[Federal Register Volume 72, Number 191 (Wednesday, October 3, 2007)]
[Notices]
[Pages 56362-56363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-4882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Nominations for Membership on the Board of Directors of the 
Reagan-Udall Foundation From Consumer Advocacy Groups, Professional 
Scientific and Medical Societies, and Industry Trade Organizations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
opportunity for patient and consumer advocacy groups, professional 
scientific and medical societies, and industry trade organizations to 
nominate candidates to serve on the Board of Directors (the Board) of a 
new non-profit foundation, the Reagan-Udall Foundation for the Food and 
Drug Administration (the Foundation). The Foundation will be dedicated 
to modernizing medical, veterinary, food, food ingredient, and cosmetic 
product development, accelerating innovation, and enhancing product 
safety.

DATES:  Submit written or electronic nominations on or before October 
15, 2007.

ADDRESSES: Submit written nominations either by fax to Lisa Rovin or 
Nancy Stanisic at 301-443-9718 or by e-mail to <a href="/cdn-cgi/l/email-protection#4113242026202f6c1425202d2d6c032e203325010705006f0909126f060e17"><span class="__cf_email__" data-cfemail="cd9fa8acaaaca3e098a9aca1a1e08fa2acbfa98d8b898ce385859ee38a829b">[email protected]</span></a>.

FOR FURTHER INFORMATION CONTACT:
    Lisa Rovin, Office of Policy and Planning (HF-11), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1443; 
or
    Nancy Stanisic, Office of Critical Path Programs (HF-18), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
1660.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, the President signed into law the Food and 
Drug Administration Amendments Act of 2007 (FDAAA). The law 
reauthorizes the Prescription Drug User Fee Act, the Medical Device 
User Fee Act, the Best Pharmaceuticals for Children Act, and the 
Pediatric Research Equity Act of 2007, and enacts the Pediatric Medical 
Device Safety and Improvement Act of 2007 as well as additional 
requirements and authorities for FDA. Title VI of FDAAA creates the 
Foundation. The purpose of the Foundation is 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.''
    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 FDA-regulated 
products, and the establishment of scientific and other projects and 
programs to meet those needs.

II. Criteria for Board Membership

    The statute mandates a 14-member Board of Directors, composed of 
the following:
    <bullet> Four representatives of the general pharmaceutical, 
device, food, cosmetic, and biotechnology industries;
    <bullet> Three representatives of academic research organizations;
    <bullet> Two representatives of patient or consumer advocacy 
organizations;
    <bullet> One representative of health care providers; and
    <bullet> Four at-large representatives with expertise or experience 
relevant to the purpose of the Foundation.
    The Board must include individuals with expertise in areas 
including the sciences of developing, manufacturing, and evaluating the 
safety and effectiveness of devices, including diagnostics, biological 
products, and drugs, and the safety of food, food ingredients, and 
cosmetics.
    The Foundation's Board will be responsible for governing the 
organization and ensuring that it succeeds in its mission. To that end, 
the Board members will oversee the mission and operations of the 
Foundation, including: Approving programs and monitoring their 
effectiveness, coordinating Foundation activities with federal research 
programs, awarding grants, and ensuring financial solvency and raising 
resources.
    The initial Board is to be appointed no later than 30 days after 
enactment, September 27, 2007, by the ex officio board members 
designated in the statute: The Commissioner of Food and Drugs, 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. Nine Board members are to 
be appointed from a list of candidates provided by the National Academy 
of Sciences. Five Board members are to be appointed from lists of 
candidates provided by ``patient and consumer advocacy groups, 
professional scientific and medical societies, and industry trade 
organizations.''

III. Process and Criteria for Nominations

    To facilitate nomination of candidates from patient and consumer 
advocacy groups, professional scientific and medical societies, and 
industry trade organizations, FDA is publishing this notice and 
accepting nominations by fax or e-mail submission (see ADDRESSES). We 
welcome nominations from any such organization, and are not limiting 
the number of nominations each organization may submit. We will accept 
joint nominations from multiple organizations.
    Each nomination should include the following information:
    (1) Name, affiliation, and contact information for each nominating 
organization, and a statement indicating to which of the following 
categories the nominating organization belongs: Patient and consumer 
advocacy groups, professional scientific and medical societies, and 
industry trade organizations.
    (2) Name, title, affiliation (if any), resume or curriculum vitae, 
and contact information for each nominee. In addition, please include 
no more than one paragraph describing the individual's qualifications 
in relation to the mission of the Foundation and the statutory criteria 
for Board membership, described in section II of this document. A 
nominee may qualify in more than one of the statutory categories for 
Board membership; please list all categories for which each nominee 
qualifies.

[[Page 56363]]

IV. Electronic Access

    Persons with access to the Internet may obtain the FDAAA statute 
at: http://www.fda.gov/oc/initiatives/advance/fdaaa.html.

    Dated: September 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-4882 Filed 9-28-07; 1:26 pm]
BILLING CODE 4160-01-S


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