[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Notices]
[Page 58117-58118]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc03-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0338]
Food and Drug Administration Obesity Working Group; Public
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public meeting: Public Meeting on Obesity. The topic to be
discussed involves issues within FDA's jurisdiction related to obesity
and nutrition. The purpose of this public meeting, which is being
sponsored by FDA's Obesity Working Group, is to discuss FDA's role and
responsibilities in addressing the major public health problem of
obesity, to focus on issues related to promoting better consumer
dietary and lifestyle choices that have the potential to significantly
improve the health and well-being of Americans, and to obtain
stakeholder views on how best to build a framework for messages to
consumers about reducing obesity and achieving better nutrition.
The agency has developed a web page for this initiative where
interested persons can register to attend and/or make an oral
presentation at the meeting, submit comments, and obtain related
information. This Web Site is located at http://www.fda.gov/oc/opacom/hottopics/obesity.html
.
DATES: The meeting will be held on October 23, 2003, from 9 a.m. to 5
p.m. Registration to attend the meeting must be received by October 17,
2003 at 5 p.m. Submit written comments by November 21, 2003.
ADDRESSES: The meeting will be held at the Jack Masur Auditorium,
Warren Grant Magnuson Clinical Center (Bldg. 10), National Institutes
of Health (NIH), 9000 Rockville Pike, Bethesda, MD. Important
information about transportation and directions to the NIH campus,
parking, and security procedures are found at http://www.nih.gov/about/visitor/index.htm
.
Visitors must show two forms of identification, one of which must
be a government-issued photo identification such as a Federal employee
badge, driver's license, passport, green card, etc. If you are planning
to drive to and park on the NIH campus, you must enter at the South Dr.
entrance of the campus which is located on Wisconsin Ave. (the Medical
Center Metro entrance), and allow extra time for vehicle inspection.
Detailed information about security procedures is located on http://www.nih.gov/about/visitorsecurity.htm
.
FOR FURTHER INFORMATION CONTACT:
For General Information: Brian R. Somers, Center for Food Safety
and Applied Nutrition (CFSAN), Food and Drug Administration (HFS-820),
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1692, FAX: 301-436-2636, e-mail: Brian.Somers@CFSAN.FDA.GOV.
For Registration Information: Patricia A. Alexander, Office of
Regulatory Affairs (HFC-150), 5600 Fishers Lane, Rockville, MD 20857, 301-827-6328, FAX: 301-443-2143, e-mail: registration@ora.fda.gov.
Registration and Requests for Oral Presentations
If you would like to attend the meeting, you must register with the
appropriate contact person (see For Further Information Contact) by
October 17, 2003, at 5 p.m. by providing your name, title,
organizational affiliation, address, telephone, fax number (optional),
and e-mail address (optional). Registration will be conducted on a
first-come, first-served basis, and seating will be limited. To
expedite processing, this registration information may also be faxed or
e-mailed to Patricia A. Alexander (see For Further Information
Contact). If you need special accommodations due to a disability,
please contact Patricia A. Alexander (see For Further Information
Contact) at least 7 days in advance.
If, in addition to attending, you wish to make an oral presentation
during the meeting, you must inform Patricia A. Alexander (see For
Further Information Contact) when you register and submit the following
items: (1) A brief written statement of the general nature of the views
you wish to present, (2) the names and addresses of all persons who
will participate in the presentation, and (3) an indication of the
approximate time that you request to make your presentation. FDA asks
that groups having similar interests consolidate their comments and
present them through a single representative. Scheduled speakers should
provide two copies of their presentation for the docket at the meeting.
The agency requests that speakers annotate and organize their
presentations to specifically identify which of the six questions (see
SUPPLEMENTARY INFORMATION) are addressed in their presentations.
The agency will allocate the time available for the public meeting
among persons who have preregistered to give an oral presentation. If
time permits, FDA may allow interested persons attending the meeting
who did not preregister to give a presentation to make an oral
presentation at the end of the meeting.
After reviewing the requests for oral presentations and
accompanying information, FDA will schedule each appearance and notify
each participant of the time allotted to the person and the approximate
time the person's oral presentation is scheduled to begin. The
presentation schedule will be available at the meeting. After the
meeting, it will be placed on file in the Division of Dockets
Management under the docket number found in brackets in the heading of
this document.
SUPPLEMENTARY INFORMATION:
I. Background
Obesity is a growing and urgent public health problem in the United
States. There have been steady and substantial increases in adult
obesity in the United States since the late 1980s. Today, almost two-
thirds of all Americans are overweight; in 1988 through 1992, less than
56 percent were overweight. In 1988 through 1992, less than 23 percent
of American adults were obese and by 1999 through 2000, the figure had
increased by a quarter, to over 30 percent. The trends for children are
even more worrisome. Recent research by the U.S. Centers for Disease
Control and Prevention shows that 13 percent of children aged 6 to 11
are overweight--almost double the rate of two decades ago. World Health
Organization surveys show that weight is on the rise all over the
world. The health of Americans suffers as they get heavier. According
to some estimates, at least 300,000 deaths each year are associated
with cases of heart disease, diabetes, cancer, and other serious
chronic diseases that, in many instances, result from unhealthy
nutritional choices and lack of physical
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activity. The avoidable medical costs of obesity exceed $50 billion
each year, well over 5 percent of total U.S. health expenditures, at a
time when we can ill afford these costs. The total economic costs of
obesity approach $100 billion each year.
