Premarket Notification for a New Dietary Ingredient

ICR 201311-0910-012

OMB: 0910-0330

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-11-25
IC Document Collections
ICR Details
0910-0330 201311-0910-012
Historical Active 201108-0910-010
HHS/FDA 20818
Premarket Notification for a New Dietary Ingredient
Extension without change of a currently approved collection   No
Regular
Approved without change 02/12/2014
Retrieve Notice of Action (NOA) 11/25/2013
Previous terms of clearance remain in effect. OMB notes that FDA intends to submit a revision to this package to allow for electronic collection "within months." Therefore, this package is approved for a period of one year.
  Inventory as of this Action Requested Previously Approved
02/28/2015 36 Months From Approved 02/28/2014
55 0 55
1,100 0 1,100
0 0 0

This information collection supports the premarket notification requirements for a new dietary ingredient (NDI). Respondents include manufacturers, distributors, packagers, holders, labelers, exporters, and importers of dietary supplements that contain NDIs who must report product information to FDA at least 75 days before an NDI or a dietary supplement that contains an NDI can be introduced or delivered into interstate commerce.

US Code: 21 USC 350b(a) Name of Law: null
  
None

Not associated with rulemaking

  78 FR 52773 08/26/2013
78 FR 69095 11/18/2013
Yes

1
IC Title Form No. Form Name
Reporting - Submission of a 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 55 55 0 0 0 0
Annual Time Burden (Hours) 1,100 1,100 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,330,086
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
11/25/2013


© 2024 OMB.report | Privacy Policy