2020-09-30 13:11 :00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Yiannas :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 30 Sep 2020 09:11:00-0400 

It's a big news day w debate, COVID, etc. 

We'll be prepared to reac(. ___________________________________________ J_b )( 5) ________________________________________________ i 

FDA-OC_FOl_2020-6423_004402 
2021-01-19 14:06:48 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Yiannas :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 19 Jan 2021 09:06:48 -0500 

Commissioner, I was exchanging some messages w Heidi on the 21 Forward voices piece. 

FDA-OC_FOl_2020-6423_004403 
2021-01-19 14:07:20 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Yiannas :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 19 Jan 2021 09:07:20 -0500 

Thx 

FDA-OC_FOl_2020-6423_004404 
2021-01-19 14:07:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Yiannas :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 19 Jan 2021 09:07:51 -0500 

[ ________________________________________________________ ( b) ( 5) ________________________________________________________ I 

FDA-OC_FOl_2020-6423_004405 
2020-11-17 14:00:35 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 17 Nov 2020 09:00:35 -0500 

What is the Darian Tarver telecon about? 

FDA-OC_FOl_2020-6423_004406 
2020-11-17 14:04:42 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 17 Nov 2020 09:04:42 -0500 

Checking - Heidi Rebello requested it, confirming with her- but believe hi{ ____________________ (b ){6) ______________________ ! 

FDA-OC_FOl_2020-6423_004407 
2020-11-17 14:16:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 17 Nov 2020 09:16:55 -0500 

Confirmed - Dariani (b)(G) [ •-·-·-·--~~.!.!...J,_,_~·-·-•-T-~•-·-•-·-· L-:;.r·::=::::..£·-~-v:-·:."-:::::::;~-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·. 

l_ ______________________________ (_b )( 6) _______________________________ i 

FDA-OC_FOl_2020-6423_004408 
2020-11-19 17:18:47 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 12:18:47 -0500 

12:30 PM - AMA OWS Vaccine Distribution Briefing for the VP: 

I _________ ( b) (6_) ________ ! 

FDA-OC_FOl_2020-6423_004409 
2020-11-19 18:53:18 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 13:53:18 -0500 

2:00 PM - Birx/Fauci/Redfield/Hahn: 

l _____________________ ( b )( 6) -·-·-·-·-·-·-·-·-·-·-· i 

[Tyler Ann has notified that Birx may be delayed in joining the call, please stay on the line for her - she will join as soon as 

the OWS board meeting wraps] 

FDA-OC_FOl_2020-6423_004410 
2020-11-19 19:14:33 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 14:14:33 -0500 

Binc call is canceled. WHTF was reduced to a small group. 

Your next call with be 4 pm with Sen. Scott. 

FDA-OC_FOl_2020-6423_004411 
2020-11-19 19:15:22 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 14:15:22 -0500 

Okthx 

FDA-OC_FOl_2020-6423_004412 
2020-11-19 22:00:11 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages 1 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 17:00:11 -0500 

5:15 PM - Telecon: Vaccine Alignment and Updates: 

[ _____________________________ ( b) ( 6) ·-·-·-·-·-·-·-·-·-·-·-·-·__j 

FDA-OC_FOl_2020-6423_004413 
2020-11-20 14:28:20 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 20 Nov 2020 09:28:20 -0500 

9:30 AM - Telecon Check-In: PREPP Initiative: 

I _________________________ ( b) ( 6 ) _________________________ I 

FDA-OC_FOl_2020-6423_004414 
2020-11-20 15:00:55 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 20 Nov 2020 10:00:55 -0500 

10:10 AM - Telecon: Birx/Hahn: 

Dr. Birx will call your mobile 

FDA-OC_FOl_2020-6423_004415 
2020-11-20 18:13:28 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 20 Nov 2020 13:13:28 -0500 

1 :30 PM - OWS Check-In with the Commissioner and COS: 

l ____________________________ ( b) ( 6) ·-·-·-·-·-·-·-·-·-·-·-·-·__j 

FDA-OC_FOl_2020-6423_004416 
2020-12-01 19:39:17 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 14:39:17 -0500 

