Setter: A FOIA Getter

Request Summary: Pursuant to the Freedom of Information Act (5 U.S.C. § 552), I am requesting all non-exempt records submitted to the FDA by Medtronic, Inc. under PMA P960009 and related supplements concerning materials testing, extractables and leachables analysis, degradation product identification, and toxicologic…

Requester: Katie Merkle

Exhibit 10.2 to Form 10-Q filed by Usec Inc, on August 6, 2008

Requester: Brozyna, Malgorzata

request access to a digital log of unruly passengers reported to FAA Northwest Mountain Region between Jan 1st 2014 to Dec 31st 2024. Please include the followingincident number date, time, location, airline, origin of flight and intended destination, and if any enforcement action or fines were imposed.

Requester: Kornfeld, Joshua

Exhibit 10.9 to Form S-1 filed by Asalliances Biofuels, LLC on September 15, 2006

Requester: Brozyna, Malgorzata

I would like to request a list of companies who have listed Coast to Coast Produce LLC DUNS number 15-143-3380 during the time period of 11/08/2024 - 05/28/2025. We would like this information provide in Excel format. The data we have received in the past for an FSVP importer provided 23 releasable data points .

Requester: Katherine Palmieri - Coast to Coast Produce LLC

digital log of incidents of unruly passengers reported to FAA between Jan 1st 2014 and Dec 31st 2024. Please include the following incident number, date, time, location if applicable, airline, origin of flight, intended destination and a distinction between cases where enforcement action or fines were imposed.

Requester: Kornfeld, Joshua

a copy of the Medical Certification records pertaining to [Exemption 6]

Requester: Dekker, Travis

Exhibit 10.1 to Form 8-K filed by Uniqure N.V. on October 19, 2017

Requester: Brozyna, Malgorzata

The most current/recent drug product specification for NDA 207-964, Chlorhexidine Gluconate 2% Topical Cloths (ReadyPrep CHG), OTC, owned by Medline Industries

Requester: Katherine Flinchum - Xttrium Laboratories, Inc.

a copy of the Medical Certification records pertaining to [Exemption 6]

Requester: Crumbley, Dolores

Exhibit 10.1 to Form 10-Q filed by Athersys, Inc. / New on May 6, 2016

Requester: Brozyna, Malgorzata

On behalf of the White Coat Waste Project (WCW) and pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, I request copies of all correspondence from January 1, 2020 to June 16, 2025 to or from any Office of the Commissioner personnel, including but not limited to Office of Policy, Legislation, and Inter…

Requester: Kailey - White Coat Waste Project

Exhibit 10.1 to Form 10-Q filed by Chimerix, Inc., on May 7, 2018

Requester: Brozyna, Malgorzata

REQUEST THE FAA MANAGER RANKING LIST FOR THE NCEPT 2024 PANEL.

Requester: CARTER, TRAE

Dear Sir/Madam, I would like to request the Tentative Approval letter for SITAGLIPTIN PHOSPHATE TABLET;ORAL, EQ 25 MG, 50 MG and 100 MG. ANDA-214784, Applicant – AJANTA PHARMA LTD.

Requester: Jyothi Avirineni - Dr. Reddy's Laboratories Inc.

Exhibit 10.8 to Form F-1 filed by uniQure B.V. on January 2, 2014

Requester: Brozyna, Malgorzata

Seeking the FDA 483 report from Hologic, Inc's Inspection, ending 24 September 2024. _x000D_ _x000D_ FEI Number: 1000120743_x000D_ Firm Name: Hologic, INC_x000D_ Firm Address: 250 Campus Dr, Marlborough, MA, 01752, United States_x000D_ Inspection Details:_x000D_ Inspection ID: 1240946_x000D_ Inspection End Date: 09/24…

Requester: Jynx Boyne - Boston Scientific

a copy of the Medical Certification records and applicant notes pertaining to [Exemption 6]

Requester: Barnett, Jackson

Seeking the Form 483 issued from an inspection._x000D_ FEI Number: 1314492_x000D_ Firm Name: Baxter Healthcare Corporation_x000D_ Firm Address: 711 Park Ave, Medina, New York 14103, United States_x000D_ Inspection ID: 126623_x000D_ Inspection End Date: 04/04/2025_x000D_ Program Area: Devices_x000D_

Requester: Jynx Boyne - Boston Scientific

a copy of the Medical Certification records and applicant notes pertaining to [Exemption 6]

Requester: Ison, Anthony

Exhibit 99.1 to Form 8-K filed by Cooper Companies, Inc., on December 21, 2012

Requester: Brozyna, Malgorzata

All customs data from the above-referenced dates for any entries that list Wegmans Food Markets, Inc. as the FSVP importer, including derivations such as Wegmans, Wegmans Warehouse, Wegman's, Wegmans Supermarkets, etc. Please include the following DUNS: 059650069, 118708099, 118986651, 808765866, 118708129, 118708145,…

Requester: Julie Cook - Wegmans Food Markets, Inc.

Regarding the 11/5/24 accident at Falcon Field Airport (MSC/KFFZ) in Mesa, AZ involving aircraft N57HP: 1. Any and all investigative documents regarding this accident. 2. Any FAA “Air Traffic Package” prepared in connection with or as a result of this accident 3. Any FAA report of investigation, regardless of type o…

Requester: Wicinski, Kelly

Exhibit 10.40 to Form SB-2/A filed by Advanced Bioenergy, LLC, on February 7, 2007

Requester: Brozyna, Malgorzata

All FAERS data on compounded bioidentical hormone therapy (cBHT) shared with the National Academies of Science, Engineering and Medicine to produce this 2020 report: \The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety

Requester: Julian Gill - Houston Chronicle

Want an accident report from Jake Arner airport, Lehighton , pa. Incident was August 2023, plane N7695W.

