Public Information; Communications With State and Foreign Government Officials

Part V

Department of Health and Human Services

_______________________________________________________________________

Food and Drug Administration

_______________________________________________________________________

21 CFR Part 20

Public Information; Communications With State and Foreign Government

Officials

Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 20

[Docket No. 94N-0308]

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 officials of State and

foreign governments. This proposal will permit FDA to disclose to, and

receive from, these officials certain nonpublic information without

being compelled to disclose the information to the public generally.

This proposal addresses the nonpublic exchange of two types of

information. First, it allows the disclosure of nonpublic safety,

effectiveness, or quality information concerning FDA-regulated products

to State government officials. Second, it allows the disclosure of

draft proposed rules and other nonpublic predecisional documents

concerning regulatory requirements or activities between FDA and either

State or foreign government officials. This action is necessary to

enhance cooperation in regulatory activities, to eliminate unfounded

contradictory regulatory requirements, and to minimize redundant

application of similar requirements.

DATES: Written comments by April 27, 1995. FDA is proposing that any

final rule that may issue based on this proposal become effective on or

before February 27, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

ts, and to minimize redundant

application of similar requirements.

DATES: Written comments by April 27, 1995. FDA is proposing that any

final rule that may issue based on this proposal become effective on or

before February 27, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Linda R. Horton, International Policy

Staff (HF-23), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301-443-2831.

SUPPLEMENTARY INFORMATION:

I. Background

Historically, FDA's communications with State and foreign

government officials generally had the same status as communications

with any member of the public. Under FDA's rules as they were

originally published in 1974, under many circumstances, the disclosure

of agency records by FDA to such government officials constituted

disclosure to the public and obligated FDA to make the same records

available to the public upon request. As discussed below, however,

there have been certain longstanding exceptions to this general rule of

uniform access.

FDA is a strong supporter of the public's ``right to know'' about

government actions and public access to official information. There are

times, however, when public disclosure of information will undermine

other legitimate private rights and government responsibilities. In

drafting the Freedom of Information Act (the FOIA) (5 U.S.C. 552),

Congress recognized the need for the Federal government to be able to

withhold certain categories of information from public disclosure.

Examples of such categories of records relevant to FDA include:

1. Trade secret and confidential commercial information to protect

intellectual property rights and research incentives (5 U.S.C.

552(b)(4));

2. Predecisional documents to protect the deliberative process (5

U.S.C. 552(b)(5));

3. Information the disclosure of which may invade personal privacy

(5 U.S.C

n from public disclosure.

Examples of such categories of records relevant to FDA include:

1. Trade secret and confidential commercial information to protect

intellectual property rights and research incentives (5 U.S.C.

552(b)(4));

2. Predecisional documents to protect the deliberative process (5

U.S.C. 552(b)(5));

3. Information the disclosure of which may invade personal privacy

(5 U.S.C. 552(b)(6)); and

4. Investigatory files compiled for law enforcement purposes to

protect investigations into misconduct (5 U.S.C. 552(b)(7)).

Since 1974, significant changes in the world economy and in the

activities of the regulatory agencies of the world's governments have

caused FDA to work more closely with other government officials (i.e.,

local, State, and foreign officials, as well as fellow Federal

officials) as professional colleagues in the attempt to find solutions

to public health and consumer protection problems.

Increased international commerce and diminished resources for

regulation have resulted in efforts by public health regulatory

agencies around the globe to enhance the effectiveness and efficiency

of their operations. Public health regulatory agencies are protecting

the public by harmonizing regulatory requirements; minimizing

duplicative regulations; and cooperating in scientific, regulatory, and

enforcement activities. Similar factors have demanded enhanced

cooperation among all levels of government within the United States. To

facilitate these national and international cooperative activities,

regulatory agencies, both within the United States and worldwide, have

taken steps to increase communications with their counterparts when

developing proposed regulations or formulating important regulatory

decisions. These discussions occur not only with respect to FDA-

regulated products, but in other areas where cooperation is essential,

e.g., aircraft safety, pesticide registration, and nuclear power

regulation

th within the United States and worldwide, have

taken steps to increase communications with their counterparts when

developing proposed regulations or formulating important regulatory

decisions. These discussions occur not only with respect to FDA-

regulated products, but in other areas where cooperation is essential,

e.g., aircraft safety, pesticide registration, and nuclear power

regulation.

An example of the trend toward increased international information

sharing is the 1993 revision to FDA's public information regulations,

Sec. 20.89 (21 CFR 20.89), providing that, under specified conditions,

FDA may disclose certain nonpublic safety, effectiveness, or quality

information concerning FDA-regulated products to foreign government

officials without being compelled to disclose the information to the

public (58 FR 61598, November 19, 1993). In this document, FDA is

proposing a regulation authorizing disclosure of certain nonpublic

safety, effectiveness, and quality information to State government

officials to parallel the existing regulation for disclosure of this

kind of information to foreign government officials. The purpose of

this action is to enhance Federal-State cooperation in regulatory

activities. In this document, the term ``State government officials''

can include local officials, because local governments are the legal

instruments of the States. However, FDA generally works with State, not

local governments, and information exchange with State officials is the

more common situation.

