[Federal Register Volume 74, Number 244 (Tuesday, December 22, 2009)]
[Notices]
[Pages 68028-68034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30409]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 74, No. 244 / Tuesday, December 22, 2009 / 
Notices  

[[Page 68028]]



REAGAN-UDALL FOUNDATION


The Reagan-Udall Foundation Bylaws

ACTION: Notice; request for comments.

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SUMMARY: The Reagan-Udall Foundation, which was created by Title VI of 
the Food and Drug Administration Amendments of 2007, is publishing the 
bylaws that were adopted by its Board of Directors, for public comment.

DATES: Submit e-mail comments to: [email protected] on or before 
January 21, 2010.

FOR FURTHER INFORMATION CONTACT: Jane Reese-Coulbourne, The Reagan-
Udall Foundation, (202) 783-7877, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, the President signed into law the Food and 
Drug Administration Amendments Act of 2007 (FDAAA). Title VI of the law 
creates the Reagan-Udall Foundation, the purpose of which is to 
``advance the mission of the Food and Drug Administration to modernize 
medical, veterinary, food, food ingredient and cosmetic products 
development, accelerate innovation, and enhance product safety.'' See 
section 770(b) of the act (21 U.S.C. 379dd (b)). The duties of the 
Foundation include the identification of unmet needs in the 
development, manufacture, and evaluation (including postmarket 
evaluation) of the safety and effectiveness of Food and Drug 
Administration (FDA)-regulated products, and the establishment of 
scientific and other projects and programs to meet those needs. See 
section 770(c) (21 U.S.C. 379dd(c)).
    Among the areas where experts inside and outside the FDA believe 
the Foundation can support better science are:
     Scientific fellowships and programs to improve the 
scientific capacity of the FDA;
     Public-private collaboration to enhance the capacity and 
techniques for monitoring the safety of medical products on the market;
     Development of methods and analyses to promote the safety 
and effectiveness of medical products and foods; and
     Improvements in the science and technical capabilities of 
food safety.
    The Foundation's Board of Directors has adopted an initial set of 
bylaws, an important step toward its initiation of activity as a 
nonprofit organization. Pursuant to section 770(d)(2) of the act (21 
U.S.C. 379dd(d)(2)), these bylaws are being published in the Federal 
Register for public comment. The bylaws include provisions on conflicts 
of interest and the acceptance of donations and grants. The Foundation 
is committed to the highest standards of science in support of FDA's 
mission. As the Foundation develops additional information regarding 
the types of donations and grants (referred to in the bylaws as 
``gifts'') it may receive and the types of projects it will undertake 
and fund, it will adopt additional policies regarding conflicts of 
interest and other issues. In addition, as the Foundation gains more 
experience, it will develop detailed policies and procedures regarding 
gift review and acceptance policies. The Foundation will make these 
policies and procedures available to the public. Until that time, the 
Foundation will not accept donations or grants from entities subject to 
FDA regulation or trade associations of industries subject to FDA 
regulation. The Board will also monitor the terms of any individual 
donation or grant.

II. Bylaws of Reagan-Udall Foundation, Inc., for the Food and Drug 
Administration (Adopted by the Board of Directors on October 3, 2009)

Article I

Offices
    Section 1. Principal Office. The principal office of the Foundation 
shall be at such location as the Board of Directors designates, 
however, such location shall, if practicable be located not more than 
20 miles from the District of Columbia.
    Section 2. Other Offices. The Foundation may also have an office or 
offices other than said principal office at such place or places as the 
Board of Directors shall from time to time determine or the business of 
the Foundation may require. Such other offices shall also, if 
practicable, be located not more than 20 miles from the District of 
Columbia.

Article II

Mission
    Section 1. Mission. The Foundation is organized as a non-profit 
organization exclusively for charitable, scientific and educational 
purpose as specified in section 501(c)(3) of the Internal Revenue Code 
of 1986 and Section 770 of the Federal Food Drug and Cosmetic Act (21 
U.S.C. 379dd). The purpose of the Foundation shall be to advance the 
mission of the Food and Drug Administration to modernize medical, 
veterinary, food, food ingredient, and cosmetic product development, 
accelerate innovation, and enhance product safety.

Article III

Members
    The Foundation shall have no members. All authority that would 
otherwise be vested in or exercised by members shall be vested in the 
Board of Directors of the Foundation. Nothing in these bylaws shall be 
interpreted as requiring the Board of Directors to meet, vote, or 
otherwise act separately as members of the Foundation in order to 
exercise powers that would, if there were members of the Foundation, be 
vested in the members.