3:00 PM - White House Coronavirus Taskforce Meeting: 

Watchfloor to call your FDA cell 15 to 10 mins before (approx 2:45/2:50 PM) 

FDA-OC_FOl_2020-6423_004417 
2020-12-01 19:41 :48 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 14:41 :48 -0500 

Thx 

FDA-OC_FOl_2020-6423_004418 
2020-12-07 19:12:04 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 07 Dec 2020 14:12:04 -0500 

2:30 PM - White House Coronavirus Taskforce Meeting: 

Watchfloor to call your FDA cell 15 to 10 mins before (approx 2: 15/2:20 PM) 

FDA-OC_FOl_2020-6423_004419 
2020-12-07 19:12:15 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 07 Dec 2020 14:12:15 -0500 

Thx 

FDA-OC_FOl_2020-6423_004420 
2020-12-07 20:19:34 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 07 Dec 2020 15:19:34 -0500 

3:30 PM - Discussion with Federation of American Hospitals about COVID issues facing hospitals: 

Zoom link at the top of your inbox 

FDA-OC_FOl_2020-6423_004421 
2020-12-11 00:30:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 10 Dec 2020 19:30:12 -0500 

7:40 PM - Post-VRBPAC Meeting *SH to Join for Final 20 mins*: 

+ 1-21 o-795-oso( _______ J~J!.~L _______ i 

FDA-OC_FOl_2020-6423_004422 
2020-12-31 18:30:04 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 31 Dec 2020 13:30:04 -0500 

1 :45 PM - Birx/Fauci/Hahn/Redfield: 

[ ________________________________ ( b )_( 6) _______________________________ ] 

FDA-OC_FOl_2020-6423_004423 
2021-01-05 18:26:56 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 Jan 2021 13:26:56 -0500 

1 :30 PM - Birx/Fauci/Hahn/Adams/Giroir: 

I ____________________________ ( b )_ ( 6) ·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_004424 
2021-01-05 18:32:44 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 Jan 2021 13:32:44 -0500 

You will be dropping of this Birx call at 2 pm (early, ends at 2:30) to join CVM - TAM was notified. Then you will drop off 

the CVM All Hands (your only video of the day) at 2:15 (they are also aware, invite was until 2:30), to join the WHTF at 

2:15. 

FDA-OC_FOl_2020-6423_004425 
2021-01-0519:17:41 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 Jan 2021 14:17:41 -0500 

2:15 PM -WHTF: 

If the watch floor has not already called to connect you, they can be reached at: 

L_ ________ ( b )( 6) ·-·-·-·-· i 

FDA-OC_FOl_2020-6423_004426 
2021-01-07 15:30:44 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 07 Jan 2021 10:30:44 -0500 

10:45 AM - Vaccine Distribution Briefing: 

1-888-396-9087, J, ( b )( 6) I 

i·-·-·-·-·-·-·-·-·-·-·-· 

(Materials just came in for this meeting, putting them at the top of your inbox now) 

FDA-OC_FOl_2020-6423_004427 
2021-01-07 16:15:08 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 07 Jan 2021 11:15:08-0500 

11 :30 AM - Birx/Fauci/Hahn/Adams/Giroir: 

l _______________________________ ( b) ( 6) _______________________________ ! 

FDA-OC_FOl_2020-6423_004428 
2021-01-08 20:01 :52 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 08 Jan 2021 15:01 :52 -0500 

Binc is on - apologies on the delay in the text. 

FDA-OC_FOl_2020-6423_004429 
2021-01-08 20:02:14 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 08 Jan 2021 15:02:14 -0500 

Notified you will be on shortly, Redfield or Fauci are not on. 

FDA-OC_FOl_2020-6423_004430 
2021-01-08 20:02:44 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 08 Jan 2021 15:02:44 -0500 

Sorry, it is not Binc on - it is Seema. 

FDA-OC_FOl_2020-6423_004431 
2021-01-12 16:45:42 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 11 :45:42 -0500 

The WH would like you, or a staff member to dial in 10 mins before the 2 pm Governors call. Nick Alexander will dial in, in 

advance, and call you at 1 :58 pm to connect you to the governors call. 

