[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Notices]
[Pages 42663-42664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0335]


Agency Information Collection Activities; Proposed Collection; 
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 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a collection of information on 
nutrition labeling of dietary supplements on a ``per day'' basis.

DATES: Submit written or electronic comments on the collection of 
information by October 15, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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: Under the PRA (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, including 
each proposed extension of an existing 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 set forth in this document.
    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: 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.
    Respondent Description: Suppliers of dietary supplements.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 42664]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                    No. of       Annual Frequency     Total Annual        Hours per      Total Operating &
               21 CFR Section                    Respondents       per Response         Responses          Response      Maintenance Costs   Total Hours
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101.36(e)                                                   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 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: August 7, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-20299 Filed 8-13-01; 8:45 am]
BILLING CODE 4160-01-S