Article IV

Board of Directors
    Section 1. General Powers. The business and affairs of the 
Foundation shall be managed under the direction of the Board of 
Directors. The Board of Directors may exercise all such authority and 
powers of the Foundation and do all such lawful acts and things as 
provided by statute or the Articles of Incorporation.
    Section 2. Composition, Number and Appointment. The Board of 
Directors of the Foundation shall be composed of 16 members, two ex 
officio members (non-voting) and 14 appointed (voting) members. The ex 
officio members shall

[[Page 68029]]

be the following individuals or their designees: The Commissioner of 
Food and Drugs and the Director of the National Institutes of Health. 
Of the fourteen appointed (voting) members, no more than four members 
shall be representatives of the general pharmaceutical, device, food, 
cosmetic and biotechnology industries; three shall be representatives 
of academic research organizations; two shall be representatives of 
patient or consumer advocacy organizations, one shall be a 
representative of health care providers; and four or more shall be at 
large members with expertise or experience relevant to the purpose of 
the Foundation. No employee of the Federal Government shall be 
appointed as a member of the Board.
    Section 3. Terms of Office. The term of office of each appointed 
member of the Board shall be four years except that the terms of 
offices for the initial appointed members of the Board shall expire on 
a staggered basis as follows: one industry representative, one academic 
research representative, and one at-large representative each shall 
have an initial appointment of two years; two industry representatives, 
one at-large representative, one academic research representative, and 
one patient/consumer representative each shall have an initial term of 
three years; and one industry representative, two at-large 
representatives, one academic research representative, one patient/
consumer representative, and the one health care provider 
representative each shall have an initial term of four years. A member 
of the Board of Directors may continue to serve after the expiration of 
his or her term until a successor is appointed. A member of the Board 
of Directors may be reappointed for a subsequent term or terms. If a 
member of the Board does not serve the full term, described herein, the 
individual appointed, pursuant to section 10, to fill the resulting 
vacancy shall be appointed for the remainder of the term of the 
predecessor of the individual.
    Section 4. Annual Meeting and Annual Reporting. (a) The annual 
meeting of the Board of Directors shall be held at such time, but in no 
event later than the end of the fifth month following the end of the 
fiscal year of the Foundation, and at such place as shall be specified 
in a notice thereof given as hereinafter provided in section 7 of this 
Article IV or waiver of notice. (b) The annual meeting shall be open to 
the public. (c) At the annual meeting the Foundation shall publish a 
report for the preceding fiscal year, which shall include a 
comprehensive statement of the operations, activities, financial 
condition and accomplishments of the Foundation. (d) The Foundation 
shall make copies of each report submitted under this section 4 of 
Article IV available to any person for a charge not exceeding the cost 
of providing such copy.
    Section 5. Regular Meeting. Regular meetings of the Board of 
Directors shall be held at such time and place as the Board of 
Directors may fix.
    Section 6. Special Meetings. Special meetings of the Board of 
Directors may be called at any time or at the request of the Chair of 
the Board or the Executive Director. The person or persons authorized 
to call special meetings of the Board may fix the time and place for 
holding such special meeting.
    Section 7. Notice. Annual and special meetings of the Board of 
Directors shall be held on notice to the directors. Notice shall state 
the time and place of the meeting and, in the case of a special 
meeting, the purpose or purposes for holding such meeting. Notice of 
each such meeting shall be sent by electronic mail or mailed, postage 
prepaid, to each director, addressed to him or her at his or her 
address as shown by the records of the Foundation, at least ten days 
before the day on which such meeting is to be held, or under 
extraordinary circumstances be delivered to him or her personally or be 
given to him or her by telephone, or other similar means, at least 
twenty-four hours before the time at which such meeting is to be held. 
Notice of any such meeting need not be given to any director who 
submits a signed waiver of notice before the meeting or who attends 
such meeting without protesting, prior to or at its commencement, the 
lack of notice to him or her.
    Section 8. Quorum. A majority of the voting members of the entire 
Board of Directors shall constitute a quorum for purposes of conducting 
the business at any meeting of the Board of Directors; but if less than 
a majority of the voting directors are present at said meeting, a 
majority of the voting directors present may adjourn the meeting from 
time to time without further notice. The Chair may, under extraordinary 
circumstances, in his of her discretion, require the vote of the full 
Board (all voting members) on a particular matter, provided the Chair 
discloses to the Board the basis for requiring such a vote. When the 
vote of the full Board is required, voting members will be permitted to 
vote at a meeting of the Board or by submitting his or her vote to the 
Chair in writing.
    Section 9. Manner of Acting. The act of a majority of the voting 
directors present at a meeting at which a quorum is present shall be 
the act of the Board of Directors, unless the act of a greater number 
is required by law or these Bylaws.
    Section 10. Vacancies. Any vacancy in the membership of the Board 
shall not affect the power of the remaining directors to execute the 
duties of the Board and any such vacancy shall be filled promptly by 
appointment by the appointed directors by majority vote.
    Section 11. Resignations. Any appointed member of the Board of 
Directors may resign at any time by giving written notice of his or her 
resignation to the Board of Directors, the Chair of the Board, the 
Executive Director or the Secretary. Any such resignation shall take 
effect at the time specified therein if later than the date of its 
receipt, or if the time when it shall become effective is not specified 
therein, immediately upon its receipt. Unless otherwise specified 
therein, the acceptance of such resignation shall not be necessary to 
make it effective.
    Section 12. Removal of Directors. Except as otherwise provided by 
statute, any director may be removed for cause by the vote of a 
majority of the voting members of the Board of Directors then in 
office. The failure to participate in at least half of the meetings and 
calls scheduled over a one year period shall be a basis for such 
removal.
    Section 13. Compensation. Members of the Board may not receive 
compensation for service on the Board. Directors may be reimbursed for 
travel, the reasonable cost of meals and lodging, and other necessary 
expenses incurred in carrying out the duties of the Board, as set forth 
in these Bylaws.
    Section 14. Informal Action by Board of Directors. Any action 
required or permitted by law to be taken at a meeting of the Board of 
Directors may be taken without a meeting if a unanimous written 
consent, which sets forth the action to be taken, shall be signed by 
each voting member of the Board and filed with the minutes of 
proceedings of the Board.
    Section 15. Telephonic Meeting. Members of the Board may 
participate in a meeting by means of a telephone conference or similar 
communications equipment if all persons participating in the meeting 
can hear each other at the same time.
    Section 16. Emeritus Directors. The Board of Directors may from 
time to time appoint a former director to the honorary position of 
``Director Emeritus.'' Unless otherwise determined by the Board of 
Directors, the appointment of a Director Emeritus shall continue in 
effect for the

