[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Proposed Rules]
[Pages 40069-40072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 20

[Docket No. 98N-0518]


Public Information; Communications With State and Foreign 
Government Officials

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing communications with State and foreign 
government officials. The proposed rule would permit FDA to disclose 
confidential commercial information to international organizations 
having responsibility to facilitate global or regional harmonization of 
standards and requirements. These disclosures would, in almost all 
instances, occur only with

[[Page 40070]]

the consent of the person providing the confidential commercial 
information to FDA. The proposed rule would also streamline the process 
for FDA officials to disclose certain nonpublic, predecisional 
documents (such as draft rules and guidance documents) to State and 
foreign government officials. The proposal does not alter current 
procedures for sharing documents that contain confidential commercial 
information. These changes are intended to facilitate information 
exchanges with State and foreign governments and certain international 
organizations.

DATES: Written comments by October 13, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of December 24, 1974 (39 FR 44602), FDA 
published a regulation implementing the Freedom of Information Act and 
other laws that affect public access to government records and 
information. The rule exempted certain records, such as law enforcement 
records, from public disclosure, but did not include any provisions for 
special disclosures to foreign government officials of documents that 
were not available to the public generally.
    In the Federal Register of November 19, 1993 (58 FR 61598), FDA 
published a final rule which, among other things, authorized the agency 
to disclose confidential commercial information concerning FDA-
regulated products to foreign government officials who perform 
counterpart functions to FDA. The rule, which is now codified at 
Sec. 20.89 (21 CFR 20.89), permits these disclosures to occur only 
under various safeguards, such as a written statement from the foreign 
government agency establishing its authority to protect the 
confidential commercial information from public disclosure and a 
written commitment not to disclose such information without the consent 
of the sponsor for the confidential commercial information or written 
confirmation from FDA that the information is no longer confidential. 
Additionally, the rule requires FDA to determine either that the 
sponsor of the confidential commercial information has authorized the 
disclosure to the foreign government, or that disclosure would be in 
the interest of public health, or that disclosure is to a foreign 
scientist visiting FDA as part of a joint review or long-term 
cooperative training effort and subject to other restrictions. FDA 
included these safeguards to protect sensitive commercial information 
and to lessen industry concerns that foreign governments would further 
disclose such information without the sponsor's permission.
    Later, in the Federal Register of December 8, 1995 (60 FR 63372), 
FDA issued a final rule to permit FDA to disclose nonpublic, 
predecisional and other documents, such as draft guidance documents and 
regulations, to State and foreign government officials. (Currently, the 
term ``nonpublic, predecisional document,'' as used in Secs. 20.88(e) 
(21 CFR 20.88) and 20.89(d), does not include documents containing 
confidential commercial information such as FDA-prepared documents that 
analyze confidential commercial information.) Disclosures of nonpublic, 
predecisional documents were subject to certain safeguards similar to 
those in the 1993 rule (58 FR 61598), such as a written statement by 
the State or foreign government agency establishing its authority to 
protect the nonpublic, predecisional documents from public disclosure 
and a commitment not to disclose such documents without FDA's written 
confirmation that the documents no longer have nonpublic status (see 
Secs. 20.88(e)(1)(i) and 20.89(d)(1)(i)).
    The 1995 final rule (60 FR 63372) also stated that, for purposes of 
disclosing nonpublic, predecisional documents, the term ``official of a 
foreign government agency'' includes, but is not limited to, ``an agent 
contracted by the foreign government, and an employee of an 
international organization having responsibility to facilitate global 
harmonization of standards and requirements in FDA's areas of 
responsibility'' (see 21 CFR 20.89(d)(3)). This enabled FDA to disclose 
nonpublic, predecisional documents to international organizations such 
as the World Health Organization and the Food and Agriculture 
Organization of the United Nations.
    The 1995 rule also established similar authority for disclosing 
both confidential commercial information and nonpublic, predecisional 
documents to U.S. State government officials.
    FDA's experience under Sec. 20.89 has been excellent. Thus far, 
disclosures of confidential commercial information to foreign 
governments have occurred with the sponsor's consent in almost every 
case, and only after the foreign government has provided the necessary 
documents establishing its authority to protect the shared confidential 
commercial information from disclosure. These documents are usually 
written commitments that the foreign government has the authority to 
protect the documents from public disclosure and will protect such 
documents provided by FDA, although, on occasion, the document may be 
an exchange of letters or other agreement between FDA and the foreign 
country (see, e.g., 62 FR 60901, November 13, 1997) (exchange of 
letters between FDA and the Australian Therapeutic Goods Administration 
regarding information about a drug or biologic being considered for 
orphan status)).
    A sponsor's consent is not always necessary under Sec. 20.89. FDA 
may disclose confidential commercial information without the sponsor's 
consent where the agency determines that disclosure would be in the 
interest of public health by reason of the foreign government's 
possession of information concerning a product's safety, efficacy, or 
quality or information concerning an investigation.
    Generally, the confidential information which FDA has shared has 
consisted of internal FDA documents discussing data (rather than the 
data themselves) as the foreign governments usually have the data in an 
application for marketing authorization.
    Disclosures of nonpublic, predecisional information, mostly 
involving draft guidance documents, have been less frequent, and all 
have involved disclosures to foreign governments.
    As for disclosures to international organizations, current FDA 
regulations expressly permit the agency to disclose nonpublic, 
predecisional documents, but do not permit disclosures of confidential 
commercial information, including FDA-prepared documents that discuss 
confidential commercial information, to international organizations.

