Federal Register, Volume 76, Number 149, August 3, 2011, Pages 46595-47054 Page: 46,820
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Federal Register/Vol. 76, No. 149/Wednesday, August 3, 2011 /Notices
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.
Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of
a Scientific Body-(OMB Control
Number 0910-0374)-Extension
Section 403(r)(2)(G) and (r)(3)(C) of
the Federal Food, Drug and CosmeticAct (the FD&C Act) (21 U.S.C.
343(r)(2)(G) and (r)(3)(C)), as amended
by the FDA Modernization Act of 1997,
provides that any person may market a
food product whose label bears a
nutrient content claim or a health claim
that is based on an authoritative
statement of a scientific body of the U.S.
Government or the National Academy of
Sciences (NAS). Under this section of
the FD&C Act, a person that intends to
use such a claim must submit a
notification of its intention to use the
claim 120 days before it begins
marketing the product bearing the
claim. In the Federal Register of June
11, 1998 (63 FR 32102), FDA announced
the availability of a guidance entitled
"Guidance for Industry: Notification of
a Health Claim or Nutrient Content
Claim Based on an Authoritative
Statement of a Scientific Body." Theguidance provides the Agency's
interpretation of terms central to the
submission of a notification and the
Agency's views on the information that
should be included in the notification.
The Agency believes that the guidance
will enable persons to meet the criteria
for notifications that are established in
section 403(r)(2)(G) and (r)(3)(C) of the
FD&C Act. In addition to the
information specifically required by the
FD&C Act to be in such notifications,
the guidance states that the notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. FDA intends
to review the notifications the Agency
receives to ensure that they comply with
the criteria established by the FD&C Act.
FDA estimates the burden of this
collection of information as follows:TABLE 1-ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Number of Total annual Average
Section of the FD&C Actresponses per on burden per Total hours
Section of the FD&C Act respondents respondent response response
403(r)(2)(G) (nutrient content claims) ...........................1 1 1 250 250
403(r)(2)(C) (health claims) .................................1 1 1 450 450
Guidance for Notifications ..................................2 1 2 1 2
Total .............................................................................. .............................. ........................702
1 There are no capital costs or operating and maintenance costs associated with this collection of information.These estimates are based on FDA's
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
our jurisdiction. To avoid estimating the
number of respondents as zero, the
Agency estimates that there will be one
or fewer respondents annually for
nutrient content claim and health claim
notifications. FDA estimates that it will
receive one nutrient content claim
notification and one health claim
notification per year over the next 3
years.
Section 403(r)(2)(G) and (r)(3)(C) of
the FD&C Act requires that the
notification include the exact words of
the claim, a copy of the authoritative
statement, a concise description of the
basis upon which such person relied for
determining that this is an authoritative
statement as outlined in the FD&C Act,
and a balanced representation of the
scientific literature relating to the
relationship between a nutrient and a
disease or health-related condition to
which a health claim refers or to the
nutrient level to which the nutrient
content claim refers. This balanced
representation of the scientific literature
is expected to include a bibliography of
the scientific literature on the topic ofthe claim and a brief, balanced account
or analysis of how this literature either
supports or fails to support the
authoritative statement.
Since the claims are based on
authoritative statements of a scientific
body of the U.S. Government or NAS,
FDA believes that the information that
is required by the FD&C Act to be
submitted with a notification will be
readily available to a respondent.
However, the respondent will have to
collect and assemble that information.
Based on communications with firms
that have submitted notifications, FDA
estimates that 1 respondent will take
250 hours to collect and assemble the
information required by the statute for
a nutrient content claim notification.
Further, FDA estimates that 1
respondent will take 450 hours to
collect and assemble the information
required by the statute for a health claim
notification.
Under the guidance, notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. The
guidance applies to both nutrient
content claim and health claim
notifications. FDA has determined thatthis information should be readily
available to a respondent and, thus, the
Agency estimates that it will take a
respondent 1 hour to incorporate the
information into each notification. The
Agency expects there will be 2
respondents for a total of 2 hours.
Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19601 Filed 8-2-11; 8:45 am]
BILLING CODE 4160-01-P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0513]
Proposal To Refuse To Approve a
Supplemental New Drug Application
for Bromday (Bromfenac Ophthalmic
Solution), 0.09%; Opportunity for a
Hearing
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA), the Director of46820
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United States. Office of the Federal Register. Federal Register, Volume 76, Number 149, August 3, 2011, Pages 46595-47054, periodical, August 3, 2011; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc52326/m1/234/: accessed April 25, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.