98-19898. Public Information; Communications With State and Foreign Government Officials  

  • [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
    
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    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.
    
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     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
    
    
    

Document Information

Published:
07/27/1998
Department:
Food and Drug Administration
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
98-19898
Dates:
Written comments by October 13, 1998.
Pages:
40069-40072 (4 pages)
Docket Numbers:
Docket No. 98N-0518
PDF File:
98-19898.pdf
CFR: (3)
21 CFR 20.89(d)
21 CFR 20.88
21 CFR 20.89