[Federal Register Volume 66, Number 218 (Friday, November 9, 2001)]
[Notices]
[Pages 56687-56688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0335]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Food Labeling: Nutrition Labeling of Dietary 
Supplements on a ``Per Day'' Basis

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 
December 10, 2001.

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: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy 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 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Labeling: Nutrition Labeling of Dietary Supplements on a ``Per 
Day''' Basis

    Section 403(q)(5)(F) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 343(q)(5)(F)) provides that dietary supplements must bear 
nutrition labeling in a manner that is appropriate for the product and 
that is specified in regulations issued by FDA. FDA issued regulations 
establishing the requirements for dietary supplements in nutrition 
labeling in 21 CFR 101.36 in the September 23, 1997, final rule (62 FR 
49826). FDA published a proposed rule in the Federal Register of 
January 12, 1999 (64 FR 1765), to amend its nutrition labeling 
regulations for dietary supplements. This amendment would provide that 
the quantitative amount and the percentage of the daily value of a 
dietary ingredient may be voluntarily presented on a ``per day'' basis 
in addition to the required ``per serving'' basis. The proposed rule 
stated that this voluntary information may be provided if a dietary 
supplement label recommends that the dietary supplement be consumed 
more than once per day. These proposed provisions are in response to a 
citizen petition submitted by a manufacturer and marketer of dietary 
supplements. This proposed action would provide suppliers of dietary 
supplements flexibility to present additional label information 
voluntarily to consumers.
    In the Federal Register of August 14, 2001 (66 FR 42663), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                       Total
                      No. of          Annual       Total Annual      Hours per      Operating &
 21 CFR Section    Respondents     Frequency per     Responses       Response       Maintenance     Total Hours
                                     Response                                          Costs
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    101.36(d)               85              10             850            0.25         $83,000             213
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\1\ There are no capital costs associated with this collection of information.

    These estimates are based on agency communications with industry 
and FDA's knowledge of, and experience with, food labeling. FDA 
estimated in the September 23, 1997, final rule (62 FR 49826 at 49846) 
that there was a maximum of 850 suppliers of dietary supplements and 
that, on average, each supplier had 40 products whose labels required 
revision. FDA estimates that only 10 percent, or 85 of the dietary 
supplement suppliers, would revise the labels of their products to 
incorporate nutrition levels for the daily use of their products. FDA 
also estimates that daily use levels for nutrition information would 
generally be placed on at most 25 percent, or at most 10 of a firm's 
estimated 40 products, although this number would vary by firm based on 
the types of products that it produces. FDA also believes that the 
burden associated with the proposed disclosure of nutrition information 
on a daily use basis for dietary supplements would be a one-time burden 
for the small number of firms that would decide voluntarily to add this 
additional information to the labels for their products. FDA estimates 
that at least 90 percent of firms would coordinate the addition of 
daily use nutrition information with other changes in their labels, in 
which case the voluntary cost of transmitting the information to 
consumers in labeling would be subsumed almost entirely in the cost of 
these other voluntary or required labeling changes. The incremental 
cost for these 76 firms would be approximately $50 per label for 760 
labels, or $38,000 total. For the remaining 9 firms that would not 
coordinate changes with other labeling changes, FDA estimates that the 
cost would be approximately $500 per label (64 FR 1765 at 1769) for 90 
labels, or $45,000 total. The estimated total operating costs in table 
1 of this

[[Page 56688]]

document are, therefore, $83,000. Respondents are already required to 
disclose the quantitative amount and the percentage of the daily value 
of a dietary ingredient on a per serving basis as part of the nutrition 
information for dietary supplements. Respondents may also provide such 
information on a per unit basis. The information provided for under the 
proposed rule would be generated by simple extrapolation from that 
information.

    Dated: November 2, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-28105 Filed 11-8-01; 8:45 am]
BILLING CODE 4160-01-S