Text :: Skip Nav ::
State and federal agencies are usually happy to comply with FOIA requests, although we should point out that our collective experience has been mixed, ranging from cheerful friendly responses within a week to surly delayed responses taking years to complete. Refusal to release records is rare, but interminable waits are not. Private organizations tend to vary wildly in their policies. Based on our experience we offer information, suggestions, and tips to increase the likelihood your FOIA request will produce useful, complete information in a timely fashion. We also suggest what to avoid and why.
Key point to remember: when making a request under the Freedom of Information Act, you're requesting access to records. On this page we use the terms
information interchangably. When communicating with state or federal agencies you should consistently refer to
• Make sure the information you want isn't public information available at the time of your request.
Federal agencies can legitimately refuse to send you public records/information in the public domain at the time of your request. For example, if an agency's FOIA policy is posted on their website, the agency generally not provide you with a copy of it. By law the agencies are required to maintain
Reading Rooms where documents released under and otherwise related to FOIA are collected. Reading Rooms often have an online equivalent – look for the
Electronic Reading Room or
EFOIA on government web sites, and check carefully to make sure the information you want isn't already available. The FDA web site maintains an excellent collection online, as does the Securities and Exchange Commission. For FDA records, see if the information you want is already indexed and linked on our web site. Check the following pages at CIRCARE:
FDA Warning Letters to Institutional Review Boards (IRBs)
FDA Warning Letters to Clinical Investigators (A – E)
FDA Warning Letters to Clinical Investigators (F – L)
FDA Warning Letters to Clinical Investigators (M – R)
FDA Warning Letters to Clinical Investigators (S – Z)
FDA Warning Letters to Sponsors and Contract Research Organizations (CROs)
Form FDA 483s Notices of Inspectional Findings
Office For Human Research Protections / Determination Letters
Previous FOIA Disclosures page
FDA Information Resources
• If you want records held by U.S federal agencies try to find out if the agency previously released the records you want to another party.
Federal agencies maintain FOIA logs of requests received. The logs identify the requester, records requested, dates of request receipt and disclosure, and the FOIA case or control number assigned to the request. If the records you want have been previously disclosed you can use this information, in particular the agency FOIA case or control number, to file your own FOIA request. As a rule disclosure is very quick and invariably quicker than filing a de novo request. The trick of course is finding agency FOIA logs, so try the following:
By phone or in person — identify the appropriate agency FOIA officer, telephone her and ask if she will look through the FOIA logs to help you locate a relevant FOIA case number. If possible tell the FOIA officer you're asking for assistance to expedite your request. Some agencies won't do this while others will. If the agency refuses to do this, ask if you can do it in person. For example you can go to the FDA Dockets office and search their FOIA logs. Obviously telephoning works best for a relatively small request and one where you're able to explicitly identify the records you want.
If you're reasonably sure the records you want haven't already been disclosed, your next step is to figure out where the records are and how to request copies of them.
• Send your request to the correct person or office.
An agency or institution is under no obligation to comply with FOIA requests sent to the wrong office or employee. Check the web site or telephone and ask for the name and address of the person to whom FOIA requests should be sent. In our experience most, but not all, organizations will re-direct your request to the correct office or tell you how do this.
• Make sure your request is legible.
• Type your correspondence if possible.
• Use standard business format for addressing.
• Include your full address, daytime telephone number, and email address. Provide a fax number if possible.
• Clearly indicate your letter is a request under the Freedom of Information Act. Include a sentence above the salutation likeRequest for Information Under the Freedom of Information Actin bold-face or underlined text.
FOIA officers are human beings and often swamped with requests and hampered by arcane filing systems. To the extent your request is intelligible and provides contact information in the event clarification is necessary, you'll minimize delay.
• Write a civil business-like letter avoiding language that could be interpreted as libelous or threatening.
Requests for records under the Freedom of Information Act are themselves subject to disclosure under the act. These are generally referred to as
reverse FOIA requests. As noted above, your name, organization (if any), and records requested become part of agency FOIA logs.
