From: 

Sent: 

To: 

CC: 

Subject: 

Amin, Stacy [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=CB3764B7438648838C22881A06FC6AFB-STACY.AMIN] 

3/20/2020 11:11:23 AM 

Schiller, Lowell [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77949b06919e4f9 laa 788e9a616c50c7-Lowel I .Sch i]; Lenihan, Keaga n 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Shah, Anand 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Tierney, Ju Ii a 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern] 

Shah, Anand [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=e2172ebbd96946c08e189fd612855f51-Anand.Shah]; Guram, Jeet 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =ef73bea97 e2b4 77b84 7 ea302c4 7 30ccf-G u rjeet.G u r] 

RE: COVID-19 request for assistance re: human convalescent plasma (HCP) therapy -- on behalf of Baylor College of 

Medicine and Johns Hopkins University 

Commissioner has asked us to route these requests to Anand. He has a team tracking them and prioritizing them. I like 

to copy Jeet as well b/c Anand is in meetings all day. 

From: Schiller, Lowell <Lowell.Schiller@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:05 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; 

Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Subject: FW: COVID-19 request for assistance re: human convalescent plasma (HCP) therapy -- on behalf of Baylor 

College of Medicine and Johns Hopkins University 

Thoughts on this request? 

From: Stephen Northrup <snorthrup@rampynorthrup.com> 

Sent: Friday, March 20, 2020 10:59 AM 

To: Anna Abram <anna abram@help.senate.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Schiller, Lowell 

<Lowell.Schiller@fda.hhs.gov> 

Cc: Cybele Bjorklund <cbjorklund@jhu.edu>; Herb Butrum <butrum@bcm.edu>; Christopher Austin 

<chris.austin@jhu.edu> 

Subject: COVID-19 request for assistance re: human convalescent plasma (HCP) therapy -- on behalf of Baylor College of 

Medicine and Johns Hopkins University 

Anna, Keagan, Lowell -- I'm writing on behalf of Dr. Peter Hotez at Baylor College of Medicine and Dr. Arturo Casadevall 

at Johns Hopkins University about their efforts to advance human convalescent plasma (HCP) as a therapeutic option for 

the COVID-19 pandemic. I've copied Cybele Bjorklund and Chris Austin at JHU and also Herb Butrum at BCM. 

You're familiar with this option, I'm sure, considering Commissioner Hahn's comments yesterday. 

You may also know that JHU submitted an IND that arrived this morning at FDA, and there are close to 20 leading 

institutions now involved in the discussions about HCP therapy across the USA. These are all institutions of national 

significance, including Johns Hopkins University, Baylor College of Medicine, Duke University, Einstein Medical Center, 

Mayo Clinic, Michigan State University, University of Maryland, Loyola University Chicago, University of California, 

FDA-OSJI-FOIA-2020-3541_00001267 
University of Washington, Massachusetts General Hospital, Children's Hospital of Philadelphia, University of Pittsburgh, 

Cedars-Sinai Medical Center, and Stanford University 

Ors. Hotez and Casadevall have asked us to contact people in the senior agency leadership to make you aware of this 

effort, to ensure that Commissioner Hahn is aware of this effort, and to identify someone at a senior level who might be 

willing to be a stand-by source of assistance and guidance for them. 

I thought one of you might be able to identify the right person or people who could be that go-to resource. 

Please advise as to how you would recommend proceeding, and thanks for your attention to this request and for 

everything you are doing right now to fight this pandemic. 

A detailed article on this effort is pasted below, from the Milwaukee Journal-Sentinel. 

Best regards, 

Steve 

Stephen Northrup 

Rampy }'fo_

tlbJJH! LLC _ 

mobile:l__ _______ (b)(6) _________ : 

https://www.jsonline.com/story/news/2020/03/ l 8/coronavirus-treatment-emer bency-clinical-trial s-plasmarequested/2865766001/ 

Possible coronavirus treatment could be in 

clinical trials within weeks, using plasma from 

recovered patients, if doctors get FDA approval 

Mark JohnsonUpdated 6:55 p.m. CT March 18, 2020 

The Johns Hopkins University doctor coordinating a nationwide effort to launch emergency clinical 

trials of plasma from patients who've recovered from coronavirus said he expects to forward a plan 

to the U.S. Food & Drug Administration Wednesday and to sta11 treating the first patients in about four 

weeks. 

"We are in an emergency and this is the only thing we have," said Arturo Casadevall, chairman of 

Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health in 

Baltimore. 

"This won't help patients who are sick today, but it will help the patients who become sick in the next 

two to five weeks," he said. 

The time frame he described would still allow hospitals to begin testing the possible treatment before 

the new coronavirus peaks in the U.S., possibly a few months from now. Transfusions of plasma from 

FDA-OSJI-FOIA-2020-3541_00001268 
recovered patients carry potential side effects, including fever, allergic reaction and a very small risk of 

infectious disease transmission. 

Casadevall said the centers that take part in the clinical trial will need approval from both the FDA and 

their own institutional review boards, groups established to protect the rights of human research 

subjects. 

Treating people with plasma from a recovered patient was first used more than a century ago to save a 

child with diphtheria and has since been used to stifle numerous outbreaks of disease. The process 

would involve taking plasma, rich in virus-fighting antibodies, from patients who have recovered from 

COVID-19. That plasma would then be transfused into patients who are still sick with the disease. 

Casadevall and Liise-anne Pirofski, of the Albert Einstein College of Medicine in New York, triggered 

the push for clinical trials when they co-authored a paper published Friday in The Journal of Clinical 

Investigation. The two urged "that institutions consider the emergency use ( of plasma from recovered 

patients) and begin preparations as soon as possible. Time is of the essence." 

On Tuesday, Pirofski told the Milwaukee Journal Sentinel: "The need for this is dire. One day for those 

involved (in caring for the sick) is like a year." 

Pirofski, chief of the division of infectious diseases at Montefiore Medical Center - the teaching 

hospital associated with Einstein College - which consists of 11 hospitals, described the situation 

where she works: 

"Monday we had ( a total of) 18 patients in our center, all very sick. Today we have 10 new patients." 

She described doctors coping with shortages of basic supplies and feeling overwhelmed, experiences 

echoed by other medical staff working in viral hot spots around the world. 

"There is no personal protective equipment anywhere," she said. "We are running out. We took all of 

our medical students off the ward to avoid using up PP Es ... It's just demoralizing and there is no end in 

sight." 

She said doctors have two possible paths they can follow in using plasma from recovered patients. 

They can test it in clinical trials. They can also use it as an experimental "compassionate use" treatment 

for some of the sickest patients, as was done during the 2009 swine flu, the 2013 West African Ebola 

epidemic, and the early stages of the COVID-19 outbreak in China. 

"It's been used in China but there is just one small press release on it," Pirofski said. "We have not seen 

that data. We're all very anxious to see the results." 

100 to 150 patients, divided in half 

Experimental use would require that doctors find recovered COVID-19 patients with high antibody 

levels who are willing to serve as donors. Antibodies are blood proteins that are made by the body's 

immune system in response to bacteria, viruses and other foreign invaders. 

Casadevall said he favors starting clinical trials of plasma from recovered patients, rather than using it 

experimentally. 

Although plasma from recovered patients has been used to quell outbreaks of poliomyelitis, measles, 

mumps and influenza, the plasma of a COVID-19 survivor is something new. FDA would consider 

FDA-OSJI-FOIA-2020-3541_00001269 
that plasma an investigational drug, meaning that it has been tested in the lab and is ready to be tested 

in people. 

Survivor plasma, Pirofski said, "has not been ( extensively tested) for this disease before, and the 

compound we'd be getting is new." 

The basic setup for a clinical trial could involve 100 to 150 COVID-19 patients with half 

receiving serum from recovered patients, and the other half serving as a control group and receiving 

serum from patients who have never had COVID-19. 

Casadevall said the trials could be used to test different groups who have been infected with the virus. 

One trial would test the use of survivor plasma on people who have been exposed to virus - likely 

doctors, nurses, emergency room staff and other first-responders. This group would include family 

members who have been at home caring for a loved one with COVID-19. 

A second test of survivor plasma would involve patients who have been hospitalized with COVID-19, 

and are continuing to grow sicker. 

A third test would involve severely ill COVID-19 patients. 

Each of these tests has the potential to answer a different question: 

• Can the plasma from recovered patients be used to prevent someone who has been exposed from 

coming down with the illness? 

• Does the plasma have the ability to reverse the course of a patient whose health is declining? 

• Can the plasma rescue a patient who has reached a very late stage of the illness? 

"This is a good story in the midst of terrible news," said Casadevall, explaining how the paper he wrote 

with Pirofski led to the impromptu formation of a network of more than 100 doctors across the 

country. 

The doctors have been discussing ways of collaborating to launch clinical trials of what appears to be 

the most immediate hope for treating COVID-19 patients. Various centers are being discussed as 

possible sites for the trials. The New York Blood Center is also partnering on the project, said 

Casadevall. 

"If Johns Hopkins is ready to go, we'd very interested to see what they find," said Jeff Pothof, chief 

quality officer at UW Health in Madison. "I think we should do it quickly." 

Casadevall agreed. 

With a growing number of health care workers contracting the disease, "they're beginning to see the 

collapse of the healthcare system," he said. 

"The problem in the U.S. is that something like this has never happened. In 1918 (during the Spanish 

flu) there was no FDA. There was no Centers of Disease Control and Prevention." 

Casadevall urged the federal government to designate a point person for COVID-19 who would be 

knowledgeable enough to help hospitals and cities overcome logistical and other hurdles. 

For example, he said, "Say Milwaukee needs serum and New York has it." 

The "point person" could arrange coordination between different parts of the country that are in 

different stages of the pandemic. 

FDA-OSJI-FOIA-2020-3541_00001270 
Mark Johnson has written in-depth stories about health, science and research for the Journal Sentinel since 2000. He is a three-time 

Pulitzer Prize finalist and, in addition, was part of a team that won the 2011 Pulitzer Prize in Explanatory Reporting for a series of 

reports on the groundbreaking use of genetic technology to save a 4-year-old boy. 

Email him at 111ar/.::.1ohnson'a ,rn.co111; follow him on Twitter:"Oma;ohnso. 

FDA-OSJI-FOIA-2020-3541_00001271 
From: Amin, Stacy [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=CB3764B7438648838C22881A06FC6AFB-STACY.AMIN] 

Sent: 3/18/2020 11:51:13 PM 

To: Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Caccamo, Stephanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=950c32cebc4b4f80b302c50cf31c8524-Stephanie.C]; 2019-nCoV FDA I MG JIC 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =2897 lSa 114684 7558b07a33cca b6bccf-2019-nCoV F]; OCCReq uests-COVI D19 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =bcb 756008a41407282a58324a 7b5144a-OCCReq uests ]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Anderson, Erika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=85feca0be0694803be6030e97 c7b4adb-H INTON D]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Roberts, Rosemary 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip i ents/ en=b 7838eab9 64e4ca la 7 d703876d0841 lb-RO BE RTSR]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

CC: Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode] 

Subject: RE: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Ste hanie --i b _{�}---------------�--. 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Wednesday, March 18, 2020 11:22 PM 

To: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; 2019-nCoV FDA IMG JIC <2019-

nCoVFDAIMGJIC@fda.hhs.gov>; OCCRequests-COVID19 <0CCRequests-COVID19@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; 

Roberts, Rosemary <Rosemary.Roberts@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

I have substantive edits , see attached 

Patrizia 

From: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Sent: Wednesday, March 18, 2020 11:03 PM 

To: 2019-nCoV FDA IMG JIC <2019-nCoVFDAIMGJIC fda.hhs. ov>; OCCRequests-COVID19 <0CCRequestsCOVID19@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov>; 

Anderson, Erika <Erika.Anderson fda.hhs. ov>; Hinton, Denise <Denise.Hinton fda.hhs. ov>; Cavazzoni, Patrizia 

FDA-OSJ I-FOIA-2020-3541 _00000848 
<Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Roberts, Rosemary 

<Rosema y.Roberts@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Updated TPs for POTUS press briefing tomorrow on therapeutics. CDER/CBER-can you look at quickly? I've added edits 

and a note on attached version. This is due to HHS by 6:30am. Thanks! 

Press Conference on FDA Developments 

FDA-OSJ I-FOIA-2020-3541 _00000849 
Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Desk 301 .348.1956 

Cel I!__ _______ (b )(6) ________ _! 

stephanie.caccomo@fdahhs.gov 

FDA-OSJ I-FOIA-2020-3541 _00000850 
From: Amin, Stacy [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=CB3764B7438648838C22881A06FC6AFB-STACY.AMIN] 

Sent: 3/20/2020 8:36:51 AM 

To: Cohen, Kenneth [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

Sensitivity: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44 f565b 7 39ea4879bdc516caf2e 136bc-Ken neth .Co h]; Lenihan, Keaga n 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =ee 7320ee8c 184d66 bfd52 lb0105d 17 d2-Keaga n. Len i]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Sch ii I er, Lowe I I 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en= 77949b06919e4f91aa788e9a616c50c7-Lowel I.Schi]; Roth, Lauren 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =52bfd085 72694f269a20c508f3c04a03-La u ren. Roth]; Ca I igui ri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; Rebel lo, Heidi 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =2834ce 193ca949799ef063e34a2cfa0b-H eid i. Rebel]; Busch, Marcy 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =ec4ef9f06a 684cafbe4307 486233609e-Ma rcy. Busch]; Dennis, Cl a ire 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =2f012 lbf65bf48ad b8077a2c49324223-CI a ire. Denn]; Raza, Mark 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=5811a7d72ee34aa78ff3c8ccb59f92ee-MRaza]; Shuren, Jeff 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren ]; Flannery, Ellen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f3a88f0ebdf24b898ccd4814 707 daedf-E 11 en. Flan n]; Schwartz, Suzanne 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =60fbac0e 12a24633b 1018181711 f7849-Suza n ne.Sch] 

RE: COVID19 FDA Guidance Tracker for March 20 2020 

Company Confidential 

(b)(5) 

From: Cohen, Kenneth <Kenneth.Cohen@fda.hhs.gov> 

Sent: Friday, March 20, 2020 8:33 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Schiller, Lowell 

<Lowell.Schiller@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Roth, Lauren <Lauren.Roth@fda.hhs.gov>; 

Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Steele, Danielle (OS) 

<Danielle.Steele@hhs.gov>; Malliou, Ekaterini (OS) <Ekaterini.Malliou@hhs.gov> 

Cc: Hawkins, Jamar (OS) <jamar.hawkins@hhs.gov>; Horska, Katerina (OS) <Katerina.Horska@hhs.gov>; OC OPPB OP 

RPMS <0COPPBOPRPMS@fda.hhs.gov> 

Subject: COVID19 FDA Guidance Tracker for March 20 2020 

Sensitivity: Confidential 

At HHS orOMB 

(1) CDER, FRDTS# 2020-230, SPS# 432860, Policy for Fulfilling Certain REMS Requirements During the COVID-19 

Public Health Emergency 

• Communicates Agency's temporary policy for certain risk evaluation and mitigation strategies requirements for 

the duration of the public health emergency. 

FDA-OSJ I-FOIA-2020-3541 _00000765 
Under Development in FDA 

(b)(5) 

Cleared for Posting Yesterday 

(3) CDRH, 2020-228, 432842, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support 

Patient Monitoring During the Coronavirus Disease 

• Provides a policy for expanding the availability and capability of non-invasive remote monitoring devices to 

facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during 

the COVID-19 public health emergency. 

(4) CDER, 2020-236, 432839, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products 

During the Public Health Emergency 

• Responds to a number of queries from entities that are not currently licensed or registered drug manufacturers 

that would like to prepare alcohol-based hand sanitizers, either for public distribution or for their own internal use. 

DELIBERATIVE, INTERNAL, PRE-DECISIONAL 

Kenneth R. Cohen, MHSA, MPP 

Director, Regulations Policy and Management Staff 

Office of Policy 

301-796-7001 

(b )(6) (mobile) 

U.S. FOOD & DRUG 

AOMINISHtATION 

This e-mail is intended for the exclusive use of the recipient(s) named above. It may contain information that is 

protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not 

authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying 

is strictly prohibited. If you think you have received this e-mail message in error, please immediately e-mail the sender 

Kenneth.cohen@fda.hhs.gov 

FDA-OSJ I-FOIA-2020-3541 _00000766 
From: Amin, Stacy [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=CB3764B7438648838C22881A06FC6AFB-STACY.AMIN] 

Sent: 3/18/2020 12:06:44 PM 

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Caccamo, Stephanie 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =950c32cebc4b4f80b302c50cf3 lc8524-Stepha n i e. C]; Hahn, Stephen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =a0afac0cfa3c4b98913833e38a036e9f-Stephen. Ha h] 

CC: Shah, Anand [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah]; Abernethy, Amy 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c84171967 c724ee 799bb2658197086bc-Amy .Abernet]; Ca I igu i ri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; Rom, Col in 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f59636221 f 4340d697 d bd43ee27 255fb-Col in. Rom] 

Subject: RE: POTUS tweet 

Attachments: PM_FDAFlexibility 3.18.doc�!-

�J

�

s

!

_

!

docx 

I've seen it, it's fine.i '----------------------� (b)(S) 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Wednesday, March 18, 2020 10:51 AM 

To: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov> 

Cc: Shah, Anand <Anand.Shah@fda.hhs.gov>; Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov> 

Subject: RE: POTUS tweet 

Will call you 

From: Caccamo, Stephanie <Ste hanie.Caccomo fda.hhs. ov> 

Sent: Wednesday, March 18, 2020 10:45 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov> 

Cc: Shah, Anand <Anand.Shah@fda.hhs.gov>; Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov> 

Subject: RE: POTUS tweet 

Is it possible that there may be some announcement about an EO directing FDA to push the process for patients getting 

access to drugs? WSJ was asking. 

Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Desk 301.348.1956 

Cell 240.762.8873 

stephanie.caccomo@fda.hhs.gov 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Wednesday, March 18, 2020 9:33 AM 

To: Hahn, Stephen <SH1@fda.hhs.gov> 

FDA-OSJI-FOIA-2020-3541_00000001 
Cc: Shah, Anand <Anand.Shah@fda.hhs.gov>; Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov> 

Subject: POTUS tweet 

,. ___ f.oJ.ks.= ..ab.out.nntu.s.Jw.e..et.t.bis ..am_.tbis..is._what.t.h.e.re_c;.t_.of_W.H..tb,i n ks it is a bout. i ( b )( 5) 

i (b)(5) i Feel like we are doing that with all the guidances we 

have been doing. 

1

1 heard it was: 

(b)(5) 

Sent from my iPhone 

FDA-OSJ I-FOIA-2020-3541 _00000002 
From: 

Sent: 

To: 

Subject: 

Thanks David 

Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECA0BE0694803BE6030E97C7B4ADB-HINTOND] 

3/15/2020 4:34:13 PM 

Cho, David S (CBER) [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Shu ren, Jeff 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren ]; Schwartz, Suzanne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =60fbac0e 12a24633b 1018181711 f7849-Suza n ne.Sch]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

RE: Review Requested by 1620: Talking Points on COVID Therapeutics/Vaccines 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Sunday, March 15, 2020 4:33 PM 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Schwartz, Suzanne 

<Suzanne.Schwartz@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: Review Requested by 1620: Talking Points on COVID Therapeutics/Vaccines 

Hi Denise, 

I did not have any further comments especially on the vaccines or immunotherapy statements. 

Thanks, 

David 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Sent: Sunday, March 15, 2020 3:55 PM 

To: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Schwartz, Suzanne <Suzanne.Schwartz@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: Review Requested by 1620: Talking Points on COVID Therapeutics/Vaccines 

Dear Colleagues, 

Michael Felderbaum drafted the following and wanting to make sure you've laid eyes on it and have the opportunity to 

provide comments before it goes to Dr. Hahn if you haven't already. 

Thanks, 

Denise 

FDA-OSJI-FOIA-2020-3541_00000721 
From: Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECA0BE0694803BE6030E97C7B4ADB-HINTOND] 

Sent: 3/15/2020 6:36:42 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

CC: Farley, John [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Clarke, Mary Beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =b0124a 15b9344d84839294 70fefa403a-CLARKE M] 

RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Many thanks to all of you. 

Best, 

Denise 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Sunday, March 15, 2020 5:18 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Farley, John <John.Farley@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov> 

Subject: RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Dear Patrizia, 

Thanks for copying us. Nothing to add. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Sunday, March 15, 2020 4:39 PM 

To: Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Clarke, Mary Beth 

<Ma beth.Clarke fda.hhs. ov> 

Subject: Fwd: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Denise 

+ Peter Marks 

In the two paragraphs on IL-7 inhibitors and convalescent plasma, respectively , I recommend replacing the section 

about Reducing/heeding off need for ventilator with : 

"could potentially slow the progression of severe respiratory symptoms" 

Patrizia 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Date: March 15, 2020 at 4:16:42 PM EDT 

FDA-OSJI-FOIA-2020-3541_00001285 
To: Farley, John <John.Farley@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Hi - sorry for short notice - any input before Michael Felderbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJI-FOIA-2020-3541_00001286 
From: Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECA0BE0694803BE6030E97C7B4ADB-HINTOND] 

Sent: 3/16/2020 7:01:58 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

CC: Felberbaum, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4819a643ca2945cd b la263 lb83e69673-M i cha el. Fel] 

Subject: FW: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Attachments: Therapeutics TPs 03152020 324pm.docx 

Good morning Peter, 

Did you have any comments in addition to Patrizia's? 

Thank you, 

Denise 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Sunday, March 15, 2020 4:39 PM 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: Fwd: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Denise 

+ Peter Marks 

In the two paragraphs on IL-7 inhibitors and convalescent plasma, respectively , I recommend replacing the section 

about Reducing/heeding off need for ventilator with : 

(b)(S) 

Patrizia 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Date: March 15, 2020 at 4:16:42 PM EDT 

To: Farley, John <John.Farley@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Hi - sorry for short notice - any input before Michael Felberbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJI-FOIA-2020-3541_00001282 
From: 

Sent: 

To: 

CC: 

Subject: 

Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECA0BE0694803BE6030E97C7B4ADB-HINTOND] 

3/16/2020 5:45:00 PM 

McMeekin, Judith [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d824 f07697784fcb9ece28cbba07102b-M CME EKI NJ]; Zeller, Mitch el I 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =de 7 d2fda97 le418ba 33cb21 la4013976-M itch el I .Ze ]; Abernethy, Amy 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c84171967 c724ee 799bb2658197086bc-Amy .Abernet]; Rebel Io, Heidi 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =2834ce 193ca949799ef063e34a2cfa0b-H eid i. Rebel]; Woodcock, Janet 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]; Solomon, Steven M 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e49ac6a056dc4f299ea269945e962e82-SSOLO MON]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Mayne, Susan 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=9e69acd84a37469aa57466a957814563-Susan.Mayne]; Shuren, Jeff 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren ]; Cavazzon i, Patrizia 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Cal iguiri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; M cWi 11 i ams, Carly 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b68c7 458214244d08424fd441 fea4fda-Ca rlyl e. M cW]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=98606928b9a64edfb25abale3573fdfe-Eranders]; Hebert, Angelique A. 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9aa08f3428a045f88eb3bd92c68a27 cf-Angelique. H ]; Finn en, Apri I 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=43d74b30bbld429184b0d9081efe19bf-April.Finne]; Mair, Michael 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Hussey, Deirdre 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=41a51a9bf937431c8470b69fb055fe81-Husseyd]; Barth, Janelle 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =18d28baf2bfa435a bc9cdfa07 677 4dc0-Ja nel I e. Bar]; Stone, Eric 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5 799d336f 4c142aca 7 la655e4184d6bd-E ri c.Stone ]; Hutten locker, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =65254282fa6a4e 138f506f96cfe9049c-Den ise. Hutt]; Dom an ski, Jeffrey 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=ed00c0aa83794cbebfc0a50f6cd4d7f9-Jeffrey.Dom]; Schweitzer, Roxanne K 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =292135d254924252958e25cc5a63 b079-RSCHWE IT]; Branch, Tiffany 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=b45flb97b5d648f68cdff5ce4f75a 154-Tiffany.Bra]; Barfell, Glenda F 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =33b220e98ac9456eb32888261156f 400-G BARFELL]; Lynch, Sarah 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d24ee4a4fc6241 f48110d6b35e6704ed-Sa rah. Lynch] 

RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

FDA-OSJ I-FOIA-2020-3541 _00000841 
No suggested edits - thank you. 

Denise 

From: McMeekin, Judith <Judith.McMeekin@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:43 PM 

To: Zeller, Mitchell <Mitchell.Zeller@fda.hhs.gov>; Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Rebello, Heidi 

<Heidi.Rebello@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Solomon, Steven M 

<Steven.Solomon@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan 

<Susan.Mayne@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey.Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov>; Branch, Tiffany <Tiffany.Branch@fda.hhs.gov>; Barfell, 

Glenda F <Glenda.Barfell@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

No suggested edits from me, thanks! 

From: Zeller, Mitchell <Mitchell.Zeller fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:43 PM 

To: Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov>; Solomon, Steven M <Steven.Solomon@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Mayne, Susan <Susan.Mayne@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; 

Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey.Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer fda.hhs. ov>; Branch, Tiffany <Tiffan .Branch fda.hhs. ov>; Barfell, 

Glenda F <Glenda.Barfell fda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

Agreed. 

Is there now an expedited clearance process for these types of messages? 

Mitch 

From: Abernethy, Amy <Am .Aberneth fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:41 PM 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock 

<Steven.Solomon@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan 

<Susan.Mayne@fda.hhs.gov>; Zeller, Mitchell <Mitchell.Zeller@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; 

Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov> 

FDA-OSJ I-FOIA-2020-3541 _00000842 
Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker fda.hhs. ov>; Domanski, Jeffrey <Jeffre .Domanski tda.hhs. ov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer tda.hhs. ov>; Branch, Tiffany <Tiffan .Branch tda.hhs. ov>; Bartell, 

Glenda F <Glenda.Bartell tda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@tda.hhs.gov> 

Subject: Re: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

Reviewed. This looks good from my perspective. 

From: Rebello, Heidi <Heidi.Rebello@tda.hhs.gov> 

Sent: Monday, March 16, 2020 5:23 PM 

To: Woodcock, Janet <Janet.Woodcock tda.hhs. ov>; Solomon, Steven M <Steven.Solomon tda.hhs. ov>; Marks, 

Peter <Peter.Marks@tda.hhs.gov>; Mayne, Susan <Susan.Mayne@tda.hhs.gov>; Zeller, Mitchell 

<Mitchell.Zeller tda.hhs. ov>; Shuren, Jeff <Jeff.Shuren@tda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov>; Abernethy, Amy 

<Amy.Abernethy@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey.Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov>; Branch, Tiffany <Tiffany.Branch@fda.hhs.gov>; Bartell, 

Glenda F <Glenda.Barfell@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

FDA-OSJ I-FOIA-2020-3541 _00000843 
Sincerely, 

Stephen M. Hahn, M.D. 

FDA Commissioner 

FDA-OSJ I-FOIA-2020-3541 _00000844 
From: Lenihan, Keagan [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =EE7320E E8C184D66 BFD521B0105D 17D2-KEAGAN. LEN I] 

3/26/2020 8:56:25 AM 

To: Woodcock, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3 f72df53a-M a rksP] 

RE: CDRH response update 

Thank you. 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 8:55 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: CDRH response update 

Sure. We will get something together. jw 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 7:49 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock 

Subject: Fwd: CDRH response update 

In an effort to keep SH fully up to speed on what's happening at CDRH, they have started putting these morning reports 

together. He has a check in with Grogan every morning at 7:45. It would be really helpful to get something similar from 

CDER and CBER so it was all in one place. There are so many moving pieces, summaries would help catalog the work. Do 

you think Mary Beth and Julie could put something together like this daily? 

Pis. 

Sent from my iPhone 

Begin forwarded message: 

From: "Hillebrenner, Elizabeth J" <Elizabeth.Hillebrenner@fda.hhs.gov> 

Date: March 26, 2020 at 6:55:12 AM EDT 

To: "Lenihan, Keagan" <Keagan.Lenihan@fda.hhs.gov> 

Cc: "Shuren, Jeff" <Jeff.Shuren@fda.hhs.gov> 

Subject: FW: CDRH response update 

Keagan, 

Please let me know if I should make any adjustments to the daily emails, such as to the level of detail or otherwise. We 

want to make sure the Commissioner has what he needs. 

Elizabeth 

From: Hillebrenner, Elizabeth J 

Sent: Thursday, March 26, 2020 6:52 AM 

To: 'Hahn, Stephen' <SH1@fda.hhs.gov> 

Cc: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov> 

Subject: CDRH response update 

FDA-OSJI-FOIA-2020-3541_00001483 
Dr Hahn, 

Below please find a list of CDRH's emergency response actions from yesterday as well as anticipated actions in the 

coming 48 hours. 

March 25, 2020 actions 

• Ventilators: 

o CDRH issued a blanket EUA for ventilators, anesthesia gas machines modified for use as ventilators, and 

positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator 

tubing connectors, and ventilator accessories. Manufacturers and other stakeholders may submit a request to FDA 

under the process outlined in the EUA to have their device(s) added to the EUA. 

o CDRH authorized an EUA for Beijing Aeonmed Co., Ltd., Beijing, China, for an unapproved ventilator 

model VG70 that NY state has purchased. The ventilators will be imported next week. 

o A CDRH subject matter expert worked with the FEMA ventilator surprise chain task force to facilitate the 

availability of a splitter to enable a single ventilator to support multiple patients at one time. 

o CDRH authorized an EUA for the Prisma Health 3D printed Ventilator Expansion Splitter (VESper) that 

allows one ventilator to be used on more than one patient. 

o CDRH met with multiple stakeholders developing creative solutions to a potential ventilator shortage. 

• PPE 

(b)(S) o CDRH published Guidance on "Enforcement Policy for Face Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency." 

• Diagnostics: 

o CDRH held a Town Hall/Webinar with 1,000 participants during which we provided an overview of the 

March 16th guidance on diagnostics and answered questions from labs. 

o CDRH authorized EUAs for SARS-CoV-2 diagnostics from Avellino Labs and Perkin Elmer. Avellino labs 

notified FDA and was offering their test under the policy outlined in the Feb. 29th guidance. 

o We now have 18 authorized diagnostics and over 100 notifications from developers offering tests under 

the Feb 29th/March 16th guidance. 

Anticipated actions in the next 48 hours 

• CDRH intends to publish Guidance on gowns. The guidance will address appropriate labeling for these products 

during the COVID-19 public health emergency without requiring SlO(k) submission and clearance 

• CDRH intends to publish Guidance on "Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers 

During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." The guidance will address appropriate 

FDA-OSJI-FOIA-2020-3541_00001484 
labeling for these products during the COVID-19 public health emergency without requiring SlO(k) submission and 

clearance. 

Elizabeth 

Elizabeth Hillebrenner 

Associate Director for Scientific and Regulatory Programs 

Center for Devices and Radiological Health 

Office of the Center Director 

U.S. Food and Drug Administration 

Tel: 301-796-6346 

elizabeth.hillebrenner@fda.hhs.gov 

U.S. FOOD & DRUG 

•• 

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer 

service you have received: :llwww.research.net/s/cdrhcustomerservice?ID=2000&S=E. 

FDA-OSJI-FOIA-2020-3541_00001485 
From: SH1@fda.hhs.gov [SH1@fda.hhs.gov] 

Sent: 2/1/2020 8:14:46 AM 

To: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=85feca0be0694803be6030e97c7b4adb-HINTOND]; Abram, Anna 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram]; Lenihan, Keaga n 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Caliguiri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; Mair, Mi cha el 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Woodcock, Janet 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Sh uren, Jeff 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren] 

Anderson, Erika [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b 9a64edfb25a ba le35 73fdfe-Era nders] 

RE: CDC Coronavirus Talking Points - 1/31/20 

Thx Anna and Peter 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Date: February 1, 2020 at 7:54:58 AM EST 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>, Abram, Anna <Anna.Abram@fda.hhs.gov>, Hahn, Stephen 

<SH1@fda.hhs.gov>, Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov>, Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Cc: Anderson, Erika <Erika.Anderson@fda.hhs.gov> 

Subject: RE: CDC Coronavirus Talking Points - 1/31/20 

FDA-OSJI-FOIA-2020-3541_00000257 
From: Mair, Michael [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =F4511BDAD7564D7FAC7EADC7961467 AB-MICHAEL. MAI] 

Sent: 2/8/2020 10:07:08 AM 

To: Abram, Anna [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram]; Hahn, Stephen 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=a0afac0cfa3c4b98913833e38a036e9f-Stephen.Hah]; Solomon, Steven M 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e49ac6a056dc4f299ea269945e962e82-SSOLO MON]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd52 lb0105dl 7d2-Keagan. Leni]; Amin, Stacy 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Anderson, Erika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Schwartz, Suzanne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =60fbac0e 12a24633b 1018181711 f7849-Suza n ne.Sch] 

Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected Pneumonia in Wuhan, 

China 

JAMA: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected Pneumonia in Wuhan, 

China 

Conclusions and Relevance In this single-center case series of 138 hospitalized patients with confirmed NCIP 

in Wuhan, China, presumed hospital-related transmission of 2019-nCo V was suspected in 41 % of patients, 26% 

of patients received ICU care, and mortality was 4.3%. 

FDA-OSJI-FOIA-2020-3541_00000219 
From: Hahn, Stephen [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=A0AFACOCFA3C4B98913833E38A036E9F-STEPHEN.HAH] 

Sent: 2/9/2020 9:01:35 AM 

To: Mair, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai] 

CC: Shah, Anand [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Abram, Anna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram] 

Re: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected Pneumonia in Wuhan, 

China 

Thanks, Michael. Very interesting. 

From: "Mair, Michael" <Michael.Mair@fda.hhs.gov> 

Date: Saturday, February 8, 2020 at 10:07 AM 

To: Anna Abram <Anna.Abram@fda.hhs.gov>, Stephen Hahn <SH1@fda.hhs.gov>, Steven Solomon 

<Steven.Solomon@fda.hhs.gov>, Keagan Lenihan <Keagan.Lenihan@fda.hhs.gov>, Stacy Amin 

<Stacy.Amin@fda.hhs.gov>, Erika Anderson <Erika.Anderson@fda.hhs.gov>, Denise Hinton 

<Denise.Hinton@fda.hhs.gov>, Peter Marks <Peter.Marks@fda.hhs.gov>, "Farley, John" 

<John.Farley@fda.hhs.gov>, "Schwartz, Suzanne" <Suzanne.Schwartz@fda.hhs.gov> 

Subject: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected 

Pneumonia in Wuhan, China 

JAMA: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected Pneumonia in Wuhan. 

China 

Conclusions and Relevance In this single-center case series of 138 hospitalized patients with confirmed NCIP 

in Wuhan, China, presumed hospital-related transmission of 2019-nCo V was suspected in 41 % of patients, 26% 

of patients received ICU care, and mortality was 4.3%. 

FDA-OSJI-FOIA-2020-3541_00000161 
From: SH1@fda.hhs.gov [SH1@fda.hhs.gov] 

Sent: 3/22/2020 5:51:22 PM 

To: Shuren, Jeff [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren ]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =ee 7320ee8c184d66bfd52 lb0105d 17 d2-Keaga n. Len i] 

Subject: RE: COVID-19 Serologic Tests 

Thanks, Jeff. Peter, I want us to remove any barriers to the development of convalescent plasma and 

hyperimmune globulin. Please let me know how we can engage industry or others to expedite. 

Thanks 

From: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Date: March 22, 2020 at 5:42:18 PM EDT 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Hahn, Stephen <SH1@fda.hhs.gov>, Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Subject: RE: COVID-19 Serologic Tests 

FDA-OSJ I-FOIA-2020-3541 _00000973 
From: 

Sent: 

Hahn, Stephen [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=A0AFACOCFA3C4B98913833E38A036E9F-STEPHEN.HAH] 

3/27/2020 9:28:15 AM 

To: Rom, Colin [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =f59636221 f 4340d697 d bd43ee27 255fb-Col in. Rom] 

Fwd: CDRH response update 

Please print for me 

thanks 

From: Hillebrenner, Elizabeth J <Elizabeth.Hillebrenner@fda.hhs.gov> 

Date: March 26, 2020 at 6:52:03 AM EDT 

To: Hahn, Stephen <SHl@fda.hhs.gov> 

Cc: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>, Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>, Shah, Anand 

<Anand.Shah@fda.hhs.gov>, Rom, Colin <Colin.Rom@fda.hhs.gov> 

Subject: CDRH response update 

Dr Hahn, 

Below please find a list of CDRH's emergency response actions from yesterday as well as anticipated actions in the 

coming 48 hours. 

March 25, 2020 actions 

• Ventilators: 

o CDRH issued a blanket EUA for ventilators, anesthesia gas machines modified for use as ventilators, and 

positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator 

tubing connectors, and ventilator accessories. Manufacturers and other stakeholders may submit a request to FDA 

under the process outlined in the EUA to have their device(s) added to the EUA. 

o CDRH authorized an EUA for Beijing Aeonmed Co., Ltd., Beijing, China, for an unapproved ventilator 

model VG70 that NY state has purchased. The ventilators will be imported next week. 

o A CDRH subject matter expert worked with the FEMA ventilator surprise chain task force to facilitate the 

availability of a splitter to enable a single ventilator to support multiple patients at one time. 

o CDRH authorized an EUA for the Prisma Health 3D printed Ventilator Expansion Splitter (VESper) that 

allows one ventilator to be used on more than one patient. 

o CDRH met with multiple stakeholders developing creative solutions to a potential ventilator shortag_�: _________ _ 

• PPE 

(b)(S) o CDRH published Guidance on "Enforcement Policy for Face Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency." 

• Diagnostics: 

o CDRH held a Town Hall/Webinar with 1,000 participants during which we provided an overview of the 

March 16th guidance on diagnostics and answered questions from labs. 

o CDRH authorized EUAs for SARS-CoV-2 diagnostics from Avellino Labs and Perkin Elmer. Avellino labs 

notified FDA and was offering their test under the policy outlined in the Feb. 29th guidance. 

FDA-OSJI-FOIA-2020-3541_00000971 
o We now have 18 authorized diagnostics and over 100 notifications from developers offering tests under 

the Feb 29th/March 16th guidance. 

Anticipated actions in the next 48 hours 

• CDRH intends to publish Guidance on gowns. The guidance will address appropriate labeling for these products 

during the COVID-19 public health emergency without requiring SlO(k) submission and clearance 

• CDRH intends to publish Guidance on "Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers 

During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." The guidance will address appropriate 

labeling for these products during the COVID-19 public health emergency without requiring SlO(k) submission and 

clearance. 

Elizabeth 

Elizabeth Hillebrenner 

Associate Director for Scientific and Regulatory Programs 

Center for Devices and Radiological Health 

Office of the Center Director 

U.S. Food and Drug Administration 

Tel: 301-796-6346 

elizabeth.hillebrenner@fda.hhs.gov 

U.S. FOOD & DRUG 

•• 

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer 

service you have received: http :llwww.research.net/s/cdrhcustomerservice?ID=2000&S=E. 

FDA-OSJ I-FOIA-2020-3541 _00000972 
From: Lenihan, Keagan [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =EE7320E E8C184D66 BFD521B0105D 17D2-KEAGAN. LEN I] 

3/27/2020 12:11:27 PM 

To: Hahn, Stephen [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =a0afac0cfa3c4b98913833e38a036e9f-Stephen. Ha h] 

FW: PETER PLEASE SEE ASAP: Corn ms for Today 

Attachments: WH Presser TPs 03272020 1206pm.docx 

It is Texas. Peter confirmed and he has small edits to the presser. Michael will send you clear copy. 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 27, 2020 12:08 PM 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Lenihan, 

Keagan <Keagan.Lenihan@fda.hhs.gov> 

Subject: RE: PETER PLEASE SEE ASAP: Com ms for Today 

Dear Michael, 

Very minor edits. Let's just stick with Texas for today. Thanks. (with attachment) 

Best Regards, 

Peter 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 27, 2020 12:00 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Lenihan, 

Keagan <Keagan.lenihan@fda.hhs.gov> 

Subject: PETER PLEASE SEE ASAP: Com ms for Today 

Importance: High 

Hi PeterFrom what I understand from the AEG call,! �-------------------� (b)(5) i have removed from 

Dr. Hahn's WH talking points - and we need to remove from the press release as well, correct? 

Al so he said you had mentioned that the i·-·-·-·-·-·-·-·-·-·-·-·-·- -------------(-b) ·-·-·-·-·-·-·-·-·-·-·-·-·-· ( 5 )--------------------------------------------------------] 

-·-·-·-·-·-·-·-·-·-· ( b )( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

Can you please weigh in ASAP so we make sure he has what he needs? 

Thanks! 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

FDA-OSJ I-FOIA-2020-3541 _00000966 
Tel 240-402-9548 / Celli (b)(G) i 

michael.felberbaum@fdahhs.gov 

U.S. FOOD &. DRUG 

A l)M r N t$TA:4 TION 

DCllZl ·· II 

FDA-OSJ I-FOIA-2020-3541 _00000967 
From: 

Sent: 

Hahn, Stephen [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=A0AFACOCFA3C4B98913833E38A036E9F-STEPHEN.HAH] 

3/28/2020 1:49:10 PM 

To: Katz, Mitchell [Mitchell.Katz@nychhc.org] 

Subject: Re: is there a way to get other countries to produce convalescent serum? 

Mitch 

Are you all using convalescent plasma in NY? We set up/allowed/provided guidance about this starting earlier 

this week using a compassionate use process. Our plan is to move next week to an expanded access protocol? 

We're working on identifying donors so I'll pass along your suggestion to the team. Mitch, you are doing great 

work. Please take care. 

Steve 

From: Katz, Mitchell <Mitchell.Katz@nychhc.org> 

Date: March 28, 2020 at 12: 41: 07 PM EDT 

To: Hahn, Stephen <SHl@fda.hhs.gov> 

Subject: is there a way to get other countries to produce convalescent serum? 

Steve, hope you are hanging in. Things are pretty desperate here. We are usin��

b

�

(

�iJmore ventilators today than 

yesterday for covid and we are onlY:(b)(4)

jof hospital capacity. j __________ i 

The countries that are recovering abroad from this pandemic, especially china, seem like they would have capacity to 

produce convalescent serum and ship to US. 

I don't know that this is a FDA issue. I know companies normally come to you to ask for licensing their product but could 

you give me any advice on how US could encourage this to happen. 

Thank, Mitch 

CONFIDENTIALITY NOTICE: The information in this E-Mail may be confidential and may be legally 

privileged. It is intended solely for the addressee(s). If you are not the intended recipient, any disclosure, 

copying, distribution or any action taken or omitted to be taken in reliance on this e-mail, is prohibited 

and may be unlawful. If you have received this E-Mail message in error, notify the sender by reply EMail and delete the message. 

FDA-OSJ I-FOIA-2020-3541 _00000970 
From: 

Sent: 

Hahn, Stephen [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=A0AFACOCFA3C4B98913833E38A036E9F-STEPHEN.HAH] 

3/28/2020 2:22:18 PM 

To: Katz, Mitchell [Mitchell.Katz@nychhc.org] 

Subject: RE: is there a way to get other countries to produce convalescent serum? 

Do you have time for a quick call? 

From: Katz, Mitchell <Mitchell.Katz@nychhc.org> 

Date: March 28, 2020 at 2:02:03 PM EDT 

To: Hahn, Stephen <SHl@fda.hhs.gov> 

Subject: RE: is there a way to get other countries to produce convalescent serum? 

Yes thanks to your guidance we are setting it up in NYC health and hospitals. Mt Sinai already doing it. I am thinking 

though that our ability to identify people who are immune and have antibodies and do the plasmapheresis will likely 

limit application. If a country that was over the bad part of the epidemic could be brought into service for money it 

might save lives. 

Appreciate any suggestions your team has. Thanks for being so responsive. mitch 

From: Hahn, Stephen <SH1@fda.hhs.gov> 

Sent: Saturday, March 28, 2020 1:49 PM 

To: Katz, Mitchell <Mitchell.Katz@nychhc.org> 

Subject: Re: is there a way to get other countries to produce convalescent serum? 

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the 

sender and know the content is safe. Forward suspect email to pamad · @ , chbc.org as an attachment (Click the More butto°' then 

forward as attachment). 

Mitch 

Are you all using convalescent plasma in NY? We set up/allowed/provided guidance about this starting earlier 

this week using a compassionate use process. Our plan is to move next week to an expanded access protocol? 

We're working on identifying donors so I'll pass along your suggestion to the team. Mitch, you are doing great 

work. Please take care. 

Steve 

From: Katz, Mitchell <Mitchell.Katz@nychhc.or b> 

Date: March 28, 2020 at 12: 41: 07 PM EDT 

To: Hahn, Stephen <SH1@fda.hhs.gov> 

Subject: is there a way to get other countries to produce convalescent serum? 

Steve, hope you are hanging in. Things are pretty desperate here. We are usin$(b)(4Jf110re ventilators today than 

yesterday for covid and we are onl�(b)(4)iof hospital capacity. j_ _________ ! 

FDA-OSJ I-FOIA-2020-3541 _00000968 
The countries that are recovering abroad from this pandemic, especially china, seem like they would have capacity to 

produce convalescent serum and ship to US. 

I don't know that this is a FDA issue. I know companies normally come to you to ask for licensing their product but could 

you give me any advice on how US could encourage this to happen. 

Thank, Mitch 

CONFIDENTIALITY NOTICE: The information in this E-Mail may be confidential and may be legally 

privileged. It is intended solely for the addressee(s). If you are not the intended recipient, any disclosure, 

copying, distribution or any action taken or omitted to be taken in reliance on this e-mail, is prohibited 

and may be unlawful. If you have received this E-Mail message in error, notify the sender by reply EMail and delete the message. 

FDA-OSJ I-FOIA-2020-3541 _00000969 
From: Mair, Michael [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =F4511BDAD7564D7FAC7EADC7961467 AB-MICHAEL. MAI] 

Sent: 1/10/2020 1:30:38 PM 

To: Hinton, Denise [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=85feca0be0694803be6030e97c7b4adb-HINTOND]; Abram, Anna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Sadove, Elizabeth [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fd45c627000d4f34b9db362ff2b6af4b-SADOVE E] 

Subject: Update on Undiagnosed Pneumonia - China 

Hi. I wanted to provide you with a quick update on the outbreak of pneumonia of unknown cause that is ongoing in 

Wuhan, China. 

Overview: 

• There are 59 cases of pneumonia listed as unknown etiology, 7 listed as severe. 

• There is a limited clinical picture. Symptom onset of cases is from 12-29 December. Wuhan health officials have 

not announced any new cases since 05 Jan. 

• All known cases are linked to live fish market in Wuhan (closed on 01 December) that also sells other animals. 

• There have been no reported health care worker infections or human-to-human transmission. 

• 153 known close contacts are being monitored. 

• Chinese authorities have made a preliminary determination of a novel coronavirus as the etiologic agent, 

identified in a hospitalized person with pneumonia in Wuhan 

• Science is reporting that the "Two groups isolated the virus from samples from one patient ... [that] ... A total of 15 

[of the 59 cases] were positive for the novel virus, [based on] sequencing samples of [fluid injected into the lung and 

collected for examination] ... [and that] ... the virus is similar to some of the published [corona]viruses collected from bats. 

But it is not close to SARS and not close to MERS." 

