Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs

ICR 201908-0910-015

OMB: 0910-0667

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-09-11
IC Document Collections
IC ID
Document
Title
Status
207965
Modified
191877
Modified
ICR Details
0910-0667 201908-0910-015
Active 201608-0910-007
HHS/FDA CDER
Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs
Extension without change of a currently approved collection   No
Regular
Approved without change 10/08/2019
Retrieve Notice of Action (NOA) 09/12/2019
  Inventory as of this Action Requested Previously Approved
10/31/2022 36 Months From Approved 10/31/2019
100,138 0 807,145
59,105 0 132,546
194,285 0 0

This information collection supports information collection 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.

US Code: 21 USC 301 et. seq. Name of Law: FFDCA: Positron Emission Tomography Drugs
  
None

Not associated with rulemaking

  83 FR 61653 11/30/2018
84 FR 46540 09/04/2019
Yes

2
IC Title Form No. Form Name
RECORDKEEPING for PET Drugs
3rd PARTY DISCLOSURE: Sterility Test Failure Notices

  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 100,138 807,145 0 0 -707,007 0
Annual Time Burden (Hours) 59,105 132,546 0 0 -73,441 0
Annual Cost Burden (Dollars) 194,285 0 0 0 194,285 0
No
No
The information collection reflects adjustments. Because fewer PET drug batches have been produced at the respective sites, the burden estimate reflects a decrease of 707,007 fewer records and 73,441 fewer hours, which we believe reflects the average burden for all respondents.

$725,000
No
    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.
09/12/2019


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