[Federal Register Volume 65, Number 95 (Tuesday, May 16, 2000)]
[Notices]
[Pages 31178-31179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1268]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Additives and Food Additive Petitions

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 
(the PRA), 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 requirements relating to the 
approval and labeling of food additives.

DATES: Submit written comments on the collection of information by July 
17, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (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

[[Page 31179]]

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 PRA (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 set forth 
in this document.
    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.

Food Additives and Food Additive Petitions--21 CFR 171.1 and Parts 
172, 173, 175 through 178, and 180--(OMB Control Number 0910-
0016)--Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(a)) provides that any particular use or intended 
use of a food additive shall be deemed to be unsafe, unless the 
additive and its use or intended use are in conformity with a 
regulation issued under Section 409 of the act that describes the 
condition(s) under which the additive may be safely used, or unless the 
additive and its use or intended use conform to the terms of an 
exemption for investigational use, or unless a food contact 
notification submitted under paragraph (h) is effective. Food additive 
petitions are submitted by individuals or companies to obtain approval 
of a new food additive or to amend the conditions of use permitted 
under an existing food additive regulation. Section 171.1 (21 CFR 
171.1) specifies the information that a petitioner must submit in order 
to establish that the proposed use of a food additive is safe and to 
secure the publication of a food additive regulation describing the 
conditions under which the additive may be safely used. Parts 172, 173, 
175 through 178, and 180 (21 CFR parts 172, 173, 175 through 178, and 
180) contain labeling requirements for certain food additives to ensure 
their safe use.
    FDA scientific personnel review food additive petitions to ensure 
the safety of the intended use of the food additive in or on food, or 
of a food additive that may be present in food as a result of its use 
in articles that contact food. FDA requires food additive petitions to 
contain the information specified in Sec. 171.1 in order to determine 
whether a petitioned use for a food additive is safe, as required by 
the act. This regulation (Sec. 171.1) implements section 409(b)(2) of 
the act.
    Respondents are businesses engaged in the manufacture or sale of 
food, food ingredients, or substances used in materials that come into 
contact with food.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
       21 CFR Section/Part            No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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171.1                                  13               1              13           5,332          69,316
Part 172                               13               1              13               0               0
Part 173                               13               1              13               0               0
Parts 175 through 178                  13               1              13               0               0
Part 180                               13               1              13               0               0
Total                                                                                             69,316
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This estimate is based on the number of new food additive petitions 
received in fiscal year 1999 and the total hours expended by 
petitioners to prepare the petitions. A reduction was estimated based 
on expected eligibility of some substances previously submitted as food 
additive petitions for submission as food contact notices under new 
section 409(h) of the the act. The burden varies with the complexity of 
the petition submitted, because food additive petitions involve the 
analysis of scientific data and information, as well as the work of 
assembling the petition itself. Because labeling requirements under 
parts 172, 173, 175 through 178, and 180 for particular food additives 
involve information required as part of the food petition safety review 
process under Sec. 171.1, the estimate for the number of respondents is 
the same and the burden hours for labeling are included in the estimate 
for Sec. 171.1.

    Dated: May 9, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-12181 Filed 5-15-00; 8:45 am]
BILLING CODE 4160-01-F