• There has been no known international spread, but many countries in the region have activated protocols to 

monitor for pneumonia patients of unknown etiology who have recently traveled to China. 

WHO Activities: 

• WHO is closely monitoring the situation and is in close contact with national authorities in China. 

• WHO has requested more information from China on the epidemiological situation and ongoing investigations 

• WHO is not currently recommending any specific measures for travelers. 

• WHO is developing guidance for member states. 

• WHO R&D Blueprint Team held a teleconference on 10 Jan to update members of the Global Coordination 

Mechanism on the cluster of pneumonia cases and discuss next steps. 

USG Activities: 

• CDC issued a level 1 travel notice on 06 Jan. 

• CDC issued a Health Alert Network notice on 08 Jan. 

FDA Activities: 

• The FDA Emerging Threats Task Force is monitoring the situation and working to advance and coordinate 

response activities as necessary. 

• The Division of Microbiology (OHT7-OIR/CDRH) is proactively coordinating with CDC on diagnostic activities: 

o DMD had a telecon with CDC on 08 Jan: 

FDA-OSJI-FOIA-2020-3541_00000991 
■ CDC briefed DMD on the current situation and noted that they expect the genetic sequence information to be 

released soon. ■ In anticipation of testing specimens from returning travelers, CDC is developing a molecular test, likely based on 

the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay (which FDA authorized for use under EUA in June 2014 for the 

presumptive detection of MERS-CoV), that they will CLIA validate for use in their labs. ■ From a preparedness standpoint CDC is also planning on submitting a pre-EUA package in case distribution of 

the test within the Laboratory Response Network is necessary to meet testing demands. DMD is working on an EUA 

Review template outlining the data requirements for the Pre-EUA package based on previous experience with MERSCoV. 

FDA-OSJ I-FOIA-2020-3541 _00000992 
From: McWilliams, Carly [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =B68C7 45 8214244D08424F D441FEA4FDA-CARL YLE. MCW] 

Sent: 3/2/2020 5:54:44 PM 

To: Janik, Heather [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =117bc4d27 d7b4 7 dd bebeeeSffeeb 7f3d-H eather .Jan]; Ca I igui ri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; Lynch, Sarah 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=d24ee4a4fc6241f48110d6b35e6704ed-Sarah.Lynch]; Mair, Michael 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc7961467a b-M ichael. Mai]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND] 

CC: Lutter, Randall [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =868b2 ld b20e3456a b4e lb3109b56c23 f-Ra nda 11. Lut]; Shah, Anand 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=e2172ebbd96946c08e 189fd612855f51-Anand.Shah]; Rom, Col in 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f59636221 f 4340d697 d bd43ee27 255fb-Col in. Rom]; Gross, Karas 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =0b6d3dc4ee4b415d 86ec634c536453b6-Ka ra. Gross]; Black, Jennifer 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=aaf8a19f3672492293a7clb2d1498059-Jennifer.BI]; Tantillo, Andrew 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=c43045bfeef846fa99daa0c3d4772alc-Andrew.Tant]; Rath, Prakash (FDA) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9 lbc5673d b6c416e87a453f8b9527 cc0-Pra kash. Rat] 

Science Magazine Article 

; 

Hi, I was sent this article by Randy. Based on the ta_l_�Jo_g points I have seen though._1�! __ (b_)_(5_) __ _ (b)(5) 

Were they coordinating distribution of tests? Fortunately, it does note that things will get better. Could 

we 1.i (b) 5 i 

The United States badly bungled coronavirus testing-but things 

may soon improve 

By Jon Cohen Feb. 28, 2020 , 5:45 PM 

Speed is critical in the response to COVID-19. So why has the United States been so slow in its 

attempt to develop reliable diagnostic tests and use them widely? 

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five 

commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South 

Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), 

FDA-OSJ I-FOIA-2020-3541 _00000988 
in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit 

to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the 

country eager to test more suspected cases-and test them faster-have been unable to do so. No 

commercial or state labs have the approval to use their own tests. 

In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern 

California who turned out to be the first probable COVID19 case without known links to an infected 

person. 

The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is 

accurate. the official tally of 60 confirmed cases in the United States is accurate. "There have been blunders, 

and there could be an underlying catastrophe that we don't know about," says epidemiologist Michael Mina, 

who helps run a microbiology testing lab at Brigham and Women's Hospital. "It's been very complicated and 

confusing for everyone with almost no clarity being provided by the CDC." 

The situation may soon improve. State labs and commercial diagnostic developers hope to win 

approval from the Food and Drug Administration (FDA) for their own tests, and FDA and CDC on 

Wednesday agreed on a workaround for the faulty CDC kit-which has a problem that is not essential 

to its proper functioning-so that it can now be used by at least some of the state labs that have it. 

But there's widespread discontent with the way the system has worked. "The U.S. government has 

not appropriately prioritized diagnostic tests and supported the laboratory response network to the 

degree they should have been supported over the years," says Luciana Borio, who in previous jobs 

had lead roles in responding to emerging threats at the National Security Council and FDA 

If a new disease emerges, CDC normally "gets the ball rolling" with diagnostics because it has the 

expertise and the biosafety laboratories to handle dangerous novel pathogens, says Borio, who now 

works for ln-Q-Tel, a not-for-profit venture capital firm. Typically, there are few confirmed viral 

samples from patients at the outset, which researchers need to validate their tests, and CDC has the 

capability to grow the virus for this critical quality assurance step. Once the agency has a working 

test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce 

their own tests or scale-up the CDC one. "I would have hoped to see that third phase by now," Borio 

says. 

In the case of SARS-CoV-2, as the virus causing COVID-19 is officially known, CDC's sluggishness 

was apparent 1 month ago. On 26 January, the agency held an unusual Sunday teleconference for 

the media to provide an update about the rapidly growing outbreak. There were then five cases in the 

United States, but the CDC lab in Atlanta was still the only one in the country able to test for the virus, 

and it repeatedly had backlogs. Asked why more labs weren't able to do the tests, Nancy Messonnier, 

who then was leading CDC's response, said it was a quality issue. "We hold ourselves to an 

incredibly high standard of precision in terms of laboratory testing," Messonnier said. "We wouldn't 

want to inadvertently make a mistake in patient care." 

CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it 

revealed that several labs had difficulty validating the test because of a problem with one of the 

reagents. 

The key problem with the kits is what's known as a negative control, says Kelly Wroblewski, director 

of infectious diseases at the Association of Public Health Laboratories (APHL). CDC's test uses the 

polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a 

nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. 

The assay should not react to this negative control, but the CDC reagents did at many, but not all, 

state labs. The labs where the negative control failed were not allowed to use the test; they have to 

continue to send their samples to Atlanta. 

The declaration of a public health emergency ... limited the diagnostic capacity of this 

country. It's insane. 

FDA-OSJ I-FOIA-2020-3541 _00000989 
Michael Mina, Brigham and Women's Hospital 

In principle, many hospital and academic labs around the country have the capability to carry out tests 

themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The 

CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. 

Well-equipped state or local labs can use these-or come up with their own-to produce what are known as a 

"laboratory-developed tests" for in-house use. 

But at the moment, they're not allowed to do that without FDA approval. When the United 

States declared the outbreak a public health emergency on 31 January, a bureaucratic process 

kicked in that requires FDA's "emergency use approval" for any tests. "The declaration of a public 

health emergency did exactly what it shouldn't have. It limited the diagnostic capacity of this country," 

Mina says. "It's insane." 

On 24 February, APHL asked FDA Commissioner Stephen Hahn for "enforcement discretion" to 

sidestep the emergency process and allow APHL members labs to use their own tests. On 26 

February, Hahn replied that the CDC test could be modified to use just the primers that specifically 

detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look 

the other way to make more widespread testing possible. 

CDC has notified labs of FDA's decision in a letter, but the agency must still file an emergency use 

authorization with FDA for the protocol change. Once it does, it won't take long, Hahn promised in his 

letter to APHL: "FDA has been able to authorize tests for public health emergencies within as little as 

1 day upon receipt of the complete validation." 

In New York, the State Department of Health has designed its own test based on the CDC protocol 

and plans to seek emergency use authorization. 

CDC provided an update about the situation in an email but did not respond to Science's request for 

an interview with a scientist to discuss the details of the problem. Mina stresses he has great respect 

for CDC's competence overall, but says, "There's no good explanation for what's going on here." 

FDA-OSJ I-FOIA-2020-3541 _00000990 
From: Mair, Michael [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =F4511BDAD7564D7FAC7EADC7961467 AB-MICHAEL. MAI] 

Sent: 3/2/2020 6:15:38 PM 

To: McWilliams, Carly [/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b68c7 458214244d08424fd441 fea4fda-Ca rlyl e. M cW]; Janik, Heather 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =117bc4d27 d7b4 7 dd bebeeeSffeeb 7f3d-H eather .Jan]; Ca I igui ri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; Lynch, Sarah 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d24ee4a4fc6241 f48110d6b35e6704ed-Sa rah. Lynch]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND] 

Lutter, Randall [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =868b2 ld b20e3456a b4e lb3109b56c23 f-Ra nda 11. Lut]; Shah, Anand 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=e2172ebbd96946c08e 189fd612855f51-Anand.Shah]; Rom, Col in 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f59636221 f 4340d697 d bd43ee27 255fb-Col in. Rom]; Gross, Karas 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =0b6d3dc4ee4b415d 86ec634c536453 b6-Ka ra. Gross]; Black, Jennifer 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=aaf8a19f3672492293a7clb2d1498059-Jennifer.BI]; Tantillo, Andrew 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=c43045bfeef846fa99daa0c3d4772alc-Andrew.Tant]; Rath, Prakash (FDA) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9 lbc5673d b6c416e87a453f8b9527 cc0-Pra kash. Rat]; Scherf, Uwe 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=b184b713fc4d4edc84dlaed078aafec7-UXS]; Sapsford, Kim E 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =564aa450b 77d455b922015ece2101829-KIS] 

RE: Science Magazine Article 

On 27 Feb, Tedros that WHO has "shipped testing kits to 57 countries and personal protective equipment to 85 

countries who need it." Copying CDRH folks in case they have info on what WHO has shipped 

From: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> 

Sent: Monday, March 2, 2020 5:55 PM 

To: Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Subject: Science Magazine Article 

Hi, I was ,c,rt,r-10 by Randy. on talking points I seen though, i (b)(5) 

(b)(5) 

Were they coordinating distribution of tests? Fortunately, it does note that thing� __ \11,'._i_lJ_get better. Could 

we! b 5 ! 

(b)(S) 

FDA-OSJ I-FOIA-2020-3541 _00000985 
(b)(S) 

The United States badly bungled coronavirus testing-but things 

may soon improve 

By Jon Cohen Feb. 28, 2020 , 545 PM 

Speed is critical in the response to COVID-19. So why has the United States been so slow in its 

attempt to develop reliable diagnostic tests and use them widely? 

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five 

commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South 

Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), 

in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit 

to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the 

country eager to test more suspected cases-and test them faster-have been unable to do so. No 

commercial or state labs have the approval to use their own tests. 

In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern 

California who turned out to be the first probable COVID19 case without known links to an infected 

person. 

The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is 

accurate. the official tally of 60 confirmed cases in the United States is accurate. "There have been blunders, 

and there could be an underlying catastrophe that we don't know about," says epidemiologist Michael Mina, 

who helps run a microbiology testing lab at Brigham and Women's Hospital. "It's been very complicated and 

confusing for everyone with almost no clarity being provided by the CDC." 

The situation may soon improve. State labs and commercial diagnostic developers hope to win 

approval from the Food and Drug Administration (FDA) for their own tests, and FDA and CDC on 

Wednesday agreed on a workaround for the faulty CDC kit-which has a problem that is not essential 

to its proper functioning-so that it can now be used by at least some of the state labs that have it. 

But there's widespread discontent with the way the system has worked. "The U.S. government has 

not appropriately prioritized diagnostic tests and supported the laboratory response network to the 

degree they should have been supported over the years," says Luciana Borio, who in previous jobs 

had lead roles in responding to emerging threats at the National Security Council and FDA 

If a new disease emerges, CDC normally "gets the ball rolling" with diagnostics because it has the 

expertise and the biosafety laboratories to handle dangerous novel pathogens, says Borio, who now 

works for ln-Q-Tel, a not-for-profit venture capital firm. Typically, there are few confirmed viral 

samples from patients at the outset, which researchers need to validate their tests, and CDC has the 

capability to grow the virus for this critical quality assurance step. Once the agency has a working 

test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce 

their own tests or scale-up the CDC one. "I would have hoped to see that third phase by now," Borio 

says. 

In the case of SARS-CoV-2, as the virus causing COVID-19 is officially known, CDC's sluggishness 

was apparent 1 month ago. On 26 January, the agency held an unusual Sunday teleconference for 

the media to provide an update about the rapidly growing outbreak. There were then five cases in the 

United States, but the CDC lab in Atlanta was still the only one in the country able to test for the virus, 

and it repeatedly had backlogs. Asked why more labs weren't able to do the tests, Nancy Messonnier, 

who then was leading CDC's response, said it was a quality issue. "We hold ourselves to an 

FDA-OSJ I-FOIA-2020-3541 _00000986 
incredibly high standard of precision in terms of laboratory testing," Messonnier said. "We wouldn't 

want to inadvertently make a mistake in patient care." 

CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it 

revealed that several labs had difficulty validating the test because of a problem with one of the 

reagents. 

The key problem with the kits is what's known as a negative control, says Kelly Wroblewski, director 

of infectious diseases at the Association of Public Health Laboratories (APHL). CDC's test uses the 

polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a 

nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. 

The assay should not react to this negative control, but the CDC reagents did at many, but not all, 

state labs. The labs where the negative control failed were not allowed to use the test; they have to 

continue to send their samples to Atlanta. 

The declaration of a public health emergency ... limited the diagnostic capacity of this 

country. It's insane. 

Michael Mina, Brigham and Women's Hospital 

In principle, many hospital and academic labs around the country have the capability to carry out tests 

themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The 

CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. 

Well-equipped state or local labs can use these-or come up with their own-to produce what are known as a 

"laboratory-developed tests" for in-house use. 

But at the moment, they're not allowed to do that without FDA approval. When the United 

States declared the outbreak a public health emergency on 31 January, a bureaucratic process 

kicked in that requires FDA's "emergency use approval" for any tests. "The declaration of a public 

health emergency did exactly what it shouldn't have. It limited the diagnostic capacity of this country," 

Mina says. "It's insane." 

On 24 February, APHL asked FDA Commissioner Stephen Hahn for "enforcement discretion" to 

sidestep the emergency process and allow APHL members labs to use their own tests. On 26 

February, Hahn replied that the CDC test could be modified to use just the primers that specifically 

detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look 

the other way to make more widespread testing possible. 

CDC has notified labs of FDA's decision in a letter, but the agency must still file an emergency use 

authorization with FDA for the protocol change. Once it does, it won't take long, Hahn promised in his 

letter to APHL: "FDA has been able to authorize tests for public health emergencies within as little as 

1 day upon receipt of the complete validation." 

In New York, the State Department of Health has designed its own test based on the CDC protocol 

and plans to seek emergency use authorization. 

CDC provided an update about the situation in an email but did not respond to Science's request for 

an interview with a scientist to discuss the details of the problem. Mina stresses he has great respect 

for CDC's competence overall, but says, "There's no good explanation for what's going on here." 

FDA-OSJ I-FOIA-2020-3541 _00000987 
From: Caliguiri, Laura [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =AA086F2 D6C0346C49E996932D86AC62E-LA URA. CALI G] 

Sent: 3/2/2020 6:20:13 PM 

To: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; M cWil Ii a ms, Carly 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b68c7 458214244d08424fd441 fea4fda-Ca rlyl e. M cW]; Janik, Heather 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =117bc4d27 d7b4 7 dd bebeeeSffeeb 7f3d-H eather .Jan]; Lynch, Sarah 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =d24ee4a4fc6241 f48110d6b35e6704ed-Sa rah. Lynch]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Lutter, Randall [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=868b21db20e3456ab4elb3109b56c23f-Randall.Lut]; Shah, Anand 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=e2172ebbd96946c08e 189fd612855f51-Anand.Shah]; Rom, Col in 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f59636221 f 4340d697 d bd43ee27255fb-Col in. Rom]; Gross, Karas 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =0b6d3dc4ee4b415d86ec634c536453b6-Ka ra. Gross]; Black, Jennifer 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=aaf8a19f3672492293a7clb2d1498059-Jennifer.BI]; Tantillo, Andrew 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=c43045bfeef846fa99daa0c3d4772alc-Andrew.Tant]; Rath, Prakash (FDA) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9 lbc5673d b6c416e87a453f8b9527 cc0-Pra kash. Rat]; Scherf, Uwe 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=b184b713fc4d4edc84dlaed078aafec7-UXS]; Sapsford, Kim E 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =564aa450b 77d455b922015ece2101829-KIS] 

RE: Science Magazine Article 

+ Peter who is in communication with WHO on this. Will let Peter share her response in detail but topline, this is 

inaccurate. They don't ship testing kits, they do provide assays. 

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laborato y-guidance 

From: Mair, Michael <Michael.Mair@fda.hhs.gov> 

Sent: Monday, March 2, 2020 6:16 PM 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; Scherf, Uwe 

<Uwe.Scherf@fda.hhs.gov>; Sapsford, Kim E <Kim.Sapsford@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

On 27 Feb, Tedros said that WHO has "shipped testing kits to 57 countries and personal protective equipment to 85 

countries who need it." Copying CDRH folks in case they have info on what WHO has shipped 

From: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> 

Sent: Monday, March 2, 2020 5:55 PM 

To: Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <_La_u_r_a_.C_a_li_��--�-

FDA-OSJ I-FOIA-2020-3541 _00000981 
<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Subject: Science Magazine Article 

Hi, I was sent this article by Randy. Based on the talking points I have seen though,i (b)(5) 

(b)(5) 

Were they coordinating distribution of tests? Fortunately, it does note that things will get better. Could 

wei (b)(5) i 

The United States badly bungled coronavirus testing-but things 

may soon improve 

By Jon Cohen Feb. 28, 2020 , 545 PM 

Speed is critical in the response to COVID-19. So why has the United States been so slow in its 

attempt to develop reliable diagnostic tests and use them widely? 

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five 

commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South 

Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), 

in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit 

to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the 

country eager to test more suspected cases-and test them faster-have been unable to do so. No 

commercial or state labs have the approval to use their own tests. 

In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern 

California who turned out to be the first probable COVID19 case without known links to an infected 

person. 

The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is 

accurate. the official tally of 60 confirmed cases in the United States is accurate. "There have been blunders, 

and there could be an underlying catastrophe that we don't know about," says epidemiologist Michael Mina, 

who helps run a microbiology testing lab at Brigham and Women's Hospital. "It's been very complicated and 

confusing for everyone with almost no clarity being provided by the CDC." 

The situation may soon improve. State labs and commercial diagnostic developers hope to win 

approval from the Food and Drug Administration (FDA) for their own tests, and FDA and CDC on 

Wednesday agreed on a workaround for the faulty CDC kit-which has a problem that is not essential 

to its proper functioning-so that it can now be used by at least some of the state labs that have it. 

But there's widespread discontent with the way the system has worked. "The U.S. government has 

not appropriately prioritized diagnostic tests and supported the laboratory response network to the 

degree they should have been supported over the years," says Luciana Borio, who in previous jobs 

had lead roles in responding to emerging threats at the National Security Council and FDA 

FDA-OSJ I-FOIA-2020-3541 _00000982 
If a new disease emerges, CDC normally "gets the ball rolling" with diagnostics because it has the 

expertise and the biosafety laboratories to handle dangerous novel pathogens, says Borio, who now 

works for ln-Q-Tel, a not-for-profit venture capital firm. Typically, there are few confirmed viral 

samples from patients at the outset, which researchers need to validate their tests, and CDC has the 

capability to grow the virus for this critical quality assurance step. Once the agency has a working 

test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce 

their own tests or scale-up the CDC one. "I would have hoped to see that third phase by now," Borio 

says. 

In the case of SARS-CoV-2, as the virus causing COVID-19 is officially known, CDC's sluggishness 

was apparent 1 month ago. On 26 January, the agency held an unusual Sunday teleconference for 

the media to provide an update about the rapidly growing outbreak. There were then five cases in the 

United States, but the CDC lab in Atlanta was still the only one in the country able to test for the virus, 

and it repeatedly had backlogs. Asked why more labs weren't able to do the tests, Nancy Messonnier, 

who then was leading CDC's response, said it was a quality issue. "We hold ourselves to an 

incredibly high standard of precision in terms of laboratory testing," Messonnier said. "We wouldn't 

want to inadvertently make a mistake in patient care." 

CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it 

revealed that several labs had difficulty validating the test because of a problem with one of the 

reagents. 

The key problem with the kits is what's known as a negative control, says Kelly Wroblewski, director 

of infectious diseases at the Association of Public Health Laboratories (APHL). CDC's test uses the 

polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a 

nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. 

The assay should not react to this negative control, but the CDC reagents did at many, but not all, 

state labs. The labs where the negative control failed were not allowed to use the test; they have to 

continue to send their samples to Atlanta. 

The declaration of a public health emergency ... limited the diagnostic capacity of this 

country. It's insane. 

Michael Mina, Brigham and Women's Hospital 

In principle, many hospital and academic labs around the country have the capability to carry out tests 

themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The 

CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. 

Well-equipped state or local labs can use these-or come up with their own-to produce what are known as a 

"laboratory-developed tests" for in-house use. 

But at the moment, they're not allowed to do that without FDA approval. When the United 

States declared the outbreak a public health emergency on 31 January, a bureaucratic process 

kicked in that requires FDA's "emergency use approval" for any tests. "The declaration of a public 

health emergency did exactly what it shouldn't have. It limited the diagnostic capacity of this country," 

Mina says. "It's insane." 

On 24 February, APHL asked FDA Commissioner Stephen Hahn for "enforcement discretion" to 

sidestep the emergency process and allow APHL members labs to use their own tests. On 26 

February, Hahn replied that the CDC test could be modified to use just the primers that specifically 

detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look 

the other way to make more widespread testing possible. 

CDC has notified labs of FDA's decision in a letter, but the agency must still file an emergency use 

authorization with FDA for the protocol change. Once it does, it won't take long, Hahn promised in his 

letter to APHL: "FDA has been able to authorize tests for public health emergencies within as little as 

1 day upon receipt of the complete validation." 

FDA-OSJ I-FOIA-2020-3541 _00000983 
In New York, the State Department of Health has designed its own test based on the CDC protocol 

and plans to seek emergency use authorization. 

CDC provided an update about the situation in an email but did not respond to Science's request for 

an interview with a scientist to discuss the details of the problem. Mina stresses he has great respect 

for CDC's competence overall, but says, "There's no good explanation for what's going on here." 

FDA-OSJ I-FOIA-2020-3541 _00000984 
From: 

Sent: 

Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECA0BE0694803BE6030E97C7B4ADB-HINTOND] 

3/2/2020 8:10:25 PM 

To: Mair, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai] 

FW: Science Magazine Article 

From: Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov> 

Sent: Monday, March 2, 2020 7:25 PM 

To: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>; 

Tomasello, Jennifer <Jennifer.Tomasello@fda.hhs.gov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

Sidenote, there is another chain on this and Peter has been running to ground with WHO. 

From: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Sent: Monday, March 2, 2020 7:21 PM 

To: McWilliams, Carly <Carl .McWilliams fda.hhs. ov>; Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov>; Paulos, 

Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather 

<Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Cali uiri fda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; 

Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov> 

Subject: RE: Science Magazine Article 

Yes, there are several publications that I'll be reaching out to, thanks for following up. 

From: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> 

Sent: Monday, March 02, 2020 7:13 PM 

To: Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Cali uiri fda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; 

Hinton, Denise <Denise.Hinton fda.hhs. ov>; Caccamo, Stephanie <Ste hanie.Caccomo fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov> 

Subject: RE: Science Magazine Article 

; 

Extremely helpful. I neglected to include Stephanie on this chain. Stephanie and Laur� (b )( 5) (b)(5) i �- -------� 

FDA-OSJ I-FOIA-2020-3541 _00000976 
From: Tomasello, Jennifer <Jennifer.Tomasello@fda.hhs.gov> 

Date: March 2, 2020 at 7:06:18 PM EST 

To: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>, McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Cali uiri fda.hhs. ov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>, Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov> 

Subject: RE: Science Magazine Article 

Thanks again all. 

Jeff said WHO confirmed that they have not made a test, shipped a test, or listed a test. The news stories are not 

accurate, so we should be clear about it. 

Best, 

Jennifer 

Jennifer Brown Tomasello, MPA 

Senior Policy Advisor 

Center for Devices and Radiological Health 

Office of Policy 

U.S. Food and Drug Administration 

Tel 301-796-8924 CellL_ _________ (b)(6) -·-·-·-·-·-·! 

iennifer.tomasello@fda.hhs.gov 

U.S. FOOD & DRUG 

A0MINISTllAltON 

DClm •• II 

E'(cellenl customer service is important to us. Please take a moment to provide feedback regarding the customer service you have 

received: 

h s:/lwww.research.net/slcdrhcustomerservice?ID=5000&S=E 

From: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Sent: Monday, March 2, 2020 6:20 PM 

To: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; McWilliams, Carly <-"-C=ar--'-IL...C..C.----"-'---'--=='----"--"'"--'--'='---'-'--'-'--'-'-'-''--'­

Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Cali uiri fda.hhs. ov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov>; Tomasello, Jennifer 

<Jennifer.Tomasello fda.hhs. ov> 

Subject: Re: Science Magazine Article 

Looping in Tim and Jennifer. 

From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

FDA-OSJ I-FOIA-2020-3541 _00000977 
Date: March 2, 2020 at 6:12:00 PM EST 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>, Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Subject: Re: Science Magazine Article 

+ Lauren 

From: McWilliams, Carly <Carl .McWilliams fda.hhs. ov> 

Date: March 2, 2020 at 5:54:45 PM EST 

To: Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura <Laura.Cali uiri 

<Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Subject: Science Magazine Article 

Hi, I was sent this article by Randy. Based on the talking points I have seen though,! (b)(5) 

(b)(5) ·-·- . ·------. 

Were they coordinatina distribution of tests? Fortunately it does note that thinas will aet better. Could 

we 1. i (b)(5) ·- ·i 

The United States badly bungled coronavirus testing-but things 

may soon improve 

By Jon Cohen Feb. 28, 2020 , 545 PM 

Speed is critical in the response to COVID-19. So why has the United States been so slow in its 

attempt to develop reliable diagnostic tests and use them widely? 

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five 

commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South 

Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), 

in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit 

to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the 

country eager to test more suspected cases-and test them faster-have been unable to do so. No 

commercial or state labs have the approval to use their own tests. 

FDA-OSJ I-FOIA-2020-3541 _00000978 
In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern 

California who turned out to be the first probable COVID19 case without known links to an infected 

person. 

The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is 

accurate. the official tally of 60 confirmed cases in the United States is accurate. "There have been blunders, 

and there could be an underlying catastrophe that we don't know about," says epidemiologist Michael Mina, 

who helps run a microbiology testing lab at Brigham and Women's Hospital. "It's been very complicated and 

confusing for everyone with almost no clarity being provided by the CDC." 

The situation may soon improve. State labs and commercial diagnostic developers hope to win 

approval from the Food and Drug Administration (FDA) for their own tests, and FDA and CDC on 

Wednesday agreed on a workaround for the faulty CDC kit-which has a problem that is not essential 

to its proper functioning-so that it can now be used by at least some of the state labs that have it. 

But there's widespread discontent with the way the system has worked. "The U.S. government has 

not appropriately prioritized diagnostic tests and supported the laboratory response network to the 

degree they should have been supported over the years," says Luciana Borio, who in previous jobs 

had lead roles in responding to emerging threats at the National Security Council and FDA 

If a new disease emerges, CDC normally "gets the ball rolling" with diagnostics because it has the 

expertise and the biosafety laboratories to handle dangerous novel pathogens, says Borio, who now 

works for ln-Q-Tel, a not-for-profit venture capital firm. Typically, there are few confirmed viral 

samples from patients at the outset, which researchers need to validate their tests, and CDC has the 

capability to grow the virus for this critical quality assurance step. Once the agency has a working 

test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce 

their own tests or scale-up the CDC one. "I would have hoped to see that third phase by now," Borio 

says. 

In the case of SARS-CoV-2, as the virus causing COVID-19 is officially known, CDC's sluggishness 

was apparent 1 month ago. On 26 January, the agency held an unusual Sunday teleconference for 

the media to provide an update about the rapidly growing outbreak. There were then five cases in the 

United States, but the CDC lab in Atlanta was still the only one in the country able to test for the virus, 

and it repeatedly had backlogs. Asked why more labs weren't able to do the tests, Nancy Messonnier, 

who then was leading CDC's response, said it was a quality issue. "We hold ourselves to an 

incredibly high standard of precision in terms of laboratory testing," Messonnier said. "We wouldn't 

want to inadvertently make a mistake in patient care." 

CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it 

revealed that several labs had difficulty validating the test because of a problem with one of the 

reagents. 

The key problem with the kits is what's known as a negative control, says Kelly Wroblewski, director 

of infectious diseases at the Association of Public Health Laboratories (APHL). CDC's test uses the 

polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a 

nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. 

The assay should not react to this negative control, but the CDC reagents did at many, but not all, 

state labs. The labs where the negative control failed were not allowed to use the test; they have to 

continue to send their samples to Atlanta. 

The declaration of a public health emergency ... limited the diagnostic capacity of this 

country. It's insane. 

Michael Mina, Brigham and Women's Hospital 

In principle, many hospital and academic labs around the country have the capability to carry out tests 

themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The 

CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. 

FDA-OSJ I-FOIA-2020-3541 _00000979 
Well-equipped state or local labs can use these-or come up with their own-to produce what are known as a 

"laboratory-developed tests" for in-house use. 

But at the moment, they're not allowed to do that without FDA approval. When the United 

States declared the outbreak a public health emergency on 31 January, a bureaucratic process 

kicked in that requires FDA's "emergency use approval" for any tests. "The declaration of a public 

health emergency did exactly what it shouldn't have. It limited the diagnostic capacity of this country," 

Mina says. "It's insane." 

On 24 February, APHL asked FDA Commissioner Stephen Hahn for "enforcement discretion" to 

sidestep the emergency process and allow APHL members labs to use their own tests. On 26 

February, Hahn replied that the CDC test could be modified to use just the primers that specifically 

detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look 

the other way to make more widespread testing possible. 

CDC has notified labs of FDA's decision in a letter, but the agency must still file an emergency use 

authorization with FDA for the protocol change. Once it does, it won't take long, Hahn promised in his 

letter to APHL: "FDA has been able to authorize tests for public health emergencies within as little as 

1 day upon receipt of the complete validation." 

In New York, the State Department of Health has designed its own test based on the CDC protocol 

and plans to seek emergency use authorization. 

CDC provided an update about the situation in an email but did not respond to Science's request for 

an interview with a scientist to discuss the details of the problem. Mina stresses he has great respect 

for CDC's competence overall, but says, "There's no good explanation for what's going on here." 

FDA-OSJ I-FOIA-2020-3541 _00000980 
From: 

Sent: 

To: 

Subject: 

Attachments: 

Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECA0BE0694803BE6030E97C7B4ADB-HINTOND] 

3/15/2020 4:16:41 PM 

Farley, John [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Cavazzo ni, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Clarke, Mary Beth 

[Marybeth.Clarke@fda.hhs.gov] 

Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Therapeutics TPs 03152020 324pm.docx 

Hi - sorry for short notice - any input before Michael Felderbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJ I-FOIA-2020-3541 _00000359 
From: Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECA0BE0694803BE6030E97C7B4ADB-HINTOND] 

Sent: 3/19/2020 6:45:11 PM 

To: Nabakowski, Andrei [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =8c8bcecc310c4e45a 5012d4 7 d40886e 1-NABAKOWSKIA] 

Subject: FW: FOR YOUR REVIEW: today's all hands 

Attachments: Day 4 all hands.rtf 

From: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 4:59 PM 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Abernethy, Amy 

<Amy.Abernethy@fda.hhs.gov>; Hebert, Angelique A.<Angelique.Hebert@fda.hhs.gov> 

Cc: Sigg, Jim <Jim.Sigg@fda.hhs.gov>; Tse, Tania <Tania.Tse@fda.hhs.gov> 

Subject: FOR YOUR REVIEW: today's all hands 

Please review today's draft all hands. 00 secured clearance with center EOs on the 3rd paragraph detailing reporting 

requirements. 

FDA-OSJ I-FOIA-2020-3541_00000974 
Sincerely, 

Stephen M. Hahn, M.D. 

Commissioner of Food and Drugs 

FDA-OSJI-FOIA-2020-3541_00000975 
From: Lenihan, Keagan [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =EE7320E E8C184D66 BFD521B0105D 17D2-KEAGAN. LEN I] 

Sent: 1/28/2020 1:03:58 PM 

To: Copeland, Jakea [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =d7fe05ed 233c42b68be990b12a e2c8c8-Ja kea. Copel] 

Subject: FW: TELECON: Weekly CBER Meeting with the Commissioner and Chief of Staff 

Attachments: CBER Agenda for January 29.docx 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Tuesday, January 28, 2020 12:48 PM 

To: Olivarria, Frank <Frank.Olivarria@fda.hhs.gov> 

Cc: Jenkins, Charlene <Charlene.Jenkins@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Abram, Anna 

<Anna.Abram@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Witten, Celia (CBER) 

<Celia.Witten@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Subject: RE: TELECON: Weekly CBER Meeting with the Commissioner and Chief of Staff 

Dear Frank, 

Please see the attached. Thanks very much. 

Best Regards, 

Peter 

From: Olivarria, Frank <Frank.Olivarria@fda.hhs.gov> 

Sent: Tuesday, January 28, 2020 12:26 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Jenkins, Charlene <Charlene.Jenkins fda.hhs. ov> 

Subject: RE: TELECON: Weekly CBER Meeting with the Commissioner and Chief of Staff 

Hi Dr. Marks, 

I know you're generally on this without a reminder or inquiry, simply a gentle reminder that agenda items are for 

tomorrow's Weekly CBER Mtg, if you have them to us by 4:30 PM today, we'll be able to send the Commissioner with a 

hardcopy. 

Thank you, 

Frank 

-----Original Appointment-----

From: Sheehy, Janice On Behalf Of Hahn, Stephen 

Sent: Monday, December 30, 2019 11:56 AM 

To: Hahn, Stephen; Marks, Peter; Witten, Celia (CBER); Keagan Lenihan ('"""'Ke.cc..acc.u..c�=.c.....c..c...c..c'--'-'-"-....C....C=..c..c...c..c.cu..c_.c.. 

FDA (Anna.Abram@fda.hhs.gov) 

Cc: Tierney, Julia 

Subject: TELECON: Weekly CBER Meeting with the Commissioner and Chief of Staff 

When: Wednesday, January 29, 2020 2:30 PM-3:00 PM (UTC-05:00) Eastern Time (US & Canada). 

Where: 1-877-465-7975,,j (b)(6) � 

FDA-OSJ I-FOIA-2020-3541 _00000602 
From: Lenihan, Keagan [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =EE7320E E8C184D66 BFD521B0105D 17D2-KEAGAN. LEN I] 

Sent: 1/31/2020 5:06:01 PM 

To: Olivarria, Frank [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c 18072 ld b 77 4423f99990dd86e6705 7 c-Fra n k. 01 iva]; Rom, Col in 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f59636221 f 4340d697 d bd43ee27255fb-Col in. Rom] 

FW: Vaccine TPs 

Attachments: Considerations in coronavirus vaccine development 013120.docx 

Updated talkers for AMA meeting. 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, January 31, 2020 4:56 PM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Abram, Anna <Anna.Abram@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: Vaccine TPs 

Dear Keagan, 

Here is a slightly updated version of the TPs. Don't expect any more edits for now on our end until we have some more 

data. 

Best Regards, 

Peter 

From: Marks, Peter 

Sent: Friday, January 31, 2020 8:04 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Anna Abram (Anna.Abram@fda.hhs.gov) <Anna.Abram@fda.hhs.gov>; Hinton, Denise 

<Denise.Hinton@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Cho, David S (CBER) 

(David.Cho@fda.hhs.gov) <David.Cho@fda.hhs.gov> 

Subject: Vaccine TPs 

Dear Keagan, 

Please see the attached talking points on vaccine development. We have tried to distill this down and use the least 

technical language. Just let me know if you have any questions. 

Best Regards, 

Peter 

FDA-OSJ I-FOIA-2020-3541 _00000597 
From: 

Sent: 

To: 

Keagan.Lenihan@fda.hhs.gov [Keagan.Lenihan@fda.hhs.gov] 

3/2/2020 9:11:20 PM 

McWilliams, Carly [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =b68c7 458214244d08424fd441 fea4fda-Ca rlyl e. M cW] 

Re: Science Magazine Article+ UPDATE+ TOMORROW's Plan 

Would like to see anything before it goes to SH. Thanks. 

Sent from my iPhone 

On Mar 2, 2020, at 9:07 PM, McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> wrote: 

Thank you all for your attention on this. I am also going to be helping coordinate on this outbreak from the 

commissioners office. Trying to loop the two groups together for tomorrow's deliverables based on the WHTF meeting 

this afternoon. 

The VP has asked Dr. Hahn to address two things at the press conference in the afternoon 1. CDC lab contamination and 

2. Clarification that the WHO is not actually manufacturing/developing tests. So, we do not need to do press outreach as 

he is going to proactively discuss at press conference and this could also potentially be brought up at hearing for 

tomorrmN. (b)(5) 

Dr. Marks, please let us know what you learn from WHO on testing. 

Stephanie and I developed talking points for the press conference. We are going to send to Denise and Michael first this 

evening and then it will go through the clearance process which needs to be done by 1PM TOMORROW. 

Separately, I will also be pulling together his background for his briefing at WHTF tomorrow on any updates, which will 

also be due at 1pm tomorrow. I will be pulling that from this evenings sit rep. 

Thank you in advance for your help and please let me know if you have questions. 

From: Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov> 

Sent: Monday, March 2, 2020 7:25 PM 

To: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>; 

Tomasello, Jennifer <Jennifer.Tomasello@fda.hhs.gov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

FDA-OSJI-FOIA-2020-3541_00001024 
Sidenote, there is another chain on this and Peter has been running to ground with WHO. 

From: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Sent: Monday, March 2, 2020 7:21 PM 

To: McWilliams, Carly <Carl .McWilliams fda.hhs. ov>; Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov>; Paulos, 

Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather 

<Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Cali uiri fda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; 

Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

Yes, there are several publications that I'll be reaching out to, thanks for following up. 

From: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> 

Sent: Monday, March 02, 2020 7:13 PM 

To: Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Cali uiri fda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; 

Hinton, Denise <Denise.Hinton fda.hhs. ov>; Caccamo, Stephanie <Ste hanie.Caccomo fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

; 

;_.Extr.emeJy_bel.oful • .J..)1eglected to include Stephanie on this chain. Stephanie and Laura1 (b}(5} i (b)(5) i �- ----� 

From: Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov> 

Date: March 2, 2020 at 7:06:18 PM EST 

To: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>, McWilliams, Carly 

<Carl .McWilliams fda.hhs. ov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Cali uiri fda.hhs. ov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>, Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov> 

Subject: RE: Science Magazine Article 

Thanks again all. 

Jeff said WHO confirmed that they have not made a test, shipped a test, or listed a test. The news stories are not 

accurate, so we should be clear about it. 

Best, 

Jennifer 

Jennifer Brown Tomasello, MPA 

Senior Policy Advisor 

FDA-OSJI-FOIA-2020-3541_00001025 
Center for Devices and Radiological Health 

Office of Policy 

U.S. Food and Drup-4.dmini.sJ:r.a.tinn. _______ ; 

Tel 301-796-8924 l (bJ16) ! 

iennifer.tornasello@fda.hhs.gov 

<i rnage007. png> 

<i rnage009 .jpg> 

<irnage011.jpg> 

<irnage013.jpg> 

<irnage015.jpg> 

<i rnage0 17 .jpg> 

E-.;cellenr customer service is important to us. Please take a moment to provide feedback regarding the customer service you have 

received: 

h s:/lwww.research.net/slcdrhcustomerservice?JD=5000&S=E 

From: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Sent: Monday, March 2, 2020 6:20 PM 

To: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; McWilliams, Carly <_C_ar_l�---�---�­

Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Cali uiri fda.hhs. ov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov>; Tomasello, Jennifer 

<Jennifer.Tomasello fda.hhs. ov> 

Subject: Re: Science Magazine Article 

Looping in Tim and Jennifer. 

From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Date: March 2, 2020 at 6:12:00 PM EST 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>, Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Subject: Re: Science Magazine Article 

+ Lauren 

From: McWilliams, Carly <Carl .McWilliams 

Date: March 2, 2020 at 5:54:45 PM EST 

FDA-OSJI-FOIA-2020-3541_00001026 
To: Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>, Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Subject: Science Magazine Article 

Hi, I was sent this article by Randy. Based on the ta_l_k_i_D..g points I have seen thougt}1.�i -�(b)(5)_� 

i (b)(5) 

Were they coordinating distribution of tests? Fortunately, it does note that thinqs will get better. Could 

__ w_e: (b)(§_} i 

The United States badly bungled coronavirus testing-but things 

may soon improve 

By Jon Cohen Feb. 28, 2020 , 545 PM 

Speed is critical in the response to COVID-19. So why has the United States been so slow in its 

attempt to develop reliable diagnostic tests and use them widely? 

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five 

commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South 

Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), 

in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit 

to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the 

country eager to test more suspected cases-and test them faster-have been unable to do so. No 

commercial or state labs have the approval to use their own tests. 

In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern 

California who turned out to be the first probable COVID19 case without known links to an infected 

person. 

The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is 

accurate. the official tally of 60 confirmed cases in the United States is accurate. "There have been blunders, 

and there could be an underlying catastrophe that we don't know about," says epidemiologist Michael Mina, 

who helps run a microbiology testing lab at Brigham and Women's Hospital. "It's been very complicated and 

confusing for everyone with almost no clarity being provided by the CDC." 

The situation may soon improve. State labs and commercial diagnostic developers hope to win 

approval from the Food and Drug Administration (FDA) for their own tests, and FDA and CDC on 

Wednesday agreed on a workaround for the faulty CDC kit-which has a problem that is not essential 

to its proper functioning-so that it can now be used by at least some of the state labs that have it. 

But there's widespread discontent with the way the system has worked. "The U.S. government has 

not appropriately prioritized diagnostic tests and supported the laboratory response network to the 

degree they should have been supported over the years," says Luciana Borio, who in previous jobs 

had lead roles in responding to emerging threats at the National Security Council and FDA 

FDA-OSJI-FOIA-2020-3541_00001027 
If a new disease emerges, CDC normally "gets the ball rolling" with diagnostics because it has the 

expertise and the biosafety laboratories to handle dangerous novel pathogens, says Borio, who now 

works for ln-Q-Tel, a not-for-profit venture capital firm. Typically, there are few confirmed viral 

samples from patients at the outset, which researchers need to validate their tests, and CDC has the 

capability to grow the virus for this critical quality assurance step. Once the agency has a working 

test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce 

their own tests or scale-up the CDC one. "I would have hoped to see that third phase by now," Borio 

says. 

In the case of SARS-CoV-2, as the virus causing COVID-19 is officially known, CDC's sluggishness 

was apparent 1 month ago. On 26 January, the agency held an unusual Sunday teleconference for 

the media to provide an update about the rapidly growing outbreak. There were then five cases in the 

United States, but the CDC lab in Atlanta was still the only one in the country able to test for the virus, 

and it repeatedly had backlogs. Asked why more labs weren't able to do the tests, Nancy Messonnier, 

who then was leading CDC's response, said it was a quality issue. "We hold ourselves to an 

incredibly high standard of precision in terms of laboratory testing," Messonnier said. "We wouldn't 

want to inadvertently make a mistake in patient care." 

CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it 

revealed that several labs had difficulty validating the test because of a problem with one of the 

reagents. 

The key problem with the kits is what's known as a negative control, says Kelly Wroblewski, director 

of infectious diseases at the Association of Public Health Laboratories (APHL). CDC's test uses the 

polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a 

nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. 

The assay should not react to this negative control, but the CDC reagents did at many, but not all, 

state labs. The labs where the negative control failed were not allowed to use the test; they have to 

continue to send their samples to Atlanta. 

The declaration of a public health emergency ... limited the diagnostic capacity of this 

country. It's insane. 

Michael Mina, Brigham and Women's Hospital 

In principle, many hospital and academic labs around the country have the capability to carry out tests 

themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The 

CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. 

Well-equipped state or local labs can use these-or come up with their own-to produce what are known as a 

"laboratory-developed tests" for in-house use. 

But at the moment, they're not allowed to do that without FDA approval. When the United 

States declared the outbreak a public health emergency on 31 January, a bureaucratic process 

kicked in that requires FDA's "emergency use approval" for any tests. "The declaration of a public 

health emergency did exactly what it shouldn't have. It limited the diagnostic capacity of this country," 

Mina says. "It's insane." 

On 24 February, APHL asked FDA Commissioner Stephen Hahn for "enforcement discretion" to 

sidestep the emergency process and allow APHL members labs to use their own tests. On 26 

February, Hahn replied that the CDC test could be modified to use just the primers that specifically 

detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look 

the other way to make more widespread testing possible. 

CDC has notified labs of FDA's decision in a letter, but the agency must still file an emergency use 

authorization with FDA for the protocol change. Once it does, it won't take long, Hahn promised in his 

letter to APHL: "FDA has been able to authorize tests for public health emergencies within as little as 

1 day upon receipt of the complete validation." 

FDA-OSJI-FOIA-2020-3541_00001028 
In New York, the State Department of Health has designed its own test based on the CDC protocol 

and plans to seek emergency use authorization. 

CDC provided an update about the situation in an email but did not respond to Science's request for 

an interview with a scientist to discuss the details of the problem. Mina stresses he has great respect 

for CDC's competence overall, but says, "There's no good explanation for what's going on here." 

FDA-OSJI-FOIA-2020-3541_00001029 
From: McWilliams, Carly [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =B68C7 45 8214244D08424F D441FEA4FDA-CARL YLE. MCW] 

3/2/2020 9:12:01 PM 

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =ee 7320ee8c184d66bfd52 lb0105d 17 d2-Keaga n. Len i] 

RE: Science Magazine Article+ UPDATE+ TOMORROW's Plan 

Yes. Are you in clearance chain? Will make sure it goes to you after if you are not already in the chain. 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Monday, March 2, 2020 9:11 PM 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> 

Subject: Re: Science Magazine Article+ UPDATE+ TOMORROW's Plan 

Would like to see anything before it goes to SH. Thanks. 

Sent from my iPhone 

Thank you all for your attention on this. I am also going to be helping coordinate on this outbreak from the 

commissioners office. Trying to loop the two groups together for tomorrow's deliverables based on the WHTF meeting 

this afternoon. 

The VP has asked Dr. Hahn to address two things at the press conference in the afternoon 1. CDC lab contamination and 

2. Clarification that the WHO is not actually manufacturing/developing tests. So, we do not need to do press outreach as 

he is going to proactively discuss at press conference and this could also potentially be brought up at hearing for 

tomorrow! (b)(5) 

Dr. Marks, please let us know what you learn from WHO on testing. 

Stephanie and I developed talking points for the press conference. We are going to send to Denise and Michael first this 

evening and then it will go through the clearance process which needs to be done by 1PM TOMORROW. 

