[Federal Register Volume 61, Number 110 (Thursday, June 6, 1996)]
[Notices]
[Pages 28881-28882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14137]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0162]


Review of the Calcium and Related Nutrient Needs of the U.S. 
Population; Announcement of Open Meetings and Request for Data

Agency: Food and Drug Administration, HHS.

Action: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
National Academy of Sciences (NAS), Institute of Medicine (IOM), and 
Food and Nutrition Board (FNB) will begin a review of data on calcium 
intakes in the U.S. population and data on calcium metabolism in humans 
throughout their lives. This review will also include the metabolism of 
related nutrients (such as vitamin D, magnesium, phosphorus, and 
fluoride) and of nonnutrient components of foods (such as phytosterols 
and fiber) as they relate to bioavailability of calcium. Reviews will 
also be conducted to determine upper safe levels of intake that will 
diminish the potential risk of adverse effects. This review by NAS/IOM/
FNB was requested by the Government, and it is intended to provide FDA 
and the National Institutes of Health (NIH), and the National Heart, 
Lung, and Blood Institute (NHLBI) with an up-to-date review of the 
needs of the American public for calcium and related nutrients. To 
assist in the preparation of its scientific report, NAS/IOM/FNB is 
inviting the submission of scientific data and information on this 
topic. In addition, FDA is announcing that NAS/IOM/FNB will provide an 
opportunity for oral presentations at two open meetings on the review 
of calcium and related nutrient needs of the U.S. population.

DATES: The first meeting will be held on July 9 and 10, 1996, 8:30 a.m. 
to 5:30 p.m. Submit an abstract with references to the FNB by June 17, 
1996, to be considered for a 3-minute presentation to the panel. The 
second meeting will be held on July 15 and 16, 1996, 8:30 a.m to 5:30 
p.m. Submit an abstract with references to the FNB by June 24, 1996, to 
be considered for a 3-minute presentation to the panel.

ADDRESSES: The meetings will be held at the National Academy of 
Sciences Bldg., Auditorium, 2101 Constitution Ave. NW., Washington, DC 
20418. Submit written requests to make oral presentations of scientific 
data, information, and views at the open meetings to Sandra A. 
Schlicker, Food and Nutrition Board, Institute of Medicine, National 
Academy of Sciences Bldg., 2101 Constitution Ave. NW., rm. 3046, 
Washington, DC 20418, 202-334-1383, and to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. Two copies of the scientific data, 
information, and views should be submitted to each office.

FOR FURTHER INFORMATION CONTACT: James T. Tanner, Center for Food 
Safety

[[Page 28882]]

and Applied Nutrition (HFS-451), Food and Drug Administration, 200 C 
St. SW., rm. 2804, Washington, DC 20204, 202-205-4168.

SUPPLEMENTARY INFORMATION: FDA has a contract with NHLBI to provide 
partial support of the NAS project entitled ``Calcium and Related 
Nutrients: Needs of Americans.'' Recent research and data have 
suggested that calcium intakes may be inadequate to meet the needs of 
many population groups in the United States, particularly with regard 
to the calcium intake during adolescence and young adulthood. However, 
controversy exists regarding what the optimal intake should be for 
calcium and related nutrients (such as vitamin D, magnesium, 
phosphorus, and fluoride) in order to prevent deficiency states (such 
as osteomalacia and rickets) while at the same time reducing the risk 
of degenerative diseases (such as osteoporosis) and also taking into 
account the potential effects of chronic ingestion of lower levels of 
intake during some life stages.
    In response to recent suggestions that calcium requirements of 
healthy Americans are greater than previous estimates, the NAS/IOM is 
undertaking a study to review both the scientific literature on calcium 
metabolism in humans throughout their lives and also available data on 
calcium intakes by the U.S. population. The analysis also will include 
a review of the requirements for the related nutrients, vitamin D, 
magnesium, phosphorus, and fluoride. The impact of these nutrients and 
of other nonnutrient components of foods (such as phytosterols, fiber) 
on bioavailability of calcium will also be evaluated.
    The study also will review existing data and will develop estimates 
of dietary intake levels that are compatible with good nutrition 
throughout the life cycle, which may result in decreasing risk of 
chronic disease. In addition, reviews will be conducted to -determine 
upper safe levels of intake that will diminish the potential risk of 
adverse effects.
     On July 9 and 10, 1996, a meeting to solicit scientific opinion on 
the functional indicators of calcium, phosphorus, magnesium, fluoride, 
and vitamin D status for each stage of the life span will be held. This 
meeting will be held by the panel on calcium and related nutrients, a 
subunit of the standing committee on the Scientific Evaluation of 
Dietary Reference Intakes, a committee of the FNB of the IOM. Speakers 
have been invited to present their views on appropriate measures to 
ensure adequate intake of these nutrients. In addition, interested 
individuals and organizations may present their perspectives regarding 
the determination of dietary reference intakes during the open forum 
session of the meeting. In order to be considered for a 3-minute 
presentation to the panel, an abstract with references must be 
submitted to the FNB by June 24, 1996. Interested parties should 
contact Sandra A. Schlicker (address above) for further information.
     On July 15 and 16, 1996, a meeting to solicit scientific opinion 
on criteria to evaluate risk assessment data in developing a model for 
establishing maximum levels of nutrient intake compatible with low risk 
of adverse effects will be held. This meeting will be held by the 
Subcommittee on Upper Reference Levels of Nutrients, a subunit of the 
Standing Committee on the Scientific Evaluation of Dietary Reference 
Intakes, a committee of the FNB of the IOM. Speakers have been invited 
to present their views on appropriate measures of adequacy for these 
nutrients. In addition, interested individuals and organizations may 
present their perspectives regarding the determination of dietary 
reference intakes during the open forum session of the meeting. In 
order to be considered for a 3-minute presentation to the panel, an 
abstract with references must be submitted to the FNB by June 17, 1996. 
Interested parties should contact Sandra A. Schlicker (address above) 
for further information. This study will provide guidance useful in the 
development of recommendations for requirements and upper safe limits 
of the topic nutrients.

    Dated: May 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-14137 Filed 6-5-96; 8:45 am]
BILLING CODE 4160-01-F