Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities

ICR 202112-0910-003

OMB: 0910-0883

Federal Form Document

IC Document Collections
ICR Details
0910-0883 202112-0910-003
Received in OIRA 202011-0910-008
HHS/FDA CDER
Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
Extension without change of a currently approved collection   No
Regular 01/05/2022
  Requested Previously Approved
36 Months From Approved 01/31/2022
600 600
600 600
0 0

FDA seeks to engage in research to analyze and better understand perspectives on challenges and opportunities faced by outsourcing facilities as they attempt to supply safe, high-quality drug products needed by patients. The Agency currently lacks this information and cannot obtain it from other sources. An electronic survey will be administered to approximately 80 outsourcing facilities to gather information regarding the challenges an opportunities these entities face. The results of this research will be used by FDA to develop a comprehensive understanding of the outsourcing facility sector, its challenges, and opportunities for advancement. The information will be essential to help identify knowledge and information gaps, operational barriers, and views on interactions with FDA. The research results will inform FDA's future approaches to communication, education, training, and other engagement with outsourcing facilities to address challenges and support advancement of the industry in its ability to produce high-quality drug products that are safe for patients.

None
None

Not associated with rulemaking

  86 FR 54450 10/01/2021
87 FR 228 01/04/2022
Yes

1
IC Title Form No. Form Name
Compounding Outsourcing Facilities Survey

  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 600 600 0 0 0 0
Annual Time Burden (Hours) 600 600 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$14,220
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 [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.
01/05/2022


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