[Federal Register Volume 63, Number 55 (Monday, March 23, 1998)]
[Notices]
[Pages 13861-13863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7472]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0157]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection provisions in FDA's
food labeling regulations.
DATES: Submit written comments on the collection of information by May
22, 1998.
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. Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-1223.
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 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 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.
Food Labeling Regulations (21 CFR Parts 101, 102, 104, and 105)
FDA regulations require food producers to disclose to consumers and
others specific information about themselves or their products on the
label or labeling of their products. Related regulations require that
food producers retain records establishing the basis for the
information contained in the label or labeling of their products and
provide those records to regulatory officials. Finally, certain
regulations provide for the submission of food labeling petitions to
FDA. FDA's food labeling regulations in parts 101, 102, 104, and 105
(21 CFR parts 101, 102, 104, and 105) were issued under the authority
of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (the
FPLA) (15 U.S.C. 1453, 1454, and 1455) and of sections 201, 301, 402,
403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most
of these regulations derive from section 403 of the act, which provides
that a food product shall be deemed to be misbranded if, among other
things, its label or labeling fails to bear certain required
information concerning the food product, is false or misleading in any
particular, or bears certain types of unauthorized claims. The
disclosure requirements and other collections of information in the
regulations in parts 101, 102, 104, and 105 are necessary to ensure
that food products produced or sold in the United States are in
compliance with the labeling provisions of the act and the FPLA. The
purpose of this notice is to consolidate all of the information
collection provisions in these regulations into one notice for public
comment under the PRA.
Section 101.3 of FDA's food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity
(i.e., the name of the product), including, as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form. Section 101.5 requires that
the label of a food product in packaged form specify the name and place
of business of the manufacturer, packer, or distributor and, if the
food producer is not the manufacturer of the food product, its
connection with the food product. Section 101.9 requires that nutrition
information be provided for all food products intended for human
consumption and offered for sale, unless an exemption in Sec. 101.9(j)
applies to the product. Section 101.9(g)(9) also provides for the
submission to FDA of requests for alternative approaches to nutrition
labeling. Finally, Sec. 101.9(j)(18) provides for the submission to FDA
of notices from firms claiming the small business exemption from
nutrition labeling.
Section 101.10 requires that restaurants provide nutrition
information, upon request, for any food or meal for which a nutrient
content claim or health claim is made. Section 101.12(e) provides that
a manufacturer that adjusts the reference amount customarily consumed
(RACC) of an aerated food for the difference in density of the aerated
food relative to the density of the appropriate nonaerated reference
food must be prepared to show FDA detailed protocols and records of all
data that were used to determine the density-adjusted RACC. Section
101.12(g)
[[Page 13862]]
requires that the label or labeling of a food product disclose the
serving size that is the basis for a claim made for the product if the
serving size on which the claim is based differs from the RACC. Section
101.12(h) provides for the submission of petitions to FDA to request
changes in the reference amounts defined by regulation.
Section 101.13 requires that nutrition information be provided in
accordance with Sec. 101.9 for any food product for which a nutrient
content claim is made. Under some circumstances, Sec. 101.13 also
requires the disclosure of other types of information as a condition
for the use of a nutrient content claim. For example, under
Sec. 101.13(j), if the claim compares the level of a nutrient in the
food with the level of the same nutrient in another ``reference'' food,
the claim must also disclose the identity of the reference food, the
amount of the nutrient in each food, and the percentage or fractional
amount by which the amount of the nutrient in the labeled food differs
from the amount of the nutrient in the reference food. Section
101.13(q)(5) requires that restaurants document and provide to
appropriate regulatory officials, upon request, the basis for any
nutrient content claims they have made for the foods they sell.
Section 101.14 provides for the disclosure of nutrition
information in accordance with Sec. 101.9 and, under some
circumstances, certain other information as a condition for making a
health claim for a food product. Section 101.15 provides that, if the
label of a food product contains any representation in a foreign
language, all words, statements, and other information required by or
under authority of the act to appear on the label shall appear thereon
in both the foreign language and in English. Section 101.22 contains
labeling requirements for the disclosure of spices, flavorings,
colorings, and chemical preservatives in food products. Section
101.22(i)(4) sets forth reporting and recordkeeping requirements
pertaining to certifications for flavors designated as containing no
artificial flavor. Section 101.30 specifies the conditions under which
a beverage that purports to contain any fruit or vegetable juice must
declare the percentage of juice present in the beverage and the manner
in which the declaration is to be made.
Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in
Sec. 101.36(h) applies. Section 101.36(f)(2) cross references the
provisions in Sec. 101.9(g)(9) for the submission to FDA of requests
for alternative approaches to nutrition labeling. Also,
Sec. 101.36(h)(2) cross references the provisions in Sec. 101.9(j)(18)
for the submission of small business exemption notices.
Section 101.42 requests that food retailers voluntarily provide
nutrition information for raw fruits, vegetables, and fish at the point
of purchase, and Sec. 101.45 contains guidelines for providing such
information. Also, Sec. 101.45(c) provides for the submission of
nutrient data bases and proposed nutrition labeling values for raw
fruit, vegetables, and fish to FDA for review and approval.
Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify
information that must be disclosed as a condition for making particular
nutrient content claims. Section 101.67 cross references requirements
in other regulations for ingredient declaration (Sec. 101.4) and
disclosure of information concerning performance characteristics
(Sec. 101.13(d)). Section 101.69 provides for the submission of a
petition requesting that FDA authorize a particular nutrient content
claim by regulation. Section 101.70 provides for the submission of a
petition requesting that FDA authorize a particular health claim by
regulation. Section 101.77(c)(2)(ii)(D) requires the disclosure of the
amount of soluble fiber per serving in the nutrition labeling of a food
bearing a health claim about the relationship between soluble fiber and
a reduced risk of coronary heart disease. Section 101.79(c)(2)(iv)
requires the disclosure of the amount of folate per serving in the
nutrition labeling of a food bearing a health claim about the
relationship between folate and a reduced risk of neural tube defects.
Section 101.100(d) provides that any agreement that forms the
basis for an exemption from the labeling requirements of section
403(c), (e), (g), (h), (i), (k), and (q) of the act be in writing and
that a copy of the agreement be made available to FDA upon request.
Section 101.100 also contains reporting and disclosure requirements as
conditions for claiming certain labeling exemptions.
Section 101.105 specifies requirements for the declaration of the
net quantity of contents on the label of a food in packaged form and
prescribes conditions under which a food whose label does not
accurately reflect the actual quantity of contents may be sold, with
appropriate disclosures, to an institution operated by Federal, State
or local government. Section 101.108 provides for the submission to FDA
of a written proposal requesting a temporary exemption from certain
requirements of Secs. 101.9 and 105.66 for the purpose of conducting
food labeling experiments with FDA's authorization.
Regulations in part 102 define the information that must be
included as part of the statement of identity for particular foods and
prescribe related labeling requirements for some of these foods. For
example, Sec. 102.22 requires that the name of a protein hydrolysate
shall include the identity of the food source from which the protein
was derived.
Part 104, which pertains to nutritional quality guidelines for
foods, cross references several labeling provisions in part 101 but
contains no separate information collection requirements.
Part 105 contains special labeling requirements for hypoallergenic
foods, infant foods, and certain foods represented as useful in
reducing or maintaining body weight.
The disclosure and other information collection requirements in the
above regulations are placed primarily upon manufacturers, packers, and
distributors of food products. Because of the existence of exemptions
and exceptions, not all of the requirements apply to all food producers
or to all of their products. Some of the regulations affect food
retailers, such as supermarkets and restaurants.
The purpose of the food labeling requirements is to allow
consumers to be knowledgeable about the foods they purchase. Nutrition
labeling provides information for use by consumers in selecting a
nutritious diet. Other information enables a consumer to comparison
shop. Ingredient information also enables consumers to avoid substances
to which they may be sensitive. Petitions or other requests submitted
to FDA provide the basis for the agency to permit new labeling
statements or to grant exemptions from certain labeling requirements.
Recordkeeping requirements enable FDA to monitor the basis upon which
certain label statements are made for food products and whether those
statements are in compliance with the requirements of the act or the
FPLA.
