[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
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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