Separately, I will also be pulling together his background for his briefing at WHTF tomorrow on any updates, which will 

also be due at 1pm tomorrow. I will be pulling that from this evenings sit rep. 

Thank you in advance for your help and please let me know if you have questions. 

From: Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov> 

Sent: Monday, March 2, 2020 7:25 PM 

To: Caccamo, Stephanie <Ste hanie.Caccomo ov>; McWilliams, Carly <Carl .McWilliams ov>; 

FDA-OSJI-FOIA-2020-3541_00001037 
Tomasello, Jennifer <Jennifer.Tomasello@fda.hhs.gov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov> 

Subject: RE: Science Magazine Article 

Sidenote, there is another chain on this and Peter has been running to ground with WHO. 

From: Caccamo, Stephanie <Ste hanie.Caccomo fda.hhs. ov> 

Sent: Monday, March 2, 2020 7:21 PM 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>; Tomasello, Jennifer <Jennifer.Tomasello@fda.hhs.gov>; Paulos, 

Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather 

<Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; 

Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov> 

Subject: RE: Science Magazine Article 

Yes, there are several publications that I'll be reaching out to, thanks for following up. 

From: McWilliams, Carly <Carl .McWilliams fda.hhs. ov> 

Sent: Monday, March 02, 2020 7:13 PM 

To: Tomasello, Jennifer <Jennifer.Tomasello@fda.hhs.gov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; 

Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov> 

Subject: RE: Science Magazine Article 

Extremely helpful. I neglected to include Stephanie on this chain. Stephanie and Laurai �---���----� (b)(5) 

(b)(5) 

From: Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov> 

Date: March 2, 2020 at 7:06:18 PM EST 

To: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>, McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>, Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

Thanks again all. 

FDA-OSJI-FOIA-2020-3541_00001038 
Jeff said WHO confirmed that they have not made a test, shipped a test, or listed a test. The news stories are not 

accurate, so we should be clear about it. 

Best, 

Jennifer 

Jennifer Brown Tomasello, MPA 

Senior Policy Advisor 

Center for Devices and Radiological Health 

Office of Policy 

U.S. Food and Dm�i_.L\rl.mh:ii"'-t.r.atinn.. __________ , 

Tel 301-796-8924 � (b)(G) i iennifer.tornasello@fda.hhs.gov 

<i rnage007. png> 

<i rnage009 .jpg> 

<irnage011.jpg> 

<irnage013.jpg> 

<irnage015.jpg> 

<i rnage0 17 .jpg> 

E'(cellenl customer service is important to us. Please take a moment to provide feedback regarding the customer service you have 

received: 

h s:/lwww.research.net/slcdrhcustomerservice?ID=5000&S=E 

From: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Sent: Monday, March 2, 2020 6:20 PM 

To: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; McWilliams, Carly <_C_ar_l�---�---�­

Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Cali uiri fda.hhs. ov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>; Stenzel, Timothy <Ti moth .Stenzel fda.hhs. ov>; Tomasello, Jennifer 

<Jennifer.Tomasello fda.hhs. ov> 

Subject: Re: Science Magazine Article 

Looping in Tim and Jennifer. 

From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Date: March 2, 2020 at 6:12:00 PM EST 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>, Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Subject: Re: Science Magazine Article 

FDA-OSJI-FOIA-2020-3541_00001039 
+ Lauren 

From: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> 

Date: March 2, 2020 at 5:54:45 PM EST 

To: Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura <Laura.Cali uiri fda.hhs. ov>, Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Subject: Science Magazine Article 

Hi, I was sent this article by Randy. Based on the talking points I have seen though, i (!:?l(§�> -� (b)(5) 

Were they coordinating distribution of tests? Fortunately1 it does note that things will get better. Could 

we 1 (b).(5) ! 

The United States badly bungled coronavirus testing-but things 

may soon improve 

By Jon Cohen Feb. 28, 2020 , 545 PM 

Speed is critical in the response to COVID-19. So why has the United States been so slow in its 

attempt to develop reliable diagnostic tests and use them widely? 

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five 

commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South 

Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), 

in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit 

to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the 

country eager to test more suspected cases-and test them faster-have been unable to do so. No 

commercial or state labs have the approval to use their own tests. 

In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern 

California who turned out to be the first probable COVID19 case without known links to an infected 

person. 

The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is 

accurate. the official tally of 60 confirmed cases in the United States is accurate. "There have been blunders, 

and there could be an underlying catastrophe that we don't know about," says epidemiologist Michael Mina, 

who helps run a microbiology testing lab at Brigham and Women's Hospital. "It's been very complicated and 

confusing for everyone with almost no clarity being provided by the CDC." 

The situation may soon improve. State labs and commercial diagnostic developers hope to win 

approval from the Food and Drug Administration (FDA) for their own tests, and FDA and CDC on 

FDA-OSJI-FOIA-2020-3541_00001040 
Wednesday agreed on a workaround for the faulty CDC kit-which has a problem that is not essential 

to its proper functioning-so that it can now be used by at least some of the state labs that have it 

But there's widespread discontent with the way the system has worked. "The U.S. government has 

not appropriately prioritized diagnostic tests and supported the laboratory response network to the 

degree they should have been supported over the years," says Luciana Borio, who in previous jobs 

had lead roles in responding to emerging threats at the National Security Council and FDA 

If a new disease emerges, CDC normally "gets the ball rolling" with diagnostics because it has the 

expertise and the biosafety laboratories to handle dangerous novel pathogens, says Borio, who now 

works for ln-Q-Tel, a not-for-profit venture capital firm. Typically, there are few confirmed viral 

samples from patients at the outset, which researchers need to validate their tests, and CDC has the 

capability to grow the virus for this critical quality assurance step. Once the agency has a working 

test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce 

their own tests or scale-up the CDC one. "I would have hoped to see that third phase by now," Borio 

says. 

In the case of SARS-CoV-2, as the virus causing COVID-19 is officially known, CDC's sluggishness 

was apparent 1 month ago. On 26 January, the agency held an unusual Sunday teleconference for 

the media to provide an update about the rapidly growing outbreak. There were then five cases in the 

United States, but the CDC lab in Atlanta was still the only one in the country able to test for the virus, 

and it repeatedly had backlogs. Asked why more labs weren't able to do the tests, Nancy Messonnier, 

who then was leading CDC's response, said it was a quality issue. "We hold ourselves to an 

incredibly high standard of precision in terms of laboratory testing," Messonnier said. "We wouldn't 

want to inadvertently make a mistake in patient care." 

CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it 

revealed that several labs had difficulty validating the test because of a problem with one of the 

reagents. 

The key problem with the kits is what's known as a negative control, says Kelly Wroblewski, director 

of infectious diseases at the Association of Public Health Laboratories (APHL). CDC's test uses the 

polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a 

nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. 

The assay should not react to this negative control, but the CDC reagents did at many, but not all, 

state labs. The labs where the negative control failed were not allowed to use the test; they have to 

continue to send their samples to Atlanta. 

The declaration of a public health emergency ... limited the diagnostic capacity of this 

country. It's insane. 

Michael Mina, Brigham and Women's Hospital 

In principle, many hospital and academic labs around the country have the capability to carry out tests 

themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The 

CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. 

Well-equipped state or local labs can use these-or come up with their own-to produce what are known as a 

"laboratory-developed tests" for in-house use. 

But at the moment, they're not allowed to do that without FDA approval. When the United 

States declared the outbreak a public health emergency on 31 January, a bureaucratic process 

kicked in that requires FDA's "emergency use approval" for any tests. "The declaration of a public 

health emergency did exactly what it shouldn't have. It limited the diagnostic capacity of this country," 

Mina says. "It's insane." 

On 24 February, APHL asked FDA Commissioner Stephen Hahn for "enforcement discretion" to 

sidestep the emergency process and allow APHL members labs to use their own tests. On 26 

February, Hahn replied that the CDC test could be modified to use just the primers that specifically 

FDA-OSJI-FOIA-2020-3541_00001041 
detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look 

the other way to make more widespread testing possible. 

CDC has notified labs of FDA's decision in a letter, but the agency must still file an emergency use 

authorization with FDA for the protocol change. Once it does, it won't take long, Hahn promised in his 

letter to APHL: "FDA has been able to authorize tests for public health emergencies within as little as 

1 day upon receipt of the complete validation." 

In New York, the State Department of Health has designed its own test based on the CDC protocol 

and plans to seek emergency use authorization. 

CDC provided an update about the situation in an email but did not respond to Science's request for 

an interview with a scientist to discuss the details of the problem. Mina stresses he has great respect 

for CDC's competence overall, but says, "There's no good explanation for what's going on here." 

FDA-OSJI-FOIA-2020-3541_00001042 
From: 

Sent: 

To: 

Keagan.Lenihan@fda.hhs.gov [Keagan.Lenihan@fda.hhs.gov] 

3/2/2020 9:12:50 PM 

McWilliams, Carly [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =b68c7 458214244d08424fd441 fea4fda-Ca rlyl e. M cW] 

Re: Science Magazine Article+ UPDATE+ TOMORROW's Plan 

Thx 

Sent from my iPhone 

On Mar 2, 2020, at 9:12 PM, McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> wrote: 

Yes. Are you in clearance chain? Will make sure it goes to you after if you are not already in the chain. 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Monday, March 2, 2020 9:11 PM 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov> 

Subject: Re: Science Magazine Article+ UPDATE+ TOMORROW's Plan 

Would like to see anything before it goes to SH. Thanks. 

Sent from my iPhone 

On Mar 2, 2020, at 9:07 PM, McWilliams, Carly wrote: 

Thank you all for your attention on this. I am also going to be helping coordinate on this outbreak from the 

commissioners office. Trying to loop the two groups together for tomorrow's deliverables based on the WHTF meeting 

this afternoon. 

The VP has asked Dr. Hahn to address two things at the press conference in the afternoon 1. CDC lab contamination and 

2. Clarification that the WHO is not actually manufacturing/developing tests. So, we do not need to do press outreach as 

he is going to proactively discuss at press conference and this could also potentially be brought up at hearing for 

tomorrow.i (b)(S) j 

Dr. Marks, please let us know what you learn from WHO on testing. 

Stephanie and I developed talking points for the press conference. We are going to send to Denise and Michael first this 

evening and then it will go through the clearance process which needs to be done by 1PM TOMORROW. 

Separately, I will also be pulling together his background for his briefing at WHTF tomorrow on any updates, which will 

also be due at 1pm tomorrow. I will be pulling that from this evenings sit rep. 

FDA-OSJI-FOIA-2020-3541_00001018 
Thank you in advance for your help and please let me know if you have questions. 

From: Caliguiri, Laura <Laura.Cali ov> 

Sent: Monday, March 2, 2020 7:25 PM 

To: Caccamo, Stephanie <Ste hanie.Caccomo fda.hhs. ov>; McWilliams, Carly <Carl .McWilliams ov>; 

Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

Sidenote, there is another chain on this and Peter has been running to ground with WHO. 

From: Caccamo, Stephanie <Ste hanie.Caccomo fda.hhs. ov> 

Sent: Monday, March 2, 2020 7:21 PM 

To: McWilliams, Carly <Carl .McWilliams fda.hhs. ov>; Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov>; Paulos, 

Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather 

<Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; 

Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

Yes, there are several publications that I'll be reaching out to, thanks for following up. 

From: McWilliams, Carly <Carl .McWilliams 

Sent: Monday, March 02, 2020 7:13 PM 

To: Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov>; Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>; Rath, Prakash 

(FDA) <Prakash.Rath@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; 

Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

, ___ _Extremely helpful. I neglected to include Stephanie on this chain. Stephanie and Laura! (b)(5) i (b)(S) ! �- -���--

From: Tomasello, Jennifer <Jennifer.Tomasello fda.hhs. ov> 

Date: March 2, 2020 at 7:06:18 PM EST 

To: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>, McWilliams, Carly 

<Carl .McWilliams fda.hhs. ov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Cali uiri fda.hhs. ov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

FDA-OSJI-FOIA-2020-3541_00001019 
Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>, Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov> 

Subject: RE: Science Magazine Article 

Thanks again all. 

Jeff said WHO confirmed that they have not made a test, shipped a test, or listed a test. The news stories are not 

accurate, so we should be clear about it. 

Best, 

Jennifer 

Jennifer Brown Tomasello, MPA 

Senior Policy Advisor 

Center for Devices and Radiological Health 

Office of Policy 

U.S. Food and Drug Al';lmit1!s.trm:ion. ____ 0 

Tel 301-796-8924 Cel[ ______ (b)(G) ______ ___: iennifer.tornasello@fda.hlis.gov 

<irnage007. png> 

<i rnage009 .jpg> 

<irnage011.jpg> 

<irnage013.jpg> 

<irnage015.jpg> 

<i rnage0 17 .jpg> 

E-.;cellenr customer service is important to us. Please take a moment to provide feedback regarding the customer service you have 

received: 

h s:/lwww.research.net/slcdrhcustomerservice?ID=5000&S=E 

From: Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Sent: Monday, March 2, 2020 6:20 PM 

To: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; McWilliams, Carly <_C_ar_l�---�---�­

Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; Black, Jennifer <Jennifer.Black@fda.hhs.gov>; 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Stenzel, Timothy <Timothy.Stenzel@fda.hhs.gov>; Tomasello, Jennifer 

<Jennifer.Tomasello@fda.hhs.gov> 

Subject: Re: Science Magazine Article 

Looping in Tim and Jennifer. 

From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

FDA-OSJI-FOIA-2020-3541_00001020 
Date: March 2, 2020 at 6:12:00 PM EST 

To: McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>, Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>, Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, 

Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo fda.hhs. ov>, Paulos, Lauren <Lauren.Paulos@fda.hhs.gov> 

Subject: Re: Science Magazine Article 

+ Lauren 

From: McWilliams, Carly <Carl .McWilliams fda.hhs. ov> 

Date: March 2, 2020 at 5:54:45 PM EST 

To: Janik, Heather <Heather.Janik@fda.hhs.gov>, Caliguiri, Laura <Laura.Cali uiri 

<Sarah.Lynch@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Lutter, Randall <Randall.Lutter@fda.hhs.gov>, Shah, Anand <Anand.Shah@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Gross, Karas <Karas.Gross@fda.hhs.gov>, Black, Jennifer <Jennifer.Black@fda.hhs.gov>, 

Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>, Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Subject: Science Magazine Article 

Hi, I was sent this article by Randy. Based on the talking points I have seen thoug_b) (b)(5) 

(b)(5) �� �-.___, 

Were they coordinating distribution of tests? Fortunately, it does note that things will get better. Could 

we 1 . : t>J1�). i 

The United States badly bungled coronavirus testing-but things 

may soon improve 

By Jon Cohen Feb. 28, 2020 , 545 PM 

Speed is critical in the response to COVID-19. So why has the United States been so slow in its 

attempt to develop reliable diagnostic tests and use them widely? 

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five 

commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South 

Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), 

in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit 

to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the 

country eager to test more suspected cases-and test them faster-have been unable to do so. No 

commercial or state labs have the approval to use their own tests. 

FDA-OSJI-FOIA-2020-3541_00001021 
In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern 

California who turned out to be the first probable COVID19 case without known links to an infected 

person. 

The problems have led many to doubt that the official tally of 60 confirmed cases in the United States is 

accurate. the official tally of 60 confirmed cases in the United States is accurate. "There have been blunders, 

and there could be an underlying catastrophe that we don't know about," says epidemiologist Michael Mina, 

who helps run a microbiology testing lab at Brigham and Women's Hospital. "It's been very complicated and 

confusing for everyone with almost no clarity being provided by the CDC." 

The situation may soon improve. State labs and commercial diagnostic developers hope to win 

approval from the Food and Drug Administration (FDA) for their own tests, and FDA and CDC on 

Wednesday agreed on a workaround for the faulty CDC kit-which has a problem that is not essential 

to its proper functioning-so that it can now be used by at least some of the state labs that have it. 

But there's widespread discontent with the way the system has worked. "The U.S. government has 

not appropriately prioritized diagnostic tests and supported the laboratory response network to the 

degree they should have been supported over the years," says Luciana Borio, who in previous jobs 

had lead roles in responding to emerging threats at the National Security Council and FDA 

If a new disease emerges, CDC normally "gets the ball rolling" with diagnostics because it has the 

expertise and the biosafety laboratories to handle dangerous novel pathogens, says Borio, who now 

works for ln-Q-Tel, a not-for-profit venture capital firm. Typically, there are few confirmed viral 

samples from patients at the outset, which researchers need to validate their tests, and CDC has the 

capability to grow the virus for this critical quality assurance step. Once the agency has a working 

test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce 

their own tests or scale-up the CDC one. "I would have hoped to see that third phase by now," Borio 

says. 

In the case of SARS-CoV-2, as the virus causing COVID-19 is officially known, CDC's sluggishness 

was apparent 1 month ago. On 26 January, the agency held an unusual Sunday teleconference for 

the media to provide an update about the rapidly growing outbreak. There were then five cases in the 

United States, but the CDC lab in Atlanta was still the only one in the country able to test for the virus, 

and it repeatedly had backlogs. Asked why more labs weren't able to do the tests, Nancy Messonnier, 

who then was leading CDC's response, said it was a quality issue. "We hold ourselves to an 

incredibly high standard of precision in terms of laboratory testing," Messonnier said. "We wouldn't 

want to inadvertently make a mistake in patient care." 

CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it 

revealed that several labs had difficulty validating the test because of a problem with one of the 

reagents. 

The key problem with the kits is what's known as a negative control, says Kelly Wroblewski, director 

of infectious diseases at the Association of Public Health Laboratories (APHL). CDC's test uses the 

polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a 

nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. 

The assay should not react to this negative control, but the CDC reagents did at many, but not all, 

state labs. The labs where the negative control failed were not allowed to use the test; they have to 

continue to send their samples to Atlanta. 

The declaration of a public health emergency ... limited the diagnostic capacity of this 

country. It's insane. 

Michael Mina, Brigham and Women's Hospital 

In principle, many hospital and academic labs around the country have the capability to carry out tests 

themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The 

CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. 

FDA-OSJI-FOIA-2020-3541_00001022 
Well-equipped state or local labs can use these-or come up with their own-to produce what are known as a 

"laboratory-developed tests" for in-house use. 

But at the moment, they're not allowed to do that without FDA approval. When the United 

States declared the outbreak a public health emergency on 31 January, a bureaucratic process 

kicked in that requires FDA's "emergency use approval" for any tests. "The declaration of a public 

health emergency did exactly what it shouldn't have. It limited the diagnostic capacity of this country," 

Mina says. "It's insane." 

On 24 February, APHL asked FDA Commissioner Stephen Hahn for "enforcement discretion" to 

sidestep the emergency process and allow APHL members labs to use their own tests. On 26 

February, Hahn replied that the CDC test could be modified to use just the primers that specifically 

detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look 

the other way to make more widespread testing possible. 

CDC has notified labs of FDA's decision in a letter, but the agency must still file an emergency use 

authorization with FDA for the protocol change. Once it does, it won't take long, Hahn promised in his 

letter to APHL: "FDA has been able to authorize tests for public health emergencies within as little as 

1 day upon receipt of the complete validation." 

In New York, the State Department of Health has designed its own test based on the CDC protocol 

and plans to seek emergency use authorization. 

CDC provided an update about the situation in an email but did not respond to Science's request for 

an interview with a scientist to discuss the details of the problem. Mina stresses he has great respect 

for CDC's competence overall, but says, "There's no good explanation for what's going on here." 

FDA-OSJI-FOIA-2020-3541_00001023 
From: 

Sent: 

To: 

Subject: 

Lenihan, Keagan [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =EE7320E E8C184D66 BFD521B0105D 17D2-KEAGAN. LEN I] 

3/22/2020 5:51:34 PM 

Felberbaum, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4819a643ca 2945cd b la263 lb83e69673-M i cha el. Fel ]; Cacco mo, Stephanie 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =950c32cebc4b4 f80b302c50cf3 lc8524-Stepha n i e. C] 

FW: COVID-19 Serologic Tests 

Team working together cross center. Examples I will start forwarding you to message on. Thanks! 

From: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Sent: Sunday, March 22, 2020 5:41 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Hahn, Stephen <SH1@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Subject: COVID-19 Serologic Tests 

Peter, 

Kudos to you on the work you are doing to help treat patients with COVID-19. I appreciate the importance of identifying 

patients with an antibody response to the virus. Under a new policy we issued earlier this week, developers of serologic 

tests do not need to get authorization from the FDA to market these tests if they have completed their validation, notified 

us of their intent via email, and included certain statements in their labeling. For those Test developers who have met 

those criteria, we post their names on our website. I will send you the link to the webpage in a separate email. 

Please let me know if there is anything we at CDRH can do to help. 

Jeff 

FDA-OSJI-FOIA-2020-3541_00001033 
From: 

Sent: 

Keagan.Lenihan@fda.hhs.gov [Keagan.Lenihan@fda.hhs.gov] 

3/26/2020 7:33:28 AM 

To: 

CC: 

Hillebrenner, Elizabeth J [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =a67a 1369827 44bd baada3648642e87a 7-EJT] 

Shuren, Jeff [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren] 

Re: CDRH response update 

This is extremely helpful. Thank you. 

Sent from my iPhone 

On Mar 26, 2020, at 6:52 AM, Hillebrenner, Elizabeth J <Elizabeth.Hillebrenner@fda.hhs.gov> wrote: 

Dr Hahn, 

Below please find a list of CDRH's emergency response actions from yesterday as well as anticipated actions in the 

coming 48 hours. 

March 25, 2020 actions 

• Ventilators: 

o CDRH issued a blanket EUA for ventilators, anesthesia gas machines modified for use as ventilators, and 

positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator 

tubing connectors, and ventilator accessories. Manufacturers and other stakeholders may submit a request to FDA 

under the process outlined in the EUA to have their device(s) added to the EUA. 

o CDRH authorized an EUA for Beijing Aeonmed Co., Ltd., Beijing, China, for an unapproved ventilator 

model VG70 that NY state has purchased. The ventilators will be imported next week. 

o A CDRH subject matter expert worked with the FEMA ventilator surprise chain task force to facilitate the 

availability of a splitter to enable a single ventilator to support multiple patients at one time. 

o CDRH authorized an EUA for the Prisma Health 3D printed Ventilator Expansion Splitter (VESper) that 

allows one ventilator to be used on more than one patient. 

o CDRH met with multiple stakeholders developing creative solutions to a potential ventilator shortage. 

• PPE 

{b){5) o CDRH published Guidance on "Enforcement Policy for Face Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency." 

• Diagnostics: 

o CDRH held a Town Hall/Webinar with 1,000 participants during which we provided an overview of the 

March 16th guidance on diagnostics and answered questions from labs. 

o CDRH authorized EUAs for SARS-CoV-2 diagnostics from Avellino Labs and Perkin Elmer. Avellino labs 

notified FDA and was offering their test under the policy outlined in the Feb. 29th guidance. 

o We now have 18 authorized diagnostics and over 100 notifications from developers offering tests under 

the Feb 29th/March 16th guidance. 

Anticipated actions in the next 48 hours 

FDA-OSJI-FOIA-2020-3541_00001031 
• CDRH intends to publish Guidance on gowns. The guidance will address appropriate labeling for these products 

during the COVID-19 public health emergency without requiring SlO(k) submission and clearance 

• CDRH intends to publish Guidance on "Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers 

During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." The guidance will address appropriate 

labeling for these products during the COVID-19 public health emergency without requiring SlO(k) submission and 

clearance. 

Elizabeth 

Elizabeth Hillebrenner 

Associate Director for Scientific and Regulatory Programs 

Center for Devices and Radiological Health 

Office of the Center Director 

U.S. Food and Drug Administration 

Tel: 301-796-6346 

elizabeth.hillebrenner@fda.hhs.gov 

<i mage001. png> 

<i mage002.j pg> 

<i mage003.j pg> 

<i mage004.j pg> 

<i mage005.j pg> 

<i mage006.j pg> 

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer 

service you have received: http :llwww.research.net/s/cdrhcustomerservice?ID=2000&S=E. 

FDA-OSJI-FOIA-2020-3541_00001032 
From: Caccomo, Stephanie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =950C32CEBC4B4F80B302C50CF31C8524-STEPHAN IE. C] 

3/26/2020 7:46:50 AM 

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =ee 7320ee8c184d66bfd52 lb0105d 17 d2-Keaga n. Len i] 

RE: CDRH response update 

Yes please!!! 

Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Desk 301 .348.1956 

Cell L._._jb)(6l_._._.J 

stephanie.caccomo@fda.hhs.gov 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 7:46 AM 

To: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Subject: Re: CDRH response update 

Agreed.! �----------------------------� (b)(5) 

Sent from my iPhone 

Got it-thanks for saying something. We had a chat about providing below to SH, Carly and me. Will be very helpful 

going forward. 

Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Desk 301 .348.1956 

Cell L-·-·-·-·-· (b)(G) ·-·-·-·-·-: 

stephanie.caccomo@fda.hhs.gov 

From: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Sent: Thursday, March 26, 2020 7:33 AM 

To: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Subject: Fwd: CDRH response update 

Sent from my iPhone 

Begin forwarded message: 

From: "Hillebrenner, Elizabeth J" <Elizabeth.Hillebrenner 

Date: March 26, 2020 at 6:52:03 AM EDT 

FDA-OSJI-FOIA-2020-3541_00001034 
To: "Hahn, Stephen" <SH1@fda.hhs.gov> 

Cc: "Shuren, Jeff" <Jeff.Shuren@fda.hhs.gov>, "Lenihan, Keagan" <Keagan.Lenihan@fda.hhs.gov>, "Shah, Anand" 

<Anand.Shah@fda.hhs.gov>, "Rom, Colin" <Colin.Rom@fda.hhs.gov> 

Subject: CDRH response update 

Dr Hahn, 

Below please find a list of CDRH's emergency response actions from yesterday as well as anticipated actions in the 

coming 48 hours. 

March 25, 2020 actions 

• Ventilators: 

o CDRH issued a blanket EUA for ventilators, anesthesia gas machines modified for use as ventilators, and 

positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator 

tubing connectors, and ventilator accessories. Manufacturers and other stakeholders may submit a request to FDA 

under the process outlined in the EUA to have their device(s) added to the EUA. 

o CDRH authorized an EUA for Beijing Aeonmed Co., Ltd., Beijing, China, for an unapproved ventilator 

model VG70 that NY state has purchased. The ventilators will be imported next week. 

o A CDRH subject matter expert worked with the FEMA ventilator surprise chain task force to facilitate the 

availability of a splitter to enable a single ventilator to support multiple patients at one time. 

o CDRH authorized an EUA for the Prisma Health 3D printed Ventilator Expansion Splitter (VESper) that 

allows one ventilator to be used on more than one patient. 

o CDRH met with multiple stakeholders developing creative solutions to a potential ventilator shortage. 

(b)(5) • PPE 

o CDRH published Guidance on "Enforcement Policy for Face Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency." 

• Diagnostics: 

o CDRH held a Town Hall/Webinar with 1,000 participants during which we provided an overview of the 

March 16th guidance on diagnostics and answered questions from labs. 

o CDRH authorized EUAs for SARS-CoV-2 diagnostics from Avellino Labs and Perkin Elmer. Avellino labs 

notified FDA and was offering their test under the policy outlined in the Feb. 29th guidance. 

o We now have 18 authorized diagnostics and over 100 notifications from developers offering tests under 

the Feb 29th/March 16th guidance. 

Anticipated actions in the next 48 hours 

FDA-OSJI-FOIA-2020-3541_00001035 
• CDRH intends to publish Guidance on gowns. The guidance will address appropriate labeling for these products 

during the COVID-19 public health emergency without requiring SlO(k) submission and clearance 

• CDRH intends to publish Guidance on "Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers 

During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." The guidance will address appropriate 

labeling for these products during the COVID-19 public health emergency without requiring SlO(k) submission and 

clearance. 

Elizabeth 

Elizabeth Hillebrenner 

Associate Director for Scientific and Regulatory Programs 

Center for Devices and Radiological Health 

Office of the Center Director 

U.S. Food and Drug Administration 

Tel: 301-796-6346 

elizabeth.hillebrenner@fda.hhs.gov 

<i mage001. png> 

<i mage002.j pg> 

<i mage003.j pg> 

<i mage004.j pg> 

<i mage005.j pg> 

<i mage006.j pg> 

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer 

service you have received: :llwww.research.net/s/cdrhcustomerservice?ID=2000&S=E. 

FDA-OSJI-FOIA-2020-3541_00001036 
From: Keagan.Lenihan@fda.hhs.gov [Keagan.Lenihan@fda.hhs.gov] 

Sent: 3/27/2020 7:03:05 AM 

To: Felberbaum, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =4819a643ca 2945cd b la263 lb83e69673-M i cha el. Fel] 

Subject: Fwd: Convalescent Plasma 

Attachments: Convalescent Plasma Q and A draft 032720.docx; ATTOOOOl.htm; Plasma Process Draft 032720.pptx; ATT00002.htm 

See attachments, do we need to adjust talkers? 

Sent from my iPhone 

Begin forwarded message: 

From: "Marks, Peter" <Peter.Marks@fda.hhs.gov> 

Date: March 27, 2020 at 6:55:13 AM EDT 

To: "Hahn, Stephen" <SH1@fda.hhs.gov>, "Lenihan, Keagan" <Keagan.Lenihan@fda.hhs.gov> 

Cc: "Tierney, Julia" <Julia.Tierney@fda.hhs.gov>, "McNeil!, Lorrie" <Lorrie.McNeill@fda.hhs.gov> 

Subject: Convalescent Plasma 

Dear Commissioner, 

The questions you asked last night were great and thought provoking. It is already clear that the demand for this is 

going to be quite significant. I only wish we were closer than being about a week away from delivering units as part of 

the program. My apologies for that, but we worked as fast as possible through a number of issues that came up getting 

in the way. 

After thinking about it overnight, I thought that it would be good to build out your Q and A further. Please see the 

attached. Also attaching a slide with a summary of the current workflow for the programs for your reference. I think 

that explaining what the therapy is and also reviewing the contours of what is in place and being put in place could be 

very helpful. 

Perhaps you could give me a call?! ����-� (b)(6) iThanks 

Best Regards, 

Peter 

FDA-OSJI-FOIA-2020-3541_00001030 
From: Meister, Karen G [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7F2 CDCD99E784C6CB3E8 BF491FEE03 7F-KM EISTE R] 

3/26/2020 9:06:32 PM 

To: 

Subject: 

White, Erica [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/cn=Recipients/cn=6fa70699685245178c505c69d684872d-Erica.White] 

FW: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

fyi 

From: Zavagno, Denise <Denise.Zavagno@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 8:44 PM 

To: OCCRequests-COVID19 <0CCRequests-COVID19@fda.hhs.gov>; 2019-nCoV FDA IMG JIC <2019-

nCoVFDAIMGJIC@fda.hhs.gov> 

Cc: Hunt, Christine <Christine.Hunt@fda.hhs.gov>; Madni, Rubina <Rubina.Madni@fda.hhs.gov> 

Subject: RE: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

Good evening, 

OCC clears the press release on coronavirus treatment acceleration program/plasma. 

Kind regards, 

Denise Zavagno 

From: OCCRequests-COVID19 <0CCRequests-COVID19@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 5:56 PM 

To: Zavagno, Denise <Denise.Zavagno@fda.hhs.gov>; Madni, Rubina <Rubina.Madni@fda.hhs.gov> 

Cc: OCCRequests-COVID19 <0CCRequests-COVID19@fda.hhs.gov> 

Subject: FW: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

For 8:30 PM review, on convalescent plasma and treatment acceleration program. If you'd like me to ask for more time 

or a drugs counselor, too, let me know. 

Best, 

Christine 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 5:43 PM 

To: 2019-nCoV FDA IMG JIC <2019-nCoVFDAIMGJIC@fda.hhs.gov> 

Cc: OCCRequests-COVID19 <0CCRequests-COVID19@fda.hhs.gov> 

Subject: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

Hi all, 

Attached for JIC review by 8:30 PM TODAY is a draft press release regarding the Coronavirus Treatment Acceleration 

Program and our work on convalescent plasma/hyperimmune globulin. This press release is based on the previously 

cleared press release on convalescent plasma/hyperimmune globulin, CBER-cleared talkers on new developments on 

this topic and CDER/CBER-cleared talking points on the Coronavirus Treatment Acceleration Program. 

Please make edits in SharePoint: http://sharepoint.fda.gov/orgs/OCOCET /OCETdocs/nCoV /Shared%20Documents/JIC%20-

%20FDA%201 MG/Press/For%20clearance/D RAFT PR CT AP%20+%20Plasma%2003262020.docx 

FDA-OSJI-FOIA-2020-3541_00001480 
Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Tel: 240-402-9548 i Cell:l_ __________ (b)(6) -·-·-·-·-·i 

michael.felberbaum@fda.hhs.gov 

U.S. FOOD & DRUG 

>, t>M IN tSHA. Tl◊N 

ocm-a 

FDA-OSJ I-FOIA-2020-3541 _00001481 
FDA-OSJI-FOIA-2020-3541_00001482 
From: Shuren, Jeff [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=44335A0C2F834535BC8713DFD643905E-JEFF.SHUREN] 

Sent: 3/20/2020 1:00:48 PM 

To: Felberbaum, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4819a643ca 2945cd b la263 lb83e69673-M i cha el. Fel ]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Sh ah, Anand 

[/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah] 

Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode] 

Subject: RE: Per our conversation ... 

Happy to put eyes on it, too, as well as speak with media. 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:55 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Thank you Peter and Janet. 

Janet - I appreciate the offer to speak with press on this topic (and we'll likely need that) but would also like to build out 

the responses to these questions so that we are all talking about this the same way across the agency - and in those 

instances where we can't schedule time to speak with media or others. It sounds like Peter will be freshening up 

previous responses and we can use that as a starting point (feel free to propose responses for the questions below). 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration ___ . 

Tel 240-402-9548 / Cell______(b)(6) _______ : 

michael. fel berbau m@fda. h hs. gov 

U.S. FOOD & DRUG 

ADMINISfllAllON 

ocm .. 11 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:38 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Dear Anand, 

FDA-OSJI-FOIA-2020-3541_00001277 
Thanks for the heads up on these. We have had to address very similar questions during previous outbreak. Granted, 

they were not on this scale, but the concepts are all there. We are prepared to respond and this weekend will freshen 

up the responses that we put together for previous outbreaks. 

Best Regards, 

Peter 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:23 PM 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shuren, Jeff 

<Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Hi Michael -

Thanks for sharing these potential questions. I've included Janet, Peter, and Jeff here for their thoughts. I agree it would 

be helpful for us to carefully think through these questions and, whenever possible, have a coordinated approach to 

incoming questions from stakeholders including media. 

Anand 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:18 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Subject: Per our conversation ... 

Thanks for the chat. Here are the questions I think we need to be prepared to answer on this topic. Feel free to add to 

this list and let me know if you want to relay to Janet or others. 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Aqmiois.tratiruL. ____ � 

Tel 240-402-9548 / Celli (b)(6) i 

michael. felberbaum@fda. hhs. gov·-·-·-·-·-·-·-' 

FDA-OSJI-FOIA-2020-3541_00001278 
FDA-OSJI-FOIA-2020-3541_00001279 
From: 

Sent: 

To: 

CC: 

Subject: 

Shuren, Jeff [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=44335A0C2F834535BC8713DFD643905E-JEFF.SHUREN] 

3/16/2020 5:49:10 PM 

Mayne, Susan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=9e69acd84a37469aa57466a957814563-Susan.Mayne]; Rebello, Heidi 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =2834ce 193ca949799ef063e34a2cfa0b-H eid i. Rebel]; Woodcock, Janet 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]; Solomon, Steven M 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =e49ac6a056dc4f299ea269945e962e82-SSOLO MON]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Zeller, Mitch el I 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =de 7 d2fda97 le418ba 33cb21 la4013976-M itch el I .Ze ]; Cavazzon i, Patrizia 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; McMeekin, Judith 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d824 f07697784fcb9ece28cbba07102b-M CME EKI NJ]; Abernethy, Amy 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c84171967 c724ee 799bb2658197086 be-Amy .Abernet] 

Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Cal iguiri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; M cWi 11 i ams, Carly 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b68c7 458214244d08424fd441 fea4fda-Ca rlyl e. M cW]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=98606928b9a64edfb25abale3573fdfe-Eranders]; Hebert, Angelique A. 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9aa08f3428a045f88eb3 bd92c68a27 cf-Angelique. H ]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Finnen, Apri I 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=43d74b30bbld429184b0d9081efe19bf-April.Finne]; Mair, Michael 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Hussey, Deirdre 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=41a51a9bf937431c8470b69fb055fe81-Husseyd]; Barth, Janelle 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =18d28baf2bfa435a bc9cdfa07 677 4dc0-Ja nel I e. Bar]; Stone, Eric 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5 799d336f 4c142aca 7 la655e4184d6bd-E ri c.Stone ]; Hutten locker, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =65254282fa6a4e 138f506f96cfe9049c-Den ise. Hutt]; Dom an ski, Jeffrey 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=ed00c0aa83794cbebfc0a50f6cd4d7f9-Jeffrey.Dom]; Schweitzer, Roxanne K 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =292135d254924252958e25cc5a63 b079-RSCHWE IT]; Branch, Tiffany 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=b45flb97b5d648f68cdff5ce4f75a 154-Tiffany.Bra]; Barfell, Glenda F 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =33b220e98ac9456eb32888261156f 400-G BARFELL]; Lynch, Sarah 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d24ee4a4fc6241 f48110d6b35e6704ed-Sa rah. Lynch] 

RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

FDA-OSJ I-FOIA-2020-3541 _00000834 
Looks good. Thank you. 

Jeff 

From: Mayne, Susan <Susan.Mayne@fda.hhs.gov> 

Date: March 16, 2020 at 5:46:59 PM EDT 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, 

Solomon, Steven M <Steven.Solomon@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Zeller, 

Mitchell <Mitchell.Zeller@fda.hhs.gov>, Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>, Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>, McMeekin, Judith <Judith.McMeekin@fda.hhs.gov>, Abernethy, Amy 

<Amy.Abernethy@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>, Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>, 

McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>, Anderson, Erika <Erika.Anderson@fda.hhs.gov>, 

Hebert, Angelique A <Angelique.Hebert@fda.hhs.gov>, Hinton, Denise <Denise.Hinton@fda.hhs.gov>, 

Finnen, April <April.Finnen@fda.hhs.gov>, Mair, Michael <Michael.Mair@fda.hhs.gov>, Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>, Barth, Janelle <Janelle.Barth@fda.hhs.gov>, Stone, Eric 

<Eric.Stone@fda.hhs.gov>, Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>, Domanski, Jeffrey 

<Jeffrey.Domanski@fda.hhs.gov>, Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov>, Branch, 

Tiffany <Tiffany.Branch@fda.hhs.gov>, Barf ell, Glenda F <Glenda.Barfell@fda.hhs.gov>, Lynch, Sarah 

<Sarah.Lynch@fda.hhs.gov> 

Subject: RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

No edits. Thanks! 

Susan 

From: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:24 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Solomon, Steven M <Steven.Solomon@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan <Susan.Mayne@fda.hhs.gov>; Zeller, Mitchell 

<Mitchell.Zeller@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov>; Abernethy, Amy 

<Amy.Abernethy@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Hutten locker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey. Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov>; Branch, Tiffany <Tiffany.Branch@fda.hhs.gov>; Barfell, 

Glenda F <Glenda.Barfell@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

FDA-OSJ I-FOIA-2020-3541 _00000835 
Sincerely, 

Stephen M. Hahn, M.D. 

FDA Commissioner 

FDA-OSJ I-FOIA-2020-3541 _00000836 
From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7B0453354A9A42 7DB0A66A86C7 A36F3D-JAN ET. WOO DC] 

3/26/2020 7:45:41 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Subject: RE: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

Hang in there. Jw 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Date: March 26, 2020 at 7:44:27 PM EDT 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>, Flanagan, Keith <Keith.Flanagan@fda.hhs.gov>, Rawlings, Kimberly 

<Kimberly.Rawlings@fda.hhs.gov>, Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>, Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Cc: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER@fda.hhs.gov>, CDER COVID-19 

Response <CDERCOVID l 9Response@fda.hhs.gov>, McNeill, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

Dear Janet, 

Thanks for your sage wisdom here (and groan). 

Best Regards, 

Peter 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 7:43 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Flanagan, Keith 

<Keith.Flanagan@fda.hhs.gov>; Rawlings, Kimberly <Kimberly.Rawlings@fda.hhs.gov>; Shreeve, Chris 

<Christine.Kuethe@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov> 

Cc: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER@fda.hhs.gov>; CDER COVID-19 Response 

<CDERCOVID19Response@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

I think we can simply provide comments and see what they do. Our web page once we get it up, and tweets (groan) will 

communicate CTAP better. Jw 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Date: March 26, 2020 at 7:41:04 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Flanagan, Keith <Keith.Flanagan@fda.hhs.gov>, Rawlings, 

Kimberly <Kimberly.Rawlings@fda.hhs.gov>, Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>, Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Cc: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER@fda.hhs.gov>, CDER COVID-19 Response 

<CDERCOVID19Response@fda.hhs.gov>, McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

Dear All, 

FDA-OSJI-FOIA-2020-3541_00001186 
We originally had a separate release for these two products and the com ms folks grafted it to the Accelerator. 

Please feel absolutely free to remove these two products and replace them with CDER examples or start with CDER 

examples before these. We could also simply separate the releases again. Thanks. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 7:22 PM 

To: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov>; Rawlings, Kimberly <Kimberly.Rawlings@fda.hhs.gov>; Shreeve, 

Chris <Christine.Kuethe@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER@fda.hhs.gov>; CDER COVID-19 Response 

<CDERCOVI D19Response@fda.hhs.gov> 

Subject: RE: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

I have the same comment as Keith's. CTAP originated in CDER (and specifically JW's brain) and doesn't showcase 

anything that CDER to andance new therapies. Antivirals? lmmunomodulators? Expanded access programs? 

+ Peter Marks, who also needs to clear this 

Patrizia 

From: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 7:13 PM 

To: Rawlings, Kimberly <Kimberly.Rawlings@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Clarke, Mary 

Beth <Marybeth.Clarke@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov> 

Cc: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER@fda.hhs.gov>; CDER COVID-19 Response 

<CDERCOVI D19Response@fda.hhs.gov> 

Subject: RE: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

I made one technical edit in SharePoint per the instructions below. 

Their draft has rhetorical overview, collapses the CDER-CBER content explaining CTAP, and showcases the CBER plasma 

products - and inter-Agency collaboration on it - in depth. 

JW's original messaging (in the draft we sent them earlier today) is much crisper and would be well suited for inaugural 

JW Tweet(s). 

From: Rawlings, Kimberly <Kimberly.Rawlings@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 6:10 PM 

To: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov> 

Cc: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER@fda.hhs.gov>; CDER COVID-19 Response 

<CDERCOVI D19Response@fda.hhs.gov> 

Subject: FW: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

Keith, 

Please review the PR to announce the Coronavirus Treatment Acceleration Program (CTAP). 

FDA-OSJI-FOIA-2020-3541_00001187 
From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Thursday, March 26, 2020 5:43 PM 

To: 2019-nCoV FDA IMG JIC <2019-nCoVFDAIMGJIC@fda.hhs.gov> 

Cc: OCCRequests-COVID19 <0CCRequests-COVID19@fda.hhs.gov> 

Subject: FOR JIC REVIEW: Press Release on Coronavirus Treatment Acceleration Program/Plasma 

Hi all, 

Attached for JIC review by 8:30 PM TODAY is a draft press release regarding the Coronavirus Treatment Acceleration 

Program and our work on convalescent plasma/hyperimmune globulin. This press release is based on the previously 

cleared press release on convalescent plasma/hyperimmune globulin, CBER-cleared talkers on new developments on 

this topic and CDER/CBER-cleared talking points on the Coronavirus Treatment Acceleration Program. 

Please make edits in SharePoint: http://sharepoint.fda.gov/orgs/OCOCET /OCETdocs/nCoV /Shared%20Documents/JIC%20-

%20FDA%2DI MG/Press/For%20clearance/D RAFT PR CT AP%20+%20Plasma%2003262020.docx 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drup Administration 

Tel 240-402-9548 /! (b)_(6) : 

michael. fel berbau m@fda. h hs. gov 

U.S. FOOD & DRUG 

ADMINISr!tATION 

DC'lm .. ■ 

FDA-OSJI-FOIA-2020-3541_00001188 
FDA-OSJI-FOIA-2020-3541_00001189 
From: Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

Sent: 3/15/2020 4:38:46 PM 

To: Hinton, Denise [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND] 

CC: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Clarke, Mary Beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =b0124a 15b9344d84839294 70fefa403a-CLARKE M] 

Subject: Fwd: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Attachments: Therapeutics TPs 03152020 324pm.docx 

Denise 

+ Peter Marks 

In the two paragraphs on IL-7 inhibitors and convalescent plasma, respectively, I recommend replacing the 

section about Reducing/heeding off need for ventilator with : 

(b)(5) 

Patrizia 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Date: March 15, 2020 at 4:16:42 PM EDT 

To: Farley, John <John.Farley@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Clarke, 

Mary Beth <Marybeth.Clarke@fda.hhs.gov> 

Subject: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Hi - sorry for short notice - any input before Michael Felderbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJ I-FOIA-2020-3541 _00000865 
From: 

Sent: 

Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

3/16/2020 11:31:09 AM 

To: Jungman, Elizabeth [/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J] 

Kraus, Stefanie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4fc39a 7 eb324539215bc-Stefa n i e. Kr] 

Subject: RE! (b)(S) : 

Attachments: Therapeutics TPs 03152020 749pm.docx 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 11:27 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE: i (b)(5) 

Patrizia: The attachment did not come through. Can you please re-send? 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 10:43 AM 

To: Sipes, Grail <Grail.Sipes@fda.hhs.gov> 

Cc: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Subject: REi (b)(5) i 

EJ 

These are TPs for SH that Peter Marks and I clear last night. I thought they could be helpful 

Patrizia 

From: Sipes, Grail <Grail.Sipes@fda.hhs.gov> 

Sent: Monday, March 16, 2020 10:13 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Subject: RE:i (b)(5) ! 

