MRA

NOTICE OF INTENT TO SOLE SOURCE

This is a notice of the Government's intent to solicit, negotiate and award to National Academy of Sciences under the authority of FAR 6.302-1.

The U.S. Food and Drug Administration (FDA), intends to award a sole source Basic Ordering Agreement (BOA) to National Academy of Sciences - Engineering - Medicine, 500 Fifth Street, North West KECK 1051, Washington, DC 20001, to provide all personnel and services necessary to support the following Statement of Objectives and Questions that need to be addressed.

Statement of Objectives
In the regulation of pharmaceutical products, some National Regulatory Authorities (NRAs) are increasingly using mutual recognition agreements (MRAs) to leverage their regulatory resources and remit. The range and approach of these MRAs varies widely: some NRAs may recognize and rely upon other regulatory authorities in the conduct of inspections (GMP inspections), and/or in drugs/medicinal products entering the marketplace that are manufactured in one country and imported in the other country, including active pharmaceutical ingredients and veterinary pharmaceuticals. Some NRAs may use MRAs as one of several factors when determining when to "rely" upon another NRAs regulatory actions or findings.
QUESTIONS TO ADDRESS: What is the current global landscape of these types of Mutual Recognition Agreements? And more importantly when MRAs are implemented, what are the public health impacts, resource savings and/or resource redirection, e.g., to areas of higher risks? And over time, what if any are the impacts to an NRA's technical, scientific and regulatory competencies?
This announcement is published for informational purpose only. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS OR QUOTATIONS. Request for copies of a solicitation in response to this notice will not be honored or acknowledged.

The anticipated award date is approximately September 30, 2018. Please note that this is not a request for competitive proposals. However, all interested parties who believe they can meet the requirements are invited to submit in writing complete information describing their ability to provide the product/services listed above. Deadline date for the submittals is The response date for the submittals is 9/26/2018 at 12 noon EST.

A determination by the government not to compete this requirement, based on responses to this notice, is solely within the discretion of the government. Information received will be considered solely for determining whether to conduct a competitive procurement in the future.

The closing date for this notice is 9/26/2018 at 12 noon EST. Inquiries should be emailed to the Contracting Specialist at the following address:

Kristine.Zechman@psc.hhs.gov

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