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
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)
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 FDAâs 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.
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.
CERSI Compounding PRA SSB 2019.pdf
JHU-CERSI Parent Questionnaire