Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act, 31583-31585 [E7-10911]
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Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
rwilkins on PROD1PC63 with NOTICES
Harmonized System of Classification
and Labeling of Chemicals (GHS), the
EPA, and the European Union hazard
classification systems. NICEATM and
ICCVAM prepared a comprehensive
background review document (BRD) on
each of the four in vitro test methods.
Each BRD included an analysis of test
method performance (i.e., reliability and
relevance) as compared to the in vivo
rabbit eye reference test method, based
on all available data. ICCVAM
developed recommendations on the
usefulness and limitations of these in
vitro test methods for identifying ocular
corrosives/severe irritants after
considering the BRDs, comments
received from the public and the
Scientific Advisory Committee on
Alternative Toxicological Methods
(SACATM), and comments and
recommendations received from an
independent expert panel (Federal
Register Vol. 70, No. 53, pp 13513–
13514, March 21, 2005 and Vol. 70, No.
211, p 66451, November 2, 2005).
ICCVAM is now reviewing the
validation status of these and other in
vitro test methods for identifying
nonsevere ocular irritants (i.e., those
that induce reversible ocular damage)
and non-irritants.
Request for Data
As part of the review process,
NICEATM requests the submission of
data from substances tested for ocular
irritancy in humans, rabbits, and/or in
vitro. Data received by July 23, 2007 will
be compiled and added to the database
maintained by NICEATM and utilized
where appropriate in the evaluation of
in vitro ocular irritation test methods.
Data received after this date will also be
considered and used where applicable
for future evaluation activities. All
information submitted in response to
this notice will be made publicly
available upon request to NICEATM.
When submitting substance and
protocol information/test data, please
reference this Federal Register notice
and provide appropriate contact
information (name, affiliation, mailing
address, phone, fax, e-mail, and
sponsoring organization, as applicable).
NICEATM prefers data to be
submitted as copies of pages from study
notebooks and/or study reports, if
available. Raw data and analyses
available in electronic format may also
be submitted. Each submission for a
substance should preferably include the
following information, as appropriate:
• Common and trade name.
• Chemical Abstracts Service Registry
Number (CASRN).
• Chemical and/or product class.
• Commercial source.
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• In vitro test protocol used.
• Rabbit eye test protocol used.
• Human eye test protocol used.
• Individual animal/human or in
vitro responses at each observation time
(i.e., raw data).
• The extent to which the study
complied with national/international
Good Laboratory Practice (GLP)
guidelines.
• Date and testing organization.
Additional information on the
submission of data may be obtained at
https://iccvam.niehs.nih.gov/methods/
ocutox/ivocutox.htm.
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
federal regulatory and research agencies
that use or generate toxicological
information. ICCVAM conducts
technical evaluations of new, revised,
and alternative methods with regulatory
applicability and promotes the scientific
validation and regulatory acceptance of
toxicological test methods that more
accurately assess the safety and hazards
of chemicals and products and that
refine, reduce, or replace animal use.
The ICCVAM Authorization Act of 2000
(42 U.S.C. 285l–3, available at https://
iccvam.niehs.nih.gov/docs/about_docs/
PL106545.pdf) established ICCVAM as a
permanent interagency committee of the
NIEHS under NICEATM. NICEATM
administers the ICCVAM and provides
scientific and operational support for
ICCVAM-related activities. NICEATM
and ICCVAM work collaboratively to
evaluate new and improved test
methods applicable to the needs of
federal agencies. Additional information
about ICCVAM and NICEATM is
available on the following Web site:
https://iccvam.niehs.nih.gov.
Dated: May 25, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–10966 Filed 6–6–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institution for Occupational
Safety and Health (NIOSH) Advisory
Board on Radiation and Worker Health
(ABRWH or Advisory Board)
Correction: This notice was published
in the Federal Register on May 22,
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31583
2007, Volume 72, Number 98, pages
28697–28698. The meeting was
originally scheduled to be held at the
Westin Westminster Hotel. The
Committee will now convene at the
Sheraton Denver West Hotel, 360 Union
Boulevard, Lakewood, Colorado 80228,
Phone 303.987.2000, Fax 303.969.0263.
Times and Dates:
9 a.m.–5 p.m., June 11, 2007.
8 a.m.–3 p.m., June 12, 2007.
Contact Person for More Information:
Dr. Lewis V. Wade, Executive Secretary,
NIOSH, CDC, 4676 Columbia Parkway,
Cincinnati, Ohio 45226, Telephone
513.533.6825, Fax 513.533.6826.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: May 31, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office Centers for Disease Control
and Prevention.
