Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

ICR 202103-0910-004

OMB: 0910-0409

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0409 202103-0910-004
Received in OIRA 201804-0910-006
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Extension without change of a currently approved collection   No
Regular 04/14/2021
  Requested Previously Approved
36 Months From Approved 05/31/2021
15 2
18,750 4,000
0 0

This information collection supports agency regulations at 21 CFR 315.4, 315.5, and 315.6. The regulations require manufacturers of diagnostic radiopharmaceuticals to submit certain information demonstrating safety and effectiveness of these products.

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
   US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act

Not associated with rulemaking

  85 FR 71923 11/12/2020
86 FR 19622 04/14/2021

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

  Total Request 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 15 2 0 0 13 0
Annual Time Burden (Hours) 18,750 4,000 0 0 14,750 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Our estimated burden for the information collection reflects an overall increase of 14,750 hours and a corresponding increase of 13 responses, including submissions involving NDAs, which we mentioned in our last information collection and supplement to approved NDAs, which we are now mentioning in this information collection. We attribute this adjustment to an increase in the number of submissions for NDAs for diagnostic radiopharmaceuticals we received over the past few years and because we are now capturing supplements to approved NDA for diagnostic radiopharmaceuticals.

Domini Bean 301 796-5733 [email protected]


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.

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