Compounding Animal Drugs from Bulk Drug Substances

ICR 202204-0910-005

OMB: 0910-0904

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
202204-0910-005
Received in OIRA
HHS/FDA CVM
Compounding Animal Drugs from Bulk Drug Substances
New collection (Request for a new OMB Control Number)   No
Regular 04/14/2022
  Requested Previously Approved
36 Months From Approved
8,505,000 0
144,585 0
0 0

This information collection accounts for burden that may be attendant to recommendations discussed in FDA guidance applicable to pharmacists and veterinarians who compound animal drugs from bulk drug substances.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  84 FR 64085 11/20/2019
87 FR 22212 04/14/2022
Yes

1
IC Title Form No. Form Name
Documenting rationales by licensed veterinarian/pharmacist compounder

  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 8,505,000 0 0 0 8,505,000 0
Annual Time Burden (Hours) 144,585 0 0 0 144,585 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection.

$0
No
    Yes
    No
No
No
No
No
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.
04/14/2022


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