Document ID: FDA-2011-N-0535-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry; Health Claim or Nutrient Content Claim Based on Authoritative Statement of Scientific Body
Posted Date: 2011-08-03T04:00Z

[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46819-46820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19601]

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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; 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits 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 October 3, 2011.

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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether

[[Page 46820]]

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 
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), 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.
    FDA estimates 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 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: 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