Thank you Elizabeth and please keep me in the loop! 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 9:54 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Birnkrant, Debra B 

<Debra.Birnkrant@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Jungman, Elizabeth 

<Elizabeth.Jungman@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: RE:i (!>).@ ____ __ 

FDA-OSJ I-FOIA-2020-3541 _00000866 
Yes, and I will speak with EJ, who can work with Julia in CBER. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:53 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Farley, John <John.Farley@fda.hhs.gov>; Birnkrant, Debra B 

<Debra.Birnkrant fda.hhs. ov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Jungman, Elizabeth 

<Elizabeth.Jun man fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Then EJ/ORP is the lead for developing the response? jw 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:52 AM 

To: Woodcock, ov>; Farley, John <John.Farley@fda.hhs.gov>; Birnkrant, Debra B 

<Debra.Birnkr , I.Si es fda.hhs. ov>; Jungman, Elizabeth 

<Elizabeth.Jun > 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch 

Subject: RE:i (b)(5) 

We need to spare John and Debbie. I will review and clear, along with EJ 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:50 AM 

ov> 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Farley, John <John.Farley@fda.hhs.gov>; Birnkrant, Debra B 

<Debra.Birnkrant fda.hhs. ov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Jungman, Elizabeth 

<Elizabeth.Jun man fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch 

Subject: FW:i (b)(5)�--� 

ov> 

I don't see any need for this. Who should collect the comments? ORP? John and Debbie, you should not have to spend 

any time on this, I know you are busy with protocol review. Peter, we should coordinate. jw 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW: i (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

(b)(S) �----------------------------� i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

FDA-OSJ I-FOIA-2020-3541 _00000867 
Best, 

Anand 

FDA-OSJI-FOIA-2020-3541 _00000868 
From: 

Sent: 

To: 

CC: 

Subject: 

Attachments: 

Importance: 

Jungman, Elizabeth [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =5238A0CAE C064BA8B5 D598115BC4F99F-ELIZABETH .J] 

3/16/2020 4:27:04 PM 

Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Ma I on ey, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ q1 =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

FW:i (b)(S) i 

High 

(b)(5) 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

! (b)(5)!if you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

'· respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b}(5} • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

! __________ ( b )( 6 ) _______ ___! ( work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FWi (b)(S) 

PRE-DECISIONAL, CONFIDENTIAL 

FDA-OSJ I-FOIA-2020-3541 _00000832 
Dear Janet and Peter -

�----------------------------� (b)(5) i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000833 
From: 

Sent: 

To: 

CC: 

Subject: 

Attachments: 

Maloney, Diane [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E59205500E944C9EACC4524EA18EDSBB-MALONEYD] 

3/16/2020 4:38:13 PM 

Jungman, Elizabeth [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE:i (b)(5) : 

(b)(5) 

Thanks, Elizabeth. I think this looks great. I added some comments for consideration. 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 4:27 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, _ _}ohanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: FWi (b)(5) i 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i (b)(5)! If you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

' respond to HHS by 5pm today, so apologies for the tight turnaround. 

I 

On the substance of the response: 

(b)(5) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

[ __________ ( b )( 6) -·-·-·-·-· i ( work cell) 

FDA-OSJ I-FOIA-2020-3541 _00000796 
From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FWj (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

(b)(5) i Stacy will also be sharing with the '-----------------------------------' 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000797 
From: 

Sent: 

To: 

CC: 

Subject: 

Jw 

Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7B0453354A9A42 7DB0A66A86C7 A36F3D-JAN ET. WOO DC] 

3/16/2020 4:56:50 PM 

Jungman, Elizabeth [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Ma I on ey, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

Re:j (b)(5) 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>, Maloney, 

Diane <Diane"_Malo.n�y@Jd.iLbhs..,_goy> McLa.tGhy, Johanna <J ohanna.McLatchy@fda.hhs.gov> 

Subject: FWi (b)(5) i 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

FDA-OSJI-FOIA-2020-3541_00000791 
Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i (b)(5)!1f you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

' respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(S) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) !(work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FWi (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�----------------------------� (b)(5) ! Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000792 
From: 

Sent: 

To: 

CC: 

Subject: 

Jungman, Elizabeth [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =5238A0CAE C064BA8B5 D598115BC4F99F-ELIZABETH .J] 

3/16/2020 5:01:47 PM 

Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Ma I on ey, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE:! (b)(5) ! 

Thank you all. I know Patrizia was going to circulate comments in the same vein, so we'll punch it up and recirculate. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 4:59 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; 

Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: RE:j (b)(5) ·1 

Dear Janet, 

Thanks. I don't have anything more to add to Janet's comments, except to note the minor additional edit in the 

attached. 

Best Regards, 

Peter 

From: Woodcock, Janet <Janet.Woodcock 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchv, .. Johanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: Re; (b )( 5) i 

FDA-OSJ I-FOIA-2020-3541 _00000782 
Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FWi (b)(S) 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

___ Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i (b)(5)!1f you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

' respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(5) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) !(work cell) 

FDA-OSJ I-FOIA-2020-3541 _00000783 
From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(5) �---� 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�-----------------------------� (b)(5) i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000784 
From: 

Sent: 

To: 

CC: 

Subject: 

Attachments: 

Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

3/16/2020 5:09:42 PM 

Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Jungman, EI iza beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8b5d598115bc4f99f-E I iza beth .J]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Ma I on ey, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE:! (�K�)'===='----------------------

(b)(S) 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Mal ney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: Re: (b)(5) 

Jw 

FDA-OSJ I-FOIA-2020-3541 _00000870 
From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW:j (b)(5) 

Importance: 'Righ 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i (b)(5)ilf you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

' respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(5) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) !(work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.�-�<!���-@fda.hhs.gov> 

Subject: FW! (b)(5) �----

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�----------------------------� (b)(5) i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJI-FOIA-2020-3541_00000871 
From: 

Sent: 

To: 

CC: 

Subject: 

Kraus, Stefanie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =9D3959F 3365B4FC39A 7EB324539215BC-STE FAN IE. KR] 

3/16/2020 5:43:52 PM 

Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Jungman, EI iza beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Ma I oney, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE:i (_l?lt�,_) ________________ _ Attachments: i 

�--------------------------� (b)(5) 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE1 (�K5-.l�---� 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: Re:i l�)J?�) ---� 

FDA-OSJ I-FOIA-2020-3541 _00000845 
Jw 

From: Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: FW:i (_!:>X�.l�---� 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i (b)(5)ilf you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

' respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(S) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) (work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.�l_?.l_r_��-(_§)fda.hhs.gov> 

Subject: FWi (b)(5) �---� 

FDA-OSJ I-FOIA-2020-3541 _00000846 
PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

'-----------------------------' (b)(5) i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541_00000847 
From: 

Sent: 

To: 

CC: 

Subject: 

Attachments: i 

Stephanie 

Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

3/16/2020 5:49:25 PM 

Kraus, Stefanie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Jungman, EI iza beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Ma I oney, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE:i (�)_@ 

(b)(5) 

One edits, for internal consistency . Also, feel free to edit the text I added if you think it may be too forceful. 

Patrizia 

From: Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:44 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, 

Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:j (b)(S) 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Jungman, Elizabeth <=E'-'--liz=a=b....ce....c.th'--'--.'-'-Ju=n

-'-'-'-'--'C-'--'-""'--'--"-..CC..C..C..C..C...C..C.-"-'-'-'­

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>; Maloney, Diane 

<Diane.Maloney@fda.hhs_.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: RE! (b)(5) 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

FDA-OSJ I-FOIA-2020-3541 _00000882 
From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: Re: i (b)(S) 

Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: FW:! (b)(5) 

·-·-·! 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

: (b)(S)ilf you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

... respond to HHS by 5pm today, so apologies for the tight turnaround. 

I 

On the substance of the response: 

(b)(5) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

FDA-OSJ I-FOIA-2020-3541 _00000883 
Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) !(work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW! (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�----------------------------� (b)(5) !Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000884 
From: 

Sent: 

To: 

Subject: 

No comments 

Patrizia 

Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

3/16/2020 5:49:59 PM 

Rebello, Heidi [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =2834ce 193ca949799ef063e34a2cfa0b-H eid i. Rebel] 

RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

From: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:24 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Solomon, Steven M <Steven.Solomon@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan <Susan.Mayne@fda.hhs.gov>; Zeller, Mitchell 

<Mitchell.Zeller@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov>; Abernethy, Amy 

<Amy.Abernethy@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey.Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov>; Branch, Tiffany <Tiffany.Branch@fda.hhs.gov>; Barfell, 

Glenda F <Glenda.Barfell@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

FDA-OSJ I-FOIA-2020-3541 _00000880 
Sincerely, 

Stephen M. Hahn, M.D. 

FDA Commissioner 

FDA-OSJ I-FOIA-2020-3541 _00000881 
From: 

Sent: 

To: 

CC: 

Subject: 

Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7B0453354A9A42 7DB0A66A86C7 A36F3D-JAN ET. WOO DC] 

3/16/2020 6:00:20 PM 

Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Jungman, EI iza beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Ma I oney, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

(b)(5) i 

Looks very good now. I think we can send forward. Jw 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Date: March 16, 2020 at 5:50:54 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>, 

Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Maloney, Diane <Diane.Maloney@fda.hhs.gov>, McLatchy, 

Johanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) ! 

Dear Stephanie, 

This looks good to me. Patrizia's edit took care of my one edit, so I am set. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:49 PM 

To: Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, 

Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.McLatchy@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Stephanie 

One edits, for internal consistency . Also, feel free to edit the text I added if you think it may be too forceful. 

Patrizia 

FDA-OSJ I-FOIA-2020-3541 _00000822 
From: Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:44 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: Re:j (b)(5) 

FDA-OSJ I-FOIA-2020-3541 _00000823 
Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>, Woodcock, Janet <Janet.Woodcock fda.hhs. ov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW:i (b)(5) 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

: (b)(5)!1f you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

'· respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

{b){S) 

• Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out the 

first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

'------------------------------� (b)(5) istacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

FDA-OSJ I-FOIA-2020-3541 _00000824 
Best, 

Anand 

FDA-OSJI-FOIA-2020-3541 _00000825 
From: Jungman, Elizabeth [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =5238A0CAE C064BA8B5 D598115BC4F99F-ELIZABETH .J] 

3/16/2020 6:00:34 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Ma I oney, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

Subject: RE:i (b)(S) : 

Super. Assuming Dr. Woodcock is also on board, should we respond to the Commissioner's office or would others prefer 

to carry that message? Either works. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:51 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov>; Woodcock, 

Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Dear Stephanie, 

This looks good to me. Patrizia's edit took care of my one edit, so I am set. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:49 PM 

To: Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, 

Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Stephanie 

One edits, for internal consistency . Also, feel free to edit the text I added if you think it may be too forceful. 

FDA-OSJ I-FOIA-2020-3541 _00000814 
Patrizia 

From: Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:44 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(S) �---� 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: Re:i (b)(5) 

FDA-OSJI-FOIA-2020-3541_00000815 
(b){5) 

Jw 

From: Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>, Woodcock, Janet <Janet.Woodcock fda.hhs. ov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW:i (b)(S) 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

,

·-·-Stef�nie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i_(_b)(S)_i If you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(5) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) !(work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: FWj (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�------------------------------ (b)(S) !Stacy will also be sharing with the 

ace team. 

FDA-OSJ I-FOIA-2020-3541 _00000816 
Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJI-FOIA-2020-3541_00000817 
From: 

Sent: 

To: 

CC: 

Subject: 

Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7B0453354A9A42 7DB0A66A86C7 A36F3D-JAN ET. WOO DC] 

3/16/2020 6:01:22 PM 

Jungman, Elizabeth [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Ma I oney, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE:i (l?.H_5), ___ � 

Looks good. Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 6:00:35 PM EDT 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Kraus, 

Stefanie <Stefanie.Kraus@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Maloney, Diane <Diane.Maloney@fda.hhs.gov>, McLatchy, 

Johanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Super. Assuming Dr. Woodcock is also on board, should we respond to the Commissioner's office or would others prefer 

to carry that message? Either works. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

!._ _______ ( b )( 6) ________ _i( work cell) 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:51 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov>; Woodcock, 

Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.McLatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Dear Stephanie, 

This looks good to me. Patrizia's edit took care of my one edit, so I am set. 

FDA-OSJI-FOIA-2020-3541_00000810 
Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:49 PM 

To: Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Jungman, 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:! (b)(5) 

Stephanie 

One edits, for internal consistency . Also, feel free to edit the text I added if you think it may be too forceful. 

Patrizia 

From: Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:44 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE: i (b)(S) 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (�1l5-)�---

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: Re:i (b)(S) 

FDA-OSJI-FOIA-2020-3541_00000811 
Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW:i (b)(S) 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i

_

(b)(5)ilf you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(5) 

• Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out the 

first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

FDA-OSJ I-FOIA-2020-3541 _00000812 
From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:j (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�----------------------------� (b)(5) i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJI-FOIA-2020-3541_00000813 
From: 

Sent: 

Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

3/16/2020 6:05:11 PM 

To: Jungman, Elizabeth [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J] 

Subject: RE:i (b)(5) 

How about you send to Ananda Shah, Stacy and Keagan, cc JW, Peter M, Julia, Grail and I? 

Or if you prefer, I can send 

Patrizia 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 6:01 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie 

<Stefanie. Kraus@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Super. Assuming Dr. Woodcock is also on board, should we respond to the Commissioner's office or would others prefer 

to carry that message? Either works. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

[ _________ (b)(6) ________ .J(work cell) 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:51 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Woodcock, 

Janet <Janet.Woodcock fda.hhs. ov>; Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <"-D.C.CiaC.C...n-"e=.M---=-al-"-o'-'-ne "-'-'-....C....C='-'..C..C...C..C.C.U..C-'­

<Johanna.M.c_�<!!��-Y..!Wfda.hhs.gov> 

Subject: RE:i (b)(5) 

Dear Stephanie, 

This looks good to me. Patrizia's edit took care of my one edit, so I am set. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:49 PM 

To: Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Jungman, 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Stephanie 

FDA-OSJ I-FOIA-2020-3541 _00000872 
One edits, for internal consistency . Also, feel free to edit the text I added if you think it may be too forceful. 

Patrizia 

From: Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:44 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b )( 5) 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: Re:i (b)(5) 

FDA-OSJ I-FOIA-2020-3541 _00000873 
{b){5) 

Jw 

From: Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>, Woodcock, Janet <Janet.Woodcock fda.hhs. ov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW:j (b)(5) 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i (b)(5)ilf you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

' respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(5) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

{b){6) i(work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

FDA-OSJ I-FOIA-2020-3541_00000874 
�----------------------------- (b)(5) i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJI-FOIA-2020-3541_00000875 
From: Jungman, Elizabeth [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =5238A0CAE C064BA8B5 D598115BC4F99F-ELIZABETH .J] 

3/16/2020 6:05:26 PM 

To: Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Subject: RE:i (b)(5) 

On it. Thanks. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Date: March 16, 2020 at6:05 :ll PM EDT 

To: Jungman� Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Subject: RE:j (b)(5) i 

How about you send to Ananda Shah, Stacy and Keagan, cc JW, Peter M, Julia, Grail and I? 

Or if you prefer, I can send 

Patrizia 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 6:01 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie 

<Stefanie. Kraus@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.McLatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Super. Assuming Dr. Woodcock is also on board, should we respond to the Commissioner's office or would others prefer 

to carry that message? Either works. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:51 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Kraus, Stefanie ov>; Woodcock, 

Janet <Janet.Woodcock fda.hhs. ov>; Jungman, Elizabeth <Elizabeth.Jun man 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <_D_ia_n_e_.M_al_o_ne�---�­

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Dear Stephanie, 

FDA-OSJ I-FOIA-2020-3541 _00000802 
This looks good to me. Patrizia's edit took care of my one edit, so I am set. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Sent: Monday, March 16, 2020 5:49 PM 

To: Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Jungman, 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Stephanie 

One edits, for internal consistency . Also, feel free to edit the text I added if you think it may be too forceful. 

Patrizia 

From: Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:44 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE: i (b )(5) 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: Re:! (b)(S) 

FDA-OSJ I-FOIA-2020-3541 _00000803 
Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>, Mclatchy!

..Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW:i (b)(5) . 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

,._Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

l (b)(5)_!1f you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(5) 

• Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out the 

first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

FDA-OSJ I-FOIA-2020-3541 _00000804 
From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:j (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�--------------(b_)_(5_) ______________ �!Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000805 
From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7B0453354A9A42 7DB0A66A86C7 A36F3D-JAN ET. WOO DC] 

3/17/2020 9:50:46 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Subject: RE:! (b)(5) i 

I will be at 796 3426 for an hour. w 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:48 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Dear Janet and Patrizia, 

Do you have a minute to discuss? I had a call with Anand, Geet, and OIRA yesterday on vaccines that provided some 

interesting insight. 

Best Regards, 

Peter 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:45 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Thank you all for the quick turnaround As a next step, Dr. Hahn is interested in ideas! (b)(5) 1-.--�-�---· __ (_b)(_S)_( b_ )_(_

5

_) _____ ___,!Just let us know if you 

have any questions on this request. 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Date: March 17, 2020 at 9:06:09 AM EDT 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>, Amin, Stacy <Stacy.Amin@fda.hhs.gov>, Lenihan, Keagan 

<Keagan.lenihan@fda.hhs.gov>, Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>, Sipes, Grail <Grail.Sipes@fda.hhs.gov>, Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) 

FDA-OSJI-FOIA-2020-3541_00000818 
Hi Elizabeth - ··-·-·-· . 

Steve reviewed the response to th�<bH5>iand has some feedback. Jeet will follow up shortly 

Thanks again 

Anand 

From: Shah, Anand 

j_ ______ _! 

Sent: Tuesday, March 17, 2020 6:47 AM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Thank you, Elizabeth and team, for the detailed review that I have also shared with Steve. 

Anand 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 6:12 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: FW:i (b)(S) 

Please see attached a joint CDER-CBER proposed response to the i (b)(5) '------------'----'--'----'-----------' 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

[_ _____ ___( b )( 6 ) ______ ___

i 

( work cell) 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:52 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE:i (b)(S) �----

Janet and Peter good to meet you - I recently joined OC from CMS. 

FDA-OSJI-FOIA-2020-3541_00000819 
Just let us know; also as fyi, initial/high-level comments would be most helpful on this. Thanks so much. 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

Food and Drug Administration 

+1 (202) 230-0451 I ieet.guram@fda.hhs.gov 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:49 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Janet and Peter -

I've asked Jeet to reach out to you with some additional context 

Please let us know the best #'s to reach you for a few min 

Anand 

PRE-DECISIONAL, CONFIDENTIAL 

From: Shah, Anand 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(5) ·-----

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�-----------------------------� (b)(5) i Stacy will also be sharing with the 

OCC team. 

FDA-OSJ I-FOIA-2020-3541 _00000820 
Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJI-FOIA-2020-3541_00000821 
From: 

Sent: 

Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

3/17/2020 9:59:56 AM 

To: Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3 f72df53a-M a rksP] 

Subject: RE:j (b)(S) 

We can use my dial-in number 

Dial In Number Local/Toll Number 1-210-795-1100 Freephone/Toll Free Number 866-880-0098 Passcodes Leader: 

!._ __ (�){_�)____! Pa r

t

i 

c

i pant t__J�)_(_�_}____ ! 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:51 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE:i (b)(S) 

I will be at 796 3426 for an hour. w 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:48 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE: i (b )(5) 

Dear Janet and Patrizia, 

Do you have a minute to discuss? I had a call with Anand, Geet, and OIRA yesterday on vaccines that provided some 

interesting insight. 

Best Regards, 

Peter 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:45 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) 

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�I _____________ . ___ (b_)(_5_) _{_b_)_<_5

_> _________ �! Just let us know if you 

have any questions on this request. 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

FDA-OSJ I-FOIA-2020-3541 _00000876 
Date: March 17, 2020 at 9:06:09 AM EDT 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>, Amin, Stacy <Stacy.Amin@fda.hhs.gov>, Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>, Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>, Sipes, Grail <Grail.Sipes@fda.hhs.gov>, Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:! (�)_(�,_) ___ _, 

Hi Elizabeth -

Steve reviewed the response to the!(b)(sJ!and has some feedback. Jeet will follow up shortly 

Thanks again 

Anand 

From: Shah, Anand 

j ______ j 

Sent: Tuesday, March 17, 2020 6:47 AM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Thank you, Elizabeth and team, for the detailed review that I have also shared with Steve. 

Anand 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 6:12 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: FW:i (b)(5) 

Please see attached a joint CDER-CBER proposed response to the! �-------��-------� (b)(5) 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

FDA-OSJ I-FOIA-2020-3541 _00000877 
From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:52 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Janet and Peter good to meet you - I recently joined OC from CMS. 

Just let us know; also as fyi, initial/high-level comments would be most helpful on this. Thanks so much. 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

Food and Drug Administration 

+1 (202) 230-0451 I ieet.guram@fda.hhs.gov 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:49 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Janet and Peter -

I've asked Jeet to reach out to you with some additional context 

Please let us know the best #'s to reach you for a few min 

Anand 

PRE-DECISIONAL, CONFIDENTIAL 

From: Shah, Anand 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW: i (b )(5) 

FDA-OSJ I-FOIA-2020-3541 _00000878 
PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

'------------------------------' (b)(5) ! Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000879 
From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7B0453354A9A42 7DB0A66A86C7 A36F3D-JAN ET. WOO DC] 

3/17/2020 10:01:50 AM 

To: Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Subject: RE:i (b)(5) 

Peter just called me. I'm going to call Anand.! (b)(5) 

(b)(5) .!·::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::.-----------------------------� 

! (b)(5) : If you call me, 63426 we can discuss additional developments. jw 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 10:00 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE:i (b)(S) 

We can use my dial-in number 

Dial In Number Local/Toll Number 1-210-795-1100 Freephone/Toll Free Number 866-880-0098 Passcodes Leader: 

i (b)(6) !Participant:! (b)(6) : 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:51 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE:i (b)(S) �----

I will be at 796 3426 for an hour. w 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:48 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE:i (b)(S) �----' 

Dear Janet and Patrizia, 

Do you have a minute to discuss? I had a call with Anand, Geet, and OIRA yesterday on vaccines that provided some 

interesting insight. 

Best Regards, 

Peter 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:45 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:j (b)(5) 

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(b)(5) 

FDA-OSJ I-FOIA-2020-3541 _00000798 
(b)(5) 

�----------------------------------� (b)(5) ! Just let us know if you 

have any questions on this request. 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Date: March 17, 2020 at 9:06:09 AM EDT 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>, Amin, Stacy <Stacy.Amin@fda.hhs.gov>, Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>, Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>, Sipes, Grail <Grail.Sipes@fda.hhs.gov>, Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Hi Elizabeth -

Steve reviewed the response to the!_��!

-

�_!and has some feedback. Jeet will follow up shortly 

Thanks again 

Anand 

From: Shah, Anand 

Sent: Tuesday, March 17, 2020 6:47 AM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:! lb.){�>�--� 

Thank you, Elizabeth and team, for the detailed review that I have also shared with Steve. 

Anand 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 6:12 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: FW:j (b)(5) i 

Please see attached a joint CDER-CBER proposed response to the �-------���------� 

i (b)(5) 

Elizabeth Jungman 

FDA-OSJ I-FOIA-2020-3541 _00000799 
Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i (work cell) 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:52 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE: i (b)(S) 

Janet and Peter good to meet you - I recently joined OC from CMS. 

Just let us know; also as fyi, initial/high-level comments would be most helpful on this. Thanks so much. 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

Food and Drug Administration 

+1 (202) 230-0451 I ieet.guram@fda.hhs.gov 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:49 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Subject: RE:i (b)(5) �----

Janet and Peter -

I've asked Jeet to reach out to you with some additional context 

Please let us know the best #'s to reach you for a few min 

Anand 

PRE-DECISIONAL, CONFIDENTIAL 

From: Shah, Anand 

Sent: Monday, March 16, 2020 9:46 AM 

FDA-OSJ I-FOIA-2020-3541 _00000800 
To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�----------------------------� (b)(5) ! Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJI-FOIA-2020-3541_00000801 
From: Caccomo, Stephanie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =950C32CEBC4B4F80B302C50CF31C8524-STEPHAN IE. C] 

Sent: 3/18/2020 11:03:23 PM 

To: 2019-nCoV FDA IMG JIC [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =2897 lSa 114684 7558b07a33cca b6bccf-2019-nCoV F]; OCCReq uests-COVI D19 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en=bcb 756008a41407282a58324a 7b5144a-OCCReq uests ]; Amin, Stacy 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Anderson, Erika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Roberts, Rosemary 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b 7838eab964e4ca la 7 d703876d0841 lb-RO BE RTSR]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Subject: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Attachments: POTUS_ TPS _llpm_FDA.docx 

Updated TPs for POTUS press briefing tomorrow on therapeutics. CDER/CBER-can you look at quickly? I've added edits 

and a note on attached version. This is due to HHS by 6:30am. Thanks! 

Press Conference on FDA Developments 

FDA-OSJI-FOIA-2020-3541_00000775 
Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Des� _301._348.195� 

Cel I !__ ______ ( b )( 6) _______ _! 

stephanie.caccomo@fdahhs.gov 

FDA-OSJ I-FOIA-2020-3541 _00000776 
From: Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

Sent: 3/18/2020 11:22:26 PM 

To: Caccomo, Stephanie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=950c32cebc4b4f80b302c50cf3 lc8524-Stephanie.C]; 2019-nCoV FDA I MG JIC 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en=289715a 114684 7558 b07 a33cca b6bccf-2019-nCoV F]; OCCReq uests-COVI D19 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =bcb 756008a41407282a58324a 7b5144a-OCCReq uests ]; Amin, Stacy 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Anderson, Erika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=85feca0be0694803be6030e97c7b4ad b-H INTON D]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Roberts, Rosemary 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b 7838eab964e4ca la 7 d703876d0841 lb-RO BE RTSR]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

CC: Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode] 

Subject: RE: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Attachments: POTUS_TPS_llpm_FDA_CDER.docx 

I have substantive edits , see attached 

Patrizia 

From: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Sent: Wednesday, March 18, 2020 11:03 PM 

To: 2019-nCoV FDA IMG JIC <2019-nCoVFDAIMGJIC@fda.hhs.gov>; OCCRequests-COVID19 <0CCRequestsCOVID19@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; 

Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Roberts, Rosemary 

<Rosemary.Roberts@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Updated TPs for POTUS press briefing tomorrow on therapeutics. CDER/CBER-can you look at quickly? I've added edits 

and a note on attached version. This is due to HHS by 6:30am. Thanks! 

Press Conference on FDA Developments 

FDA-OSJ I-FOIA-2020-3541 _00000862 
Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Desk; __ 3_Q1..3A8�J.9..5_!;l 

Cell l_ ______ (b )(6) ____ ___: 

stephanie.caccomo@fdahhs.gov 

FDA-OSJ I-FOIA-2020-3541 _00000863 
FDA-OSJI-FOIA-2020-3541 _00000864 
From: Caccomo, Stephanie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =950C32CEBC4B4F80B302C50CF31C8524-STEPHAN IE. C] 

Sent: 3/19/2020 7:02:23 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; 2019-nCoV FDA IMG JIC 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

Got it thx 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =2897 lSa 114684 7558b07a33ccab6bccf-2019-nCoV F]; OCCReq uests-COVI D19 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =bcb 756008a41407282a58324a 7b5144a-OCCReq uests ]; Amin, Stacy 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Anderson, Erika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Roberts, Rosemary 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b 7838ea b964e4ca la 7 d703876d0841 lb-RO BE RTSR] 

RE: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Desk 301.348.1956 

Celli (b)(6) i 

stephanfo�'ci'iccomo@fda h hs. gov 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 7:02 AM 

To: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; 2019-nCoV FDA IMG JIC <2019-

nCoVFDAIMGJIC@fda.hhs.gov>; OCCRequests-COVID19 <0CCRequests-COVID19@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Roberts, Rosemary 

<Rosemary.Roberts@fda.hhs.gov> 

Subject: RE: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Dear Stephanie, 

The situation for blood has changed somewhat, so updated that, including language that CDC and FDA agreed upon. 

Best Regards, 

Peter 

FDA-OSJ I-FOIA-2020-3541 _00000788 
From: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Sent: Wednesday, March 18, 2020 11:03 PM 

To: 2019-nCoV FDA IMG JIC <2019-nCoVFDAIMGJIC fda.hhs. ov>; OCCRequests-COVID19 <0CCRequestsCOVID19@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov>; 

Anderson, Erika <Erika.Anderson fda.hhs. ov>; Hinton, Denise <Denise.Hinton fda.hhs. ov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni fda.hhs. ov>; Farley, John <John.Farley@fda.hhs.gov>; Roberts, Rosemary 

<Rosema .Roberts fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Updated TPs for POTUS press briefing tomorrow on therapeutics. CDER/CBER-can you look at quickly? I've added edits 

and a note on attached version. This is due to HHS by 6:30am. Thanks! 

Press Conference on FDA Develo ments 

FDA-OSJ I-FOIA-2020-3541 _00000789 
Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Desk 301 .348.1956 

Celll._ _____ (b)(6) ____ ___! 

stephanie.caccomo@fdahhs.gov 

FDA-OSJ I-FOIA-2020-3541 _00000790 
From: Woodcock, Janet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 7B0453354A9A42 7DB0A66A86C7 A36F3D-JAN ET. WOO DC] 

Sent: 3/20/2020 12:34:10 PM 

To: Shah, Anand [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah]; Felberbaum, Mi cha el 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4819a643ca2945cd b la263 lb83e69673-M i cha el. Fel] 

CC: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Shuren, Jeff 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren ]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Subject: RE: Per our conversation ... 

(b)(5) i Happy to help in talking to the press. jW 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:23 PM 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shuren, Jeff 

<Jeff.Shu ren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Hi Michael -

Thanks for sharing these potential questions. I've included Janet, Peter, and Jeff here for their thoughts. I agree it would 

be helpful for us to carefully think through these questions and, whenever possible, have a coordinated approach to 

incoming questions from stakeholders including media. 

Anand 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:18 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Subject: Per our conversation ... 

Thanks for the chat. Here are the questions I think we need to be prepared to answer on this topic. Feel free to add to 

this list and let me know if you want to relay to Janet or others. 

{b){S) 

FDA-OSJ I-FOIA-2020-3541 _00000773 
Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Tel 240-402-9548 / Celli (b)(6) i 

michael. fel berbau m@fda.hns:qov-·-·-·-·-·-·-·-·-·-·· 

U.S. FOOD & DRUG 

AOMlt�ISUATION 

DCllZl ·· II 

FDA-OSJ I-FOIA-2020-3541_00000774 
From: Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

Sent: 3/21/2020 7:52:58 AM 

To: Hahn, Stephen [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =a0afac0cfa3c4b98913833e38a036e9f-Stephen. Ha h]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni] 

CC: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Am in, Stacy 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Rom, Colin 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f59636221 f 4340d697 d bd43ee27 255fb-Col in. Rom]; Edmonds, Arna nda 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =232186a24a534 7 4298d2760c060a4cc7-Ama nda. Ed mo]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode] 

Re: Vaccine development idea 

In case Sen.Daines' office insists to make contact directly, here is the contact information. Existence and description of 

the trials is publicly available as of this morning (we gave Roche-Genentech authorization to proceed yesterday). 

Regeneron 

phase 2/3 clinical program studying arthritis med Kevzara as a therapy for patients hospitalized with severe COVID19, Sanofi said Monday. 

Maya Bermingham 

Vice President, Public Policy and Government Affairs 

914-598-3031 

Roche-Genentech 

randomized, double-blind, placebo-controlled phase 3 clinical trial to study Actemra in hospitalized patients with 

severe COVID-19 pneumonia 

Catherine Phillips 

Director 

919-308-1942 

FDA-OSJI-FOIA-2020-3541_00000851 
From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Date: March 20, 2020 at 7:43:45 PM EDT 

To: Hahn, Stephen <SH1@fda.hhs.gov>, Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>, Amin, Stacy <Stacy.Amin@fda.hhs.gov>, Rom, Colin 

<Colin.Rom@fda.hhs.gov>, Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>, Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov> 

Subject: Re: Vaccine development idea 

This started when Peter suggested that we include monoclonals . They have a completely different purpose vs vaccines. 

We have already reached out to the Government Affairs contacts at Regeneron and Roche - Genentech to contact the 

Senator's office . The information on the IL-6 inhibitors is CCI, as opposed to vaccines which is apparently public . 

Patrizia 

From: Hahn, Stephen <SH1@fda.hhs.gov> 

Date: March 20, 2020 at 7:07:53 PM EDT 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>, Rom, Colin <Colin.Rom@fda.hhs.gov>, Edmonds, Amanda 

<Amanda.Edmonds@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: Re: Vaccine development idea 

Very helpful. Thanks, Peter. 

Patrizia, a similar list would be helpful for me to pass along to the Senator. 

Steve 

Sent from my iPad 

On Mar 20, 2020, at 6:39 PM, Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> wrote: 

Very helpful! Thank you Peter. 

Patrizia, are you sending the same thing or just encouraging your firms to reach out to Daines? 

Sent from my iPhone 

On Mar 20, 2020, at 6:12 PM, Marks, Peter <Peter.Marks@fda.hhs.gov> wrote: 

Dear Keagan, 

Sorry- took a while to get permission from manufacturers. Just got the last one. Please see the attached and 

below. Just let me know if you need assistance talking to anyone over the weekend. 

Best Regards, 

Peter 

FDA-OSJ I-FOIA-2020-3541 _00000852 
ModernaTX, 

Inc. 

mRNA-1273, a novel lipidencapsulated mRNA-based 

prophylactic vaccine encoding 

the pre-fusion stabilized Spike 

(S) glycoprotein of the SARSCoV-2 virus 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:47 PM 

Tal Zaks, MD 

Chief Medical Officer 

ModernaTX Inc 

Tal.zaks.@modernatx.com I modernatx.com 

I mobile!._ ________ ___( b )( 6) _________ ___i 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Any update on vaccines? 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:38 PM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Amin, Stacy <Sta y.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

FDA-OSJ I-FOIA-2020-3541 _00000853 
Thanks. That sounds fine to me. I have a feeling that we will not have the vaccine information ready until late today, so 

we might need to have this call over the weekend. 

Best Regards, 

Peter 

From: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Sent: Friday, March 20, 2020 12:36 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Thank you all. Would like to make sure we are coordinated and understand what we are getting back to the Hill. 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:09 AM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

My vote is that we get more info, get it prepped for the hill and then touch bases if need be, or after it is reviewed on 

the hill to take care of questions. 

Best Regards, 

Peter 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:05 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; 

Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Do we need a call? Or more info first? 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Friday, March 20, 2020 10:49 AM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; 

Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Peter and I spoke. We are going to take the same approach as CBER, ie reach out to Gov Affairs in the companies in 

question (monoclonals) and ask them that they reach out to Sen. Daines 

Patrizia 

FDA-OSJ I-FOIA-2020-3541 _00000854 
From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:58 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; 

Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: Re: Vaccine development idea 

Should we hop on a call to discuss? 

Sent from my iPhone 

On Mar 20, 2020, at 9:53 AM, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> wrote: 

We don't think this is a good idea. 

Patrizia 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:26 AM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

Definitely would consider these! This is CDER's domain, so looping Patrizia in. (Patrizia - let me know when you have 

time and I can call you to loop you in.) 

Best Regards, 

Peter 

From: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Sent: Friday, March 20, 2020 9:19 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov> 

Subject: Re: Vaccine development idea 

Peter- can you think through monoclonal antibodies as well, and if we should be exploring that avenue with the 

vaccines? 

Sent from my iPhone 

On Mar 20, 2020, at 9:08 AM, Marks, Peter <Peter.Marks@fda.hhs.gov> wrote: 

Dear Commissioner and Amanda, 

FDA-OSJ I-FOIA-2020-3541 _00000855 
We are working on getting permission from the most promising 3-4 vaccine companies for permission to have the 

Senator or staffers to contact them. Expect this by the end of the day. 

I remain available at any time if you need anything here. 

Best Regards, 

Peter 

From: Amin, Stacy <Stacy.Amin@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:06 AM 

To: Hahn, Stephen <SH1@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Rom, Colin <Colin.Rom@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Edmonds, Amanda 

<Amanda. Edmonds@fda.hhs.gov> 

Subject: Vaccine development idea 

Commissioner - I have Amanda Edmonds working on this-Amanda is my best lawyer and will get this worked through 

with Peter. We agree it will require some creative leg writing. 

Is the next step for us to connect with Sen Daines once we have an idea of how to do this? 

Best, 

Stacy 

***************************************** 

Stacy Cline Amin 

Chief Counsel 

Food and Drug Administration 

Deputy General Counsel 

Department of Health and Human Services 

<SARS-CoV-2 vaccine manufacturers.docx> 

FDA-OSJ I-FOIA-2020-3541 _00000856 
From: 

Sent: 

Cavazzoni, Patrizia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C42ABD33834044ECBAA03D075CCOA5D2-PATRIZIA.CA] 

3/21/2020 10:46:13 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

RE: Vaccine development idea 

No problem . 

Patrizia 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Date: March 21, 2020 at 10:20:34 AM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Dear Patrizia, 

Sorry - did not mean to cause you headaches. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Friday, March 20, 2020 7:44 PM 

To: Hahn, Stephen <SH1@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov> 

Subject: Re: Vaccine development idea 

This started when Peter suggested that we include monoclonals . They have a completely different purpose vs vaccines. 

We have already reached out to the Government Affairs contacts at Regeneron and Roche - Genentech to contact the 

Senator's office . The information on the IL-6 inhibitors is CCI, as opposed to vaccines which is apparently public . 

Patrizia 

From: Hahn, Stephen <SH1@fda.hhs.gov> 

Date: March 20, 2020 at 7:07:53 PM EDT 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>, Rom, Colin <Colin.Rom@fda.hhs.gov>, Edmonds, Amanda 

<Amanda.Edmonds@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: Re: Vaccine development idea 

Very helpful. Thanks, Peter. 

Patrizia, a similar list would be helpful for me to pass along to the Senator. 

Steve 

FDA-OSJI-FOIA-2020-3541_00000857 
Sent from my iPad 

On Mar 20, 2020, at 6:39 PM, Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> wrote: 

Very helpful! Thank you Peter. 

Patrizia, are you sending the same thing or just encouraging your firms to reach out to Daines? 

Sent from my iPhone 

On Mar 20, 2020, at 6:12 PM, Marks, Peter <Peter.Marks@fda.hhs.gov> wrote: 

Dear Keagan, 

Sorry- took a while to get permission from manufacturers. Just got the last one. Please see the attached and 

below. Just let me know if you need assistance talking to anyone over the weekend. 

Best Regards, 

Peter 

ModemaTX, 

Inc. 

mRNA-1273, a novel lipidencapsulated mRNA-based 

prophylactic vaccine encoding 

the pre-fusion stabilized Spike 

(S) glycoprotein of the SARSCoV-2 virus 

Tal Zaks, MD 

Chief Medical Officer 

ModemaTX Inc 

Tal.zaks@modernatx.com I modernatx.com 

I mobilei (b)(6) i 

FDA-OSJ I-FOIA-2020-3541 _00000858 
From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:47 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Any update on vaccines? 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:38 PM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

Thanks. That sounds fine to me. I have a feeling that we will not have the vaccine information ready until late today, so 

we might need to have this call over the weekend. 

Best Regards, 

Peter 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:36 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Thank you all. Would like to make sure we are coordinated and understand what we are getting back to the Hill. 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:09 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

My vote is that we get more info, get it prepped for the hill and then touch bases if need be, or after it is reviewed on 

the hill to take care of questions. 

Best Regards, 

Peter 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:05 AM 

FDA-OSJ I-FOIA-2020-3541 _00000859 
To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; 

Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Do we need a call? Or more info first? 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Sent: Friday, March 20, 2020 10:49 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; 

Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Peter and I spoke. We are going to take the same approach as CBER, ie reach out to Gov Affairs in the companies in 

question (monoclonals) and ask them that they reach out to Sen. Daines 

Patrizia 

From: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Sent: Friday, March 20, 2020 9:58 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; 

Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: Re: Vaccine development idea 

Should we hop on a call to discuss? 

Sent from my iPhone 

We don't think this is a good idea. 

Patrizia 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:26 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Amin, Stacy <Sta y.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

Definitely would consider these! This is CDER's domain, so looping Patrizia in. (Patrizia - let me know when you have 

time and I can call you to loop you in.) 

Best Regards, 

Peter 

FDA-OSJ I-FOIA-2020-3541 _00000860 
From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:19 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov> 

Subject: Re: Vaccine development idea 

Peter- can you think through monoclonal antibodies as well, and if we should be exploring that avenue with the 

vaccines? 

Sent from my iPhone 

On Mar 20, 2020, at 9:08 AM, Marks, Peter <Peter.Marks@fda.hhs.gov> wrote: 

Dear Commissioner and Amanda, 

We are working on getting permission from the most promising 3-4 vaccine companies for permission to have the 

Senator or staffers to contact them. Expect this by the end of the day. 

I remain available at any time if you need anything here. 

Best Regards, 

Peter 

From: Amin, Stacy <Stacy.Amin@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:06 AM 

To: Hahn, Stephen <SH1@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Rom, Colin <Colin.Rom@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Edmonds, Amanda 

<Amanda. Edmonds@fda.hhs.gov> 

Subject: Vaccine development idea 

Commissioner - I have Amanda Edmonds working on this-A_r:!]_anda is my best lawyer and will get this worked through 

with Peter. We agree it will requirei (b)(5) i 

Is the next step for us to connect with Sen Daines once we have an idea of how to do this? 

Best, 

Stacy 

***************************************** 

Stacy Cline Amin 

Chief Counsel 

Food and Drug Administration 

Deputy General Counsel 

Department of Health and Human Services 

<SARS-CoV-2 vaccine manufacturers.docx> 

FDA-OSJI-FOIA-2020-3541_00000861 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

3/19/2020 9:08:46 AM 

To: Hess, Maureen [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =23ed9c01196f 4 765b89921c35 7f855f9-H essma] 

RE: COVID vaccines meeting -- request to post FDA statement 

OhhQ 

From: Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 9:08 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Subject: RE: COVID vaccines meeting -- request to post FDA statement 

I guess that my sarcasm doesn't come across in email. 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:57 AM 

To: Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: COVID vaccines meeting -- request to post FDA statement 

No, I do not think so. 

From: Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:30 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Subject: RE: COVID vaccines meeting -- request to post FDA statement 

Trump kept teasing in his press conference yesterday about something big/great that 

the FDA is doing, that he would announce today- maybe this is it! 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:02 AM 

To: Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: FW: COVID vaccines meeting -- request to post FDA statement 

FYI - There is a story to this that I can fill you in on by phone some time. i (b)(5) 

I will let you know if there is going to be an FDA statement. The Europe FDA office discussing right now. 

Marion 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 7:32 AM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce <Bruce.Ross@fda.hhs.gov>; Klein, Vashti* 

<Vashti.Klein@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber@fda.hhs.gov>; Kweder, Sandra L <Sandra.Kweder@fda.hhs.gov> 

Subject: COVID vaccines meeting -- request to post FDA statement 

Hi Karen - Re: COVID vaccine global regulators meeting yesterday -- we'd like to do an FDA posting to piggy back on this 

EMA statement: 

FDA-OSJ I-FOIA-2020-3541 _00000909 
https ://www.ema.eu ropa .eu/ en/ news/ti rst-regu la to ry-workshop-covid-19-faci I itates-glo ba I-co 11 a bo ration-vaccinedevelo pment 

Peter Marks is fine with moving ahead with this as a joint EMA-FDA statement so I think best to use the same wording 

from EMA's statement. 

I've copied CBER leads and they can help if any questions and also consider if you have other suggestions for PR. We'll 

definitely add a blurb in OGPS' next monthly distribution. 

Thanks, 

Ritu 

FDA-OSJI-FOIA-2020-3541_00000910 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

Sent: 3/19/2020 12:45:54 PM 

To: Nalubola, Ritu [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=3103228e5eba458f9c2aa la846d25c7c-PNal ubol]; Louati, Claudia (FSN )* 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c682e89ffb b049c6be9 5d65e2eeb04eb-Cla ud i a. Lou]; Kweder, Sandra L 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=3dcee61a387b4de49117ed8a0a80eea5-KWEDER]; Blair, Joan W. (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR] 

CC: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Abdoo, Mark 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=dca42e5fl 795433c9df447f8fllbc80e-Mark.Abdoo ]; Ross, Bruce 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4ae28 ldfd2164cb8959133dfe0026cee-Bruce. Ross] 

RE: Vaccines meeting -- narrative for State Dept cable 

Attachments: Vaccines meeting -Narrative for cable.docxclean.docx; Vaccines meeting -Narrative for cable.docx 

DearRitu, 

Please see attached document with track changes and a version of clean document. I have shortened taking out 

some of the details and tried to summarize (high level) main points discussed. This document needs probably to 

be tweaked a bit more by the communication experts. Happy to look at another version. Thank you for 

providing me with the opportunity to review. 

Marion 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 10:38 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov>; Kweder, 

Sandra L <Sandra.Kweder@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: Vaccines meeting -- narrative for State Dept cable 

Hi all -Attached first stab at write up intended for use by front office in drafting the State Dept cable. Please review and 

send comments by COB today your time. Marion, I relied heavily on the summary notes that you are working on with 

Marco. Please feel free to edit/rewrite as you see fit. It is very technical and if you can make it less so, that would be 

great. 

DCA wants to be able to send out cable tomorrow COB here. Just FYI, State Dept cables have a wide distribution but still 

internal USG. 

(Peter -we can share a near final version if you want to hold off -or you can review this now. I defer to you and 

Marion.) 

Thanks, 

Ritu 

Ritu Nalubola, Ph.D. 

Director, Europe Office 

U.S. Food and Drug Administration 

FDA-OSJI-FOIA-2020-3541_00000917 
U.S. Mission to the European Union 

Boulevard du Regent 40 

B-1000 Brussels, Belgium 

Phone: +32-2-811-5733 

Mobile:i (l?.H_6J __ � 

Email: Ritu.Nalubola/a fda.hhs.goy 

U.S. FOOD & DRUG 

ADMIN15lltAJ!OM 

FDA-OSJI-FOIA-2020-3541_00000918 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

Sent: 3/19/2020 12:55:14 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; M cN ei 11, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en= 77b0b352c9c2485 lbfOc7330f53e00d9-McNeil I]; Tierney, Julia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Ma I oney, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=e59205500e944c9eacc4524ea18ed5bb-MaloneyD]; Cho, David S (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Rouse, David 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=185bae767862490d88eda44db74a75b3-RouseD]; Blair, Joan W. (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR] 

Frantz-Bohn, Susan [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4c4a 1082 lc77 4 ffa9c5cf59bda6bcf75-fra ntz _ boh n]; Ba rte I I, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e9ea8198fc524f22a 73af02438cba lc5-Ba rte I I]; Richards, Pa u I 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =04b2b41d2 86c4c12b60b827b5fb0c96c-richa rds ]; Hess, Maureen 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pi ents/ en=23ed9c01196f 4 765b8992 lc35 7f855f9-H essma]; Na I u bola, Ritu 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =3103228e5eba458f9c2aa la846d25c7 c-PN a I u bol] 

RE: Statement/Communication requested about COVID Vaccine meeting 

Attachments: Vaccines meeting -Narrative for cable.docxclean.docx 

All, 

As discussed below, this is the draft for the State Dept. cable. I just sent my revisions back to Ritu and I am 

attaching a clean version for your considerations. If we want to do some sort of public statement the remaining 

technical aspects in this document could probably be taken out. 

Marion 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 9:24 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

Dear All, 

I support Marion's approach here. 

Best Regards, 

Peter 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:48 AM 

FDA-OSJI-FOIA-2020-3541_00000914 
To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

I just got off the phone with Ritu and they are doing a State dept cable. I will work with her on 

language so that we get at least that one right. We could use similar language if we are to 

communicate as I think we should. I am not in favor of retweeting EMA's statement as we can 

do better than that. 

Marion 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:39 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov> 

Subject: FW: Statement/Communication requested about COVID Vaccine meeting 

Good morning - please see the emails below regarding the ICMRA meeting yesterday. Would welcome thoughts on 

best approach on this. I think we could develop tweets and retweet EMA's statement, which doesn't say much. 

Thanks -

Lorrie 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:33 AM 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov> 

Subject: Statement/Communication requested about COVID Vaccine meeting 

Yesterday the International Coalition of Medicines Regulatory Authorities held a virtual international workshop, cochaired by the EMA and FDA, on the development of vaccines against COVID-19. The EMA subsequently put out a brief 

statement about the meeting, which you can see in the link below. My folks would like us to put out something as well. 

