[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
