RFI - FAERS Data Management Program Support Services.pdf

Food and Drug Administration Request for Information/Sources Sought

FAERS Data Management Program Support Services

This Request for Information (RFI)/Sources Sought is for information, planning and market research purposes only and shall not be construed as either an RFP/RFQ solicitation or obligation on the part of the Food and Drug Administration or its Centers.

The purpose of this RFI is to help the FDA understand industry best practices, technical solutions, and the market’s capability of fulfilling the FDA’s task requirements as described in this RFI.

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. The information received may be used (for planning purposes) to inform the solicitation.

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. Questions regarding the RFI cannot be accepted.

Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties.

However, the FDA reserves the right to contact vendors if additional information is necessary.

Capability Package:

The Government is seeking responses from ONLY qualified 8(a) certified small business vendors to provide feedback against the attached draft task requirements.

The respondent shall self-certify as a small business under the North American Industry Classification System (NAICS) Code 518210 - Data Processing, Hosting, and Related Services.

Responses are limited to ten (10) pages, electronically submitted, in Microsoft Word or Portable Document format (PDF), using 11 font size and Calibri font.

Please include a Rough Order of Magnitude (ROM) against the attached draft task requirements, for “informational purposes only.”

The 8(a) small business vendor shall include the following information:

• Company name, company’s primary address location, website address, Cage/DUNs number

• Point of contact information: name, telephone number, and email address

• Company’s small business size, and 8(a) graduation date.

• An acknowledgement of your registration for NAICS code 518210

• Qualification information (type & duration of employee experience directly relevant to the task requirements)

• Level of involvement information (prime and/or sub-contractor) and timeframe(s) for work on the same and/or similar projects

Questionnaire:

A complete response to the RFI shall also include answers to each of the questions stated below associated with the attached draft task requirements document. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not demonstrate the capability to provide the services required. Responses shall describe capability and experience, not merely repeating and affirming the respondent's capability (e.g.: The response must go beyond the statement that, "XYZ company can provide…….").

A. Contract Mechanisms/Types of Contracts

1. Does your company have experience with performing the draft task requirement services under a PWS, SOO, or SOW type of contract mechanism? If so, please explain your experience and the pros/cons for each one selected.

2. Does your company have experience with performing the draft task requirement services under a firm-fixed-price contract, labor hour contract, IDIQ contract with a combination of fixed-price, labor-hour, and/or time-and-materials type contract? If so, please explain your experience and the pros/cons for each one selected.

B. Task Requirements Capability (See Attached Draft Task Requirements)

1. Does your company have prime contractor experience with data entry type contracts valued at or above $2,000,000 performed within the last 5 years? If so, please explain in further detail.

2. Does your company have the capability to provide processes and analytics to manage productivity and data entry quality supporting approximately 40 employees, including processes to monitor your individual contractor employees and other processes to show larger trends to FDA? If so, please explain in further detail.

a. Does your company have the capability to use these processes to establish a culture of continuous improvement? If so, please explain in further detail.

3. Does your company have different innovative approaches to data entry that may not be common with other companies? If so, please explain in further detail.

4. Does your company have the capability to address any potential FDA policy and technology changes causing potential shifts in the work environment? If so, please explain in further detail.

5. Do your company (contractor employees) have any experience with providing these types of services remotely (100% working from home)?

If so, please explain your management process for cyber security and physical security of equipment (i. e. laptops, iPhones, etc.); and how you are leveraging innovation for remote work.

6. Does your company have the capability to provide daily local courier services? If so, please explain in further detail.