[Federal Register Volume 61, Number 238 (Tuesday, December 10, 1996)]
[Notices]
[Pages 65067-65068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31320]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0433]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995,
Federal agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on requests for exemption from the food additive
listing requirements that are submitted under Sec. 170.39 (21 CFR
170.39).
DATES: Submit written comments on the collection of information by
February 10, 1996.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1223.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520), Federal agencies must obtain approval from the
Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Threshold of Regulation for Substances Used in Food-Contact
Articles--Sec. 170.39--(OMB Control Number 0910-0298)--Extension
Under section 409(a) of the act (21 U.S.C. 348(a)), the use of a
food additive is deemed unsafe unless it either conforms to the terms
of a regulation prescribing its use or to an exemption for
investigational use. Consequently, the safety of the substance under
its intended conditions of use must be established, and a food additive
regulation issued, before the substance can be used in food. In
accordance with section 409 of the act, manufacturers of all components
of a food-contact article (e.g., food packaging or food processing
equipment) whose use meets the food additive definition in 201(s) of
the act (21 U.S.C. 321(s)) must submit a petition establishing the safe
conditions of use before such food-contact articles may be marketed,
unless they are the subject of an exemption for investigational use
under section 409(i) of the act.
Section 170.39 establishes a process that provides a manufacturer
with an opportunity to demonstrate that the likelihood or extent of
migration to food of a substance used in a food-contact article is so
trivial that the use need not be the subject of a food additive listing
regulation (Federal Register of July 17, 1995 (60 FR 36582)). The
agency has established two thresholds for the regulation of substances
used in food-contact articles. The first exempts those substances used
in food-contact articles where the resulting dietary concentration is
at or below 0.5 part per billion. The second exempts regulated direct
food additives for use in food-contact articles where the resulting
dietary exposure is 1 percent or less of the acceptable daily intake
for these substances.
In order to determine whether the intended use of a substance in a
food-contact article meets the threshold criteria, certain information
specified in Sec. 170.39(c) must be submitted to FDA. This information
includes: (1) The chemical composition of the substance for which the
request is made; (2) detailed information on the conditions of use of
the substance; (3) a clear statement of the basis for the request for
exemption from regulation as a food additive; (4) data that will enable
FDA to estimate the daily dietary concentration resulting from the
proposed use of the substance; (5) results of a literature search for
toxicological data on the substance and its impurities; and (6)
information on the environmental impact that would result from the
proposed use.
FDA uses this information to determine whether the food-contact
article meets the threshold criteria. Respondents to this information
collection are individual manufacturers and suppliers of substances
used in food-contact articles (i.e., food packaging and food processing
equipment) or of the articles themselves.
FDA estimates the burden of this collection of information as
follows:
[[Page 65068]]
Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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170.39 60 1 60 88 5,280
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There are no capital costs or operating and maintenance costs associated with this collection of information.
This annual reporting estimate is based on information received
from representatives of the food packaging and processing industries
and on agency records. Typically, FDA receives 60 threshold of
regulation exemption requests per year; these requests are equally
divided between simple and complex type submissions. These requests
require between 26 to 110 hours to prepare.
Dated: December 3, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31320 Filed 12-9-96; 8:45 am]
BILLING CODE 4160-01-F