How to ask the FDA for a document

The request itself has required contents

Asking for an agency record is a formal act with a specified shape, and getting the shape wrong is the usual reason a request stalls.

All requests must be in writing, by mail, by fax, or through the agency's online submission portal. Each must contain the requester's postal address and telephone number, and the name of the person responsible for paying any fees.

The substance matters more. A request "shall reasonably describe the records being sought, in a way that they can be identified and located."

If the description is not enough to locate the records, the agency notifies the requester and indicates what additional information is needed. It is also required to make every reasonable effort to help identify and locate the records sought.

Once received, the request is entered in a public log recording the date received, the requester's name, the nature of the record requested and the action taken.

The clock, and the thing that does not start it

Timing is the part people misjudge most often, because the clock does not begin when you think it does.

Time limits start when the request is logged in by the disclosure office. Not when it was written, and not when it arrived somewhere else in the agency.

A written request sent elsewhere in the agency starts no clock until it is redirected and logged in. And the rule is blunt about the other route: "An oral request for records shall not begin any time requirement."

From the log-in date the agency has a defined window. "Within 20 working days (excluding Saturdays, Sundays, and legal public holidays)" it must send a letter with its determination on whether and to what extent it will comply, and the reasons for any denial.

That letter is a determination, not necessarily the documents. It may state that records have not all been located, or that a final decision has not been made because someone affected has to be consulted first.

The window can be extended in unusual circumstances. Requests can also be aggregated where the same requester, or a group acting in concert, files clearly related requests that the agency reasonably believes are really one.

Not every request is in the same queue

Two mechanisms decide how fast a request moves, and both are worth knowing before filing.

The first is multitrack processing. Each agency component decides whether to sort requests into tracks by how much work or time they need, and requests are then handled first in, first out within their track.

There is a lever attached to it. Where a request does not qualify for the fastest track, "the requester may be provided an opportunity to limit the scope of the request in order to qualify for faster processing."

The second is expedited processing, which needs a demonstrated compelling need. One route is a threat, where failure to get the records quickly "could reasonably be expected to pose an imminent threat to the life or physical safety of an individual".

That route is narrow about who may use it. The request must come from the individual under threat, a family member, a medical or health care professional, or another authorized representative.

The other route is publication. It requires showing that the requester is "primarily engaged in disseminating information to the general public and not merely to a narrow interest group". It also requires an urgent need whose value would be lost by delay.

Three fee categories, and which one you fall into

Cost depends on why you are asking, not on what you are asking for.

For a commercial use request, "the Food and Drug Administration will charge for the costs of search, review, and duplication." That is the fullest set of charges.

For an educational or noncommercial scientific institution operated primarily for scholarly or scientific research, or a representative of the news media, only duplication is charged. The agency also "will not charge the copying costs for the first 100 pages of duplication".

Everything else falls into a third category, charged for search and duplication but not review.

The fee schedule itself is defined by reference to federal pay grades and steps rather than fixed amounts, with hourly rates keyed to the grade of the employee doing the search or review.

Two rules limit charging. Nothing is charged where collecting and processing the fee would likely cost as much as the fee. And search or duplication fees are not assessed where the agency misses its own time limits, unless unusual circumstances apply and more than five thousand pages are responsive, with a notice and discussion requirement attached.

The waiver test has two halves and both must be met

Fees can be waived or reduced, but the standard is specific and it is conjunctive.

Disclosure must be in the public interest "because it is likely to contribute significantly to public understanding of the operations or activities of the Government". It must also not be primarily in the commercial interest of the requester.

The public interest half is analyzed against four factors. Whether the records pertain to federal government operations or activities. Whether disclosure would reveal meaningful information not already public knowledge.

Whether it advances the understanding of the general public rather than a narrow segment. And whether the contribution to public understanding will be significant.

Inside the third factor sits a sentence that decides a lot of waiver requests. "An unsupported claim to be doing research for a book or article does not demonstrate that likelihood", while the same claim from a representative of the news media is treated as better evidence.

There is also an anti-splitting rule. Where a requester, alone or with others, "is breaking down a single request into a series of requests in order to avoid (or reduce) the fees charged", the requests may be aggregated for fee purposes.

What a denial letter has to tell you

A refusal is not allowed to be a bare refusal, and the required contents are the raw material for an appeal.

A denial in whole or in part is signed by the head of the disclosure office or a delegate.

The letter must set out the name and title or position of each person who participated in the denial, which may be satisfied by attaching a list.

It must state the reasons for the denial, and name the review official and the address for an appeal. It must also state that the appeal must be transmitted "within 90 calendar days from the date of the adverse determination".

The agency also makes a reasonable effort to include an estimate of the volume of records denied, ordinarily as an approximate page count. That estimate is omitted where providing it would itself harm a protected interest, or where the volume is already evident from the redactions on partly released documents.

Contact information for the disclosure public liaison and for the government information services office must be included as well.

Two rules that quietly save money

A pair of provisions are easy to miss and both reduce cost.

The first is format. The agency must make reasonable efforts to provide a record in any requested form or format where it is readily reproducible that way. If it is not, the agency may offer alternatives, and if the requester expresses no preference it chooses.

The second is reviewing without copying. Where the records contain only disclosable information, a requester may review them without copies, and the agency "will charge only for the costs of searching for the records."

Where the records mix disclosable and nondisclosable information, they are first copied with the nondisclosable parts blocked out, and both searching and copying are charged.

The agency also states that requesters may contact its disclosure staff or public liaison to help reformulate a request to meet their needs at lower cost.

What this gets you, and what it does not

For a reader trying to check something about a medicine or a facility, this is the mechanism behind most of the documents that eventually become public.

It is also slow, scoped and priced, and the wording of the request is what determines all three.

A separate provision handles the opposite pressure. Nonspecific requests, or requests for a large number of documents needing substantial staff time, are processed after weighing the public benefit against the diversion of agency resources. The requester will be asked to narrow the request and agree an orderly production procedure.

None of this decides whether a record is disclosable at all. That question is answered by the exemptions and by the category rules, which are covered separately on this site.

Two limits on this article. Only subpart C of part 20 was read, plus the two general provisions on search and on form or format. No request was filed and no portal was exercised, so this describes the rules as written rather than any experience of using them.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 20.40, Filing a request for records, read in full for the required contents and the public log — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
2. Title 21 Code of Federal Regulations section 20.41, Time limitations, read in full for when the clock starts and the twenty working day determination — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
3. Title 21 Code of Federal Regulations section 20.43, Multitrack processing, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
4. Title 21 Code of Federal Regulations section 20.44, Expedited processing, read in full for the two compelling need routes — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
5. Title 21 Code of Federal Regulations section 20.45, Fees to be charged, read for the three request categories, the anti-splitting rule and the pay-grade fee schedule — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
6. Title 21 Code of Federal Regulations section 20.46, Waiver or reduction of fees, read for the two-part standard and the four public interest factors — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
7. Title 21 Code of Federal Regulations section 20.49, Denial of a request for records, read in full for the required contents of a denial letter — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
8. Title 21 Code of Federal Regulations section 20.54, Request for review without copying, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
9. Title 21 Code of Federal Regulations section 20.50, Nonspecific and overly burdensome requests, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003