[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18031-18032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0124]


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 a 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 June 7, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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:  Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 requirement 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 Modernization Act of 1997 (FDAMA), provides that a 
food producer 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. Under this section of the act, a food producer 
that intends to use such

[[Page 18032]]

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 food producers 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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  Section of the
   Act/Basis of          No. of        No. of Responses     Total Annual        Hours per         Total Hours
      Burden          Respondents       per Respondent       Responses           Response
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403(r)(2)(G)                       1                  1                  1                250                250
 (nutrient
 content claims)
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403(r)(3)(C)                       2                  1                  2                450                900
 (health claims)
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Guidance for                       3                  1                  3                  1                  3
 notifications
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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 our jurisdiction. Because the claims are based on an 
authoritative statement of certain scientific bodies of the Federal 
Government or the National Academy of Sciences or one of its 
subdivisions, FDA believes that the information submitted with a 
notification will either be provided as part of the authoritative 
statement, or readily available as part of the scientific literature to 
firms wishing to make claims. Presentation of a supporting bibliography 
and a brief balanced account or analysis of this literature should be 
fairly straightforward.

    Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7024 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S