SUPPORTING STATEMENT
Terms of Clearance: None.
1. Circumstances
Making the Collection of Information Necessary
Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as amended by the FDA Modernization Act of 1997 (FDAMA), provides that any person may 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 U.S. Government or the National Academy of Sciences. Under this section of the FD&C Act, a person that intends to use such a claim must submit a notification of its intention to use the claim 120 days before it begins marketing the product bearing the claim. 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 the notification. The guidance can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm056975.htm.
FDA is requesting extension of OMB approval of these notification procedures and the provisions contained in the guidance entitled, “Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body.”
2. Purpose
and Use of the Information Collection
The
agency believes that the guidance will enable persons to meet the
criteria for notifications that are established in section
403(r)(2)(G) and (r)(3)(C) of the FD&C Act. In addition to the
information specifically required by the FD&C 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
intends to review the notifications the agency receives to ensure
that they comply with the criteria established by the FD&C Act.
Description of Respondents: The respondents include businesses that market food products whose label bears a nutrient content claim or a health claim that is based on an authoritative statement of a scientific body of the U.S. Government or the National Academy of Sciences. Respondents are from the private sector (for-profit businesses).
3. Use
of Improved Information Technology and Burden Reduction
Firms
may submit notifications by e-mail at [email protected].
The agency estimates that fifty percent (50%) of notifications will
be submitted electronically in the next three years.
4. Efforts
to Identify Duplication and Use of Similar Information
FDA
is the only Federal agency with the authority to receive
notifications of claims based on authoritative statements. 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. Impact
on Small Businesses or Other Small Entities
FDA
estimates that ten percent (10 %) of respondents are small
businesses. The same information is requested from large and small
firms and is the minimal amount needed. There is no special burden
placed on small businesses by this regulation. However,
FDA aids small businesses in complying with its requirements through
the agency’s Regional Small Business Representatives and
through the scientific and administrative staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website
at http://www.fda.gov/oc/industry/.
6. Consequences
of Collecting the Information Less Frequently
Data
collection occurs occasionally. 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 FD&C Act and would, therefore, be
misbranded.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
This collection of information does not involve more than quarterly submission of information to the agency, written responses to the agency in less than 30 days, submission of more than an original and 2 copies, retention of records for more than three years, the use of statistical methods, pledges of confidentiality by FDA not supported by authority established in statute or regulation, or require the disclosure of trade secrets or other proprietary information. The collection fully complies with 5 CFR 1320.5(d)(2).
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of August 3, 2011 (76 FR
46819). No comments were received.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Description
of Respondents: The
respondents include businesses that market food products whose label
bears a nutrient content claim or a health claim that is based on an
authoritative statement of a scientific body of the U.S. Government
or the National Academy of Sciences. Respondents are from the
private sector (for-profit businesses).
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1 |
|||||
Section of the FD&C Act |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
403(r)(2)(G) (nutrient content claims) |
1 |
1 |
1 |
250 |
250 |
403(r)(2)(C) (health claims) |
1 |
1 |
1 |
450 |
450 |
Guidance for Notifications |
2 |
1 |
2 |
1 |
2 |
Total |
|
|
|
|
702 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA's experience with health claims, nutrient content claims, and other similar notification procedures that fall under our jurisdiction. To avoid estimating the number of respondents as zero, the agency estimates that there will be one or fewer respondents annually for nutrient content claim and health claim notifications. FDA estimates that it will receive one nutrient content claim notification and one health claim notification per year over the next three years.
Sections 403(r)(2)(G) and 403(r)(3)(C) of the FD&C 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 FD&C 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 U.S. Government or the National Academy of Sciences, FDA believes that the information that is required by the FD&C Act to be submitted with a notification will be readily available to a respondent. However, the respondent will have to collect and assemble that information. Based on communications with firms that have submitted notifications, FDA estimates that one respondent will take 250 hours to collect and assemble the information required by the statute for a nutrient content claim notification. Further, FDA estimates that one respondent will take 450 hours to collect and assemble the information required by the statute for a health claim notification.
Under the guidance, notifications should also contain information on analytical methodology for the nutrient that is the subject of a claim based on an authoritative statement. The guidance applies to both nutrient content claim and health claim notifications. FDA has determined that this information should be readily available to a respondent and, thus, the agency estimates that it will take a respondent 1 hour to incorporate the information into the notification. The agency expects there will be 2 respondents for a total of 2 hours.
12 b. Annualized Cost Burden Estimate
FDA estimates that the annualized cost to respondents for the hour burden associated with the preparation and submission of notifications to be $59,894.64. This estimate is based on the base hourly 2011 rate of a GS-13 salary ($42.66) plus overhead expenses as being equal to salary for a total hourly cost of $85.32 (702 hours x $85.32/hour = $59,894.64).
13. Estimates
of Other Total Annual Costs to Respondents and/or
Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
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 = 2 x 200 = 400 hours; or
Estimated number of notifications = 2
Estimated number of hours for the review and evaluation of notifications = 200
Estimated cost for review and evaluation = $34,128
Total time of 400 hours x $42.66/hour
for review and evaluation (salary) = $17,064
Overhead = $17,064
Total cost (Salary + Overhead) = $34,128
Hourly cost for review and evaluation of the cost to the U.S. government is estimated as being equivalent to that of a GS-13 salary in Washington, DC in 2011. Overhead is estimated as being equal to salary.
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 2,000
hours for each unacceptable notification.
15. Explanation
for Program Changes or Adjustments
As
shown in Table 1, CFSAN has made slight adjustments in the burden
table to update estimates for the number of respondents expected to
submit notifications over the next 3 years. The
changes in the 2011 estimates from the 2008 estimates can be
described as follows.
In 2008, CFSAN estimated that there would be 2 respondents for health claim notifications per year over the next three years. CFSAN did not receive any notifications over that period of time and does not expect that to change over the next three years. To avoid estimating the number of respondents as zero, the agency estimates that there will be one or fewer respondents annually for health claim notifications. Thus, CFSAN changed the estimate from 2 respondents for health claim notifications to 1.
This adjustment also affected the number of respondents for the guidance. Since CFSAN’s estimate for respondents was reduced by one, the estimate for the number of respondents for the guidance is reduced by one as well. Thus, CFSAN changed the estimate from 3 respondents for the guidance to 2.
The total hours for health claim notifications decreased from 900 to 450 hours. The total hours for the guidance decreased from 3 to 2 hours. The total hours for this information collection decreased from 1,153 to 702 hours.
16. Plans for Tabulation and Publication and Project Time Schedule
The
agency has no plans for publication of information from this
information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There
are no reasons why display of the expiration date for OMB approval of
the information collection would be inappropriate.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | DPresley |
| File Modified | 2011-12-09 |
| File Created | 2011-12-09 |