Helping consumers improve their diets is one of the nation's most
pressing public health problems and an increasingly urgent part of
FDA's activities. The consequences of poor diets, including the growing
prevalence of excess weight and growing risks of diabetes, high blood
pressure, heart disease, arthritis, respiratory difficulties, and many
cancers that go along with excess weight, are endangering and
diminishing the lives of millions of Americans. The challenge
confronting the Government, researchers, the food and restaurant
industry, consumers, the medical community, schools, and the public
health communitym is to determine what kind of information and
assistance the public needs in order to help them improve their dietary
choices and reduce the incidence of overweight and obesity.
To address the problem of obesity and to meet the challenge of
helping Americans improve their diet and nutrition, Secretary Tommy G.
Thompson has led the Department of Health and Human Services (DHHS) in
its efforts to encourage healthy habits such as nutritious diets, more
exercise, and healthy choices. Secretary Thompson has challenged DHHS
agencies and the leadership of the public health community to intensify
their efforts to realize these improvements.
On July 30, 2003, Secretary Thompson held a roundtable discussion
on obesity and nutrition with leading scientific experts in obesity and
weight management. The Secretary's roundtable on obesity/nutrition was
intended to enhance a DHHS discussion with leading thinkers and experts
in the public health community on the role that DHHS can play in
reducing or reversing the weight gain that leads to obesity. The
roundtable dialogue centered on five key questions, which are the
foundation of the questions on which FDA seeks input in the forthcoming
public meeting.
On August 11, 2003, FDA's Commissioner of Food and Drugs, Mark B.
McClellan established FDA's Obesity Working Group to confront the
current obesity epidemic in the United States and to develop new and
innovative ways to help consumers lead healthier lives through better
nutrition. Dr. Lester M. Crawford, FDA's Deputy Commissioner, is the
Chair of the working group, and Mr. Joseph Levitt, Director of FDA's
CFSAN office, is the Vice Chair. As a part of his charge to the working
group, Commissioner McClellan directed that it provide for an active
dialogue with external stakeholders including consumer groups,
academia, the medical community, and the food and restaurant industry,
on developing a framework for messages to consumers about reducing
obesity and achieving better nutrition. This public meeting is one of
the avenues that the working group is using to initiate this dialogue.
II. Scope of Discussion and Format
The scope of this public meeting will be limited to the following
questions:
1. What is the available evidence on the effectiveness of various
education campaigns to reduce obesity?
2. What are the top priorities for nutrition research to reduce
obesity in children?
3. What is the available evidence that FDA can look to in order to
guide rational, effective public efforts to prevent and treat obesity
by behavioral or medical interventions, or combinations of both?
4. Are there changes needed to food labeling that could result in
the development of healthier, lower calorie foods by industry and the
selection of healthier, lower calorie foods by consumers?
5. What opportunities exist for the development of healthier foods/
diets and what research might best support the development of healthier
foods?
6. Based on the scientific evidence available today, what are the
most important things that FDA could do that would make a significant
difference in efforts to address the problem of overweight and obesity?
This meeting will include an opening session during which FDA will
present a discussion of obesity and related issues associated with the
tools available to the agency to assist consumers to improve their
diets. The agency may ask experts to provide presentations on specific
issues. Individuals who have registered to give oral presentations in
advance of the meeting will be provided with the opportunity to speak
following the opening session. A schedule of oral presentations will be
available at the meeting.
III. Comments
To permit time for all interested persons to submit data,
information, or views on this subject, the administrative record of
this meeting will remain open for 30 days after the meeting. Interested
persons may submit to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, written or electronic comments by November 21, 2003. You may
also send comments to the Division of Dockets Management via e-mail to FDADockets@oc.fda.gov. or on FDA's Web site at http://www.fda.gov/oc/
opacom/hottopics/obesity.html.
You should annotate and organize your comments to identify the
specific questions to which your comments refer. Submit two paper
copies of comments, identified with the docket number found in brackets
in the heading of this document. Individuals may submit one paper copy.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Comments may be
placed on the Internet and, if so, will be available for public
viewing.
IV. Transcripts
You may request a transcript of the meeting in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15
working days after the meeting, at a cost of 10 cents per page. You may
examine the transcript of the meeting after November 10, 2003, at the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, as well as on FDA's Web site at http://www.fda.gov/oc/opacom/hottopics/obesity.html
Dated: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25645 Filed 10-7-03; 8:45 am]
BILLING CODE 4160-01-S