OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

ICR 200809-0910-005 · OMB 0910-0635 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC IDCollectionTypeStatusForm
186733 Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act New
186732 Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act New
ICR Details
0910-0635 200809-0910-005
Historical Active
HHS/FDA
Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 05/29/2009
Retrieve Notice of Action (NOA) 09/26/2008
OMB approves this previously unapproved collection under the following conditions: 1) Since this information was collected without OMB approval, it will need to be reported as a violation in the next ICB. 2) In the future, FDA must correctly identify these types of request in ROCIS as an “existing collection in use without an OMB number” and not as a “new collection.” Otherwise, OMB will return as improperly submitted.
  Inventory as of this Action Requested Previously Approved
05/31/2012 36 Months From Approved
828 0 0
1,490 0 0
0 0 0
The information collection required from dietary supplement manufacturers include submissions of reports of serious adverse events; reports concerning follow-up medical information, and maintenance of records of dietary supplement manufacturers.
US Code: 21 USC 379aa Name of Law: FFDCA
  
US Code: 21 USC 379aa Name of Law: FFDCA
Not associated with rulemaking
Other Documents for OIRA Review
  72 FR 58313 10/15/2007
73 FR 53252 09/15/2008
Yes
  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 828 0 828 0 0 0
Annual Time Burden (Hours) 1,490 0 1,490 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new collection. The increase in reporting and recordkeeping burdens reflect our estimate of the number of serious adverse events related to dietary supplements that would need to be reported to FDA annually; this burden includes any follow-up medical information and the associated recordkeeping regarding the event.
$4,037,752
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto 3018274659
  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.
09/26/2008