I will text you closer to 2 pm to remind you. 

FDA-OC_FOl_2020-6423_004432 
2021-01-12 17:00:25 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 12:00:25 -0500 

I can call in instead of Nick 

FDA-OC_FOl_2020-6423_004433 
2021-01-12 17:01 :40 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 12:01 :40 -0500 

Are you able to dial in 10 mins ahead of time? You'll be on a stakeholder call, and if we let Nick dial in first and conference 

you in, he can listen in (otherwise he cannot). 

FDA-OC_FOl_2020-6423_004434 
2021-01-12 17:02:48 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 12:02:48 -0500 

Ok for Nick to do so 

FDA-OC_FOl_2020-6423_004435 
2021-01-12 17:03:21 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 12:03:21 -0500 

Copy! Thank you. 

FDA-OC_FOl_2020-6423_004436 
2021-01-1218:01:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12Jan202113:01:12-0500 

1 :15 pm - Discussion with Pediatric Stakeholder Groups on COVID-19 Vaccines & Emergency Use Authorization: 

1-888-81o-47961:_ (b )( 6) __ i 

FDA-OC_FOl_2020-6423_004437 
2021-01-12 18:04:26 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 13:04:26 -0500 

If you have a moment to text me when you hang up the pediatric call, please do and I'll alert Nick - otherwise he will call at 

1 :58. But he did ask to let us know if you hang up before that. 

FDA-OC_FOl_2020-6423_004438 
2021-01-12 18:07:00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 13:07:00 -0500 

Liked "If you have a moment to text me when you hang up the pediatric call, please do and I'll alert Nick - otherwise he 

will call at 1 :58. But he did ask to let us know if you hang up before that." 

FDA-OC_FOl_2020-6423_004439 
2021-01-12 18:50:03 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

To: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 13:50:03 -0500 

I'm off the pediatric call 

FDA-OC_FOl_2020-6423_004440 
2021-01-12 18:50:20 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 12 Jan 2021 13:50:20 -0500 

Thx 

FDA-OC_FOl_2020-6423_004441 
2021-01-15 20:02:26 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 15 Jan 2021 15:02:26 -0500 

Redfield and Verma were confirmed today, to be dialing in. They should be joining any moment. 

FDA-OC_FOl_2020-6423_004442 
2021-01-19 18:45:38 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}tsf"-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 19 Jan 2021 13:45:38 -0500 

WHTF is to begin at 2:00 PM: 

WHSR to call your mobile 

FDA-OC_FOl_2020-6423_004443 
2020-06-08 19:24:58 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 08 Jun 2020 15:24:58 -0400 

Yes 

FDA-OC_FOl_2020-6423_004920 
2020-06-22 22:10:24 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 22 Jun 2020 18:10:24 -0400 

We are moving forward with the EO submission pass back to HHS that is due COB today. 

Also, CBER's vaccine guidance has cleareid_O.P_and.OCC~_We_are_oojna..to.Jlaa..for.AnandJn.case._b.e_wantsJo...lo.ok.aUL. ___ _ 

before we keeQ it movinq forward to HHS. L ,-----------------·-·-·-·-·-·-·-·-·-·-·-·-·~---·-·-·-·-· (b)(S) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·~----·-·-·-·-·-~----·-·-·-·-·-·-·--·i 

:_ _________________________________________________________ ( b )( s) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i Than ks! 

FDA-OC_FOl_2020-6423_004921 
2020-06-22 22:51 :06 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 22 Jun 2020 18:51:06-0400 

Could you show EO to Anand and let me review the vaccine guidance? 

FDA-OC_FOl_2020-6423_004922 
2020-06-22 23:00:28 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 22 Jun 2020 19:00:28-0400 

Yes on both fronts 

FDA-OC_FOl_2020-6423_004923 
2020-06-23 00:13:53 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 22 Jun 2020 20:13:53-0400 

Tyx 

FDA-OC_FOl_2020-6423_004924 
2020-06-26 16:41 :49 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 12:41:49-0400 

Vaccine guidance now at OIRA, one step closer 

FDA-OC_FOl_2020-6423_004925 
2020-06-26 16:44:47 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 12:44:47 -0400 

Great. Thanks. Did you give Satya a heads up? 

