[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11443-11444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04380]


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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; 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) 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 April 
2, 2015.

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

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.

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

[[Page 11444]]

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.
    In the Federal Register of November 21, 2014 (79 FR 69494), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
     Section of the FD&C Act         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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.
    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: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04380 Filed 3-2-15; 8:45 am]
BILLING CODE 4164-01-P