[Federal Register Volume 63, Number 156 (Thursday, August 13, 1998)]
[Notices]
[Pages 43400-43401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21796]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0389]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Notification of a Health Claim or a Nutrient Content
Claim Based on an Authoritative Statement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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,
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 submission of notifications of health claims
or nutrient content claims based on authoritative statements of
scientific bodies. This action is in response to provisions of the FDA
Modernization Act of 1997 (FDAMA). In the Federal Register of August
6, 1998 (63 FR 42053), FDA published a notice announcing OMB's approval
of this collection of information (OMB control number 0910--0374).
Since this was an emergency approval that expires on November 30, 1998,
FDA is following the normal PRA clearance procedures by issuing this
notice.
DATES: Submit written comments on the collection of information by
October 13, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, 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: Margaret R. 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 collection
of information set forth below.
With respect to the following collection of information, FDA
invites comments on: (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.
Notification of a Health Claim or a Nutrient Content Claim Based on
an Authoritative Statement (OMB Control Number 0910-0347--
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 FDAMA, provides that a food producer may
[[Page 43401]]
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 Federal 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.
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 a notification. 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 estimates the burden of this collection of information as
follows:
Table 1.-- Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
Guidance for Notifications 12 5 60 1 60
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The agency believes that this 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 during the interim period while
the agency is initiating notice-and-comment rulemaking in this matter.
FDA intends to review the notifications it receives to ensure that they
comply with the criteria established for them by the act.
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 be either provided as part of the authoritative
statement or readily available to firms wishing to make claims.
The hour burden estimates contained in Table 1 of this document
are for the information collection requests in the guidance only and do
not include statutory requirements specifically mandated by the act.
Dated: August 6, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21796 Filed 8-12-98; 8:45 am]
BILLING CODE 4160-01-F
