under the contract. Contracts listed may include those entered into by the Federal Government or agencies of state and local Governments

In regards to factor 1 corporate experience examples, please confirm that the references can from prime, subcontractors or team leads of a contractor teaming arrangements.

See amended Attachment C for Factor 1, Relevant Experince. which now states:

"Relevant Experience contracts where each contract is similar to the requirements in the Attachment_A_SOW in terms of type, scope, complexity, and dollar value, as defined below, in which the Quoter performed as the Prime, subcontractor or team lead in a teaming arrangement that can be ongoing or have been completed within the last three (3) years."

Attachment C:

SOL_RFQ #

7540124Q00348 xi.ii (Volume II - I. - Tab A: PowerPoint Slides for Oral Presentation (No Limit))

9 Only content of the oral presentation is being considered in the evaluation regardless if it is included in the slide deck. If information Quoters present is not spoken, it will not be evaluated.

Will the oral presentation be recorded? No

Attachment C:

SOL_RFQ #

7540124Q00348 ix.ii (Factor 2 - Oral Presentation of Questions for FDA OCI Internet Monitoring Services (Phase II))

10 Question 1: How would you approach simultaneously managing multiple informational requests at the same time special projects are assigned? Provide a description of management methods, communication approach, approach to status reporting, approach to problem resolution and ensuring quality and timeliness of deliverables.

It is unclear if the last sentence in Question 1 is intended for the entire contract or just for the sentence that precedes (approach to simultaneously managing multiple informational requests at the same time special projects are assigned). Please clarify.

For the entire contract. Contractor shall describe the system in place that will allow the contractor to manage all contract activities, including situations where multiple projects are assigned in a short period of time.

Attachment C:

SOL_RFQ #

7540124Q00348 ix.ii (Volume III: Tab B: Price Quote Instructions);

and, viii.d (Advisory Down- Selection Notification, Table 1)

13 Quoters participating in teaming/partnering arrangements for this acquisition shall submit their teaming/partnering agreements with their quote. The agreements shall be signed by the parties and shall demonstrate the relationship between firms and identify contractual relationships and authorities to bind the firm and the team/partnership. Quoters proposing major subcontracts (subcontracts exceeding 10% of the overall prime contract value) shall submit signed letters of commitment from the subcontractors which define the contractual relationship and identify contribution to the planned arrangement in terms of the type and proportion of work to be performed. Copies of agreements and letters of commitment shall be submitted with the quote under this section and will not count towards the page limitation.

The text on page 13 requires that Quoters provide copies of teaming/partnering agreements and major subcontractor letters of commitment in Volume III, Tab B, Price Quote.

Table 1 on page 3 shows that Tab B of Volume III is the Pricing Excel Workbook. Can FDA please confirm that Tab B should consist of two documents - the Pricing Excel Workbook and a PDF of the required partner documents?

Paragraph for teaming/parting arrangements is removed. See amended Attachment C.

Information in table 1 on page 3 is correct. Only the Pricing Excel workbook is to be submitted for tab B.

Attachment C:

SOL_RFQ #

7540124Q00348 ix.ii (Volume III: Tab B: Price Quote Instructions and Evaluation)

13 Quoters shall submit pricing, including unit pricing, for each item requested and total final price. Quote shall clearly state the overall cost to the Government, including options.

To support us in providing accurate and completeness of our pricing quote of unit cost, what was the historical monthly and yearly unit volume of informational requests in 2023 and 2022? More specifically, is the volume of initial information requests (IIRs) and secondary information requests (SIRs) relatively consistent each month over time, or should vendors plan for periods of higher and lower volume, and consequently plan to surge labor and resources during periods of higher volume?

Maximum requests for task 2 and task 3 from the statement of work have been defined. Volume varies from month to month; the Government is unable to anticipate when there are higher volumes of work. The contractor must be able to provide required services regardless of the monthly volume. Please see updated Attachment_A_SOW for revised maximum number of informational request numbers.

