[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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

[[Page 58118]]

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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