21 CFR 20.61 - Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process.
(b) Commercial or financial information that is privileged or confidential means valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs.
(c) Data and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.
(d) A person who submits 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 person may make this designation either at the time the records are submitted to the Government or within a reasonable time thereafter. The designation must be in writing. Where a legend is required by a request for proposals or request for quotations, pursuant to 48 CFR 352.215-12, then that legend is necessary for this purpose. Any such designation will expire 10 years after the records were submitted to the Government.
(e) The procedures in this paragraph apply to records on which the submitter has designated information as provided in paragraph (d) of this section. These procedures also apply to records that were submitted to the Food and Drug Administration when the agency has substantial reason to believe that information in the records could reasonably be considered exempt under exemption 4 of the Freedom of Information Act. Certain exceptions to these procedures are set forth in paragraph (f) of this section.
(1) When the Food and Drug Administration receives a request for such records and determines that disclosure may be required, the Food and Drug Administration will make reasonable efforts to notify the submitter about these facts. The notice will include a copy of the request, and it will inform the submitter about the procedures and time limits for submission and consideration of objections to disclosure. If the Food and Drug Administration must notify a large number of submitters, notification may be done by posting or publishing a notice in a place where the submitters are reasonably likely to become aware of it.
(2) The submitter has 5 working days from receipt of the notice to object to disclosure of any part of the records and to state all bases for its objections.
(3) The Food and Drug Administration will give consideration to all bases that have been stated in a timely manner by the submitter. If the Food and Drug Administration decides to disclose the records, the Food and Drug Administration will notify the submitter in writing. This notice will briefly explain why the agency did not sustain the submitter's objections. The Food and Drug Administration will include with the notice a copy of the records about which the submitter objected, as the agency proposes to disclose them. 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.
(4) If a requester files suit under the Freedom of Information Act to obtain records covered by this paragraph, the Food and Drug Administration will promptly notify the submitter.
(5) Whenever the Food and Drug Administration sends a notice to a submitter under paragraph (e)(1) of this section, the Food and Drug Administration will notify the requester that the Food and Drug Administration is giving the submitter a notice and an opportunity to object. Whenever the Food and Drug Administration sends a notice to a submitter under paragraph (e)(3) of this section, the Food and Drug Administration will notify the requester of this fact.
(f) The notice requirements in paragraph (e) of this section do not apply in the following situations:
(1) The Food and Drug Administration decided not to disclose the records;
(2) The information has previously been published or made generally available;
(3) Disclosure is required by a regulation issued after notice and opportunity for public comment, that specifies narrow categories of records that are to be disclosed under the Freedom of Information Act, but in this case a submitter may still designate records as described in paragraph (d) of this section, and in exceptional cases, the Food and Drug Administration may, at its discretion, follow the notice procedures in paragraph (e) of this section;
(4) The information requested has not been designated by the submitter as exempt from disclosure when the submitter had an opportunity to do so at the time of submission of the information or within a reasonable time thereafter, unless the Food and Drug Administration has substantial reason to believe that disclosure of the information would result in competitive harm; or
(5) The designation appears to be obviously frivolous, but in this case the Food and Drug Administration will still give the submitter the written notice required by paragraph (e)(3) of this section (although this notice need not explain our decision or include a copy of the records), and the Food and Drug Administration will notify the requester as described in paragraph (e)(5) of this section.
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 20 after this date.
- 21 CFR 314.430 — Availability for Public Disclosure of Data and Information in an Application or Abbreviated Application.
- 21 CFR 514.11 — Confidentiality of Data and Information in a New Animal Drug Application File.
- 21 CFR 17.28 — Protective Order.
- 21 CFR 571.1 — Petitions.
- 21 CFR 17.33 — The Hearing and Burden of Proof.
- 21 CFR 601.70 — Annual Progress Reports of Postmarketing Studies.
- 21 CFR 171.1 — Petitions.
- 21 CFR 514.87 — Annual Reports for Antimicrobial Animal Drug Sales and Distribution.
- 21 CFR 108.25 — Acidified Foods.
- 21 CFR 601.51 — Confidentiality of Data and Information in Applications for Biologics Licenses.
- 21 CFR 20.117 — New Drug Information.
- 21 CFR 720.8 — Confidentiality of Statements.
- 21 CFR 71.15 — Confidentiality of Data and Information in Color Additive Petitions.
- 21 CFR 170.39 — Threshold of Regulation for Substances Used in Food-Contact Articles.
- 21 CFR 807.3 — Definitions.
- 21 CFR 17.41 — The Administrative Record.
- 21 CFR 860.5 — Confidentiality and Use of Data and Information Submitted in Connection With Classification and Reclassification.
- 21 CFR 120.12 — Records.
- 21 CFR 361.1 — Radioactive Drugs for Certain Research Uses.
- 21 CFR 807.93 — Content and Format of a 510(k) Statement.
- 21 CFR 803.9 — What Information From the Reports Do We Disclose to the Public?
- 21 CFR 516.171 — Confidentiality of Data and Information in an Index File.
- 21 CFR 806.40 — Public Availability of Reports.
- 21 CFR 170.102 — Confidentiality of Information in a Premarket Notification for a Food Contact Substance (FCN).
- 21 CFR 314.81 — Other Postmarketing Reports.
- 21 CFR 100.2 — State Enforcement of Federal Regulations.
- 21 CFR 600.82 — Notification of a Permanent Discontinuance or an Interruption in Manufacturing.
- 21 CFR 809.4 — Confidentiality of Submitted Information.