FDA-OC_FOl_2020-6423_004926 
2020-06-26 16:45:03 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 12:45:03 -0400 

Already done 

FDA-OC_FOl_2020-6423_004927 
2020-06-26 16:45:09 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 12:45:09 -0400 

Thx 

FDA-OC_FOl_2020-6423_004928 
2020-06-26 16:45:19 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 12:45:19 -0400 

Yep 

FDA-OC_FOl_2020-6423_004929 
2020-06-26 20:40:58 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 16:40:58 -0400 

Steve we are putting a quick call together on a timely matter you need to know about 

FDA-OC_FOl_2020-6423_004930 
2020-06-26 20:41 :01 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 16:41 :01 -0400 

Regarding vaccine guidance 

FDA-OC_FOl_2020-6423_004931 
2020-06-26 20:57:33 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 16:57:33 -0400 

Hold that Peter just said there was a late breaking development negating the need for a call 

FDA-OC_FOl_2020-6423_004932 
2020-06-26 21 :00:09 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 17:00:09 -0400 

Excellent 

FDA-OC_FOl_2020-6423_004933 
2020-06-26 21 :02:52 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 17:02:52 -0400 

Just saw this 

FDA-OC_FOl_2020-6423_004934 
2020-06-26 21 :02:54 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 17:02:54 -0400 

Thx 

FDA-OC_FOl_2020-6423_004935 
2020-06-26 21 :04:28 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 17:04:28 -0400 

! ____________________ (_b )(_5) ____________________ ! 

FDA-OC_FOl_2020-6423_004936 
2020-06-26 21 :04:39 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 17:04:39 -0400 

Amazing team effort! 

FDA-OC_FOl_2020-6423_004937 
2020-06-26 22:22:32 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 18:22:32 -0400 

CBD guidance is with hhs now. We hit the timeline of getting it out of fda by cob today. Thanks! 

FDA-OC_FOl_2020-6423_004938 
2020-06-26 23:04:49 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 26 Jun 2020 19:04:49 -0400 

Liked "CBD guidance is with hhs now. We hit the timeline of getting it out of fda by cob today. Thanks! " 

FDA-OC_FOl_2020-6423_004939 
2020-06-29 16:00:04 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:00:04 -0400 

Just got OIRA's comments back on the guidance 

FDA-OC_FOl_2020-6423_004940 
2020-06-29 16:00:22 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:00:22 -0400 

The team is following up ASAP 

FDA-OC_FOl_2020-6423_004941 
2020-06-29 16:00:34 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:00:34 -0400 

Good news. 

FDA-OC_FOl_2020-6423_004942 
2020-06-29 16:00:37 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:00:37 -0400 

Ok to publish tomorrow? 

FDA-OC_FOl_2020-6423_004943 
2020-06-29 16:00:54 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:00:54 -0400 

Won't know until we finish scrubbing the comments 

FDA-OC_FOl_2020-6423_004944 
2020-06-29 16:01 :05 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:01 :05 -0400 

Will update as soon as we have a more definitive read 

FDA-OC_FOl_2020-6423_004945 
2020-06-29 16:01 :18 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:01:18-0400 

Okthx 

FDA-OC_FOl_2020-6423_004946 
2020-06-29 16:06:29 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:06:29-0400 

Just did a quick skim. Looking good. Will keep you posted. 

FDA-OC _FOl_2020-6423_00494 7 
2020-06-29 16:07:04 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 12:07:04 -0400 

Liked "Just did a quick skim. Looking good. Will keep you posted. " 

FDA-OC_FOl_2020-6423_004948 
2020-06-29 20:05:07 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 16:05:07 -0400 

We are a go for posting tomorrow am. Incredible team effort. 

FDA-OC_FOl_2020-6423_004949 
2020-06-29 20:12:33 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 29 Jun 2020 16:12:33 -0400 

Liked "We are a go for posting tomorrow am. Incredible team effort." 

