21 C.F.R. § 20.111

Data and information submitted voluntarily to the Food and Drug Administration

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(a) The provisions of this section shall apply only to data and information submitted voluntarily to the Food and Drug Administration, whether in the course of a factory inspection or at any other time, and not as a part of any petition, application, master file, or other required submission or request for action. Data and information that may be required to be submitted to the Food and Drug Administration but that are submitted voluntarily instead are not subject to the provisions of this section and will be handled as if they had been required to be submitted.

(b) A determination that data or information submitted voluntarily 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.

(c) The following data and information submitted voluntarily to the Food and Drug Administration are available for public disclosure unless extraordinary circumstances are shown:

(1) All safety, effectiveness, and functionality data and information for a marketed ingredient or product, except as provided in § 330.10(a)(2) of this chapter for OTC drugs.

(2) A protocol for a test or study, unless it is shown to fall within the exemption established in § 20.61 for trade secrets and confidential commercial or financial information.

(3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information shall be disclosed as follows:

(i) If submitted by a consumer or user of the product, the record is available for public disclosure after deletion of names and other information that would identify the person submitting the information.

(ii) If submitted by the manufacturer of the product, the record is available for public disclosure after deletion of:

(a) Names and any information that would identify the person using the product.

(b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.

(c) Names and any other information that would identify the manufacturer or the brand designation of the product, but not the type of product or its ingredients.

(iii) If submitted by a third party, such as a physician or hospital or other institution, the record is available for public disclosure after deletion of:

(a) Names and any information that would identify the person using the product.

(b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.

(iv) If obtained through a Food and Drug Administration investigation, the record shall have the same status as the initial report which led to the investigation, i.e., it shall be disclosed in accordance with paragraph (c)(3)(i) through (iii) of this section.

(v) Any compilation of data, information, and reports prepared in a way that does not reveal data or information which is not available for public disclosure under this section is available for public disclosure.

(vi) If a person requests a copy of any such record relating to a specific individual or a specific incident, such request will be denied unless accompanied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Administration and the individual who is the subject of the report. The record will be disclosed to the individual who is the subject of the report upon request.

(4) A list of all ingredients contained in a food or cosmetic, whether or not it is in descending order of predominance, or a list of all active ingredients and any inactive ingredients previously disclosed to the public as defined in § 20.81 contained in a drug, or a list of all ingredients or components in a device.

(5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in § 20.61.

(d) The following data and information submitted voluntarily to the Food and Drug Administration are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61:

(1) All safety, effectiveness, and functionality data and information for a developmental ingredient or product that has not previously been disclosed to the public as defined in § 20.81.

(2) Manufacturing methods or processes, including quality control procedures.

(3) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.

(4) Quantitative or semiquantitative formulas.

(e) For purposes of this regulation, safety, effectiveness, and functionality data include all studies and tests of an ingredient or a product on animals and humans and all studies and tests on the ingredient or product for identity, stability, purity, potency, bioavailability, performance, and usefulness.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25287, May 12, 2003]

Notes of Decisions

Cited in 6 cases, 1986–2015 · leading case: Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993).

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Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993). · cites it 2× “The same confidentiality provisions can be found at 21 C.F.R. § 20.111 (c)(3)(ii)(b) (1991) (data and information submitted voluntarily to the FDA), and 21 C.”

Newsom v. Breon Labs. Inc., 709 S.W.2d 559 (Tenn. 1986). · cites it 2× “See 21 C.F.R. § 20.111 (c)(iii). Defendants assert that disclosure of the identity of the doctors will inhibit the effectiveness of the voluntary reporting system that the Federal Drug Administration and the drug industry rely upon for determining the effectiveness and safety of…”

In Re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 632 F. Supp. 2d 1370 (M.D. Ga. 2009). · cites it 4× “63 (f); 21 C.F.R. § 20.111 ; 21 C.F.R. § 803.9 (b)(3).”

Stahl v. Rhee, 136 A.D.2d 539 (N.Y. App. Div. 1988). “We note that the identities of the reporting sources are exempted from disclosure under the Freedom of Information Act (21 CFR 20.111 [c] [3]). While no New York court has passed on the question of whether the identities of the reporting sources of drug experience reports should…”

Slim-Fast Foods Co. v. Brockmeyer, 627 So. 2d 104 (Fla. 4th DCA 1993). “Petitioner relies in part upon the privilege set forth in 21 C.F.R. § 20.111 (c)(3), which protects against disclosure of identifying information about consumers who file complaints with the Food and Drug Administration (FDA).”

in Re Benevis, LLC, Dentistry of Brownsville, P.C., & Kool Smiles, P.C. (Tex. App. 2015). “regulations themselves permit disclosure under proper court The same confidentiality provisions can be found order, 4 and that the regulations were not meant to and do not at 21 C.F.R. § 20.111 (c)(3)(ii)(b) (1991) (data and information submitted voluntarily to the FDA), and 21…”

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