Current Good Manufacturing Practices for Positron Emission Tomography Drugs

ICR 201608-0910-007

OMB: 0910-0667

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-08-04
ICR Details
0910-0667 201608-0910-007
Historical Active 201307-0910-007
HHS/FDA CDER
Current Good Manufacturing Practices for Positron Emission Tomography Drugs
Extension without change of a currently approved collection   No
Regular
Approved without change 09/21/2016
Retrieve Notice of Action (NOA) 08/04/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved 09/30/2016
807,145 0 694,402
132,546 0 147,456
0 0 0

This information collection supports recordkeeping requirements under the Current Good Manufacturing Practice regulations for Positron Emission Tomography (PET) drugs. The regulations establish recordkeeping requirements that include: Batch Production and Control Records; Equipment and Facilities Records; Records of Components, Containers, and Closures; Process Vertification; Laboratory Testing Records; Sterility Test Failure Notices; Conditional Final Releases; Out-of-Specification Investigations; Reprocessing Procedures; Distribution Records; and Complaints. The regulations also require 3rd Party Disclosure requirements regarding specific notices. Respondents to the collection are manufacturers of PET drugs.

None
None

Not associated with rulemaking

  80 FR 81332 12/29/2015
81 FR 44876 07/11/2016
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 807,145 694,402 0 112,743 0 0
Annual Time Burden (Hours) 132,546 147,456 0 -14,910 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Individual ICs have been consolidated where appropriate reducing 17 ICs to 2. This is explained more fully in the agency's supporting statement at Q.15.

$725,000
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
08/04/2016


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