Attachment C:

SOL_RFQ #

7540124Q00348 x 14 The provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (MAY 2024), applies to this acquisition. The vendor shall complete only paragraph (b) of this provision if the vendor has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal.

What Volume/Tab should Quoters include their completed Representations and Certifications?

Quoters shall include their completed Represenations and Certifications in Tab C - Quote Assumptions, Exceptions, Dependencies. Please ensure the additional information is clearly identified.

Attachment C:

SOL_RFQ #

7540124Q00348 xi (52.212-4) 14 The contractor may propose an invoicing and payment plan that the Government may consider.

What Volume/Tab should Quoters include their proposed invoicing and payment plan?

Quoters shall include their completed Represenations and Certifications in Tab C - Quote Assumptions, Exceptions, Dependencies. Please ensure the additional information is clearly identified.

Attachment C:

SOL_RFQ #

7540124Q00348 xii (52.219-9) 15 Small Business Subcontracting Plan (Sep 2023) (15 U.S.C.

637(d)(4)).

The FAR clause for a Small Business Subcontracting Plan is marked as being applicable.

What Volume/Tab should Quoters include their Small Business Subcontracting Plan (or in the case of a small business prime, what Volume/Tab should Quoters include a statement that a plan is not required)?

Quoters shall include their small business subcontracting plan or a statement that a small business subcontracting plan is not required, in Tab C - Quote Assumptions, Exceptions, Dependencies. Please ensure the additional information is clearly identified.

Attachment C:

SOL_RFQ #

7540124Q00348 xiii (352.239-71 Security Requirements for Information Technology Resources (FEB 2024)

(DEVIATION))

24 All quotes submitted in response to this solicitation or request for quotation shall address the approach for completing the security plan and accreditation requirements in clause 352.239-71, Security Requirements for Information Technology Resources.

(End of provision)

What Volume/Tab should Quoters include their approach for completing the security plan and accreditation requirements in Clause 352.239-71?

Per section 16.3 in Attachment A SOW, the system security plan (SSP) will be requested as the discretion of the COR. It is not required to be submitted with the quote.

Attachment C:

SOL_RFQ #

7540124Q00348 xiii (352.239-78 Information and Communication Technology Accessibility Notice

(FEB 2024)

(DEVIATION))

25 Whole Section HHSAR Clause 352.239-78 includes instructions for Quoters to submit several items as part of their quote, including a VPAT, Accessibility Conformance Report, "...enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues," and "identify any inability to conform to Section 508 requirements."

What Volume/Tab should Quoters include their responses to the requirements in HHSAR Clause 352.239-78?

Quoters shall attest to sections (e), (f), and (g) in their response to HHSAR provision 352.239-78.

section (e) As appropriate, the quoter shall provide a statement similar to: "[Quoter name] confirms that for all proposed Information and Communication Technology (ICT) services, [Quoter] meet applicable Section 508 accessibility standardsaccessibility standards."

(f) As appropriate, Quoter must follow the instructions under this section. If quoter is able to conform to section 508 requirements, quoter shall indicate as such.

(g) As appropriate, the quoter shall provide a statement similar to the following:

"[Quoter name] confirms that all items delivered as electronic content will be accessible to HHS acceptance criteria."

N/A N/A N/A N/A Based on the response to questions, Quoters may need time to adjust their quotes based on new or different information. Will the government provide an extension of the due date for Phase I to allow Quoters to adjust their proposals/solutions based on the government's responses to questions?

See amended due date and time posted on SAM.gov for phase 1 quotes.

N/A N/A N/A We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services. If not brand new, could you please provide the current / previous contract number?

This is a recompete of award #HHSF223201910006C; awarded to Legit Script.

Att C SOL RFQ iv 1 The associated North American Industry Classification System (NAICS) Code is 541519 Other Computer Related Services with a small business size standard of $34 million.

The solicitation is for full and open competition.

Can you provide insight to the full and open procurement strategy when historically it has been a small business set aside especially considering the scope of work as not changed?

No. Additionally, see response to question 21.

