[Federal Register Volume 67, Number 58 (Tuesday, March 26, 2002)]
[Notices]
[Pages 13786-13787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0102]


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 May 28, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 Schlosburg, Office of 
Information Resources Management (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 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 extension of 
existing collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary

[[Page 13787]]

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 No. 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 Food and Drug Administration 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 these sections of the act, a 
food producer 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 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 it receives to ensure that they comply with the criteria 
established for them 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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   Basis of                                No. of Responses per      Total Annual     Hours per
    Burden        No. of Respondents            Respondent            Responses       Response      Total Hours
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Section                              1                         1                1      250            250
 403(r)(2)(G)
 nutrient
 content
 claims
Section                              2                         1                2      450            900
 403(r)(3)(C)
 health
 claims
Guidance for                         3                         1                3        1              3
 notification
 s
  Totals                             3                         1                3                   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 
and nutrient content claims and with other similar notification 
procedures that fall under its jurisdiction. Because the claims are 
based on authoritative statements 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: March 19, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7179 Filed 3-25-02; 8:45 am]
BILLING CODE 4160-01-S