[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.

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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, 
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                                 
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                                                      Annual                                                    
                                      No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
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 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