[Federal Register Volume 59, Number 62 (Thursday, March 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7796]
[[Page Unknown]]
[Federal Register: March 31, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 90A-0416, 91A-0330, 93F-0232]
Background Document for Food Advisory Committee; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a background briefing document for the Food Advisory
Committee meeting that was announced in the Federal Register of
Tuesday, March 15, 1994, and scheduled for April 6, 7, and 8, 1994.
This action is being taken to ensure that all interested parties are
aware of the issues that are the subject of the committee's discussion.
ADDRESSES: Single copies of the background briefing document may be
requested in writing from the Freedom of Information Staff (HFI-35),
Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville,
MD 20857, at a cost of 10 cents per page. Requests should be identified
with the docket number found in brackets in the heading of this
document. The background briefing document is available for public
examination at the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Lynn A. Larsen, Center for Food Safety
and Applied Nutrition (HFS-5), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-205-4727.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 15, 1994
(59 FR 11997), FDA announced that a meeting of the Food Advisory
Committee will be held on April 6, 7, and 8, 1994. The purpose of the
meeting is to have a scientific discussion by the committee members of
the agency's procedures for the safety review of whole foods produced
by new biotechnologies. A genetically modified tomato currently under
review by the agency will serve as an example and focus for the
discussion. In this notice, FDA is announcing the availability of
material being supplied to the committee as background information.
FDA regulations (21 CFR 14.75(a)(1)) state that the agency will
make available for public disclosure at the time it is provided to a
committee any written information given to the committee that may be
publicly disclosed. However, material provided to a committee often
includes documents that may not be publicly disclosed. Such material is
not ordinarily made available to the public, although some of its
content may become apparent during open committee discussion.
Much of the background information being provided to the Food
Advisory Committee for its April 1994 meeting is publicly available
from other sources. However, the material also includes a summary
document prepared by the Center for Food Safety and Applied Nutrition
that ordinarily would not be publicly releasable at this time because
it contains an overview of the Center's evaluation of the data and
information concerning the genetically engineered tomato that will
serve as the focus of the committee's discussion.
FDA is taking the unusual step of releasing this summary document
to ensure that all interested parties may fully understand the issues
that are the subject of the committee's discussion. The agency believes
that in these particular circumstances, it is appropriate to release
this summary, even though it contains material that ordinarily would
not be disclosed publicly at this stage because all of the data
discussed in the summary have been previously made available to the
public.
Copies of the background briefing document, and a bibliography of
documents available from other sources, may be seen in the Dockets
Management Branch (address above) or obtained from the agency's Freedom
of Information Staff (address above). Copies of the background briefing
document and the bibliography will also be available at the committee
meeting.
Dated: March 28, 1994.
Jane E. Henney,
Deputy Commissioner for Operations.
[FR Doc. 94-7796 Filed 3-29-94; 11:31 am]
BILLING CODE 4160-01-F
