Current Good Manufacturing Practices for Finished Pharmaceuticals

ICR 201502-0910-014

OMB: 0910-0139

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-03-02
ICR Details
0910-0139 201502-0910-014
Historical Active 201109-0910-005
HHS/FDA CDER
Current Good Manufacturing Practices for Finished Pharmaceuticals
Extension without change of a currently approved collection   No
Regular
Approved without change 05/18/2015
Retrieve Notice of Action (NOA) 03/06/2015
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved 05/31/2015
1,301,095 0 1,248,727
882,203 0 848,625
0 0 0

The CGMP regulations help ensure that drug products meet the statutory requirements for safety and have their purported or represented identity, strength, quality, and purity characteristics. The information collection requirements in the CGMP regulations provide FDA with the necessary information to perform its duty to protect public health and safety. CGMP requirements establish accountability in the manufacturing and processing of drug products, provide for meaningful FDA inspections, and enable manufacturers to improve the quality of drug products over time. The CGMP recordkeeping requirements also serve preventive and remedial purposes and provide crucial information if it is necessary to recall a drug product.

US Code: 21 USC 374 Name of Law: FD&C Act
   US Code: 21 USC 331(f) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  79 FR 66724 11/10/2014
80 FR 10117 02/25/2015
No

  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 1,301,095 1,248,727 0 0 52,368 0
Annual Time Burden (Hours) 882,203 848,625 0 0 33,578 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$77,825,000
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.
03/06/2015


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