FDA is also proposing to exchange (i.e., to disclose, to receive,

or to do both) certain nonpublic predecisional documents concerning

FDA's or another government's (local, State, or foreign) regulations,

requirements, or activities without being compelled to generally

disclose the information to the public

vernments, and information exchange with State officials is the

more common situation.

FDA is also proposing to exchange (i.e., to disclose, to receive,

or to do both) certain nonpublic predecisional documents concerning

FDA's or another government's (local, State, or foreign) regulations,

requirements, or activities without being compelled to generally

disclose the information to the public. The purpose of this action is

to facilitate the elimination of unnecessary, contradictory regulatory

requirements and to minimize unwarranted, redundant application of

similar requirements by multiple domestic and foreign regulatory

bodies. Further, this proposed action is intended to enhance FDA's

implementation, consistent with the laws it administers, of U.S.

policies and obligations resulting from our country's duties under

international agreements. FDA believes both changes proposed in this

document will enhance consumer protection and increase consumer access

to safe, effective, and high quality products that are regulated by

FDA.

A. Disclosure of Information to the Public: General Statutory and

Regulatory Provisions

FDA's regulations governing public information in part 20 (21 CFR

part 20) implement the FOIA, 5 U.S.C. 552, and other laws

that affect public access to government records and information (e.g.,

the Trade Secrets Act (18 U.S.C. 1905) and section 301(j) of the

Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331(j)).

Section 20.21 of FDA's public information regulations states a general

rule that any record of the agency that is disclosed in an authorized

manner to any member of the public is available for disclosure to all

members of the public. As stated earlier, communications by FDA with

State and local government officials and with foreign government

officials generally have had the same status as communications with any

member of the public

egulations states a general

rule that any record of the agency that is disclosed in an authorized

manner to any member of the public is available for disclosure to all

members of the public. As stated earlier, communications by FDA with

State and local government officials and with foreign government

officials generally have had the same status as communications with any

member of the public.

However, subpart E of part 20 identifies several categories of

officials or institutions to whom, under specified limitations,

disclosure of certain FDA records may be made without requiring uniform

access under Sec. 20.21. These include State and local government

officials, under limitations specified in Sec. 20.88, and foreign

government officials, under limitations specified in Sec. 20.89. FDA

believes that consumer protection will be enhanced if FDA is able to

exchange information with other government agencies at an earlier stage

than is possible under present rules, and if FDA is able to share with

these officials certain categories of information that may not be

exchanged under present rules. FDA further believes that protection of

intellectual property rights, research incentives, deliberative

processes, and similar important needs will not be compromised if

certain conditions are met by the recipients of such information.

B. Exchanging Confidential Commercial Information With State and

Local Government Officials: Statutory and Regulatory Provisions

exchanged under present rules. FDA further believes that protection of

intellectual property rights, research incentives, deliberative

processes, and similar important needs will not be compromised if

certain conditions are met by the recipients of such information.

B. Exchanging Confidential Commercial Information With State and

Local Government Officials: Statutory and Regulatory Provisions

Special provisions of the act and FDA regulations permit FDA to

treat State and local government officials commissioned by FDA or under

contract with FDA essentially as FDA employees. The act authorizes the

Secretary of the Department of Health and Human Services (HHS) to

conduct examinations and investigations for the purposes of the act

through employees of HHS or through any health, food, or drug officer

or employee of any State, territory, or political subdivision thereof,

commissioned by the Secretary as an officer of HHS (21 U.S.C. 372(a)).

This authority has been delegated to FDA (21 CFR 5.10(a)). To

facilitate implementation of this provision, Sec. 20.88(a) provides

that a State or local government official commissioned by FDA under 21

U.S.C. 372(a) shall have the same status with respect to disclosure of

FDA records as any special government employee under Federal personnel

law.

These provisions allow these commissioned officials to review

confidential FDA investigative files and proposed policy statements

that normally must be restricted to Federal employees. FDA's ability to

solicit the advice and tap the expertise of its State and local

colleagues without publicly disclosing investigational information

outside the agency is a major advantage of the State Commissioning

Program. The same rationale supports a broadening of FDA's ability to

share information with other State employees

tatements

that normally must be restricted to Federal employees. FDA's ability to

solicit the advice and tap the expertise of its State and local

colleagues without publicly disclosing investigational information

outside the agency is a major advantage of the State Commissioning

Program. The same rationale supports a broadening of FDA's ability to

share information with other State employees.

FDA's current regulations also provide that communications with

State and local government officials with respect to law enforcement

activities undertaken pursuant to a contract with FDA shall be subject

to the same rules that protect FDA investigatory records from public

disclosure. (See Sec. 20.88(b)). Under existing Sec. 20.88, however,

communications by FDA with State and local government officials who are

neither commissioned by FDA under 21 U.S.C. 372(a), nor under FDA

contract, have the same status as communications with any member of the

public. Although Sec. 20.88(c)(1) does provide additional protection

for investigatory records and trade secrets and confidential commercial

information that have been voluntarily disclosed to FDA as part of

cooperative law enforcement and regulatory efforts by such

noncommissioned and noncontract State and local government officials,

the existing regulation does not allow FDA employees to reciprocate

with respect to confidential commercial information. FDA may not

disclose to noncontract and noncommissioned State officials

confidential commercial information submitted to or incorporated into

records prepared by FDA. Under current regulations, such disclosure

would invoke the uniform access to records requirement in Sec. 20.21,

and trigger public availability of this information

ciprocate

with respect to confidential commercial information. FDA may not

disclose to noncontract and noncommissioned State officials

confidential commercial information submitted to or incorporated into

records prepared by FDA. Under current regulations, such disclosure

would invoke the uniform access to records requirement in Sec. 20.21,

and trigger public availability of this information.