[[Page 68030]]

remainder of the person's life. A former director holding such honorary 
position shall be entitled to receive notice of, and to attend meetings 
or portions of meetings of the Board of Directors, but shall have no 
voting or other rights of a director.

Article V

Committees
    Section 1. Committees. The Board of Directors, by resolution 
adopted by a majority of the voting directors in office, shall 
designate and appoint an Executive Committee, a Governance Committee 
and a Finance Committee, and may designate and appoint one or more 
other committees each of which shall consist of two or more directors, 
and delegate to such committees any of the powers of the Board of 
Directors, except the power to amend, alter, and repeal the Bylaws; to 
elect, appoint or remove any member of such committee or any member of 
the Board or any officer of the Foundation; to amend or restate the 
Articles of Incorporation; or to adopt a plan of merger or 
consolidation with another corporation. The appointment of any 
committee, the delegation of authority to it, or action by it under 
that authority shall not operate to relieve the Board of Directors, or 
any individual member of the Board, of any responsibility imposed upon 
it or upon him or her by law.
    Section 2. Executive Committee. The Executive Committee shall carry 
out the responsibilities of the Board of Directors between meetings of 
the Board of Directors.
    The Chair of the Board shall be chair of the Executive Committee 
and the Secretary of the Foundation shall act as secretary thereof. The 
Chairs of the Governance and Finance Committees shall be members of the 
Executive Committee. The Executive Director shall be an ex officio, 
non-voting member of the Executive Committee. In the absence of the 
Chair, Executive Director or Secretary at any meeting of the Executive 
Committee, the committee shall appoint a chair or secretary of the 
meeting as the case may be.
    Section 3. Governance Committee. The Governance Committee shall be 
responsible for making recommendations to the Board on all matters 
affecting governance, reviewing the Board's performance policies and 
these Bylaws, and making recommendations to the Board for director 
nominees and Officer appointments. The Vice Chair of the Board shall 
chair the Governance Committee.
    Section 4. Finance Committee. The Finance Committee shall be 
responsible for developing and reviewing fiscal procedures and shall 
make recommendations to the Board regarding the budget and other 
financial matters. The Treasurer of the Foundation shall chair the 
Finance Committee.
    Section 5. Term of Office. All committees of the Board of Directors 
shall serve at the pleasure of the Board of Directors. Members of 
committees who are designated by the Board of Directors shall serve at 
the pleasure of the Board of Directors. Each chair of a committee shall 
hold such office for one year and until his or her death, resignation 
or removal, whichever occurs first. A chair of a committee may continue 
to serve as chair after the expiration of his or her term until a 
successor is appointed.
    Section 6. Organization, Meetings of Committees. The Board of 
Directors shall appoint one member of each of the other committees that 
may be created to be the chair of such committee. All committees may 
adopt rules governing the time, or the method of call or holding their 
meetings, and the conduct of their affairs. All committees shall keep a 
record of their acts and proceedings and shall report thereon to the 
Board of Directors.
    Section 7. Vacancies. A vacancy in the membership of any committee 
may be filled by appointments made in the same manner as provided in 
the case of the original appointments.
    Section 8. Quorum. Unless otherwise provided in the resolution of 
the Board of Directors designating a committee, a majority of the whole 
committee shall constitute a quorum and the act of a majority of the 
members present at a meeting at which a quorum is present shall be the 
act of the committee.