FDA-OC_FOl_2020-6423_004950 
2020-07-10 14:41 :48 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 10 Jul 2020 10:41 :48 -0400 

Steve, we did a call with Anand and Jeet this morning. Oplia is pulling the regulator country data to hand off to them and CBER/CDER to contextualize. We also ave them related back round r·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-i>·-·s·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·: 

["-·-·-·-·-·-·-·-·-·-·1iiiisi"-·-·-·-·-·-·-·-·-·-·1•m rateful thei are leading on the follgw up offfifs·i:fssigfi"frienrgfvJ·n~~e-oorfcu"frenfponcf·-·' 

priority work OPLIA is going lull steam on. We will continue to advise and comment on what,.they produce _as_optior,s . accordingJy, but _really g_lad _they_ are_ leadin_g _ _given_ the_ clinical significance of this discussion.l_ __________________ (b)(5) ·-·-·-·-·-·-·-·-·-.! 

i_·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-( b) ( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-___: 

FDA-OC_FOl_2020-6423_004951 
2020-09-19 13:27:02 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 19 Sep 2020 09:27:02 -0400 

EUA vaccine guidance is now back with HHS. Went back this morning. 

FDA-OC_FOl_2020-6423_004952 
2020-09-19 13:27:46 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 19 Sep 2020 09:27:46 -0400 

Thx 

FDA-OC_FOl_2020-6423_004953 
2020-09-19 13:28:02 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 19 Sep 2020 09:28:02 -0400 

l·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-( b) ( 5) _·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_004954 
2020-09-19 13:29:43 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 19 Sep 2020 09:29:43 -0400 

Yes. 

FDA-OC_FOl_2020-6423_004955 
2020-09-19 13:30:19 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 19 Sep 2020 09:30:19 -0400 

I will forward you both the passback so you have the latest as well. 

FDA-OC_FOl_2020-6423_004956 
2020-09-19 13:34:04 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 19 Sep 2020 09:34:04 -0400 

Thx 

FDA-OC_FOl_2020-6423_004957 
2020-09-19 13:34:32 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 19 Sep 2020 09:34:32 -0400 

Great and thanks 

FDA-OC_FOl_2020-6423_004958 
2020-09-21 18:17:37 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 21 Sep 2020 14:17:37 -0400 

Good news 

FDA-OC_FOl_2020-6423_004959 
2020-09-22 12:21 :18 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 08:21 :18 -0400 

Bob cleared EUA guidance with our language intact? 

FDA-OC_FOl_2020-6423_004960 
2020-09-22 12:21 :56 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 08:21 :56 -0400 

That is my understanding. 

FDA-OC_FOl_2020-6423_004961 
2020-09-22 12:24:30 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 08:24:30 -0400 

Yes 

FDA-OC_FOl_2020-6423_004962 
2020-09-22 12:24:52 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 08:24:52 -0400 

I separately confirmed with CBER to make sure we were 100% clear 

FDA-OC_FOl_2020-6423_004963 
2020-09-22 12:34:08 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 08:34:08 -0400 

Liked "I separately confirmed with CBER to make sure we were 100% clear'' 

FDA-OC_FOl_2020-6423_004964 
2020-09-22 13:13:26 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 09:13:26 -0400 

This is not the forum for this discussion.! ___________________________ (b )( 5) ________________________ ___! 

FDA-OC_FOl_2020-6423_004965 
2020-09-22 13:13:44 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 09:13:44 -0400 

Agreed. 

FDA-OC_FOl_2020-6423_004966 
2020-09-22 13:13:50 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 09:13:50 -0400 

Agreed 

FDA-OC_FOl_2020-6423_004967 
2020-09-22 13:59:41 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 09:59:41 -0400 

That was very disheartening to hear about the guidance. 

FDA-OC_FOl_2020-6423_004968 
2020-09-22 14:00:40 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:00:40 -0400 

For sure 

FDA-OC_FOl_2020-6423_004969 
2020-09-22 14:02:22 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:02:22 -0400 

Guidance went to!__ __________________________________________________________________________________________ (b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_004970 
2020-09-22 14:04:47 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:04:47 -0400 

! ____ (b )( 5) _ ___! 