Att C SOL RFQ viii.f. Oral Presentation

4 The Quoter participants in the oral presentations must have one (1) Key Personnel proposed by the quoter in the quote submission, in addition up to two (2) responsible corporate officials for a total of up to three (3) participants, but this does not limit how many key personnel shall be provided in the staffing approach.

During the oral presentation each key personnel shall present in addition to the corporate official.

These two sentences are contradictory- please clarify the definition of key personnel and the expectations of who the participants should be during the oral presentation.

Please see Key Personnel as defined in HHSAR 352.237-75. The Project Manager is designated as a Key Personnel under this requirement. As noted in section viii.f. Oral Presentations of Attachment_C_SOL_RFQ, quoters can have up to three (3) participants for the oral presentation. Of the three (3) participants, one (1) of the participants MUST be the key personnel as indicated in the Statement of Work. The other two (2) participants are at the discretion of the quoter.

Att C SOL RFQ Factor 1: Relevant Experience (Phase I) I. TAB B: Relevant Experience:

6 Contracts listed may include those entered into by the Federal Government or agencies of state and local Governments.

Are commercial contracts and past performance also acceptable?

No. Contracts submitted should include those entered into by the Federal Government or agencies of state and local Governments.

Att C SOL RFQ Factor 1: Relevant Experience (Phase I) I. TAB B: Relevant Experience:

6 The Quoters shall provide a total of three (3) separate Relevant Experience contracts where each contract is similar to the requirements in the Attachment_A_SOW in terms of type, scope, complexity, and dollar value, as defined below, in which the Quoters is the Prime/subcontractor or team lead in a teaming arrangement that can be ongoing or have been completed within the last three (3) years. Each narrative shall describe the work performed solely by the Quoters under the contract. Contracts listed may include those entered into by the Federal Government or agencies of state and local Governments.

Is a relevant experience from a proposed subcontractor acceptable to submit as an example? If so, is there a limit to the experiences submitted by the quoter from their proposed subcontractor?

See response to question 10.

Att C SOL RFQ Factor 1: Relevant Experience (Phase I) I. TAB B: Relevant Experience:

7 The Quoters shall, for each relevant experience contract identified above, submit the following information (if a subcontract, contact information for the prime contractor, not the customer, shall be included):

1. Name of contracting activity (Federal Government agency, State/local government, commercial customer);

2. Name of company who performed the work

3. Contract number;

4. Contract type;

5. Total contract value, and subcontract value (if applicable);

6. If an order, the total value of just the order for which the Quoter was awarded;

7. Contracting Officer contact information (name, phone number, email);

8. Project Officer/Contracting Officer’s Representative contact information (name, phone number, email);

9. Administrative Contracting Officer contact information

– if different from item #5 (name, phone number, email);

10. Period of performance of the project.

This section on page 7 appears to be duplicate from language on page 6, within the same section. Please confirm or elaborate on the difference?

Page 6 details the instructions for the relevant experience evaluation factor and page 7 describes the basis of evaluation of the relevant experience factor.

Att C SOL RFQ xv. Quote and

Question Due Dates and Time

25 PHASE I Quote Due: July 18th, 2024, by 3:00PM ET Would the government consider an extension to this due date to allow for partnership and potential subcontractor evaluation?

See response to question 20.

Att C SOL RFQ xv. Quote and

Question Due Dates and Time

26 PHASE I Questions Due: July 15th, 2024, by 3:00PM ET Will answers to questions be released by the due date of phase I, relevant performance (7/18/24)?

Yes

Att A SOW

3.0 Requirements/4a.

Contractor Requirements/D

2 D. The Contractor shall possess an archive of research data that contains at least five (5) years of web artifacts about illegal sales of FDA regulated products. These data can be leveraged to provide historical context when creating reports for OCI requests

What evidence is expected to demonstrate capacity to meet this requirement.? What source documents would meet this requirement?

It is at the discretion of the quoter to demonstrate their capacity to meet this requirement.

Att A SOW

3.0 Requirements/4a.

Contractor Requirements/F

2 F. Primarily the contractor will be proactively and reactively monitoring the open internet as directed by FDA-OCI staff in writing or verbally.