With respect to investigatory records compiled for law enforcement

purposes, FDA's rules have long provided the agency with authorization

to exchange such investigatory records with State or local government

officials who perform counterpart functions to FDA at the State or

local levels as part of cooperative law enforcement efforts. (See

Sec. 20.88(c)). Such an exchange does not invoke the uniform access

rule established by Sec. 20.21. FDA is proposing to expand the

categories of information subject to this approach in order to enhance

Federal-State efforts to protect the public health.

C. Exchanging Confidential Commercial Information With Foreign

Government Officials: Recent Changes in Regulatory Provisions

When FDA's regulations governing exchange of information with

foreign government officials were first codified, national economies

worldwide were more independent of one another than now, and regulatory

agencies worldwide discharged their responsibilities more independently

of one another. Even in 1974, however, the importance of those

relationships to the public health and the mission of FDA was clear to

the agency. In the preamble to the proposed regulations, the

Commissioner of Food and Drugs emphasized ``the importance of

maintaining good working relationships with counterpart agencies

throughout the world both to sound diplomatic relations with foreign

nations and to the availability of important new information of

regulatory significance. Such cooperation is encouraged by sections 301

and 308 of the Public Health Service Act (42 U.S.C. 241 and 242f)

mmissioner of Food and Drugs emphasized ``the importance of

maintaining good working relationships with counterpart agencies

throughout the world both to sound diplomatic relations with foreign

nations and to the availability of important new information of

regulatory significance. Such cooperation is encouraged by sections 301

and 308 of the Public Health Service Act (42 U.S.C. 241 and 242f).

Unless regulatory information can be exchanged without required public

disclosure, FDA will lose its sources of important information that are

vital to protect the public, and will be unable to disseminate

preliminary information when it is first generated within this country

in order to help protect the public health throughout the world.'' (See

39 FR 44602 through 44621, December 24, 1974).

Although the agency at that time declined to implement the

suggestions of foreign governments that FDA exchange nonpublic safety

and effectiveness data with counterpart officials, the Commissioner's

response to those suggestions was at least partially based on the

belief that the regulations proposed in 1974 would ``adequately satisfy

the need for international exchange of important regulatory information

of this type.'' (See 39 FR 44602 at 44636 and 44637).

In the intervening 20 years there have been great changes in the

world economy and the working relationships of regulatory agencies

around the globe. Experience has shown that efficient and effective

regulation can be facilitated by the exchange of confidential

commercial information between governments. Cooperation in review of

product approval applications is one example of the benefit such

exchange can bring to consumers and to industry.

In 1992, FDA proposed to amend Sec. 20.89 to expand the exchange of

information with foreign officials to include certain

confidential commercial information, such as studies supporting product

approval (57 FR 61598, June 26, 1992). The agency issued a final rule

on November 19, 1993 (58 FR 61598)

plications is one example of the benefit such

exchange can bring to consumers and to industry.

In 1992, FDA proposed to amend Sec. 20.89 to expand the exchange of

information with foreign officials to include certain

confidential commercial information, such as studies supporting product

approval (57 FR 61598, June 26, 1992). The agency issued a final rule

on November 19, 1993 (58 FR 61598). Section 20.89 as amended allows the

agency, under specified conditions, to disclose confidential commercial

information such as nonpublic safety, effectiveness, or quality

information concerning FDA-regulated products to foreign government

officials who perform counterpart functions, without compelling the

public disclosure of the information. The rule covers confidential

commercial information submitted to the agency, or incorporated into

agency-prepared records, as part of cooperative law enforcement or

regulatory efforts. Under the amended regulation, several conditions

must be met before FDA may disclose the information to the foreign

government official. The conditions are the same as those proposed

below with respect to analogous disclosures to State and local

government officials.

One condition requires the foreign government agency to provide a

written statement certifying its authority to protect the information

from public disclosure and its commitment not to disclose the

information without the written permission of the sponsor or written

confirmation from FDA that the information no longer has confidential

status

closures to State and local

government officials.

One condition requires the foreign government agency to provide a

written statement certifying its authority to protect the information

from public disclosure and its commitment not to disclose the

information without the written permission of the sponsor or written

confirmation from FDA that the information no longer has confidential

status. FDA requires this written statement to: (1) Include specified

language; (2) bear the signature, name, and title of the responsible

foreign government official; and (3) be submitted to FDA after the

official is informed about the significance the agency attaches to the

confidentiality of the information and understands that disclosure by

the foreign government could constitute a criminal violation and would

seriously jeopardize any further interaction between FDA and the

foreign counterpart agency.