Article VI

Officers, Employees, Agents and Contractors
    Section 1. Number and Qualifications of Officers. The Officers of 
the Foundation (except for the initial Chair, which shall be appointed 
by the ex-officio directors) shall be elected by the Board of Directors 
and shall include the Chair and Vice Chair of the Board, the Secretary, 
the Treasurer, and any other officers as may be necessary or desirable 
for the business of the Foundation.
    Section 2. Election and Term of Office. The officers of the 
Foundation, except the Chair of the Board, shall be elected annually by 
the members of the Board of Directors at its annual meeting. Each such 
officer shall hold office until death, resignation, removal or until 
the next annual meeting of the Board of Directors and until his or her 
successor shall be duly elected. The members of the Board of Directors 
shall elect a member of the Board to serve as the Chair of the Board, 
who shall serve through the end of his or her term. An officer may be 
re-elected for subsequent terms.
    Section 3. Resignations. Any officer of the Foundation may resign 
at any time by giving written notice of his or her resignation to the 
Board of Directors, the Chair of the Board, the Executive Director or 
the Secretary. Any such resignation shall take effect at the time 
specified therein or, if the time when it shall become effective is not 
specified therein, immediately upon its receipt. Unless otherwise 
specified therein, the acceptance of any such resignation shall not be 
necessary to make it effective.
    Section 4. Removal. Any officer of the Foundation elected or 
appointed by the Board of Directors may be removed by an affirmative 
vote of a majority of the then incumbent voting members of the Board of 
Directors whenever in its judgment the best interests of the Foundation 
would be served thereby, but such removal shall be without prejudice to 
the contract rights, if any, of the officer so removed.
    Section 5. Vacancies. A vacancy in any office because of death, 
resignation, removal, disqualification or otherwise shall be filled by 
the vote of a majority of the voting members of the Board of Directors 
for the unexpired portion of the term.
    Section 6. Chair of the Board. The Chair of the Board shall be a 
member of the Board, an officer of the Foundation and, if present, 
shall preside at each meeting of the Board of Directors. He or she 
shall advise and counsel with the Executive Director and in his or her 
absence with the other officers of the Foundation, and shall perform 
such other duties as may from time to time be assigned to him or her by 
the Board of Directors.
    Section 7. Vice-Chair of the Board. The Vice-Chair of the Board 
shall be a member of the Board, an officer of the Foundation and, if 
present, shall preside at each meeting of the Board of Directors at 
which the Chair of the Board is not present, and shall perform the 
other duties of the Chair of the Board during such times as the Chair 
of the Board is unavailable to perform such duties.
    Section 8. Treasurer. The Treasurer shall be a member of the Board 
and shall (a) Have charge and custody of, and be responsible for, all 
the funds and securities of the Foundation; (b) keep or cause to be 
kept full and accurate

[[Page 68031]]

accounts of receipts and disbursements in books belonging to the 
Foundation; (c) deposit or cause to be deposited all moneys and other 
valuables to the credit of the Foundation in such depositories as may 
be designated by the Board of Directors or pursuant to its direction; 
(d) receive, and give receipts for, moneys due and payable to the 
Foundation from any source whatsoever; (e) disburse the funds of the 
Foundation; (f) render to the Board of Directors, whenever the Board of 
Directors may require, an account of the financial condition of the 
Foundation; and (g) in general, perform all duties incident to the 
office of Treasurer and such other duties as from time to time may be 
assigned to him or her by the Board of Directors.
    Section 9. Secretary. The Secretary shall be a member of the Board 
and shall (a) Keep or cause to be kept the minutes of all meetings of 
the Board of Directors; (b) see that all notices are duly given in 
accordance with the provisions of these Bylaws and as required by law; 
(c) be custodian of the records and the seal of the Foundation and 
affix and attest the seal to all other documents to be executed on 
behalf of the Foundation under its seal; (d) see that the books, 
reports, statements, certificates, and other documents and records 
required by law to be kept and filed are properly kept and filed; (e) 
in general, perform all duties incident to the office of Secretary and 
such other duties as from time to time may be assigned to him or her by 
the Board of Directors.
    Section 10. Executive Director. The Board of Directors shall 
appoint an Executive Director who shall serve at the pleasure of the 
Board of Directors. The Executive Director shall be the chief executive 
officer of the Foundation who shall be responsible for the day-to-day 
operations of the Foundation. If the Board of Directors has not elected 
a Chair or Vice Chair of the Board or if the Chair and Vice Chair of 
the Board are absent, the Executive Director shall preside at such 
meeting of the Board of Directors. He or she shall perform all duties 
incident to the office of the Executive Director and such other duties 
as may from time to time be assigned to him or her by the Board of 
Directors.
    Section 11. Compensation. The Foundation may pay reasonable 
compensation for services rendered by employees of the Foundation. All 
amounts paid as compensation by the Foundation to any employee shall be 
approved by the Board of Directors. The compensation of the Executive 
Officer shall not be greater than the compensation of the Commissioner 
of the Food and Drug Administration.
    Section 12. Agents and Contractors. The Executive Director shall be 
responsible for hiring, promoting, and discharging all other employees 
and agents of the Foundation. The Executive Director shall also be 
responsible for defining the duties of such employees and agents and 
determining the compensation to be paid to such employees.

