# SUPPORTING STATEMENT

**NOTIFICATIONS OF A HEALTH CLAIM**

**OR NUTRIENT CONTENT CLAIM BASED ON AN**

**AUTHORITATIVE STATEMENT OF A SCIENTIFIC BODY**

**0910-0374**

**A. JUSTIFICATION**

**1. Necessity of the Information Collection**

The Food and Drug Administration Modernization Act (FDAMA) amended the
Federal Food, Drug, and Cosmetic Act (the act) by adding sections
403(r)(2)(G) and 403(r)(3)(C) (21 U.S.C. 343(r)(2)(G) and 343(r)(3)(C))
(Attachment A). Sections 403(r)(2)(G) and 403(r)(3)(C) of the act
respectively, provide that a firm may market a conventional food product
bearing a label containing 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. Further section
403(r)(2)(G) provides for such nutrient content claims on dietary
supplements. Under these sections of the act, a firm that is intending
to use such a claim must submit a notification of its intention to use
the claim 120 days before it begins marketing a product bearing the
claim.

FDA is requesting OMB approval of an extension of the notification
procedures described in FDA "Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim Based on an Authoritative
Statement of a Scientific Body\" which it published on July 11, 1998 (63
FR 32102). This guidance provides industry with FDA's considerations on
the information that should be in a notification of a health claim or
nutrient content claim based on an authoritative statement, including
instructions on where to submit the notifications, FDA's interpretation
of the various terms used in the two relevant sections of the act, and
instructions on the content of such notifications.

**2. How, by Whom, and for What Purpose Information is Used**

Sections 403(r)(2)(G) and 403(r)(3)(C) of the act specify the
information that is required to be reported in notifications that are
the subject of this guidance as a condition for marketing a product that
bears a label containing a nutrient content claim or health claim based
on an authoritative statement. The information collected allows the FDA
to determine whether the claim complies with the requirements of
sections 403(r)(2)(G) and 403(r)(3)(C) of the act. A claim that does not
comply with these requirements may misbrand a food product bearing such
claims.

**3. Use of Improved Information Technology**

The guidance does not discuss the use of automated, electronic,
mechanical, or other technological techniques or other forms of
information technology by firms. Companies are free to use whatever
forms of information technology may best assist them in developing the
notification.

**4. Identification of Duplication and Similar Information Already
Available**

There is no likelihood of Federal duplication of effort because of the
clear Congressional authorization of FDA jurisdiction pertaining to
notifications of claims based on authoritative statements, as
distinguished from to the jurisdictions of the U.S. Department of
Agriculture (meats and poultry) and the Federal Trade Commission
(advertising).

**5. Small Businesses**

The reporting provisions discussed in the guidance are applicable to all
businesses including small businesses. However, FDA aids small
businesses in dealing with its requirements of the act through the Small
Business Representatives and through the scientific and administrative
staffs within the agency.

**6. Consequences if Data Were Collected Less Frequently and Technical
or Legal Obstacles**

The information is only collected if a firm is preparing to market a
product that bears a label containing a nutrient content claim or health
claim based on an authoritative statement of a scientific body. If the
information is not collected or is collected less frequently, and the
health or nutrient content claim is not otherwise authorized, the
product bearing the claim will not be in compliance with sections 403(r)
of the act and would, therefore, be misbranded. Further, if the
information is not collected or is collected less frequently, there will
be fewer notifications for the agency to review. This poses no direct
consequence to Federal program or policy activities.

**7. Special Circumstances**

Not applicable.

**8. Outside Consultation**

In the Federal Register of March 26, 2002 (67 FR 13786), FDA solicited
comments on this information collection (Attachment B). FDA received one
comment that did not pertain to this information collection.

**9. Gifts or Payment to Respondents**

This information collection does not provide for gifts or payment to
respondents.

**10. Confidentiality**

Sections 403(r)(2)(G) and 403(r)(3)(C) do not provide that information
in a notification based on an authoritative statement will be kept
confidential. However, all information received by FDA is subject to the
agency's regulations concerning confidentiality in 21 CFR 20.61.

**11. Sensitive Questions**

This information collection does not involve any questions of a
sensitive nature.

**12. Respondent Hour Burden and Annualized Burden Hour Costs
Estimates**

[Burden Hours]{.underline}

FDA estimates the burden of this information as follows:

+----------------+----------+---------------+---------+--------+-----+
| Estimated      |          |               |         |        |     |
| Annual         |          |               |         |        |     |
| Reporting      |          |               |         |        |     |
| Burden^1^      |          |               |         |        |     |
+----------------+----------+---------------+---------+--------+-----+
| Basis of       | No. of   | No. Of        | Total   | Hours  | To  |
| Burden         | Res      | Responses per | Annual  | per    | tal |
|                | pondents | Respondent    | Re      | Re     | Ho  |
|                |          |               | sponses | sponse | urs |
+----------------+----------+---------------+---------+--------+-----+
| Section        | 1        | 1             | 1       | 250    | 250 |
| 403(r)(2)(G)   |          |               |         |        |     |
|                |          |               |         |        |     |
| nutrient       |          |               |         |        |     |
| content claims |          |               |         |        |     |
+----------------+----------+---------------+---------+--------+-----+
| Section        | 2        | 1             | 2       | 450    | 900 |
| 403(r)(3)(C)   |          |               |         |        |     |
| health claims  |          |               |         |        |     |
+----------------+----------+---------------+---------+--------+-----+
| Guidance for   | 3        | 1             | 3       | 1      | 3   |
| Notifications  |          |               |         |        |     |
+----------------+----------+---------------+---------+--------+-----+
| Totals         | 3        | 1             | 3       |        | 1   |
|                |          |               |         |        | 153 |
+----------------+----------+---------------+---------+--------+-----+

^1^There are no capital costs or operating and maintenance costs
associated with this collection of information.

Based on FDA's experience in the last three years, FDA estimates that no
more than 3 food producers may submit a notification for a health claim
or nutrient content claim based on an authoritative statement per year.
The agency further estimates that each producer would on average submit
1 such notification.

In this request for extension of an existing collection, the agency is
following its current interpretation of the Paperwork Reduction Act and
is also including in its burden estimate, the burden hours of the
notification process imposed by the statute. The statute requires that
the notification include the exact words of the claim, a copy of the
authoritative statement, a concise description of the basis upon which
such person relied for determining that this is an authoritative
statement as outlined in the statute, and a balanced representation of
the scientific literature relating to the relationship between a
nutrient and a disease or health-related condition to which a health
claim refers or to the nutrient level to which the nutrient content
claim refers. This balanced representation of the scientific literature
is expected to include a bibliography of the scientific literature on
the topic of the claim and a brief, balanced account or analysis of how
this literature either supports or fails to support the authoritative
statement.

Since the claims are based on authoritative statements of a scientific
body of the Federal government or the National Academy of Sciences, FDA
believes that the information that is required by the act to be
submitted with a notification will be readily available to the
producers. However, producers will have to collect and assemble that
information.

Because the burden estimate now includes the time necessary to fulfill
those requirements imposed by the statute, the estimated burden hours
have increased.

FDA arrived at these revised numbers through consultation with two of
the three firms that submitted successful notifications in the past
three years, namely Tropicana Products, Inc. and Central Soya Company,
Inc. It determined that approximately 250 hours are required to complete
the reporting requirements imposed by the statue for nutrient content
claim notifications and approximately 450 hours are required for health
claim notifications. This difference reflects the difference in the type
of information that is the basis of the two types of claims, namely
support for a daily intake level for nutrient content claims versus a
diet disease relationship for health claims.

## Estimated Annualized Cost for the Burden Hours

FDA estimates that the annualized cost to respondents for the hour
burden associated with the preparation and submission of notifications
to be \$66,874. This estimate is based on the base hourly rate of a
GS-13 salary (\$29.00) plus overhead expenses as being equal to salary
for a total hourly cost of \$58.00 (1153 hours x \$58.00/hour =
\$66,874).

**13. Annual Cost Burden to Respondent**

There are no capital costs or operating and maintenance costs associated
with this collection beyond those related to the hour burden for
submitting the notification.

**14. Annualized Cost to the Federal Government**

The annualized cost to the Federal government for the review and
evaluation of notifications is estimated as follows:

### Estimated number of hours per year = 3 x 110 = 330 hours; or

### Estimated number of notifications = 3

#### Estimated number of hours for the review and evaluation of notifications = 110

### Estimated cost for review and evaluation = \$21,120

Total time of 330 hours x \$32.00/hour for review and evaluation
(salary) = \$10,560

Overhead = \$10,560

Total cost (Salary + Overhead) = \$21,120

Hourly cost for review and evaluation of the cost to the Federal
government is estimated as being equivalent to that of a GS-13 salary in
Washington, DC. Overhead is estimated as being equal to salary.

**15. Changes of Adjustments in Burden**

Due to agency policy as understood at the time, the original burden
estimate for the guidance only included the additional burden imposed by
the agency on the notification process. Pursuant to the guidance,
analytical methodology for the nutrients that are the subject of such a
claim should be submitted. The agency determined that this information
should be readily available and should take no longer than 1 hour on
average to incorporate into a notification for submission to the agency.
In this request for extension of an existing collection, the agency is
following its current interpretation of the Paperwork Reduction Act and
is also including in its burden estimate, the burden hours of the
notification process imposed by the statute.

**16. Statistical Analysis, Publication Plans, and Schedule**

There are no plans to publish the information collected under the
provisions of this guidance for statistical use.

**17. Approval Not to Display Expiration Date**

There are no reasons why display of the expiration date for OMB approval
of the information collection would be inappropriate.

**18. Exceptions to Certification Statement**

No exceptions to the certification statement identified in Item 19 of
the instructions for completing OMB Form 83-i have been identified.

**B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS**

This collection of information required under the provisions of this
proposed regulation does not employ statistical methods.