As discussed in the preamble to the 1993 final rule, that

rulemaking was undertaken because FDA concluded that it needed to

revise its public information regulations to disclose to foreign

government officials confidential commercial information submitted to

FDA or incorporated into agency-prepared records in order to provide

clear authority for cooperation in reviews of pending submissions and

other important international exchanges of regulatory information. The

1993 final rule facilitates the approval of products that are shown to

be safe and effective, expedites the withdrawal of approval of products

that are found not to be safe and effective, and enhances the

efficiency of FDA's enforcement efforts, while providing safeguards

against public disclosures of proprietary information and conflicts of

interest.

D. The Need to Extend to State Government Officials the Recent

Changes in Provisions for Exchanging Confidential Commercial

Information With Foreign Government Officials

of products

that are found not to be safe and effective, and enhances the

efficiency of FDA's enforcement efforts, while providing safeguards

against public disclosures of proprietary information and conflicts of

interest.

D. The Need to Extend to State Government Officials the Recent

Changes in Provisions for Exchanging Confidential Commercial

Information With Foreign Government Officials

FDA and State agencies work cooperatively and in a complementary

manner to protect the nation's public health with regard to FDA-

regulated consumer products. While States usually defer to FDA to

approve the marketing of FDA-regulated products, some States actively

regulate or monitor, within their State and under their own

authorities, the clinical trials of some investigational new drugs,

biologic products, and medical devices. In addition, most States have

active enforcement programs, especially for foods.

FDA needs to be able to exchange information with State or local

officials, without being limited to those who are commissioned or are

under contract under Sec. 20.88(a) and (b), FDA commissions State

government officials, or enters into contracts with State agencies,

primarily for the performance of cooperative regulatory work. However,

certain cooperative efforts are more dependent on information exchange

followed by coordination between Federal and State authorities, rather

than on actual work performed by State authorities on behalf of Federal

programs. In some regulatory efforts where the need for information

exchange is paramount, FDA may be able to rely on FDA commissioned and

contract employees in order to share confidential commercial

information in the possession of FDA that is necessary to accomplish

the agency's public health mission

uthorities, rather

than on actual work performed by State authorities on behalf of Federal

programs. In some regulatory efforts where the need for information

exchange is paramount, FDA may be able to rely on FDA commissioned and

contract employees in order to share confidential commercial

information in the possession of FDA that is necessary to accomplish

the agency's public health mission. But, as discussed below,

commissioning and contracting, which are essential prerequisites under

the current regulation, consume inordinate time and human resources and

are not suited to dealing with information exchanges on rapidly

developing problems.

Arrangements for issuing commissions are handled by State

commission liaison officers located in FDA's regional offices. The

commissioning process includes identifying suitable candidates (which

often will require that supervisors or State agency heads also be

commissioned), reviewing the candidates' qualifications to carry out

activities specified in the commission, issuing certificates and

credentials, and accounting for the credentials on a periodic basis.

FDA's experience has been that this mechanism is too rigorous, costly,

and time-consuming to enable the rapid exchanges of confidential

information with State government officials that are essential in

public health emergencies and investigations. Furthermore, the State

government official who is commissioned, and therefore permitted access

to confidential commercial information in FDA's possession, is

frequently not the employee who, in any particular case, is best

capable of analyzing or evaluating the nonpublic information.

Similarly, contracting projects are not suited for cooperative

Federal-State regulatory efforts requiring rapid exchange of

information. Contracts are solicited, negotiated, and put in place

according to formal U.S. Government contracting procedures; for

continuing work, contracts must be renewed annually

particular case, is best

capable of analyzing or evaluating the nonpublic information.

Similarly, contracting projects are not suited for cooperative

Federal-State regulatory efforts requiring rapid exchange of

information. Contracts are solicited, negotiated, and put in place

according to formal U.S. Government contracting procedures; for

continuing work, contracts must be renewed annually. In addition to

being time-consuming to establish, contracts cannot be relied upon to

cover all FDA program areas. The services most commonly procured by FDA

through contracts with the States are for establishment inspections,

with related collection and analysis of samples, report preparation,

and followup activity undertaken by the State agency under its own

authority and program. FDA program areas are not covered uniformly

across the States, with FDA having contracts in many (but not all)

States for food inspections, but in only a few States for drug,

biologic product, and medical device inspections.

The following are examples of situations in which the ability to

share confidential commercial information with State governments in a

less encumbered manner would have allowed more timely review of

significant public health issues, or would have enhanced the

effectiveness of regulatory activities:

1. FDA and some States acquire information from ongoing clinical

investigations of new drugs, biologic products, or medical devices,

including unanticipated adverse reaction or device malfunction data,

clinical protocols, identities of study sites, and names of clinical

investigators. When problems occur that could have an impact upon the

safety of study subjects, public health decisions concerning the

continuation of the study must be based upon the most complete

information possible

iologic products, or medical devices,

including unanticipated adverse reaction or device malfunction data,

clinical protocols, identities of study sites, and names of clinical

investigators. When problems occur that could have an impact upon the

safety of study subjects, public health decisions concerning the

continuation of the study must be based upon the most complete

information possible. This is facilitated by access to records at the

study sites, and in certain situations it would be consistent with

public health protection for State officials to have access to records

that FDA must evaluate in its review of the problem.