Article VII

Conflicts of Interest
    Section 1. General Policy. No director, officer, employee, fellow 
or trainee of the Foundation (hereinafter ``Interested Persons'') shall 
take any action on or participate in the consideration or determination 
of any Foundation matter in which he or she, his or her spouse, minor 
child, general partner, non-federal organization in which he or she is 
serving as an officer, director, trustee, general partner or employee, 
or any person or nonfederal organization with whom he or she is 
negotiating or has any arrangement concerning potential employment, has 
a financial interest.
    Section 2. Responsibilities of Interested Persons. In addition to 
actual conflicts of interest, Interested Persons are also obliged to 
avoid actions that could be perceived or interpreted to be in conflict 
with the Foundation's best interests. Interested Persons shall disclose 
their financial interest in entities doing business with the Foundation 
and refrain from participating in decisions affecting transactions 
between the Foundation and those other entities without approval by the 
Board of Directors.
    Section 3. Additional Conflict of Interest Policies and Procedures. 
Appendix A to these Bylaws includes more detailed policies and 
procedures for identifying and managing conflicts of interest.
    Section 4. Oversight Responsibilities. The Chair of the Board shall 
be responsible for the application of the Foundation's conflicts of 
interest policies and procedures to Board Members, committee members, 
and the Executive Director. The Executive Director shall be responsible 
for the application and interpretation of this policy as it relates to 
all other employees, fellows, and trainees.
    Section 5. Project Specific Conflicts Policies. The Foundation 
shall, as appropriate, develop conflicts of interest policies and 
procedures specific to an individual project and/or consortium 
developed to carry out the goals of the Foundation. Such policies and 
procedures shall be made available to the public.

Article VIII

Acceptance of Donations and Grants
    Section 1. General Policy. It shall be the policy of the Foundation 
to accept donations and grants (hereinafter ``Gifts'') that further its 
missions, supporting the Food and Drug Administration. This mission is 
realized through Gifts that support the programs and projects of the 
Foundation, Gifts that secure the operation and future growth of the 
Foundation, or Gifts that otherwise facilitate the Foundation in 
providing services to the Food and Drug Administration. The Board of 
Directors shall develop and adopt detailed Gift review and acceptance 
policies and procedures that define what constitutes acceptable Gifts. 
Such policies and procedures shall be made available to the public. The 
Board of Directors shall be responsible for ensuring that the 
requirements of this Article VIII and the Foundation's Gift policies 
and procedures are met.
    Section 2. Review of Gifts. The Board of Directors has the 
discretion to accept or refuse all Gifts and is charged with the 
responsibility of reviewing and properly screening all Gifts made to 
the Foundation. The Board of Directors shall determine whether 
acceptance of a gift will reflect unfavorably on, or compromise the 
integrity of the Foundation. The Board of Directors shall have the 
discretion to refuse any Gift that is deemed inappropriate for any 
reason, such as the appearance of, or an actual conflict of interest, 
unreasonable or burdensome restrictions, costs to the Foundation in 
fulfilling the terms of, or administering the Gift, or any other 
reason. The Board of Directors shall make decisions regarding 
acceptance or refusal of gifts by a majority of voting members present 
at a regularly scheduled meeting of the Board or by a majority of all 
voting members if the decision is made between regularly scheduled 
meetings. If a vote is taken between regularly scheduled meetings, 
members may vote in writing by regular mail or e-mail.
    Section 3. Restrictions on Gifts. The Foundation will accept 
unrestricted Gifts. The Foundation may also accept Gifts for specific 
programs and purposes, provided such Gifts are not inconsistent with 
its mission, purposes, and priorities. The Foundation will not accept 
Gifts that are too restrictive in purpose or otherwise inappropriate.
    Section 4. Availability of Information on Gift Acceptance. 
Information about

[[Page 68032]]

the Foundation's acceptance of Gifts shall be made available to the 
public.

Article IX

Grants and Contracts
    Section 1. Grantee/Contractor Selection and Award Principles. The 
selection and award of grants and/or contracts by the Foundation will 
be conducted to ensure fairness, impartiality, and inclusiveness. All 
grant and contract awards shall be approved by the Board of Directors.
    Section 2. Solicitation. The Foundation will take reasonable steps 
to make each solicitation widely known to the public.
    Section 3. Peer Review. An objective peer-review process will be 
used to assess responses to solicitations and provide recommendations 
to the Board of Directors.
    Section 4. Objectivity. All reviews and assessments shall be made 
objectively and shall not be based on commercial or proprietary 
interests.
    Section 5. Conflicts of Interest. All participants involved in the 
development, review, and selection process shall abide by the 
Foundation's Conflict of Interest policies.
    Section 6. Administrative Expenses Cap. Grants, contracts and 
cooperative agreements shall provide that the administrative expenses 
allocable to funds provided by the Foundation not exceed 25%.
    Section 7. Exclusions. This Article shall not apply to the 
selection and award of grants and contracts related to running the day-
to-day operations of the Foundation.