FDA-OC_FOl_2020-6423_004971 
2020-09-22 14:05:49 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:05:49 -0400 

Because tony brought up yesterday the issue ofj ___________________________________________________________ (b )( 5) __________________________________________________________ i 

FDA-OC_FOl_2020-6423_004972 
2020-09-22 14:06:14 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:06:14 -0400 

I'm confirming with hhs exec sec 

FDA-OC_FOl_2020-6423_004973 
2020-09-22 14:06:38 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:06:38 -0400 

Tony Fauci on the HHS prep call for the Help hearing 

FDA-OC _FOl_2020-6423_00497 4 
2020-09-22 14:07:41 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:07:41 -0400 

I {b){5) ! 

L---·-·-·-·-·-·-·-·-•-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· 

FDA-OC_FOl_2020-6423_004975 
2020-09-22 14:08:06 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:08:06 -0400 

Okthx 

FDA-OC_FOl_2020-6423_004976 
2020-09-22 14:10:49 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:10:49 -0400 

Peter does a nice job briefing ama 

FDA-OC_FOl_2020-6423_004977 
2020-09-22 14:11 :13 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10: 11: 13 -0400 

Agreed 

FDA-OC_FOl_2020-6423_004978 
2020-09-22 14:19:03 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:19:03 -0400 

It went out more broadly. I am trying to get the distribution list from exec exec. It went to their covid 19 distribution list and 

I'm trying to get the list of offices on that distribution. 

FDA-OC_FOl_2020-6423_004979 
2020-09-22 14:19:42 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:19:42 -0400 

Ok 

FDA-OC_FOl_2020-6423_004980 
2020-09-22 14:29:11 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:29:11 -0400 

The distribution was extensive. It went to NIH. 

FDA-OC_FOl_2020-6423_004981 
2020-09-22 14:31 :30 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 22 Sep 2020 10:31 :30 -0400 

Makes me feel a little better. 

FDA-OC_FOl_2020-6423_004982 
2020-09-24 11 :28:38 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Sep 2020 07:28:38 -0400 

When should I expect the 1 pager. I'd like to get back to Brad ASAP 

FDA-OC_FOl_2020-6423_004983 
2020-09-24 11 :33:12 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Sep 2020 07:33:12 -0400 

Will check in with Peter now. 

FDA-OC_FOl_2020-6423_004984 
2020-09-24 11 :44:07 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Sep 2020 07:44:07 -0400 

He said it will be ready shortly. 

FDA-OC_FOl_2020-6423_004985 
2020-09-24 11 :51 :35 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Sep 2020 07:51 :35 -0400 

Sir, Peter outlined what he is pulling together in his morning update. If there is anything else you need pis highlight for 

him. 

FDA-OC_FOl_2020-6423_004986 
2020-09-24 11 :53:25 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Sep 2020 07:53:25 -0400 

That's correct. Call me? 

FDA-OC_FOl_2020-6423_004987 
2020-09-28 14:17:23 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Mon, 28 Sep 2020 10:17:23-0400 

Steve, FDA IGA staff is going to cover the covid tribal consultations. After seeing more details from the dept, this 

approach is a better fit. Thanks! 

FDA-OC_FOl_2020-6423_004988 
2020-10-06 18:13:45 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 06 Oct 2020 14:13:45 -0400 

Guidance is now live 

FDA-OC_FOl_2020-6423_004989 
2020-10-06 18:15:02 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 06 Oct 2020 14:15:02 -0400 

Excellent 

FDA-OC_FOl_2020-6423_004990 
2020-10-08 13:42:49 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 09:42:49 -0400 

Why are we seeing an uptick internally on guidances? 

FDA-OC_FOl_2020-6423_004991 
2020-10-08 14:21 :42 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 10:21 :42 -0400 

The centers are working on their various items on their respective timelines and they ended up coming forward 

concurrently, which is consistent with the general ebb and flow on guidances we see, including on COVID. 