Under the existing regulations, State government officials can

share information that they receive or acquire with FDA. However,

because information concerning investigational drugs and medical

devices is often confidential commercial information, FDA cannot

reciprocate, unless the State officials are commissioned or under

contract for law enforcement purposes. As explained above, the

processes for issuing commissions to State government officials or

placing them under contract are so cumbersome and time-consuming as to

impede joint Federal-State efforts on clinical trials in progress that

require a two-way exchange of relevant information. Such restrictions

on the exchange of this information can hinder decisionmaking, for both

FDA and State governments, where timeliness is important to protecting

public health.

Further, State governments, on occasion, have not had ready access

to information about pending FDA regulatory actions concerning clinical

trials in progress that may involve health care institutions or

individuals which operate under State licenses, permits, or

registrations. In such circumstances, the current impediments to full-

information exchanges thwart effective, coordinated regulatory

solutions to public health problems

on, have not had ready access

to information about pending FDA regulatory actions concerning clinical

trials in progress that may involve health care institutions or

individuals which operate under State licenses, permits, or

registrations. In such circumstances, the current impediments to full-

information exchanges thwart effective, coordinated regulatory

solutions to public health problems. For example, in the case of

Narcotic Treatment Programs (NTP's), FDA coordinates actions with the

State agencies charged with regulating these types of clinics. Such

coordination is essential because if FDA plans enforcement action that

would close a program, the assistance of the State agencies is

necessary to minimize disruption to the treatment of patients. The

rapid exchange of nonpublic information can also enhance protection of

the public health when a State has broad authority to require an unsafe

or violative establishment within its borders to cease operations.

2. Both FDA and State agencies have responsibilities for

Institutional Review Boards (IRB's), which are the boards or committees

formally designated by institutions to review, to approve the

initiation of, and to conduct periodic review of, biomedical research

involving use in human subjects of FDA-regulated products (21 CFR

Sec. 56.102(g)). In the case of noncompliant IRB's, FDA regulations

allow the agency to notify relevant State and Federal regulatory

agencies and other parties with a direct interest about any action FDA

may take against the IRB or its parent institution (21 CFR 56.120). In

some instances, State action against violations may be preferable to

Federal action, or a State may have authority to expeditiously revoke

the license of a program or clinic operating under that violative IRB

notify relevant State and Federal regulatory

agencies and other parties with a direct interest about any action FDA

may take against the IRB or its parent institution (21 CFR 56.120). In

some instances, State action against violations may be preferable to

Federal action, or a State may have authority to expeditiously revoke

the license of a program or clinic operating under that violative IRB.

However, State officials may need access to confidential information

about the protocol or investigational product, including nonpublic

confidential commercial information contained in IND's and NDA's, in

order to take effective action. This proposed rule would permit FDA to

share such information, where the agency, in its discretion, believes

it is appropriate.

3. Health fraud enforcement often involves several agencies or

officials at both the Federal and State government levels. At the

outset of a case, the involved State officials may be commissioned by

FDA or under contract to FDA and, therefore, have access to relevant

confidential commercial information in FDA records. However, as

evidence is gathered and the case develops, a point is reached when

enforcement strategy must be discussed with other State government

officials, who seldom hold FDA commissions or are under contract. Under

the current regulations, these State government officials may not have

access to pertinent information from FDA records, including information

about the identity of investigational products or distribution data

that may bear on the case. In such circumstances, the process of

investigating and prosecuting the case is frustrated and delayed. That

delay and the resulting harm to specific investigations are aggravated

in cases where a perpetrator may be operating in several States

nent information from FDA records, including information

about the identity of investigational products or distribution data

that may bear on the case. In such circumstances, the process of

investigating and prosecuting the case is frustrated and delayed. That

delay and the resulting harm to specific investigations are aggravated

in cases where a perpetrator may be operating in several States.

In one particular case, a State official responsible for issuing

and revoking medical licenses requested reports covering FDA

investigations of health fraud by a physician who was illegally

importing and distributing unapproved drugs. The State was initiating a

license revocation proceeding. Because the current version of

Sec. 20.88 makes disclosure to a noncommissioned or noncontract State

employee a public disclosure, the records provided by FDA had to be

purged of information vital to the State's revocation case.

Consequently, action to protect the public health in this instance was

impeded by FDA's inability to disclose nonpublic information to the

appropriate State official in a timely manner.

4. Data in FDA's possession about the distribution of an imported

product may contain confidential commercial information. Many imported

products can be tracked by State officials more economically and

efficiently than by FDA officials, because the tracking can be done in

the course of regular State inspectional activities. Under current

regulations, FDA's authority to disclose nonpublic information about

consignees to State government officials for followup action, such as

embargo of violative products, is limited.

A common element of these examples is that joint FDA and State

government efforts on significant public health issues, including

effective regulatory activities, have been encumbered by existing

regulatory restrictions on FDA's ability to exchange confidential

commercial information with State governments

nment officials for followup action, such as

embargo of violative products, is limited.

