[Federal Register Volume 67, Number 125 (Friday, June 28, 2002)]
[Notices]
[Pages 43633-43634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16343]


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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