Do not make accusations or statements in a FOIA request that essentially or actually libel an individual or organization. If you're angry or upset, put the request aside for a few days or ask a trusted friend to read it before you send it. Re-read your letter of request before sending it. If you would be embarrassed (or worse) if the request was made public, considering editing it.
• Indicate the amount of money you're willing to pay and ask to be contacted if (or when) the cost of your request is more than this. Generally speaking, a FOIA request for a single record might indicate the requester is willing to pay up to $25; a request for multiple records (e.g.,All records related to Sam's Widgets, Inc. between 1990 and 2006) might indicate you're willing to paying up to $250, depending upon the number of records and their size. Federal agencies charge nonprofit organizations and consumers lower fees, so don't forget to indicate this where applicable.
You should expect to pay reasonable fees for copying and the time it takes staff to locate records. If you make a request that's likely to include several hundred pages of records, decide how much you can afford to pay and ask the agency or organization to contact you when (or if) charges reach this amount. Some federal agencies will do this automatically when fees hit $250; others don't. If cost is a concern it's safer to specify in advance how much you're willing to pay. Costs range from nothing to thousands of dollars, and as a rule federal agencies charge less than private organizations. In fact some federal agencies don't charge anything for requests totaling less than a certain amount ($10, for example) because such requests cost more to bill than can be recouped in fees.
While uncommon, it's not unheard of for an institution to try to dissuade FOIA requests with outrageous fees. If you receive an estimate so astronomical that no private citizen could realistically afford to pay it, inspect the estimate carefully. How many pages are there? How many hours will it take to locate the information and what is the hourly rate for this? Is this a standard fee at the institution or agency? Find the per-page copying fee — is it appropriate? Most agencies and institutions allow
reasonable charges for copying. Keep in mind that
reasonable may be significantly more than you pay for copying at your local office supply store. Do these charges add up? What is the institutional FOIA policy? Can you appeal FOIA charges at a later date? If, after considering these things and asking for clarification, you still find the price out of reach, there are several options. Consider how to pare down your request by figuring out which, if any, of the records requested are likely to be refused or disclosed with so many redactions as to amount to non-disclosure. In theory an institution could present you with a bill for several hundred blank pages of redacted records. If you genuinely believe an institution is using FOIA charges to prevent disclosure of something particularly messy, it's probably time to seek help from state or federal regulatory agencies, the media, or your elected representatives.
• Describe the information you want as fully and concisely as possible.
• Specify the information you're requesting by identifying or describing the records you want; use full names and titles for individuals; specify a date or range of dates where possible, and if you want any and all available records, indicate this.
• Identify the record(s) you're requesting by name whenever possible.
• Indicate whether you prefer electronic or paper records, or if you're willing to accept records in any media. Keep in mind agencies are not obligated to provide records in your choice of media.
• To speed up the process, ask that records to be disclosed on an as available basis.
The single most important thing to keep in mind when making a FOIA request is that the Freedom of Information Act pertains to records, rather than to information per se. To get information under FOIA, you have to request records that contain the information you want. Identifying records is easier said than done, and often requires familiarity with a specific industry, agency, and applicable regulations. Agencies and private institutions comply with FOIA requests by releasing records, and to a lesser extent, by answering specific questions. Ideally FOIA requests should identify records (documents) wanted. If there is a name for the form you seek, do try to use the full and correct name of the form, for example
Form FDA 1572 Statement of Investigator. If in doubt, call the agency and ask before you send your request. It's always preferable to ask for records, but if you must ask questions, make sure the questions are likely to elicit factual answers.
For example, a request asking
Why did you conduct this ghastly clinical trial is likely to yield unhelpful information (
Because the IRB approved it may be factually accurate, but useless). Such a request might be rejected because it does not ask for records or documents. A request for institutional review board meeting minutes, complete study protocol, consent form, associated attachments, including all versions of same, study budget, annual reviews, and all correspondence between the investigator and IRB is a comprehensive description of records related to the study you're interested in. Whether or not an institution would release any or all of these records is anyone's guess. If you want as much information as possible, include a request for
All correspondence in any media reasonably related to X. State laws differ in terms of what information can be released. Generally speaking, it's easier to get information under FOIA from federal agencies than from private institutions.