A common element of these examples is that joint FDA and State

government efforts on significant public health issues, including

effective regulatory activities, have been encumbered by existing

regulatory restrictions on FDA's ability to exchange confidential

commercial information with State governments. The amendment being

proposed would facilitate such disclosures and thereby contribute to

economy of effort, efficient use of public resources, and enhanced

public health protection.

Additionally, FDA believes it should have the ability to disclose

proprietary information to State government scientists visiting FDA as

part of a joint review or long-term cooperative training effort

authorized under section 708 of the act (21 U.S.C. 379), pursuant to

the same procedures FDA recently promulgated for visiting foreign

scientists. Efficient public administration requires that FDA be able

to deal with visiting State government scientists in the same manner as

it does with visiting foreign government scientists.

This proposed rule, therefore, would provide, through an amendment

to Sec. 20.88, the same mechanisms for exchanges of confidential

commercial information between FDA and State government officials as

were recently provided for foreign government officials through an

amendment to Sec. 20.89. Under the proposed amendment, several

conditions must be met prior to FDA's disclosure of such information to

State government officials.

First, the State government agency must provide a written statement

certifying its authority to protect the information from public

disclosure and its commitment not to disclose the information without

the written permission of the sponsor or written confirmation from FDA

that the information no longer has confidential status

DA's disclosure of such information to

State government officials.

First, the State government agency must provide a written statement

certifying its authority to protect the information from public

disclosure and its commitment not to disclose the information without

the written permission of the sponsor or written confirmation from FDA

that the information no longer has confidential status. Second, FDA

must make one or more of the following determinations: (1) The sponsor

of the product application has provided written authorization for the

disclosure; (2) 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 (3) the disclosure is to a

State government scientist visiting FDA on the agency's premises as

part of a joint review or cooperative training effort, and FDA (a)

retains physical control over the information, (b) requires a written

commitment to protect the confidentiality of the information, and (c)

implements specific conflicts-of-interest safeguards.

E. Cooperation and Harmonization Needs for Exchanging Nonpublic

Predecisional Documents and Other Nonpublic Information With State

and Foreign Government Officials

FDA is committed to cooperation with counterpart officials in State

and foreign governments. Because public health problems respect neither

State boundaries nor international borders, such cooperation is

essential to consumer protection.

If FDA can provide foreign government officials with information on

impending new or changed regulations and other requirements or

activities, the agency can encourage adoption of uniform science-based

measures that fully protect consumers, and can help reduce both

duplication of regulatory activities and unfounded or contradictory

regulatory requirements

s

essential to consumer protection.

If FDA can provide foreign government officials with information on

impending new or changed regulations and other requirements or

activities, the agency can encourage adoption of uniform science-based

measures that fully protect consumers, and can help reduce both

duplication of regulatory activities and unfounded or contradictory

regulatory requirements. FDA likewise benefits from the ability to

receive drafts of proposed regulations from foreign and State

government officials without being required to disclose these drafts to

an FOIA requester because the risk of such public disclosure frequently

inhibits foreign and State counterparts from full disclosure of useful

information to FDA. For continuity in regulatory harmonization efforts

at all levels of geopolitical organization (State, national, and

international), FDA must be able to more freely communicate on

regulatory matters and initiatives with counterpart government

officials.

The following are examples of situations in which the ability to

exchange nonpublic predecisional documents with State and foreign

government counterparts would improve Federal-State uniformity and

facilitate global harmonization of regulatory requirements.

1. Information exchange between FDA and its foreign government

counterparts is necessary in order to utilize the technical expertise

of other regulatory agencies for purposes of harmonizing regulations

and regulatory activities. Current increases in worldwide trade, as

well as recent trade agreements, add impetus to harmonization

activities already underway

zation of regulatory requirements.

1. Information exchange between FDA and its foreign government

counterparts is necessary in order to utilize the technical expertise

of other regulatory agencies for purposes of harmonizing regulations

and regulatory activities. Current increases in worldwide trade, as

well as recent trade agreements, add impetus to harmonization

activities already underway. For example, FDA wanted to, but could not,

disclose to foreign counterpart officials at 1993 international

meetings, the drafts of its proposed rules on medical device good

manufacturing practices (published in the Federal Register of November

23, 1993 (58 FR 61952)), and on regulations of seafood safety through

Hazard Analysis Critical Control Points (HACCP) (published in the

Federal Register of January 28, 1994 (59 FR 4142)). FDA believes its

harmonization and rulemaking activities in these areas would be

enhanced by nonpublic exchange of such draft proposals.

2. The Food Code, published in the Federal Register of January 28,

1994 (59 FR 4085), consists of model requirements to safeguard public

health and assure that food is unadulterated and honestly presented

when offered to consumers. The Food Code was offered as a model for

local, State, and Federal governmental jurisdictions to adopt under

their own authorities as regulations for food service, retail food

stores, or food-vending operations. Because concerns about

confidentiality limited FDA's ability to exchange predecisional

documents, access to developmental materials and drafts was limited to

State government officials who were commissioned by FDA. Consequently,

it was difficult for FDA to get technical contributions and

professional views from the reservoir of expertise among many other

State officials. FDA believes this limitation on nonpublic exchange is

detrimental to Federal-State cooperation. By its very nature, the Food

Code is central to public health programs of Federal, State, and local

government organizations

sioned by FDA. Consequently,

it was difficult for FDA to get technical contributions and

professional views from the reservoir of expertise among many other

State officials. FDA believes this limitation on nonpublic exchange is

detrimental to Federal-State cooperation. By its very nature, the Food

Code is central to public health programs of Federal, State, and local

government organizations. As such, FDA would have preferred to share

developmental materials and drafts with a spectrum of State government

officials to assure participation in the development of the document by

some of the officials who will rely on it in the course of their

ongoing work.

