[Federal Register: August 14, 2001 (Volume 66, Number 157)]
[Notices]
[Page 42663-42664]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14au01-86]
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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