We could mirror the EMA statement, or even post it, as we have done in the past, although I think more information 

could be added. Could we do something like this today? At the very least, I will look for the statement on Twitter and 

will retweet it. 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 7:32 AM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce <Bruce.Ross@fda.hhs.gov>; Klein, Vashti* 

<Vashti.Klein@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber@fda.hhs.gov>; Kweder, Sandra L <Sandra.Kweder@fda.hhs.gov> 

Subject: COVID vaccines meeting -- request to post FDA statement 

FDA-OSJI-FOIA-2020-3541_00000915 
Hi Karen - Re: COVID vaccine global regulators meeting yesterday -- we'd like to do an FDA posting to piggy back on this 

EMA statement: 

https ://www.ema.eu ropa .eu/ en/ news/ti rst-regu la to ry-workshop-covid-19-faci I itates-glo ba I-co 11 a bo ration-vaccinedevelo pment 

Peter Marks is fine with moving ahead with this as a joint EMA-FDA statement so I think best to use the same wording 

from EMA's statement. 

I've copied CBER leads and they can help if any questions and also consider if you have other suggestions for PR. We'll 

definitely add a blurb in OGPS' next monthly distribution. 

Thanks, 

Ritu 

FDA-OSJI-FOIA-2020-3541_00000916 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

Sent: 3/19/2020 4:34:36 PM 

To: Nalubola, Ritu [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=3103228e5eba458f9c2aa la846d25c7c-PNal ubol]; Louati, Claudia (FSN )* 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c682e89ffb b049c6be9 5d65e2eeb04eb-Cla ud i a. Lou]; Kweder, Sandra L 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=3dcee61a387b4de49117ed8a0a80eea5-KWEDER]; Blair, Joan W. (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR] 

CC: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Abdoo, Mark 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=dca42e5fl 795433c9df447f8fllbc80e-Mark.Abdoo ]; Ross, Bruce 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4ae28 ldfd2164cb8959133dfe0026cee-Bruce. Ross] 

Subject: RE: Vaccines meeting -- narrative for State Dept cable 

Attachments: Vaccines meeting -Narrative for cable-clean-EO.docxMFG 031920.docx 

Dear all, 

Here are my further revisions and comments. 

Marion 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 2:38 PM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov>; Kweder, 

Sandra L <Sandra.Kweder@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: RE: Vaccines meeting -- narrative for State Dept cable 

Many thanks, Marion! Sandy, Claudia, and I made just a few more changes for context and plain-language. All of our 

input is tracked - please see attached and add any further changes. 

Dear Peter - This version is ready for your review. Please send any input by end today, if at all possible. Or just let us 

know if you don't plan on reviewing. Thanks! 

Best regards, 

Ritu 

From: Gruber, Marion 

Sent: Thursday, March 19, 2020 5:46 PM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati 

L <Sandra.Kweder fda.hhs. ov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: RE: Vaccines meeting -- narrative for State Dept cable 

DearRitu, 

Please see attached document with track changes and a version of clean document. I have shortened taking out 

some of the details and tried to summarize (high level) main points discussed. This document needs probably to 

FDA-OSJ I-FOIA-2020-3541 _00000928 
be tweaked a bit more by the communication experts. Happy to look at another version. Thank you for 

providing me with the opportunity to review. 

Marion 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 10:38 AM 

To: Gruber, Marion <Marion.Gruber fda.hhs. ov>; Louati, Claudia (FSN)* <Claudia.Louati 

Sandra L <Sandra.Kweder fda.hhs. ov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: Vaccines meeting -- narrative for State Dept cable 

Hi all -Attached first stab at write up intended for use by front office in drafting the State Dept cable. Please review and 

send comments by COB today your time. Marion, I relied heavily on the summary notes that you are working on with 

Marco. Please feel free to edit/rewrite as you see fit. It is very technical and if you can make it less so, that would be 

great. 

DCA wants to be able to send out cable tomorrow COB here. Just FYI, State Dept cables have a wide distribution but still 

internal USG. 

(Peter -we can share a near final version if you want to hold off -or you can review this now. I defer to you and 

Marion.) 

Thanks, 

Ritu 

Ritu Nalubola, Ph.D. 

Director, Europe Office 

U.S. Food and Drug Administration 

U.S. Mission to the European Union 

Boulevard du Regent 40 

B-1000 Brussels, Belgium 

Phone: +32-2-811-5733 

Mobile:! (b)(G) 

Email: Ritu.Nalubola'dfda.hhs.gm 

U.S. FOOD & DRUG 

AOMINISlllATION 

FDA-OSJ I-FOIA-2020-3541 _00000929 
From: Maloney, Diane [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E59205500E944C9EACC4524EA18EDSBB-MALONEYD] 

Sent: 3/19/2020 4:49:37 PM 

To: Gruber, Marion [/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BOHF23SPDL T)/en=Recipients/en=019cd2669c7048f7a 116d72b7682de44-gruber ]; McNeil I, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c24851 bf0c7330f53e00d9-M cN eil I]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Tierney, Ju Ii a 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=1160d300bc4248b790ded292a082e9a8-Julia.Tiern]; Cho, David S ( CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Rouse, David 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=185bae767862490d88eda44db74a75b3-RouseD]; Blair, Joan W. (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR] 

Frantz-Bohn, Susan [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4c4a 1082 lc77 4 ffa9c5cf59bda6bcf75-fra ntz _ boh n]; Ba rte I I, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e9ea8198fc524f22a 73af02438cba lc5-Ba rte I I]; Richards, Pa u I 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =04b2b41d2 86c4c12b60b827b5fb0c96c-richa rds ]; Hess, Maureen 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en =Recipients/ en=23ed9c01196f4 765b8992 lc35 7f855f9-H essma] 

RE: Statement/Communication requested about COVID Vaccine meeting 

Attachments: Vaccines meeting -Narrative for cable.docxredlineaccepteddm.docx; Vaccines meeting -Narrative for 

cable.docxcleandm.docx 

Hi Marion, 

Thanks so much for your work on this. my understanding is that this would be used as a summary of the meeting. Is 

that correct? That's what I considered as I reviewed it. Please see my suggested edits - given in the spirit of trying to 

help. the first document is somewhat clean (I revised some of the narrative and made additional changes but left my 

comments in the margin). The second one is the redline. I may have introduced inaccuracies inadvertently. 

If I can help at all, just let me know. 

Thanks, 

Diane 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:48 AM 

To: McNeil I, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

I just got off the phone with Ritu and they are doing a State dept cable. I will work with her on 

language so that we get at least that one right. We could use similar language if we are to 

communicate as I think we should. I am not in favor of retweeting EMA's statement as we can 

do better than that. 

Marion 

FDA-OSJ I-FOIA-2020-3541 _00000898 
From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:39 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov> 

Subject: FW: Statement/Communication requested about COVID Vaccine meeting 

Good morning - please see the emails below regarding the ICMRA meeting yesterday. Would welcome thoughts on 

best approach on this. I think we could develop tweets and retweet EMA's statement, which doesn't say much. 

Thanks -

Lorrie 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:33 AM 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov> 

Subject: Statement/Communication requested about COVID Vaccine meeting 

Yesterday the International Coalition of Medicines Regulatory Authorities held a virtual international workshop, cochaired by the EMA and FDA, on the development of vaccines against COVID-19. The EMA subsequently put out a brief 

statement about the meeting, which you can see in the link below. My folks would like us to put out something as well. 

We could mirror the EMA statement, or even post it, as we have done in the past, although I think more information 

could be added. Could we do something like this today? At the very least, I will look for the statement on Twitter and 

will retweet it. 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 7:32 AM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce <Bruce.Ross@fda.hhs.gov>; Klein, Vashti* 

<Vashti.Klein@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber@fda.hhs.gov>; Kweder, Sandra L <Sandra.Kweder@fda.hhs.gov> 

Subject: COVID vaccines meeting -- request to post FDA statement 

Hi Karen - Re: COVID vaccine global regulators meeting yesterday -- we'd like to do an FDA posting to piggy back on this 

EMA statement: 

https://www.ema.europa.eu/en/news/first-regulatory-workshop-covid-19-facilitates-global-collaboration-vaccinedevelopment 

Peter Marks is fine with moving ahead with this as a joint EMA-FDA statement so I think best to use the same wording 

from EMA's statement. 

I've copied CBER leads and they can help if any questions and also consider if you have other suggestions for PR. We'll 

definitely add a blurb in OGPS' next monthly distribution. 

Thanks, 

FDA-OSJ I-FOIA-2020-3541 _00000899 
Ritu 

FDA-OSJI-FOIA-2020-3541 _00000900 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

3/19/2020 4:58:15 PM 

To: Hess, Maureen [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =23ed9c01196f 4 765b89921c35 7f855f9-H essma] 

RE: Statement/Communication requested about COVID Vaccine meeting 

Give me 20 min, I send something revised then. 

From: Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 4:53 PM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

Do you want me to try to flesh this out more- the intro, stuff like that? 

Maureen 

From: Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 4:50 PM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; 

Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

Hi Marion, 

Thanks so much for your work on this. my understanding is that this would be used as a summary of the meeting. Is 

that correct? That's what I considered as I reviewed it. Please see my suggested edits - given in the spirit of trying to 

help. the first document is somewhat clean (I revised some of the narrative and made additional changes but left my 

comments in the margin). The second one is the redline. I may have introduced inaccuracies inadvertently. 

If I can help at all, just let me know. 

Thanks, 

Diane 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:48 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

I just got off the phone with Ritu and they are doing a State dept cable. I will work with her on 

language so that we get at least that one right. We could use similar language if we are to 

FDA-OSJI-FOIA-2020-3541_00000911 
communicate as I think we should. I am not in favor of retweeting EMA's statement as we can 

do better than that. 

Marion 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:39 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov> 

Subject: FW: Statement/Communication requested about COVID Vaccine meeting 

Good morning - please see the emails below regarding the ICMRA meeting yesterday. Would welcome thoughts on 

best approach on this. I think we could develop tweets and retweet EMA's statement, which doesn't say much. 

Thanks -

Lorrie 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:33 AM 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov> 

Subject: Statement/Communication requested about COVID Vaccine meeting 

Yesterday the International Coalition of Medicines Regulatory Authorities held a virtual international workshop, cochaired by the EMA and FDA, on the development of vaccines against COVID-19. The EMA subsequently put out a brief 

statement about the meeting, which you can see in the link below. My folks would like us to put out something as well. 

We could mirror the EMA statement, or even post it, as we have done in the past, although I think more information 

could be added. Could we do something like this today? At the very least, I will look for the statement on Twitter and 

will retweet it. 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 7:32 AM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce <Bruce.Ross@fda.hhs.gov>; Klein, Vashti* 

<Vashti.Klein@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber@fda.hhs.gov>; Kweder, Sandra L <Sandra.Kweder@fda.hhs.gov> 

Subject: COVID vaccines meeting -- request to post FDA statement 

Hi Karen - Re: COVID vaccine global regulators meeting yesterday -- we'd like to do an FDA posting to piggy back on this 

EMA statement: 

https ://www.ema.eu ropa .eu/ en/ news/fi rst-regu la to ry-workshop-covid-19-faci I itates-glo ba I-co 11 a bo ration-vaccinedevelo pment 

Peter Marks is fine with moving ahead with this as a joint EMA-FDA statement so I think best to use the same wording 

from EMA's statement. 

FDA-OSJI-FOIA-2020-3541_00000912 
I've copied CBER leads and they can help if any questions and also consider if you have other suggestions for PR. We'll 

definitely add a blurb in OGPS' next monthly distribution. 

Thanks, 

Ritu 

FDA-OSJI-FOIA-2020-3541_00000913 
From: Louati, Claudia (FSN)* [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =C682E89FF BB049C6BE95D65E2EE B04E B-CLAU DIA. LOU] 

Sent: 3/20/2020 7:04:53 AM 

To: Gruber, Marion [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/cn=Recipients/cn=019cd2669c7048f7a 116d72b7682de44-gruber ]; Cavaleri Marco 

[Marco.Cavaleri@ema.europa.eu] 

CC: Nalubola, Ritu [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =3103228e5eba458f9c2aa la846d25c7 c-PN a I u bol] 

Subject: RE: March 18 Global regulators meeting summary final 

Attachments: March 18 Global regulators meeting summary_final.pdf 

Yes, we have a final document and a final email (Q) I will send within the next 30 minutes. Thank you all for your help 

and the great communication! 

Best, 

Claudia 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:01 PM 

To: louati, Claudia (FSN)* <Claudia.louati@fda.hhs.gov>; Cavaleri Marco <Marco.Cavaleri@ema.europa.eu> 

Cc: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final 

You saw my very latest email, right? 

From: louati, Claudia (FSN)* <Claudia.louati 

Sent: Friday, March 20, 2020 6:49 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cavaleri Marco <Marco.Cavaleri@ema.europa.eu> 

Cc: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final 

I will pdf to discourage track changes. I guess I'm still waiting for Agnes' feedback before sending, right, Marco? 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:47 AM 

To: Cavaleri Marco <Marco.Cavaleri ema.euro a.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final 

Changes accepted. 

From: Cavaleri Marco <Marco.Cavaleri@ema.europa.eu> 

Sent: Friday, March 20, 2020 3:47 AM 

To: Gruber, Marion <Marion.Gruber fda.hhs. ov> 

Cc: louati, Claudia (FSN)* <Claudia.louati fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Subject: March 18 Global regulators meeting summary final 

Thanks Marion, excellent 

A couple of very minor suggestions 

Marco 

FDA-OSJI-FOIA-2020-3541_00000901 
Classified as confidential by the European Medicines Agency 

This e-mail has been scanned for all known viruses by European Medicines Agency. 

FDA-OSJ I-FOIA-2020-3541 _00000902 
From: Nalubola, Ritu [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =3103228ESE BA458F9C2AA 1A846D25C7C-PNALU BOL] 

Sent: 3/20/2020 8:00:01 AM 

To: Gruber, Marion [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=019cd2669c7048f7a 116d72b7682de44-gruber ]; Louati, Claudia (FSN )* 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c682e89ffb b049c6be95d65e2eeb04eb-Cla ud i a. Lou]; Kweder, Sandra L 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=3dcee61a387b4de49117ed8a0a80eea5-KWEDER]; Blair, Joan W. (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR] 

Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Abdoo, Mark 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=dca42e5fl 795433c9df447f8fllbc80e-Mark.Abdoo ]; Ross, Bruce 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4ae28 ldfd2164cb8959133dfe0026cee-Bruce. Ross] 

Subject: RE: Vaccines meeting -- narrative for State Dept cable 

Attachments: Vaccines meeting-Draft cable-3.20.20- (Baker Henry N (USEU)).docx 

Thanks, Marion. I edited out the sections i (b)(5) 

Others here review/add from broader USEU lens and make it into a cable form without harming our technical input -

standard cable drafting and clearance process. 

Attached is the near-final form. I'll send the final when it's issued. 

Best regards, 

Ritu 

From: Gruber, Marion 

Sent: Thursday, March 19, 2020 9:35 PM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov>; Kweder, Sandra 

L <Sandra.Kweder@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: RE: Vaccines meeting -- narrative for State Dept cable 

Dear all, 

Here are my further revisions and comments. 

Marion 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 2:38 PM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov>; Kweder, 

Sandra L <Sandra.Kweder@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: RE: Vaccines meeting -- narrative for State Dept cable 

Many thanks, Marion! Sandy, Claudia, and I made just a few more changes for context and plain-language. All of our 

input is tracked - please see attached and add any further changes. 

Dear Peter - This version is ready for your review. Please send any input by end today, if at all possible. Or just let us 

know if you don't plan on reviewing. Thanks! 

FDA-OSJ I-FOIA-2020-3541 _00000885 
Best regards, 

Ritu 

From: Gruber, Marion 

Sent: Thursday, March 19, 2020 5:46 PM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati 

L <Sandra.Kweder fda.hhs. ov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: RE: Vaccines meeting -- narrative for State Dept cable 

DearRitu, 

Please see attached document with track changes and a version of clean document. I have shortened taking out 

some of the details and tried to summarize (high level) main points discussed. This document needs probably to 

be tweaked a bit more by the communication experts. Happy to look at another version. Thank you for 

providing me with the opportunity to review. 

Marion 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 10:38 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov>; Kweder, 

Sandra L <Sandra.Kweder@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov> 

Subject: Vaccines meeting -- narrative for State Dept cable 

Hi all -Attached first stab at write up intended for use by front office in drafting the State Dept cable. Please review and 

send comments by COB today your time. Marion, I relied heavily on the summary notes that you are working on with 

Marco. Please feel free to edit/rewrite as you see fit. It is very technical and if you can make it less so, that would be 

great. 

DCA wants to be able to send out cable tomorrow COB here. Just FYI, State Dept cables have a wide distribution but still 

internal USG. 

(Peter -we can share a near final version if you want to hold off -or you can review this now. I defer to you and 

Marion.) 

Thanks, 

Ritu 

Ritu Nalubola, Ph.D. 

Director, Europe Office 

U.S. Food and Drug Administration 

U.S. Mission to the European Union 

Boulevard du Regent 40 

B-1000 Brussels, Belgium 

Phone: +32-2-811-5733 

Mobile:! (b)(G) 

Email: Ritu.Nalubola/afda.hhs.go\ 

FDA-OSJ I-FOIA-2020-3541 _00000886 
FDA-OSJI-FOIA-2020-3541 _00000887 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

Sent: 3/20/2020 11:46:41 AM 

To: McNeil!, Lorrie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c2485 lbf0c7330f53e00d9-M cN eil I] 

CC: Maloney, Diane [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Hess, Maureen 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =23ed9c01196f 4 765b89921c35 7f855f9-H essma] 

Subject: RE: Vaccines mtg -- comms heads-up 

Attachments: March 18 Global regulators meeting summary final.docx; FDA communication regarding March 18 Global regulators 

meeting.docx; Vaccines meeting-Draft cable-3.20.20- (Baker Henry N (USEU)).docx 

Dear Lorrie, 

As per our discussions, please see attached the March 18 Global regulators meeting summary that is to be 

posted by ICMRA, EMA and FDA (EMA wants to post early next week and there is some urgency as regulators 

want to have that document). The "FDA communications regarding .. "document I wrote yesterday to be used 

as a potential FDA PR or to serve as communication to be postet together with key bullets. I am also attaching 

the State Dept. cable. 

Marion 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:16 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Subject: RE: Vaccines mtg -- comms heads-up 

Hi Marion - I have about 5 minutes before I have to jump on a call - 301-412-0976 

From: Gruber, Marion <Marion.Gruber fda.hhs. ov> 

Sent: Friday, March 20, 2020 11:15 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: Vaccines mtg -- comms heads-up 

Lorrie, can I briefly call you?? What number? 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Friday, March 20, 2020 10:38 AM 

To: Gruber, Marion <Marion.Gruber fda.hhs. ov>; Riley, Karen <Karen.Riley@fda.hhs.gov>; Nalubola, Ritu 

<Ritu.Nalubola@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati fda.hhs. ov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov> 

Subject: RE: Vaccines mtg -- comms heads-up 

There are so many different email strings, I think we need to pull this back together and get everyone on the same 

page. I believe we were thinking about taking the document Marion drafted and turn that into some type of agency 

statement? If that's not the case, please let me know. We will need to clear it in both of our organizations, then it will 

have to go through agency clearance per the current process. I'm happy to coordinate that, but we really need to make 

sure we're all on board and not working at cross purposes. 

Lorrie 

FDA-OSJI-FOIA-2020-3541_00000919 
From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Friday, March 20, 2020 10:33 AM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Blair, Joan W. (CBER) 

<Joan.Blair@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeil! fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati fda.hhs. ov> 

Subject: RE: Vaccines mtg -- comms heads-up 

Why are we not taking the text I wrote and do our own posting? 

Marion 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Friday, March 20, 2020 10:32 AM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; McNeil!, Lorrie 

<Lorrie.McNeil! fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber 

<Claudia. Louati@fda.hhs.gov> 

Subject: RE: Vaccines mtg -- comms heads-up 

+ McNeil! 

Looks like the EMA will be writing a press release to reference this summary document. If so, we can readily point to 

that on Twitter and can also post the release on our website. Lorrie, other ideas? 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Friday, March 20, 2020 10:23 AM 

To: Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber fda.hhs. ov>; Louati, Claudia (FSN)* 

<Claudia.Louati fda.hhs. ov> 

Subject: Vaccines mtg -- comms heads-up 

Internal FDA only. 

Hi Joan - I'm sharing below as a heads-up with Karen Riley from OGPS side. 

Mission wants to do their own public sharing after the next round of FDA posting so we'll just stay tuned for when that 

occurs. 

Thanks, 

Ritu 

From: Saint Raymond Agnes< nes.Saint-Ra mond ema.euro a.eu> 

Sent: Friday, March 20, 2020 2:08 PM 

To: Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Heine Marie-Agnes <Marie- gnes.Heine@ema.europa.eu>; Gruber, 

Marion <Marion.Gruber@fda.hhs.gov>; Cavaleri Marco <Marco.Cavaleri@ema.europa.eu> 

Cc: Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

Dear Joan 

Our Communication Department intends to accompany the summary with a 'press release', which I think fits with 

what you have in mind and what Marion had produced yesterday. We will share when it's ready (thanks to my 

colleagues!) 

Kind regards 

FDA-OSJ I-FOIA-2020-3541 _00000920 
Dr Agnes Saint-Raymond 

Head of Division 

+31 (0)88781 7017 

Office 17-S-27 

International Affairs I European Medicines Agency 

Agnes Saint-Raymond I Riccardo Luigetti I Elena Mezquita Gonzalez I Magdalena Pajewska I Tania 

Teixeira 

Sandra Gogo I Christoph Hasslbock I Clement Lagalice 

Domenico Scarlattilaan 6 I 1083 HS Amsterdam I The Netherlands 

EMAinternational@ema .europa. eu 

Follow us: 

HJRC>P[AN tvHDICINES AC,ENCY 

This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is 

intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the 

intended recipient(s) ( or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying 

of its contents, or any action taken ( or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this email in error, please inform the sender immediately . 

.A Please consider the environment before printing this email 

Classified as re5tricted by the European Medicine5 Agency 

From: Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Sent: 20 March 2020 13:58 

To: Heine Marie-Agnes <Marie- gnes.Heine@ema.europa.eu>; Saint Raymond Agnes <Agnes.SaintRaymond@ema.europa.eu>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cavaleri Marco 

<Marco.Cavaleri@ema.europa.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

I may have been unclear, and my assumption may be wrong. What I am referencing in terms of narrative is perhaps any 

opening, contextual narrative that leads into the summary. If no one plans to have any, that's fine. 

From: Blair, Joan W. (CBER) 

Sent: Friday, March 20, 2020 8:38 AM 

To: Heine Marie-Agnes <Marie- gnes.Heine@ema.europa.eu>; Saint Raymond Agnes <Agnes.SaintRaymond@ema.europa.eu>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cavaleri Marco 

<Marco.Cavaleri@ema.europa.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

FDA-OSJI-FOIA-2020-3541_00000921 
Will EMA write the first draft of the narrative around the meeting summary that would be posted on the ICMRA site and 

the EMA site? FDA would like to align as possible so would appreciate learning of any proposed language. Thank you! -

Joan 

From: Heine Marie-Agnes <Marie- gnes.Heine@ema.europa.eu> 

Sent: Friday, March 20, 2020 7:30 AM 

To: Saint Raymond Agnes <A a.eu>; Gruber, Marion <Marion.Gruber 

Cavaleri Marco <Marco.Cavaleri ema.euro a.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

Thanks to all of you. 

Monday, would be the better option to get more visibility. 

Best wishes 

Marie-Agnes 

Marie-Agnes Heine 

Head 

Communication Department 

Stakeholders & Communication Division 

Office 16-N-24 I Ext. 7805 I Mobile +31650089390 

From: Saint Raymond Agnes< gnes.Saint-Raymond@ema.europa.eu> 

Sent: 20 March 2020 12:28 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cavaleri Marco <Marco.Cavaleri@ema.europa.eu>; Heine MarieAgnes <Marie- nes.Heine ema.euro a.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

Perfect! What timeframe for the publication would you consider? Next Monday to get more attention? Or as early as 

possible (Marie-Agnes?) 

Dr Agnes Saint-Raymond 

Head of Division 

+31 (0)88781 7017 

Office 17-S-27 

International Affairs I European Medicines Agency 

Agnes Saint-Raymond I Riccardo luigetti I Elena Mezquita Gonzalez I Magdalena Pajewska I Tania 

Teixeira 

Sandra Gogo I Christoph Hasslbock I Clement lagalice 

Domenico Scarlattilaan 6 I 1083 HS Amsterdam I The Netherlands 

EMAinternational@ema .europa. eu 

Follow us: CJ ml� 

FDA-OSJ I-FOIA-2020-3541 _00000922 
HJRC>P[AN tvHDICINES AC,ENCY 

This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is 

intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the 

intended recipient(s) ( or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying 

of its contents, or any action taken ( or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this email in error, please inform the sender immediately . 

.6 Please consider the environment before printing this email 

Classified as re5tricted by the European Medicine5 Agency 

From: Gruber, Marion <Marion.Gruber fda.hhs. ov> 

Sent: 20 March 2020 12:26 

To: Saint Raymond Agnes <Agnes.Saint-Raymond@ema.europa.eu>; Cavaleri Marco <Marco.Cavaleri@ema.europa.eu>; 

Heine Marie-Agnes <Marie- gnes.Heine@ema.europa.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

Dear Agnes, 

I have discussed this with Marco and others and we were not expecting comments. We tried to word the 

summary carefully as to not imply a consensus agreement but we feel rather strongly that there was broad 

agreement on the key points documented. That being said, if particular NRAs have questions we would be 

happy to engage in discussions. A simultaneous publication on ICMRA, FDA and EMA website would be ideal 

from my perspective. I have copied Peter and Joan on this email. 

Marion 

From: Saint Raymond Agnes< nes.Saint-Ra a.eu> 

Sent: Friday, March 20, 2020 7:12 AM 

To: Gruber, Marion <Marion.Gruber fda.hhs. ov>; Cavaleri Marco <_M_ a_ r_c_o_.C_a_v_a_le_r�i ----�­

Agnes <Marie- nes.Heine ema.euro a.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

Thank you Marion 

I am copying Marie-Agnes as Head of our communication team. They will prepare a text 'from ICM RA' for the website 

and let us know. Then when the participants have seen the summary, do you expect them to agree? Do we need a 

deadline for them or do we not expect any comment? 

I would suggest then a simultaneous publication on ICMRA, FDA and EMA websites? Is this possible for FDA and do 

you agree? 

Kind regards 

Dr Agnes Saint-Raymond 

Head of Division 

+31 (0)88781 7017 

Office 17-S-27 

EMA International Affairs I European Medicines Agency 

\ Agnes Saint-Raymond I Riccardo luigetti I Elena Mezquita Gonzalez I Magdalena Pajewska I Tania 

Teixeira 

Sandra Gogo I Christoph Hasslbock I Clement lagalice 

FDA-OSJ I-FOIA-2020-3541 _00000923 
Domenico Scarlattilaan 6 I 1083 HS Amsterdam I The Netherlands 

EMAinternational@ema .europa. eu 

Follow us: CJII� 

HJRC>P[AN tvHDICINES AC,ENCY 

This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is 

intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the 

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.6 Please consider the environment before printing this email 

Classified as re5tricted by the European Medicine5 Agency 

From: Gruber, Marion <Marion.Gruber fda.hhs. ov> 

Sent: 20 March 2020 12:00 

To: Cavaleri Marco <Marco.Cavaleri@ema.europa.eu>; Saint Raymond Agnes< gnes.Saint-Raymond@ema.europa.eu> 

Cc: louati, Claudia (FSN)* <Claudia.louati@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Subject: RE: March 18 Global regulators meeting summary final (002) 

Dear all, 

Thank you for your helpful comments and revisions to this document. I have updated and considered all 

revisions but had to reject some, in particular in the introduction. Please see attached the FINAL version of this 

document. 

Thank you for your input. 

Sincerely, 

Marion 

From: Cavaleri Marco <Marco.Cavaleri ema.euro a.eu> 

Sent: Friday, March 20, 2020 5:33 AM 

To: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Subject: March 18 Global regulators meeting summary final (002) 

Hi Marion, here are comments from Agnes. 

Marco 

Clas5ifiecl as internal/staff & contractors by the European Medicine5 Agency 

This e-mail has been scanned for all known viruses by European Medicines Agency. 

This e-mail has been scanned for all known viruses by European Medicines Agency. 

FDA-OSJ I-FOIA-2020-3541 _00000924 
This e-mail has been scanned for all known viruses by European Medicines Agency. 

This e-mail has been scanned for all known viruses by European Medicines Agency. 

FDA-OSJ I-FOIA-2020-3541 _00000925 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

Sent: 3/20/2020 5:33:48 PM 

To: Riley, Karen [/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

(FYDI BOHF23SPDL T)/en=Recipients/en=9941d592a 1354b74be835c6288542ed5-Karen.Riley ]; McNeil I, Lorrie 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c24851 bf0c7330f53e00d9-M cN eil I]; Na I u bola, Ritu 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=3103228e5eba458f9c2aa la846d25c7c-PNal ubol]; Louati, Claudia (FSN )* 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =c682e89ffb b049c6be95d65e2eeb04eb-Cla ud i a. Lou] 

Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Blair, Joan W. (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Ma lo ney, Di a ne 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Hess, Maureen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =23ed9c01196f 4 765b8992 lc35 7f855f9-H essma] 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Attachments: 20200320_FDA Voices - March 18 Global regulators meetingkr.docx 

I am concerned about some of the edits made and revisions introduced. See my comments. 

Marion 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:26 PM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia. Louati@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Blair, Joan W. (CBER) 

<Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Here are my initial edits. 

From: McNeil!, Lorrie <Lorrie.McNeil! 

Sent: Friday, March 20, 2020 4:31 PM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Riley, Karen <Karen.Riley@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia. Louati@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Blair, Joan W. (CBER) 

<Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: Draft FDA Voices - ICMRA Meeting 

Importance: High 

Good afternoon - I spoke at length earlier with the press lead on COVID-19 about developing an FDA statement or press 

release on COVID-19. She spoke with Laura Caliguiri, who is supportive of putting out an FDA Voices piece on the 

meeting. Attached is a draft for your review, which has been cleared in CBER. We would appreciate your comments as 

soon as possible so that we can move this into JIC and OCC clearance. 

If you have any questions, please let me know. Thank you in advance! 

FDA-OSJ I-FOIA-2020-3541 _00000926 
BestLorrie 

Lorrie H. McNeil! 

Director 

Office of Communication, Outreach and Development 

Center for Biologics Evaluation and Research 

U.S. Food and Drug Administration 

Tel: 240-402-8119 

lorrie.mcneill@fdahhs.gov 

U.S. FOOD & DRUG 

A 0MIM!1, UA f!QN 

Cl .. 

FDA-OSJ I-FOIA-2020-3541 _00000927 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 3/20/2020 5:44:21 PM 

To: Gruber, Marion [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=019cd2669c7048f7a 116d72b7682de44-gruber ]; Riley, Karen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

(FYDI BOHF23SPDL T)/en=Recipients/en=9941d592a 1354b74be835c6288542ed5-Karen.Riley ]; Nal ubola, Ritu 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=3103228e5eba458f9c2aa la846d25c7c-PNal ubol]; Louati, Claudia (FSN )* 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =c682e89ffb b049c6be95d65e2eeb04eb-Cla ud i a. Lou] 

Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Blair, Joan W. (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Ma lo ney, Diane 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Hess, Maureen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =23ed9c01196f 4 7 65b8992 lc35 7f855f9-H essma] 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Attachments: 20200320_FDA Voices - March 18 Global regulators meetingkr.docx 

Suggested revisions based on Marion's comments. 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:34 PM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Nalubola, Ritu 

<Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Hess, Maureen 

<Maureen.Hess@fda.hhs.gov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

I am concerned about some of the edits made and revisions introduced. See my comments. 

Marion 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:26 PM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia. Louati@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Blair, Joan W. (CBER) 

<Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Here are my initial edits. 

From: McNeil!, Lorrie <Lorrie.McNeil! 

Sent: Friday, March 20, 2020 4:31 PM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Riley, Karen <Karen.Riley@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia. Louati@fda.hhs.gov> 

FDA-OSJ I-FOIA-2020-3541 _00000894 
Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Blair, Joan W. (CBER) 

<Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: Draft FDA Voices - ICMRA Meeting 

Importance: High 

Good afternoon - I spoke at length earlier with the press lead on COVID-19 about developing an FDA statement or press 

release on COVID-19. She spoke with Laura Caliguiri, who is supportive of putting out an FDA Voices piece on the 

meeting. Attached is a draft for your review, which has been cleared in CBER. We would appreciate your comments as 

soon as possible so that we can move this into JIC and OCC clearance. 

If you have any questions, please let me know. Thank you in advance! 

BestLorrie 

Lorrie H. McNeil! 

Director 

Office of Communication, Outreach and Development 

Center for Biologics Evaluation and Research 

U.S. Food and Drug Administration 

Tel: 240-402-8119 

lorrie. rncneill@fda. hhs. gov 

U.S. FOOD & DRUG 

ACH,<lll'•ll$"1a,\t10H 

.. 

FDA-OSJ I-FOIA-2020-3541 _00000895 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 3/20/2020 6:03:42 PM 

To: McNeil!, Lorrie [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en= 77b0b352c9c2485 lbfOc7330f53e00d9-McNeil I]; Riley, Karen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=9941d592a1354b74be835c6288542ed5-Karen.Riley]; Gruber, Marion 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=019cd2669c7048f7a 116d72b7682de44-gruber ]; Nal ubola, Ritu 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=3103228e5eba458f9c2aa la846d25c7c-PNal ubol]; Louati, Claudia (FSN )* 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c682e89ffb b049c6be95d65e2eeb04eb-Cla ud i a. Lou] 

CC: Blair, Joan W. (CBER) [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=8cc3d088be164491a76b9ce048d71a02-BLAIR]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Ma lo ney, Di a ne 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Hess, Maureen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =23ed9c01196f 4 765b8992 lc35 7f855f9-H essma] 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Attachments: 20200320_FDA Voices - March 18 Global regulators meeting (1).docx 

Dear All, 

I tried to address some of Karen's concerns in the attached. Hopefully, we can quickly settle on something. 

We need to stop wasting too much time on this in the middle of our response to the most challenging global public 

health crisis of our lifetimes. 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:58 PM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Nalubola, Ritu 

<Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Hess, Maureen 

<Maureen.Hess@fda.hhs.gov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Understood. But so you're aware, the instructions I received (in order to speed clearance) were to keep short and 

sweet. 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:52 PM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Nalubola, Ritu 

<Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Hess, Maureen 

<Maureen.Hess@fda.hhs.gov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

FDA-OSJ I-FOIA-2020-3541 _00000888 
This article will be read by nonscientists. Readers can't be expected to be familiar with the vaccine development process. 

That should be explained so they can understand the significance of this first meeting. An FDA Voice is not a press 

release, it is the opportunity to use a news peg to explain something. Also, the first mention of the Phase 1 trial is 

confusing. Has this happened? 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:44 PM 

To: Gruber, Marion <Marion.Gruber fda.hhs. ov>; Riley, Karen <Karen.Riley@fda.hhs.gov>; Nalubola, Ritu 

<Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Hess, Maureen 

<Maureen.Hess fda.hhs. ov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Suggested revisions based on Marion's comments. 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:34 PM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Nalubola, Ritu 

<Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Hess, Maureen 

<Maureen.Hess fda.hhs. ov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

I am concerned about some of the edits made and revisions introduced. See my comments. 

Marion 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:26 PM 

To: McNeil!, Lorrie <Lorrie.McNeil! fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia. Louati fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber fda.hhs. ov>; Blair, Joan W. (CBER) 

<Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Maloney, Diane 

<Diane.Malone fda.hhs. ov>; Hess, Maureen <Maureen.Hess fda.hhs. ov> 

Subject: RE: Draft FDA Voices - ICMRA Meeting 

Here are my initial edits. 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Friday, March 20, 2020 4:31 PM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Riley, Karen <Karen.Riley@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia.Louati fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Gruber, Marion <Marion.Gruber fda.hhs. ov>; Blair, Joan W. (CBER) 

<Joan.Blair@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Maloney, Diane 

<Diane.Malone fda.hhs. ov>; Hess, Maureen <Maureen.Hess fda.hhs. ov> 

Subject: Draft FDA Voices - ICMRA Meeting 

Importance: High 

Good afternoon - I spoke at length earlier with the press lead on COVID-19 about developing an FDA statement or press 

release on COVID-19. She spoke with Laura Caliguiri, who is supportive of putting out an FDA Voices piece on the 

meeting. Attached is a draft for your review, which has been cleared in CBER. We would appreciate your comments as 

soon as possible so that we can move this into JIC and OCC clearance. 

FDA-OSJ I-FOIA-2020-3541 _00000889 
If you have any questions, please let me know. Thank you in advance! 

BestLorrie 

Lorrie H. McNeil! 

Director 

Office of Communication, Outreach and Development 

Center for Biologics Evaluation and Research 

U.S. Food and Drug Administration 

Tel: 240-402-8119 

lorrie.mcneill@fdahhs.gov 

U.S. FOOD & DRUG 

A 0MIM!1, UA f!QN 

Cl .. 

FDA-OSJ I-FOIA-2020-3541 _00000890 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 3/23/2020 8:09:44 AM 

To: Nalubola, Ritu [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =3103228e5eba458f9c2aa la846d25c7 c-PN a I u bol]; Gruber, Marion 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =019cd2669c7048f7a 116d72b 7682de44-gru ber] 

CC: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Blair, Joan W. (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOH F23SPDL T)/en=Recipients/en=8cc3d088be 164491a76b9ce048d71a02-BLAI R]; Louati, Claudia (FSN )* 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c682e89ffb b049c6be95d65e2eeb04eb-Cla ud i a. Lou]; Riley, Karen 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =994 ld592a 1354b 7 4be835c6288542ed5-Ka ren. Riley] 

Subject: RE: Vaccines mtg PR 

Attachments: 20200320_FDA Voices - March 18 Global regulators meeting FINAL.docx 

Good morning, Ritu and Marion -

Attached is the OCC-cleared version of the FDA Voices draft. Unless there are any show-stoppers, I will work with the JIC 

and OEA on next steps for posting. The target for posting the piece is today. 

Thanks very much in advance -

Lorrie 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Monday, March 23, 2020 6:53 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov> 

Subject: Vaccines mtg PR 

Hi Lorrie, Karen - Wondering if we're still on for today release of the additional details about the workshop, plus FDA 

Voices statement. 

Please send me the weblinks when done. Don't need to see anything else. Happy to defer on coordination with EMA, as 

well, to you. 

Thanks so much! 

Ritu 

Ritu Nalubola, Ph.D. 

Director, Europe Office 

U.S. Food and Drug Administration 

U.S. Mission to the European Union 

Boulevard du Regent 40 

B-1000 Brussels, Belgium 

Phone: +32-2-811-5733 

Mobile:[ _____________ (b)(6) ·-·-·-·-·-·-! 

Email: Ritu.Nalubola/o fda.hhs.go\ 

U.S. FOOD & DRUG 

ADMIN15lltAJ!OM 

FDA-OSJI-FOIA-2020-3541_00000891 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 3/23/2020 3:58:06 PM 

To: Gruber, Marion [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =019cd2669c7048f7a 116d72 b 7682de44-gru ber] 

Subject: RE: Vaccines mtg PR 

Attachments: March 18 Global regulators meeting summary final.docx 

Forgive me, Marion - I completely missed that we were going to post the bullets, too. I will chat with Kristin about 

where we should post on our site, and we can ask OEA to add a link to the FDA Voices document once it's up. 

My sincere apologies. I'm not doing terribly well at keeping the plates spinning. 

Lorrie 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Monday, March 23, 2020 3:53 PM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: Vaccines mtg PR 

Lorie, 

The bullet summary document, when will that post and where? 

Marion 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, March 23, 2020 3:15 PM 

To: Gruber, Marion <Marion.Gruber fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia.Louati fda.hhs. ov>; Riley, Karen <Karen.Riley@fda.hhs.gov>; Hess, Maureen <Maureen.Hess fda.hhs. ov>; 

Frantz-Bohn, Susan <Susan.Frantzbohn fda.hhs. ov> 

Subject: RE: Vaccines mtg PR 

Hi all - the FDA Voices piece has posted on the web: https://www.fda.gov/news-events/fda-voices-perspectives-fdaleadership-and-experts/fda-and-ema-collaborate-facilitate-sars-cov-2-vaccine-development. 

OEA is working on clearing tweets to send with a link to the piece. 

Any questions, please let me know. 

Lorrie 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Monday, March 23, 2020 8:58 AM 

To: McNeil!, Lorrie <Lorrie.McNeil! fda.hhs. ov>; Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia.Louati fda.hhs. ov>; Riley, Karen <Karen.Riley@fda.hhs.gov> 

Subject: RE: Vaccines mtg PR 

No show stoppers from my side. 

Marion 

FDA-OSJ I-FOIA-2020-3541 _00000896 
From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, March 23, 2020 8:10 AM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov>; Gruber, Marion <Marion.Gruber fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Louati, Claudia (FSN)* 

<Claudia.Louati fda.hhs. ov>; Riley, Karen <Karen.Riley@fda.hhs.gov> 

Subject: RE: Vaccines mtg PR 

Good morning, Ritu and Marion -

Attached is the OCC-cleared version of the FDA Voices draft. Unless there are any show-stoppers, I will work with the JIC 

and OEA on next steps for posting. The target for posting the piece is today. 

Thanks very much in advance -

Lorrie 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Monday, March 23, 2020 6:53 AM 

To: McNeil!, Lorrie <Lorrie.McNeil! fda.hhs. ov>; Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber fda.hhs. ov>; Louati, Claudia (FSN)* <Claudia.Louati fda.hhs. ov> 

Subject: Vaccines mtg PR 

Hi Lorrie, Karen - Wondering if we're still on for today release of the additional details about the workshop, plus FDA 

Voices statement. 

Please send me the weblinks when done. Don't need to see anything else. Happy to defer on coordination with EMA, as 

well, to you. 

Thanks so much! 

Ritu 

Ritu Nalubola, Ph.D. 

Director, Europe Office 

U.S. Food and Drug Administration 

U.S. Mission to the European Union 

Boulevard du Regent 40 

B-1000 Brussels, Belgium 

Phone: +32-2-811-5733 

Mobile:! lbJ(�l�-� 

Email: Ritu.Nalubola/a fda.hhs.go,· 

U.S. FOOD & DRUG 

ADMIN15lltAl!ON 

FDA-OSJ I-FOIA-2020-3541 _00000897 
From: Gruber, Marion [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =019CD26 69C7048 F7 Al 16D7 2B 7682DE44-G RU BER] 

Sent: 3/31/2020 6:59:33 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Subject: FW: Exchange of Information under our Confidentiality Arrangements: Press release on treatments and vaccines in 

the context of pandemic 

Attachments: Press release - Update on treatments and vaccines against COVID-19 under development.docx 

I wonder whether FF A should consider doing something like this? 

From: Kweder, Sandra L <Sandra.Kweder@fda.hhs.gov> 

Sent: Tuesday, March 31, 2020 6:26 AM 

To: Farley, John <John.Farley@fda.hhs.gov>; Nambiar, Sumathi <Sumathi.Nambiar@fda.hhs.gov>; Birnkrant, Debra B 

<Debra.Birnkrant@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Cc: Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Mullin, Theresa <Theresa.Mullin@fda.hhs.gov>; Limoli, Michelle 

<Michelle.Limoli@fda.hhs.gov>; Badoo, Judith <Judith.Badoo@fda.hhs.gov>; Nalubola, Ritu 

<Ritu.Nalubola@fda.hhs.gov>; Louati, Claudia (FSN)* <Claudia.Louati@fda.hhs.gov>; Thor, Shannon 

<Shannon.Thor@fda.hhs.gov> 

Subject: FW: Exchange of Information under our Confidentiality Arrangements: Press release on treatments and 

vaccines in the context of pandemic 

All, 

Sending this along, a statement to publish at 4 PM today in Europe (10 AM EDT). No surprises. 

Sandy 

From: Synodinou Aliki fmailto:Aliki.Synodinou ema.europa.euj On Behalf Of Garcia Juan 

Sent: Tuesday, March 31, 2020 12:19 PM 

To: Garcia Juan <Juan.Garcia ema.euro a.eu> 

Cc: De Verdiere Morgane <Morgane.DeVerdiere@ema.europa.eu>; Lupescu Diana <Diana.Lupescu@ema.europa.eu>; 

Malaguti Linda <linda.malaguti@ema.europa.eu>; Synodinou Aliki <Aliki.Synodinou@ema.europa.eu> 

Subject: Exchange of Information under our Confidentiality Arrangements: Press release on treatments and vaccines in 

the context of pandemic 

Dear Colleagues, 

Please find attached the planned EMA press release which provides a brief overview of treatments and vaccines 

candidates in the context of COVID-19 and currently under development. 

The attached document will be published on EMA website today, Tuesday, 31 March 2020, 16:00hrs, CEST. Please 

note that there is an embargo until such time. 

Please forward this message to relevant colleagues within your organisation. 

If you need further information, please do not hesitate to contact me. 

Best regards, 

Juan Garcia Burgos 

Head of Public and Stakeholders Engagement 

Stakeholders and Communication Division 

European Medicines Agency 

Telephone +31 (0)88 781 7120 

Juan.Garcia@ema.europa.eu I www.ema.europa.eu 

FDA-OSJ I-FOIA-2020-3541 _00000938 
Follow us: CJ ml fl 

l:UR()f"f:t\N tvHDICINES AC,ENCY 

This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is 

intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the 

intended recipient(s) ( or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying 

of its contents, or any action taken ( or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this email in error, please inform the sender immediately. 

Classified as confidential by the European Medicines Agency 

This e-mail has been scanned for all known viruses by European Medicines Agency. 

FDA-OSJ I-FOIA-2020-3541 _00000939 
Sent: 

To: 

CC: 

Subject: 

Dear Peter, 

5/19/2020 10:55:47 AM 

Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Krause, Philip [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =00c6330fea0042fd b55 7 lc3fdef792ed-kra use] 

FW: COVID-19 Update 

I came across the message from the Commissioner that he sent last Sunday. Please see hift�Eghted text 

below. i · 

(b)(5) 

(b)(5) 

Marion 

From: A Message from the Commissioner <message@fda.hhs.gov> 

Sent: Sunday, May 17, 2020 10:22 AM 

To: FDA-Wide <FDA-Wide@fda.hhs.gov> 

Subject: COVID-19 Update 

From the Desk of 

the Commissioner 

Dear Colleagues, 

U.S. FOOD & DRUG 

ld}MINIS.lRAllON 

In a White House press conference Friday, it was announced that our own Ors. Janet Woodcock and Peter Marks will be 

bringing their diverse experience to cross-government efforts to expedite the development and availability of 

therapeutics and vaccines to combat COVID-19 under the Operation Warp Speed Project. The fact that Ors. Woodcock 

and Marks are playing such pivotal leadership roles in this effort speaks volumes to their abilities and the confidence the 

nation has in our agency. Drs. Woodcock and Marks will continue as directors of their respective centers while working 

closely with other center and agency leadership to ensure continuity of day-to-day operations. They will also recuse 

themselves from the supervisory chain of command in matters related to product review decisions for applications 

related to the areas that they are advancing that have a nexus to COVID-19. 

The President's Coronavirus Task Force continues to analyze and monitor the prevalence of the virus in the U.S. using 

the best available science to track, predict and mitigate the curve of the pathogen. While there are metropolitan areas 

that are now moving to a stable or declining state in COVID-19 positive cases, such as New York City, Providence, Boston, 

Chicago and Houston, some cities are seeing persistence in COVID-19 positive cases, including the Washington, DC and 

Baltimore areas, Minneapolis, Dallas and Portland. 

