Food Labeling; Notification Procedures for Statements on Dietary Supplements
SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
The
Dietary Supplement Health and Education Act (DSHEA) amended the
Federal Food, Drug, and Cosmetic Act (the act) by adding section
403(r)(6) (21 U.S.C. 343(r)(6)), which provides for the notification
of the Secretary (and by delegation the Food and Drug Administration
(FDA)) no later than 30 days after the first marketing of a dietary
supplement product that bears a nutritional support statement on its
label or in its labeling.
Section § 101.93 (21 CFR 101.93) establishes procedures for submitting the required information. Section 101.93 requires submission of a notification to FDA no later than 30 days after first marketing a dietary supplement that bears a statement of nutritional support. Information that is required in the submission includes: (1) The name and address of the manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is being made; (3) the name of the dietary ingredient or supplement that is the subject of the statement; (4) the name of the dietary supplement (including the brand name); and (5) a signature of a responsible individual who can certify the accuracy of the information presented.
This information collection is necessary because the notification from the responsible firm is required by the act in order for the firm to be able to lawfully make a claim pursuant to 21 U.S.C. 343(r)(6) in its labeling.
We request the extension of OMB approval for the following collection of information requirement:
21 CFR 101.93 - Reporting
Requires submission of a notification to FDA no later than 30 days after first marketing a dietary supplement that bears a statement of nutritional support and that the notification be signed by a responsible individual who can certify the accuracy of the information presented.
2. Purpose
and Use of the Information Collection
DSHEA
requires the notifications that are the subject of this regulation.
The notification alerts the FDA that a dietary supplement is being
marketed that bears a nutritional support statement and provides to
FDA the text of the nutritional support statement. FDA utilizes the
information to ensure that statements of nutritional support made by
dietary supplement manufacturers or distributors about their products
comply with section 403(r)(6) of the act.
Description
of Respondents: Respondents to this collection of information
include manufacturers, packers, or distributors of dietary
supplements that bear section 403(r)(6) of the act statements on
their labels or labeling. Respondents are from the private sector
(for profit businesses).
3. Use
of Improved Information Technology and Burden Reduction
The
agency is not equipped to receive these submissions electronically at
this time. Therefore, this information collection will not involve
the use of automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology. FDA
is working diligently to develop the necessary technology
infrastructure to enable it to accept these submissions
electronically in the future. The agency has made progress toward
completion of a Public Key Infrastructure (PKI) capable system that
we expect to enable us to accept these submissions electronically.
Accordingly, FDA has carefully evaluated the nature and regulatory
significance of the submission, in particular the significant legal
consequences attendant to the signing and submitting of the
notification, and request that the agency be authorized to continue
this information collection activity in non-electronic format.
The notification must be signed by a responsible person, and in signing the notice, that person is certifying that the information is accurate and that the firm is in possession of substantiation that the claim that is the subject of the notification is truthful and not misleading. The signatory of the notification is, therefore, assuming potential liability under 18 U.S.C. 1001. Moreover, if the person who signs the notification is, in fact, not a responsible person authorized by the firm to certify that the firm is in compliance with all applicable requirements of the Act, then the submission of a noncompliant notification may also exposure the firm and/or its products to liability under the act.
The notification carries legal implications for the firm and the signatory. Therefore, these documents carry significant risk of repudiation. For this reason, FDA believes that the significant legal consequences attendant to the signature warrant a level of authentication and signer non-repudiation that only digital signatures in a PKI model can currently provide. Because CFSAN lacks that model, but is working with other FDA units toward putting it in place, the agency believes that other forms of electronic submission that the agency might be able to accept present unacceptable risks that provide a basis to not accept these submissions electronically until an acceptable infrastructure is in place.
FDA
estimates that none of the respondents (0%) will use electronic means
to submit the required information.
4. Efforts
to Identify Duplication and Use of Similar Information
The
FDA is the only Federal agency that collects this information. There
are no similar data that can be used or modified for this use. This
notification is only given when a dietary supplement bearing a
nutritional support statement on its label or in its labeling is
marketed. Therefore, the information being submitted to the agency
will be original for each submission.
5. Impact
on Small Businesses or Other Small Entities
FDA
estimates that approximately seventy-five percent (75%) of the
respondents are small businesses. The reporting requirements of this
regulation are mandated by DSHEA and the agency has concluded that
they will not be a burden to small businesses. However, FDA aids
small businesses in dealing with its requirements through the
agency’s Regional Small Business Representatives and through
the scientific and administrative staffs within the agency.
6. Consequences
of Collecting the Information Less Frequently
Respondents
will submit the required information on an occasional basis,
associated with the marketing of their products, as required by
section 403(r)(6) of the act. The information is only collected if a
manufacturer of a dietary supplement is making a statement of
nutritional support on its label or in its labeling. If the
collection is not conducted or is conducted less frequently, the
manufacturers of the dietary supplement making the statement of
nutritional support will not be in compliance with section 403(r)(6)
of the act.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There
are no special circumstances associated with this collection of
information.
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 June 2, 2009 (74 FR 26406).
FDA received two letters in response, each containing one or more
comments. One these letters was received several months after the
close of the comment period. The comments that were timely filed
were outside the scope of the comment request in the notice.
12. Estimates
of Annualized Burden Hours and Costs
12
a. Annualized Hour Burden Estimate
The total estimated hour burden associated with this collection is 1,650 hours annually. The agency believes that there will be minimal burden on industry to generate information to meet the requirements of section 403 of the act in submitting information regarding section 403(r)(6) of the act statements on labels or in labeling of dietary supplements. FDA is requesting only information that is immediately available to the manufacturer, packer, or distributor of the dietary supplement that bears such a statement on its label or in its labeling. FDA estimates that listing the information required by section 403 of the act, and presenting it in a format that will meet the procedures of §101.93, will require a burden of approximately 45 minutes (0.75 hour) per submission. FDA bases its estimate on its experience with similar notification programs. The agency estimates that the manufacturers, packers, or distributors will submit approximately 2,200 notifications a year. This estimate is based on the average number of notification submissions received by the agency in the preceding 12 months.
ESTIMATED ANNUAL REPORTING BURDEN
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
101.93 |
2,200 |
1 |
2,200 |
45/60 |
1,650 |
12 b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of information to be approximately $102,861. FDA estimates that this notification will be prepared by an employee making an average wage similar that of a Federal government employee at the GS-11/Step-3 rate for the Washington-Baltimore locality pay area for the year 2009, which is $31.17 per hour. To account for overhead, this cost is increased by 100 percent, which is $62.34 per hour. Thus, the annual wage cost for completion and submission of these notifications is approximately $102,861 (1,650 hours x $62.34 per hour).
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 information collection.
14. Annualized
Cost to the
Federal Government
The
estimated cost to the Federal government is approximately $17,326.
FDA bases its estimate on the salary of one (1) full-time employee
(FTE) at GS-13, Step 1, in the Washington-Baltimore Locality Pay Area
for the year 2009 who spends an estimated 416 hours (416 hours x
$41.65/hour = $17,326)
15. Explanation
for Program Changes or Adjustments
The estimated burden has decreased from 1,875 hours to 1,650 hours.
This adjustment is the result of a decrease in the estimated number
of respondents from 2,500 to 2,200.
16. Plans for Tabulation and Publication and Project Time Schedule
The
information from this collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB
approval of this 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 | 2010-01-27 |
| File Created | 2010-01-27 |