[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: 21CFR20.89]
[Page 208-210]
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 E Limitations on Exemptions
Sec. 20.89 Communications with foreign government officials.
Communications with foreign government officials shall have the same
status as communications with any member of the public, except that:
(a) Investigatory records compiled for law enforcement purposes by
foreign government officials who perform counterpart functions to the
Food and Drug Administration in a foreign country, and trade secrets and
confidential commercial or financial information obtained by such
officials, which are voluntarily disclosed to the Food and Drug
Administration as part of cooperative law enforcement and regulatory
efforts, shall be exempt from public disclosure to the same extent to
which the records would be so exempt pursuant to Sec. Sec. 20.61 and
20.64, as if they had been prepared by or submitted directly to Food and
Drug Administration employees, except that investigatory
[[Page 209]]
records shall be exempt from disclosure for a longer period of time if
the foreign government officials so require as a condition of their
furnishing the information to the Food and Drug Administration.
(b) Disclosure of investigatory records compiled for law enforcement
purposes by the Food and Drug Administration to foreign government
officials who perform counterpart functions to the Food and Drug
Administration in a foreign country as part of cooperative law
enforcement efforts does not invoke the rule established in Sec. 20.21
that such records shall be made available for disclosure to all members
of the public.
(c)(1) The Commissioner of Food and Drugs, or any other officer or
employee of the Food and Drug Administration whom the Commissioner may
designate to act on his or her behalf for the purpose, may authorize the
disclosure of confidential commercial information submitted to the Food
and Drug Administration, or incorporated into agency-prepared records,
to foreign government officials who perform counterpart functions to the
Food and Drug Administration as part of cooperative law enforcement or
regulatory efforts, provided that:
(i) The foreign government agency has provided both a written
statement establishing its authority to protect confidential commercial
information from public disclosure and a written commitment not to
disclose any such information provided without the written permission of
the sponsor or written confirmation by the Food and Drug Administration
that the information no longer has confidential status; and
(ii) The Commissioner of Food and Drugs or the Commissioner's
designee makes one or more of the following determinations:
(A) The sponsor of the product application has provided written
authorization for the disclosure;
(B) Disclosure would be in the interest of public health by reason
of the foreign government's possessing information concerning the
safety, efficacy, or quality of a product or information concerning an
investigation; or
(C) The disclosure is to a foreign scientist visiting the Food and
Drug Administration on the agency's premises as part of a joint review
or long-term cooperative training effort authorized under section 708 of
the act, the review is in the interest of public health, the Food and
Drug Administration retains physical control over the information, the
Food and Drug Administration requires the visiting foreign scientist to
sign a written commitment to protect the confidentiality of the
information, and the scientist provides a written assurance that he or
she has no financial interest in the regulated industry of the type that
would preclude participation in the review of the matter if the
individual were subject to the conflict of interest rules applicable to
the Food and Drug Administration advisory committee members under Sec.
14.80(b)(1) of this chapter. Subject to all of the foregoing conditions,
visiting foreign scientists may have access to trade secret information,
entitled to protection under section 301(j) of the Federal Food, Drug,
and Cosmetic Act (the act), in those cases where such disclosures would
be a necessary part of the joint review or training.
(2) Except as provided under paragraph (c)(1)(ii)(C) of this
section, this provision does not authorize the disclosure to foreign
government officials of other countries of trade secret information
concerning manufacturing methods and processes prohibited from
disclosure by section 301(j) of the act, unless pursuant to an express
written authorization provided by the submitter of the information.
(3) Any disclosure under this section of information submitted to
the Food and Drug Administration or incorporated into agency-prepared
records does not invoke the rule established in Sec. 20.21 that such
records shall be made available to all members of the public.
(d)(1) The Senior Associate Commissioner for Policy, Planning, and
Legislation, or the Deputy Commissioner for International and
Constituent Relations, or any other officer or employee of the Food and
Drug Administration whom the Senior Associate Commissioner for Policy,
Planning, and Legislation or the Deputy Commissioner for International
and Constituent Relations may designate to act on their behalf for the
purpose, may authorize the
[[Page 210]]
disclosure to, or receipt from, an official of a foreign government
agency of nonpublic, predecisional documents concerning the Food and
Drug Administration's or the other government agency's regulations or
other regulatory requirements, or other nonpublic information relevant
to either agency's activities, as part of cooperative efforts to
facilitate global harmonization of regulatory requirements, cooperative
regulatory activities, or implementation of international agreements,
provided that:
(i) The foreign government agency has the authority to protect such
nonpublic documents from public disclosure and will not disclose any
such documents provided without the written confirmation by the Food and
Drug Administration that the documents no longer have nonpublic status;
and
(ii) The Senior Associate Commissioner for Policy, Planning, and
Legislation or the Deputy Commissioner for International and Constituent
Relations or their designee makes the determination that the exchange is
reasonably necessary to facilitate global harmonization of regulatory
requirements, cooperative regulatory activities, or implementation of
international agreements.
(2) Any exchange under this section of nonpublic documents does not
invoke the rule established in Sec. 20.21 that such records shall be
made available to all members of the public.
(e) For purposes of this section, the term ``official of a foreign
government agency'' includes, but is not limited to, employees (whether
temporary or permanent) of and agents contracted by the foreign
government, or by an international organization established by law,
treaty, or other governmental action and having responsibility to
facilitate global or regional harmonization of standards and
requirements in FDA's areas of responsibility or to promote and
coordinate public health efforts. For such officials, the statement and
commitment required by paragraph (c)(1)(i) of this section shall be
provided on behalf of both the organization and the individual.
[42 FR 15616, Mar. 22, 1977, as amended at 58 FR 61603, Nov. 19, 1993;
60 FR 63382, Dec. 8, 1995; 65 FR 11888, Mar. 7, 2000]
Back to Top
© 2007 Betterchem Corp.
|
