21 U.S.C. § 379dd — Establishment and functions of the Foundation

This section creates a nonprofit organization to help the FDA fill scientific gaps, and sets out how it is run and funded. (a) In general. This section establishes a nonprofit corporation called the Reagan-Udall Foundation for the Food and Drug Administration (called "the Foundation" in this part). It is headed by an Executive Director, appointed by the Board of Directors under subsection (e). The Foundation is not a federal government agency or arm. (b) Purpose of Foundation. The Foundation exists to advance the FDA's mission: modernizing how medical, veterinary, food, food ingredient, and cosmetic products are developed, speeding up innovation, and improving product safety. (c) Duties of the Foundation. Taking FDA's Critical Path reports and priorities into account, the Foundation must: (1) identify unmet needs in developing, making, and evaluating the safety and effectiveness — including after approval — of devices (including diagnostics, biologics, and drugs), and the safety of food, food ingredients, and cosmetics, including better tools to measure safety; (2) set goals and priorities to meet those needs; (3) work with the Secretary to find existing and planned federal research programs tied to those goals, coordinate with them, and avoid duplicating them; (4) give grants, or make contracts, agreements, or cooperative agreements with scientists and organizations — which can include the FDA, university groups, public-private partnerships, colleges, tax-exempt charities under section 501(c)(3) of title 26, and industry — to advance those goals efficiently; (5) recruit people for, and hold or help sponsor, meetings that further those goals; (6) publish information and data, and where practical, license, distribute, and release materials, lab supplies, and techniques, to make them as available as possible to the FDA, nonprofits, and academic and industry researchers; (7) make sure that (A) the Foundation takes steps to patent its own inventions, (B) it takes steps to allow those inventions to be licensed, and (C) its licenses, agreements, and contracts push, as much as practical, for those patented and licensed inventions to be used commercially and non-commercially; (8) give the FDA — and, on request, other federal agencies — objective clinical and scientific information to help regulatory policy keep up with science and the agency's public health mission; (9) assess the unmet needs from (1) every year; and (10) do any other activities that fit the Foundation's purpose, as the Board decides. (d) Board of Directors. (1) The Foundation has a Board made up of ex officio members and appointed members, all of whom vote once appointed. The ex officio members are the FDA Commissioner, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Director of the Agency for Healthcare Research and Quality (or their designees). Those ex officio members, by majority vote, appoint 14 more people to the Board: 9 chosen from a list the National Academy of Sciences provides, and 5 chosen from lists provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade groups. Of those 14: 4 must represent the general pharmaceutical, device, food, cosmetic, and biotechnology industries; 3 must represent academic research organizations; 2 must represent patient or consumer advocacy groups; 1 must represent health care providers; and 4 are at-large members with relevant expertise. The Board can later add more seats through its bylaws, filled the same way, as long as industry representatives never make up more than 30 percent of all voting Board members. The Board must make sure its members include people with expertise developing, making, and evaluating the safety of devices, biologics, drugs, food, food ingredients, and cosmetics. No federal government employee (other than a "special Government employee" as section 202(a) of title 18 defines that term) can be appointed to the Board. Within 30 days after September 27, 2007, the Secretary had to convene the ex officio members to incorporate the Foundation and appoint the first Board members. Once that first Board was appointed, the CDC Director's and the AHRQ Director's terms as ex officio members ended, while the Commissioner and the NIH Director stayed on as ex officio members, but without a vote. The ex officio members chose one appointed Board member to serve as Chair. The Board must adopt bylaws that: are published in the Federal Register for public comment; set policies for choosing the Foundation's officers, employees, agents, and contractors; set policies (including ethics rules) for accepting, asking for, and using donations and grants, and for handling the Foundation's assets, including limits on how much control a donor can keep over how their gift is used; require all Foundation employees, fellows, and trainees to follow the conflict-of-interest rules in section 208 of title 18; set licensing, distribution, and publishing policies that let the public use Foundation-funded information and inventions as widely and freely as