[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: 21CFR20.88]
[Page 206-208]
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. 20.88 Communications with State and local government officials.
(a) A State or local government official commissioned by the Food
and Drug Administration pursuant to 21 U.S.C. 372(a) shall have the same
status with respect to disclosure of Food and
[[Page 207]]
Drug Administration records as any special government employee.
(b) Communications with State and local government officials with
respect to law enforcement activities undertaken pursuant to a contract
between the Food and Drug Administration and such officials shall be
subject to the rules for public disclosure established in Sec. 20.64.
(c) Communications with State and local government officials who are
not commissioned pursuant to 21 U.S.C. 372(a) or under a contract to
perform law enforcement activities shall have the same status as
communications with any member of the public, except that:
(1) Investigatory records compiled for law enforcement purposes by
State and local government officials who perform counterpart functions
to the Food and Drug Administration at the State and local level, 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
records shall be exempt from disclosure for a longer period of time if
the State or local government officials so require as a condition of
their furnishing the information to the Food and Drug Administration.
(2) Disclosure of investigatory records compiled for law enforcement
purposes by the Food and Drug Administration to State and local
government officials who perform counterpart functions to the Food and
Drug Administratrion at the State and local level 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.
(d)(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 State government officials as part of cooperative law enforcement or
regulatory efforts, provided that:
(i) The State 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 State government's possessing information concerning the safety,
effectiveness, or quality of a product or information concerning an
investigation, or by reason of the State government being able to
exercise its regulatory authority more expeditiously than the Food and
Drug Administration; or
(C) The disclosure is to a State government 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 Federal Food, Drug, and Cosmetic Act (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 State government scientist to sign
a written commitment to protect the confidentiality of the information,
and the visiting State government 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
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and Drug Administration advisory committee members under Sec.
14.80(b)(1) of this chapter. Subject to all the foregoing conditions, a
visiting State government scientist may have access to trade secret
information, entitled to protection under section 301(j) of 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 (d)(1)(ii)(C) of this
section, this provision does not authorize the disclosure to State
government officials 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.
(e)(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 disclosure to, or receipt from, an official
of a State 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
efforts to improve Federal-State uniformity, cooperative regulatory
activities, or implementation of Federal-State agreements, provided
that:
(i) The State 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 improve Federal-State uniformity, cooperative
regulatory activities, or implementation of Federal-State agreements.
(2) Any exchange under this section of nonpublic documents does not
invoke the rule established at Sec. 20.21 that such records shall be
made available to all members of the public.
(3) For purposes of this paragraph, the term official of a State
government agency includes, but is not limited to, an agent contracted
by the State government, and an employee of an organization of State
officials having responsibility to facilitate harmonization of State
standards and requirements in FDA's areas of responsibility. For such
officials, the statement and commitment required by paragraph (e)(1)(i)
of this section shall be provided by both the organization and the
individual.
[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 63381, Dec. 8, 1995; 65
FR 11887, Mar. 7, 2000]
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