[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]
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