NOI-NASEM.pdf

This synopsis is hereby issued in accordance with FAR Part 5.203 and FAR 6.302 in response to the mandatory requirement for a 15 day notification. The purpose of this synopsis is to announce the Food and Drug Administration's intent to negotiate a Firm Fixed Price sole source award with the National Academies of Science, Engineering, and Medicine (NASEM) located at 500 Fifth Street NW, Washington DC 20001 for a consensus study and report on “Emerging Technology for Pharmaceutical Manufacturing.”

Only One Responsible Source and no other type of services will satisfy the needs of the agency. Created by a Congressional Charter signed by President Lincoln in 1863, the Academy is a federally chartered non-profit institution dedicated to the furtherance of science and its use for the general welfare. The Congressional Charter is codified at 36 U.S.C.A. 150301-150305. Although the Academy is a private non-profit corporation, it is called upon by the terms of its Congressional Charter to act as an official, yet independent, advisor to the federal government in matters of science and technology.

The capacity of the Academy to play a unique role in advising the Federal government stems from the net impact of three interrelated attributes:

1. To a degree unmatched elsewhere, the Academy can elicit the participation of virtually any expert whom it invites to serve. As a consequence, there are at any one time some 800 committees, addressing an enormous diversity of problems, peopled by about 8,000 unpaid volunteers.

2. The credibility of Academy Reports is maximized by the recognized impartiality of the institution, which manufactures no product, possesses no funds to disperse, has no power of decision over the scientific establishment, and enjoys no executive or regulatory authority. Thus, there is no vested interest in the outcome of deliberations and the independent advice is of unparalleled objectivity.

3. Finally, for those studies that involve sharply divergent and well-fixed points of view, the Academy has repeatedly been able to bring together about its conference tables assemblages of persons who have been conspicuously reluctant to address mutual issues, in an atmosphere of comparative calm.

Committees are composed of the nation’s top scientists, doctors, engineers and other experts, all of whom volunteer their time to study specific concerns. Nominees for membership in committees at the Committee are subjected to rigorous procedures for appointment. These procedures ensure the selection of the most qualified scientists who represent a broad range of views and who, as a group, represent the spectrum of scientific thought in a subject area.

The Academy’s unique status was confirmed by President George Bush in Executive Order 12832 (January 19, 1993), which specifically recognizes the Academy’s unique qualifications, and the appropriateness of sole source awards to the Academy:

“When a department or agency of the executive branch of the Government determines that the Academy, because of its unique qualifications, is the only source that can provide the measure of expertise, independence, objectivity, and audience acceptance necessary to meet the department's or agency's program requirements, acquisition of services by the Academy may be obtained on a noncompetitive basis if otherwise in accordance with applicable law and regulations.”

These unique qualifications were confirmed by the General Accounting Office in Moshman Associates (B-216107), which upheld the Department of Education’s sole source justification for an award to the

Academy. The Comptroller General agreed with the agency that only the Academy could “provide a combination of the highest caliber of scientific expertise, independence, impartiality, credibility and audience acceptance.” The GAO specifically relied on the special independent status of Academy as a nonprofit organization, congressionally chartered for the purpose of conducting studies for the government, and that the Academy historically has enjoyed a high degree of credibility, that its scientific expertise and resources are of the highest caliber, and that it is a "distinguished and respected body."

Most importantly, for this project to be successful, the contractor must be able to attract the right speakers and audience and to have the broad reach across all of the relevant stakeholders. To achieve the best advice possible, the activity must be developed and coordinated with the highest scientific and professional standards. This is a hallmark of the Academy. Additionally, as it is the honorary body for premier US scientists, engineers, and doctors, it has a unique capacity to obtain the voluntary participation of these experts on consensus studies. The process for the development of a report with findings and recommendations uses an expert, consensus-driven committee that is independent of the Agency sponsoring the study. In the pharmaceutical sciences and manufacturing sector, their independence will ensure that all relevant stakeholders feel comfortable providing input in a manner that may not be possible if they were providing input to a regulatory agency directly or via a less independent process. The expert consensus process also provides critical layers of interpretation, analysis, and peer review that are not found at other organizations. Finally, being subject to FACA means that the NASEM must provide transparency about the data provided to the committee during its deliberations to a level that one may not obtain through other organizations.

No personal remuneration is made for the services of the scientists, engineers and other experts serving on Academy committees and, by law, no fee or profit is paid to the Academy.

Therefore, it is in the public interest to receive the independent advice of unparalleled objectivity of the highest quality that provides an inherent degree of acceptability. Considering the volunteer nature of committee members as well as the independence, objectivity, quality and acceptance of Academy recommendations, the Academy represents a cost effective means for examining the critical issues of this project.

Under the anticipated award, NASEM shall perform the following work:

An expert consensus study performed by the National Academies of Sciences, Engineering, and Medicine (NASEM) to

a) Describe and evaluate innovative, emerging pharmaceutical manufacturing and analysis technologies that may be translated into FDA drug applications within the next 5-10 years

b) Provide input into FDA’s review of the regulatory framework related to quality assessment

The anticipated period of performance of this work is twenty-two (22) months following award.

The estimated total amount is approximately $1,000,000.00

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS, however, interested firms may submit a capability statement in response to the above requirement with pricing information by May 31, 2019 @ 2:30 PM Local Time to Richard Robinson, Contract Specialist, Phone: (301) 796-6508, Email: Richard.robinson@fda.hhs.gov.

mailto:Richard.robinson@fda.hhs.gov