possible, which can include charging cost-based fees for published material; set standards for reviewing and awarding grants and contracts, including peer review, matching those used by the Foundation for the National Institutes of Health as far as practical; cap how much of a grant, contract, or cooperative agreement a recipient can spend on administrative costs; set policies for agreements between the Foundation and other groups, including the FDA; set policies for funding training fellowships — at the Foundation, at academic institutions, or at the FDA — for scientists, doctors, and other professionals who do not work for regulated industry, to build expertise and help move basic research into real-world regulatory practice; set up a yearly Board review of how the Foundation is running; and spell out the Executive Director's specific duties. The Board must also set the Foundation's overall direction and priorities, evaluate the Executive Director's performance, and handle whatever else the Foundation needs to function. Board members serve 4-year terms, staggered so they do not all end at once, as the ex officio members (or later, the sitting Board) decide. A vacancy does not stop the rest of the Board from working, and is filled by majority vote of the appointed members. Someone appointed to fill a vacancy serves out the rest of that term. A member can keep serving past their term until a successor is appointed. Board members are not paid for their service, though they can be reimbursed for travel and other necessary expenses under the bylaws. (e) Incorporation. The ex officio members act as the incorporators and do whatever is needed to legally form the Foundation. (f) Nonprofit status. The Board's policies and bylaws, and the Executive Director's actions, must keep the Foundation qualified as a tax-exempt charity under sections 501(c)(3) and 501(a) of title 26. (g) Executive Director. The Board appoints an Executive Director, who serves at the Board's discretion, runs the Foundation day to day, and has whatever specific duties the Board sets. The Board also sets the Executive Director's pay. (h) Administrative powers. Acting through the Executive Director, the Board may: adopt and use a corporate seal; hire, promote, pay, and fire officers, employees, and agents, and define their jobs; set rules for acquiring, holding, and transferring Foundation property, for how it generally operates, and for using its legal privileges; use another federal agency's information, services, or facilities with that agency's consent; contract with public or private groups to write, edit, print, and publish books and other materials; hold, manage, invest, and spend gifts given to the Foundation under subsection (i); make other contracts, leases, and agreements the Board thinks appropriate; modify contracts or agreements it is party to; take steps to patent and license devices and procedures the Foundation or its employees develop; sue and be sued in its own name; appoint outside advisory groups as needed; and exercise other powers this section grants, plus whatever incidental powers it needs to do its work. (i) Acceptance of funds from other sources. The Executive Director may accept funds, gifts, grants, or bequests of property for the Foundation, including from private entities, to carry out the Foundation's duties. (j) Service of Federal employees. Federal employees may serve on Foundation advisory committees and otherwise help the Foundation, as long as they do not direct or control what the Foundation does. (k) Detail of Government employees; fellowships. Federal agencies can lend their employees to the Foundation, with or without reimbursement, at any time, without those employees losing civil service status; each employee must follow both their home agency's and the Foundation's rules. The Executive Director may accept the services of employees loaned this way. The FDA Commissioner may also accept uncompensated services from Foundation fellows or trainees, which counts as an activity under contract with the Secretary as described in section 379 of this title. (l) Annual reports. Anyone who gets a grant, contract, fellowship, or cooperative agreement from the Foundation must send the Foundation a yearly report on their activities for as long as the award lasts. Starting with fiscal year 2009, the Executive Director must send Congress and the Commissioner a yearly report describing the Foundation's activities and progress toward its goals, including its real-world impact on product development; a full accounting of where its money came from and how it was spent; and how the FDA could use the Foundation's results in its own regulatory work. (m) Separation of funds. The Executive Director must manage money the Foundation receives from the Treasury under subsection (i) as separate program funds, following standard accounting practices. (n) Funding. Each year, out of the FDA's own appropriated funds, the Commissioner must transfer between $1,250,000 and $5,000,000 to the Foundation, to carry out subsections (a), (b), and (d) through (m).