[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Notices]
[Page 47736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19623]



[[Page 47736]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1268]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
September 5, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    In the Federal Register of May 16, 2000 (65 FR 31178), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--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: July 28, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-19623 Filed 8-2-00; 8:45 am]
BILLING CODE 4160-01-F