FDA-OC_FOl_2020-6423_004992 
2020-10-08 14:38:08 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 10:38:08 -0400 

Okthx 

FDA-OC_FOl_2020-6423_004993 
2020-10-08 18:11 :36 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 14:11 :36 -0400 

! Steve, __ I . strongly recommend i ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- (bH SJ -·-·-·-·-·-·-·-· ( b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-.l._·_·: 

c~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~: ( b) ( 5) ~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:fl"h an "ks. ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· . 

FDA-OC_FOl_2020-6423_004994 
2020-10-08 18:17:42 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 14:17:42 -0400 

Ok let's do that. Can someone ask Anand? 

FDA-OC_FOl_2020-6423_004995 
2020-10-08 18:23:37 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 14:23:37 -0400 

Anna, you go this or need me to check with Anand? 

FDA-OC_FOl_2020-6423_004996 
2020-10-08 18:24:15 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 14:24:15 -0400 

No, IGA is handling. Nick is teaching out tonhim. 

FDA-OC_FOl_2020-6423_004997 
2020-10-08 18:24:27 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 14:24:27 -0400 

Thx 

FDA-OC_FOl_2020-6423_004998 
2020-10-08 18:24:52 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 14:24:52 -0400 

Oops, reaching out to him. 

FDA-OC_FOl_2020-6423_004999 
2020-10-08 18:34:52 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 14:34:52 -0400 

Yes, our FDA IGA team (Nick) is following up with him. Thanks! 

FDA-OC_FOl_2020-6423_005000 
2020-10-08 20:11 :43 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 16: 11 :43 -0400 

Steve, keagan and I connected and I wanted to flag that CBER felt strongly about doing the NGA outreach tomorrow so 

Peter will now be covering. This is an FDA- NGA dialogue, no hhs or WH involvement. Didn't want you surprised if this 

came up with Peter. Thanks! 

FDA-OC_FOl_2020-6423_005001 
2020-10-08 20:12:21 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 08 Oct 2020 16:12:21 -0400 

Ok 

FDA-OC_FOl_2020-6423_005002 
2020-08-21 14:17:08 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Anand Shah [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 10:17:08 -0400 

Henry Walke at CDC is the contact. 

!._ _______ ( b) ( 6) _________ i 

FDA-OC_FOl_2020-6423_005003 
2020-08-21 14:19:24 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 10:19:24 -0400 

Thx. Anand, let's try and get this buttoned up before SH lands. Send the compromise language around before the 

proposed 5:30 call with Birx. 

FDA-OC_FOl_2020-6423_005004 
2020-08-21 14:53:10 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 10:53:10 -0400 

We will try 

FDA-OC_FOl_2020-6423_005005 
2020-08-21 15:06:07 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 11 :06:07 -0400 

Just spoke w cdc Henry and he is going to send me language ASAP to review 

FDA-OC_FOl_2020-6423_005006 
2020-08-21 15:08:28 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 11:08:28-0400 

Great. Thanks, Anand. 

FDA-OC_FOl_2020-6423_005007 
2020-08-21 18:16:17 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Anand Shah [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 14:16:17 -0400 

Thx Anand. Appreciate your follow up on this. Were you able to touch base with Brett? 

FDA-OC_FOl_2020-6423_005008 
2020-08-21 18:37:45 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 14:37:45 -0400 

~ 

Jrt spokeh~i~h BrettH He is satisfJ.~5:l__~i1b_'!'v..~EilfEil_'!'v..8-__ ~1,!_~r:_9-~_!ly __ ?.r.~_'!'v..i!b.J=AQ __ ?.!1_q _ _guidanc~ ~nd fTels we h~ve le~ned in 

p enty on t 1s issue. e suggests: ___________________________________________ J~H~L._ ______________________________________ _j •• once ave anguage ram enry, we 

will stitch it all together and get it done 

FDA-OC_FOl_2020-6423_005009 
2020-08-21 18:56:52 UTC: i (b)(G) i Messages -> 

i (b)(6) ! Messages, i (b)(6) j Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Anand Shah [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 21 Aug 2020 14:56:52 -0400 

Excellent work. I've spoken to Birx and Giroir. I think we're good but we'll see 

FDA-OC_FOl_2020-6423_005010 
2020-06-25 16:47:45 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [4 

recipients] 

From: Karas Gross [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 25 Jun 2020 12:47:45 -0400 

.·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· ! i 

I {b){S) I ! i 

L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· 

FDA-OC_FOl_2020-6423_005011 
2020-06-25 17:26:21 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [4 

recipients] 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 25 Jun 2020 13:26:21 -0400 

Yes 

FDA-OC_FOl_2020-6423_005012 
2020-06-25 17: 31 : 17 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [ 4 

recipients] 

From: Karas Gross [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 25 Jun 2020 13:31:17 -0400 

Great-thanks. 

