**SUPPORTING STATEMENT**

**Notifications of a Health Claim**

**or Nutrient Content Claim Based on an**

**Authoritative Statement of a Scientific Body**

**OMB No.** **0910-0374 \-- Extension**

**A. JUSTIFICATION**

**1. Necessity of the Information Collection**

Sections 403(r)(2)(G) and 403(r)(3)(C) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 343(r)(2)(G) and 343(r)(3)(C))
(Attachment A), 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 the guidance document entitled, "Guidance for
Industry: Notification of a Health Claim or Nutrient Content Claim Based
on an Authoritative Statement of a Scientific Body\" available at
<http://www.cfsan.fda.gov/guidance.html> . This guidance provides
industry with FDA's recommendations on the information that should be
provided in a notification of a health claim or nutrient content claim
based on an authoritative statement. The guidance also provides industry
with instructions on where to submit the notifications, FDA's
interpretation of the various terms used in the two relevant sections of
the act, and recommendations 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 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 section 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 April 8, 2005 (70 FR 18031), FDA solicited
comments on the information collection. (Attachment B). FDA received one
comment which was not relevant to the 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 that the total annual hour burden for this information
collection is 1153 hours. It may be calculated as follows:

+----------------+----------+---------------+---------+--------+-----+
| Table 1        |          |               |         |        |     |
| Estimated      |          |               |         |        |     |
| Annual         |          |               |         |        |     |
| Reporting      |          |               |         |        |     |
| Burden ^1^     |          |               |         |        |     |
+================+==========+===============+=========+========+=====+
| Section of the | No. of   | No. Of        | Total   | Hours  | To  |
| Act/Basis of   | Res      | Responses per | Annual  | per    | tal |
| Burden         | 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   |
| No             |          |               |         |        |     |
| tifications^2^ |          |               |         |        |     |
+----------------+----------+---------------+---------+--------+-----+
| Totals         | 3        | 1             | 3       |        | 1   |
|                |          |               |         |        | 153 |
+----------------+----------+---------------+---------+--------+-----+

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

^2^ Required for both nutrient content claims and health claims
submissions.

Based on FDA's continued experience, FDA estimates that, annually, no
more than 3 food producers will submit a notification for a health claim
or nutrient content claim based on an authoritative statement of a
scientific body. The agency further estimates that each producer would,
on average, submit 1 such notification.

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 addition, the agency is including in its burden estimate the burden
hours of the notification process imposed by sections 403(r)(2)(G) and
403(r)(3)(C) of the act. These sections of the act require 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 act, 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.

The burden estimate includes the time necessary to fulfill those
requirements imposed by the act.

FDA continues to rely on its determination of the burden hour
established at the time of the last renewal. FDA arrived at these
numbers through consultation with two firms that submitted successful
notifications in the past. 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]{.underline}

FDA estimates that the annualized cost to respondents for the hour
burden associated with the preparation and submission of notifications
to be \$71,486. This estimate is based on the base hourly 2005 rate of a
GS-13 salary (\$31.00) plus overhead expenses as being equal to salary
for a total hourly cost of \$62.00 (1153 hours x \$62.00/hour =
\$71,486).

**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 200 = 600 hours; or

> Estimated number of notifications = 3
>
> Estimated number of hours for the review and evaluation of
> notifications = 200

Estimated cost for review and evaluation = \$43,200

Total time of 600 hours x \$36/hour

> for review and evaluation (salary) = \$21,600
>
> Overhead = \$21,600
>
> Total cost (Salary + Overhead) = \$43,200

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 in 2005. Overhead is estimated as being equal to salary.
This estimate has been increased by 90 hours per application due to
changes in the review process.

Note: Should the notification be determined by the agency to be
unsatisfactory and an acceptable resolution between the notifier and the
agency is not reached, the agency will have the additional burden of
conducting notice and comment rulemaking. This would result in a
substantial increased burden to the agency of approximately 2000 hours
for each unacceptable notification.

**15. Changes of Adjustments in Burden**

This is an extension of a collection of information.

**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.