[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