[Federal Register Volume 63, Number 112 (Thursday, June 11, 1998)]
[Notices]
[Pages 32102-32103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15484]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0320]


Agency Emergency Processing Request Under OMB Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns 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).

DATES: Submit written comments on the collection of information by June 
22, 1998.

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, Washington, DC 20503, Attn: 
Desk Officer for FDA. 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:
    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

[[Page 32103]]

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

    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 market a food 
product whose label bears a nutrient 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.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
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 Burden<SUP>1                                  
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                                                      No. of                                                    
                                      No. of       Responses per   Total Annual      Hours per     Total Annual 
                                    Respondents     Respondent       Responses       Response          Hours    
----------------------------------------------------------------------------------------------------------------
Guidance for Notifications             12               5              60               1              60       
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\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 sections 
403(r)(2)(G) and 403(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.
    FDA has requested emergency processing of this proposed collection 
of information under section 3507(j) of the PRA and 5 CFR 1320.13. The 
information is needed immediately to implement FDAMA, and it is 
essential to the agency's mission of protecting and promoting the 
public health. The use of normal clearance procedures would be likely 
to result in the prevention or disruption of this collection of 
information.

    Dated: June 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15484 Filed 6-10-98; 8:45 am]
BILLING CODE 4160-01-F