[Federal Register: March 26, 2002 (Volume 67, Number 58)]
[Notices]
[Page 13786-13787]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr02-58]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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