[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Notices]
[Pages 75812-75813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of a Workshop and a Request for Public Comment on 
Questions Regarding Dietary Reference Intakes and Chronic Disease 
Endpoints

AGENCY: Office of Disease Prevention and Health Promotion, Office of 
the Assistant Secretary for Health, Office of the Secretary, Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: The Dietary Reference Intakes (DRI) Committees of the U.S. and 
Canadian governments will hold a workshop entitled ``Options for 
Consideration of Chronic Disease Endpoints for Dietary Reference 
Intakes.'' The objective of the workshop is to critically evaluate key 
scientific issues involved in using chronic disease endpoints for 
setting DRIs and, in this context, to provide information for future 
decisions as to whether and/or how chronic disease endpoints can be 
incorporated into the setting of DRI values. In preparation for this 
meeting, the DRI Committees are asking for public comment on the set of 
questions that the meeting panelists will discuss.

DATES: This meeting will be held on March 10, 2015 from 8:30 a.m. to 
5:00 p.m. E.D.T. and on March 11, 2015 from 8:30 a.m. to 12:30 p.m. 
E.D.T.

ADDRESSES: The workshop will be held at the Lister Hill Auditorium, 
National Institutes of Health, in Bethesda, Maryland, USA. The workshop 
will be open to the public either in-person (seating is limited) or by 
videocast on the Internet.

FOR FURTHER INFORMATION CONTACT: Additional information about this 
workshop and the agenda will be made available on the Internet at 
http://www.health.gov/dri/as the meeting approaches. You may also send 
emails to [email protected].

SUPPLEMENTARY INFORMATION:

Background Information

    The current DRI approaches for selecting indicators of adequacy and 
toxicity and for estimating dose-response relationships between 
nutrient intakes and selected outcomes derive from several Food and 
Nutrition Board committee reports published by the Institute of 
Medicine (IOM) in 1994 \1\ and 1998.\2\ These committees recommended 
that DRIs for adequacy be expressed as Estimated Average Requirements 
(EARs) and Recommended Dietary Allowances (RDAs, representing 97.5% of 
population requirements). They also recommended that reference values 
for Tolerable Upper Intake Levels (ULs) be included in future DRI 
evaluations. Additionally, the 1994 IOM committee concluded that future 
RDA processes (now called DRIs) should include the concept of chronic 
disease risk reduction in addition to the classical nutrient deficiency 
endpoints. The approaches recommended by the 1994 and 1998 committees 
were applied, with a few additions (e.g., Adequate Intakes, Acceptable 
Macronutrient Distribution Ranges), for all seven of the DRI reviews 
published from 1997 to 2011. These reports can be accessed at the 
following Web site: http://

[[Page 75813]]

fnic.nal.usda.gov/dietary-guidance/dietary-reference-intakes/dri-
reports.
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    \1\ Food and Nutrition Board, Institute of Medicine. 1994. How 
Should the Recommended Dietary Allowances Be Revised? National 
Academy Press, Washington, DC.
    \2\ Dietary Reference Intakes: A Risk Assessment Model for 
Establishing Upper Intake Levels for Nutrients. National Academy 
Press, Washington, DC.
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    It has become apparent that a number of unanticipated challenges 
were encountered when chronic disease endpoints were considered as 
indicators for setting DRI reference values. Many of these challenges 
were discussed in a 2007 ``lessons learned'' workshop conducted by the 
IOM after the first six DRI reports were published.\3\ Other scientific 
publications have also discussed the challenges, but approaches for 
addressing the identified challenges have not yet been adequately 
explored.
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    \3\ The Development of DRIs 1994-2004: Lessons Learned and New 
Challenges, Workshop Summary, November 30, 2007. Available from: 
http://www.iom.edu/Reports/2007/The-Development-of-DRIs-1994-2004-Lessons-Learned-and-New-Challenges-Workshop-Summary.aspx.
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    Recently, the DRI Committees of the U.S. and Canadian governments 
called for nominations for nutrients to be considered for future DRI 
reviews. Many of the nominated nutrients cited new data on chronic 
disease relationships as the justification for new DRI reviews, 
including three of the four nutrients selected by the DRI Committees 
for further consideration based on the availability of sufficient new 
and relevant evidence. Given the clear need for more in-depth 
evaluation of the challenges involved in incorporating chronic disease 
endpoints into DRI processes prior to initiating a new DRI review, the 
two government committees announced plans to sponsor a workshop to be 
held in 2015 to address whether, and how, chronic disease outcomes can 
be incorporated into the process of setting DRI values.
    The limited time available for the workshop may preclude 
consideration of all issues relevant to the incorporation of chronic 
disease endpoints into DRI processes. As warranted, subsequent 
activities will address issues that arise in the workshop or that have 
been identified in other activities but not covered in workshop 
discussions.

Written Public Comments

    The key questions for the workshop, on which the committees would 
like public comments, are derived from prior discussions of the major 
challenges in incorporating chronic disease endpoints into DRI 
considerations:
    1. What dose-response models can be considered for future DRI 
reviews when chronic disease endpoints are used?
    a. What are the scientific issues?
    b. What are the options for addressing these issues?
    c. What are the advantages and disadvantages of the various 
options?
    2. What are the evidentiary challenges important in selecting and 
using chronic disease endpoints in future DRI reviews?
    a. What are the scientific issues?
    b. What are the options for addressing these issues?
    c. What are the advantages and disadvantages of the various 
options?
    3. What arguments can be made for and against continuing to include 
chronic disease endpoints in future DRI reviews?
    a. What are the scientific issues?
    b. What are the options for addressing these issues?
    c. What are the advantages and disadvantages of the various 
options?

Public comments are to be submitted via email to [email protected]. Provide a 
brief summary (approx. 250 words) of the points or issues. If providing 
literature or other resources, one of the following forms is preferred:

 Complete citation, as in a bibliographic entry
 Abstract
 Electronic link to full article or report

Please provide comments as early as possible in order to increase the 
likelihood of having a meaningful impact, as the workshop panelists 
will be considering them prior to the workshop. The deadline for 
comment submission is Friday, January 30, 2015. Comments received later 
than January 30, 2015 will not be considered.
    Meeting Registration: The meeting will be publicly accessible both 
in-person and by videocast on the Internet. Due to limited seating 
capacity, registration will be required for in-person attendance. 
Notice of registration will be available on http://www.health.gov/dri/
prior to the workshop; registration is expected to open on or about 
February 15, 2015.

    Dated: December 16, 2014.
Don Wright,
Deputy Assistant Secretary for Health,
Office of Disease Prevention and Health Promotion,
Office of the Assistant Secretary for Health,
U.S. Department of Health and Human Services.
[FR Doc. 2014-29766 Filed 12-18-14; 8:45 am]
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