Notice: 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

Federal Register: September 25, 2008 (Volume 73, Number 187)            
                  Page 55516-55517

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 October 
27, 2008.

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: 202-395-6974, or e-mailed to baguilar@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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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 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 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

[[Page 55517]]

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.
    In the Federal Register of May 7, 2008 (73 FR 25749), FDA published 
a 60-day notice requesting public comment on the information collection 
provisions. FDA received one letter of comment that was not related to 
the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
 Section of the Act/Basis of       No. of       Annual Frequency   Total Annual      Hours Per
            Burden               Respondents      per Response       Responses       Response       Total Hours
----------------------------------------------------------------------------------------------------------------
403(r)(2)(G) (nutrient                      1                  1               1             250             250
 content claims)
----------------------------------------------------------------------------------------------------------------
403(r)(2)(C) (health claims)                2                  1               2             450             900
----------------------------------------------------------------------------------------------------------------
Guidance for notifications                  3                  1               3               1               3
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,153
----------------------------------------------------------------------------------------------------------------
\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.

    Dated: September 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22636 Filed 9-25-08; 8:45 am]

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