Setter: A FOIA Getter

All emails between any of these HHS officials on the new administration’s “beachhead team”: Amanda Street, Carla DiBlasio, Paula Stannard or Tim Clark and anyone who has any of the following domains: @fed soc.org, @alston.com, @ClarkStrategyGroup.com @heritage.org, @aei.org, @gmail.com, @ama assn.org, @aha.org, @amoor…

Requester: Faturechi, Robert

Eaton Corporation

Requester: Gavin, J. Patrick

requesting all records and communications, including but not limited to emails, memos, reports, transcriptions, that mention one or both of the following key words between Jan. 1, 2025 and the present (Feb. 6, 2025 or whenever this request is processed): • DOGE • Department of Government Efficiency

Requester: Ulmer, Alexandra

I request access to and copies of any and all electronic correspondence (i.e., email) received by or originating from Sylvia Burwell regarding corporate board of director positions. The requested correspondence would likely have been received by Mrs. Burwell or originate from Mrs. Burwell between June 9, 2014 and Jan…

Requester: Greene, Daniel

In my capacity as counsel for Hologic and Focal Therapeutics (since acquired by Hologic) I am seeking to certify six 510k application files, five clearance letters, and three establishment inspection reports. I have copies of all documents (referenced in the attached index) and need the FDA FOIA office to certify the …

Requester: Sarah Engell - Arnold & Porter

I am requesting the contact information for the CMV’s Office of New Animal Product Evaluations, specifically contact information for who determines what drugs be classified as an over the counter or RX drug. This request is on behalf of my dog (Pot Roast) in regards to an nonsteriod anti-inflammation drug named Carp…

Requester: Sarah Baggech - None

Requesting any or all complaints and grievances made against Heartland Health Care Center Hannahan, 1800 Eagle Landing Blvd., Hannahan, South Carolina 29410, within the previous ten calendar years.

Requester: Sophia, Katharyn

Douglas Dynamics, Inc

Requester: Gavin, J. Patrick

Latest approved Prescribing Information leaflet (PIL) of RLD- ELIMITE (N019855)

Requester: Santosh Gawas - KLM Laboratories Private Limit

Dell Technologies, Inc

Requester: Gavin, J. Patrick

This letter constitutes a request under the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, et seq. Pursuant to the FOIA, I request access to and copies of the following records: — All communications, including but not limited to emails, from the Federal Aviation Administration’s Aviation Safety office and/or Of…

Requester: Ogozalek, Sam

Request all the names of commissioned Public Health Officers (physicians, pharmacists. And physician assistants), both MDs and DOs to include: 1) Full Name (last, first, middle initial), 2) Position Title, 3) Title of Facility, 4) Official Duty Station (to include complete mailing address), 5) Category (physician, pha…

Requester: Sabatino, Diana

I am working on a project with the University of Utah. I am looking for a copy of the510(k), K112267, in addition to the summary that is available on the FDA website.

Requester: Santosh Bhagat

Definitive Healthcare Corp

Requester: Gavin, J. Patrick

I am working on a project with the University of Utah. I am looking for a copy of the 510(k), K230794, in addition to the summary that is available on the FDA website.

Requester: Santosh Bhagat

Ramboll Environ US Corporation (Ramboll Environ) is seeking environmental information regarding facility located at 30653 and 30651 FM 529 in Brookshire, Texas. (Date Range for Record Search: From 01/09/1901 To 01/30/2017)

Requester: DeVito, Lauren

Please provide me with a copy of my Substantial Equivalence Report submission for all my brands ( All American Brands Inc. _x000D_ Is there anyway we can expedite this request my contact info is 213-447-4678 and emailed is sbrahib@gmail.com I am the owner of the submission

Requester: Sandy Rahib - All American Brands Inc.

— All emails sent by and received by Brandon Roberts, executive director of the Federal Aviation Administration’s Office of Rulemaking, from 8 a.m. Eastern time 02/03/2025 to 11:59 p.m. Eastern time 02/04/2025. Please search all email inboxes assigned, issued and/or used by Roberts. Provide all responsive file attac…

Requester: Ogozalek, Sam

Request additional search for nominations for membership on the CFSAC received between January 2, 2015 and May 13, 2016, already received records for the following: Dr. Cindy Bateman, Dr. Nancy Klimas, Dr. Lenny Jason, and Mary Dimmock. Dr. Ken Friedman's name was excluded from the previous records.

Requester: Spotila, Jennifer

Could you please provide all cause neutropenia (including degree of severity) from the Clozaril (Clozapine) Patient Monitoring System for each year data was collected?

Requester: Samantha Larsen - RTW Investments

requesting a copy of an FAA-approved Part 141 Single Engine Seaplane (SES) add-on training program. Specifically, requesting: A copy of any currently or previously FAA-approved Part 141 Single Engine Seaplane (SES) add-on course syllabi, such as the current certificate holder #S86S877K, or similar. Any associated doc…

Requester: Closi, Peter

1. Certified copies of the STC file for STC No. SA01476WI; 2.Flight manuals, maintenance manuals, operator’s manuals, documents concerning flight tests, certification studies, reports, data, photographs, videos, correspondence, memoranda, email and/or other documents whose subject matter is STC No. No. SA01476WI; and …

Requester: Devers, Cynthia

Could you please provide the NDA and FDA review package for Clozaril?

Requester: Samantha Larsen - RTW Investments

Could you please provide patient summary data for frequency of neutropenia, agranulocytosis, and leukopenia from the Clozaril (Clozapine) Patient Monitoring System for each year data was submitted to the FDA?

