Justification Memo

“Surveys CDER Small Business and Industry Assistance (SBIA) Soliciting Feedback on Conferences”

(OMB Control Number 0910-0697)

CHANGE REQUEST (83-C)

Date: July 21, 2015

The Food and Drug Administration Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance Program (SBIA) is requesting a non-substantive change to 0910-0697 to add one question to this approval. This question will enable SBIA to add a focus group to its collection of data at its upcoming REdI Conference. The information collected during the 9 participant focus group will help CDER SBIA better serve the small pharmaceutical business community. CDER SBIA needs additional information from small pharmaceutical companies seeking approvals from the FDA in order to better gauge how well current CDER SBIA programs are fulfilling their needs and to better determine which communications channels are the most efficient and effective to reach them with announcements and updates about upcoming support opportunities.

Question to be added:

“At the September 29 – 30, 2015 Conference, would you be available and willing to participate in an in-person, two-hour focus group?

Yes
No

**The CDER SBIA focus group will take place from 5-7 PM on the first afternoon of the Conference. Individual and company names of those selected for the focus group will be kept confidential. CDER SBIA will select participants from among those who indicate they are available and willing to participate in a focus group at the Conference.”