II. Description of the Proposed Rule

    FDA is now contemplating possible arrangements with international 
organizations in which FDA may want to be able to disclose confidential 
commercial information to international organizations under the same 
conditions and procedures found in Sec. 20.89 for disclosing 
confidential commercial information to foreign governments. The agency 
is not proposing to change those conditions or procedures with respect 
to sharing confidential commercial

[[Page 40071]]

information with foreign governments. The proposal would simply add 
international organizations to the disclosure provisions of Sec. 20.89 
dealing with confidential commercial information.
    For example, an international organization may wish to request 
certain confidential commercial information from FDA so that it may 
investigate possible adverse events associated with an approved drug 
product or as part of a cooperative investigation. This occurred 
recently when the Pan American Health Organization (PAHO) sought 
certain product and manufacturing information from FDA after an 
incident in Haiti where over 80 children died and even more were 
injured by an acetaminophen syrup contaminated with diethylene glycol. 
FDA was able to share the information with PAHO only after information 
had been publicly disclosed by non-FDA sources. As stated earlier, 
current FDA regulations do not explicitly provide a mechanism for 
providing confidential commercial information to an international 
organization even under the same circumstances in which FDA can provide 
confidential commercial information to a foreign government under 
Sec. 20.89.
    The proposal would amend Sec. 20.89 to clarify that disclosures of 
confidential commercial information and nonpublic, predecisional 
documents may be made to an international organization having 
responsibility to facilitate harmonization of standards and 
requirements in FDA's areas of responsibility. Thus, the proposed rule 
would move the language regarding an ``official of a foreign government 
agency'' from Sec. 20.89(d)(3), where it applies only to disclosures of 
nonpublic, predecisional documents, to a new Sec. 20.89(e) so that it 
would apply to all disclosures under Sec. 20.89. The proposal would 
also revise the reference to international organizations to refer to 
international organizations that facilitate ``global or regional'' 
harmonization of standards and requirements. The reference to 
``regional'' harmonization efforts is intended to reflect the fact that 
some international organizations operate primarily on a regional, 
rather than global, scale. (FDA, for purposes of this rule, interprets 
the term ``international organizations'' as referring to public or 
intergovernmental organizations, whether established by treaties or 
other means, instead of private or nongovernmental organizations.)
    The proposal would also clarify that the term ``official of a 
foreign government'' includes both temporary and permanent employees 
and agents. When FDA first proposed Sec. 20.89(d)(3) on January 27, 
1995 (60 FR 5530), the term ``official of a foreign government'' was 
understood as including foreign government employees. Comments 
submitted in response to the 1995 proposed rule (60 FR 5530) suggested 
including ``agents'' of a foreign government, and so FDA amended the 
rule to include ``agents'' on December 8, 1995 (60 FR 63372 at 63377). 
However, the express mention of agents, and not employees of a foreign 
government, has caused some confusion, and so FDA is proposing to amend 
the rule to refer to employees of and agents contracted by a foreign 
government or by an international organization. This change would be 
especially appropriate for international organizations because many 
international organizations rely on government officials who are 
temporarily assigned to the international organization and on 
consultants and contractors. It would also be analogous to the existing 
requirements for FDA's consultants, advisory committee members, and 
commissioned officials who are subject to the same disclosure 
restrictions that apply to FDA employees even though such persons are 
not agency employees themselves (see 21 CFR 20.84).
    Additionally, the proposed rule would amend Secs. 20.88(e)(1)(i) 
and 20.89(d)(1)(i) to eliminate the need for the written statement from 
a U.S. State or a foreign government agency official when FDA provides 
nonpublic, predecisional documents. The requirement of a written 
statement was originally included to mirror the existing parallel 
requirement for such a statement before FDA disclosed any confidential 
commercial information to a foreign government. However, because 
information exchanges involving nonpublic, predecisional documents do 
not contain confidential commercial information, the written statement 
adds little value because only FDA's deliberative interests would be 
directly affected by a premature public disclosure. Furthermore, FDA's 
experience under Sec. 20.89 suggests that the written statement 
requirement is contrary to customary international practice in which 
drafts are shared with trusted individuals in counterpart agencies as 
part of a well-understood, well-established practice that the document 
will not be disclosed or made public. Moreover, some foreign agencies 
have been reluctant to execute the written statement due to 
uncertainties as to who in their government possesses the authority to 
sign such a statement. Others have even expressed concern that the 
written statement might, under their government's policies or laws, be 
considered an international agreement under international treaty law 
that might require new national legislation or legislative consent.
    Thus, the proposed rule would delete the written statement from 
Sec. 20.89(d) for exchanges involving nonpublic, predecisional 
information. Furthermore, the proposal would delete the written 
statement from Sec. 20.88(e) so that State government officials have 
the same access to nonpublic, predecisional documents as foreign 
government officials. The agency will require State and foreign 
governments to execute a written statement establishing their authority 
to protect documents from public disclosure only where the documents 
contain confidential commercial information.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of this proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize new benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and the 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined in the Executive 
Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The proposed rule will have no significant economic 
impact on small entities under the Regulatory Flexibility Act because 
it regulates only conduct of FDA, foreign governments, and 
international organizations, and not small entities under the 
Regulatory Flexibility Act. In any case, the proposed rule will have no 
significant economic impact on any small entities.