Federal agencies are generally very helpful about identifying records and explaining which records can be disclosed. When you're uncertain about what records exist or the names of records, call and ask before making your request. Federal agencies publish FOIA policies and related information on their web sites, and there is often a telephone number for questions about FOIA requests. In any case you should briefly consult the FOIA policy of an agency or institution before you make a request.
• Expect some redactions and refusals.
Agencies and institutions are legally prohibited from disclosing certain information, or disclosing it without permission from the relevant parties. Broadly speaking, you won't get proprietary information or anything that could be considered a trade secret, educational records, information related to an open investigation, personal or financial information (including salaries, personnel records, medical records, and social security numbers), unrelated third-party information, or information submitted to agencies in confidence.
• Find out what records (if any) were refused, and why.
To make sure you know about any records that were withheld and the basis upon which they were withheld, include a sentence in your request like
If the agency decides to withhold any record(s) or redact any information from the record(s), please identify the legal basis you assert for each such decision. A list of records and information withheld or redacted and the legal basis for same is called a Vaughn Index.
• Read between the lines.
A response indicating that
No records exist responsive to your request is disappointing, but differs from a response in which an agency or institution refuses to disclose multiple records requested or parts thereof. If you submitted a comprehensive request for records related to a particular study (see above), the latter response suggests the study at least went through IRB review and approval, while the former suggests serious non-compliance. To whatever extent possible, you should try to figure out what records should exist in terms of applicable federal regulations before you make a FOIA request.
In the Addresses section below we list records you might want to ask for in FOIA requests related to research. Once an agency receives your request, you'll receive a letter indicating this and assigning your request a case number. You'll usually get this letter several weeks after you file a FOIA request, but don't get too excited because it's often many weeks weeks if not months until you receive the actual records. If you feel you've waited too long, send a letter of inquiry. If this doesn't get results, send a second letter with copies to your senator and congressional representative if you've made a request to a government agency. Include the FOIA case number assigned to your request in all correspondence. If this fails, you're left with the option of filing a lawsuit. The costs involved make such litigation impossible for most individuals.
• Consider using a professional FOIA service.
Several companies offer FOIA retrieval services for a flat fee, and some offer free consultations. If time is short and cost isn't a major constraint, professional help can be a good choice. One such company is linked on our Previous FOIA Disclosures page (e.g., FOI Services Inc., because their web site has useful resources); you can find other providers by searching the web for
• If you disagree with the disclosure decision you have the right to appeal it. You will loose your right to appeal, however, if you don't follow instructions precisely. Federal agency FOIA responses provide directions for making appeals. If no instructions are provided immediately contact the agency and request instructions for appeal. There is virtually always a date by which you must appeal or you loose your right to do so. An appeal should contain a clear statement of why you believe the agency should disclose the records you seek.Should disclosehere applies to disclosure exemptions in the Freedom of Information Act and the agency's interpretation of them. Some appeals are likely to be straightforward while others will turn on fine points of law. You may wish to consult an experienced attorney and you should expect to pay a fee for her professional service unless you can find pro bono representation. Before you decide to consult an attorney you might want to check out Public Citizen's excellent FOIA resources: http://www.citizen.org/litigation/free_info/. Then spend some time searching the internet for FOIA websites, especially those with forums. With luck the experience of others may help you.
The Reporters Committee for Freedom of the Press (RCFP) has an on-line FOI letter generator that asks for basic information and produces a letter to download and print.
RCFP FOI Letter Generator: http://www.rcfp.org/foi_letter/generate.php
Below is a simple model letter for making a request under the Freedom of Information Act. There is no single best model for writing FOIA requests and you shouldn't feel obligated to follow our model.
