[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: 21CFR20.63]
[Page 202]
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 D Exemptions
Sec. 20.63 Personnel, medical, and similar files, disclosure of which
constitutes a clearly unwarranted invasion of personal privacy.
(a) The names or other information which would identify patients or
research subjects in any medical or similar report, test, study, or
other research project shall be deleted before the record is made
available for public disclosure.
(b) The names and other information which would identify patients or
research subjects should be deleted from any record before it is
submitted to the Food and Drug Administration. If the Food and Drug
Administration subsequently needs the names of such individuals, a
separate request will be made.
(c) Requests for deletion of business or product names prior to
disclosure of any record to the public shall not be granted on the
ground of privacy, but such deletion may be justified under another
exemption established in this subpart, e.g., the exemption for trade
secrets and confidential commercial or financial information under Sec.
20.61.
(d) Names of individuals conducting investigations, studies, or
tests on products or ingredients shall not be deleted prior to
disclosure of any record to the public unless extraordinary
circumstances are shown.
(e) A request for all records relating to a specific individual will
be denied as a clearly unwarranted invasion of personal privacy unless
accompanied by the written consent of the individual named.
(f) The names and any information that would identify the voluntary
reporter or any other person associated with an adverse event involving
a human drug, biologic, or medical device product shall not be disclosed
by the Food and Drug Administration or by a manufacturer in possession
of such reports in response to a request, demand, or order. Information
that would identify the voluntary reporter or persons identified in the
report includes, but is not limited to, the name, address, institution,
or any other information that would lead to the identities of the
reporter or persons identified in a report. This provision does not
affect disclosure of the identities of reporters required by a Federal
statute or regulation to make adverse event reports. Disclosure of the
identities of such reporters is governed by the applicable Federal
statutes and regulations.
(1) Exceptions. (i) Identities may be disclosed if both the
voluntary reporter and the person identified in an adverse event report
or that person's legal representative consent in writing to disclosure,
but neither FDA nor any manufacturer in possession of such reports shall
be required to seek consent for disclosure from the voluntary reporter
or the person identified in the adverse event report or that person's
legal representative; or
(ii) Identities of the voluntary reporter and the person who
experienced the reported adverse event may be disclosed pursuant to a
court order in the course of medical malpractice litigation involving
both parties; or (iii) The report, excluding the identities of any other
individuals, shall be disclosed to the person who is the subject of the
report upon request.
(2) Preemption. No State or local governing entity shall establish
or continue in effect any law, rule, regulation, or other requirement
that permits or requires disclosure of the identities of the voluntary
reporter or other person identified in an adverse event report except as
provided in this section.
[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 16968, Apr. 3, 1995]
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