With those data in mind, Chief Operating Officer Jim Sigg provided important direction Friday that all FDA teleworkeligible employees should continue teleworking until further notice. This direction is in alignment with the National 

Guidelines for O enin U America ain, guidance from the Office of Management and Budget (0MB) and the Office of 

Personnel Management (OPM), and the FDA Leadership Team's commitment to putting our employees and their 

families first. 

FDA-OSJ I-FOIA-2020-3541 _00000964 
As we continue to develop plans for an eventual phased return to FDA facilities, we will also continue to take a 

measured and deliberate approach that ensures your health and safety remain uppermost in our approach. We will be 

closely assessing local health and operational conditions in states across our nation, particularly in the Washington, DC, 

Maryland, and Virginia area since the data indicate that this geographic area is continuing to experience COVID-19 cases. 

Remember you have my commitment that employees will be afforded maximum flexibility for continuing to take care of 

children and other family members while carrying out FDA work. As we continue to go through this together, I really 

commend everyone for doing their very best in meeting your work responsibilities while being mindful of what we are 

all going through as individuals. I know it hasn't been easy, and everyone's circumstance is unique, which is also why I 

want employees to feel supported during this prolonged period of time. So, when the FDA decides the time is right to 

initiate a phased approach for employees to return to FDA facilities, the agency will continue to offer workplace 

flexibilities to employees, including those who the CDC identifies as being at high risk for severe illness from COVID-19, 

and employees managing dependent care while continuing to work. 

I want to end by saying thank you for all of the warm thoughts sent my way after sharing with you my potential 

exposure to COVID-19. I continue to feel healthy as well as truly blessed to be a part of the FDA family. 

To all employees, please be extra careful to keep yourself and your loved ones safe, using the power you have as 

individuals to #SlowTheSpread. Be good to yourselves and please take the time you need to protect and promote YOUR 

public health. Stay safe, well and #FDAStrong. 

Sincerely, 

Stephen M. Hahn, M.D. 

Commissioner of Food and Drugs 

FDA-OSJ I-FOIA-2020-3541 _00000965 
From: Tierney, Julia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=1160D300BC4248B790DED292A082E9A8-JULIA.TIERN] 

Sent: 1/24/2020 11:16:52 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

Subject: FW: information on coronavirus 

Attachments: Wuhan Coronavirus Briefer _1.22.2020_.docx 

From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Sent: Friday, January 24, 2020 10:45 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Cc: Jordan, Lillian T <Lillian.Jordan@fda.hhs.gov>; OC OCOD Contacts <0COCODContacts@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Subject: RE: information on coronavirus 

Thanks, Lorrie. We also reached out to other folks to get a little more clarification on the request, and it turns out the 

Commissioner received the attached briefer a few days ago. OCET is coordinating the coronavirus effort and we'll work 

with them to get updates going forward. 

Thank you, 

Prakash 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Friday, January 24, 2020 10:33 AM 

To: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Cc: Jordan, Lillian T <Lillian.Jordan@fda.hhs.gov>; OC OCOD Contacts <0COCODContacts@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Subject: RE: information on coronavirus 

HI Prakash -

Thank you for the additional time. Below high-level talking points: 

• FDA/CBER will take all effective measures to ensure the safety of the nation's blood supply and tissue supply. 

• There are no immediate concerns about blood and tissue safety. FDA remains in close communication with our 

sister agencies within HHS and international regulatory partners, and will continue to actively monitor the situation 

going forward. 

• CBER is collaborating with FDA's other medical product centers to assist with the development of reagents for 

diagnostic products. 

• CBER is also collaborating with other government agencies and regulated industry to facilitate the development 

of medical countermeasures, including vaccines, for the prevention and treatment of coronavirus. 

As the situation develops, we're happy to provide updates as needed. If you have any questions, please let us know. 

BestLorrie 

FDA-OSJ I-FOIA-2020-3541 _00000733 
From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Sent: Thursday, January 23, 2020 11:17 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; OC OCOD Contacts <0COCODContacts@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Cc: Jordan, Lillian T <Lillian.Jordan@fda.hhs.gov> 

Subject: RE: information on coronavirus 

Thank you. In that case, if you are able to send something by tomorrow around noon, that would be really helpful. 

Prakash 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Thursday, January 23, 2020 11:15 AM 

To: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov>; OC OCOD Contacts <0COCODContacts@fda.hhs.gov>; Tierney, 

Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Cc: Jordan, Lillian T <Lillian.Jordan@fda.hhs.gov> 

Subject: RE: information on coronavirus 

Hi Prakash -

We don't have any TPs that have been provided in response to media inquiries (I don't believe OMA has contacted us on 

any media questions). We can discuss and get something to you soonest. 

Lorrie 

From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Sent: Thursday, January 23, 2020 11:11 AM 

To: OC OCOD Contacts <0COCODContacts@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov> 

Cc: Jordan, Lillian T <Lillian.Jordan@fda.hhs.gov> 

Subject: information on coronavirus 

Hello, 

The commissioner is starting his rounds meeting with various Congressman. As we update background memos for him 

we are being asked to include information on the coronavirus outbreak. Do you all have TP's that you are providing for 

media inquires that you could share with us? If you already have something cleared, could you please send information 

by COB today? 

Thanks, 

Prakash 

FDA-OSJ I-FOIA-2020-3541 _00000734 
From: 

Sent: 

To: 

CC: 

Subject: 

Attachments: 

Dear Frank, 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

1/28/2020 12:48:29 PM 

Olivarria, Frank [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/cn=Recipients/cn=c180721db774423f99990dd86e67057c-Frank.Oliva] 

Jenkins, Charlene [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ cn=0e 722b6438b04d2e9029c72543639a67-Cha rl ene .Je ]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/cn=Recipients/cn=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Anna Abram 

(Anna.Abram@fda.hhs.gov) [/o=FDA/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/cn=Recipients/cn=Anna.Abram3ba]; Shah, Anand [/o=Exchangelabs/ ou=Exchange 

Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]; 

Celia Witten (celia.witten@fda.hhs.gov) [celia.witten@fda.hhs.gov]; Tierney, Julia (Julia.Tierney@fda.hhs.gov) 

[/o=FDA/ou=First Administrative Group/cn=Recipients/cn=Julia.Tierney] 

RE: TELECON: Weekly CBER Meeting with the Commissioner and Chief of Staff 

CBER Agenda for January 29.docx 

Please see the attached. Thanks very much. 

Best Regards, 

Peter 

From: Olivarria, Frank <Frank.Olivarria@fda.hhs.gov> 

Sent: Tuesday, January 28, 2020 12:26 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Jenkins, Charlene <Charlene.Jenkins@fda.hhs.gov> 

Subject: RE: TELECON: Weekly CBER Meeting with the Commissioner and Chief of Staff 

Hi Dr. Marks, 

I know you're generally on this without a reminder or inquiry, simply a gentle reminder that agenda items are for 

tomorrow's Weekly CBER Mtg, if you have them to us by 4:30 PM today, we'll be able to send the Commissioner with a 

hardcopy. 

Thank you, 

Frank 

-----Original Appointment-----

From: Sheehy, Janice On Behalf Of Hahn, Stephen 

Sent: Monday, December 30, 2019 11:56 AM 

To: Hahn, Stephen; Marks, Peter; Witten, Celia (CBER); Keagan Lenihan (JS§@.!J£!.!l�I!!t@.!J�!:f!..§!:.!:!J��O; Anna Abram -

FDA l����Jf:!!.IQ.!!:J�:.&Q'L/ 

Cc: Tierney, Julia 

Subject: TELECON: Weekly CBER Meeting with the Commissioner and Chief of Staff 

When: Wednesday, Janu�_�y 29, 2020 2:30 PM-3:00 PM (UTC-05:00) Eastern Time (US & Canada). 

Where: 1-877-465-7975,L_ ______ (b )(6) ________ i 

FDA-OSJ I-FOIA-2020-3541 _00000760 
From: Cho, David S (CBER) [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D4 7 AF9D991AF4ClFBF7CB4ClD287F83E-CH OD] 

1/30/2020 8:08:01 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

RE: daily nCoV PCC 

HI Peter, 

Should I cover the PCC this morning and ask David Rouse to sit in on the convalescent serum call with you and OBRR? I 

am flexible and we can cover both meetings this way. Just let me know. 

Thanks, 

David 

From: Mair, Michael <Michael.Mair@fda.hhs.gov> 

Sent: Wednesday, January 29, 2020 11:29 PM 

To: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: daily nCoV PCC 

I am going to try to attend 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Wednesday, January 29, 2020 10:28 PM 

To: Mair, Michael <Michael.Mair@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: daily nCoV PCC 

Thanks Michael, 

I'm glad we can join by SVTC. Given where we still are in the response and with some potential competing CoV meetings 

in the mornings the next couple of days, is OCET able to cover these calls? If not or if you think we need to be there also, 

we can look to readjust. 

Thanks, 

David 

From: Mair, Michael <Michael.Mair@fda.hhs.gov> 

Sent: Wednesday, January 29, 2020 9:01 PM 

To: Hinton, Denise <Denise.Hinton fda.hhs. ov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Fisher, Robert 

<Robert.Fisher@fda.hhs.gov>; Yates, Thomas <Thomas.Yates@fda.hhs.gov> 

Subject: daily nCoV PCC 

Hi. The daily nCoV PCC has been rescheduled for 9 - 10:30 AM daily for the foreseeable future. CDC Atlanta, NIAD, and 

FDA are the only entities that are authorized for SVTC. 

Thomas - hi. Please advise if we can get the SCIF. Thx - m 

FDA-OSJI-FOIA-2020-3541_00001324 
From: McSeveney, Megan [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=0D4B7FCOCFED46C7B1BFCDDD41F240D7-MEGAN.MCSEV] 

Sent: 2/3/2020 6:32:43 AM 

To: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; M cN ei 11, Lorrie 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en= 77b0b352c9c2485 lbfOc7330f53e00d9-McNeil I]; Mair, Michael 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Abram, Anna 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en =Recipients/ en=fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Sadove, EI iza beth 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fd45c627000d4f34b9db362ff2b6af4b-SADOVE E] 

Finnen, April [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =43d7 4b30bbld429184b0d908 lefe 19bf-Apri I. Finne]; Janik, Heather 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =117bc4d27 d7b4 7 dd bebeeeSffeeb 7f3d-H eather .Jan]; Ca I igui ri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; Stark, Angel a 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d04b 10a5e0ec40ffa2ebfedd71 le83af-Angela .Star]; Felberbaum, Mi cha el 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =4819a643ca 2945cd b la263 lb83e69673-M i cha el. Fel ]; Meyer, Lyndsay 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =00176f099 lc84d34b3927bfb410d5483-Lyndsay. Mey] 

Subject: For review - NIH Media Inquiry for FDA review 

Attachments: NIH Media inquiry.docx 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

Megan McSeveney 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Adrni.ais.b";uinrL, 

Tel 240-402-4514/Cell[ ______ __(

b )(6) ____ ___! 

Megan.McSeveney@fda.hhs.gov 

U.S. FOOD & DRUG 

ADMINISTRATION 

DCllZI .. 

FDA-OSJ I-FOIA-2020-3541 _00000729 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 2/3/2020 8:46:09 AM 

To: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/cn=Recipients/cn=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =d4 7af9d99 laf 4cl fbf7 cb4c ld287f83e-ChoD] 

Subject: FW: For review - NIH Media Inquiry for FDA review 

Attachments: NIH Media inquiry.docx 

Good morning -

Please see the email below and attached responses NIH plans to use for response to a press inquiry. I'm okay with 

Megan's revisions, although I did move one phrase towards the end from where she inserted. 

Please let me know if you have any comments or edits. The response is due back to Megan at 3:00pm today. 

Thanks! 

Lorrie 

From: McSeveney, Megan <Megan.McSeveney@fda.hhs.gov> 

Sent: Monday, February 3, 2020 6:33 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Cc: Finnen, April <April.Finnen@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Stark, Angela <Angela.Stark@fda.hhs.gov>; Felberbaum, Michael 

<Michael.Felberbaum@fda.hhs.gov>; Meyer, Lyndsay <Lyndsay.Meyer@fda.hhs.gov> 

Subject: For review - NIH Media Inquiry for FDA review 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

Megan McSeveney 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Tel 240-402-4514/Cel

\._ _______ (b)(6) ________ _! Megan.McSeveney@fda.hhs.gov 

U.S. FOOD & DRUG 

JJ. OM I�� tST RI\ Tl()N 

ocm •· 

FDA-OSJ I-FOIA-2020-3541 _00000732 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 2/3/2020 8:51:14 AM 

To: McNeil!, Lorrie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/cn=Recipients/cn=77b0b352c9c24851bf0c7330f53e00d9-McNeill]; Cho, David S (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =d4 7af9d99 laf 4cl fbf7 cb4c ld287f83e-ChoD] 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Attachments: NIH Media inquiry (1).docx 

Dear Lorrie, 

Sorry that the suggested edits in the attached are not in your version. Thanks. 

Best Regards, 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:46 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: FW: For review - NIH Media Inquiry for FDA review 

Good morning -

Please see the email below and attached responses NIH plans to use for response to a press inquiry. I'm okay with 

Megan's revisions, although I did move one phrase towards the end from where she inserted. 

Please let me know if you have any comments or edits. The response is due back to Megan at 3:00pm today. 

Thanks! 

Lorrie 

From: McSeveney, Megan <Megan.McSeveney@fda.hhs.gov> 

Sent: Monday, February 3, 2020 6:33 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Cc: Finnen, April <April.Finnen@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Stark, Angela <Angela.Stark@fda.hhs.gov>; Felberbaum, Michael 

<Michael.Felberbaum@fda.hhs.gov>; Meyer, Lyndsay <Lyndsay.Meyer@fda.hhs.gov> 

Subject: For review - NIH Media Inquiry for FDA review 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

Megan McSeveney 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

FDA-OSJI-FOIA-2020-3541_00000758 
Tel 240-402-4514/Cell: _________ (b )(6) _____ ___! Megan.McSeveney@fda.hhs.gov 

U.S. FOOD & DRUG 

AC>Ml��tSlltATION 

Dr.Jr:!:I •· 

FDA-OSJI-FOIA-2020-3541_00000759 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 2/3/2020 8:54:05 AM 

To: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/cn=Recipients/cn=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =d4 7af9d99 laf 4cl fbf7 cb4c ld287f83e-ChoD] 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Attachments: NIH Media inquiry.docx 

Hi PeterI'm not sure what I did, I must not have saved correctly. My suggested edit is in the version you edited (last 

paragraph). Sorry about that! 

Lorrie 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:51 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Dear Lorrie, 

Sorry that the suggested edits in the attached are not in your version. Thanks. 

Best Regards, 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:46 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: FW: For review - NIH Media Inquiry for FDA review 

Good morning -

Please see the email below and attached responses NIH plans to use for response to a press inquiry. I'm okay with 

Megan's revisions, although I did move one phrase towards the end from where she inserted. 

Please let me know if you have any comments or edits. The response is due back to Megan at 3:00pm today. 

Thanks! 

Lorrie 

From: McSeveney, Megan <Megan.McSeveney@fda.hhs.gov> 

Sent: Monday, February 3, 2020 6:33 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Cc: Finnen, April <April.Finnen@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Stark, Angela <Angela.Stark@fda.hhs.gov>; Felberbaum, Michael 

FDA-OSJ I-FOIA-2020-3541 _00000730 
<Michael.Felberbaum@fda.hhs.gov>; Meyer, Lyndsay <Lyndsay.Meyer@fda.hhs.gov> 

Subject: For review - NIH Media Inquiry for FDA review 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

Megan McSeveney 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Adm.injs.tr.atio.tL, 

Tel 240-402-4514/Celli (b)(6) i 

Megan. M cSeven ey@fcla]lfis�gov·-·-·-·-·-·-

U.S. FOOD & DRUG 

AOMINISHAYION 

ocm •· 

FDA-OSJ I-FOIA-2020-3541 _00000731 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 2/3/2020 8:55:21 AM 

To: McNeil!, Lorrie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/cn=Recipients/cn=77b0b352c9c24851bf0c7330f53e00d9-McNeill]; Cho, David S (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =d4 7af9d99 laf 4cl fbf7 cb4c ld287f83e-ChoD] 

RE: For review - NIH Media Inquiry for FDA review 

Dear Lorrie, 

Thanks! 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:54 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Hi PeterI'm not sure what I did, I must not have saved correctly. My suggested edit is in the version you edited (last 

paragraph). Sorry about that! 

Lorrie 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:51 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Dear Lorrie, 

Sorry that the suggested edits in the attached are not in your version. Thanks. 

Best Regards, 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:46 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: FW: For review - NIH Media Inquiry for FDA review 

Good morning -

Please see the email below and attached responses NIH plans to use for response to a press inquiry. I'm okay with 

Megan's revisions, although I did move one phrase towards the end from where she inserted. 

Please let me know if you have any comments or edits. The response is due back to Megan at 3:00pm today. 

Thanks! 

FDA-OSJI-FOIA-2020-3541_00000756 
Lorrie 

From: McSeveney, Megan <Megan.McSeveney@fda.hhs.gov> 

Sent: Monday, February 3, 2020 6:33 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Cc: Finnen, April <April.Finnen@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Stark, Angela <Angela.Stark@fda.hhs.gov>; Felberbaum, Michael 

<Michael.Felberbaum@fda.hhs.gov>; Meyer, Lyndsay <Lyndsay.Meyer@fda.hhs.gov> 

Subject: For review - NIH Media Inquiry for FDA review 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

Megan McSeveney 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration __ _ 

Tel 240-402-4514/Celli (b)(6) i 

Megan. McSeveney@fda. hhs. gov ·-·-·-·-·' 

U.S. FOOD & DRUG 

AOMINISHAYION 

ocm •· 

FDA-OSJI-FOIA-2020-3541_00000757 
From: Cho, David S (CBER) [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D4 7 AF9D991AF4ClFBF7CB4ClD287F83E-CH OD] 

Sent: 2/3/2020 9:00:00 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; M cN ei 11, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c24851 bf0c7330f53e00d9-M cN eil I] 

RE: For review - NIH Media Inquiry for FDA review 

HI Lorrie, 

I read through the most updated version and did not have any additional comments. 

Thanks, 

David 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:55 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Dear Lorrie, 

Thanks! 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:54 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Hi PeterI'm not sure what I did, I must not have saved correctly. My suggested edit is in the version you edited (last 

paragraph). Sorry about that! 

Lorrie 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:51 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Dear Lorrie, 

Sorry that the suggested edits in the attached are not in your version. Thanks. 

Best Regards, 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:46 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: FW: For review - NIH Media Inquiry for FDA review 

FDA-OSJ I-FOIA-2020-3541 _00000727 
Good morning -

Please see the email below and attached responses NIH plans to use for response to a press inquiry. I'm okay with 

Megan's revisions, although I did move one phrase towards the end from where she inserted. 

Please let me know if you have any comments or edits. The response is due back to Megan at 3:00pm today. 

Thanks! 

Lorrie 

From: McSeveney, Megan <Megan.McSeveney@fda.hhs.gov> 

Sent: Monday, February 3, 2020 6:33 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Cc: Finnen, April <April.Finnen@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Stark, Angela <Angela.Stark@fda.hhs.gov>; Felberbaum, Michael 

<Michael.Felberbaum@fda.hhs.gov>; Meyer, Lyndsay <Lyndsay.Meyer@fda.hhs.gov> 

Subject: For review - NIH Media Inquiry for FDA review 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

Megan McSeveney 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug A,dmials.tr.atioo ___ _

Tel 240-402-4514/Celli_ ________ (b)(6) ________ _: 

Meqan.McSeveney@fda.hhs.gov 

U.S. FOOD & DRUG 

AC>Ml��tSlltATION 

Dr.Jr:!:I •· 

FDA-OSJ I-FOIA-2020-3541 _00000728 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 2/3/2020 9:01:17 AM 

To: Cho, David S (CBER) [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

RE: For review - NIH Media Inquiry for FDA review 

Thanks David! 

Lorrie 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Monday, February 3, 2020 9:00 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

HI Lorrie, 

I read through the most updated version and did not have any additional comments. 

Thanks, 

David 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:55 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Dear Lorrie, 

Thanks! 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:54 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Hi PeterI'm not sure what I did, I must not have saved correctly. My suggested edit is in the version you edited (last 

paragraph). Sorry about that! 

Lorrie 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:51 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Dear Lorrie, 

FDA-OSJ I-FOIA-2020-3541 _00000725 
Sorry that the suggested edits in the attached are not in your version. Thanks. 

Best Regards, 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, February 3, 2020 8:46 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: FW: For review - NIH Media Inquiry for FDA review 

Good morning -

Please see the email below and attached responses NIH plans to use for response to a press inquiry. I'm okay with 

Megan's revisions, although I did move one phrase towards the end from where she inserted. 

Please let me know if you have any comments or edits. The response is due back to Megan at 3:00pm today. 

Thanks! 

Lorrie 

From: McSeveney, Megan <Megan.McSeveney@fda.hhs.gov> 

Sent: Monday, February 3, 2020 6:33 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Cc: Finnen, April <April.Finnen@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<laura.Caliguiri@fda.hhs.gov>; Stark, Angela <Angela.Stark@fda.hhs.gov>; Felberbaum, Michael 

<Michael.Felberbaum@fda.hhs.gov>; Meyer, Lyndsay <Lyndsay.Meyer@fda.hhs.gov> 

Subject: For review - NIH Media Inquiry for FDA review 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

Megan McSeveney 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug A,d.mio.i.s.t.rati.n1L., 

Tel 240-402-4514/Celli (b)(G) ! 

Meqan.McSeveney@tda.hhs.gov 

U.S. FOOD & DRUG 

AOMINISHAYION 

ocm •· 

FDA-OSJ I-FOIA-2020-3541 _00000726 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 2/3/2020 9:37:05 AM 

To: McSeveney, Megan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=0d4b7fc0cfed46c7blbfcddd41f240d7-Megan.McSev]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd 38445cb9c9adca3 f72df53a-M a rksP]; Mair, Mi cha el 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Abram, Anna 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =fb 77660891384232a 7 cd9086fcbbla3b-An na .Abram]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Sadove, EI iza beth 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fd45c627000d4f34b9db362ff2b6af4b-SADOVE E] 

CC: Finnen, April [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =43d7 4b30bbld429184b0d908 lefe 19bf-Apri I. Finne]; Janik, Heather 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =117bc4d27 d7b4 7 dd bebeeeSffeeb 7f3d-H eather .Jan]; Ca I igui ri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; Stark, Angel a 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d04b 10a5e0ec40ffa2ebfedd71 le83af-Angela .Star]; Felberbaum, Mi cha el 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4819a643ca 2945cd b la263 lb83e69673-M i cha el. Fel ]; Meyer, Lyndsay 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =00176f099 lc84d34b3927bfb410d5483-Lyndsay. Mey] 

Subject: RE: For review - NIH Media Inquiry for FDA review 

Attachments: NIH Media inquiry.docx 

Hi MeganPlease see suggested edits from CBER. Thanks much. 

Lorrie 

From: McSeveney, Megan <Megan.McSeveney@fda.hhs.gov> 

Sent: Monday, February 3, 2020 6:33 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Mair, Michael 

<Michael.Mair@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Cc: Finnen, April <April.Finnen@fda.hhs.gov>; Janik, Heather <Heather.Janik@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; Stark, Angela <Angela.Stark@fda.hhs.gov>; Felberbaum, Michael 

<Michael. Felberbaum@fda.hhs.gov>; Meyer, Lyndsay <Lyndsay.Meyer@fda.hhs.gov> 

Subject: For review - NIH Media Inquiry for FDA review 

Good morning! During this coronavirus response, as with the Ebola response, we are working to coordinate messaging 

across the department. NIH has shared through HHS a media inquiry they received from the Times of London about their 

efforts to work on a coronavirus vaccines. Attached is that inquiry which has some initial edits in track changes for your 

review. The deadline is COB today for NIH, so I am requesting this back by 3pm today. Thank you! 

FDA-OSJ I-FOIA-2020-3541 _00000723 
Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration ____ _ 

Tel 240-402-4514/Cel! (b)(6) : 

Megan. McSeveney@fda. hhs. gov-·-·-·-·-·-· 

U.S. FOOD & DRUG 

AC>Ml��tSlltATION 

Dr.Jr:!:I •· 

FDA-OSJ I-FOIA-2020-3541 _00000724 
From: Cho, David S (CBER) [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D4 7 AF9D991AF4ClFBF7CB4ClD287F83E-CH OD] 

Sent: 2/7/2020 4:18:11 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; M cN ei 11, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c24851 bf0c7330f53e00d9-M cN eil I] 

FW: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi Lorrie, 

Just sending your way for awareness and in case you had any comments on these tweets. A couple near end on 

vaccines. 

Thanks, 

David 

From: Leggin, Brooke <Brooke.Leggin@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:14 PM 

To: 2019-nCoV FDA IMG <2019-nCoVFDAIMG@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Beers, Donald 

<Donald.Beers@fda.hhs.gov>; Kumar, Dinesh <Dinesh.Kumar@fda.hhs.gov> 

Cc: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Subject: 5pm review request - tweets for Commissioner Hahn on nCoV 

Below are draft tweets for your review and clearance. Please send any edits or questions by 5pm today. Thank you. 

@Steve FDA 

• Today, the President's #Coronavirus Task Force provided an update to the public on current outbreak efforts. 

Here at FDA, we continue to coordinate closely with our @HHSgov & USG partners and are ready to respond around the 

clock to the outbreak. #2019nCoV [IMAGE or QRT] 

• At today's press briefing on the 2019 novel #coronavirus, I shared that FDA has received no reports of disruptions 

to the supply chain from medical supply manufacturers. We continue to monitor this closely & communicate w/ 

manufacturers. #2019nCoV [HAHN VIDEO] 

• A key focus of FDA is providing regulatory advice, guidance, and technical assistance to help expedite the 

development & availability of critical medical products to diagnose, treat, mitigate and prevent #2019nCoV. 

• [_(b)(5) j at FDA, we are fully engaged with our experts participating in USG response efforts to develop vaccines & 

therapeutics for novel #coronavirus and are working closely with our government and international partners. 

Brooke Leggin, MPH 

Writer Editor 

Office of Editorial and Creative Services 

Office of External Affairs 

U.S. Food and Drug Administration 

{b){5) 

FDA-OSJI-FOIA-2020-3541_00001322 
Mon, Thurs, Fri 301-796-8466 

Tues, Wed 301-864-2607 

brooke.leggin@fda.hhs.gov 

U.S. FOOD & DRUG 

A0MINt$'1'1tATION 

ocm .. ■ 

FDA-OSJI-FOIA-2020-3541_00001323 
From: Cho, David S (CBER) [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D4 7 AF9D991AF4ClFBF7CB4ClD287F83E-CH OD] 

Sent: 2/7/2020 4:18:55 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; M cN ei 11, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c24851 bf0c7330f53e00d9-M cN eil I] 

RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Peter, please comment if you see anything to note. Overall looked ok. 

Thanks, 

David 

From: Cho, David S (CBER) 

Sent: Friday, February 7, 2020 4:18 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: FW: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi Lorrie, 

Just sending your way for awareness and in case you had any comments on these tweets. A couple near end on 

vaccines. 

Thanks, 

David 

From: Leggin, Brooke <Brooke.Le fda.hhs. ov> 

Sent: Friday, February 7, 2020 4:14 PM 

To: 2019-nCoV FDA IMG <2019-nCoVFDAIMG fda.hhs. ov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Beers, Donald 

<Donald.Beers@fda.hhs.gov>; Kumar, Dinesh <Dinesh.Kumar@fda.hhs.gov> 

Cc: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Subject: 5pm review request - tweets for Commissioner Hahn on nCoV 

Below are draft tweets for your review and clearance. Please send any edits or questions by 5pm today. Thank you. 

@Steve FDA 

• Today, the President's #Coronavirus Task Force provided an update to the public on current outbreak efforts. 

Here at FDA, we continue to coordinate closely with our @HHSgov & USG partners and are ready to respond around the 

clock to the outbreak. #2019nCoV [IMAGE or QRT] 

• At today's press briefing on the 2019 novel #coronavirus, I shared that FDA has received no reports of disruptions 

to the supply chain from medical supply manufacturers. We continue to monitor this closely & communicate w/ 

manufacturers. #2019nCoV [HAHN VIDEO] 

• A key focus of FDA is providing regulatory advice, guidance, and technical assistance to help expedite the 

development & availability of critical medical products to diagnose, treat, mitigate and prevent #2019nCoV. 

• i (b )(5) i at FDA, we are fully engaged with our experts participating in USG response efforts to develop vaccines & 

therapeutics for novel #coronavirus and are working closely with our government and international partners. 

FDA-OSJI-FOIA-2020-3541_00001320 
Brooke Leggin, MPH 

Writer Editor 

Office of Editorial and Creative Services 

Office of External Affairs 

U.S. Food and Drug Administration 

Mon. Thurs. Fri: 301-796-8466 

Tues. Wed 301-864-2607 

brooke.leggin@fda.hhs.gov 

U.S. FOOD & DRUG 

A0MINt$1'1tATION 

ocm .. ■ 

(b)(S) 

FDA-OSJI-FOIA-2020-3541_00001321 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 2/7/2020 4:21:00 PM 

To: Cho, David S (CBER) [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi DavidThanks for sharing these. No comments from me. 

Lorrie 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:18 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: FW: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi Lorrie, 

Just sending your way for awareness and in case you had any comments on these tweets. A couple near end on 

vaccines. 

Thanks, 

David 

From: Leggin, Brooke <Brooke.Le fda.hhs. ov> 

Sent: Friday, February 7, 2020 4:14 PM 

To: 2019-nCoV FDA IMG <2019-nCoVFDAIMG@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Beers, Donald 

<Donald.Beers@fda.hhs.gov>; Kumar, Dinesh <Dinesh.Kumar@fda.hhs.gov> 

Cc: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Subject: 5pm review request - tweets for Commissioner Hahn on nCoV 

Below are draft tweets for your review and clearance. Please send any edits or questions by 5pm today. Thank you. 

@Steve FDA 

• Today, the President's #Coronavirus Task Force provided an update to the public on current outbreak efforts. 

Here at FDA, we continue to coordinate closely with our @HHSgov & USG partners and are ready to respond around the 

clock to the outbreak. #2019nCoV [IMAGE or QRT] 

• At today's press briefing on the 2019 novel #coronavirus, I shared that FDA has received no reports of disruptions 

to the supply chain from medical supply manufacturers. We continue to monitor this closely & communicate w/ 

manufacturers. #2019nCoV [HAHN VIDEO] 

• A key focus of FDA is providing regulatory advice, guidance, and technical assistance to help expedite the 

development & availability of critical medical products to diagnose, treat, mitigate and prevent #2019nCoV. 

FDA-OSJI-FOIA-2020-3541_00001318 
• i (b)(S) �t FDA, we are fully engaged with our experts participating in USG response efforts to develop vaccines & 

therapeutics for novel #coronavirus and are working closely with our government and international partners. 

Brooke Leggin, MPH 

Writer Editor 

Office of Editorial and Creative Services 

Office of External Affairs 

U.S. Food and Drug Administration 

Mon, Thurs, Fri 301-796-8466 

Tues, Wed 301-864-2607 

brooke.leggin@fda.hhs.gov 

U.S. FOOD & DRUG 

A0MINt$'1'1tATION 

ocm .. ■ 

(b)(S) 

FDA-OSJI-FOIA-2020-3541_00001319 
From: Cho, David S (CBER) [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D4 7 AF9D991AF4ClFBF7CB4ClD287F83E-CH OD] 

Sent: 2/7/2020 4:22:37 PM 

To: McNeil!, Lorrie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/cn=Recipients/cn= 77b0b352c9c2485 lbfOc7330f53e00d9-McNeil I]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =dfbb2b5bd38445 cb9c9adca3f72df53a-M a rksP] 

RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Thanks Lorrie. 

David 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:21 PM 

To: Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi DavidThanks for sharing these. No comments from me. 

Lorrie 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:18 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: FW: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi Lorrie, 

Just sending your way for awareness and in case you had any comments on these tweets. A couple near end on 

vaccines. 

Thanks, 

David 

From: Leggin, Brooke <Brooke.Leggin@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:14 PM 

To: 2019-nCoV FDA IMG <2019-nCoVFDAIMG fda.hhs. ov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Beers, Donald 

<Donald.Beers@fda.hhs.gov>; Kumar, Dinesh <Dinesh.Kumar@fda.hhs.gov> 

Cc: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Subject: 5pm review request - tweets for Commissioner Hahn on nCoV 

Below are draft tweets for your review and clearance. Please send any edits or questions by 5pm today. Thank you. 

@Steve FDA 

• Today, the President's #Coronavirus Task Force provided an update to the public on current outbreak efforts. 

Here at FDA, we continue to coordinate closely with our @HHSgov & USG partners and are ready to respond around the 

clock to the outbreak. #2019nCoV [IMAGE or QRT] 

• At today's press briefing on the 2019 novel #coronavirus, I shared that FDA has received no reports of disruptions 

to the supply chain from medical supply manufacturers. We continue to monitor this closely & communicate w/ 

manufacturers. #2019nCoV [HAHN VIDEO] 

FDA-OSJI-FOIA-2020-3541_00001316 
• A key focus of FDA is providing regulatory advice, guidance, and technical assistance to help expedite the 

development & availability of critical medical products to diagnose, treat, mitigate and prevent #2019nCoV. 

• i._(b)(5)_ jat FDA, we are fully engaged with our experts participating in USG response efforts to develop vaccines & 

therapeutics for novel #coronavirus and are working closely with our government and international partners. 

Brooke Leggin, MPH 

Writer Editor 

Office of Editorial and Creative Services 

Office of External Affairs 

U.S. Food and Drug Administration 

Mon. Thurs. Fri: 301-796-8466 

Tues. Wed 301-864-2607 

brooke.leggin@fda.hhs.gov 

U.S. FOOD & DRUG 

A0MINt$1'1tATION 

ocm .. ■ 

(b)(5) 

FDA-OSJI-FOIA-2020-3541_00001317 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 2/7/2020 4:32:47 PM 

To: Cho, David S (CBER) [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD ]; M cN ei 11, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c24851 bf0c7330f53e00d9-M cN eil I] 

RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Dear David, 

These look fine to me. 

Best Regards, 

Peter 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:19 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Peter, please comment if you see anything to note. Overall looked ok. 

Thanks, 

David 

From: Cho, David S (CBER) 

Sent: Friday, February 7, 2020 4:18 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: FW: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi Lorrie, 

Just sending your way for awareness and in case you had any comments on these tweets. A couple near end on 

vaccines. 

Thanks, 

David 

From: Leggin, Brooke <Brooke.Leggin@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:14 PM 

To: 2019-nCoV FDA IMG <2019-nCoVFDAIMG fda.hhs. ov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Beers, Donald 

<Donald.Beers@fda.hhs.gov>; Kumar, Dinesh <Dinesh.Kumar@fda.hhs.gov> 

Cc: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Subject: 5pm review request - tweets for Commissioner Hahn on nCoV 

Below are draft tweets for your review and clearance. Please send any edits or questions by 5pm today. Thank you. 

@Steve FDA 

• Today, the President's #Coronavirus Task Force provided an update to the public on current outbreak efforts. 

Here at FDA, we continue to coordinate closely with our @HHSgov & USG partners and are ready to respond around the 

clock to the outbreak. #2019nCoV [IMAGE or QRT] 

FDA-OSJI-FOIA-2020-3541_00001436 
• At today's press briefing on the 2019 novel #coronavirus, I shared that FDA has received no reports of disruptions 

to the supply chain from medical supply manufacturers. We continue to monitor this closely & communicate w/ 

manufacturers. #2019nCoV [HAHN VIDEO] 

• A key focus of FDA is providing regulatory advice, guidance, and technical assistance to help expedite the 

____ dey_e.lo.nme.oL&_aYailabililv...of_critic_aLmed.i.caJ . .nrndu..c.ts_.to._dlaa.oo_s.e .•. tre.aL.mitioate __ and . .nce.vent#2.Q1.9nCo_�-----� 

• [_(b)(5) jat FDA, we are fully engaged with our experts participating in USG response efforts to develop vaccines & 

I 

therapeutics for novel #coronavirus and are working c

c'b )

'

c°S)

vemment and international partners. 

Brooke Leggin, MPH 

Writer Editor 

Office of Editorial and Creative Services 

Office of External Affairs 

U.S. Food and Drug Administration 

Mon, Thurs, Fri 301-796-8466 

Tues, Wed 301-864-2607 

brooke.leggin@fda.hhs.gov 

U.S. FOOD & DRUG 

AC>MiNtSU-A.110,N 

ocm .. ■ 

FDA-OSJI-FOIA-2020-3541_00001437 
From: Cho, David S (CBER) [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D4 7 AF9D991AF4ClFBF7CB4ClD287F83E-CH OD] 

Sent: 2/7/2020 4:34:25 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; M cN ei 11, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c24851 bf0c7330f53e00d9-M cN eil I] 

RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Thanks Peter, 

David 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:33 PM 

To: Cho, David S (CBER) <David.Cho@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Dear David, 

These look fine to me. 

Best Regards, 

Peter 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:19 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: RE: 5pm review request - tweets for Commissioner Hahn on nCoV 

Peter, please comment if you see anything to note. Overall looked ok. 

Thanks, 

David 

From: Cho, David S (CBER) 

Sent: Friday, February 7, 2020 4:18 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: FW: 5pm review request - tweets for Commissioner Hahn on nCoV 

Hi Lorrie, 

Just sending your way for awareness and in case you had any comments on these tweets. A couple near end on 

vaccines. 

Thanks, 

David 

From: Leggin, Brooke <Brooke.Leggin@fda.hhs.gov> 

Sent: Friday, February 7, 2020 4:14 PM 

To: 2019-nCoV FDA IMG <2019-nCoVFDAIMG fda.hhs. ov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Beers, Donald 

<Donald.Beers@fda.hhs.gov>; Kumar, Dinesh <Dinesh.Kumar@fda.hhs.gov> 

Cc: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov> 

Subject: 5pm review request - tweets for Commissioner Hahn on nCoV 

Below are draft tweets for your review and clearance. Please send any edits or questions by 5pm today. Thank you. 

FDA-OSJI-FOIA-2020-3541_00001314 
@Steve FDA 

• Today, the President's #Coronavirus Task Force provided an update to the public on current outbreak efforts. 

Here at FDA, we continue to coordinate closely with our @HHSgov & USG partners and are ready to respond around the 

clock to the outbreak. #2019nCoV [IMAGE or QRT] 

• At today's press briefing on the 2019 novel #coronavirus, I shared that FDA has received no reports of disruptions 

to the supply chain from medical supply manufacturers. We continue to monitor this closely & communicate w/ 

manufacturers. #2019nCoV [HAHN VIDEO] 

• A key focus of FDA is providing regulatory advice, guidance, and technical assistance to help expedite the 

development & availability of critical medical products to diagnose, treat, mitigate and prevent #2019nCoV. 

• L_{b)(5) _

!at FDA, we are fully engaged with our experts participating in USG response efforts to develop vaccines & 

therapeutics for novel #coronavirus and are working closely with our government and international partners. 

Brooke Leggin, MPH 

Writer Editor 

Office of Editorial and Creative Services 

Office of External Affairs 

U.S. Food and Drug Administration 

Mon, Thurs, Fri 301-796-8466 

Tues, Wed 301-864-2607 

brooke.leggin@fda.hhs.gov 

U.S. FOOD & DRUG 

A0MINt$'1'1tATION 

ocm .. ■ 

(b)(S) 

FDA-OSJI-FOIA-2020-3541_00001315 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 3/8/2020 8:46:14 PM 

To: Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=1160d300bc4248b790ded292a082e9a8-Julia.Tiern]; Cho, David S ( CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4cl fbf7 cb4c ld287f83e-ChoD ]; M cN ei 11, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c2485 lbf0c7330f53e00d9-M cN eil I]; Hussey, Deirdre 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=41a51a9bf937431c8470b69fb055fe81-Husseyd] 

Subject: RE: COVID19 CONPLAN review 

Attachments: 20200305_FDA_COVID19 CONPLAN_March_2020 Vl.2.3.4_updatedjctpwm.docx 

Dear All, 

Please see my additional suggested edits added to those previously made in the attached. 

Best Regards, 

Peter 

From: Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Sent: Sunday, March 8, 2020 1:49 PM 

To: Cho, David S (CBER) <David.Cho@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: COVID19 CONPLAN review 

Thanks, 

Julie 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Saturday, March 7, 2020 10:58 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Hussey, Deirdre <Deirdre.Hussey@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: COVID19 CONPLAN review 

Thanks Lorrie, 

Thanks, 

David 

(b){S) 

FDA-OSJI-FOIA-2020-3541_00001432 
From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Date: March 7, 2020 at 10:29:24 AM EST 

To: Cho, David S (CBER) <David.Cho@fda.hhs.gov>, Hussey, Deirdre <Deirdre.Hussey@fda.hhs.gov>, Tierney, Julia 

<Julia.Tierney@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: COVID19 CONPLAN review 

Hi David-

(b)(S) 

Lorrie 

From: Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Sent: Saturday, March 7, 2020 10:01 AM 

To: Hussey, Deirdre <Deirdre.Hussey@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: COVID19 CONPLAN review 

Hi Deirdre, 

I added my comments onto Lorrie's version. 

Thanks, 

David 

From: Hussey, Deirdre <Deirdre.Hussey@fda.hhs.gov> 

Sent: Friday, March 6, 2020 6:08 PM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: COVID19 CONPLAN review 

Thank you. 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Date: March 6, 2020 at 4:40:11 PM EST 

To: Hussey, Deirdre <Deirdre.Hussey@fda.hhs.gov>, Cho, David S (CBER) <David.Cho@fda.hhs.gov>, Tierney, Julia 

<Julia.Tierney@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: COVID19 CONPLAN review 

Hi DeirdreA comment on page 6 and two minor edits and a comment on page 30. 

Thanks -

FDA-OSJI-FOIA-2020-3541_00001433 
Lorrie 

From: Hussey, Deirdre <Deirdre.Hussey@fda.hhs.gov> 

Sent: Friday, March 6, 2020 12:26 PM 

To: Cho, David S (CBER) <David.Cho@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: FW: COVID19 CON PLAN review 

All, 

We've been asked to not share this widely, but to review and provide comments by Monday at noon. Could you let me 

know if you have any comments? Thanks. 

Deirdre 

From: Branch, Tiffany <Tiffany.Branch@fda.hhs.gov> 

Date: March 6, 2020 at 11:09:25 AM EST 

To: Stone, Eric <Eric.Stone@fda.hhs.gov>, Barfell, Glenda F <Glenda.Barfell@fda.hhs.gov>, Barth, Janelle 

<Janelle.Barth@fda.hhs.gov>, Hutten locker, Denise <Denise.Huttenlocker@fda.hhs.gov>, Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>, Cason, Winona <Winona.Cason@fda.hhs.gov>, Domanski, Jeffrey 

<Jeffrey.Domanski@fda.hhs.gov>, Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov> 

Subject: FW: COVID19 CON PLAN review 

Good morning, 

Below please find the link to the COVID-2019 ConOps plan. I will share more on the call. 

Best, 

Tiffany 

From: Carter, Lionel <Lionel.Carter@fda.hhs.gov> 

Sent: Friday, March 6, 2020 12:11 AM 

To: Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Sigg, Jim <Jim.Sigg@fda.hhs.gov>; Branch, Tiffany <Tiffany.Branch@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov>; Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Solomon, Steven M <Steven.Solomon@fda.hhs.gov>; Caliguiri, Laura 

<Laura.Caliguiri@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov>; Shuren, Jeff 

<Jeff.Shuren@fda.hhs.gov>; Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Tootle, 

William <William.Tootle@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Tse, Tania <Tania.Tse@fda.hhs.gov>; Rogers, Michael <Michael.Rogers@fda.hhs.gov>; 

Mayne, Susan <Susan.Mayne@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov>; Solberg, Tim <Tim.Solberg@fda.hhs.gov>; Musser, Steven M 

<Steven.Musser@fda.hhs.gov>; Tyler, James <James.Tyler@fda.hhs.gov>; Throckmorton, Douglas C 

<Douglas.Throckmorton@fda.hhs.gov>; Mignone, Alfred <Alfred.Mignone@fda.hhs.gov>; Abram, Anna 

<Anna.Abram@fda.hhs.gov>; Forfa, Tracey <Tracey.Forfa@fda.hhs.gov>; Keller, Melanie <Melanie.Keller@fda.hhs.gov>; 

Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Zeller, Mitchell <Mitchell.Zeller@fda.hhs.gov>; Ross, Bruce 

<Bruce.Ross@fda.hhs.gov>; Musser, Steven M <Steven.Musser@fda.hhs.gov> 

Subject: COVID19 CONPLAN review 

To All 

FDA-OSJI-FOIA-2020-3541_00001434 
Here is the updated CON PLAN in SharePoint for AEG review. Comments are due by 12:00 noon on Monday, March 9, 

2020. 

V/r, 

Lionel Carter Acting Director 

Office of Security and Emergency Management 

10903 New Hampshire Avenue, WO32 RM1353 

Silver Spring, MD 20993 

PH: 301-796-2796 I Mobile:! (b)(6) 

Lionel.Carter@fda.hhs.gov 

FDA-OSJI-FOIA-2020-3541_00001435 
From: 

Sent: 

To: 

Subject: 

Hi Denise, 

Cho, David S (CBER) [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D4 7 AF9D991AF4ClFBF7CB4ClD287F83E-CH OD] 

3/15/2020 4:32:43 PM 

Hinton, Denise [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Shu ren, Jeff 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren ]; Schwartz, Suzanne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =60fbac0e 12a24633b 1018181711 f7849-Suza n ne.Sch]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

RE: Review Requested by 1620: Talking Points on COVID Therapeutics/Vaccines 

I did not have any further comments especially on the vaccines or immunotherapy statements. 

Thanks, 

David 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Sent: Sunday, March 15, 2020 3:55 PM 

To: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Schwartz, Suzanne <Suzanne.Schwartz@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov> 

Subject: Review Requested by 1620: Talking Points on COVID Therapeutics/Vaccines 

Dear Colleagues, 

Michael Felderbaum drafted the following and wanting to make sure you've laid eyes on it and have the opportunity to 

provide comments before it goes to Dr. Hahn if you haven't already. 

Thanks, 

Denise 

FDA-OSJ I-FOIA-2020-3541 _00000722 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 3/15/2020 5:17:53 PM 

To: Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND] 

CC: Farley, John [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897ac979b0619b-FARLEY J]; Clarke, Mary Beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =b0124a 15b9344d84839294 70fefa403a-CLARKE M] 

RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Dear Patrizia, 

Thanks for copying us. Nothing to add. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Sunday, March 15, 2020 4:39 PM 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: Fwd: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Denise 

+ Peter Marks 

In the two paragraphs on IL-7 inhibitors and convalescent plasma, respectively , I recommend replacing the section 

about Reducing/heeding off need for ventilator with : 

(b)(S) 

Patrizia 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Date: March 15, 2020 at 4:16:42 PM EDT 

To: Farley, John <John.Farley@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>, Clarke, Mary Beth 

<Ma beth.Clarke fda.hhs. ov> 

Subject: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Hi - sorry for short notice - any input before Michael Felderbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJ I-FOIA-2020-3541 _00001431 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 3/16/2020 7:22:41 AM 

To: Hinton, Denise [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND] 

CC: Felberbaum, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4819a643ca2945cd b la263 lb83e69673-M i cha el. Fel] 

Subject: RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Attachments: Therapeutics TPs 03152020 324pm (1).docx 

Dear Denise, 

Please see the attached with one comment. 