3. The successful development and implementation of a comprehensive

food safety strategy, beyond the program for seafood safety, will

depend on a joint effort between FDA and State government officials.

FDA's decisions would benefit greatly from exchange of technical

expertise and professional views at all stages in the development of a

strategy. The importance of State government input and partnership is

underscored by the fact that, while FDA regulatory authority is very

broad, in practice many phases of food production and distribution are

regulated principally by State or local governments.

4. Some aspects of the Nutrition Labeling and Education Act (the

NLEA) address consumer issues that traditionally have been addressed by

State governments in food label review, e.g., content descriptors, net

weight declarations, and other elements that could relate to economic

deception. Congress intended, and FDA desires, that there be a

partnership between FDA officials and their State government

counterparts in the education and enforcement aspects of this

legislation. However, although FDA has been able to involve State

government officials who hold FDA commissions in strategy discussions,

the agency has not been able to utilize the broader base of expertise

that resides throughout State governments

sires, that there be a

partnership between FDA officials and their State government

counterparts in the education and enforcement aspects of this

legislation. However, although FDA has been able to involve State

government officials who hold FDA commissions in strategy discussions,

the agency has not been able to utilize the broader base of expertise

that resides throughout State governments. Further, although the NLEA

empowers the States to take action under the authority of the act, and

requires the States to notify FDA prior to initiating any action, it

requires the sharing of only very basic information. Enhanced ability

to exchange nonpublic information between FDA and State government

officials will facilitate enforcement of the NLEA.

5. The Mammography Quality Standards Act of 1992 (the MQSA), which

is now being implemented, poses many challenges with regard to Federal-

State cooperation and coordination. The MQSA calls for FDA to delegate

the MQSA authority to States that meet certain requirements, and for

FDA to provide oversight to ensure that States fulfill their

responsibilities. One objective of the MQSA is to maintain a certain

consistency of standards across State programs. Like the Federal

government, States establishing new programs and standards are bound by

administrative rulemaking processes, and will want to undertake those

rulemakings as soon as possible. So long as FDA's regulations limit the

nonpublic exchange of draft regulations, States may draft rules that

will turn out to be inconsistent with FDA's. That inconsistency may

delay and frustrate implementation of the provisions of the MQSA that

are intended to encourage State involvement in programs to assure

quality mammography. If FDA and State officials could exchange draft

regulations at all stages of the process, States could propose

regulations that were consistent with Federal regulations within

coordinated timeframes

ent with FDA's. That inconsistency may

delay and frustrate implementation of the provisions of the MQSA that

are intended to encourage State involvement in programs to assure

quality mammography. If FDA and State officials could exchange draft

regulations at all stages of the process, States could propose

regulations that were consistent with Federal regulations within

coordinated timeframes.

The enforcement and sanctions processes for the MQSA also pose

challenges to Federal-State cooperation and coordination. There are

approximately 11,300 facilities to be inspected, only about 30 percent

of which will be inspected by FDA. Strategies for inspection priorities

and Federal-State uniformity in the application of

enforcement actions and sanctions will be very important. If FDA cannot

easily exchange nonpublic information with State government officials,

cooperative efforts may be less effective.

F. Summary of Background

Exchanges of nonpublic information that meet the conditions

established in the proposal will facilitate Federal-State uniformity

and international harmonization in order to maximize consumer

protection and minimize the possibility that unnecessarily disparate

measures will be adopted on a particular issue. In order to enhance

effective regulatory activities and expeditious review of significant

public health issues, FDA has concluded that it needs the ability, in

selected circumstances, to disclose confidential commercial information

to State government officials, just as it earlier determined that it

may be necessary at times to disclose such information to foreign

government officials. Furthermore, in order to prepare new regulations

or modify existing regulations, issue technical requirements, or

undertake a variety of other activities, FDA may need to exchange draft

proposals with counterpart State government or foreign government

officials in the same way it exchanges similar information with other

U.S. government agencies

ch information to foreign

government officials. Furthermore, in order to prepare new regulations

or modify existing regulations, issue technical requirements, or

undertake a variety of other activities, FDA may need to exchange draft

proposals with counterpart State government or foreign government

officials in the same way it exchanges similar information with other

U.S. government agencies. Federal-State uniformity and international

harmonization are facilitated when such exchanges can take place at

early stages under circumstances that allow the frank exchange of views

among technical experts. FDA's experience over the last decade has

convinced the agency that foreign and State government technical and

scientific staff perform the same advisory function, in many instances,

as other agency employees and that the recommendations of such experts

are important to effective decisionmaking.