Requester: Samantha Larsen - RTW Investments

Ramboll Environ US Corporation (Ramboll Environ) is seeking information regarding the facility located at 43253 Old Houston Highway in Prairie View, TX. I am seeking information pertaining to environmental matters at the site, including, but not limited to, information regarding underground storage tanks, above ground…

Requester: DeVito, Lauren

1. Certified copies of the STC file for STC No. SA01805SE, main gear gravel deflectors; _x000D_ 2. Flight manuals, maintenance manuals, operator’s manuals, documents concerning flight tests, certification studies, reports, data, photographs, videos, correspondence, memoranda, email and/or other documents whose subject…

Requester: Devers, Cynthia

Could you please provide the full documentation for the Zyprexa FDA review. We have gone through the published review document and are specifically looking for the hematological analysis (complete blood counts) completed on a weekly basis for each study that formed the primary safety database. These data are not inclu…

Requester: Samantha Larsen - RTW Investments

Request any service records for (b)(6), service time 9/10/1988 12/31/2015

Requester: Hinds, Tina

Dana, Inc

Requester: Gavin, J. Patrick

1. Certified copies of the STC file for STC No. SA4651NM, main gear gravel deflectors; _x000D_ 2. Flight manuals, maintenance manuals, operator’s manuals, documents concerning flight tests, certification studies, reports, data, photographs, videos, correspondence, memoranda, email and/or other documents whose subject …

Requester: Devers, Cynthia

Children's Place, Inc

Requester: Gavin, J. Patrick

We are seeking for the 510k submission documents for K243750. I am willing to pay fee no more than $200. We prefer obtain the 510k submission documents by email.

Requester: Sally He - Micro-Tech (Nanjing) Co., Ltd.

Request for a copy of my Independant Medical Evaluation Report conducted on January 19, 2017 at 9:00 am.by the following provider: Deborah J. Mazzarella, PSYD, ABPP 6716 Patterson Avenuel Richmond, VA 23226@9am._x000D_ Referral Number: 3908998.1.2. In addition please include all documents provided to Deborah J. Mazzar…

Requester: b(6)

1. Certified copies of the STC file for STC No. SA02271AK, nose gear gravel deflector; 2. Flight manuals, maintenance manuals, operator’s manuals, documents concerning flight tests, certification studies, reports, data, photographs, videos, correspondence, memoranda, email and/or other documents whose subject matter …

Requester: Devers, Cynthia

We are seeking for the 510k submission documents for K171886. I am willing to pay fee no more than $200. We prefer obtain the 510k submission documents by email.

Requester: Sally He - Micro-Tech (Nanjing) Co., Ltd.

This request is for a copy of any and all documents relating to complaints and enforcement actions against covered entities and their business associates for over charging for copies of electronically maintained protected health information requested under the HITECH act. This request is made for any complaints and e…

Requester: Salvo, Brean

Cardinal Health, Inc

Requester: Gavin, J. Patrick

Form 483 issued to Sun Pharma post the USFDA inspection of the company's site at Halol in June 2025

Requester: Saion Mukherjee - Nomura Financial Services, Ind

A copy of the unredacted 2011 Radio Commission on Aeronautics study report No. RTCA DO-329.

Requester: Ravnitzky, Michael

March 2013 Warning letter from the FDA to Stryker Corporation from a November 2012 inspection at the Portage, Michigan plant citing multiple manufacturer violations. (Date Range for Record Search: From 11/1/2012 To 3/31/2013)

Requester: Bullard, Nancy

Bioequivalence study data submitted in support of ANDA approval for Unichem Pharmaceuticals’ guanfacine hydrochloride 1¿mg immediate-release tablet and Ajanta Pharmaceuticals guanfacine hydrochloride 1¿mg immediate-release tablet referencing Tenex® as the RLD in both cases.”_x000D_ _x000D_ Please provide:_x000D…

Requester: Saadet Ulas Acikgoz - Saadet Ulas Acikgoz

Balchem Corp

Requester: Gavin, J. Patrick

Two FDA Maude Reports: Report No. MW5027653 request the entire case file for this Device Report, including all documents, memos, photos, investigations, notes, emails and other forms of communication, and other ancillary reports separately related to it. and Report No. 1811755 2012 04221 request the entire case fi…

Requester: Bullard, Nancy

Apollo Global Management, Inc

Requester: Gavin, J. Patrick

Requesting copy of any or all documents regarding HHS relationship with UNOS Review and Recommendations Life Alliance Organ Procurement Organization inclusive to University of Miami and Jackson Memorial Hospitals.

Requester: Harty, Mary

Amerisafe, Inc

Requester: Gavin, J. Patrick

requesting in electronic format "Civil Penalty Quarterly Reports" for the calendar year 2024. These records are described by the FAA as a compilation of enforcement actions by the Federal Aviation Administration against regulated aviation entities that are closed with either a civil penalty or issuance of a certificat…

Requester: Leonard, Matthew

Jessica Peltz Zatulove of Hannah Grey Ventures, LLC

Requester: Kirk, Alex

We Laboratoire CCD are requesting access to specific records related to our 510(k) clearance K894259 for our medical device: RIGISTER device, that we manufacture. In particular, we seek:_x000D_ -A copy of the original 510(k) submission file for K894259, including s and product code assignment documentation;_x000D_ -…

Requester: Rym KACI - LABORATOIRE CCD

requesting all ATC audio listed below for the incident that took place on May 24, 2019 Aircraft: Cessna 560 Registration N832R Location: Atlantic Ocean: 1. Report Date: May 30, 2019, Report No. 19-003-ZTL , Reporting Facility: St. Louis Lambert TRACON (T75) 2. Report Date: May 31, 2019 Report No.: 19-003-ZTL Reportin…

Requester: Mayorga, Valeria