[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Notices]
[Pages 25749-25750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0272]


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 written or electronic comments on the collection of 
information by July 7, 2008.

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: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration,5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 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 act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as 
amended by the FDA

[[Page 25750]]

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 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 act. In addition to the information 
specifically required by the 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 act.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.-- Estimated Annual Reporting Burden\1\
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                                                   Annual
Section of the Act/Basis of       No. of       Frequency per     Total Annual      Hours Per       Total Hours
           Burden              Respondents        Response        Responses         Response
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403(r)(2)(G) (nutrient                     1                1                1              250              250
 content claims)
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403(r)(2)(C) (health                       2                1                2              450              900
 claims)
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Guidance for notifications                 3                1                3                1                3
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Total                                                                                                      1,153
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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 the agency's jurisdiction. FDA estimates that it will 
receive one nutrient content claim notification and two health claim 
notifications per year.
    Section 403(r)(2)(G) and 403(r)(3)(C) of the 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 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 Federal government or NAS, FDA believes that the 
information that is required by the 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 it will take a respondent 250 hours to collect and 
assemble the information required by the statute for nutrient content 
claim notifications and 450 hours to collect and assemble the 
information required by the statute for health claim notifications.
    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 the notification.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10180 Filed 5-6-08; 8:45 am]
BILLING CODE 4160-01-S