[FR Doc. E7–10987 Filed 6–6–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0466]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 9,
2007.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974. All comments should be
ADDRESSES:
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Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
identified with the OMB control number
‘‘0910–NEW’’ and title, ‘‘Substantiation
for Dietary Supplement Claims Made
Under Section 403(r)(6) of the Federal
Food, Drug, and Cosmetic Act.’’ Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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 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.
In the Federal Register of November
9, 2004 (69 FR 64962), FDA published
a Notice of Availability of the draft
guidance document with a 60-day
notice requesting public comment on
the collection of information provisions.
We received a number of letters
containing one or more comments,
several of which responded to our
request for comments on the proposed
information collection.
(Comment 1) Several comments
challenged the accuracy of the estimated
number of hours it would take to
prepare the information needed to
substantiate a claim when that claim is
widely known and accepted. We
estimated it would take 1 hour because
supporting material for such claims
should be readily available in textbooks
and reference books. Two comments
asserted that the burden estimate was
too low but did not propose an
alternative estimate or provide
information to support a higher
estimate. One comment did provide
such information. Based on a review of
how long it took to assemble the
supporting information for
approximately 50 claims involving
products containing from 1 to 3 herbs,
the comment stated that, for these
claims, it took 18 to 24 hours to
assemble the supporting information
and an additional 2 to 4 hours to have
a qualified expert review the
information. In addition, the comment
stated that, for products with more
complicated formulations, it took
approximately 40 hours plus the expert
review time to assemble the supporting
information.
(Response) FDA has considered the
information provided in the comment.
Based on this information, we have
increased our estimate of the burden of
preparing the information needed to
substantiate a claim on a dietary
supplement when the claim is widely
known and accepted from 1 hour to 44
hours.
(Comment 2) One comment disagreed
with our statement that there are no
capital, operating, or maintenance costs
associated with this collection of
information. The comment stated that
they use staff support, copying and
scanning equipment, and electronic and
hard copy file storage when preparing
substantiation files. The comment also
stated that there is a capital cost to
maintain a botanical library collection
of historical references and current
scientific journals. Finally, it stated
there is an on-going cost associated with
reviewing scientific literature for new
scientific developments.
(Response) FDA believes that it is
accurate to state that there are no
capital, operating, or maintenance costs
associated with this collection of
information. Collecting the required
information may generate some capital
costs associated with using electronic
equipment such as scanners and
computers and using hard-copy file
cabinets. However, we estimate that this
cost is negligible because most firms
probably already have this equipment,
and the incremental cost of using this
equipment for the purposes described
would be very small. The few firms that
do not own the necessary equipment
could pay for access to scanners and
computers for a minimal charge.
Operating costs for this equipment
would consist of the incremental cost of
electricity for this equipment during the
time it was used for the purposes
described. Maintenance costs for this
equipment would consist of the overall
maintenance costs pro rated for the time
the equipment was used for the
purposes described. Both operating and
maintenance costs would be minimal.
Personnel costs associated with using
this equipment have already been
included as part of the burden hours
that we presented in table 1 of this
document. Further, we do not agree
with the comment’s assertion that a
respondent would need to maintain a
botanical library collection of historical
references and current scientific
journals. It is not necessary for a
respondent to maintain a Botanical
Library in order to access the requested
information. In addition, the guidance
does not recommend the firms
continually update supporting material.
We do not agree that the on-going cost
of reviewing scientific literature for new
scientific developments is a cost of this
information collection. Therefore, FDA
has not changed its assessment that
there are no capital, operating, or
maintenance costs associated with this
collection of information.
FDA estimates the burden for this
information collection as follows:
TABLE 1.—ESTIMATED ANNUAL ONE-TIME REPORTING BURDEN1
No. of
Respondents
rwilkins on PROD1PC63 with NOTICES
Claim type
Annual Frequency
per Response
Total Annual
Responses
Hours per
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
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Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL ONE-TIME REPORTING BURDEN1—Continued
No. of
Respondents
Claim type
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Total
rwilkins on PROD1PC63 with NOTICES
1 There
189,428
are no capital 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
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
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20:59 Jun 06, 2007
Jkt 211001
increased this estimated burden from 1
hour per claim to 44 hours per claim
based on information received from
industry, as noted in our response to
comment 1. 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 final rule on statements made
for dietary supplements concerning the
effect of the product on the structure or
function of the body (structure/function
final rule (65 FR 1000, January 6, 2000)),
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 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).
