[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]


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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.

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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 (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                                  
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                                                                                               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 
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                                 Table 2.--Estimated Annual Recordkeeping Burden                                
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                                                                                                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       
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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 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