Will the FDA-OCI be requesting open-source investigative information of a maximum of 10,000 websites annually based upon information leads provided to the contractor by the COR?

Yes; as stated under SOW section 4a.F.

Att A SOW Task Area 2 – Information Requests

3-5 3. Upon an Initial Information Request from FDA-OCI, the contractor shall provide to FDA-OCI a report highlighting relevant data and statistical information on any website, affiliate network, social media presence, online chatter, email address, IP address of any other cyber-related request for information.

In what areas might the contractor encounter jurisdictional issues in the marketing of said products?

The FDA does not anticipate areas where jurisdictional issues will arise. The FDA has not historically experienced any issues.

Att A SOW Task Area 2 – Information Requests/D.

Deconfliction Services

5 D. Deconfliction Services. The contractor must establish a system to notify the COR of any instances where an Initial Information Request involves or is related to a previous Initial or Secondary Information Request.

2. All Initial and Secondary Data Form requests must undergo internal deconfliction

In the case where deconfliction is necessary, will the FDA- OCI make available the research conducted by a prior contractor?

Deconfliction will be based on data the contractor collects moving forward. The contractor will not be asked to deconflict based on work preformed by a different contractor.

Att A SOW Task Area 2 – Information Requests/D.

Deconfliction Services

5 D. Deconfliction Services. The contractor must establish a system to notify the COR of any instances where an Initial Information Request involves or is related to a previous Initial or Secondary Information Request.

2. All Initial and Secondary Data Form requests must undergo internal deconfliction

Does the FDA-OCI maintain a database of platforms and their respective public policy, and posting on illegal drug sales?

The requested information is not relevant to this acquisition and is not necessary in order to submit a quote for this requirement.

Att A SOW Task Area 2 – Information Requests/D.

Deconfliction Services

5 D. Deconfliction Services. The contractor must establish a system to notify the COR of any instances where an Initial Information Request involves or is related to a previous Initial or Secondary Information Request.

2. All Initial and Secondary Data Form requests must undergo internal deconfliction

How does this project interface with local or state law enforcement efforts to investigate illegal sales of FDA products?

It doesn't. This is for FDA internal deconfliction.

Att A SOW Task Area 3 – A.

Special Projects/1.

5 1. Occasionally, the COR will request research be conducted pursuant to a special project or operation.

What is an example of a special project as defined? Any issue that is determined by the COR to be or potentially be a public threat.

Att A SOW 11.0 Travel 9 Performance under this purchase order may require travel by Contractor personnel. The need for travel will be determined and accepted by the COR and CO. All travel will be managed at by the COR and CO and in accordance with the requirements set forth within the purchase order. If travel is required, the Contractor is responsible for making all needed arrangements for Contractor ’s personnel. All travel shall be in accordance with the Federal Travel Regulations (FTR) and FAR 31.205-46(a)(2).

If there are any discrepancies between language under this agreement and the FTR, the FTR shall take precedence.

Can you please provide more information regarding the need for travel, including examples of the type of activities travel is needed for? Where would travel be to and for what purpose? (Also, durations, locations, agenda, personnel involved, etc.)

Please see Attachment_A_SOW; page 9; section 10 (place of performance) - "Requests which result in the collection of large amounts of data may require the contractor to present the findings to FDA-OCI in-person at a Government site within the United States. The contractor may also be required to testify in court."

Att A SOW 16.1 Baseline Security Requirements

b. Operate a Federal System Containing Information

12 A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

Does the contractor have access to FDA databases relevant to performing this work? If so, please list/detail what resources will be shared.

The contractor would not require access to FDA databases.

Att A SOW 16.1 Baseline Security Requirements

b. Operate a Federal System Containing Information

12 b. Provide security for any Contractor systems What protections does FDA/OCI have in place to avoid risk and harm to the contractor. Risks or harm in the form of retaliation by sellers, syndicates, or rings illegally selling FDA products?

The contractor is only required to gather open source information. As stated under section 2 objective, "...via the Internet including, but not limited to, websites, social media platforms, and chat/messaging services."

