[Federal Register Volume 64, Number 83 (Friday, April 30, 1999)]
[Notices]
[Pages 23336-23337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10792]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 (the PRA).

DATES:  Submit written comments on the collection of information by 
June 1, 1999.

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.

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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Notification of a Health Claim or a Nutrient Content Claim Based on 
an Authoritative Statement (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 FDA Modernization Act of 1997, 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 
certain scientific bodies of the Federal Government or of the National 
Academy of Sciences or any of its subdivisions. Under these sections of 
the act, a food producer may use such a claim in the labeling of an 
appropriate product 120 days after a complete notification of the claim 
is submitted to FDA.
     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'' (hereinafter 
referred to as ``the guidance''). As stated in that guidance, under 
section 403(r)(2)(G) and (r)(3)(C) of the act, a notification is to 
include: (1) The exact words used in the claim, (2) a concise 
description of the basis upon which the submitter relied for 
determining that the requirements for an authoritative statement have 
been satisfied, (3) a copy of the statement upon which the submitter 
relied in making the claim, and (4) for a health claim, a balanced 
representation of the scientific literature relating to the 
relationship between a nutrient and a disease or health-related 
condition to which the claim refers, or, for a nutrient content claim, 
a balanced representation of the scientific literature relating to the 
nutrient level to which the claim refers.
    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 such a notification. In addition 
to the information specifically required by the act to be such a 
notification, the guidance states that a notification should also 
contain information on analytical methodology for the nutrient that is 
the subject of a claim based on an authoritative statement. Further, 
the guidance explains that to present a balanced representation of the 
scientific literature, as required by statute, a bibliography of the 
scientific literature on the topic of the claim should be compiled. The 
guidance also states that

[[Page 23337]]

a brief, balanced account or analysis of how this literature either 
supports or fails to support that authoritative statement should be 
submitted.
     The information collection provisions contained in the guidance 
received emergency approval from OMB under control number 0910-0374. 
The emergency approval expires on June 30, 1999. FDA is now seeking an 
extension of the OMB approval.
     As part of this process, the agency requested comments on the 
proposed collection of information in the Federal Register of August 
13, 1998 (63 FR 43400; corrected at 63 FR 49130, September 14, 1998).
    One comment was submitted by a food industry association. This 
comment addressed several points, only some of which were relevant to 
the information collection provisions contained in the guidance. Most 
of the other points were relevant to a group of interim final rules the 
agency issued in June 1998 in response to a notification for nine 
claims based on authoritative statements; these points will be 
addressed in the rulemakings to which they pertain. The points in the 
comment that are relevant to the information collection provisions in 
the guidance are discussed in the following paragraphs.
    The comment first stated that the guidance goes further than 
provided by the statute in two respects: First, in the guidance's 
request that notifications include a ``potentially burdensome'' account 
or analysis of how the scientific literature relating to the 
relationship between a nutrient and a disease or health-related 
condition or to the nutrient level to which the claim refers either 
supports or fails to support the authoritative statement, and second, 
in the guidance's request that information on analytical methodology 
for the nutrient that is the subject of the claim be submitted. The 
comment expressed the opinion that, although the kind of information 
identified by the guidelines may be useful to FDA and could be 
submitted voluntarily, the information should not be a mandatory 
element of a notification; moreover, the lack of such information 
should not be the basis for prohibiting a health claim based on an 
authoritative statement. The comment stated that notifications should 
not impose any significant regulatory burden on manufacturers, adding 
that, as a general matter, it would object to any expansion of 
information required as part of a notification.
    First, the agency notes that neither the account of the scientific 
literature relating to the claim nor the information about analytical 
methodology is described in the guidance as a mandatory element of a 
notification. In both cases, the agency uses the term ``should'' to 
convey its view that the inclusion of such information is desirable. 
Further, the guidance states explicitly, ``An alternative approach may 
be used if such approach satisfies the requirement of the applicable 
statute, regulations, or both. ''
    Second, the agency does not believe that providing the account of 
the relevant scientific information and the analytical methodology are 
overly burdensome. FDA believes that most companies would prepare an 
account of the scientific literature that supports or fails to support 
a claim in the normal course of evaluating potential claims based on 
authoritative statements and making the business decision of whether to 
use such claims in the marketing of their products. Similarly, FDA 
believes that most companies would be knowledgeable about the 
analytical methodologies that might be used to determine the amount of 
a nutrient or other substance present in their products. The agency 
recognizes that including such information in a notification causes 
some burden. The agency provided an estimate of this burden in the 
August 13, 1998, notice. This estimate also appears in Table 1 of this 
document. No comments were submitted addressing the accuracy of this 
estimate.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
Guidance for Notification              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 to implement 
those sections of the act. 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: April 23, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10792 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F