GFI: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities

ICR 201807-0910-006

OMB: 0910-0858

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0858 201807-0910-006
Active
HHS/FDA CDER
GFI: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 08/17/2018
Retrieve Notice of Action (NOA) 07/20/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved
250 0 0
13 0 0
0 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.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  81 FR 96011 12/29/2016
83 FR 32882 07/16/2018
Yes

1
IC Title Form No. Form Name
GFI recommendations re. consultation between prescriber and compounder

  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 250 0 0 0 250 0
Annual Time Burden (Hours) 13 0 0 0 13 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection.

$27,500
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.
07/20/2018


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