Att A SOW 16.1 Baseline Security Requirements 11. a.

15 The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

Will the government assist the contractor in obtaining an

ATO?

As stated under section 16.1, section 1).d, there is not PII involved under this requirement. The PTA/PIA is not required.

Att A SOW 5) Desktops, Laptops, and Other Computing Devices Required for Use by the Contractor.

22 Desktops, Laptops, and Other Computing Devices Required for Use by the Contractor. The Contractor (and/or any subcontractor) shall ensure that all IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices, etc.) used to process information on behalf of FDA are deployed and operated in accordance with approved security configurations and meet the following minimum requirements:

Please confirm the quoter will be responsible for issuing equipment to the staff designated to this program. Does FDA anticipate issuing GFE (laptops, PIV cards, etc.) to staff supporting this contract?

No government furnished equipment will be provided. Per Attachment_A_SOW;

page 9; section 10 (place of performance), the majority of the contractor services shall be performed at the conractors site.

Also see response to question 63 regarding Government Furnished Property.

Att A SOW 16.0 Organization

Conflict of Interest 27-29 NA Is there a specific contract or scope of work that would be considered a conflict of interest in performing this work?

Organizational conflict of interest would be present if the contractor is deemed to be illicit sellers of FDA regulated products or if a contractor employee is associated with the target of an OCI investigation.

Att A SOW 16.0 Organization Conflict of Interest

27-29 NA If a firm provides services to companies who sell FDA regulated products, including product certifications, would that represent a conflict of interest? And would that firm be conflicted out of being awarded the contract?

If the firms are deemed to be illicit sellers of FDA regulated products, then yes, there is a conflict of interest.

Att A SOW Appendix I 30 C. 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

A) Are there any deliverables associated with the proactive monitoring referenced throughout the SOW?

B) How are contractors expected to bill for this?

See responses to questions 2 and 3.

Att B Pricing

Deliverable Schedule Costs NA NA

Is this pricing workbook meant as a sample or baseline, or are quoters to required to use and complete this workbook as-is?

Quoters are required to use and complete Attachment_B_Pricing_Excel_Workbook.

Att B Pricing

Deliverable Schedule Costs NA NA

Can quoters deviate from the labor category descriptions, adding and/or removing labor categories for their quote?

See response to question 6.

Att B Pricing Deliverable Schedule Costs NA NA

Can quoters deviate from the 4 CLINS provided to include CLINS based on the SOW for the monitoring of 10,000 sites, straw purchases, and deconfliction services?

No, quoters may not deviate from the established five (5) CLINs . However, see responses to questions 2 and 3.

Att B Pricing Deliverable Schedule Costs NA

Special Projects as requested by COR: Maximum Annual Amount: Up to fifteen (15) special projects at thirty (30) hours each.

The deliverables for Initial and Secondary Information Requests did not specify the approximate hours required for each. Can you please also provide that detail for the other CLINs/Task 2 Deliverables?

The approximate hours required are determined at the discretion of the quoter. As provided under SOW Task 2, the contractor is shall provide a complete report which provides all of the details indicated under this task area.

Att B Pricing Deliverable Schedule Costs NA Travel Cost, Maximum 3/year

It is recommended that travel is included as a Not to Exceed (NTE) CLIN with a value determined by the government for all quoters. Especially since travel is not defined in scope, therefore should not affect the quoters overall price evaluated.

As stated under section SOW section 11, "Performance under this purchase order may require travel by Contractor personnel." Quoters should not include travel in their proposed Firm Fixed Price quotation. See amended Attachment B.

Attachment A 11.0 Travel 9 Performance under this purchase order may require travel by Contractor personnel. The need for travel will be determined and accepted by the COR and CO.

Attachment B - Pricing Excel asks bidders to provide a cost for travel 3/maximum (Line 11).

To estimate costs, bidders need the anticipated location to which they will need to travel and the duration of the trip.

Will FDA provide us with this information?

Alternatively, would FDA consider providing a Not to Exceed Number (NTE) on Line 11?

