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PROPOSED AGENDA Welcome & SOI Update IRT Information & Status Ongoing Public Comment Proceedings Topic 20 \| Application Change Requests (cont’d) Updated Language Discussion Topic 3 \| Applications Assessed in Rounds (cont’d) Updated Language Discussion Topic 23 \| Closed Generics Proposed Language Discussion Upcoming IRT Meetings AOB BACKGROUND DOCUMENTS Topic 3 \| Applications Assessed in Rounds Proposed AGB Language_v04_2024-03-27 Topic 20 \| Application Change Requests Proposed AGB Language_v02_2024-03-27 Topic 23 \| Closed Generics Proposed AGB Language_v01_2024-03-27

Info

PROPOSED AGENDA

Welcome & SOI Update
IRT Information & Status
Ongoing Public Comment Proceedings
Topic 20 | Application Change Requests (cont’d)
1. Updated Language
2. Discussion
Topic 3 | Applications Assessed in Rounds (cont’d)
1. Updated Language
2. Discussion
Topic 23 | Closed Generics
1. Proposed Language
2. Discussion
Upcoming IRT Meetings
AOB

BACKGROUND DOCUMENTS

Topic 3 | Applications Assessed in Rounds
- Proposed AGB Language_v04_2024-03-27
Topic 20 | Application Change Requests
- Proposed AGB Language_v02_2024-03-27
Topic 23 | Closed Generics
- Proposed AGB Language_v01_2024-03-27

Tip

title	PARTICIPATION

Info

title	RECORDINGS

Note

title	ACTION ITEMS

Members to:
1. Update/create SOIs
2. Inform org if they wish to participate in ASP, RSP or RST sub-tracks
Org to:
1. Verify Conflicts of Interest policy for RSP program
2. Update and circulate
  1. The Quick Look Mechanism language
  2. The Objections flowchart
  3. The Application Queuing language
  4. Th Application Change Requests language
  5. The IDNs language
  6. The Applications Assessed in Rounds language
  7. The Closed Generics language