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Fmt 4703
Sfmt 4703
There are no capital costs or operating
and maintenance costs associated with
this information collection.
Dated: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–10911 Filed 6–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0201]
Determination That CEFOTAN
(Cefotetan Disodium For Injection),
Equivalent 1 Gram Base/Vial and 2
Grams Base/Vial, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that CEFOTAN (cefotetan disodium for
injection), equivalent 1 gram (g) base/
vial and 2 g base/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for cefotetan
disodium for injection, equivalent 1 g
base/vial and 2 g base/vial, if all other
legal and regulatory requirements are
met.
Nam
Kim, Center for Drug Evaluation and
Research (HFD–7), Food and Drug
Administration, 5515 Security Lane,
Rockville, MD 20852, 301–443–5537.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31583-31585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10911]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0466]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July 9,
2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974. All comments should be
[[Page 31584]]
identified with the OMB control number ``0910-NEW'' and title,
``Substantiation for Dietary Supplement Claims Made Under Section
403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' Also include
the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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.
In the Federal Register of November 9, 2004 (69 FR 64962), FDA
published a Notice of Availability of the draft guidance document with
a 60-day notice requesting public comment on the collection of
information provisions. We received a number of letters containing one
or more comments, several of which responded to our request for
comments on the proposed information collection.
(Comment 1) Several comments challenged the accuracy of the
estimated number of hours it would take to prepare the information
needed to substantiate a claim when that claim is widely known and
accepted. We estimated it would take 1 hour because supporting material
for such claims should be readily available in textbooks and reference
books. Two comments asserted that the burden estimate was too low but
did not propose an alternative estimate or provide information to
support a higher estimate. One comment did provide such information.
Based on a review of how long it took to assemble the supporting
information for approximately 50 claims involving products containing
from 1 to 3 herbs, the comment stated that, for these claims, it took
18 to 24 hours to assemble the supporting information and an additional
2 to 4 hours to have a qualified expert review the information. In
addition, the comment stated that, for products with more complicated
formulations, it took approximately 40 hours plus the expert review
time to assemble the supporting information.
(Response) FDA has considered the information provided in the
comment. Based on this information, we have increased our estimate of
the burden of preparing the information needed to substantiate a claim
on a dietary supplement when the claim is widely known and accepted
from 1 hour to 44 hours.
(Comment 2) One comment disagreed with our statement that there are
no capital, operating, or maintenance costs associated with this
collection of information. The comment stated that they use staff
support, copying and scanning equipment, and electronic and hard copy
file storage when preparing substantiation files. The comment also
stated that there is a capital cost to maintain a botanical library
collection of historical references and current scientific journals.
Finally, it stated there is an on-going cost associated with reviewing
scientific literature for new scientific developments.
(Response) FDA believes that it is accurate to state that there are
no capital, operating, or maintenance costs associated with this
collection of information. Collecting the required information may
generate some capital costs associated with using electronic equipment
such as scanners and computers and using hard-copy file cabinets.
However, we estimate that this cost is negligible because most firms
probably already have this equipment, and the incremental cost of using
this equipment for the purposes described would be very small. The few
firms that do not own the necessary equipment could pay for access to
scanners and computers for a minimal charge. Operating costs for this
equipment would consist of the incremental cost of electricity for this
equipment during the time it was used for the purposes described.
Maintenance costs for this equipment would consist of the overall
maintenance costs pro rated for the time the equipment was used for the
purposes described. Both operating and maintenance costs would be
minimal. Personnel costs associated with using this equipment have
already been included as part of the burden hours that we presented in
table 1 of this document. Further, we do not agree with the comment's
assertion that a respondent would need to maintain a botanical library
collection of historical references and current scientific journals. It
is not necessary for a respondent to maintain a Botanical Library in
order to access the requested information. In addition, the guidance
does not recommend the firms continually update supporting material. We
do not agree that the on-going cost of reviewing scientific literature
for new scientific developments is a cost of this information
collection. Therefore, FDA has not changed its assessment that there
are no capital, operating, or maintenance costs associated with this
collection of information.
FDA estimates the burden for this information collection as
follows:
Table 1.--Estimated Annual One-Time Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Claim type Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Widely known, 667 1 667 44 29,348
established
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
[[Page 31585]]
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital 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 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 response to comment 1. 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 final rule on statements made for dietary supplements
concerning the effect of the product on the structure or function of
the body (structure/function final rule (65 FR 1000, January 6, 2000)),
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 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.
Dated: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10911 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S
