FDA Law

FDA SOL---14-223-SOL-00054
This is a Combined Solicitation Synopsis for a commercial item prepared in accordance with FAR Part 12 in conjunction with the policies and procedures for solicitation, evaluation and award as prescribed in FAR Part 15 - Contracting by negotiation. The Food and Drug Administration has a commercial item requirement to train its field and headquarters operational personnel in the basic legal aspects of the Food, Drug, & Cosmetic Act and related regulations.
The contractor shall supply necessary qualified personnel to provide instructional services at a minimum of twelve (12) or an estimated maximum of two hundred seventy five (275) courses over a period of five (5) years. The course titles are as follows:

1. The Basic Food and Drug Law Course
2. Compliance Law Course
3. Practical Compliance Applications Course
4. Advanced Import Investigations Course
5. Regulatory Science Course

This procurement is full and open to any vendor that has the ability to provide the training listed above. A Firm-Fixed Price Indefinite Quantity contract with Cost Reimbursement travel is planned. It is anticipated that an award will be made for a 12 month base contract period with the possibility of up to four 12 month options. Vendors must be registered in System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov. The NAICS code for this requirement is 611710 and the Size Standard is $6.5 million.

Prospective offerors are responsible for downloading the attached solicitation and any subsequent amendments. It is the responsibility of the offeror to monitor the FedBizOpps website for any releases and or amendments. Hard copies will be provided to individuals under the Americans with Disabilities Act and Rehabilitation Act upon request.

This modification also deletes in Section L ( of the RFP), page 62 (B) "Alternate Proposals"
 

Sources Sought Synopsis

The Food and Drug Administration (FDA) is conducting a market survey to assess the availability and technical capability of small business firms as defined by NAICS code 611710 or 611430 to perform training courses in accordance with the Food, Drug & Cosmetic Act (FD&C Act). This notice is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers.

FDA welcomes responses from all interested parties. 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. 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. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

Background

Field personnel are the first line in gathering and reviewing evidence, maintaining its integrity, and recognizing its significance with respect to the laws enforced by FDA. The Office of Regulatory Affairs (ORA) staff in the past have coordinated the formalized basic food and drug law training of field and headquarters personnel, and as the coordinating unit, it will ensure continuity in both training and performance. Continuation of this quality training is essential in order for the FDA to maintain a cadre of field and headquarters personnel sufficiently acquainted with the FDA laws and regulations to enforce agency policies and statutes in a uniform manner.

FDA has a need to offer more advanced training for FDA staff of varying duration and complexity. Expertise needs to be presented in the import and compliance areas, advanced applications of the FD&C Act and expertise pertaining to commodity assets that the FDA regulates, such as veterinary medicine, drugs, devices, foods and regulatory actions pertaining to the law such as for seizures and injunction actions, etc.

Scope of work

The contractor shall supply necessary qualified personnel to provide instructional services at a minimum of seven or an estimated maximum of two hundred courses over a period of a base year and four option years. The contractor should have sufficient personnel to conduct several courses at the same time if necessary to meet the growing needs of the Agency. The content for the classes will include: food and drug law, basic and advanced import regulations, courtroom testimony, injunction, seizure, and aspects of the law pertaining to a particular commodity area (i.e. devices, drugs, foods, biologics, veterinary medicines, etc.). Independently and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work described below:

The content and duration of each course will vary as follows:

1. Basic Food and Drug Law Course - 4 - 5 day course

This course is designed to differentiate between FDA Policy, Regulation and Law and to locate the appropriate statutory sections for FDA regulated commodities, sanctions and various violative categories of regulated products.

2. Compliance Law Course - 4 - 5 day course

Course is a review of the FD&C Act and the new statutory obligations, amendments and updates as well as general discussions regarding court vs. administrative actions.

3. Practical Compliance Applications Course - 10 day course

This is a two week course designed for the directors of compliance branch (DCB) and compliance officer (CO) who perform compliance work to provide them with the "practical applications" of selecting and processing seizures and injunctions.
Instructor is only for needed for 2 days

4. Advanced Import Investigations Course - 4 -5 Day course

This course is designed to provide those who work in imports with the specific skills and tools needed to make effective and equitable regulatory decisions of the FDA and Customs penalty actions on violative imported products.
Instructor is only needed for 2 days

5. Regulatory Science Course - 1 day course

This one day course is designed to accurately generate work sheets for regulatory sample analysis and this presentation will primarily focus on the preparation of regulatory analysts for courtroom testimony.
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These courses will be held at Government selected sites for approximately 40-60 students per class.

All capability statements furnished should demonstrate:

1. Understanding of the objectives of each course;
2. Technical approach to the presentation of each course;
3. The organizational flexibility to modify the labor mix to allow several courses to be taught at the same time;
4. Professional qualifications and knowledge of staff to present classes on FD&C Act and;
5. The firm's status as a small business under NAICS code 611710 or 611430.

Please provide the following with your capability statement:

• Organization name
• DUNS number
• Organization's website
• Contact Name
• Contact Telephone
• Contact E-mail address
• Size designation
• Number of employees in your organization

This is not a Request for Proposal (RFP). Please provide a copy of Capability Statements to Julia Savage Julia.savage@fda.hhs.gov or via fax at (301)827-7039 by 12 noon EST February 21, 2014. Capability statements should not exceed more than 5 pages in length.

(initially posted as SS Notice on Feb 6, 2014) See attachments for solicitation