Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals

ICR 201109-0910-005

OMB: 0910-0139

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-09-23
ICR Details
0910-0139 201109-0910-005
Historical Active 200809-0910-008
HHS/FDA
Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals
Extension without change of a currently approved collection   No
Regular
Approved without change 04/09/2012
Retrieve Notice of Action (NOA) 09/29/2011
In accordance with 5 CFR 1320, the information collection is approved. The agency is reminded that the type of burden (recordkeeping, reporting, third-party disclosure) should be properly entered in the ROCIS system.
  Inventory as of this Action Requested Previously Approved
04/30/2015 36 Months From Approved 04/30/2012
1,248,727 0 1,174,427
848,625 0 798,132
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 are necessary to 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 CGBP recordkeeping requirements also serve as crucial information if it is necessary to recall a drug product.

US Code: 21 USC 301 Name of Law: FFDCA
  
None

Not associated with rulemaking

  76 FR 31342 05/31/2011
76 FR 60052 09/28/2011
Yes

1
IC Title Form No. Form Name
Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals

  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 1,248,727 1,174,427 0 0 74,300 0
Annual Time Burden (Hours) 848,625 798,132 0 0 50,493 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$45,280,000
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@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.
09/29/2011


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