[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]
[Page 25749-25750]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my08-84]
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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