[Federal Register: June 28, 2002 (Volume 67, Number 125)]
[Notices]
[Page 43633-43634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn02-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0102]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Medical Devices; 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 that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by July
29, 2002.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235,
[[Page 43634]]
Washington, DC 20503, Attn: Stuart Shapiro, Desk Officer for FDA.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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.
In the Federal Register of March 26, 2002 (67 FR 13786), the agency
requested comments on the proposed information collection. One comment
was received that did not pertain to the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1.-- Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual Hours per
Basis of Burden No. of Respondents Response Responses Response Total Hours
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Section 403(r)(2)(G) nutrient content claims ...................... 1 250 250 ..................
Section 403(r)(3)(c) 2 1 2 450 900
Guidance for notifications 3 1 3 1 3
Totals 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: June 21, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16343 Filed 6-27-02; 8:45 am]
BILLING CODE 4160-01-S