Changes to an Approved Application

ICR 199708-0910-002

OMB: 0910-0315

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
5886
Migrated
ICR Details
0910-0315 199708-0910-002
Historical Active 199601-0910-003
HHS/FDA
Changes to an Approved Application
Revision of a currently approved collection   No
Regular
Approved without change 09/18/1997
Retrieve Notice of Action (NOA) 08/06/1997
  Inventory as of this Action Requested Previously Approved
09/30/2000 09/30/2000 03/31/1999
2,363 0 1,550
100,200 0 58,160
0 0 1,249,280,000

The final rule will allow manufacturers to report changes in product, labeling, production process, quality controls, equipment, facilities, and responsible personnel in different formats depending on the potential of the change to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.

None
None


No

1
IC Title Form No. Form Name
Changes to an Approved Application

  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 2,363 1,550 0 813 0 0
Annual Time Burden (Hours) 100,200 58,160 0 42,040 0 0
Annual Cost Burden (Dollars) 0 1,249,280,000 0 -1,249,280,000 0 0
Yes
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.
08/06/1997


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