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

ICR 202001-0910-001

OMB: 0910-0883

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0910-0883 202001-0910-001
Active
HHS/FDA CDER
Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/21/2020
Retrieve Notice of Action (NOA) 01/15/2020
  Inventory as of this Action Requested Previously Approved
01/31/2021 36 Months From Approved
600 0 0
600 0 0
0 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

  84 FR 36609 07/29/2019
84 FR 68462 12/16/2019
Yes

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

  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 600 0 0 600 0 0
Annual Time Burden (Hours) 600 0 0 600 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request.

$14,220
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
01/15/2020


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