CIRCARE sample FOIA request (Microsoft Word® file): http://www.circare.org/FOIA/samplefoiarequest.doc
To download free viewers for Microsoft Access®, Excel®, Powerpoint®, and Word® files follow this link to Microsoft Office® Online
CIRCARE sample FOIA request (PDF file): http://www.circare.org/FOIA/samplefoiarequest.pdf
Office For Human Research Protections (OHRP)
Public Health Service FOIA Office
Parklawn Building, Room 17-66
5600 Fishers Lane
Rockville MD 20857
Phone: (301) 443-5252
You may also send your request via email to email@example.com or by fax to (301) 443-0925
Source: OHRP FOIA Requests — Freedom of Information Act. Accessed on 2010-09-12 at: http://www.hhs.gov/ohrp/about/#foia
U.S. Food and Drug Administration (FDA)
Food and Drug Administration
Division of Freedom of Information (HFI-35)
Office of Shared Services
Office of Public Information and Library Services
5600 Fishers Lane
Rockville, MD 20857
Questions related to FDA FOI requests should be directed to the Division of the Freedom of Information Offices at: (301) 827-6567
FDA FOIA requests should be sent by mail or by Fax: (301) 443-1726 or (301) 443-1719
To confirm fax receipt or report fax problems, call: (301) 443-2414
Source: FDA How to Make a FOIA Request. Accessed on 2010-09-12 at: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm
See also: FDA Freedom of Information Home Page
FDA FOIA Contacts, Whom to Contact About FOIA: http://www.fda.gov/RegulatoryInformation/FOI/WhotoContactAboutFOIA/default.htm
Form FDA 483 Notice of Inspectional Findings. A list of violations and objectionable conditions provided to sponsors, investigators, institutional review boards (IRBs), and organizations after inspection.
Form FDA 483 example: Form FDA 483 Issued to Alkis Togias M.D., Johns Hopkins Asthma & Allergy Clinic. 2001-06-28. Available from http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/ucm064082.htm
FDA Establishment Inspection Reports (EIRs). Narrative report of inspectional findings. Copies of records made during FDA inspections are included in the List of Exhibits at the end of EIRs. If you want records in an EIR's List of Exhibits, indicate you want the
Establishment Inspection Report and all records in the List of Exhibits.
FDA EIR example: FDA Establishment Inspection Report (EIR), Great Lakes College of Clinical Medicine IRB. 1999-12-01. Available from http://www.circare.org/foia2/glccm_fdaeir19991201.pdf
Hint: Form FDA 483s are relatively short, perhaps two to five pages. FDA EIRs are long detailed reports (35 to 100 pages). The fee you're charged for a FOIA request may include per-page copying fees so try to decide how much information you really need.
FDA Warning Letters.
A Warning Letter is an informal advisory, to a firm or clinical investigator, communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. A Warning Letter is issued for significant regulatory violations that require prompt and adequate corrective actions. FDA Center for Drug Evaluation and Research, Division of Scientific Investigations. Accessed 2010-09-12 at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm
Hint: For FDA warning letters issued after November, 1996 see the CIRCARE indices (above) of alphabetized warning letters issued to clinical investigators, institutional review boards (IRBs), sponsors and contract research organizations (CROs).
To find dates and results of FDA inspections of clinical investigators in drug studies conducted under Investigational New Drug applications (INDs) use the FDA Center for Drug Evaluation and Research (CDER) Clinical Investigator Inspection List search or download the data file. To find FDA inspections of clinical investigators in biologic studies (cell and tissue-derived products, vaccines, products tested in gene transfer research, etc.), consult the FDA Center for Biologic Research and Evaluation Clinical (CBER) Investigator Inspection List.
FDA Center for Drug Evaluation and Research (CDER) Clinical Investigator Inspection List Advanced Search: http://www.accessdata.fda.gov/scripts/cder/CLIIL/index.cfm?fuseaction=Search.ShowAdvancedSearchForm
FDA Center for Drug Evaluation and Research (CDER) Clinical Investigator Inspection List File Download: http://www.fda.gov/Drugs/InformationOnDrugs/ucm135198.htm
FDA Center for Biologic Research and Evaluation Clinical (CBER) Investigator Inspection List: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/UCM167052.pdf
Help! I still don't know what FDA records to ask for.