FDA estimates the burden of this collection of information as
follows:
[[Page 13863]]
Table 1.--Estimated Annual Reporting Burden
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Total Operating,
21 CFR Section/Part No. of Total Annual Hours per Total Hours Capital, or
Respondents Responses Response Maintenance Costs
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Secs. 101.3, 101.22,
parts 102 and 104 17,000 17,500 0.5 8,750 0
Secs. 101.4, 101.22,
101.100, parts 102, 104,
and 105 17,000 17,500 1 17,500 0
Sec. 101.5 17,000 17,500 0.25 4,375 0
Secs. 101.9, 101.13(n),
101.14(d)(3), 101.62, and
part 104 17,000 17,500 4 70,000 $1,000,000
Secs. 101.9(g)(9) and
101.36(f)(2) 12 12 4 48 0
Secs. 101.9(j)(18) and
101.36(h)(2) 8,600 8,600 8 68,800 0
Sec. 101.10 265,000 397,500 0.25 99,375 0
Sec. 101.12(e) 25 25 1 25 0
Sec. 101.12(g) 5,000 5,000 1 5,000 0
Sec. 101.12(h) 5 5 80 400 $400,000
Secs. 101.13(d)(1) and
101.67 200 200 1 200 0
Secs. 101.13(j)(2),
101.13(k), 101.54,
101.56, 101.60, 101.61,
and 101.62 2,500 2,500 1 2,500 0
Sec. 101.13(q)(5) 265,000 397,500 0.75 298,125 0
Sec. I01.14(d)(2) 265,000 397,500 0.75 298,125 0
Sec. 101.15 160 1,600 8 12,800 0
Sec. 101.22(i)(4) 25 25 1 25 0
Secs. 101.30 and 102.33 1,500 5,000 1 5,000 0
Sec. 101.36 300 12,000 4 48,000 $15,000,000
Secs. 101.42 and 101.45 72,270 72,270 0.50 36,135 0
Sec. 101.45(c) 5 20 4 80 0
Sec. 101.69 3 3 25 75 0
Sec. 101.70 3 3 80 240 $400,000
Sec. 101.77(c)(2)(ii)(D) 1,000 1,000 0.25 250 0
Sec. 101.79(c)(2)(iv) 100 100 0.25 25 0
Sec. 101.100(d) 1,000 1,000 1 1,000 0
Secs. 101.105 and
101.100(h) 17,000 17,500 0.5 8,750 0
Sec. 101.108 0 0 40 0 0
Total Burden Hours 985,603 16,800,000
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Table 2.--Estimated Annual Recordkeeping Burden
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Total
Operating,
21 CFR Section No. of Total Annual Hours per Total Hours Capital, or
Recordkeepers Records Recordkeeper Maintenance
Costs
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101.12(e) 25 25 1 25 0
101.13(q)(5) 265,000 397,500 0.75 298,125 0
101.14(d)(2) 265,000 397,500 0.75 298,125 0
101.22(i)(4) 25 25 1 25 0
101.100(d)(2) 1,000 1,000 1 1,000 0
101.105(t) 100 100 1 100 0
Total Burden Hours 597,400 0
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These estimates are based on FDA's ``Regulatory Impact Analysis of
the Final Rules to Amend the Food Labeling Regulations,'' the agency's
most recent comprehensive review of food labeling costs that published
in the Federal Register of January 6, 1993 (58 FR 2927); agency
communications with industry; and FDA's knowledge of and experience
with food labeling and the submission of petitions and requests to the
agency. Where an agency regulation implements an information collection
requirement in the act or the FPLA, only any additional burden
attributable to the regulation has been included in FDA's burden
estimate.
No burden has been estimated for those requirements where the
information to be disclosed is information that has been supplied by
FDA. Also, no burden has been estimated for information that is
disclosed to third parties as a usual and customary part of a food
producer's normal business activities. Under 5 CFR 1320.3(c)(2), the
public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
is not a collection of information. Under 5 CFR 1320.3(b)(2), the time,
effort, and financial resources necessary to comply with a collection
of information are excluded from the burden estimate if the reporting,
recordkeeping, or disclosure activities needed to comply are usual and
customary because they would occur in the normal course of activities.
Dated: March 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7472 Filed 3-20-98; 8:45 am]
BILLING CODE 4160-01-F