[[Page 40072]]

 The proposed rule would authorize FDA to disclose confidential 
commercial information to international organizations, subject to the 
same safeguards against public disclosure of that information that 
apply in the case of disclosures to foreign government agencies and to 
disclose predecisional information to foreign governments under relaxed 
procedures. These disclosures would likely facilitate marketing review 
and approval of various FDA-regulated products in foreign countries, 
and disclosures would almost always occur only with the consent of the 
business that generated the confidential commercial information. This 
beneficial effect of the rule would outweigh any possible adverse 
impact. Thus, the agency certifies that this proposed rule will not 
have a significant impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required. FDA requests comment on this conclusion.

V. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.
    Interested persons may, on or before October 13, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 20 be amended as follows:

PART 20--PUBLIC INFORMATION

    1. The authority citation for 21 CFR part 20 is revised to read as 
follows:

    Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

    2. Section 20.88 is amended by revising paragraph (e)(1)(i) to read 
as follows:


Sec. 20.88  Communications with State and local government officials.

* * * * *
    (e)(1) * * *
    (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
* * * * *
    3. Section 20.89 is amended by revising paragraph (d)(1)(i), by 
removing paragraph (d)(3), and by adding paragraph (e) to read as 
follows:


Sec. 20.89  Communications with foreign government officials.

* * * * *
    (d)(1) * * *
    (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
* * * * *
    (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 having responsibility to 
facilitate global or regional harmonization of standards and 
requirements in the Food and Drug Administration's areas of 
responsibility. For such officials, the statement and commitment 
required by paragraph (d)(1)(i) of this section shall be provided by 
both the organization and the individual.

    Dated: July 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19898 Filed 7-24-98; 8:45 am]
BILLING CODE 4160-01-F