Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

ICR 201501-0910-002

OMB: 0910-0409

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-01-06
IC Document Collections
ICR Details
0910-0409 201501-0910-002
Historical Active 201110-0910-003
HHS/FDA CDER
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Extension without change of a currently approved collection   No
Regular
Approved without change 04/06/2015
Retrieve Notice of Action (NOA) 01/08/2015
  Inventory as of this Action Requested Previously Approved
04/30/2018 36 Months From Approved 04/30/2015
2 0 2
4,000 0 4,000
0 0 0

21 CFR 315.4, 315.5, and 315.6 require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical or of a new indication for use of an approved diagnostic radiopharmaceutical.

US Code: 21 USC 355 Name of Law: FD&C Act
   PL: Pub.L. 105 - 115 122 Name of Law: FDA Modernization Act of 1997
   US Code: 42 USC 262 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  79 FR 42337 07/21/2014
79 FR 78443 12/30/2014
No

1
IC Title Form No. Form Name
In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

  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 2 0 0 0 0
Annual Time Burden (Hours) 4,000 4,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$5,500,000
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.
01/08/2015


© 2024 OMB.report | Privacy Policy