Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

ICR 202405-0910-002

OMB: 0910-0858

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2024-09-05
ICR Details
0910-0858 202405-0910-002
Received in OIRA 202107-0910-008
HHS/FDA CDER
Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Regular 09/24/2024
  Requested Previously Approved
36 Months From Approved 09/30/2024
2,217 2,123
1,082 968
0 0

This information collection supports FDA guidance regarding compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies, Federal facilities, or other facilities that are not outsourcing facilities and that hold a radioactive materials license for medical use issued by the Nuclear Regulatory Commission or by an Agreement State compounds or repackages radiopharmaceuticals for human use that are not registered as outsourcing facilities. Because these radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to drug production, FDA developed guidance to describe conditions under which the Agency does not intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a state-licensed nuclear pharmacy or a federal facility that is not an outsourcing facility compounds or repackages radiopharmaceuticals for human use.

US Code: 21 USC 353 Name of Law: Federal Food, Drug and Cosmetic Act
  
None

Not associated with rulemaking

  89 FR 49880 06/12/2024
89 FR 77528 09/23/2024
No

  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 2,217 2,123 0 0 94 0
Annual Time Burden (Hours) 1,082 968 0 0 114 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden estimate is adjusted to reflect a resulting increase of 114 hours and 94 responses annually.

$27,500
No
    No
    No
No
No
No
No
Rachel Showalter 202 693-2146 [email protected]

  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.
09/24/2024


© 2024 OMB.report | Privacy Policy