To find documents and records created by FDA related to inspection, compliance, and enforcement activities, try the following:
Browse the FDA Office of Regulatory Affairs Investigations Operations Manual (2004): http://www.fda.gov/ICECI/Inspections/IOM/default.htm. In particular chapters 5,Establishment Inspections,and 9,Investigations,to get an idea of what information FDA collects.
Consult the FDA Investigations Operations Manual'sList of Exhibitsto find the name of specific FDA forms on which information gathered during inspection is recorded: http://www.fda.gov/ICECI/Inspections/IOM/ucm127372.htm
FDA Inspections Guide: http://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm
FDA Office of Regulatory Affairs: http://www.fda.gov/AboutFDA/CentersOffices/ORA/default.htm
To locate information/records submitted to FDA, try the following, keeping in mind that not all of them are subject to disclosure under FOIA:
FDA Forms Distribution Page: http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm
Find Drug Approval Packages (redacted New Drug Applications with FDA reviews): http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ (Click on the link for the name of drug, selectApproval History, and thenReview)
NIH FOIA requests are handled by the coordinator(s) of the NIH institute or center that funded (or sponsored) the research. Consult the list of names and addresses of NIH Freedom of Information Office Coordinators and send your request to the NIH FOIA coordinator for the NIH institute or center that funded the research in which you're interested: http://www.nih.gov/icd/od/foia/coord.htm
NIH FOIA requests will be processed more quickly if you include the complete study title, grant award identification number(s), and the name of the principal investigator and institution.
Use the NIH RePort database to find grant award identification numbers and titles of studies: http://report.nih.gov/rcdc/categories/
If you don't know which institute or center funded the research, you should be able to find this information by searching for the name of the principal investigator in the NIH RePort database: http://report.nih.gov/rcdc/categories/
Hint: If you have little or no information, set the default search options toall.
Try searching for the principal investigator or her institution in the annual listing of NIH Extramural Awards by State & Foreign Site (Archived page): http://web.archive.bibalex.org/web/*/http://grants1.nih.gov/grants/award/state/state03.htm
If you know the study title, try searching the NIH Guide: http://grants1.nih.gov/grants/guide/index.html
You may be able to find information by searching ClinicalTrials.gov: http://www.clinicaltrials.gov/ct/screen/SimpleSearch
You can find clinical trials sponsored by NIH using ClinicalTrials.gov Focused Search. Click the box for NIH in theSupported Byfield: http://www.clinicaltrials.gov/ct/screen/AdvancedSearch
You can browse clinical trials by NIH center or institute: http://www.clinicaltrials.gov/ct/screen/BrowseAny?path=%2Fbrowse%2Fby-sponsor%2FNIH&recruiting=true
Hint: to find clinical trials that are completed or no longer recruiting subjects, check the box labeledInclude trials that are no longer recruiting patients.
Hint: at the bottom of the study registration is a link titledHistory of Changes. Most of the time you can identify investigators and study sites that no longer appear in the study registration.
Also useful are:
If you still can't locate information contact the NIH FOIA coordinator for the most likely NIH institute or center and ask for assistance before you send a request. Time and again it's been our experience that that FOIA officers are glad to help.
Grant applications (also called
PHS 398 forms), study protocols, consent forms, and grant award records.
Hint: Specify that you want the
final version of the study protocol in case changes were required.
Rosters of reviewers for Study Sections or Special Emphasis Panels.
Current reviewer rosters for permanent Study Sections and current (e.g., 30 days) Special Emphasis panels: http://www.csr.nih.gov/Committees/rosterindex.asp
Last Updated: 2010-09-12
If you find the information on this page helpful, please support CIRCARE with a tax-deductible contribution today. Because CIRCARE doesn't accept funds from pharmaceutical or medical device manufacturers, we depend on contributions from individuals like you to help us advocate for meaningful protection of human subjects in research. Donating is quick and easy. Find out more on our Support page
All material on this site © CIRCARE Incorporated (2002- ) or as indicated. Single copies can be downloaded for personal education. Adobe® Reader :: ::