[Federal Register Volume 65, Number 234 (Tuesday, December 5, 2000)]
[Notices]
[Pages 75940-75941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1575]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Nutrition Labeling; Declaration of Caloric Amounts and 
Serving Sizes for Breath Mints

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 information collection 
requirements regarding the nutrition labeling of breath mints.

DATES: Submit written or electronic comments on the collection of 
information by February 5, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
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 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.

Nutrition Labeling; Declaration of Caloric Amounts and Serving 
Sizes for Breath Mints--21 CFR 101.9(b) and 101.9(c)(1) (OMB 
Control Number 0910-0364)--Extension

    Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 343(q)) requires that the label or labeling of a food 
bear nutrition information, including information on: (1) The serving 
size and number of servings per container, and (2) the number of 
calories present in a serving of the food. Under FDA's nutrition 
labeling regulations in Sec. 101.9(d)(3) (21 CFR 101.9(d)(3)), the 
nutrition facts panel of the food label must disclose the serving size 
of the food product and the number of servings in each package. Under 
Sec. 101.9(c)(1), the nutrition facts panel must disclose the number of 
calories present in a serving of the food.
    In the Federal Register of December 30, 1997 (62 FR 67775), FDA 
published a proposed rule to amend the nutrition labeling regulations 
by changing the label serving size for the product category ``Hard 
candies, breath mints'' to one unit. FDA proposed this change in 
response to a petition to provide a serving size for breath mints that 
more accurately reflects the amount customarily consumed per eating 
occasion. In a related issue, FDA also proposed to: (1) Modify the 
rounding rules for calories to allow the declaration of caloric amounts 
of less than 5 calories on the nutrition label,

[[Page 75941]]

and (2) require that the number of calories declared on the nutrition 
label of a food product be consistent with any claims about caloric 
content that are made in its labeling. As a result of this proposed 
rule, manufacturers, packers, or distributors who make labeling claims 
that their products contain between 1 and 5 calories would be required 
to change the declaration of the amount of calories on the nutrition 
label. In addition, manufacturers of small breath mints would be 
required, under Sec. 101.9(b), to change the serving size and, under 
Sec. 101.9(c) and (d), to modify the amounts and Daily Values for 
nutrients listed in the nutrition label for their products. The 
proposal included burden estimates for the proposed changes and 
solicited public comment. In the interim, however, FDA is seeking an 
extension of OMB approval for the current regulations.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Additional Reporting Burden \1\
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                                                                                       Total
         21 CFR Section               No. of       Total No. of      Hours per       Operating      Total Hours
                                    Respondents      Responses       Response          Costs
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101.9(b) and (c)(1)                     4              30               1         $15,000             30
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\1\ There are no capital or maintenance costs associated with this collection of information.

    The proposed modification of the rules for the declaration of the 
amount of calories and the proposed change of the label serving size on 
the nutrition facts panel would result in a one-time burden created by 
the need for firms to revise their labels. In addition to changing the 
statement of calories and the serving sizes, firms would have to 
recalculate the number of servings per container and any nutrient 
amounts and Daily Values affected by the change in serving size. Of 
those breath mints for which FDA has information regarding the size of 
the product, there are 4 firms producing 5 brands of small breath 
mints, or approximately 30 distinct small breath mint labels. These are 
the only firms that would be affected by this proposed rule. FDA 
estimates that these firms would require an average of 1 hour per label 
to comply with the requirements of a final rule based on this proposal. 
For breath mint products, the average administrative, redesign, and 
inventory disposal costs for a labeling change of this type, with a 1-
year compliance period, would result in a one-time operating cost of 
$500 per label or a total estimated operating cost of $15,000.

    Dated: November 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-30828 Filed 12-4-00; 8:45 am]
BILLING CODE 4160-01-F