Article X

Information and Inventions
    Section 1. Information and Data. All information and data developed 
by the Foundation or with Foundation funds shall be released and 
published, to the extent practicable, to maximize their use by the Food 
and Drug Administration, nonprofit organizations and academic and 
industrial researchers to further the goals and priorities of the 
Foundation. The Foundation may charge cost-based fees for published 
materials produced by the Foundation.
    Section 2. Inventions. The Foundation shall ensure that (a) Action 
is taken to obtain patents for inventions developed by the Foundation 
or with funds from the Foundation; (b) action is taken to enable the 
licensing of such inventions; and (c) executed licenses, memoranda of 
understanding, material transfer agreements, contracts and other such 
instruments promote, to the maximum extent practicable, the broadest 
conversion to commercial and noncommercial applications of licensed and 
patented inventions of the Foundation to further the goals and 
priorities of the Foundation. The Foundation may, consistent with the 
policy to support the widest and least restrictive use of inventions, 
charge a reasonable royalty for the use of such inventions.

Article XI

Training Fellowships
    The Foundation will establish fellowships for: Scientists, doctors 
and other professionals, who are not employees of any FDA-regulated 
industry; FDA professionals to obtain training outside the agency; and 
non-FDA professionals to obtain training at the Foundation, academic or 
scientific institutions or the FDA. The purpose of such fellowships 
shall be to foster greater understanding of and expertise in new 
scientific tools, diagnostics, manufacturing techniques, and potential 
barriers to translating basic research into clinical and regulatory 
practice, train scientific or regulatory professionals in regulatory 
science and policy, and increase the exchange of scientific information 
between FDA and external entities.

Article XII

Memoranda of Understanding and Cooperative Agreements
    Section 1. Review. All memoranda of understanding and cooperative 
agreements between the Foundation and other entities, including the 
Food and Drug Administration, shall promote the goals and priorities of 
the Foundation, shall comply with the Foundation's Conflict of Interest 
policies and shall be reviewed and approved by the Board of Directors 
to ensure that such requirements are met.
    Section 2. Execution. All memoranda of understanding and 
cooperative agreements between the Foundation and other entities, 
including the Food and Drug Administration, shall be signed by the 
Executive Director, after obtaining appropriate approval of the Board 
of Directors.

Article XIII

Indemnification
    Section 1. Officers and Directors. To the maximum extent permitted 
by the laws of the State of Maryland in effect from time to time, and 
subject to compliance with any procedures and other requirements 
prescribed by said laws and by such rules and regulations, non 
inconsistent with said laws, as the Board of Directors may in its 
discretion impose in general or particular cases or classes of cases, 
any person who is threatened to be made a party to any threatened, 
pending or completed action, suit, or proceeding, whether civil, 
criminal, administrative or investigative, by reason of the fact that 
he or she is or was a Director or officer of the Foundation shall be 
indemnified by the Foundation against judgments, penalties, fines, 
settlements, and reasonable expenses, including attorney's fees, 
actually and necessarily incurred by him or her in connection with such 
action, suit or proceeding, or in connection with any appeal therein 
(which reasonable expenses may be paid or reimbursed in advance of 
final disposition of any such suit, action, or proceeding subject to 
the receipt of a written undertaking to repay such expenses in the 
event that such person is determined not to be entitled to be 
indemnified).
    Section 2. Employees and Agents. To the maximum extent permitted by 
the laws of the State of Maryland in effect from time to time, and 
subject to compliance with any procedures and other requirements 
prescribed by said laws and by such rules and regulations, not 
inconsistent with said laws, as the Board of Directors may in its 
discretion impose in general or particular cases or classes of cases, 
any person who is threatened to be made a party to any threatened, 
pending or completed action, suit, or proceeding, whether civil, 
criminal, administrative or investigative, by reason of the fact that 
he or she is or was an employee or agent of the Foundation may (but 
need not) be indemnified by the Foundation against judgments, 
penalties, fines, settlements, and reasonable expenses, including 
attorney's fees, actually and necessarily incurred by him or her in 
connection with such action, suit or proceeding, or in connection with 
any appeal therein (which reasonable expenses may be paid or reimbursed 
in advance of final disposition of any such suit, action, or proceeding 
subject to the receipt of a written undertaking to repay such expenses 
in the event that such person is determined not to be entitled to be 
indemnified).

