[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69494-69496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0535]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on our 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,

[[Page 69495]]

including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment. This notice 
invites comments on the collection of information associated with the 
submission of notifications of health claims or nutrient content claims 
based on authoritative statements of scientific bodies of the U.S. 
Government.

DATES: Submit either electronic or written comments on the collection 
of information by January 20, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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.

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 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), we 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. We believe 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. We intend to review the notifications we 
receive to ensure that they comply with the criteria established by the 
FD&C Act.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
     Section of the FD&C Act         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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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
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    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 our 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, we estimate that there will be one or fewer 
respondents annually for nutrient content claim and health claim 
notifications. We estimate that we 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.

[[Page 69496]]

    Since the claims are based on authoritative statements of a 
scientific body of the U.S. Government or NAS, we believe 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, we 
estimate that one respondent will take 250 hours to collect and 
assemble the information required by the statute for a nutrient content 
claim notification. Further, we estimate that one 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. We have 
determined that this information should be readily available to a 
respondent and, thus, we estimate that it will take a respondent 1 hour 
to incorporate the information into each notification. We expect there 
will be two respondents for a total of 2 hours.

    Dated: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27517 Filed 11-20-14; 8:45 am]
BILLING CODE 4164-01-P