[Federal Register Volume 73, Number 18 (Monday, January 28, 2008)]
[Notices]
[Pages 4875-4877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1362]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0030] (formerly Docket No. 2004D-0466)
Agency Information Collection Activities; Proposed Collection;
Comment Request; Draft Guidance for Industry: Substantiation for
Dietary Supplement Claims Made Under the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the draft guidance entitled ``Guidance for Industry: Substantiation for
Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal
Food, Drug, and Cosmetic Act.''
DATES: Submit written or electronic comments on the collection of
information by March 28, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 before
submitting the collection to OMB for approval. To comply with this
requirement, in the Federal Register of November 9, 2004 (69 FR 64962),
FDA published a notice of availability of the draft guidance document
providing a 60-day public comment period on the collection of
information provisions. Thereafter, in the Federal Register of June 7,
2007 (72 FR 31583), FDA published a 30-day notice responding to
comments on the collection of information provisions received in
response to the November 9, 2004, notice and announcing that the
proposed collection of information had been submitted to OMB. In
response to a request by OMB, FDA is republishing notice of the
proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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
[[Page 4876]]
of automated collection techniques, when appropriate, and other forms
of information technology.
Substantiation for Dietary Supplement Claims Made Under Section
403(r)(6) of the Federal Food, Drug, and Cosmetic Act (OMB Control
Number 0910--NEW)
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary
supplement making a nutritional deficiency, structure/function, or
general well-being claim have substantiation that the statement is
truthful and not misleading. The draft guidance document entitled
``Guidance for Industry: Substantiation for Dietary Supplement Claims
Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic
Act'' is intended to describe the amount, type, and quality of evidence
FDA recommends a dietary supplement manufacturer have to substantiate a
claim under section 403(r)(6) of the act. This draft guidance does not
discuss the types of claims that can be made concerning the effect of a
dietary supplement on the structure or function of the body, nor does
it discuss criteria to determine when a statement about a dietary
supplement is a disease claim. Persons with access to the Internet may
obtain the draft guidance at the following Web site: http://
www.cfsan.fda.gov/~dms/guidance.html. A copy of the draft guidance also
is available for public examination in the Division of Dockets
Management (see ADDRESSES).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
Claim Type Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Widely known, established 667 1 667 44 29,348
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-existing, not widely established 667 1 667 120 80,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
Novel 667 1 667 120 80,040
................. .................... ................. ................. .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 189,428
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dietary supplement manufacturers will only need to collect
information to substantiate their product's nutritional deficiency,
structure/function, or general well-being claim if they chose to place
a claim on their product's label. Gathering evidence on their product's
claim is a one time burden; they collect the necessary substantiating
information for their product as required by section 403(r)(6) of the
act.
The standard discussed in the draft guidance for substantiation of
a claim on the labeling of a dietary supplement is consistent with
standards set by the Federal Trade Commission for dietary supplements
and other health-related products that the claim be based on competent
and reliable scientific evidence. This evidence standard is broad
enough that some dietary supplement manufacturers may only need to
collect peer-reviewed scientific journal articles to substantiate their
claims; other dietary supplement manufacturers whose products have
properties that are less well documented may have to conduct studies to
build a body of evidence to support their claims. It is unlikely that a
dietary supplement manufacturer will attempt to make a claim when the
cost of obtaining the evidence to support the claim outweighs the
benefits of having the claim on the product's label. It is likely that
manufacturers will seek substantiation for their claims in the
scientific literature.
The time it takes to assemble the necessary scientific information
to support their claims depends on the product and the claimed
benefits. If the product is one of several on the market making a
particular claim for which there is adequate publicly available and
widely established evidence supporting the claim, then the time to
gather supporting data will be minimal; if the product is the first of
its kind to make a particular claim or the evidence supporting the
claim is less publicly available or not widely established, then
gathering the appropriate scientific evidence to substantiate the claim
will be more time consuming.
FDA assumes that it will take 44 hours to assemble information
needed to substantiate a claim on a particular dietary supplement when
the claim is widely known and established. We increased this estimated
burden from 1 hour per claim to 44 hours per claim based on information
received from industry, as noted in our June 7, 2007, notice in
response to comment 1 (72 FR 31583 and 31584). FDA believes it will
take closer to 120 hours to assemble supporting scientific information
when the claim is novel or when the claim is pre-existing but the
scientific underpinnings of the claim are not widely established. These
are claims that may be based on emerging science, where conducting
literature searches and understanding the literature takes time. It is
also possible that references for claims made for some dietary
ingredients or dietary supplements may primarily be found in foreign
journals and in foreign languages or in the older, classical literature
where it is not available on computerized literature databases or in
the major scientific reference databases, such as the National Library
of Medicine's literature database, all of which increases the time of
obtaining substantiation.
In the Federal Register of January 6, 2000, FDA published a final
rule on statements made for dietary supplements concerning the effect
of the product on the structure or function of the body (65 FR 1000).
FDA estimated that there were 29,000 dietary supplement products
marketed in the United States (65 FR 1000 at 1045). Assuming that the
flow of new products is 10 percent per year, then 2,900 new dietary
supplement products will come on the market each year. The structure/
function final rule estimated that about 69 percent of dietary
supplements have a claim on their labels, most probably a structure/
function claim (65 FR 1000 at 1046). Therefore, we assume that
supplement manufacturers will need time to assemble the evidence to
substantiate each of the 2,001 claims (2,900 x 69 percent) made each
year. If we assume that the 2,001 claims are
[[Page 4877]]
equally likely to be pre-existing widely established claims, novel
claims, or pre-existing claims that are not widely established, then we
can expect 667 of each of these types of claims to be substantiated per
year. Table 1 of this document shows that the annual burden hours
associated with assembling evidence for claims is 189,428 (the sum of
667 x 44 hours, 667 x 120 hours, and 667 x 120 hours).
There are no capital costs or operating and maintenance costs
associated with this information collection.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: January 18, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1362 Filed 1-25-08; 8:45 am]
BILLING CODE 4160-01-S