Requester: Krupa, Edward

Exhibits 10.1 and 10.2 to Form 10-Q filed by Tobira Therapeutics, Inc., on September 9, 2016

Requester: Brozyna, Malgorzata

All state referral letters sent by the FDA to the Texas State Board of Pharmacy regarding 503A and 503B compounding pharmacies since 2013.

Requester: Julian Gill - Houston Chronicle

Exhibit 10.32 to Form 10-K filed by Aerie Pharmaceuticals, Inc., on February 2, 2021

Requester: Brozyna, Malgorzata

Please provide in CSV or Excel format the FAA-WHQ FOIA log of requests submitted during the period from December 1, 2024 to December 31, 2024. Please include fields for the requester name, requester organization, request description, request date, request ID number, and any other routine fields.

Requester: Doherty, Caitlin

All adverse event reports and complaints filed by or against Empower Pharmacy in Houston, TX, in the FDA Compounding Incidents Program in the specified time frame. I ask that the data be separated by year and include information about the drug and the negative drug reaction. Please provide the data in an excel spreads…

Requester: Julian Gill - Houston Chronicle

trying to get information on the following incident: Date of Incident: March 23, 2024 Location of Incident: 04W - Field of Dreams Airport, Hinckley, MN Aircraft Involved: N75132 Pilot flying: [Exemption 6] / Certificate number [Exemption 6] Description of Incident: Runway excursion with aircraft and property damage I…

Requester: Long, Jeffery

Exhibits 10.1 and 10.2 to Form 10-Q filed by Tobira Therapeutics, Inc., on May 9, 2016

Requester: Brozyna, Malgorzata

I am requesting the dossier that was submitted to the FDA by Innovacyn, Inc. in its 510(k) application_x000D_ for K232080 (Puracyn Plus Antimicrobial Irrigation Solution).

Requester: Julia Amrock - Sonoma Pharmaceuticals, Inc.

request the following: Documents sufficient to account for the agency's occupancy data/vacancy data for the agency's headquarters building by day (or month by month) for the year of 2024. Search Instructions: Please limit all searches in response to this to the timeframe of January 1, 2024 to December 31, 2024. Please…

Requester: Aamot, Colin

Exhibit 10.5 to Form 8-K/A filed by Agfeed Industries, Inc., on November 19, 2012

Requester: Brozyna, Malgorzata

Decision summary for K242604, Helios+ UV-C System.

Requester: Juan L. Gonzalez - Xenex Disinfection Services In

Exhibit 10.1 to Form 10-Q filed by Threshold Pharmaceuticals Inc., on May 5, 2016

Requester: Brozyna, Malgorzata

- All correspondence sent and received between Paul Devoti, FAA Senior Rep, and the Korea Office of Civil Aviation, the Korea Airports Corporation, and South Korea's Railway Accident Investigation Board between December 25 and January 2, 2024.

Requester: Power, John

Exhibit 10.10 to Form DRS/A filedby Sylvamo Corp., on July 13, 2021

Requester: Brozyna, Malgorzata

requesting the N90 Standard Terminal Automation Replacement System (STARS) electronic adaptation data package preferably delivered to me in an archive, such as a .ZIP file. The file(s) are kept at the tech ops office at the N90 TRACON facility in Westbury, NY or at the FAA William J. Hughes Technical Center in Atlanti…

Requester: Heath, Vinh

Requesting a copy of the FDA EIR from an FDA inspection that was conducted in our CSL Plasma, Inc. - Kansas City 410 location, FEI #1930460 from March 18, 2025, to March 21, 2025.

Requester: Joyce Castaneda - CSL Plasma, Inc.

Exhibit 10 to Form DRS filed by Agios Pharmaceuticals, Inc., on May 23, 2013

Requester: Brozyna, Malgorzata

requesting access to and copies of all records related to the protest submitted by Veracity Engineering, LLC (“Veracity”) regarding the award for contract Solicitation DTFAWA-16-R-00015 to LS Technologies (Contract Award DTFAWA17D00015), associated with ODRA case file 17-ODRA-00791. Specifically, seeking: 1. All corre…

Requester: Johnson, Justina

Requesting a copy of the FDA EIR from an FDA inspection that was conducted in our CSL Plasma, Inc. - Minneapolis 414 center, FEI #2177738 from February 20, 2025, to February 26, 2025

Requester: Joyce Castaneda - CSL Plasma, Inc.

Exhibit 10.4 to Form S-1 filed by Applied Genetic Technologies, Corp., on October 1, 2014

Requester: Brozyna, Malgorzata

Flight track data from the National Offload Program or similar for flights within a 20 mile radius of DCA for dates between and including 9/1/2024 and 12/31/2024.

Requester: McEnearney, Mark

Records from 2018–present on the survivability, transformation, or environmental reentry of pharmaceutical or synthetic biological compounds—including mRNA vaccine components, lipid nanoparticles, gene therapy agents, prions, psychiatric drugs, and chemotherapy residues—resulting from the alkaline hydrolysis of …

Requester: Joseph Anthony Reyna - Dreams Over Dollars Foundation

Exhibit 10.1 to Form 10-Q filed by Seacor Holdings Inc /New/ October 28, 2013

Requester: Brozyna, Malgorzata

Exhibit 10.1 to Form 10-Q filed by Sangamo Therapeutics, Inc, on November 6, 2019

Requester: Brozyna, Malgorzata