[Federal Register: October 3, 2007 (Volume 72, Number 191)]
[Notices]
[Page 56362-56363]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc07-68]
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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
Reagan-Udall-Board@FDA.HHS.GOV.
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:
Four representatives of the general pharmaceutical,
device, food, cosmetic, and biotechnology industries;
Three representatives of academic research organizations;
Two representatives of patient or consumer advocacy
organizations;
One representative of health care providers; and
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]
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