[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.111]
[Page 215-216]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20 PUBLIC INFORMATION--Table of Contents
Subpart F Availability of Specific Categories of Records
Sec. 20.111 Data and information submitted voluntarily to the Food and Drug
Administration.
(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
Sec. 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 Sec. 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:
[[Page 216]]
(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 Sec. 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 Sec. 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
Sec. 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 Sec. 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 Sec. 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]
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