Public Information; Communications With State and Foreign Government Officials

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

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

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.

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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