Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 77838-77839 [2011-32025]
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77838
Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
not necessarily indicate the likelihood
of experiencing a health problem; (13)
when a chemical is listed without a
quantity it may mean that a
manufacturer has not yet tested its
products for that chemical; and/or that
a test was conducted but it was not
sensitive enough to measure the amount
of chemical in the product; and/or that
a way to test for that chemical is still
being developed. Unintended
consequences will be assessed by
measuring respondents’ susceptibility to
initiation of tobacco use, motivation and
confidence to quit tobacco use, risk
perceptions about tobacco use, and
emotional reactivity.
understood and not misleading to a lay
person, and is expected to provide
information that may inform Agency
communications about HPHCs. The data
obtained from this study is one factor
that will be used to inform FDA’s
decisionmaking regarding the public
display of the list of HPHCs required
under section 904(d)(1) of the FD&C
Act. By evaluating respondents’
understanding of the concepts listed
previously in this document we do not
intend to imply that consumer
understanding of all concepts is needed
to comply with these requirements.
FDA estimates the burden of this
collection of information as follows:
FDA proposes to conduct an
experimental study with current
smokers aged 15 years and older, former
smokers aged 15 years and older, and
nonsmokers aged between 13 and 25
years who may be susceptible to
initiation of smoking. Data will be
collected from members of an Internet
panel. The study will include an
oversampling of subjects with limited
health literacy. Participation in the
experimental study is voluntary. The
information collected from the study is
necessary to inform the Agency’s efforts
to implement the requirement of the
FD&C Act to place on public display a
list of HPHCs in tobacco products and
tobacco smoke in a format that is
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Pretest ..................................................................................
Screener ...............................................................................
Experimental Survey ............................................................
60
10,000
3,000
1
1
1
60
10,000
3,000
0.5
0.0167
0.5
30
167
1,500
Total ..............................................................................
13,060
........................
........................
........................
1,697
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here. Sixty panel members
will take part in a pretest of the study,
estimated to last 30 minutes (0.5 hours),
for a total of 30 hours. Approximately
10,000 respondents will complete a
screener to determine eligibility for
participation in the study, estimated to
take 1 minute (0.0167 hours), for a total
of 167 hours. Three thousand
respondents will complete the full
study, estimated to last 30 minutes (0.5
hours), for a total of 1,500 hours. The
total estimated burden is 1,697 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
ACTION:
[FR Doc. 2011–32026 Filed 12–13–11; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2011–N–0535]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Notification of a Health Claim
or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body
AGENCY:
Food and Drug Administration,
HHS.
Notice.
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 January 13,
2012.
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) 395–7285, or emailed to
SUMMARY:
PO 00000
Frm 00073
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oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0374. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
3793.
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.
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 Cosmetic
Act (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
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14DEN1
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Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
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.’’ The
guidance 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.
In the Federal Register of August 3,
2011 (76 FR 46819), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses
per
respondent
Number of
respondents
Section of the FD&C Act
Average
burden per
response
Total annual
responses
Total hours
403(r)(2)(G) (nutrient content claims) ..................................
403(r)(2)(C) (health claims) .................................................
Guidance for notifications ....................................................
1
1
2
1
1
1
1
1
2
250
450
1
250
450
2
Total ..............................................................................
........................
........................
........................
........................
702
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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 of
the 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
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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 that
this 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: December 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–32025 Filed 12–13–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Cultural and
Linguistic Competency and Health
Literacy Data Collection Checklist (OMB
No. 0915–xxxx)—[New].
The Health Resources and Services
Administration’s (HRSA) vision is
‘‘Healthy Communities, Healthy
People.’’ In addition, the HRSA mission
statement is ‘‘To improve health and
achieve health equity through access to
quality services, a skilled health
workforce and innovative programs.’’
This framework supports a health care
system that assures access to
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]]>Agencies
[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77838-77839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0535]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Notification of a Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of a Scientific Body
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 January
13, 2012.
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) 395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0374.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, (301) 796-3793.
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.
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
Cosmetic Act (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
[[Page 77839]]
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.'' The guidance 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.
In the Federal Register of August 3, 2011 (76 FR 46819), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Section of the FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
403(r)(2)(G) (nutrient content 1 1 1 250 250
claims)........................
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 of the 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 that this 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: December 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32025 Filed 12-13-11; 8:45 am]
BILLING CODE 4160-01-P
