SOLICITATION NOTICE
U -- Web Based Training for cGMP and GCP
- Notice Date
- 7/20/2018
- Notice Type
- Presolicitation
- NAICS
- 611430
— Professional and Management Development Training
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 18-011269
- Point of Contact
- Susan Nsangou, Phone: 3014969351
- E-Mail Address
-
susan.nsangou@nih.gov
(susan.nsangou@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institutes of Health (NIH), Clinical Center (CC), Office of Research Support and Compliance, intends to enter into a contract on a sole source basis, under the authority of FAR 13.106(b), a contract for training services for cGMP and GCP practices. The Clinical Center (CC) plans to procure, on a sole source basis, from UL Pure Learning, 202 Carnegie Center, Suite 301, Princeton, NJ, 08540. The requirement is for course elements in risk management, handling a FDA complaint, data integrity, introduction to GMP's, and GMP training requirements. This acquisition will be processed under FAR Part 13 and will be made pursuant to the authority in FAR 13.106-1(b)(2). The North American Industry Classification System Code is 611430 and the business size standard $11 million. Only one award will be made as a result of this solicitation. This will be a firm fixed price type contract. The NIH Clinical Center (CC) serves as a center of excellence in medical research, training and the clinical care for patients with unique and rare conditions. ORSC's role in training is to develop and deliver a variety of educational programs and operate a regulatory training program for NIH staff, trainees, and postdoctoral fellows. The training program will focus on the federal laws, regulations and guidance, etc., associated with medical products. NIH is committed to providing proper initial and periodic cGMP and GCP training and competency assessment for all employees who work in the Intramural Research Program under GMP and GCP compliance. NIH is in the process of developing a cGMP/GCP training program for all regulated employees in the Intramural Program to ensure a thorough and complete understanding of, and appreciation for the importance of Quality / CGMP / GCP compliance to each job - as well as its impact on product quality and safety of the patient. In order to limit the overall cost of the program and increase efficiencies, the intent is to provide the course elements in an on-line, web-based format. UL Pure Learning is the only known source to have the courses readily available and in a web-based format. This notice of intent is not a request for competitive proposals. However, all proposals received prior to the closing date of this synopsis will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.. NO COLLECT CALLS OR FACSIMILE TRANSMISSIONS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL TO THE POINT OF CONTACT LISTED IN THIS NOTICE OF INTENT SYNOPSIS. All information received in response to this notice that is marked Proprietary will be handled accordingly. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-011269/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, United States
- Record
- SN05001236-W 20180722/180720230944-cf41649bdfb9f876bf2e3a3c756d1e06 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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