Article XIV

General Provisions
    Section 1. Seal. The seal of the Foundation shall be in such form 
as shall be approved by the Board of Directors.
    Section 2. Fiscal Year. The fiscal year of the Foundation shall end 
on December 31 of each year or on such

[[Page 68033]]

other date as may be fixed by resolution of the Board of Directors.
    Section 3. Checks, Notes, Drafts, Etc. All checks, notes, drafts, 
or other orders for the payment of money of the Foundation shall be 
signed endorsed, or accepted in the name of the Foundation by such 
officer, person or persons as from time to time may be designated by 
the Board of Directors or by an officer or officers authorized by the 
Board of Directors to make such designation.
    Section 4. Execution of Contracts, Deeds, Etc. The Board of 
Directors may authorize any officer or officers, the Executive 
Director, or any agent or agents, in the name and on behalf of the 
Foundation to enter into or execute and deliver any and all deeds, 
bonds, mortgages, contracts and other obligations or instruments, and 
such authority may be general or confined to specific instances.
    Section 5. Deposits. All funds of the Foundation shall be deposited 
from time to time to the credit of the Foundation in such banks, trust 
companies or other depositories as the Board of Directors may select.

Article XV

Amendments
    These Bylaws may be amended, altered or repealed or new Bylaws may 
be adopted by a majority of the voting directors present at any regular 
meeting or at any special meeting, if at least two days written notice 
is given of intention to alter, amend, repeal or adopt new bylaws at 
such meeting.

Appendix A to Bylaws

Ethical Guidelines for Identifying and Managing Conflicts of Interest

    Congress created the Reagan-Udall Foundation (Foundation) to 
support the mission of the FDA by identifying, funding, and supporting 
projects and programs that will help equip FDA staff with the highest 
caliber science and technology to enhance the safety and effectiveness 
of FDA regulated products. The Foundation will not participate in 
regulatory matters nor will it offer advice to FDA on policy matters. 
In addition, to support its independence and to maximize its scientific 
impact, the Foundation is implementing specific guidelines and 
procedures that identify and avoid potential bias--and appearances of 
such bias--and that provide a transparent process for individual and 
institutional decisions.

I. Individual Conflicts

    Article VII of the Bylaws describes an individual's obligations 
with respect to conflicts of interest as follows: ``No director, 
officer, employee, fellow or trainee of the Foundation (hereinafter 
`Interested Persons') shall take any action on or participate in the 
consideration or determination of any Foundation matter in which he or 
she, his or her spouse, minor child, general partner, non-federal 
organization in which he or she is serving as an officer, director, 
trustee, general partner or employee, or any person or nonfederal 
organization with whom he or she is negotiating or has any arrangement 
concerning potential employment, has a financial interest. In addition 
to actual conflicts of interest, Interested Persons are also obliged to 
avoid actions that could be perceived or interpreted to be in conflict 
with the Foundation's best interests. Interested Persons shall disclose 
their financial interest in entities doing business with the Foundation 
and refrain from participating in decisions affecting transactions 
between the Foundation and those other entities without approval by the 
Board of Directors.''

Staff

    Goal: To ensure that issues involving conflicts of interest are 
addressed when staff are hired and on an ongoing, annual basis.
    (1) Data Gathering.
    The following FDA Financial Disclosure form is to be filled out by 
prospective employees prior to being hired and filled out annually by 
Foundation Employees: FDA's form for Senior FDA Employees at http://www.oge.gov/forms/form_450.aspx.
    (2) Process for Review.
    The completed form is to be reviewed by the Foundation's General 
Counsel (hereinafter General Counsel), who will be responsible for 
identifying conflicts and determining what actions would be necessary 
to ensure that a prospective or current employee does not participate 
in matters in which such a conflict would or could exist. The General 
Counsel will advise the Executive Committee regarding such conflicts 
and necessary actions.
    (3) Process for Addressing Conflicts of Interest.
    The General Counsel will advise the Executive Committee and the 
Board regarding a prospective or current employee for whom conflicts 
have been identified. With respect to a prospective employee, the 
Executive Committee will recommend whether a particular person should 
be hired in light of conflicts, and if so, how such conflicts should be 
addressed. If conflicts arise after a person has been hired, then the 
Executive Committee will advise the Board regarding appropriate steps 
to be taken, including divesting holdings causing the conflict, 
recusing the employee from particular matters and terminating the 
employee. The Board will receive all pertinent documents relating to 
any conflicts and will make the final decision with respect to hiring a 
person for whom a conflict has been identified and with respect to 
addressing conflicts that have arisen after an employee has been hired.

Board

    Goal: To ensure that the potential for, or the appearance of, 
conflicts are identified, so appropriate steps can be taken to ensure 
that the principles in the Bylaws are met.
    (1) Data Gathering.
    Upon appointment, and annually thereafter, each Board member must 
provide the General Counsel a signed statement that lists any interest, 
financial or otherwise, that the member, his or her spouse, minor 
child, general partner or employee has in any company that is regulated 
by FDA. The statement will also disclose the identity of any FDA 
regulated firm for whom any adult children of the Board member works 
and the nature of any business that such children have before the 
Foundation. Such statement must describe the nature of the interest but 
need not list its monetary value.
    (2) Process for Review.
    The statement described above will be reviewed by the Foundation's 
General Counsel, who will be responsible for identifying conflicts and 
Foundation matters from which such Board member must recuse him or 
herself from on the basis of such conflicts. The General Counsel will 
advise the Board member regarding such conflicts and necessary 
recusals.
    (3) Process for Addressing Conflicts of Interest.
    If it has been determined by the General Counsel that recusal is 
necessary, then the recused Board member shall not participate in any 
discussions or votes regarding the matter or matters on which he or she 
has been recused. Among other things, a recused Board member shall not 
participate in discussions or votes regarding whether a particular 
project should be undertaken by the Foundation or to whom a project 
grant or contract funded by the Foundation may be awarded.