Best Regards, 

Peter 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Sent: Monday, March 16, 2020 7:02 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Subject: FW: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Good morning Peter, 

Did you have any comments in addition to Patrizia's? 

Thank you, 

Denise 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Sunday, March 15, 2020 4:39 PM 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: Fwd: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Denise 

+ Peter Marks 

In the two paragraphs on IL-7 inhibitors and convalescent plasma, respectively , I recommend replacing the section 

about Reducing/heeding off need for ventilator with : 

(b)(5) 

Patrizia 

FDA-OSJI-FOIA-2020-3541_00001429 
From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Date: March 15, 2020 at 4:16:42 PM EDT 

To: Farley, John <John.Farley@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Hi - sorry for short notice - any input before Michael Felberbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJI-FOIA-2020-3541_00001430 
From: Felberbaum, Michael [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =4819A643CA2945CDB 1A2631 B83E69673-M ICH AEL. FE L] 

3/16/2020 8:19:14 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND] 

RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Thank you, Peter. I will revise the bullet based on your comment to the following: 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Tel 240-402-9548 / Cell 202-906-0229 

michael. fel berbau m@fda. h hs. gov 

U.S. FOOD & DRUG 

ADMINISfllAllON 

DClm .. II 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 7:23 AM 

(b)(S) 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Cc: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Subject: RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Dear Denise, 

Please see the attached with one comment. 

Best Regards, 

Peter 

From: Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Sent: Monday, March 16, 2020 7:02 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Subject: FW: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Good morning Peter, 

Did you have any comments in addition to Patrizia's? 

FDA-OSJI-FOIA-2020-3541_00001280 
Thank you, 

Denise 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Sent: Sunday, March 15, 2020 4:39 PM 

To: Hinton, Denise <Denise.Hinton fda.hhs. ov> 

ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: Fwd: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Denise 

+ Peter Marks 

In the two paragraphs on IL-7 inhibitors and convalescent plasma, respectively , I recommend replacing the section 

about Reducing/heeding off need for ventilator with : 

"could potentially slow the progression of severe respiratory symptoms" 

Patrizia 

From: Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Date: March 15, 2020 at 4:16:42 PM EDT 

To: Farley, John <John.Farley@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>, Clarke, Mary Beth 

<Ma beth.Clarke fda.hhs. ov> 

Subject: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Hi - sorry for short notice - any input before Michael Felberbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJ I-FOIA-2020-3541 _00001281 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/16/2020 8:22:24 AM 

To: Felberbaum, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4819a643ca 2945cd b la263 lb83e69673-M i cha el. Fel ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND] 

RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Dear Michael, 

Thanks - this looks great. It addresses the issue nicely. 

Best Regards, 

Peter 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Monday, March 16, 2020 8:19 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Subject: RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Thank you, Peter. I will revise the bullet based on your comment to the following: 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Tel 240-402-9548 / Cell 202-906-0229 

michael. fel berbau m@fda. h hs. gov 

U.S. FOOD & DRUG 

A OM It� I SH:A TION 

ocm •· a 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 7:23 AM 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

(b)(5) 

Cc: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Subject: RE: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Dear Denise, 

Please see the attached with one comment. 

Best Regards, 

FDA-OSJI-FOIA-2020-3541_00001424 
Peter 

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov> 

Sent: Monday, March 16, 2020 7:02 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Felberbaum, Michael <Michael.Felberbaum fda.hhs. ov> 

Subject: FW: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Good morning Peter, 

Did you have any comments in addition to Patrizia's? 

Thank you, 

Denise 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Sent: Sunday, March 15, 2020 4:39 PM 

To: Hinton, Denise <Denise.Hinton fda.hhs. ov> 

ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: Fwd: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Denise 

+ Peter Marks 

In the two paragraphs on IL-7 inhibitors and convalescent plasma, respectively , I recommend replacing the section 

about Reducing/heeding off need for ventilator with : 

"could potentially slow the progression of severe respiratory symptoms" 

Patrizia 

From: Hinton, Denise <Denise.Hinton fda.hhs. ov> 

Date: March 15, 2020 at 4:16:42 PM EDT 

To: Farley, John <John.Farley@fda.hhs.gov>, Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>, Clarke, Mary Beth 

<Ma beth.Clarke fda.hhs. ov> 

Subject: Quick response requested: Talking Points on COVID Therapeutics/Vaccines - by 1630 

Hi - sorry for short notice - any input before Michael Felberbaum sends to Dr. Hahn? 

Thanks, 

D 

FDA-OSJI-FOIA-2020-3541_00001425 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 3/16/2020 11:45:17 AM 

To: Jenkins, Charlene [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =0e 722b6438b04d2e9029c7 2543639a6 7-Cha rl ene .Je ]; Copel and, Ja kea 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d7fe05ed233c42b68 be990b 12ae2c8c8-Ja kea. Copel] 

RE: Materials Inquiry: Weekly CBER Meeting with the Commissioner 

Dear Jakea, 

Here is the agenda for Wednesday: 

1) Coronavirus response updates 

a. Blood supply 

b. Convalescent plasma and hyperimmune globulin 

c. Vaccines 

2) Center continuity of operations 

a. Regulatory review 

b. Laboratory research 

c. Policy development 

Best Regards, 

Peter 

From: Jenkins, Charlene <Charlene.Jenkins@fda.hhs.gov> 

Sent: Monday, March 16, 2020 11:15 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: FW: Materials Inquiry: Weekly CBER Meeting with the Commissioner 

FYI 

From: Copeland, Jakea <Jakea.Co ov> 

Sent: Monday, March 16, 2020 11:14 AM 

To: Jenkins, Charlene <Charlene.Jenkins@fda.hhs.gov> 

Cc: Olivarria, Frank <Frank.Olivarria@fda.hhs.gov> 

Subject: Materials Inquiry: Weekly CBER Meeting with the Commissioner 

Good Morning Charlene, 

Does Dr. Marks have any materials/agenda for the weekly CBER meeting with the Commissioner, 

scheduled for Wed, 3/18? If so, please send by 12pm Tues, 3/17. 

Thank you, 

Ja..kuv 

-----Original Appointment-----

From: Sheehy, Janice On Behalf Of Hahn, Stephen 

Sent: Monday, December 30, 2019 11:56 AM 

To: Hahn, Stephen; Lenihan, Keagan; Marks, Peter; Witten, Celia (CBER); Abram, Anna; Shah, Anand; Rom, Colin 

Cc: Tierney, Julia; Tierney, Julia (Julia.Tierney@fda.hhs.gov) 

Subject: Weekly CBER Meeting with the Commissioner 

FDA-OSJI-FOIA-2020-3541_00001422 
When: Wednesday, March 18, 2020 11:00 AM-11:30 AM (UTC-05:00) Eastern Time (US & Canada). 

Where: Commissioner's Office (WOl/2217) 

FDA-OSJI-FOIA-2020-3541_00001423 
From: Copeland, Jakea [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =D7FEOSE D233C42B68BE990B 12AE2C8C8-JAKEA.CO PEL] 

3/16/2020 11:50:27 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Jenkins, Charlene 

[/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =0e 722b6438b04d2e9029c7 2543639a6 7-Cha rl ene .Je] 

Olivarria, Frank [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=c180721db774423f99990dd86e67057c-Frank.Oliva] 

RE: Materials Inquiry: Weekly CBER Meeting with the Commissioner 

Thank you, Dr. Marks. 

jo...k,e,o._, 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 11:45 AM 

To: Jenkins, Charlene <Charlene.Jenkins@fda.hhs.gov>; Copeland, Jakea <Jakea.Copeland@fda.hhs.gov> 

Subject: RE: Materials Inquiry: Weekly CBER Meeting with the Commissioner 

Dear Jakea, 

Here is the agenda for Wednesday: 

1) Coronavirus response updates 

a. Blood supply 

b. Convalescent plasma and hyperimmune globulin 

c. Vaccines 

2) Center continuity of operations 

a. Regulatory review 

b. Laboratory research 

c. Policy development 

Best Regards, 

Peter 

From: Jenkins, Charlene <Charlene.Jenkins@fda.hhs.gov> 

Sent: Monday, March 16, 2020 11:15 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: FW: Materials Inquiry: Weekly CBER Meeting with the Commissioner 

FYI 

From: Copeland, Jakea <Jakea.Co ov> 

Sent: Monday, March 16, 2020 11:14 AM 

To: Jenkins, Charlene <Charlene.Jenkins@fda.hhs.gov> 

Cc: Olivarria, Frank <Frank.Olivarria@fda.hhs.gov> 

Subject: Materials Inquiry: Weekly CBER Meeting with the Commissioner 

Good Morning Charlene, 

FDA-OSJI-FOIA-2020-3541_00001287 
Does Dr. Marks have any materials/agenda for the weekly CBER meeting with the Commissioner, 

scheduled for Wed, 3/18? If so, please send by 12pm Tues, 3/17. 

Thank you, 

Ja..kuv 

-----Original Appointment-----

From: Sheehy, Janice On Behalf Of Hahn, Stephen 

Sent: Monday, December 30, 2019 11:56 AM 

To: Hahn, Stephen; Lenihan, Keagan; Marks, Peter; Witten, Celia (CBER); Abram, Anna; Shah, Anand; Rom, Colin 

Cc: Tierney, Julia; Tierney, Julia (Julia.Tierney fda.hhs.gov) 

Subject: Weekly CBER Meeting with the Commissioner 

When: Wednesday, March 18, 2020 11:00 AM-11:30 AM (UTC-05:00) Eastern Time (US & Canada). 

Where: Commissioner's Office (WOl/2217) 

FDA-OSJI-FOIA-2020-3541_00001288 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 3/16/2020 12:32:00 PM 

To: Guram, Jeet [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =ef73bea97 e2b4 77b84 7 ea302c4 7 30ccf-G u rjeet.G u r ]; Marks, Peter 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445 cb9c9adca3f72df53a-M a rksP]; Sh ah, Anand 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah] 

CC: Patel, Chaitali [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =815d91 f3d5e 143b387acd82539f7 e 149-Cha ita Ii. Pa] 

Subject: RE: Comms today - reminder 

Attachments: NIAID press release mRNA Phase 1 FINAL with numbers.docx 

Attached is the latest draft press release from NIAID - they plan to issue imminently, once they confirm the patient has 

received the vaccine. 

My recommendation would be to draft one or two tweets from the main FDA account, retweeting NI H's messaging 

and link to the press release. If you all are in agreement, I will work with the JIC and OMA to draft and clear. 

Lorrie 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Monday, March 16, 2020 12:01 PM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov> 

Cc: Patel, Chaitali <Chaitali.Patel@fda.hhs.gov> 

Subject: RE: Com ms today - reminder 

That all sounds good - thanks Lorrie 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

Food and Drug Administration 

+1 (202) 230-0451 I jeet.guram@fda.hhs.gov 

U.S. FOOD & DRUG 

ADMINISTRATION 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Monday, March 16, 2020 12:00 PM 

To: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov> 

Cc: Patel, Chaitali <Chaitali.Patel@fda.hhs.gov> 

Subject: RE: Com ms today - reminder 

Hi JeetI will work on that. As Peter notes, our regulations don't allow us to disclose any information about an IND, so I think 

amplifying their com ms is the way to go. We would refer specific questions to NIAID for response. 

I'll circle back ASAP on the draft release. 

FDA-OSJI-FOIA-2020-3541_00001455 
Lorrie 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Monday, March 16, 2020 11:58 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov> 

Cc: Patel, Chaitali <Chaitali.Patel@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeil! fda.hhs. ov> 

Subject: RE: Com ms today - reminder 

Thank you Peter, and Lorrie it's nice to meet you. Lorrie do you know if we will get a copy of NIAi D's announcement 

before it goes out, so we can be prepared to amplify and augment it? 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

Food and Drug Administration 

+1 (202) 230-0451 I jeet.guram@fda.hhs.gov 

U.S. FOOD & DRUG 

A0MIHISTRATION 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 11:56 AM 

To:Shah,Anand<Anand.Shah@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali <Chaitali.Patel@fda.hhs.gov>; McNeil!, Lorrie 

<Lorrie.McNeil! fda.hhs. ov> 

Subject: RE: Com ms today - reminder 

Dear Anand, 

Since this is under IND, we have to wait until NIAID makes an announcement before we can say anything, and even then, 

we will largely defer to them. Copying Lorrie McNeil!, who leads our comms shop. 

Best Regards, 

Peter 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 10:15 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali <Chaitali.Patel@fda.hhs.gov> 

Subject: FW: Comms today - reminder 

Hi PeterPlease see below. 

Can you connect me with folks on your team who may have more info on the vaccine patient? 

We will work with you on the com ms 

Thanks, 

Anand 

From: Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov> 

Sent: Monday, March 16, 2020 7:15 AM 

FDA-OSJI-FOIA-2020-3541_00001456 
To: Hahn, Stephen <SH1@fda.hhs.gov>; Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov> 

Subject: RE: Com ms today - reminder 

Copy sir. Re: blood we connected Peter to ARC through an EOP stakeholder inquiry. He contacted them yesterday. They 

plan to have a larger push on Wed. and he offered them a support video. Anand, can you run the vaccine patient to 

ground? TY. 

From: Hahn, Stephen <SH1@fda.hhs.gov> 

Sent: Monday, March 16, 2020 7:12 AM 

To: Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Shah, 

Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Rom, Colin 

<Colin.Rom@fda.hhs.gov> 

Subject: Com ms today - reminder 

Need comms today about first vaccine patient and our role. Also blood donation and diagnostics 

FDA-OSJI-FOIA-2020-3541_00001457 
From: Guram, Jeet [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN =EF73BEA97E2B4 77 B84 7EA302C4 730CCF-G U RJ E ET.GU R] 

Sent: 3/16/2020 3:23:32 PM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Sh ah, Anand 

[/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah] 

Patel, Chaitali [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =815d91 f3d5e 143b387acd82539f7 e 149-Cha ita Ii. Pa]; Zeta, Lowe I I 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =9c0fc7 eb68244f4cb4260898d5dacad b-Lowel I .Zeta] 

Subject: RE: FDA leg reque�s 

Perfect - Chaitali just sent an invite for 4-4:30pm today 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

Food and Drug Administration 

+1 (202) 230-0451 I jeet.guram@fda.hhs.gov 

U.S. FOOD & DRUG 

ADMINISTRATION 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Monday, March 16, 2020 1:35 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali <Chaitali.Patel@fda.hhs.gov>; Zeta, Lowell 

<Lowell .Zeta@fda.hhs.gov> 

Subject: RE: FDA leg requests 

Dear Anand, 

Sure. between 4 and 5 would be best, but will do what I need to free up before if need be. 

Best Regards, 

Peter 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 1:21 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali <Chaitali.Patel@fda.hhs.gov>; Zeta, Lowell 

<Lowell.Zeta@fda.hhs.gov> 

Subject: FW: FDA leg requests 

Importance: High 

Hi PeterCan you join a call with the White House (to be scheduled as early as later today) on COVID-19 vaccines and i {b ){ 5) 

(b)(5) !We'll need your team's expertise. Please see the note below and two attachments. 

FDA-OSJI-FOIA-2020-3541_00001283 
It might be helpful to connect for 10 minutes beforehand so that we are coordinated from FDA. 

Thanks very much 

Anand 

PRE-DECISIONAL, CONFIDENTIAL 

From: Amin, Stacy <Stacy.Amin@fda.hhs.gov> 

Sent: Monday, March 16 2020 12:20 PM 

To: Paul Ray - 0MB i (b)(6) i Shah, Anand <Anand.Shah@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov> 

Subject: FDA leg requests 

Importance: High 

Anand -i 

Paul -- attached are FDA's leg requests] 

***************************************** 

Stacy Cline Amin 

Chief Counsel 

Food and Drug Administration 

Deputy General Counsel 

Department of Health and Human Services 

(b)(5) 

(b)(5) 

(b)(5) 

(b)(5) 

FDA-OSJI-FOIA-2020-3541_00001284 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/19/2020 9:29:18 AM 

To: McNeil!, Lorrie [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en= 77b0b352c9c2485 lbf0c7330f53e00d9-M cN eil I] 

RE: Statement/Communication requested about COVID Vaccine meeting 

Dear Lorrie, 

Marion is apparently working on this with Ritu. Just let me know what you need. 

Best Regards, 

Peter 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:39 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov> 

Subject: FW: Statement/Communication requested about COVID Vaccine meeting 

Good morning - please see the emails below regarding the ICMRA meeting yesterday. Would welcome thoughts on 

best approach on this. I think we could develop tweets and retweet EMA's statement, which doesn't say much. 

Thanks -

Lorrie 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:33 AM 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov> 

Subject: Statement/Communication requested about COVID Vaccine meeting 

Yesterday the International Coalition of Medicines Regulatory Authorities held a virtual international workshop, cochaired by the EMA and FDA, on the development of vaccines against COVID-19. The EMA subsequently put out a brief 

statement about the meeting, which you can see in the link below. My folks would like us to put out something as well. 

We could mirror the EMA statement, or even post it, as we have done in the past, although I think more information 

could be added. Could we do something like this today? At the very least, I will look for the statement on Twitter and 

will retweet it. 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 7:32 AM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce <Bruce.Ross@fda.hhs.gov>; Klein, Vashti* 

<Vashti.Klein@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber@fda.hhs.gov>; Kweder, Sandra L <Sandra.Kweder@fda.hhs.gov> 

Subject: COVID vaccines meeting -- request to post FDA statement 

FDA-OSJI-FOIA-2020-3541_00001426 
Hi Karen - Re: COVID vaccine global regulators meeting yesterday -- we'd like to do an FDA posting to piggy back on this 

EMA statement: 

https ://www.ema.eu ropa .eu/ en/ news/ti rst-regu la to ry-workshop-covid-19-faci I itates-glo ba I-co 11 a bo ration-vaccinedevelo pment 

Peter Marks is fine with moving ahead with this as a joint EMA-FDA statement so I think best to use the same wording 

from EMA's statement. 

I've copied CBER leads and they can help if any questions and also consider if you have other suggestions for PR. We'll 

definitely add a blurb in OGPS' next monthly distribution. 

Thanks, 

Ritu 

FDA-OSJI-FOIA-2020-3541_00001427 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/19/2020 12:29:33 PM 

To: Nalubola, Ritu [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =3103228e5eba458f9c2aa la846d25c7 c-PN a I u bol] 

RE: Statement/Communication requested about COVID Vaccine meeting 

Dear Ritu, 

Sorry- this was not your issue at all, but one on my end. Thanks for all of your help with this. 

Best Regards, 

Peter 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 9:32 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

Sure, Peter, will do. Apologies! 

I thought I got the direction from you and so moved ahead per your concurrence - with Marion on drafting cable and 

within OGPS on FDA statement with cc to your staff -just didn't want to inundate you with further staff-level back-forth. 

I'll continue to keep you in cc. 

Best regards, 

Ritu 

From: Marks, Peter 

Sent: Thursday, March 19, 2020 2:25 PM 

To: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Subject: FW: Statement/Communication requested about COVID Vaccine meeting 

Dear Ritu, 

I am fine with having you proceed as you are planning, 

but the future please do not remove me from a communication stream when you contact my content experts. 

Best Regards, 

Peter 

From: Gruber, Marion <Marion.Gruber@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:48 AM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov>; Hess, Maureen <Maureen.Hess@fda.hhs.gov> 

Subject: RE: Statement/Communication requested about COVID Vaccine meeting 

I just got off the phone with Ritu and they are doing a State dept cable. I will work with her on 

language so that we get at least that one right. We could use similar language if we are to 

FDA-OSJI-FOIA-2020-3541_00001419 
communicate as I think we should. I am not in favor of retweeting EMA's statement as we can 

do better than that. 

Marion 

From: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:39 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Gruber, Marion <Marion.Gruber@fda.hhs.gov>; Cho, David S (CBER) 

<David.Cho@fda.hhs.gov>; Rouse, David <David.Rouse@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Bartell, Diane <Diane.Bartell@fda.hhs.gov>; Richards, Paul 

<Paul.Richards@fda.hhs.gov> 

Subject: FW: Statement/Communication requested about COVID Vaccine meeting 

Good morning - please see the emails below regarding the ICMRA meeting yesterday. Would welcome thoughts on 

best approach on this. I think we could develop tweets and retweet EMA's statement, which doesn't say much. 

Thanks -

Lorrie 

From: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 8:33 AM 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov> 

Subject: Statement/Communication requested about COVID Vaccine meeting 

Yesterday the International Coalition of Medicines Regulatory Authorities held a virtual international workshop, cochaired by the EMA and FDA, on the development of vaccines against COVID-19. The EMA subsequently put out a brief 

statement about the meeting, which you can see in the link below. My folks would like us to put out something as well. 

We could mirror the EMA statement, or even post it, as we have done in the past, although I think more information 

could be added. Could we do something like this today? At the very least, I will look for the statement on Twitter and 

will retweet it. 

From: Nalubola, Ritu <Ritu.Nalubola@fda.hhs.gov> 

Sent: Thursday, March 19, 2020 7:32 AM 

To: Riley, Karen <Karen.Riley@fda.hhs.gov> 

Cc: Abdoo, Mark <Mark.Abdoo@fda.hhs.gov>; Ross, Bruce <Bruce.Ross@fda.hhs.gov>; Klein, Vashti* 

<Vashti.Klein@fda.hhs.gov>; Blair, Joan W. (CBER) <Joan.Blair@fda.hhs.gov>; Gruber, Marion 

<Marion.Gruber@fda.hhs.gov>; Kweder, Sandra L <Sandra.Kweder@fda.hhs.gov> 

Subject: COVID vaccines meeting -- request to post FDA statement 

Hi Karen - Re: COVID vaccine global regulators meeting yesterday -- we'd like to do an FDA posting to piggy back on this 

EMA statement: 

https ://www.ema.eu ropa .eu/ en/ news/fi rst-regu la to ry-workshop-covid-19-faci I itates-glo ba I-co 11 a bo ration-vaccinedevelo pment 

Peter Marks is fine with moving ahead with this as a joint EMA-FDA statement so I think best to use the same wording 

from EMA's statement. 

FDA-OSJI-FOIA-2020-3541_00001420 
I've copied CBER leads and they can help if any questions and also consider if you have other suggestions for PR. We'll 

definitely add a blurb in OGPS' next monthly distribution. 

Thanks, 

Ritu 

FDA-OSJI-FOIA-2020-3541_00001421 
From: Schiller, Lowell [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=77949B06919E4F91AA788E9A616CS0C7-LOWELL.SCHI] 

Sent: 3/20/2020 11:19:58 AM 

To: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP]; Lenihan, Keaga n 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Shah, Anand 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e2172ebbd 96946c08e 189fd612855f51-Ana nd .Shah]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =98606928b9a64edfb25a ba le35 73fdfe-Era nders ]; Amin, Stacy 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=cb3764b7438648838c22881a06fc6afb-Stacy.Amin]; Tierney, Julia 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern] 

RE: COVID-19 request for assistance re: human convalescent plasma (HCP) therapy -- on behalf of Baylor College of 

Medicine and Johns Hopkins University 

Will loop you and Anand into the original thread now 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:16 AM 

To: Schiller, Lowell <Lowell.Schiller@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; 

Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Subject: RE: COVID-19 request for assistance re: human convalescent plasma (HCP) therapy -- on behalf of Baylor 

College of Medicine and Johns Hopkins University 

Dear 

Anand and Lowell, 

Can you please connect the lead person people who want to have a discussion with me? We recognize some of the 

investigators listed here and I am very concerned that there is not a full understanding of what the USG effort is and 

about how they should best proceed here, but we can help guide them. We should avoid cross purposes here. Thanks. 

Best Regards, 

Peter 

From: Schiller, Lowell <Lowell.Schiller@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:05 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Anderson, Erika 

<Erika.Anderson@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; 

Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Subject: FW: COVID-19 request for assistance re: human convalescent plasma (HCP) therapy -- on behalf of Baylor 

College of Medicine and Johns Hopkins University 

Thoughts on this request? 

From: Stephen Northrup <snorthrup@rampynorthrup.com> 

Sent: Friday, March 20, 2020 10:59 AM 

To: Anna Abram <anna abram@help.senate.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Schiller, Lowell 

<Lowell.Schiller@fda.hhs.gov> 

FDA-OSJI-FOIA-2020-3541_00001262 
Cc: Cybele Bjorklund <cbjorklund@jhu.edu>; Herb Butrum <butrum@bcm.edu>; Christopher Austin 

<chris.austin@jhu.edu> 

Subject: COVID-19 request for assistance re: human convalescent plasma (HCP) therapy -- on behalf of Baylor College of 

Medicine and Johns Hopkins University 

Anna, Keagan, Lowell -- I'm writing on behalf of Dr. Peter Hotez at Baylor College of Medicine and Dr. Arturo Casadevall 

at Johns Hopkins University about their efforts to advance human convalescent plasma (HCP) as a therapeutic option for 

the COVID-19 pandemic. I've copied Cybele Bjorklund and Chris Austin at JHU and also Herb Butrum at BCM. 

You're familiar with this option, I'm sure, considering Commissioner Hahn's comments yesterday. 

You may also know that JHU submitted an IND that arrived this morning at FDA, and there are close to 20 leading 

institutions now involved in the discussions about HCP therapy across the USA. These are all institutions of national 

significance, including Johns Hopkins University, Baylor College of Medicine, Duke University, Einstein Medical Center, 

Mayo Clinic, Michigan State University, University of Maryland, Loyola University Chicago, University of California, 

University of Washington, Massachusetts General Hospital, Children's Hospital of Philadelphia, University of Pittsburgh, 

Cedars-Sinai Medical Center, and Stanford University 

Ors. Hotez and Casadevall have asked us to contact people in the senior agency leadership to make you aware of this 

effort, to ensure that Commissioner Hahn is aware of this effort, and to identify someone at a senior level who might be 

willing to be a stand-by source of assistance and guidance for them. 

I thought one of you might be able to identify the right person or people who could be that go-to resource. 

Please advise as to how you would recommend proceeding, and thanks for your attention to this request and for 

everything you are doing right now to fight this pandemic. 

A detailed article on this effort is pasted below, from the Milwaukee Journal-Sentinel. 

Best regards, 

Steve 

Stephen Northrup 

Rampy Northrup LLC 

mobile:i (b)(6) 

https://www.jsonline.com/story/news/2020/03/ l 8/coronavirus-treatment-emer bency-clinical-trial s-plasmarequested/2865766001/ 

Possible coronavirus treatment could be in 

clinical trials within weeks, using plasma from 

recovered patients, if doctors get FDA approval 

Mark JohnsonUpdated 6:55 p.m. CT March 18, 2020 

FDA-OSJI-FOIA-2020-3541_00001263 
The Johns Hopkins University doctor coordinating a nationwide effort to launch emergency clinical 

trials of plasma from patients who've recovered from coronavirus said he expects to forward a plan 

to the U.S. Food & Drug Administration Wednesday and to trc"

'?',ut,Hr;,F,"" pane:ms in about four 

weeks. 

"We are in an emergency and this is the only thing we have," said Arturo Casadevall, chairman of 

Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health in 

Baltimore. 

"This won't help patients who are sick today, but it will help the patients who become sick in the next 

two to five weeks," he said. 

The time frame he described would still allow hospitals to begin testing the possible treatment before 

the new coronavirus peaks in the U.S., possibly a few months from now. Transfusions of plasma from 

recovered patients carry potential side effects, including fever, allergic reaction and a very small risk of 

infectious disease transmission. 

Casadevall said the centers that take part in the clinical trial will need approval from both the FDA and 

their own institutional review boards, groups established to protect the rights of human research 

subjects. 

Treating people with plasma from a recovered patient was first used more than a century ago to save a 

child with diphtheria and has since been used to stifle numerous outbreaks of disease. The process 

would involve taking plasma, rich in virus-fighting antibodies, from patients who have recovered from 

COVID-19. That plasma would then be transfused into patients who are still sick with the disease. 

Casadevall and Liise-anne Pirofski, of the Albert Einstein College of Medicine in New York, triggered 

the push for clinical trials when they co-authored a paper published Friday in The Journal of Clinical 

Investigation. The two urged "that institutions consider the emergency use ( of plasma from recovered 

patients) and begin preparations as soon as possible. Time is of the essence." 

On Tuesday, Pirofski told the Milwaukee Journal Sentinel: "The need for this is dire. One day for those 

involved (in caring for the sick) is like a year." 

Pirofski, chief of the division of infectious diseases at Montefiore Medical Center - the teaching 

hospital associated with Einstein College - which consists of 11 hospitals, described the situation 

where she works: 

"Monday we had ( a total of) 18 patients in our center, all very sick. Today we have 10 new patients." 

She described doctors coping with shortages of basic supplies and feeling overwhelmed, experiences 

echoed by other medical staff working in viral hot spots around the world. 

"There is no personal protective equipment anywhere," she said. "We are running out. We took all of 

our medical students off the ward to avoid using up PP Es ... It's just demoralizing and there is no end in 

sight." 

She said doctors have two possible paths they can follow in using plasma from recovered patients. 

They can test it in clinical trials. They can also use it as an experimental "compassionate use" treatment 

for some of the sickest patients, as was done during the 2009 swine flu, the 2013 West African Ebola 

epidemic, and the early stages of the COVID-19 outbreak in China. 

FDA-OSJI-FOIA-2020-3541_00001264 
"It's been used in China but there is just one small press release on it," Pirofski said. "We have not seen 

that data. We're all very anxious to see the results." 

100 to 150 patients, divided in half 

Experimental use would require that doctors find recovered COVID-19 patients with high antibody 

levels who are willing to serve as donors. Antibodies are blood proteins that are made by the body's 

immune system in response to bacteria, viruses and other foreign invaders. 

Casadevall said he favors starting clinical trials of plasma from recovered patients, rather than using it 

experimentally. 

Although plasma from recovered patients has been used to quell outbreaks of poliomyelitis, measles, 

mumps and influenza, the plasma of a COVID-19 survivor is something new. FDA would consider 

that plasma an investigational drug, meaning that it has been tested in the lab and is ready to be tested 

in people. 

Survivor plasma, Pirofski said, "has not been ( extensively tested) for this disease before, and the 

compound we'd be getting is new." 

The basic setup for a clinical trial could involve 100 to 150 COVID-19 patients with half 

receiving serum from recovered patients, and the other half serving as a control group and receiving 

serum from patients who have never had COVID-19. 

Casadevall said the trials could be used to test different groups who have been infected with the virus. 

One trial would test the use of survivor plasma on people who have been exposed to virus - likely 

doctors, nurses, emergency room staff and other first-responders. This group would include family 

members who have been at home caring for a loved one with COVID-19. 

A second test of survivor plasma would involve patients who have been hospitalized with COVID-19, 

and are continuing to grow sicker. 

A third test would involve severely ill COVID-19 patients. 

Each of these tests has the potential to answer a different question: 

• Can the plasma from recovered patients be used to prevent someone who has been exposed from 

coming down with the illness? 

• Does the plasma have the ability to reverse the course of a patient whose health is declining? 

• Can the plasma rescue a patient who has reached a very late stage of the illness? 

"This is a good story in the midst of terrible news," said Casadevall, explaining how the paper he wrote 

with Pirofski led to the impromptu formation of a network of more than I 00 doctors across the 

country. 

The doctors have been discussing ways of collaborating to launch clinical trials of what appears to be 

the most immediate hope for treating COVID-19 patients. Various centers are being discussed as 

possible sites for the trials. The New York Blood Center is also partnering on the project, said 

Casadevall. 

"If Johns Hopkins is ready to go, we'd very interested to see what they find," said Jeff Pothof, chief 

quality officer at UW Health in Madison. "I think we should do it quickly." 

Casadevall agreed. 

FDA-OSJI-FOIA-2020-3541_00001265 
With a growing number of health care workers contracting the disease, "they're beginning to see the 

collapse of the healthcare system," he said. 

"The problem in the U.S. is that something like this has never happened. In 1918 (during the Spanish 

flu) there was no FDA. There was no Centers of Disease Control and Prevention." 

Casadevall urged the federal government to designate a point person for COVID-19 who would be 

knowledgeable enough to help hospitals and cities overcome logistical and other hurdles. 

For example, he said, "Say Milwaukee needs serum and New York has it." 

The "point person" could arrange coordination between different parts of the country that are in 

different stages of the pandemic. 

Mark Johnson has written in-depth stories about health, science and research for the Journal Sentinel since 2000. He is a three-time 

Pulitzer Prize finalist and, in addition, was part of a team that won the 2011 Pulitzer Prize in Explanatory Reporting for a series of 

reports on the groundbreaking use of genetic technology to save a 4-year-old boy. 

Email him at 111ar/.::.1ohnson'a ,rn.co111; follow him on Twitter:"Oma;ohnso. 

FDA-OSJI-FOIA-2020-3541_00001266 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

Sent: 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

3/20/2020 12:40:52 PM 

To: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =dfbb2b5bd38445cb9c9adca3f72df53a-M a rksP] 

RE: Per our conversation ... 

Hi PeterWill pull something together soonest for your review. 

Thanks! 

Lorrie 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:39 PM 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Subject: FW: Per our conversation ... 

Dear Lorrie, 

Can we dust off some of the Ebola/Zika/PanFlu TPs to address some of the questions below? Would aim for early next 

week to have something together. 

Best Regards, 

Peter 

From: Marks, Peter 

Sent: Friday, March 20, 2020 12:38 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Dear Anand, 

Thanks for the heads up on these. We have had to address very similar questions during previous outbreak. Granted, 

they were not on this scale, but the concepts are all there. We are prepared to respond and this weekend will freshen 

up the responses that we put together for previous outbreaks. 

Best Regards, 

Peter 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:23 PM 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shuren, Jeff 

<Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Hi Michael -

FDA-OSJI-FOIA-2020-3541_00001272 
Thanks for sharing these potential questions. I've included Janet, Peter, and Jeff here for their thoughts. I agree it would 

be helpful for us to carefully think through these questions and, whenever possible, have a coordinated approach to 

incoming questions from stakeholders including media. 

Anand 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:18 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Subject: Per our conversation ... 

Thanks for the chat. Here are the questions I think we need to be prepared to answer on this topic. Feel free to add to 

this list and let me know if you want to relay to Janet or others. 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Tel 240-402-9548 / Cell] (b)(6) i 

michael. fel berbau m@fda.'fifis�gov·-·-·-·-·-·-·-·' 

U.S. FOOD &. DRUG 

A l)M r N t$TA:4 TION 

DCllZl ·· II 

FDA-OSJI-FOIA-2020-3541_00001273 
From: McNeil!, Lorrie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDI BO HF 23SPDL T)/CN =RE Cl Pl ENTS/CN = 77B0B352C9C24851BF0C7330F53EO0D9-MCN EI LL] 

Sent: 3/22/2020 9:01:58 PM 

To: Marks, Peter [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4cl fbf7 cb4c ld287f83e-ChoD ]; Rouse, David 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =185ba e 767 862490d88eda44d b 7 4a 7 5b3-RouseD ]; Tierney, Ju I ia 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Reci pi ents/ en= 1160d300bc4248b 790ded292a082e9a8-J u Ii a .Tiern] 

Frantz-Bohn, Susan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =4c4a 1082 lc77 4 ffa9c5cf59bda6bcf75-fra ntz _ boh n]; Maloney, Di a ne 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD] 

RE: COVID-19 MCM Accelerator Webpage Content 

Thanks Peter! I have the daily JIC call at 9:30, and then am free from 10:30 to 1:30pm. Also free before 9:30 

(anytime after 7:30am). 

Lorrie 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Date: March 22, 2020 at 7:36:20 PM EDT 

To: McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov>, Cho, David S (CBER) <David.Cho@fda.hhs.gov>, Rouse, 

David <David.Rouse@fda.hhs.gov>, Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>, Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Subject: RE: COVID-19 MCM Accelerator Webpage Content 

Dear Lorrie, 

Will give you a call, but see at least: 

1. Vaccines 

2. Convalescent plasma 

3. Hyperimmune globulin 

As things that we might be able to discuss. Will be good to touch bases live. 

Best Regards, 

Peter 

From: McNeill, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Sent: Sunday, March 22, 2020 4:50 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cho, David S (CBER) <David.Cho@fda.hhs.gov>; Rouse, 

David <David.Rouse@fda.hhs.gov>; Tierney, Julia <Julia. Tierney@fda.hhs.gov> 

FDA-OSJI-FOIA-2020-3541_0000127 4 
Cc: Frantz-Bohn, Susan <Susan.Frantzbohn@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Subject: FW: COVID-19 MCM Accelerator Webpage Content 

Hi all - please see the email below. I'm not sure what was discussed, so wanted to check to see what thoughts 

folks have on what could be included. I think we could include the efforts on convalescent plasma (to develop a 

master protocol?), and expediting discussions with sponsors of potential SARS-Co V-2 vaccines. 

Welcome thoughts on content CBER could provide. Thanks much! 

Lorrie 

From: Felberbaum, Michael <Michael.F elberbaum@fda.hhs.gov> 

Sent: Sunday, March 22, 2020 2:40 PM 

To: Choe, Lena <Lena.Choe@fda.hhs.gov>; Rawlings, Kimberly <Kimberly.Rawlings@fda.hhs.gov>; 

McNeill, Lorrie <Lorrie.McNeill@fda.hhs.gov>; MacLennan, Lori <Lori.MacLennan@fda.hhs.gov>; Pagan 

Motta, Monica <Monica.PaganMotta@fda.hhs.gov>; Schulken, Susan <Susan.Schulken@fda.hhs.gov> 

Cc: Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Elicker, Janet <Janet.Elicker@fda.hhs.gov>; 

Mulieri, Chris <Charles.Mulieri@fda.hhs.gov>; Finnen, April <April.Finnen@fda.hhs.gov>; Dooren, Jennifer 

<Jennifer.Dooren@fda.hhs.gov> 

Subject: COVID-19 MCM Accelerator Webpage Content 

Hi all -

Stemming from a conversation with CDER, CBER and CDRH leadership - they want to create a webpage that 

contains a rundown of all the work we're doing to accelerate medical countermeasures - therapeutics, etc. It 

sounded like at least some of the center leadership had already tasked their comms shops with pulling this web 

content together. I just wanted to check in to see who had already begun work and, if not, if you could please 

check in with center leadership on this request? 

Can the centers please provide an update on their efforts and anticipated timelines? I think they were looking to 

have something posted mid-week or sooner. 

Thanks, 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Ad,

ministration _______ 0 Tel 240-402-9548 / CellL_ ______ jb)(6) ______ _! michael. fel berbau m@fda. h hs. gov 

FDA-OSJI-FOIA-2020-3541_00001275 
FDA-OSJI-FOIA-2020-3541_00001276 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/23/2020 7:14:03 AM 

To: lorrie.mcneill@fda.hhs.gov 

Subject: FW: Per our conversation ... 

Dear Lorrie, 

Can you/OCOD help here with a draft that could help add to/edit? I think that the JIC is not going to be able to handle 

this effectively. Thanks. 

Best Regards, 

Peter 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Sunday, March 22, 2020 10:15 PM 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Hi PeterWe may now have a reporter (or two) asking some of these questions. Whenever you're able to share the responses 

from previous outbreaks, Michael and I will get these into Share Point for the Centers to review together. Thanks very 

much. 

Anand 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 20, 2020 2:45 PM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov> 

Cc: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

We may have answered similar questions in the past, but I think we should consider these responses in context of this 

pandemic and the political sensitivities. Appreciate working with this group on responses. I'm happy to build out based 

on anything Peter shares but will certainly need your collective expertise on the specific scientific considerations. Thanks 

all. 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Friday, March 20, 2020 2:16 PM 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shah, Anand 

<Anand.Shah@fda.hhs.gov> 

Cc: Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Well I would think that OEA would have responses to many of these from before. As I said, most of these issues are 

recurring. jw 

FDA-OSJI-FOIA-2020-3541_00001412 
From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:55 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Thank you Peter and Janet. 

Janet - I appreciate the offer to speak with press on this topic (and we'll likely need that) but would also like to build out 

the responses to these questions so that we are all talking about this the same way across the agency - and in those 

instances where we can't schedule time to speak with media or others. It sounds like Peter will be freshening up 

previous responses and we can use that as a starting point (feel free to propose responses for the questions below). 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug Administration 

Tel 240-402-9548 / Celi (b)(6) ! 

michael. fel berbau m@fda. h hs. gov·-·-·-·-·-·-· 

U.S. FOOD & DRUG 

AtHJltN t$TU,110N 

Drlt:l .. II 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:38 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Dear Anand, 

Thanks for the heads up on these. We have had to address very similar questions during previous outbreak. Granted, 

they were not on this scale, but the concepts are all there. We are prepared to respond and this weekend will freshen 

up the responses that we put together for previous outbreaks. 

Best Regards, 

Peter 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:23 PM 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shuren, Jeff 

<Jeff.Shuren@fda.hhs.gov> 

Subject: RE: Per our conversation ... 

Hi Michael -

FDA-OSJI-FOIA-2020-3541_00001413 
Thanks for sharing these potential questions. I've included Janet, Peter, and Jeff here for their thoughts. I agree it would 

be helpful for us to carefully think through these questions and, whenever possible, have a coordinated approach to 

incoming questions from stakeholders including media. 

Anand 

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:18 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Subject: Per our conversation ... 

Thanks for the chat. Here are the questions I think we need to be prepared to answer on this topic. Feel free to add to 

this list and let me know if you want to relay to Janet or others. 

Michael 

Michael Felberbaum 

Senior Advisor 

Office of Media Affairs 

Office of External Affairs 

U.S. Food and Drug A&nini<;J-r.atinn. ______ , 

Tel 240-402-9548 / Celi_ _________ (b)(6) ·-·-·-·-· I 

michael. fel berbau m@fda. h hs. gov 

U.S. FOOD &. DRUG 

A l)M r N t$TA:4 TION 

DCllZl ·· II 

FDA-OSJI-FOIA-2020-3541_00001414 
From: 

Sent: 

To: 

Subject: 

Dear Maarika, 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/24/2020 1:30:36 PM 

Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Kimbrel I, Maa rika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =6ae656d4e8 le44249270b416fle2e203-M aa ri ka. Kim]; Fl a nag an, Keith 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =15dcaa b5clea4007ad bc43e9acd413a6-Keith. Fla na ]; Tierney, Ju Ii a 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern] 

RE: Time Sensitive: WH + CTAP 

Completely agree with Janet - #'s 3, 4, 5 look best. 

Best Regards, 

Peter 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 1:23 PM 

To: Kimbrell, Maarika <Maarika.Kimbrell@fda.hhs.gov>; Flanagan, Keith <Keith.Flanagan@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: Time Sensitive: WH + CTAP 

Ok these are pretty bland. I'm OK with them, #3, 4 and 5 might be best. I had sent suggestions yesterday. jw 

From: Kimbrell, Maarika <Maarika.Kimbrell@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 1:12 PM 

To: Flanagan, Keith <Keith.Flana an fda.hhs. ov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Woodcock, Janet 

<Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: Time Sensitive: WH + CTAP 

Janet, Peter, Keith: 

Let us know if these work for you all or if you have comments: 

Draft Tweets: 

FDA-OSJI-FOIA-2020-3541_00001394 
From: Flanagan, Keith <Keith.Flana an fda.hhs. ov> 

Sent: Tuesday, March 24, 2020 1:02 PM 

To: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Kimbrell, Maarika 

<Maarika.Kimbrell@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: Time Sensitive: WH + CTAP 

Julie, send a short blurb to Maarika and she can plug it in to a CDER-CBER comm 

From: Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Date: March 24, 2020 at 12:47:00 PM EDT 

To: Flanagan, Keith <Keith.Flana an fda.hhs. ov>, Woodcock, Janet <Janet.Woodcock 

Maarika <Maarika.Kimbrell fda.hhs. ov>, Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: Time Sensitive: WH + CTAP 

Yes, I think we would want to. Maarika/Keith, please feel free to give me a call to work through. Do you want me to 

take a stab at a tweet specific to CBER therapeutics? 

From: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 12:41 PM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Kimbrell, Maarika <Maarika.Kimbrell 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Subject: Time Sensitive: WH + CTAP 

Keagan needs something to feed the beast today. Maarika, please send JW the draft top line message, 2-3 Tweets 

worth: Announcement of CTAP plus ~3 top line, short bullets re what CTAP does. 

Flagging for Julie in case CBER wants in. 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Date: March 24, 2020 at 12:27:54 PM EDT 

To: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Subject: RE: Accelerator Program 

(b)(6) 

From: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 12:20 PM 

FDA-OSJI-FOIA-2020-3541_00001395 
To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Subject: RE: Accelerator Program 

Adding Jeet, who I briefed re this. 

From: Flanagan, Keith <Keith.Flana an fda.hhs. ov> 

Date: March 24, 2020 at 12:18:24 PM EDT 

To: Lenihan, Keagan <Kea an.Lenihan 

Subject: RE: Accelerator Program 

Keagan, what's your phone#? 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Date: March 24, 2020 at 12:17:03 PM EDT 

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>, Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov>, Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>, Flanagan, Keith 

<Keith.Flanagan@fda.hhs.gov> 

Cc: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Subject: RE: Accelerator Program 

Please direct inquiries to Keith Flanagan. He is CDER's lead on this part. He told me we will have something before the 

end of the week. jw 

From: Felberbaum, Michael <Michael.Felberbaum 

Sent: Tuesday, March 24, 2020 11:36 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov> 

Cc: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Subject: RE: Accelerator Program 

We are happy to support, but need content to from the centers to build from. 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 11:30 AM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Shuren, Jeff 

<Jeff.Shuren@fda.hhs.gov> 

Cc: Caccamo, Stephanie <Ste hanie.Caccomo ov>; Felberbaum, Michael <Michael.Felberbaum ov> 

Subject: Accelerator Program 

Hi AllWH is really looking for us to get this out soon. I know everyone has a ton on their plates, but is there anything we could 

message up and show we are already doing this and just call it the work? 

FDA-OSJI-FOIA-2020-3541_00001396 
From: 

Sent: 

Flanagan, Keith [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=15DCAAB5C1EA4007ADBC43E9ACD413A6-KEITH.FLANA] 

3/24/2020 2:58:13 PM 

To: Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =dfbb2b5bd38445cb9c9adca3 f72df53a-M a rksP]; Kimbrel I, Maa rika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =6ae656d4e8 le44249270b416fle2e203-M aa ri ka. Kim]; Tierney, Julia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded292a082e9a8-J u Ii a .Tiern] 

Fwd: PER YOUR REQUEST - CTAP Blurb 

FYI 

From: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov> 

Date: March 24, 2020 at 2:57:31 PM EDT 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Subject: RE: PER YOUR REQUEST - CTAP Blurb 

Sorry I don't know when website launches. Working on that. 

I bet we could issue a more polished, aggressive description of the CTAP by end of this week or first thing next 

week. Why the delay? Because it's a real program, not a cosmetic gesture. We are working at full tilt to make 

sure we can do what we promise. This blurb was sort of a placeholder. 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Date: March 24, 2020 at 2:46:08 PM EDT 

To: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov> 

Subject: RE: PER YOUR REQUEST - CTAP Blurb 

When is the website launching and what else do you expect to put out this week? 

