To establish within the Food and Drug Administration 2 review groups to recommend solutions for the prevention, diagnosis, and treatment of rare diseases and neglected diseases of the developing world.

SA 2229. Mr. BROWNBACK submitted an amendment intended to be proposed
to amendment SA 1908 submitted by Mr. Kohl (for himself and Mr.
Brownback) to the bill H.R. 2997, making appropriations for
Agriculture, Rural Development, Food and Drug Administration, and
Related Agencies programs for the fiscal year ending September 30,
2010, and for other purposes; which was ordered to lie on the table; as
follows:

On page 85, between lines 16 and 17, insert the following:
Sec. 7__. (a) The Commissioner of Food and Drugs shall
establish within the Food and Drug Administration a review
group which shall recommend to the Commissioner of Food and
Drugs appropriate preclinical, trial design, and regulatory
paradigms and optimal solutions for the prevention,
diagnosis, and treatment of rare diseases: Provided, That the
Commissioner of Food and Drugs shall appoint 8 individuals
employed by the Food and Drug Administration to serve on the
review group: Provided further, That members of the review
group shall have specific expertise relating to the
development of articles for use in the prevention, diagnosis,
or treatment of rare diseases, including specific expertise
in developing or carrying out clinical trials.
(b) The Commissioner of Food and Drugs shall establish
within the Food and Drug Administration a review group which
shall recommend to the Commissioner of Food and Drugs
appropriate preclinical, trial design, and regulatory
paradigms and optimal solutions for the prevention,
diagnosis, and treatment of neglected diseases of the
developing world: Provided, That the Commissioner of Food and
Drugs shall appoint 8 individuals employed by the Food and
Drug Administration to serve on the review group: Provided
further, That members of the review group shall have specific
expertise relating to the development of articles for use in
the prevention, diagnosis, or treatment of neglected diseases
of the developing world, including specific expertise in
developing or carrying out clinical trials: Provided further,
That for the purposes of this section the term ``neglected
disease of the developing world'' means a tropical disease,
as defined in section 524(a)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360n(a)(3)).
(c) The Commissioner of Food and Drugs shall--
(1) submit, not later than 1 year after the date of the
enactment of this Act, a report to

[[Page S8608]]

Congress that describes both the findings and recommendations
made by the review groups under subsections (a) and (b);
(2) issue, not later than 180 days after submission of the
report to Congress under paragraph (1), guidance based on
such recommendations for articles for use in the prevention,
diagnosis, and treatment of rare diseases and for such uses
in neglected diseases of the developing world; and
(3) develop, not later than 180 days after submission of
the report to Congress under paragraph (1), internal review
standards based on such recommendations for articles for use
in the prevention, diagnosis, and treatment of rare diseases
and for such uses in neglected diseases of the developing
world.
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