See response to question 48.

Attachment A 3.0 Requirements 2 4a.D - The Contractor shall possess an archive of research data that contains at least five (5) years of web artifacts about illegal sales of FDA regulated products.

If the awardee of this contract is not the incumbent, how soon will the previous contractor's archive be released to the new contractor?

Government furnished information will be provided to the Contractor as as determined by the FDA. The statement of work does not require a transition in/out from incumbent to new contractor.

51 General Who is the incumbent contractor? See response to question 21.

General What is the incumbent contract number and total contract value?

See response to question 21.

General Is the incumbent contractor eligible to submit a proposal? The solicitation is for full and open competition.

4b. Description of Tasks (Task Areas)

5 Task 4 - Special Projects (A.3) OCI anticipates that the number of these special requests will not exceed 15 per calendar year

Is it likely that the COR will request more than one special project at a time?

How many concurrent special projects were performed on the current contract?

It is possible, OCI typically runs several projects that are preformed concurrently, but they are not typically requested of the contractor at the same time.

Attachment C viii 2 b. All electronic submitted PDF documents shall use no smaller than 12-point font

Please confirm that the MS PowerPoint presentation (not submitted to FDA) can use fonts larger than 12-point for on-screen readability by the evaluation team in a Zoom meeting.

Confirmed - Slides are NOT evaluated.

Attachment C viii 4 f. Oral Presentation - The Quoter participants in the oral presentations must have one (1) Key Personnel proposed by the quoter in the quote submission, in addition up to two (2) responsible corporate officials for a total of up to three (3) participants, but this does not limit how many key personnel shall be provided in the staffing approach.

If a bidder decides to name more than one key personnel in its Staffing Plan and chooses to have only one key personnel in the oral presentation, may the bidder choose which key personnel will participate in the oral presentation?

Yes

Attachment C viii 4 F. During the oral presentation each key personnel shall present in addition to the corporate official.

Could FDA please confirm that it is up to the bidder to decide if they want one key personnel and two corporate officials or two key personnel and one corporate official?

See response to question 23.

Factor 1: Relevant Experience (Phase I)

I. TAB B: Relevant Experience

6 Complexity: is defined as the number of requests and reports handled by the Quoters. The anticipated number of requests is five (5) per month or sixty (60) annually.

Both Attachment B and Attachment A have significantly more requests (700 annually).

Could the Government confirm that the bidders' relevant projects need to show only 60 request annually to meet the complexity benchmark?

Confirmed

II. Evaluation Criteria Factor 2: Oral Presentation of Questions for FDA OCI Internet Monitoring Services (Phase II)

Factor 3: Key Personnel for FDA OCI Internet Monitoring Services (Phase II)

11 The Quoters staffing plan shall include one (1) Key Personnel as follows

Could the Government confirm that the Project Manager is the ONLY key personnel required to be named in the Staffing Plan?

See response to question 23.

II. Evaluation Criteria Factor 2: Oral Presentation of Questions for FDA OCI Internet Monitoring Services (Phase II)

Factor 3: Key Personnel for FDA OCI Internet Monitoring Services (Phase II)

11 The Quoters staffing plan shall include one (1) Key Personnel as follows

Could the Government confirm that the Project Manager is NOT required to be part of the three-person orals presentation team?

See response to question 23.

Attachment A SOW Task Area 2, C. Straw Purchases, 4.

5 C. Straw Purchases, 4. FDA-OCI will provide the "zero balance" credit cards to the contractor, which shall be used exclusively for and at the direction of FDA-OCI. These shall remain the property of FDA-OCI and shall be returned to FDA-OCI within 24 hours of request.

Straw Purchases will be conducted using a "zero balance" credit card provided by the government. Please confirm the government will provide GFE, credentials, name, address, email, etc. for purchases.

FDA will provide this data when and if needed. Also see response to question 63.

Attachment C Factor 1: Relevant Experience (Phase 1)

6 Scope: is defined as relevant experience that are the same or similar to the Attachment_A_SOW requirements and task areas in Attachment_A_SOW Section 4.

