What a company can keep out of a public file

The word confidential on a page does nothing by itself

Section 20.27 of title 21 says this in one sentence, and it is worth reading in full because the list at the end is longer than most people expect.

Marking records submitted to FDA as confidential, "or with any other similar term, raises no obligation by the Food and Drug Administration to regard such records as confidential." The same sentence adds that there is no obligation "to return them to the person who has submitted them, to withhold them from disclosure to the public." Nor to "advise the person submitting them when a request for their public disclosure is received or when they are in fact disclosed."

So the stamp does not create a duty to treat the file as secret, a duty to give it back, a duty to withhold it, or even a duty to say when it went out.

The reason this matters beyond agency filings is that the same instinct shows up everywhere. A watermark is a wish. What protects a document is a rule that names it.

Confidentiality is created by regulation, not by agreement

Section 20.28 states where a protection actually comes from.

A determination that submitted data "will be held in confidence and will not be available for public disclosure shall be made only in the form of a regulation published or cross-referenced in this part."

That is a narrow channel. Not a letter, not an assurance from a reviewer, not a term in a contract with the agency. A published or cross-referenced regulation.

It also explains why part 20 has a whole subpart cataloguing specific document types. Those cross-references are how a category gets its status settled in advance rather than argued case by case.

And the file cannot be taken back

Section 20.29 is two sentences long. "No person may withdraw records submitted to the Food and Drug Administration."

The second sentence explains what happens instead. "All Food and Drug Administration records shall be retained by the agency until disposed of pursuant to routine record disposal procedures."

A submission is therefore a one-way action. Whatever protections apply, apply to a document the agency now holds.

What a submitter can actually do: designate

The real mechanism sits inside section 20.61, the trade secret exemption, at paragraph (d).

A person submitting records to the government "may designate part or all of the information in such records as exempt from disclosure under exemption 4 of the Freedom of Information Act."

The timing is flexible but not open-ended. The designation may be made "either at the time the records are submitted to the Government or within a reasonable time thereafter."

The form is not flexible. "The designation must be in writing."

And it does not last forever. "Any such designation will expire 10 years after the records were submitted to the Government."

What happens when somebody asks for the file

Paragraph (e) of section 20.61 sets out the sequence, and it runs on short clocks.

When FDA receives a request for designated records "and determines that disclosure may be required," it "will make reasonable efforts to notify the submitter about these facts." The notice includes a copy of the request and explains the procedure and time limits.

The submitter then "has 10 working days from the date of the notice to object to disclosure of any part of the records and to state all bases for its objections." That period can be extended.

If the agency decides to disclose anyway, it notifies the submitter in writing, briefly explains why the objections were not sustained, and includes a copy of the records as it proposes to disclose them.

Then the second clock starts. The notice "will state that the Food and Drug Administration intends to disclose the records 5 working days after the submitter receives the notice unless a U.S. District Court orders the agency not to release them."

Five situations where no notice is given at all

Paragraph (f) lists them, and two are worth a reader's attention.

No notice is required where FDA "decided not to disclose the records," or where "The information has previously been published or made generally available."

No notice is required where disclosure is required by a regulation issued after notice and comment that specifies narrow categories of records to be disclosed.

And there is one that punishes silence. No notice is required where "The information requested has not been designated by the submitter as exempt from disclosure when the submitter had an opportunity to do so." The exception is where the agency has substantial reason to believe disclosure would cause competitive harm.

A frivolous-looking designation still gets a written notice, though a shorter one that need not explain the decision or include the records.

When the status is genuinely unclear

Section 20.47 covers the uncertain case. Where confidentiality "is uncertain and there is a request for public disclosure," FDA "will consult with the person who has submitted or divulged the data or information or who would be affected by disclosure." That consultation happens "before determining whether or not such data or information is available for public disclosure."

Section 20.48 says what that consultation leads to. Where FDA consults under section 20.47 and rejects the request to withhold, "the decision constitutes final agency action that is subject to judicial review."

The window is short and specific. The affected person "will be permitted 5 days after receipt of notification of such decision within which to institute suit in a United States District Court to enjoin release of the records involved."

If suit is filed, the records stay put. FDA "will not disclose the records involved until the matter and all related appeals have been concluded."

A claim you do not defend can be treated as waived

Section 20.55 covers the mirror-image case, where FDA has already denied a request on trade secret grounds and the requester sues.

The agency will tell the submitter and "will require that such person intervene to defend the exempt status of the record."

If a court orders the records itemized and indexed, FDA will again inform the submitter "and will require that such person undertake the itemization and indexing of the records."

The consequence of sitting out is stated plainly. Where the affected person fails to intervene and to itemize and index, FDA "will take this failure into consideration in deciding whether that person has waived such exemption." A waiver would "require the Food and Drug Administration to promptly make the records available for public disclosure."

So confidentiality here is not a passive shield. It is a position somebody has to keep showing up to hold.

What a reader should take from this

The machinery is specific, and knowing its shape changes how a few common situations read.

A document handed to a buyer with a confidential banner on it is not thereby confidential in any legal sense the buyer needs to respect. The banner is a request.

A seller who says a test result or a supplier name is protected has described a claim, and claims of that kind are made in writing, defended on deadlines, and can lapse. The designation described in section 20.61 expires after ten years.

And the absence of a document from a public file can mean a designation was made and sustained, or that nobody ever asked. Those are different facts and they look the same.

This page describes the rules as written. It does not describe any company's filings, does not name any seller, and is not legal advice.

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 20.27, Submission of records marked as confidential — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
2. Title 21 Code of Federal Regulations section 20.28, Food and Drug Administration determinations of confidentiality — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
3. Title 21 Code of Federal Regulations section 20.47, Situations in which confidentiality is uncertain — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
4. Title 21 Code of Federal Regulations section 20.48, Judicial review of proposed disclosure — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
5. Title 21 Code of Federal Regulations section 20.55, Indexing trade secrets and confidential commercial or financial information — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
6. Title 21 Code of Federal Regulations section 20.61, Trade secrets and commercial or financial information which is privileged or confidential — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022