II. Review of Reagan-Udall Foundation Projects

    Goal: Strictly guard against conflicts of interest and undue 
influence while raising funds for worthwhile Foundation projects.

[[Page 68034]]

    Guidelines: Prior to initiation all specific projects must be 
reviewed and approved:
    (1) By the Reagan-Udall Board of Directors.
    Before granting its final approval to a project, the Board shall 
submit the project to independent review. In selecting reviewers, the 
Board shall insure that:
     Reviewers are qualified experts on the relevant topics.
     Each reviewer has certified that he or she meets the 
conflict of interest standard in Article VII.
    In the unusual case where a waiver of this requirement is necessary 
because there is no other practical means of ensuring the necessary 
expertise, the name of the reviewer and the justification for the 
waiver will be made public and the Board must determine that the 
financial interest is not so substantial as to be likely to affect the 
integrity of the review.
    Before granting its final approval to a project, the Board shall 
also determine that:
     Independent review was sufficient to ensure the 
objectivity, scientific validity, and feasibility of the proposal.
     The project is likely to advance the mission of the FDA to 
modernize medical, veterinary, food, food ingredient, or cosmetic 
product development, accelerate innovation, or enhance product safety.
    (2) By a meaningful independent review.
     For projects with a total budget over $250,000 (``large 
projects''), the Board may (i) use an existing independent review 
process (for example, if one of the project collaborators is an 
academic institution or foundation with an appropriate independent 
review mechanism); or (ii) utilize an ad hoc, independent panel to 
review the project.
     For small projects with a total budget of $250,000 or less 
(``small projects''), the Board may use an abbreviated independent 
review process.
     A majority of reviewers must determine that the project 
design is objective, scientifically valid, and feasible, and that the 
project is likely to advance the mission of the FDA to modernize 
medical, veterinary, food, food ingredient, or cosmetic product 
development, accelerate innovation, or enhance product safety.

III. Policies for Accepting Funds

    The Foundation has in place two sets of guidelines for the 
acceptance of funds.
    (1) Core Operating Funds can be accepted from
     Federal Government appropriations process.
     Individuals as tax deductible donations.
     Foundations and other Not for Profit organizations.
    (2) Project Funds can be accepted from
     Federal Government appropriations process.
     Individuals as tax deductible donations.
     Foundations and other Not for Profit organizations.
     Other entities.

IV. Violations of Conflicts in Interest Policy

    If the Board of Directors has reason to believe that a Foundation 
employee or Board member has failed to disclose a conflict, it shall 
inform the person of the basis for such belief and afford the person an 
opportunity to explain the alleged failure to disclose. If, after 
hearing the response of such person and making further investigations 
as may be warranted, the Board determines that the employee or Board 
member has knowingly or intentionally failed to disclose a conflict of 
interest it shall take appropriate action, including termination of the 
employee or Board member.

V. Transparency

    The Foundation will post the following on its Web site:
    (1) The Foundation Bylaws and Appendix A. Public comment will be 
sought on these bylaws and on any proposed changes prior to adoption.
    (2) A statement about RUF's commitment to transparency.
    (3) A copy of the conflict of interest form used by Foundation 
Staff.
    (4) Information regarding particular recusals of Board members or 
Staff, including the particular matters on which the Board member or 
staff will be recused and the basis for the recusal.
    (5) For each Board member, a list of any interest, financial or 
otherwise, that the member, his or her spouse, minor child, general 
partner or employee has in an FDA-regulated company that conducts 
business in areas where the Foundation is active such that the interest 
could pose a potential conflict. Such statement will describe the 
nature of the interest but need not list its monetary value.
    (6) In the unusual case when there is a waiver of the requirement 
that a reviewer have no direct financial interest in the outcome of a 
project because there is no other practical means of ensuring the 
necessary expertise, the name of the reviewer and the justification for 
the waiver.
    (7) The amount of each donation and the identity of the donor, 
including in kind donations.
    (8) Information about each project, including:
     An Executive Summary, including a summary of the review 
process.
     A list of organizational project participants and their 
role.
     The identity of all funders.
     A list of Board and/or staff members who were recused from 
discussion and decision making for the project.
    (9) The Foundation's 990 IRS filings and annual reports (for all 
years).
    (10) A section for questions, feedback and public input.

    Dated: December 15, 2009.
Mark B. McClellan,
Chairman, Reagan-Udall Foundation Board.
[FR Doc. E9-30409 Filed 12-21-09; 8:45 am]
BILLING CODE 4164-04-P