[Federal Register Volume 62, Number 22 (Monday, February 3, 1997)]
[Notices]
[Pages 5011-5012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0391]


Review of Infant Formula Nutrient Requirements for Preterm 
Infants; Announcement of Open Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) and the Life Sciences 
Research Office (LSRO) of the Federation of American Societies for 
Experimental Biology (FASEB) are announcing an open meeting on the 
review of infant formula nutrient requirements for preterm infants. The 
LSRO/FASEB has undertaken this review and will prepare a documented 
scientific report that summarizes the available information. To assist 
in the preparation of its scientific report, LSRO/FASEB is inviting the 
submission of scientific data, information, and views bearing on this 
topic both in writing and orally at the open meeting.
DATES: The LSRO will hold a 1-day open meeting on this topic on March 
26, 1997. 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 March 7, 1997. To be included in the review process, 
written presentations of scientific data, information, and views should 
be submitted on or before June 30, 1997. Written materials arriving at 
LSRO/FASEB on or before March 20, 1997, will be part of the official 
record of the open meeting.
ADDRESSES: The open meeting will be held in the Chen Auditorium, Lee 
Bldg., Federation of American Societies for Experimental Biology, 9650 
Rockville Pike, Bethesda, MD. Written requests to make oral 
presentations of scientific data, information, and views at the open 
meeting should be submitted 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 are to 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.


[[Page 5012]]


SUPPLEMENTARY INFORMATION: FDA has a contract (223-92-2185) with FASEB 
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 infants with low birthweight are regulated as 
exempt infant formulas under the Infant Formula Act of 1980 and its 
1986 amendments (21 U.S.C. 350a). Exempt infant formulas may 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. LSRO will perform a review to 
consider the scientific basis for having different recommendations for 
energy and macronutrients (protein, fat, including long-chain 
polyunsaturated fatty acids (LCPUFA's), and carbohydrates) in formulas 
for low birthweight preterm infants.
    In the Federal Register of November 15, 1996 (61 FR 58566), FDA 
announced that it asked FASEB, as a task under contract 223-92-2185, to 
provide FDA's Center for Food Safety and Applied Nutrition with both an 
up-to-date review of nutrient requirements of preterm infants and of 
the effects of new information about nutritional needs of preterm 
infants on recommendations for levels of nutrients in formulas for 
preterm infants. In response to this request, FASEB has directed LSRO 
to obtain state-of-the-art scientific information on infant nutrient 
requirements and related scientific questions on specifications for 
preterm infant formula. The LSRO/FASEB has undertaken a study and will 
prepare a documented scientific report that summarizes the available 
information related to these questions.
    LSRO is performing a review of the scientific and medical 
literature with a particular emphasis on studies published since 1986, 
when 21 U.S.C. 350a was last amended. Requirements of other 
governmental bodies are also being considered in this review. 
Specifically, LSRO will address the following issues in its review:
    (1) What scientific basis is there to support requirements for 
energy and macronutrients (protein, fat, and carbohydrates) in infant 
formulas intended for use by preterm infants as distinct from the 
requirements for energy and macronutrients in formulas for term 
infants? The American Academy of Pediatrics, the European Society for 
Pediatric Gastroenterology and Nutrition, and the Canadian Pediatric 
Society have proposed some nutrient requirements for preterm infants 
distinct from those for term infants.
    (2) Has scientific knowledge advanced to the point that distinct 
composition standards for energy and macronutrients in formulas for 
these preterm infants are warranted?
    (3) Nutrient requirements of hospitalized preterm infants who are 
fed enteral formulas are sometimes described according to stages, such 
as a first or transition stage (between birth and 10 days of age), a 
stable growing stage (from about 10 days until discharge from hospital, 
6 to 8 weeks after birth), and a post-discharge stage (from discharge 
home to approximately 1 year of age). Is there scientific evidence to 
support more than one set of energy and macronutrient requirements to 
support growth and development of the hospitalized preterm infant at 
the different stages of development? If so, how should the stages be 
defined?
    (4) Are the energy and macronutrient requirements for infant 
formulas for term infants sufficient for healthy post-discharge preterm 
infants?
    (5) Is there scientific evidence to support specific deviations 
from current nutrient standards for healthy post-discharge preterm 
infants, and if so, what would they be, and to what stage (age/weight) 
should these special formulas be given?
    (6) Does available evidence establish the essentiality of addition 
of subcomponents of the macronutrients (specifically, taurine, 
carnitine, and LCPUFA's) to formulas for preterm infants, and if so, 
does the evidence establish what the amount and ratios of these 
compounds should be in the formula? For example, the Canadian 
Guidelines for the Composition and Clinical Testing for Formulas for 
Preterm Infants (p. 17) finds that term infant formulas that contain 
adequate and balanced 18:2n-6 and 18:3n-3 fatty acids do not require 
addition of the 20 and 22 carbon n-6 and n-3 fatty acids.
    (7) Is there available evidence to suggest that this result also 
applies to preterm infant formulas? If so, is there an optimum level 
and ratio of 18:2n-6 and 18:3n-3 fatty acids in formulas for preterm 
infants?
    (8) Does the available evidence address the issue of safety of 
various sources of these LCPUFA's for use in preterm infant formulas? 
If so, is there a safe source of LCPUFA's?
    (9) Does available evidence establish the essentiality of the 
addition of nucleotides to formulas for preterm infants, and if so, 
does the evidence establish what the amounts should be in the formulas?
    LSRO will use these questions as a guide in the drafting of its 
report. LSRO notes that, in arriving at answers to the above questions, 
it will consult with the American Academy of Pediatrics' Committee on 
Nutrition and, to the extent possible, the Institute of Medicine's Food 
and Nutrition Board. LSRO will prepare a comprehensive final report 
that documents and summarizes the results of its evaluation.
    Under its contract with FDA, FASEB will provide the agency with its 
scientific report on or about September 30, 1997.

    Dated: January 24, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-2493 Filed 1-31-97; 8:45 am]
BILLING CODE 4160-01-F