FDA-OC_FOl_2020-6423_005013 
2020-07-08 12:05:48 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [4 

recipients] 

From: Maren McBride [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Wed, 08 Jul 2020 08:05:48 -0400 

~--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-. 

I (b)(S) ! 

!-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·l 

FDA-OC_FOl_2020-6423_005014 
2020-07-08 12: 12: 18 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [ 4 

recipients] 

From: Karas Gross [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Wed, 08 Jul 2020 08:12:18 -0400 

Maren, I'm talking to Dr. Hahn at 9: 15 before the call, so I'll patch you in to join us. 

FDA-OC_FOl_2020-6423_005015 
2020-07-08 12: 19: 32 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [ 4 

recipients] 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Wed, 08 Jul 2020 08:19:32 -0400 

Sounds good to me 

FDA-OC_FOl_2020-6423_005016 
2020-07-08 13: 15:28 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [4 

recipients] 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Wed, 08 Jul 2020 09:15:28 -0400 

Do we have a call in? 

FDA-OC_FOl_2020-6423_005017 
2020-07-09 19: 52: 32 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [ 4 

recipients] 

From: Maren McBride [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 09 Jul 2020 15:52:32 -0400 

(b)(5) 

FDA-OC_FOl_2020-6423_005018 
2020-07-09 19:52:51 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [4 

recipients] 

From: Maren McBride [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 09 Jul 2020 15:52:51 -0400 

Full summary of bill, report and markup coming shortly 

FDA-OC_FOl_2020-6423_005019 
2020-07-09 19:56:44 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [4 

recipients] 

From: Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Maren McBride [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 09 Jul 2020 15:56:44 -0400 

Thx! 

FDA-OC_FOl_2020-6423_005020 
2020-07-09 19:58:29 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [4 

recipients] 

From: Ann K. Abram [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Karas Gross [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 09 Jul 2020 15:58:29 -0400 

. Thank.Y.nu for flaaainaL. ______________________________________________________________________________________ (b)(5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·•-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·i 

i (b)(S) !Let's discuss at our L--nexrcrrecK-1rrain:neam: -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_005021 
2020-07-16 16:40:38 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [4 

recipients] 

From: Karas Gross [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 16 Jul 2020 12:40:38 -0400 

Hi Dr. Hahn-! (b)(5) i I may offer Dr. Shu'ren·-o"f"Sfiali"ffrsroutWanno-makEfsffre·yo"u"Wc:fulan'rp·refeflcfac;-TcTfian1<sr-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-' 

FDA-OC_FOl_2020-6423_005022 
2020-07-16 20: 14:51 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [4 

recipients] 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 16 Jul 2020 16:14:51 -0400 

Ok either way 

FDA-OC_FOl_2020-6423_005023 
2020-07-23 14: 03: 11 UT C: [ _____________________________ ___( b )( s ) ________________________________ ! Messages -> [ 4 

recipients] 

From: Maren McBride [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 23 Jul 2020 10:03:11 -0400 

Senate R covid bill- doesn't include any funding for FDA. Not a surprise be I'm told it's just the starting Place For the 

negotiations of a final package but wanted you to be aware. I'll keep you posted 

FDA-OC_FOl_2020-6423_005024 
2020-07-23 15: 38: 50 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [ 4 

recipients] 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Ann K. Abram [:::::::::j~i(sf::::::::J messages">, Karas Gross [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, 

Maren McBride [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 23 Jul 2020 11:38:50 -0400 

Thx 

FDA-OC_FOl_2020-6423_005025