[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39093-39095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0546]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
Agency: Food And Drug Administration, HHS.
Action: Notice.
-----------------------------------------------------------------------
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 (the PRA).
DATES: Submit written comments on the collection of information by
August 20, 1998.
ADDRESSES: Submit written comments on the proposed 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: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following collection of
information to OMB for review and clearance.
Food Labeling Regulations (21 CFR Parts 101, 102, 104, and 105)
FDA regulations in parts 101, 102, 104, and 105 (21 CFR parts 101,
102, 104, and 105) require food producers to disclose to consumers and
others specific information about themselves or their products on the
label or labeling of their products. Certain of these regulations also
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 submissions of information to FDA in the form
of petitions or notices. These regulations were issued under the
authority of sections 4, 5, and 6 of the Fair Packaging and Labeling
Act (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 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 sold in the United States are in compliance with the
labeling provisions of the act and the FPLA. One purpose of this
submission to OMB under the PRA is to consolidate all of the
information collection provisions in these regulations into one
submission to OMB for its review and approval.
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 the
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) 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) 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 the provisions of 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
[[Page 39094]]
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 flavors. 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 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 information 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
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 in the nutrition label 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 a 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. 101.109 and 105.66 for the purpose of conducting
food labeling experiments with FDA 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.
In a notice published in the Federal Register of March 23, 1998 (63
FR 13862), FDA invited comments on the information collection
provisions contained in its food labeling regulations in parts 101,
102, 104, and 105. FDA received no comments in response to that notice.
FDA estimates the burden of this collection of information as
follows:
[[Page 39095]]
Table 1.--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Total Operating,
21 CFR Section No. of Total Annual Hours per Total Hours Capital or
Respondents Responses Response Maintenance Costs
----------------------------------------------------------------------------------------------------------------
101.3, 101.22, parts 102 and
104 17,000 17,500 0.5 8,750 0
101.4, 101.22, 101.100, parts
102, 104, and 105 17,000 17,500 1 17,500 0
101.5 17,000 17,500 0.25 4,375 0
101.9, 101.13(n),
101.14(d)(3), 101.62, and
part 104 17,000 17,500 4 70,000 $1,000,000
101.9(g)(9) and 101.36(f)(2) 12 12 4 48 0
101.9(j)(18) and 101.36(h)(2) 8,600 8,600 8 68,800 0
101.10 265,000 397,500 0.25 99,375 0
101.12(e) 25 25 1 25 0
101.12(g) 5,000 5,000 1 5,000 0
101.12(h) 5 5 80 400 $400,000
101.13(d)(1) and 101.67 200 200 1 200 0
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
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
101.15 160 1,600 8 12,800 0
101.22(i)(4) 25 25 1 25 0
101.30 and 102.33 1,500 5,000 1 5,000 0
101.36 300 12,000 4 48,000 $15,000,000
101.42 and 101.45 72,270 72,270 0.50 36,135 0
101.45(c) 5 20 4 80 0
101.69 3 3 25 75 0
101.70 3 3 80 240 $400,000
101.77 (c)(2)(ii)(D) 1,000 1,000 0.25 250 0
101.79 (c)(2)(iv) 100 100 0.25 25 0
101.100(d) 1,000 1,000 1 1,000 0
101.105 and 101.100(h) 17,000 17,500 0.5 8,750 0
101.108 0 0 40 0 0
Total Burden Hours 985,603 16,800,000
----------------------------------------------------------------------------------------------------------------
Table 2.--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Total Operating,
No. of Total Annual Hours per Capital or
21 CFR Section Respondents Records Response Total Hours Maintenance
Costs
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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 that 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(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: July 14, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19313 Filed 7-20-98; 8:45 am]
BILLING CODE 4160-01-F