[Federal Register Volume 61, Number 222 (Friday, November 15, 1996)]
[Notices]
[Pages 58566-58567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29303]


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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 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 Federation of American 
Societies for Experimental Biology (FASEB) is about to undertake an 
assessment of the energy and macronutrient levels in infant formulas 
intended for preterm infants who are of low birth-weight because of 
their premature birth. The agency has requested that LSRO/FASEB provide 
an up-to-date scientifically documented report based on its assessment. 
FDA intends to consider this report and other relevant information in 
deciding whether a modification of the levels of energy and 
macronutrients listed in the FDA regulation for term infant formulas is 
necessary for formulas intended to meet the special needs of preterm 
infants. To assist in the preparation of its scientific report, LSRO/
FASEB is inviting the submission of scientific data and information 
bearing on this topic. LSRO/FASEB will also provide an opportunity for 
oral presentations at an open meeting.

DATES: LSRO expects to hold an open meeting on this topic during the 
period January 2, 1997, to March 31, 1997. FDA and LSRO will announce 
the date of the meeting as soon as it is set. Requests to make oral 
presentations must be submitted in writing by December 23, 1996. 
Written presentations of scientific data, information, and views should 
be submitted on or before the date 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.

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.
    Formulas for infants with low birth-weight are currently regulated 
as exempt infant formulas under the Federal Food, Drug, and Cosmetic 
Act (the act). 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 providing different recommendations for energy and 
macronutrients (protein, fat, including long-chain polyunsaturated 
fatty acids (LCPUFA's), and carbohydrates) in formulas for low birth-
weight preterm infants.
    FDA is announcing that it has asked FASEB, 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 
preterm infants and the resultant effects of new information about 
nutritional needs 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 will 
undertake a study and prepare a documented scientific report that 
summarizes the available information related to these questions.
    LSRO, in consultation with expert scientists and professional 
organizations

[[Page 58567]]

involved in the field of infant nutrition (e.g., American Academy of 
Pediatrics (AAP), the Food and Nutrition Board (FNB) of the National 
Academy of Sciences), will perform a review of the scientific and 
medical literature with a particular emphasis on studies published 
since 1986, when Congress last amended the infant formula provisions of 
the act. Requirements of other governmental bodies will also be 
considered in this review. Specifically, LSRO will address the 
following issues:
    (1) What scientific basis is there to support requirements for 
energy and macronutrients (protein, fat, and carbohydrate) 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. Has scientific knowledge advanced 
to the point that distinct composition standards for energy and 
macronutrients in formulas for these preterm infants are warranted?
    (2) 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 
justify 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? Are the energy and macronutrient requirements for infant 
formulas for term infants sufficient for healthy post-discharge preterm 
infants? 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?
    (3) 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 containing 
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. Is there 
evidence to suggest that this finding has application 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?
    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?
    (4) Does available evidence establish the essentiality of 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 its research and in the 
drafting of its report. LSRO notes that the recommendations derived 
from the answers to the above questions will be made in consultation 
with liaisons from the American Academy of Pediatrics' Committee on 
Nutrition and the Institute of Medicine's Food and Nutrition Board. A 
comprehensive final report that documents and summarizes the results of 
the evaluation will be prepared.
    FDA and FASEB are announcing that the LSRO/FASEB expects to hold an 
open meeting on this topic during the period January 2, 1997 to March 
31, 1997. FDA and FASEB will announce the date of the meeting as soon 
as it is set. The open meeting will be held in the Chen Auditorium, Lee 
Bldg., FASEB (address above). FASEB anticipates that the open meeting 
will last 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 by December 23, 1996. Written requests to 
make oral presentations of scientific data, information, and views at 
the open meeting should be submitted 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 the date of the open meeting.
    FDA and FASEB are also inviting submission of written presentations 
of scientific data, information, and views. These materials should be 
submitted on or before the date of the open meeting. Two copies of the 
written materials must be submitted to each office.
    Under its contract with FDA, FASEB will provide the agency with a 
scientific report on or about September 30, 1997.

    Dated: November 5, 1996.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 96-29303 Filed 11-14-96; 8:45 am]
BILLING CODE 4160-01-F