[Federal Register Volume 61, Number 44 (Tuesday, March 5, 1996)]
[Notices]
[Pages 8628-8629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5117]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES-

Food and Drug Administration
[Docket No. 96N-0005]


Review of Infant Formula Nutrient Requirements; 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 begin a review 
of data on the nutritional needs of infants and to make recommendations 
on appropriate concentrations of nutrients in formulas for term 
infants. The Infant Formula Act of 1980 directed FDA to ensure the 
safety and nutritional quality of infant formulas. Nutrient 
specifications for infant formulas are codified under the regulations 
for food and human consumption that were most recently revised in 1985. 
This review by LSRO/FASEB was requested by the agency, and it is is 
intended to provide FDA with an up-to-date review of the nutritional 
needs of infants and of how those needs should be reflected in the 
levels of nutrients in formulas for term infants. To assist in the 
preparation of its scientific report, LSRO/FASEB is inviting the 
submission of scientific data and information on this topic. In 
addition, LSRO/FASEB 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 May 
31, 1996. 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 May 10, 1996. Written presentations of scientific data, 
information, and views should be submitted on or before May 31, 1996.

ADDRESSES: Submit written requests to make oral presentations of 
scientific data, information, and views at the open meeting to Sue Ann 
Anderson, Life Sciences Research Office, Federation of American 
Societies for Experimental Biology, 9650 Rockville Pike, Bethesda, MD 
20814, 301-530-7030, 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: Elizabeth A. Yetley, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-205-4168.

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.
     The Infant Formula Act of 1980 (Pub. L. 96-359) directed that FDA 
ensure the safety and nutritional quality of infant formulas. 
Regulations for infant formulas are codified in part 107 (21 CFR part 
107) and include nutrient specifications for these products 
(Sec. 107.100). These nutrient specifications were last revised in 
1985. In 1986, the infant formula provisions of the Federal Food, Drug, 
and Cosmetic Act (the act) were amended (Pub. L. 99-570). Among the 
changes that Congress made was to add the list of specifications to 
section 412(i)(1) of the act (21 U.S.C. 350a(i)(1)). The act also 
provides that the Secretary of Health and Human Services (and by 
delegation FDA) can revise this list by regulation (section 412(i)(2) 
of the act).
     Since 1985, new data on nutritional needs of infants have 
accumulated from scientific investigations. In addition, a recommended 
dietary allowance (RDA) was set for selenium and estimated safe and 
adequate daily dietary intakes (ESADDI) were recommended for fluoride, 
chromium, and molybdenum by the National Research Council in 1989 (see 
Ref. 1). These four minerals are not included in the nutrient 
specifications for infant formulas in section 412(i) of the act or 
Sec. 107.100.
     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 nutritional needs of 
infants and of the resultant effects of new information about 
nutritional needs of infants on recommendations for levels of nutrients 
in formulas for term infants. In response to this request, FASEB has 
directed its Life Sciences Research Office to obtain state-of-the-art 
scientific information on infant nutritional needs and related 
scientific questions on infant formula specifications. The LSRO/FASEB 
will undertake a study and prepare a documented scientific report that 
summarizes the available information related to these questions. LSRO 
has advised FDA that in preparing this report, it will consult with 
academic and medical experts and professional organizations concerned 
with nutritional needs of infants.
     The objectives of this report will include evaluations of the 
following types of information: (1) New findings on nutrient 
requirements of infants and on any resultant need to establish or 
revise minimum and maximum amounts of nutrients required in formulas 
for term infants; (2) for macronutrients, evidence to support the 
addition of specific proteins (e.g., lactoferrin), carbohydrates (e.g., 
lactose), or fats (e.g., omega-3 fatty acids) to infant formulas; (3) 
information on the dietary essentiality of certain minerals (selenium, 
chromium, molybdenum, and fluoride), whether they should be included in 
infant formulas and, if so, at what levels; (4) scientific information 
on effects of ingestion of nucleotides, taurine, carnitine, urea, 
cholesterol, glutathione, and oligosaccharides; (5) information on 
differences in nutrient requirements of older infants (4 months of age 
and older) compared to infants younger than 4 months; (6) factors 
affecting nutrient stability and the product shelf life of infant 
formulas; and (7) the scientific basis for use of methods other than 
the protein efficiency ratio (PER) to ensure the quality of proteins 
used in infant formulas. A comprehensive final report that documents 
and summarizes the results of the evaluation will be prepared.
     FDA and FASEB are announcing that LSRO/FASEB will hold a public 
meeting on this topic on May 31, 1996. The meeting will begin at 9 a.m. 
It is anticipated that the public meeting will be held for 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 May 10, 1996. Written requests to 
make oral presentations of scientific data, information, and views at 
the open meeting should be submitted to LSRO/FASEB (address above) and 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration (address above). Two copies of the 

[[Page 8629]]
material to be presented must be submitted to each office on or before 
the date of the open meeting.
     FDA and LSRO/FASEB are also inviting submission of written 
presentations of scientific data, information, and views. These 
materials should be submitted on or before May 31, 1996. Two copies of 
the written materials must be submitted to both offices.
     Under its contract with FDA, FASEB will provide the agency with a 
scientific report on or about March 31, 1997.

Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
     1. National Research Council, ``Recommended Dietary 
Allowances,'' 10th ed., Washington, DC, National Academy Press, 
1989.

    Dated: February 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-5117 Filed 3-4-96; 8:45 am]
BILLING CODE 4160-01-F