The Food and Drug Administration (FDA) will be sending a contractor to inspect entities engaged in retail activities where tobacco regulated products may be manufactured, prepared, compounded or processed within the premises.
To complete this work, they issued a solicitation for a federal business opportunity which could result in a one- to five-year nationwide IDIQ contract. They are only accepting offers from Women Owned Small Businesses (WOSBs) until March 7, 2018.
The purpose of these inspections is to document compliance and potentially pursue enforcement actions when appropriate. Incompliance with FDA regulation could lead to warning letters, civil money penalties, and no-tobacco sale orders. The FDA is looking at misleading advertisements and sale of “new products” without FDA approval which includes modified risk tobacco products, aka electronic cigarettes or vape pens.
The contractor responsible for performing the inspections will be a Woman Owned Small Business as the funds available for the contract have been set-aside for this type of entity. In addition to the actual inspections, the contractor will be responsible for transitioning in from any current contractor, developing a quality control plan for data, participating in meetings, testifying as witness if requested, and transitioning out to the subsequent contractor. The FDA will provide training, forms, and a camera for performing the inspections.
Offers must come from a Woman Owned Business registered in the System for Award Management (SAM) and contain the following:
- Technical proposal
- Project plan/approach
- Staffing that allows the contractor perform solicitation requirements
- Relevant Past Performance (up to three relevant contracts within the past three years)
- Needs to average hourly rates which vary in different geographic regions of this nationwide contract
- Will include $80,000 for other direct costs
- Will include $1,000,000 for travel expenses
An IDIQ contract will contain task orders throughout the period of performance. The period of performance for this contract is one year, with options to extend the contract an additional year for four more years. Price quotes are estimates based on the amount of work that will be ordered. Businesses may use a third-party to complete registration and/or submit a strong offer for the best chance at winning the contract.
US Federal Contractor Registration (USFCR) is the world’s largest third-party government registration firm. They not only register companies on their behalf in SAM, but also have pioneered the Advanced Procurement Portal (APP).
APP provides a data management system and learning center so entities competing for federal contracts aren’t overwhelmed by the cumbersome and time-consuming process of federal contract acquisition. Small businesses are often at an advantage to receive federal contracts, but at a disadvantage when it comes to time and resources for winning those government opportunities. USFCR solves that problem for small business.