SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Section
413(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 350b(a)) provides that at least 75 days before the
introduction or delivery for introduction into interstate commerce of
a dietary supplement that contains a new dietary ingredient, a
manufacturer or distributor of dietary supplements or of a new
dietary ingredient is to submit to FDA (as delegate for the Secretary
of Health and Human Services) information upon which the manufacturer
or distributor has based its conclusion that a dietary supplement
containing a new dietary ingredient will reasonably be expected to be
safe. Part 190 (21 CFR part 190) implements these statutory
provisions. Section 190.6(a) requires each manufacturer or
distributor of a dietary supplement containing a new dietary
ingredient, or of a new dietary ingredient, to submit to the Office
of
Nutrition, Labeling, and Dietary Supplements notification of the basis for their conclusion that said supplement or ingredient will reasonably be expected to be safe. Section 190.6(b) requires that the notification include the following: (1) The complete name and address of the manufacturer or distributor, (2) the name of the new dietary ingredient, (3) a description of the dietary supplements that contain the new dietary ingredient, and (4) the history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe.
We request extension of OMB approval for the following information collection requirements contained in §190.6:
21 CFR 190.6 - Reporting
Requires submission of a pre-market notification at least 75 days before a new dietary ingredient or a dietary supplement that contains a new dietary ingredient can be introduced or delivered for introduction into interstate commerce.
2. Purpose
and Use of the Information Collection
The
notification requirements described previously are designed to enable
FDA to monitor the introduction into the food supply of new dietary
ingredients and dietary supplements that contain new dietary
ingredients, in order to protect consumers from unsafe dietary
supplements. FDA uses the information collected under these
regulations to help ensure that a manufacturer or distributor of a
dietary supplement containing a new dietary ingredient is in full
compliance with the act.
3. Use
of Improved Information Technology and Burden Reduction
The
regulation does not prescribe 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. 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 the manufacturer or distributor is
introducing or delivering for introduction into interstate commerce a
new dietary ingredient or a dietary supplement containing such new
dietary ingredient. Therefore, the information being submitted to
the agency will be original for each submission.
5. Impact
on Small Businesses or Other Small Entities
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. To exempt a small business would only
hurt that business since it could not market a dietary ingredient or
a dietary supplement containing such new dietary ingredient. The
agency, however, does have an office of Small Manufacturers
Assistance which may be contacted if help is needed.
6. Consequences
of Collecting the Information Less Frequently
The
information is only collected if a manufacturer or distributor is
introducing or delivering for introduction into interstate commerce a
dietary supplement that contains a new dietary ingredient. If the
collection is not conducted or is conducted less frequently,
manufacturers or distributors of the subject product will not be in
compliance with section 413(a) of the act.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There
are no special circumstances associated with this information
collection.
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 March 26,
2008 (73 FR 16020). No
comments were received.
10. Assurance
of Confidentiality Provided to Respondents
Pursuant to
the provisions of §190.6(e), FDA will not disclose the existence
of, or the information contained in, the new dietary ingredient
notification for 90 days after the filing date. After the 90th
day, all the information in the notification will be placed on public
display in docket number at FDA’s Division of Dockets
Management. However, any information that is trade secret or
otherwise confidential commercial information will not be disclosed
to the public. Confidential commercial information is protected from
disclosure under the Freedom of Information Act (FOIA) under sections
552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the
agency’s regulations (21 CFR part 20).
Table 1.--Estimated Annual Reporting Burden1 |
|||||||
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
|
|
190.6 |
71 |
1 |
71 |
20 |
1,420 |
|
|
12. Estimates
of Annualized Burden Hours and Costs
FDA
estimates the burden of this collection of information as follows:
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the agency is requesting only that information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in full compliance with the act. However, the agency estimates that extracting and summarizing the relevant information from the company's files, and presenting it in a format that will meet the requirements of section 413 of the act will require a burden of approximately 20 hours of work per submission.
The estimated number of premarket notifications and hours per response is an average based on the agency's experience with notifications received during the last three years (i.e., 2005, 2006 and 2007), and information from firms that have submitted recent premarket notifications.
Estimated Annualized Cost for the Burden Hours
FDA estimates the annualized cost to respondents for the hour burden associated with the requirements of this regulation to be approximately $50,637.20. This estimate is based upon an industry employee making a salary equivalent to a GS-12 step 3 level in the locality pay area of Washington-Baltimore at $35.66/hour in 2008 ($35.66/hr x 20 hrs x 71 respondents = $50,637.20).
13. Estimates
of Other Total Annual Cost Burden to Respondents and Record
Keepers
There
are no capital costs or operating and maintenance costs associated
with this collection.
14. Annualized
Cost to Federal
Government
FDA
estimates the staffing burden necessary to review and respond to the
current volume of received notifications for new dietary ingredients
to be 4.5 full-time employees (FTEs) at an average salary of GS-13,
Step 5, in the Washington-Baltimore Locality Pay Area for 2008 (4.5
FTEs x $94,025 = $423,112.50), and approximately half the time of
one supervisory employee at an average salary of GS-14, Step 5 (0.5
FTE x $111,104 = $55,552). Thus, the estimated cost to the
Federal Government is approximately $478,664.50 ($423,112.50 +
$55,552 = $478,664.50). To account for overhead, this cost is
increased by 100 percent, making the total estimated cost to
the Federal Government $957,329.
15. Explanation
for Program Changes or Adjustments
There was no change in the burden estimate..
16. Plans for Tabulation and Publication and Project Time Schedule
The
agency has no plans for publication of information from this
information collection. Pursuant
to the provisions of §190.6(e), FDA will not disclose the
existence of, or the information contained in, the new dietary
ingredient notification for 90 days after the filing date. After the
90th day, all the information in the notification will be placed on
public display in docket number at FDA’s Division of Dockets
Management.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Approval
to not display the expiration date for OMB approval of the
information collection is not being sought.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
No
exceptions are requested.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | DPresley |
| File Modified | 2008-07-09 |
| File Created | 2008-07-09 |