Can the government confirm that the Scope should be referring to Attachment_A_SOW Section 3.0 Contractor Requirements, instead of Attachment_A_SOW Section 4.0 Deliverables?

Confirmed. It should state "Scope: is defined as relevant experience that are the same or similar to the Attachment_A_SOW requirements and task areas in Attachment_A_SOW Section 3."

See amended Attachment C. "Attachment_C_SOL_RFQ_Amendment2"

Attachment A SOW Task Area 2, C. Straw Purchases, 4.

5 C. Straw Purchases, 4. FDA-OCI will provide the "zero balance" credit cards to the contractor, which shall be used exclusively for and at the direction of FDA-OCI. These shall remain the property of FDA-OCI and shall be returned to FDA-OCI within 24 hours of request.

Per the reference to "property of FDA-OCI" herein, we recommend the addition of FAR Clause 52.245-1.

Clause included. See amended Attachment C.

"Attachment_C_SOL_RFQ_Amendment2"

Attachment A SOW Task Area 3, D.

Deconfliction Services, 3.

5 3. Upon written or verbal authorization from the COR, the contractor must securely deconflict information contained in Initial and Secondary Data Form Requests with other federal law enforcement agencies or relevant private-sector stakeholders as directed by the COR.

In order to conduct deconfliction, access to information from other agencies will be required. Please confirm bidder will have access to other system(s) or data to complete the deconfliction task.

Information will be provided on an as needed basis.

Attachment C HHSAR CLAUSES, e. 22 (e) Authority to Operate (ATO). As required by current HHS policy, the Contractor shall submit written proof of information technology security accreditation with a valid ATO to the Contracting Officer. Such written proof may be furnished either by the Contractor or by a third party.

Accreditation shall be in accordance with HHS policy available from the Contracting Officer upon request. The Contractor shall submit for acceptance by the Contracting Officer along with this ATO a final security plan, risk assessment, security test and evaluation, privacy threshold analysis or privacy impact assessment, and a disaster recovery plan/continuity of operations plan.

Could the government list the current system(s) currently used and confirm the ATO status for each?

If an ATO is required, the contractor will be provided the necessary information. The Government does not anticipate a need to an ATO.

Attachment A SOW Task Area 2, A. Initial Informational Requests, 5.

4 5. The contractor shall provide a maximum of 500 Initial Informational Reports (which may include other associated attachments [i.e., spreadsheets, etc.]) annually under the scope of this contract.

To provide the government with accurate estimates for level of effort, can the government provide an example format for the Initial and Secondary Informational Reports (e.g. number of data fields, number of pages per report, etc.)?

See Statement of Work Task 2, item 4 for minimum requirements for the reports. See Statement of Work Task 2, section B for Secondary Informational report requirements; reports may vary depending on findings of the Initial Informational report. Please see updated Attachment_A_SOW for revised maximum number of informational request numbers.

Attachment A SOW Task Area 2, A. Initial Informational Requests, 5.

4 5. The contractor shall provide a maximum of 500 Initial Informational Reports (which may include other associated attachments [i.e., spreadsheets, etc.]) annually under the scope of this contract.

Historically, how many reports annually (on average) for each type (Initial and Secondary) have been produced over the past 5 years and could the government provide more examples of attachments associated to the report?

On average about 10 initial reports and 1-2 secondary reports per month. This can change based on number of open cases and threats occuring during a certain time period. Please see updated Attachment_A_SOW for revised maximum number of informational request numbers.

Attachment C Solicitation viii., f.

Oral Presentation

4 Oral Presentation table, Item 2, The Quoter shall present its proposed answers to the questions found under section ix and Management Approach including Staffing Plan.

Can the Government confirm that the reference to "section ix" is a typo and this should read "section II Evaluation Criteria" instead?

This is a reference to Section ix., subsection ii Evaluation Factors & Criteria, Volume II Phase II Quote Preparation Instructions & Evaluation Criteria, II. Evaluation Criteria of the solicitation.

Q&A