[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