[Federal Register: January 15, 1998 (Volume 63, Number 10)]
[Notices]               
[Page 2404-2405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja98-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0391]

 
Micronutrient Requirements for Preterm Infant Formulas; 
Announcement of Study; Request for Scientific Data and Information; 
Announcement of Open Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
Life Sciences Research Office (LSRO) of the American Society of 
Nutritional Sciences (ASNS) is undertaking an assessment of the 
scientific basis for the need to establish specific recommendations 
(minimum and maximum levels) for intake by preterm infants of 
micronutrients, that is, the vitamins and minerals specified in the 
Federal Food, Drug, and Cosmetic Act (the act) and selenium, 
molybdenum, chromium, and fluoride. To assist in this task, LSRO/ASNS 
is inviting the submission of scientific data and information on this 
topic and will provide an opportunity for oral presentations at an open 
meeting.

DATES: The LSRO will hold a 1-day public meeting on this topic on 
Friday, March 27, 1998. The meeting will begin at 9 a.m. Requests to 
make oral presentations at the open meeting must be submitted in 
writing and received by Friday, February 13, 1998. Hard copies of oral 
presentations should be delivered by Friday, March 20, 1998. 
Individuals may submit, in writing, scientific data, information, and 
views by July 1, 1998.

ADDRESSES: The open meeting will be held in the Chen Auditorium, Lee 
Bldg., American Society of Nutritional Sciences, 9650 Rockville Pike, 
Bethesda, MD. Written requests to make oral presentations of scientific 
data, information, and views at the open meeting should be submitted 
both to Daniel J. Raiten (address below) 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. These two 
copies are to be identified with the docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    Daniel J. Raiten, Life Sciences Research Office, Federation of 
American Societies for Experimental Biology, 9650 Rockville Pike, 
Bethesda, MD 20814-3998, 301-530-7030, or
    Linda H. Tonucci, Center for Food Safety and Applied Nutrition 
(HFS-456), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-205-5372.

SUPPLEMENTARY INFORMATION: FDA has a contract (223-92-2185) with ASNS 
concerning the analysis of scientific issues that bear on the safety of 
foods and cosmetics. The objectives of this contract are to provide 
information to FDA on general and specific issues of scientific fact 
associated with the analysis of human nutrition.
    Infant formulas for use by infants with low birth-weight are 
subject to regulation under 412(h) of the act (21 U.S.C. 350a(h)). 
Exempt infant formulas are permitted to have nutrients or nutrient 
levels that are different from those that are codified in 21 CFR 
107.100, if the manufacturer of the infant formula can justify the 
nutrient deviation. The agency believes that some deviations from the 
nutrient requirements established for term infants may be appropriate 
to promote healthy growth and development in low birth-weight preterm 
infants. These deviations have yet to be defined. Consequently, FDA has 
asked ASNS to perform a review to consider whether there is a 
scientific basis for having different recommendations for 
micronutrients in formulas for low birth-weight preterm infants.
    FDA is announcing that it has asked ASNS, as a task under contract 
223-92-2185, to provide FDA's Center for Food Safety and Applied 
Nutrition with an up-to-date review of the nutrient requirements of low 
birth-weight preterm infants, including a review of the implications of 
these requirements on the need for recommendations for levels of 
nutrients in formulas for these infants. In response to this request, 
ASNS has directed its LSRO to obtain state-of-the-art scientific 
information on low birth-weight preterm infant nutrient requirements 
and related scientific questions on specifications for preterm infant 
formula. The LSRO/ASNS will undertake a study and prepare a documented 
scientific report that summarizes the available information related to 
these issues.
    LSRO/ASNS will perform an assessment of the nutrient requirements 
for infant formulas intended for use by preterm (low birth-weight) 
infants that addresses the following issues:
     (1) What scientific basis is there to specify requirements for 
micronutrients in infant formulas intended for use by low birth-weight 
preterm infants? The American Academy of Pediatrics, the European 
Society for Pediatric Gastroenterology and Nutrition, and the Canadian 
Pediatric Society have proposed nutrient requirements for low birth-
weight infants distinct from those for term infants. Has scientific 
knowledge advanced to the point to warrant distinct micronutrient 
composition standards for formulas for low birth-weight preterm 
infants?
     (2) Micronutrient requirements of preterm infants fed enteral 
formulas are sometimes described according to a first or transition 
stage (between birth and 10 days of age), a stable growing stage (from 
about 10 days until discharge

[[Page 2405]]

from the hospital, often 6 to 8 weeks after birth), and a postdischarge 
stage (from discharge home to approximately 1 year). Is there 
scientific evidence to support more than one set of micronutrient 
requirements for infant formulas to support healthy growth and 
development of the preterm infant at the different stages of 
development? Are the micronutrient requirements for term infant 
formulas sufficient for thriving postdischarge preterm infants?
     (3) What is the scientific evidence to support a dietary 
recommendation for a minimum and a maximum quantitative nutrient 
concentration for selenium, chromium, molybdenum, and fluoride in 
preterm infant formulas? What limits of intake would ensure safe and 
adequate exposure to these nutrients? Is there a need to specify the 
chemical form or other characteristics of these nutrients or their 
sources to ensure safety and adequacy?
     (4) Certain micronutrient interactions, such as vitamin E:linoleic 
acid, vitamin B6:protein, and calcium:phosphorus, have been identified 
for full-term infants which have helped to ensure the adequacy of full-
term formulas. Are there micronutrient interactions that can be 
identified for preterm infants that will help to ensure the nutrient 
adequacy of infant formulas for this population? Are there recommended 
ratios for metal cations? Is the evidence of interaction between these 
minerals sufficiently strong to suggest that the ratios should be 
ensured for the health of preterm infants?
     (5) In an earlier task under this contract (61 FR 58566, November 
15, 1996), LSRO/ASNS agreed to investigate whether there is evidence of 
a benefit to preterm infants from ingestion of taurine and carnitine, 
as well as whether there is evidence that would provide a basis for a 
requirement for minimal intakes of each of these substances. Is there 
adequate evidence of benefit of other substances not listed in this 
notice to support a requirement for their inclusion in preterm infant 
formulas?
    LSRO/ASNS will use these questions as a guide in its investigation. 
ASNS will prepare a comprehensive final report that documents and 
summarizes the results of its evaluation.
    FDA and ASNS are announcing that the LSRO/ASNS expects to hold a 
public meeting on this topic on Friday, March 27, 1998. The meeting 
will begin at 9 a.m. It is anticipated that the public meeting will be 
up to 1 day, depending on the number of requests to make oral 
presentations. Requests to make oral presentations at the open meeting 
must be submitted in writing and received by Friday, February 13, 1998. 
Written requests to make oral presentations of scientific data, 
information, and views at the open meeting should be submitted both to 
Daniel J. Raiten (address above) and to the Dockets Management Branch 
(address above). Two copies of the material to be presented must be 
submitted to each office on or before March 20, 1998. The open meeting 
will be held in the Chen Auditorium, Lee Bldg., ASNS (address above).
    FDA and ASNS are also inviting submission of written presentations 
of scientific data, information, and views. These materials should be 
submitted on or before July 1, 1998. Two copies of the written 
materials must be submitted to each office.
    In accordance with its contract with FDA, ASNS will provide the 
agency with a scientific report on or about September 30, 1998.

    Dated: January 6, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-958 Filed 1-14-98; 8:45 am]
BILLING CODE 4160-01-F