Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports

ICR 201311-0910-001

OMB: 0910-0758

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-11-04
ICR Details
0910-0758 201311-0910-001
Historical Active
HHS/FDA 20836
Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/27/2014
Retrieve Notice of Action (NOA) 11/06/2013
  Inventory as of this Action Requested Previously Approved
01/31/2017 36 Months From Approved
2,876 0 0
286,150 0 0
0 0 0

The information collection pertains to the types of CMC postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality (i.e., drug product identity, strength, quality, purity, or potency), and therefore, should be documented by applicants in an annual report under 21 CFR 314.70(d).

None
None

Not associated with rulemaking

  75 FR 36421 06/25/2010
78 FR 65667 11/01/2013
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 2,876 0 0 2,876 0 0
Annual Time Burden (Hours) 286,150 0 0 286,150 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new collection

$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
11/06/2013


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