Document ID: FDA-2011-N-0535-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for 
Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
Posted Date: 2011-12-14T05:00Z

[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77838-77839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32025]

-----------------------------------------------------------------------

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; 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.

-----------------------------------------------------------------------

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 January 
13, 2012.

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

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.

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

[[Page 77839]]

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.
    In the Federal Register of August 3, 2011 (76 FR 46819), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Section of the FD&C Act         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             702
----------------------------------------------------------------------------------------------------------------
\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: December 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32025 Filed 12-13-11; 8:45 am]
BILLING CODE 4160-01-P