[Federal Register Volume 62, Number 94 (Thursday, May 15, 1997)]
[Notices]
[Pages 26803-26804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0160]


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.

DATES:  Submit written comments on the collection of information by 
June 16, 1997.

ADDRESSES:  Submit written comments on the 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. Wolff, Office of 
Information Resources Management (HFA-80), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

SUPPLEMENTARY INFORMATION:  In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collection of information to OMB for review and 
clearance:

Food Labeling; Nutrient Content Claims and Health Claims; 
Restaurant Foods

    Section 403(r) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 343(r)) provides that food labeling may contain 
nutrient content claims or health claims only if they are in compliance 
with regulations issued by FDA. FDA has issued regulations in 
Secs. 101.10, 101.13, and 101.14 (21 CFR 101.10, 101.13, and 101.14) 
that set forth the requirements for restaurants making nutrient content 
claims and health claims regarding their food products. Section 101.10 
requires that nutrition labeling in accordance with Sec. 101.9 (21 CFR 
101.9) shall be provided upon request for any restaurant food or meal 
for which a nutrient content claim or health claim is made. This 
regulation further provides that a restaurant may comply with the 
requirements of Sec. 101.9 by providing information on the nutrient 
amounts that are the subject of the claim (e.g., ``low fat, this meal 
provides less than 10 grams of fat'' may serve as the functional 
equivalent of the complete nutritional information as described in 
Sec. 101.9). For compliance purposes, a restaurant is required by 
Secs. 101.13 and 101.14 to provide appropriate regulatory officials 
with information that provides a reasonable basis to conclude that the 
food complies with the definition for the claim. For example, a 
restaurant may choose to offer an item purchased from a commercial 
manufacturer where the item is appropriately labeled by the 
manufacturer as ``low fat.'' In such a case, the restaurant would not 
have to collect any additional information. Regulatory officials will 
use the information provided by the restaurant in lieu of analysis to 
determine whether nutrient content claims or health claims made by a 
restaurant concerning its food products are in compliance with the 
requirements of Secs. 101.10, 101.13, and 101.14. FDA expects that 
restaurants will choose the least burdensome option that complies with 
the regulations.
    FDA estimates the burden resulting from the records retention and 
disclosure requirements of Secs. 101.10, 101.13, and 101.14 as follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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101.10                            265,000               1.5       397,500               0.25       99,375       
101.13(q)(5)(ii)                                                                                                
101.14(d)(2)(vii)(B) and (d)(3)                                                                                 
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                                      Estimated Annual Recordkeeping Burden                                     
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
101.10                            265,000               1.5       397,500               0.75      298,125       

[[Page 26804]]

                                                                                                                
101.13(q)(5)(ii) and                                                                                            
 101.14(d)(2)(vii)(B)                                                                                           
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    FDA estimates that there will be no more than 265,000 
establishments to which these regulations will apply. This estimate is 
based on data from the National Restaurant Association. The estimates 
also reflect the fact that some firms, e.g., large restaurant chains, 
use the same standardized foods and labeling for more than one 
establishment, thereby reducing the average burden per establishment. 
FDA estimates that the average records retention hour burden would be 
no more than 0.7 hour and the average disclosure hour burden would be 
no more than 0.25 hour for no more than 1.5 products per establishment. 
The estimated number of products is based on the average of 1 claim per 
menu or other device, such as sign or placard, and 1.5 menus or other 
devices per establishment.
     Although FDA's total burden estimate of 397,500 hours has not 
changed, an estimate for reporting burden (99,375 hours) has been added 
to reflect the time necessary to comply with the disclosure 
requirements of these regulations. In FDA's previous estimate (61 FR 
40320 at 40331, August 2, 1996), these hours were included as part of 
the recordkeeping estimate. Because FDA now believes it is more 
appropriate to characterize disclosure as a reporting burden, the 
recordkeeping estimate has been reduced accordingly.

    Dated: April 25, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-12697 Filed 5-14-97; 8:45 am]
BILLING CODE 4160-01-F