Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

ICR 201905-0910-004

OMB: 0910-0871

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2019-05-08
Supporting Statement A
2019-05-08
ICR Details
0910-0871 201905-0910-004
Active
HHS/FDA CDER
Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 06/11/2019
Retrieve Notice of Action (NOA) 05/09/2019
The OMB control number, burden statement and expiration date must appear on all instruments associated with this collection.
  Inventory as of this Action Requested Previously Approved
06/30/2022 36 Months From Approved
10,000 0 0
7,250 0 0
0 0 0

FDA has solicited nominations for the 503B bulks list and has received over 200, but these nominations often do not contain substantive information on the current and historical use of these substances in clinical practice to inform FDA’s evaluation. To inform our evaluation of bulk drug substances for inclusion on the 503B bulks list, we have entered into research studies with the University of Maryland (UMD) Center of Excellence in Regulatory Science and Innovation (CERSI) and the Johns Hopkins University (JHU) CERSI. We intend to seek input from the UMD-CERSI and JHU-CERSI on the use of these bulk drug substances in clinical practice by examining their current and historical use in compounding.

None
None

Not associated with rulemaking

  83 FR 46957 09/17/2018
84 FR 20137 05/08/2019
No

3
IC Title Form No. Form Name
UMD-CERSI Expert Focus Groups and Interviews
UMD-CERSI Expert Questionnaire
JHU-CERSI Parent Questionnaire

  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 10,000 0 0 0 10,000 0
Annual Time Burden (Hours) 7,250 0 0 0 7,250 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection.

$29,000
Yes Part B of Supporting Statement
    Yes
    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.
05/09/2019


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