Joint status report on agreed production terms — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 55 · 2022-02-02 · Docket on CourtListener

Full text

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IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
____________________________________ 
 
 
 
 
 
 
) 
PUBLIC HEALTH AND MEDICAL  
) 
PROFESSIONALS FOR 
 
 
) 
TRANSPARENCY,  
 
  
) 
) 
Plaintiff, 
 
) 
) 
v. 
 
 
 
)  
Civil Action No. 4:21-cv-01058-P 
) 
UNITED STATES FOOD AND DRUG 
) 
ADMINISTRATION, 
 
 
) 
) 
Defendant. 
 
) 
___________________________________  ) 
 
 
 
JOINT STATUS REPORT 
 
In comportment with the Court’s instruction at the January 28, 2022 Motions Hearing, 
the parties hereby submit the instant Joint Status Report. As instructed by the Court, the parties 
have, in the interim since that hearing, continued to confer and have agreed to the below terms: 
 The U.S. Food and Drug Administration’s (“FDA”) rolling productions will each be due 
on the first business day of each month, instead of once every thirty days. 
 FDA will produce 10,000 pages for the first two productions, which will be due on or 
before March 1 and April 1, 2022. 
 FDA will produce 80,000 pages on or before May 2, June 1, and July 1, 2022; 70,000 
pages on or before August 1, 2022; and then 55,000 pages on or before the first business 
day of each month thereafter.  
 FDA can “bank” any processed pages in excess of its monthly quota, such that, for 
example, if the FDA produces 90,000 pages in May 2022 (or 65,000 pages in September 
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2022), it would bank 10,000 pages. Then, in a subsequent month, if FDA is unable to 
produce the full amount of pages required, it can apply the banked pages toward its quota 
for that month. 
 For the SAS files that duplicate the data in CRF files, the FDA will count every 40 rows 
as one page instead of every 20 rows as one page.   
The parties jointly request that the Court enter an order reflecting the above terms.  
 
Dated: February 2, 2022 
 
 
Respectfully submitted, 
SIRI & GLIMSTAD LLP 
/s/ Aaron Siri 
Aaron Siri, NY Bar No. 4321790 
Elizabeth A. Brehm, NY Bar No. 4660353 
Gabrielle G. Palmer, CO Bar No. 48948 
200 Park Avenue 
17th Floor 
New York, New York 10166 
Tel: (212) 532-1091 
aaron@sirillp.com 
usmith@sirilp.com 
gpalmer@sirillp.com 
 
Attorneys for Plaintiff 
 
BRIAN M. BOYNTON 
Acting Assistant Attorney General 
Civil Division 
 
 
 
 
 
ELIZABETH J. SHAPIRO  
Deputy Director  
Federal Programs Branch 
 
 
  
/s/ Antonia Konkoly 
 
 
 
ANTONIA KONKOLY 
Trial Attorney 
United States Department of Justice 
Civil Division, Federal Programs Branch 
1100 L Street, N.W. 
Room 11110 
Washington, D.C. 20005 
Tel: (202) 514-2395 
Email: antonia.konkoly@usdoj.gov 
 
Counsel for Defendant 
 
 
 
 
 
 
 
 
 
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CERTIFICATE OF SERVICE 
 
 
I hereby certify that on February 2, 2022, I electronically transmitted the foregoing to the 
parties and the clerk of court for the United States District Court for the Northern District of 
Texas using the CM/ECF filing system. 
 
/s/ Antonia Konkoly 
 
 
 
ANTONIA KONKOLY 
Trial Attorney 
United States Department of Justice 
Civil Division, Federal Programs Branch 
1100 L Street, N.W. 
Room 11110 
Washington, D.C. 20005 
Tel: (202) 514-2395 
Email: antonia.konkoly@usdoj.gov 
 
 
 
 
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