Premarket Notification for a New Dietary Ingredient

ICR 199905-0910-001

OMB: 0910-0330

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5912
Migrated
ICR Details
0910-0330 199905-0910-001
Historical Active 199609-0910-003
HHS/FDA
Premarket Notification for a New Dietary Ingredient
Extension without change of a currently approved collection   No
Regular
Approved without change 07/01/1999
Retrieve Notice of Action (NOA) 05/04/1999
  Inventory as of this Action Requested Previously Approved
07/31/2002 07/31/2002 10/31/1999
1 0 1
220 0 120
0 0 0

The reporting requirements of this regulation implement the Dietary Supplement Health and Education Act. The subject regulation establishes reporting procedures necessary to submit to FDA the information on which a manufacturer or distributor of a dietary supplement that contains a new dietary ingredient has concluded that the dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

None
None


No

1
IC Title Form No. Form Name
Premarket Notification for a New Dietary Ingredient

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1 1 0 0 0 0
Annual Time Burden (Hours) 220 120 0 0 100 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
05/04/1999


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