[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.88]

[Page 235-237]
 
                        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 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

[[Page 236]]

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 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

[[Page 237]]

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]