From: Flanagan, Keith <Keith.Flanagan@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 2:23 PM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Kimbrell, Maarika 

<Maarika.Kimbrell@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Subject: PER YOUR REQUEST - CTAP Blurb 

Hi Keagan -

Attached please find announcement of CTAP and gist of what it does. 

I'm your point of contact for any questions, etc. 

Kind regards, 

Keith 

FDA-OSJI-FOIA-2020-3541_00001219 
From: Kimbrell, Maarika <Maarika.Kimbrell@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 1:52 PM 

To: Flanagan, Keith <Keith.Flana an fda.hhs. ov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Subject: Draft CTAP Tweets 

Maarika Kimbrell, J.D., M.S. 

Deputy Director. Office of New Drug Policy 

Center for Drug Evaluation and Research 

Office of New Drugs 

U.S. Food and Drug Administration 

Tel 240-402-5924 

maarika.kimbrell@fda.hhs.gov 

U.S. FOOD & !DRUG 

ADMINISTRATION 

FDA-OSJI-FOIA-2020-3541_00001220 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/25/2020 8:00:12 AM 

To: Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern] 

RE: Expanded Mesenchymal Stem Cells May Offer Hope for COVID-19 Patients 

Dear Julie, 

Let's sequence our comms and energy: 

Thursday: Convalescent Plasma and Hyperimmune Globulins 

Friday or Monday: Deferral changes 

Tuesday or Wednesday: Stem cell treatments 

Best Regards, 

Peter 

From: Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 10:42 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: FW: Expanded Mesenchymal Stem Cells May Offer Hope for COVID-19 Patients 

FYI and I think we need to get something on the web post haste and we can leverage that language. 

From: Rath, Prakash (FDA) <Prakash.Rath@fda.hhs.gov> 

Sent: Tuesday, March 24, 2020 10:29 AM 

To: OC OCOD Contacts <0COCODContacts@fda.hhs.gov>; Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov> 

Cc: OC OL CBER/CDRH Team <0COLCBERCDRHTeam@fda.hhs.gov> 

Subject: FW: Expanded Mesenchymal Stem Cells May Offer Hope for COVID-19 Patients 

Hi all, 

Please see the message and attachment from Sen. Paul's office. This looks like an fyi, but I would like to respond to the 

office with some messaging, perhaps sending the treatment outreach from last week. https://www.fda.gov/newsevents/press-a n no u ncements/ co ronavi rus-covid-19-update-fda-co nti n ues-facil itate-develo pment-treatm ents 

Is there anything more specific I can or should say regarding the stem cell aspect? Please let me know by this afternoon. 

Thanks, 

Prakash 

From: Bennett, Zach (Paul) <Zach Bennett@paul.senate.gov> 

Sent: Tuesday, March 24, 2020 9:50 AM 

To: Schwarcz, Cristi L. (CDC/OD/CDCWO) <zcil@cdc.gov> 

Cc: Arbes, Sarah (HHS/ASL) <Sarah.Arbes@hhs.gov>; Gross, Karas (FDA/OC) <Karas.Gross@fda.hhs.gov> 

Subject: FW: Expanded Mesenchymal Stem Cells May Offer Hope for COVID-19 Patients 

FDA-OSJI-FOIA-2020-3541_00001389 
Good morning, 

Please see the attached press release, which contains links to a journal article (and related materials) 

published in the Pain Physician about the use of umbilical cord mesenchymal stem cells in critical COVID-19 

cases to reduce morbidity and mortality. If this is an avenue the agency wishes to explore, please reach out 

directly to the article's author, Dr. Laxmaiah Manchikanti, M.D. His contact information is in the e-mail 

forwarded below. 

Thanks for all the work you're doing, 

Zach Bennett 

Legislative Counsel 

U.S. Senator Rand Paul, M.D. 

167 Russell Senate Office Building 

Washington, D.C. 20510 

From: "Henderson, William (Paul)" <William Henderson@paul.senate.gov> 

Date: Monday, March 23, 2020 at 5:00 PM 

To: "Laxmaiah Manchikanti, MD" <drcm@asipp.org> 

Cc: "Bennett, Zach (Paul)" <Zach Bennett@paul.senate.gov> 

Subject: Re: Expanded Mesenchymal Stem Cells May Offer Hope for COVID-19 Patients 

Good afternoon. Thank you for sending this. Zach can work with you to get this to the right people in the administration. 

> On Mar 23, 2020, at 4:28 PM, Laxmaiah Manchikanti, MD <drcm@asipp.org> wrote: 

> 

> 

> American Society of lnterventional Pain Physicians® 

> "The Voice of lnterventional Pain Management" 

> 81 Lakeview Drive, Paducah, KY 42001 

> Phone: (270) 554-9412 - Fax: (270) 554-5394 

> https:ljprotect2.fireeye.com/url?k=74f27034-28a779e4-74f2410b-Occ47a6a52de-9f8abe90a8b042dc&u=http:ljwww.asipp.org/ 

> 

> March 23, 2020 

> 

> Senator Rand Paul 

> 167 Russell Senate Office Building 

> Washington DC, 20510 

> william henderson@paul.senate.gov 

> 

> RE: Expanded Mesenchymal Stem Cell Infusions in COVID-19 Patients 

> 

> Honorable Senator Rand Paul: 

> 

> Thank you for all the help the Senate is providing and supporting the Administration in these hard times. We appreciate your 

dedication to the Commonwealth of Kentucky and the United States of America. As you know, small practices like ours are hit the 

most. We were hoping that the Senate bill introduced by Senator Barrasso would pass and be signed into law. However, it appears 

like it is now a longshot. 

> 

> Apart from that, we have accumulated evidence in reference to expanded mesenchymal stem cell infusions in COVID-19 patients. I 

am enclosing a manuscript describing the same. 

> 

FDA-OSJI-FOIA-2020-3541_00001390 
> Please look over the attached press release and see if there is any way we can reach the President or Coronavirus Task Force to 

provide them with this information. The links for the Fact Sheet, Abstract, and Manuscript can be found in the attached Press 

Release. 

> 

> Thank you again for all your help. 

> 

> 

> Laxmaiah Manchikanti, MD 

> Chairman of the Board and Chief Executive Officer, ASIPP and SIPMS 

> Co-Director, Pain Management Centers of America 

> Medical Director, Pain Management Centers of Paducah and Marion 

> Ambulatory Surgery Center and Pain Care Surgery Center 

> Clinical Professor 

> Anesthesiology and Peri operative Medicine 

> University of Louisville, Kentucky 

> Professor of Anesthesiology-Research 

> Department of Anesthesiology, School of Medicine 

> LSU Health Sciences Center 

> 

> 2831 Lone Oak Road 

> Paducah, KY 42003 

> 

> Phone: 270-554-8373 ext. 4101 

> Fax: 270-554-8987 

> E-mail: drm@asipp.org 

> 

> LM/den 

> To view some of Dr. Manchikanti's publications go to: 

> http:ljwww.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&term=manchikanti 

> "The most entrenched conflict of interest in medicine is a disinclination to reverse a previous opinion." Yudkin JS et al. Lancet 2011 

> "There is no limit to what a man can do or where he can go if he doesn't mind who gets the credit." Ronald Reagan 

> 

> 

FDA-OSJI-FOIA-2020-3541_00001391 
From: Maloney, Diane [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E59205500E944C9EACC4524EA18EDSBB-MALONEYD] 

Sent: 3/25/2020 11:51:02 AM 

To: Marks, Peter [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Witten, Celia (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fc08ebb3ac61486da9flb404675 7 c5cf-Witten]; Tierney, Juli a 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Verdun, Nicole 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=a3aa59faf502446fa6c7a9b2bbe5a946-VERDUNN]; Eder, Anne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =a0027 2f83bac449199cbd le5d918bf28-An ne. Eder]; Scharpf, Jennifer 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =073b4a 34a 1094aa b9 lle9662c2a43402-Scha rpf]; Zavagno, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =18ed60da ba0346b5b8f6277 ecd b5bcb4-DZavagno ]; Mad ni, Ru bi na 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d6173079ca ld4ebe9e41a 770df07016e-Ru bin a.Mad n] 

Ripley, Stephen [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ad3fa0068da444cc855fccd951355957-ripley ]; Walker Udechukwu, Jessica 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1 f84acbad5c448459cea6b29a9ec33f5-J essica. Wa I] 

FW: COVID-19 guidance 

Attachments: Blood alternative procedures guidance 032520-JDrev ljs.docx 

Dear all, 

OP reviewed. See minor edits - look okay to me. if any concerns, just let me know. 

Dear Denise and Rubina, 

Please use this version. 

Thanks, 

Diane 

From: Schiller, Lowell <Lowell.Schiller@fda.hhs.gov> 

Sent: Wednesday, March 25, 2020 11:45 AM 

To: Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Roth, Lauren <Lauren.Roth@fda.hhs.gov> 

Cc: OC OPPB OP RPMS <0COPPBOPRPMS@fda.hhs.gov>; Ripley, Stephen <Stephen.Ripley@fda.hhs.gov>; Walker 

Udechukwu, Jessica <Jessica.WalkerUdechukwu@fda.hhs.gov>; Dupont, Jarilyn <Jarilyn.Dupont@fda.hhs.gov> 

Subject: RE: COVID-19 guidance 

OP edits attached. Would you please send us a clean and a redline that incorporates OCC's edits when available? 

Thanks! 

Lowell 

From: Maloney, Diane <Diane.Maloney@fda.hhs.gov> 

Sent: Wednesday, March 25, 2020 7:06 AM 

To: Schiller, Lowell <Lowell.Schiller fda.hhs. ov>; Roth, Lauren <Lauren.Roth@fda.hhs.gov> 

Cc: OC OPPB OP RPMS <OCOPPBOPRPMS fda.hhs. ov>; Ripley, Stephen <Ste hen.Ri le fda.hhs. ov>; Walker 

Udechukwu, Jessica <Jessica.WalkerUdechukwu 

Subject: COVID-19 guidance 

FDA-OSJI-FOIA-2020-3541_00001232 
Dear Lowell and Lauren, 

Please see attached COVID-19 guidance on blood alternative procedures to address blood shortages. We would like to 

issue this guidance this week. Should you have any questions, please let us know. 

Thank you, 

Diane 

FDA-OSJI-FOIA-2020-3541_00001233 
From: Tierney, Julia [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=1160D300BC4248B790DED292A082E9A8-JULIA.TIERN] 

Sent: 4/3/2020 4:14:35 PM 

To: Edmonds, Amanda [/o=Exchangelabs/ou=Exchange Administrative Group 

CC: 

Subject: 

(FYDI BOHF23SPDL T)/en=Recipients/en=232186a24a5347 4298d2760c060a4cc7-Amanda. Edmo]; Marks, Peter 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=dfbb2b5bd38445cb9c9adca3f72df53a-MarksP]; Witten, Celia (CBER) 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fc08ebb3ac61486da9flb404675 7 c5cf-Witten]; Maloney, Diane 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Verdun, Nicole 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=a3aa59faf502446fa6c7a9b2bbe5a946-VERDUNN]; Eder, Anne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =a0027 2f83bac449199cbd le5d918bf28-An ne. Eder]; Scharpf, Jennifer 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=073b4a34a 1094aab911e9662c2a43402-Scharpf]; McNeil I, Lorrie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 77b0b352c9c2485 lbf0c7330f53e00d9-M cN eil I] 

Zavagno, Denise [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =18ed60da ba0346b5b8f6277 ecd b5bcb4-DZavagno ]; Mad ni, Ru bi na 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d6173079ca ld4ebe9e41a 770df07016e-Ru bin a.Mad n] 

RE: red line from current webpage 

Attachments: comparison to existing cp eind webpage.docx 

Try this. I have not validated all of the changes yet. 

From: Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov> 

Sent: Friday, April 3, 2020 4:09 PM 

To: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Witten, Celia (CBER) 

<Celia.Witten@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Verdun, Nicole 

<Nicole.Verdun@fda.hhs.gov>; Eder, Anne <Anne.Eder@fda.hhs.gov>; Scharpf, Jennifer 

<Jennifer.Scharpf@fda.hhs.gov>; McNeil!, Lorrie <Lorrie.McNeill@fda.hhs.gov> 

Cc: Zavagno, Denise <Denise.Zavagno@fda.hhs.gov>; Madni, Rubina <Rubina.Madni@fda.hhs.gov> 

Subject: RE: redline from current webpage 

Thanks, I didn't realize this was an update to material that was already on the web. What is the best way to view this to 

see how the current website would be different with the new updates? (There is redlining from several authors, so hard 

to tell what would be new as compared to original here). 

From: Tierney, Julia <Julia.Tierney@fda.hhs.gov> 

Sent: Friday, April 3, 2020 4:06 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Witten, Celia (CBER) <Celia.Witten@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Verdun, Nicole <Nicole.Verdun@fda.hhs.gov>; Eder, Anne <Anne.Eder@fda.hhs.gov>; 

Scharpf, Jennifer <Jennifer.Scharpf@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; McNeil!, Lorrie 

<Lorrie.McNeill@fda.hhs.gov> 

Subject: redline from current webpage 

Current web page for reference:https://www.fda.gov/vacci nes-blood-biologics/investigational-new-drug-ind-or-deviceexem ptio n-i de-process-cber /i nvestigatio na l-covid-19-conva lescent-plasm a-em ergency-i nds 

FDA-OSJI-FOIA-2020-3541_00001084 
From: 

Sent: 

To: 

CC: 

Subject: 

Attachments: 

Dear Janet, 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/16/2020 4:59:25 PM 

Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Jungman, EI iza beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8b5d598115bc4f99f-E I iza beth .J]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4 fc39a 7 eb324539215bc-Stefa n i e. Kr]; Ma I on ey, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE:i (b)(S) 

(b)(5) 

Thanks. I don't have anything more to add to Janet's comments, except to note the minor additional edit in the 

attached. 

Best Regards, 

Peter 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov> 

Subject: Rei (b)(5) ] 

FDA-OSJ I-FOIA-2020-3541 _00000785 
Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov>, Woodcock, Janet <Janet.Woodcock fda.hhs. ov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus fda.hhs. ov>, Maloney, Diane 

<Diane.Malone fda.hhs. ov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW) (b)(S) 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

i (b)(5)ilf you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

' respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

(b)(S) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

!__ ________ ( b )( 6) ________ ___!( work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Ma ybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�------------------------------ (b)(5) !Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

FDA-OSJ I-FOIA-2020-3541 _00000786 
Best, 

Anand 

FDA-OSJI-FOIA-2020-3541 _00000787 
From: 

Sent: 

To: 

CC: 

Subject: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/16/2020 5:45:44 PM 

McMeekin, Judith [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d824 f07697784fcb9ece28cbba07102b-M CME EKI NJ]; Zeller, Mitch el I 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =de 7 d2fda97 le418ba 33cb21 la4013976-M itch el I .Ze ]; Abernethy, Amy 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c84171967 c724ee 799bb2658197086bc-Amy .Abernet]; Rebel Io, Heidi 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =2834ce 193ca949799ef063e34a2cfa0b-H eid i. Rebel]; Woodcock, Janet 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]; Solomon, Steven M 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e49ac6a056dc4f299ea269945e962e82-SSOLO MON]; Mayne, Susan 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=9e69acd84a37469aa57466a957814563-Susan.Mayne]; Shuren, Jeff 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =44335a0c2f834535bc8713dfd643905e-J eff.Sh u ren ]; Cavazzon i, Patrizia 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Cal iguiri, Laura 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =aa086f2d6c0346c49e996932d86ac62e-La u ra .Ca I ig]; M cWi 11 i ams, Carly 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b68c7 458214244d08424fd441 fea4fda-Ca rlyl e. M cW]; Anderson, Erika 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=98606928b9a64edfb25abale3573fdfe-Eranders]; Hebert, Angelique A. 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9aa08f3428a045f88eb3bd92c68a27 cf-Angelique. H ]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Finnen, Apri I 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=43d74b30bbld429184b0d9081efe19bf-April.Finne]; Mair, Michael 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Hussey, Deirdre 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=41a51a9bf937431c8470b69fb055fe81-Husseyd]; Barth, Janelle 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =18d28baf2bfa435a bc9cdfa07 677 4dc0-Ja nel I e. Bar]; Stone, Eric 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5 799d336f 4c142aca 7 la655e4184d6bd-E ri c.Stone ]; Hutten locker, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =65254282fa6a4e 138f506f96cfe9049c-Den ise. Hutt]; Dom an ski, Jeffrey 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=ed00c0aa83794cbebfc0a50f6cd4d7f9-Jeffrey.Dom]; Schweitzer, Roxanne K 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO H F23SPDL T)/ en=Recip ients/ en =292135d254924252958e25cc5a63b079-RSCHWE IT]; Branch, Tiffany 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=b45flb97b5d648f68cdff5ce4f75a 154-Tiffany.Bra]; Barfell, Glenda F 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =33b220e98ac9456eb32888261156f 400-G BARFELL]; Lynch, Sarah 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d24ee4a4fc6241 f48110d6b35e6704ed-Sa rah. Lynch] 

RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

FDA-OSJI-FOIA-2020-3541_00000837 
Nor from me. Thanks so much! 

Peter 

From: McMeekin, Judith <Judith.McMeekin@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:43 PM 

To: Zeller, Mitchell <Mitchell.Zeller@fda.hhs.gov>; Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Rebello, Heidi 

<Heidi.Rebello@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Solomon, Steven M 

<Steven.Solomon@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan 

<Susan.Mayne@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey.Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov>; Branch, Tiffany <Tiffany.Branch@fda.hhs.gov>; Barfell, 

Glenda F <Glenda.Barfell@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

No suggested edits from me, thanks! 

From: Zeller, Mitchell <Mitchell.Zeller fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:43 PM 

To: Abernethy, Amy <Amy.Abernethy@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Woodcock, Janet 

<Janet.Woodcock@fda.hhs.gov>; Solomon, Steven M <Steven.Solomon@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov>; Mayne, Susan <Susan.Mayne@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; 

Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey.Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer fda.hhs. ov>; Branch, Tiffany <Tiffan .Branch fda.hhs. ov>; Barfell, 

Glenda F <Glenda.Barfell fda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: RE: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

Agreed. 

Is there now an expedited clearance process for these types of messages? 

Mitch 

From: Abernethy, Amy <Am .Aberneth fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:41 PM 

To: Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock 

<Steven.Solomon@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Mayne, Susan 

<Susan.Mayne@fda.hhs.gov>; Zeller, Mitchell <Mitchell.Zeller@fda.hhs.gov>; Shuren, Jeff <Jeff.Shuren@fda.hhs.gov>; 

Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov> 

FDA-OSJ I-FOIA-2020-3541 _00000838 
Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker fda.hhs. ov>; Domanski, Jeffrey <Jeffre .Domanski tda.hhs. ov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer tda.hhs. ov>; Branch, Tiffany <Tiffan .Branch tda.hhs. ov>; Bartell, 

Glenda F <Glenda.Bartell tda.hhs. ov>; Lynch, Sarah <Sarah.Lynch@tda.hhs.gov> 

Subject: Re: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

Reviewed. This looks good from my perspective. 

From: Rebello, Heidi <Heidi.Rebello@tda.hhs.gov> 

Sent: Monday, March 16, 2020 5:23 PM 

To: Woodcock, Janet <Janet.Woodcock tda.hhs. ov>; Solomon, Steven M <Steven.Solomon tda.hhs. ov>; Marks, 

Peter <Peter.Marks@tda.hhs.gov>; Mayne, Susan <Susan.Mayne@tda.hhs.gov>; Zeller, Mitchell 

<Mitchell.Zeller tda.hhs. ov>; Shuren, Jeff <Jeff.Shuren@tda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; McMeekin, Judith <Judith.McMeekin@fda.hhs.gov>; Abernethy, Amy 

<Amy.Abernethy@fda.hhs.gov> 

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; McWilliams, Carly 

<Carly.McWilliams@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hebert, Angelique A. 

<Angelique.Hebert@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April 

<April.Finnen@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Hussey, Deirdre 

<Deirdre.Hussey@fda.hhs.gov>; Barth, Janelle <Janelle.Barth@fda.hhs.gov>; Stone, Eric <Eric.Stone@fda.hhs.gov>; 

Huttenlocker, Denise <Denise.Huttenlocker@fda.hhs.gov>; Domanski, Jeffrey <Jeffrey.Domanski@fda.hhs.gov>; 

Schweitzer, Roxanne K <Roxanne.Schweitzer@fda.hhs.gov>; Branch, Tiffany <Tiffany.Branch@fda.hhs.gov>; Bartell, 

Glenda F <Glenda.Barfell@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov> 

Subject: Flagging for PDC/CD/ACRA: Commissioner all hands update to go out asap today 

FDA-OSJ I-FOIA-2020-3541 _00000839 
Stephen M. Hahn, M.D. 

FDA Commissioner 

FDA-OSJ I-FOIA-2020-3541 _00000840 
From: 

Sent: 

To: 

CC: 

Subject: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/16/2020 5:50:53 PM 

Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Kraus, Stefanie 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =9d3959f3365b4fc39a 7 eb324539215bc-Stefa n i e. Kr]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Jungman, EI iza beth 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =5238a0caec064ba8 b5d598115bc4f99f-E I iza beth .J] 

Tierney, Julia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =1160d300bc4248b 790ded29 2a082e9a8-J u Ii a .Tiern]; Ma I oney, Di a ne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e59205500e944c9eacc4524ea 18ed5bb-Ma I oneyD ]; Mclatchy, Johanna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =895ad3bde 51342d5817826ccc9bc lba 7-M CLATCH Y J] 

RE) (b)(S) 

Dear Stephanie, 

This looks good to me. Patrizia's edit took care of my one edit, so I am set. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:49 PM 

To: Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, 

Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (�)_(_?), ___ � 

Stephanie 

One edits, for internal consistency . Also, feel free to edit the text I added if you think it may be too forceful. 

Patrizia 

From: Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov> 

Sent: Monday, March 16, 2020 5:44 PM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Jungman, 

Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Maloney, Diane <Diane.Malone fda.hhs. ov>; Mclatchy, Johanna 

<Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Hi all; I've discussed the comments with EJ and revised the draft to address them. I'm circulating the updated draft 

with redlines to reflect the bullets suggested and language on severely ill patients. We accepted Diane's and Peter's 

edits. Please let us know if we've addressed the comments adequately and are on the right track 

-Stefanie 

FDA-OSJ I-FOIA-2020-3541 _00000829 
From: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Sent: Monday, March 16, 2020 5:10 PM 

To: Woodcock, Janet <Janet.Woodcock fda.hhs. ov>; Jungman, Elizabeth <_E _liz_a_b_e _th_._Ju_n�--�--�­

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Some added text , in the same vein as JW's comments. I think we need to be stronger and agree that the bulleted 

approach would convey the most important points clearly and upfront. 

Patrizia 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Monday, March 16, 2020 4:57 PM 

To: Jungman, Elizabeth <Elizabeth.Jun man fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni 

Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Maloney, Diane 

<Diane.Maloney@fda.hhs.gov>; Mclatchy, Johanna <Johanna.Mclatchy@fda.hhs.gov> 

Subject: Ref-·-·-·-·-·-·-·-·-·-·-·-(b)(5) ·

-i 

Jw 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Date: March 16, 2020 at 4:27:05 PM EDT 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>, Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, 

Peter <Peter.Marks@fda.hhs.gov> 

Cc: Tierney, Julia <Julia.Tierney@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>, Maloney, Diane 

<Diane.Maloney@fda.hhs_.gov>, Mclatchy, Johanna <Johanna.Mclatch fda.hhs. ov> 

Subject: FW:i (b)(5) 

Importance: High 

Ors. Woodcock, Marks, and Cavazzoni: 

FDA-OSJ I-FOIA-2020-3541 _00000830 
Stefanie Kraus from CDER/ORP worked with Julie Tierney from CBER to draft the attached proposed response to the 

: (b)(5)! If you have edits, please cc Stefanie and she can help coordinate our response. We know Anand was hoping to 

'·-respond to HHS by 5pm today, so apologies for the tight turnaround. 

On the substance of the response: 

{b){5) • Please note that if we end up needing a shorter summary response (e.g. for a cover email), we can just pull out 

the first paragraph. 

Once we have a version you are all comfortable with, please let me know whether you'd rather we follow up with Anand 

or if you'd like to do so yourself. 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(S) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

'-----------------'---'--'---'------------------' (b)(5) : Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000831 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/17/2020 9:48:22 AM 

To: Woodcock, Janet [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

RE:! (b)(5) 

Dear Janet and Patrizia, 

Do you have a minute to discuss? I had a call with Anand, Geet, and OIRA yesterday on vaccines that provided some 

interesting insight. 

Best Regards, 

Peter 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:45 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie. Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) -'-------' 

Thank ou all for the uick turnaround. As a next ste _,_ ,_ D_r.H_ _a_

h_n_i_s in

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_es_ t

_e_d

_ i

_n_ id__e_as 

_...... i 

_______ (b __ )__ (S __ )________ _ 

(b)(5) 

(b)(5) i Just let us know if you '----,------�--��---------------------------' have any questions on this request. 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Date: March 17, 2020 at 9:06:09 AM EDT 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>, Amin, Stacy <Stacy.Amin@fda.hhs.gov>, Lenihan, Keagan 

<Keagan.lenihan@fda.hhs.gov>, Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>, Sipes, Grail <Grail.Sipes@fda.hhs.gov>, Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Hi Elizabeth - r-·-·-·i 

Steve reviewed the response to the!!b)(s)!and has some feedback. Jeet will follow up shortly j ______ j 

Thanks again 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000826 
From: Shah, Anand 

Sent: Tuesday, March 17, 2020 6:47 AM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Thank you, Elizabeth and team, for the detailed review that I have also shared with Steve. 

Anand 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 6:12 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: FW:i (�)_(_?) ___ � 

Please see attached a joint CDER-CBER proposed response to the i 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i(work cell) 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:52 AM 

(b)(5) 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Janet and Peter good to meet you - I recently joined OC from CMS. 

Just let us know; also as fyi, initial/high-level comments would be most helpful on this. Thanks so much. 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

FDA-OSJ I-FOIA-2020-3541 _00000827 
Food and Drug Administration 

+1 (202) 230-0451 I ieet.guram@fda.hhs.gov 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:49 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Janet and Peter -

I've asked Jeet to reach out to you with some additional context 

Please let us know the best #'s to reach you for a few min 

Anand 

PRE-DECISIONAL, CONFIDENTIAL 

From: Shah, Anand 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW:i (b)(S) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

'--------------------------------' (b)(5) i Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000828 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/17/2020 10:01:38 AM 

To: Cavazzoni, Patrizia [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode] 

Subject: 

Dear Patrizia, 

RE:i (b)(S) 

Just had a quick touch base with Janet. I am sure that we are all on the same page. We can catch up later to synch on 

anything. 

Best Regards, 

Peter 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 10:00 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: RE: i (b )(5) 

We can use my dial-in number 

Dial In Number Local/Toll Number 1-210-795-1100 Freephone/Toll Free Number 866-880-0098 Passcodes Leader: 

[ ____ .!�J{�l __ __.!Participant:j (b)(6) i 

From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:51 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE:i (b)(S) 

I will be at 796 3426 for an hour. w 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:48 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Dear Janet and Patrizia, 

Do you have a minute to discuss? I had a call with Anand, Geet, and OIRA yesterday on vaccines that provided some 

interesting insight. 

Best Regards, 

Peter 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Tuesday, March 17, 2020 9:45 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

FDA-OSJ I-FOIA-2020-3541 _00000806 
Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE: i (b)(S) 

Thank you all for the quick turnaround. As a next step, Dr. Hahn is interested in ideas! 

(b)(5) 

(b)(S) 

(b)(5) 

! Just let us know if you ------,----...,....,---------------------------� have any questions on this request. 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Date: March 17, 2020 at 9:06:09 AM EDT 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>, Amin, Stacy <Stacy.Amin@fda.hhs.gov>, Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>, Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>, Marks, Peter <Peter.Marks@fda.hhs.gov>, Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>, Sipes, Grail <Grail.Sipes@fda.hhs.gov>, Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>, Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Hi Elizabeth -

Steve reviewed the response to ther(��:i-i and has some feedback. Jeet will follow up shortly 

Thanks again 

Anand 

From: Shah, Anand 

'-·-·-·· 

Sent: Tuesday, March 17, 2020 6:47 AM 

To: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzon_i@fda.hhs._gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: RE:i (b)(S) 

Thank you, Elizabeth and team, for the detailed review that I have also shared with Steve. 

Anand 

From: Jungman, Elizabeth <Elizabeth.Jungman@fda.hhs.gov> 

Sent: Monday, March 16, 2020 6:12 PM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Cc: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Tierney, Julia 

<Julia.Tierney@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Cavazzoni, Patrizia 

FDA-OSJ I-FOIA-2020-3541 _00000807 
<Patrizia.Cavazzoni@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov> 

Subject: FW:i (b)(5) 

Please see attached a joint CDER-CBER proposed response to the i 

�------���------� (b)(5) 

Elizabeth Jungman 

Director, Office of Regulatory Policy 

Center for Drug Evaluation & Research, FDA 

240-402-1563 (work) 

(b)(6) i (work cell) 

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:52 AM 

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter 

<Peter.Marks@fda.hhs.gov> 

Subject: RE:i (b)(5) 

Janet and Peter good to meet you - I recently joined OC from CMS. 

Just let us know; also as fyi, initial/high-level comments would be most helpful on this. Thanks so much. 

Jeet Guram, M.D. 

Senior Advisor, Office of the Commissioner 

Food and Drug Administration 

+1 (202) 230-0451 I ieet.guram@fda.hhs.gov 

From: Shah, Anand <Anand.Shah@fda.hhs.gov> 

Sent: Monday, March 16, 2020 9:49 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Guram, Jeet <Jeet.Guram@fda.hhs.gov> 

Subject: RE:j (b)(5) 

Janet and Peter -

I've asked Jeet to reach out to you with some additional context 

Please let us know the best #'s to reach you for a few min 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000808 
PRE-DECISIONAL, CONFIDENTIAL 

From: Shah, Anand 

Sent: Monday, March 16, 2020 9:46 AM 

To: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Patel, Chaitali 

<Chaitali.Patel@fda.hhs.gov>; Mclatchy, Johanna <Johanna.McLatchy@fda.hhs.gov>; Clarke, Mary Beth 

<Marybeth.Clarke@fda.hhs.gov> 

Subject: FW: i (b)(5) 

PRE-DECISIONAL, CONFIDENTIAL 

Dear Janet and Peter -

�----------------------------� (b)(5) ! Stacy will also be sharing with the 

OCC team. 

Thank you for prioritizing this review. I will need to provide HHS with comments by 5pm today. 

Best, 

Anand 

FDA-OSJ I-FOIA-2020-3541 _00000809 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 3/19/2020 7:01:40 AM 

To: Caccomo, Stephanie [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=950c32cebc4b4f80b302c50cf3 lc8524-Stephanie.C]; 2019-nCoV FDA I MG JIC 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en=289715a 114684 7558 b07 a33cca b6bccf-2019-nCoV F]; OCCReq uests-COVI D19 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =bcb 756008a41407282a58324a 7b5144a-OCCReq uests ]; Amin, Stacy 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Anderson, Erika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Cavazzon i, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en=d9dc8109c3ea49ed8f897 ac979b0619b-FARLEY J]; Roberts, Rosemary 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =b 7838ea b964e4ca la 7 d703876d0841 lb-RO BE RTSR] 

Subject: RE: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Attachments: POTUS_TPS_llpm_FDA (1).docx 

Dear Stephanie, 

The situation for blood has changed somewhat, so updated that, including language that CDC and FDA agreed upon. 

Best Regards, 

Peter 

From: Caccamo, Stephanie <Stephanie.Caccomo@fda.hhs.gov> 

Sent: Wednesday, March 18, 2020 11:03 PM 

To: 2019-nCoV FDA IMG JIC <2019-nCoVFDAIMGJIC@fda.hhs.gov>; OCCRequests-COVID19 <0CCRequestsCOVID19@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; 

Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Cavazzoni, Patrizia 

<Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Roberts, Rosemary 

<Rosemary.Roberts@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: QUICK TURN-AROUND: updated POTUS TPs, due by 6:30AM to HHS 

Updated TPs for POTUS press briefing tomorrow on therapeutics. CDER/CBER-can you look at quickly? I've added edits 

and a note on attached version. This is due to HHS by 6:30am. Thanks! 

Press Conference on FDA Developments 

(b)(5) 

FDA-OSJ I-FOIA-2020-3541 _00000793 
Stephanie Caccomo 

Press Officer 

Office of Media Affairs 

Office of External Affairs 

FDA-OSJ I-FOIA-2020-3541 _00000794 
Drug Arlrnini,�tr�tinn 

Desk 301,348, 1956 

Cell i (b)(6) i 

stepil.anfe:cacccfrno@fda. h hs. gov 

FDA-OSJ I-FOIA-2020-3541 _00000795 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 3/20/2020 6:12:21 PM 

To: Lenihan, Keagan [/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Cavazzoni, Patrizia 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =c42a bd33834044ecbaa03d075cc0a5d2-Patrizia. Ca] 

CC: Amin, Stacy [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Hahn, Stephen 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =a0afac0cfa3c4b98913833e38a036e9f-Stephen. Ha h]; Rom, Colin 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f59636221 f 4340d697 d bd43ee27 255fb-Col in. Rom]; Edmonds, Arna nda 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =232186a24a534 7 4298d2760c060a4cc7-Ama nda. Ed mo]; Woodcock, Janet 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en= 7b0453354a9a427 d b0a66a86c7a36f3d-Ja net. Woode] 

RE: Vaccine development idea 

Attachments: SARS-CoV-2 vaccine manufacturers.docx 

Dear Keagan, 

Sorry- took a while to get permission from manufacturers. Just got the last one. Please see the attached and 

below. Just let me know if you need assistance talking to anyone over the weekend. 

Best Regards, 

Peter 

ModemaTX, 

Inc. 

mRNA-1273, a novel lipidencapsulated mRNA-based 

prophylactic vaccine encoding 

the pre-fusion stabilized Spike 

(S) glycoprotein of the SARSCoV-2 virus 

Tal Zaks, MD 

Chief Medical Officer 

ModemaTX Inc 

Tal.zaks@modematx.com I modematx.com 

I mobile i (b)(6) i 

FDA-OSJ I-FOIA-2020-3541 _00000777 
From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 5:47 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov>; Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Any update on vaccines? 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:38 PM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

Thanks. That sounds fine to me. I have a feeling that we will not have the vaccine information ready until late today, so 

we might need to have this call over the weekend. 

Best Regards, 

Peter 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 12:36 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Thank you all. Would like to make sure we are coordinated and understand what we are getting back to the Hill. 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:09 AM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Dear Keagan, 

My vote is that we get more info, get it prepped for the hill and then touch bases if need be, or after it is reviewed on 

the hill to take care of questions. 

FDA-OSJ I-FOIA-2020-3541 _00000778 
Best Regards, 

Peter 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 11:05 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; 

Woodcock, Janet <Janet.Woodcock@fda.hhs.gov> 

Subject: RE: Vaccine development idea 

Do we need a call? Or more info first? 

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> 

Sent: Friday, March 20, 2020 10:49 AM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; 

Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: RE: Vaccine development idea 

Peter and I spoke. We are going to take the same approach as CBER, ie reach out to Gov Affairs in the companies in 

question (monoclonals) and ask them that they reach out to Sen. Daines 

Patrizia 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:58 AM 

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Cc: Marks, Peter <Peter.Marks@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen 

<SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; Edmonds, Amanda <Amanda.Edmonds fda.hhs. ov>; 

Woodcock, Janet <Janet.Woodcock fda.hhs. ov> 

Subject: Re: Vaccine development idea 

Should we hop on a call to discuss? 

Sent from my iPhone 

On Mar 20, 2020, at 9:53 AM, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> wrote: 

We don't think this is a good idea. 

Patrizia 

From: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:26 AM 

To: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds ov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni fda.hhs. ov> 

Subject: RE: Vaccine development idea 

FDA-OSJ I-FOIA-2020-3541 _00000779 
Dear Keagan, 

Definitely would consider these! This is CDER's domain, so looping Patrizia in. (Patrizia - let me know when you have 

time and I can call you to loop you in.) 

Best Regards, 

Peter 

From: Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov> 

Sent: Friday, March 20, 2020 9:19 AM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Rom, Colin <Colin.Rom@fda.hhs.gov>; 

Edmonds, Amanda <Amanda.Edmonds@fda.hhs.gov> 

Subject: Re: Vaccine development idea 

Peter- can you think through monoclonal antibodies as well, and if we should be exploring that avenue with the 

vaccines? 

Sent from my iPhone 

On Mar 20, 2020, at 9:08 AM, Marks, Peter <Peter.Marks@fda.hhs.gov> wrote: 

Dear Commissioner and Amanda, 

We are working on getting permission from the most promising 3-4 vaccine companies for permission to have the 

Senator or staffers to contact them. Expect this by the end of the day. 

I remain available at any time if you need anything here. 

Best Regards, 

Peter 

From: Amin, Stacy <Stacy.Amin@fda.hhs.gov> 

Sent: Friday, March 20, 2020 9:06 AM 

To: Hahn, Stephen <SH1@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Rom, Colin <Colin.Rom@fda.hhs.gov>; Lenihan, Keagan <Kea an.Lenihan fda.hhs. ov>; Edmonds, Amanda 

<Amanda.Edmonds fda.hhs. ov> 

Subject: Vaccine development idea 

Commissioner - I have Amanda Edmonds working on this-Amanda is my best lawyer and will get this worked through 

with Peter. We agree it will require some creative leg writing. 

Is the next step for us to connect with Sen Daines once we have an idea of how to do this? 

Best, 

Stacy 

***************************************** 

Stacy Cline Amin 

Chief Counsel 

Food and Drug Administration 

FDA-OSJ I-FOIA-2020-3541 _00000780 
Deputy General Counsel 

Department of Health and Human Services 

FDA-OSJ I-FOIA-2020-3541 _00000781 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 2/8/2020 10:34:20 AM 

To: Mair, Michael [/o=Exchangelabs/ou=Exchange Administrative Group 

Subject: 

Dear Michael, 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Abram, Anna 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram]; Hahn, Stephen 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=a0afac0cfa3c4b98913833e38a036e9f-Stephen.Hah]; Solomon, Steven M 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =e49ac6a056dc4f299ea269945e962e82-SSOLO MON]; Lenihan, Keaga n 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=ee 7320ee8c184d66bfd521b0105d 17d2-Keagan. Leni]; Amin, Stacy 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =cb3 764b 7 438648838c2288 la06fc6afb-Stacy .Amin]; Anderson, Erika 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =98606928b9a64edfb25aba le35 73fdfe-Era nders ]; Hinton, Denise 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Farley, John 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d9dc8109c3ea49ed8f897 ac979b0619b-FARLEY J]; Schwartz, Suzanne 

[/o=Exchangelabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =60fbac0e 12a24633b 1018181711 f7849-Suza n ne.Sch] 

RE: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected Pneumonia in Wuhan, 

China 

Thanks very much for forwarding this along. 

Best Regards, 

Peter 

From: Mair, Michael <Michael.Mair@fda.hhs.gov> 

Sent: Saturday, February 8, 2020 10:07 AM 

To: Abram, Anna <Anna.Abram@fda.hhs.gov>; Hahn, Stephen <SH1@fda.hhs.gov>; Solomon, Steven M 

<Steven.Solomon@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Amin, Stacy 

<Stacy.Amin@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Hinton, Denise 

<Denise.Hinton@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; 

Schwartz, Suzanne <Suzanne.Schwartz@fda.hhs.gov> 

Subject: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected Pneumonia in 

Wuhan, China 

JAMA: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-lnfected Pneumonia in Wuhan, 

China 

Conclusions and Relevance In this single-center case series of 138 hospitalized patients with confirmed NCIP 

in Wuhan, China, presumed hospital-related transmission of 2019-nCo V was suspected in 41 % of patients, 26% 

of patients received ICU care, and mortality was 4.3%. 

FDA-OSJI-FOIA-2020-3541_00000218 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 1/10/2020 2:35:31 PM 

To: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =f 451 lbdad7564d7fac7 eadc796146 7a b-M ichael. Mai]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDIBOHF23SPDLT)/en=Recipients/en=85feca0be0694803be6030e97c7b4adb-HINTOND]; Abram, Anna 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram]; Lenihan, Keaga n 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

CC: 

(FYDI BO HF 23SPDL T)/ en=Reci pients/ en =ee 7320ee8c184d66bfd52 lb0105d 17 d2-Keaga n. Len i] 

Sadove, Elizabeth [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fd45c627000d4f34b9db362ff2b6af4b-SADOVE E] 

Subject: RE: Update on Undiagnosed Pneumonia - China 

Dear Michael, 

Thanks so much for this update. 

Best Regards, 

Peter 

From: Mair, Michael <Michael.Mair@fda.hhs.gov> 

Sent: Friday, January 10, 2020 1:31 PM 

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Lenihan, Keagan 

<Keagan.Lenihan@fda.hhs.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov> 

Cc: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov> 

Subject: Update on Undiagnosed Pneumonia - China 

Hi. I wanted to provide you with a quick update on the outbreak of pneumonia of unknown cause that is ongoing in 

Wuhan, China. 

Overview: 

• There are 59 cases of pneumonia listed as unknown etiology, 7 listed as severe. 

• There is a limited clinical picture. Symptom onset of cases is from 12-29 December. Wuhan health officials have 

not announced any new cases since 05 Jan. 

• All known cases are linked to live fish market in Wuhan (closed on 01 December) that also sells other animals. 

• There have been no reported health care worker infections or human-to-human transmission. 

• 153 known close contacts are being monitored. 

• Chinese authorities have made a preliminary determination of a novel coronavirus as the etiologic agent, 

identified in a hospitalized person with pneumonia in Wuhan 

• Science is reporting that the "Two groups isolated the virus from samples from one patient ... [that] ... A total of 15 

[of the 59 cases] were positive for the novel virus, [based on] sequencing samples of [fluid injected into the lung and 

collected for examination] ... [and that] ... the virus is similar to some of the published [corona]viruses collected from bats. 

But it is not close to SARS and not close to MERS." 

• There has been no known international spread, but many countries in the region have activated protocols to 

monitor for pneumonia patients of unknown etiology who have recently traveled to China. 

WHO Activities: 

• WHO is closely monitoring the situation and is in close contact with national authorities in China. 

• WHO has requested more information from China on the epidemiological situation and ongoing investigations 

• WHO is not currently recommending any specific measures for travelers. 

• WHO is developing guidance for member states. 

FDA-OSJ I-FOIA-2020-3541 _00000993 
• WHO R&D Blueprint Team held a teleconference on 10 Jan to update members of the Global Coordination 

Mechanism on the cluster of pneumonia cases and discuss next steps. 

• 

• CDC issued a level 1 travel notice on 06 Jan . 

CDC issued a Health Alert Network notice on 08 Jan . 

• The FDA Emerging Threats Task Force is monitoring the situation and working to advance and coordinate 

response activities as necessary. 

• The Division of Microbiology (OHT7-OIR/CDRH) is proactively coordinating with CDC on diagnostic activities: 

o DMD had a telecon with CDC on 08 Jan: ■ CDC briefed DMD on the current situation and noted that they expect the genetic sequence information to be 

released soon. ■ In anticipation of testing specimens from returning travelers, CDC is developing a molecular test, likely based on 

the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay (which FDA authorized for use under EUA in June 2014 for the 

presumptive detection of MERS-CoV), that they will CLIA validate for use in their labs. ■ From a preparedness standpoint CDC is also planning on submitting a pre-EUA package in case distribution of 

the test within the Laboratory Response Network is necessary to meet testing demands. DMD is working on an EUA 

Review template outlining the data requirements for the Pre-EUA package based on previous experience with MERSCoV. 

FDA-OSJ I-FOIA-2020-3541 _00000994 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 1/31/2020 8:04:03 AM 

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =ee 7320ee8c184d66bfd52 lb0105d 17 d2-Keaga n. Len i] 

CC: Abram, Anna [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77660891384232a 7 cd9086fcbb la3b-An na .Abram]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Mair, Mi cha el 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOHF23SPDL T)/en=Recipients/en=f4511bdad7564d7fac7eadc7961467ab-M ichael. Mai]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD] 

Vaccine TPs 

Attachments: Considerations in coronavirus vaccine development 013120.docx 

Dear Keagan, 

Please see the attached talking points on vaccine development. We have tried to distill this down and use the least 

technical language. Just let me know if you have any questions. 

Best Regards, 

Peter 

FDA-OSJI-FOIA-2020-3541_00000561 
From: Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

Sent: 1/31/2020 4:55:46 PM 

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =ee 7320ee8c184d66bfd52 lb0105d 17 d2-Keaga n. Len i] 

CC: Abram, Anna [/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =fb 77 660891384232a 7 cd9086fcbb la3b-An na .Abram]; Hinton, Denise 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =85feca0be0694803be6030e97 c7b4ad b-H INTO ND]; Mair, Mi cha el 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

(FYDI BOH F23SPDL T)/en=Recipients/en=f4511bdad7564d7fac7eadc7961467ab-M ichael. Mai]; Cho, David S (CBER) 

[/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ en=Recip ients/ en =d4 7af9d99 laf 4c 1 fbf7 cb4cld287f83e-ChoD] 

RE: Vaccine TPs 

Attachments: Considerations in coronavirus vaccine development 013120.docx 

Dear Keagan, 

Here is a slightly updated version of the TPs. Don't expect any more edits for now on our end until we have some more 

data. 

Best Regards, 

Peter 

From: Marks, Peter 

Sent: Friday, January 31, 2020 8:04 AM 

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Cc: Anna Abram (Anna.Abram@fda.hhs.gov) <Anna.Abram@fda.hhs.gov>; Hinton, Denise 

<Denise.Hinton@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Cho, David S (CBER) 

(David.Cho@fda.hhs.gov) <David.Cho@fda.hhs.gov> 

Subject: Vaccine TPs 

Dear Keagan, 

Please see the attached talking points on vaccine development. We have tried to distill this down and use the least 

technical language. Just let me know if you have any questions. 

Best Regards, 

Peter 

FDA-OSJ I-FOIA-2020-3541 _00000566 
From: 

Sent: 

Marks, Peter [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DFBB2B5BD38445CB9C9ADCA3F72DF53A-MARKSP] 

3/16/2020 2:03:11 PM 

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group 

Subject: 

(FYDI BO HF 23SPDL T)/ cn=Recip ients/ en =ee 7320ee8c184d66bfd52 lb0105d 17 d2-Keaga n. Len i] 

RE: blood supply 

Attachments: AABB-COVI D-19-Outbrea k-Ch eckl i st.docx 

Dear Keagan, 

The blood centers have the attached extensive checklist, but the long and the short of it is the following: 

• Blood centers either have or are working on developing appointment calendars for individuals to donate, so that 

people don't have to wait in long lines 

• Blood centers screen donors before they enter the donor room to make sure that they are healthy 

• Staff are skilled at dealing with infection control practices from prior experience and will be taking all 

appropriate precautions to facilitate donor safety. 

Just let me know if you need anything else. Happy to brief anyone on this as need be. 

Best Regards, 

Peter 

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov> 

Sent: Monday, March 16, 2020 1:47 PM 

To: Marks, Peter <Peter.Marks@fda.hhs.gov> 

Subject: blood supply 

Hi Peter - Kelly Anne Conway is going to help get the message out on blood supply. Can you get me the AAV guidance 

on social distancing, but still giving blood? 

FDA-OSJI-FOIA-2020-3541_00001043