Of course, any information provided by State or foreign government

officials upon which FDA is relying in proposing a new regulation or

proposed change in existing regulations would be included in published

proposals or final rules in accordance with the Administrative

Procedure Act (5 U.S.C. 553). The general public will have ample

opportunity to comment on such proposals and their bases at that time.

FDA also emphasizes that disclosures to foreign and State counterparts

under final regulations based on these proposals would not be a routine

occurrence, but would occur only in limited situations.

II. Proposed Amendments

A. The Proposal to Extend to State Government Officials the Recent

Regulatory Provisions for Exchanging Confidential Commercial

Information With Foreign Government Officials

A also emphasizes that disclosures to foreign and State counterparts

under final regulations based on these proposals would not be a routine

occurrence, but would occur only in limited situations.

II. Proposed Amendments

A. The Proposal to Extend to State Government Officials the Recent

Regulatory Provisions for Exchanging Confidential Commercial

Information With Foreign Government Officials

Proposed Sec. 20.88(d) covers the nonpublic disclosure of certain

information that is protected from mandatory public disclosure by

exemption 4 of the FOIA, 5 U.S.C. 552(b)(4) to State government

officials. Exemption 4 covers two broad categories of information in

Federal agency records: Trade secret information, and information that

is: (1) Commercial or financial, (2) obtained from a person, and (3)

privileged or confidential (``confidential commercial information'').

Trade secret information has been defined by the courts as

information relating to the making, preparing, compounding, or

processing of trade commodities (Public Citizen Health Research Group

v. FDA, 704 F.2d 1280, 1288 (D.C. Cir. 1983)). This definition, which

requires a ``direct relationship'' between the trade secret and the

productive process, applies to a relatively narrow category of

information that coincides with information prohibited from disclosure

under section 301(j) of the act (21 U.S.C. 331(j)). FDA recently

amended Sec. 20.61 to reflect this definition (59 FR 531, January 5,

1994). That amendment was part of an update of the agency's FOIA

regulations to reflect changes that were required by the 1986

amendments to the FOIA and which have already been put into practice by

the agency. The amended definition of ``trade secret'' in part 20 is a

restatement of the standard established by Public Citizen Health

Research Group, and puts the definition in conformity with applicable

case law and with HHS's FOIA regulations

agency's FOIA

regulations to reflect changes that were required by the 1986

amendments to the FOIA and which have already been put into practice by

the agency. The amended definition of ``trade secret'' in part 20 is a

restatement of the standard established by Public Citizen Health

Research Group, and puts the definition in conformity with applicable

case law and with HHS's FOIA regulations. Because FDA's practice has

been in accordance with the judicial standards that resulted from

Public Citizen Health Research Group and with the definitions

established by HHS, the amendment to Sec. 20.61 did not alter the

agency's practice in any way or the expectations of the public or

regulated industry concerning FDA's treatment of particular types of

information.

Nor will the proposed amendment to Sec. 20.88 alter FDA's existing

practice with respect to the narrow category of information that can be

considered ``trade secret.'' The proposed amendment to Sec. 20.88

expressly excludes the disclosure of information that would fall into

the trade secret category to State government officials, without the

express authorization of the submitter. The only exception is that

State scientists visiting FDA as part of a joint review or long-term

training effort authorized under section 708 of the act (21 U.S.C. 379)

may, under additional safeguards specified in the rule, be allowed

access to such information.

It has been an agency practice to disclose confidential

information, including trade secret information, to visiting government

scientists insofar as that access is authorized under confidentiality

agreements for a training or joint review activity under section 708 of

the act and Sec. 20.90. This proposed rule (Sec. 20.88(d)(1)(ii)(C))

codifies the procedures for providing access to such information in the

rule on exchanging information with State government officials rather

than continuing this practice under the more general Sec. 20.90

procedures

is authorized under confidentiality

agreements for a training or joint review activity under section 708 of

the act and Sec. 20.90. This proposed rule (Sec. 20.88(d)(1)(ii)(C))

codifies the procedures for providing access to such information in the

rule on exchanging information with State government officials rather

than continuing this practice under the more general Sec. 20.90

procedures.

The principal focus of this part of the proposed rulemaking is the

disclosure to State government officials of the other category of

information covered by exemption 4 of the FOIA, ``confidential

commercial information,'' including agency-prepared reviews of such

information, and records that include such information. Commercial or

financial information that a person is required to provide FDA is

``confidential'' for purposes of exemption 4 if disclosure of the

information is likely to: (1) Impair the Government's ability to obtain

necessary information in the future or (2) cause substantial harm to

the competitive position of the person from whom the information was

obtained. (See Critical Mass Energy Project v. NRC, 975 F.2d 871, 877-

880 (D.C. Cir. 1992) (en banc), cert. denied, 113 S.Ct. 1579 (1993);

National Parks and Conservation Association v. Morton, 498 F.2d 765,

770 (D.C. Cir. 1974).) Commercial or financial information that is

provided to FDA on a voluntary basis is ``confidential'' if it is of a

kind that the provider would not customarily release to the public.

(See Critical Mass Energy Project at 880). The types of information

that may be exempt from public disclosure pursuant to this section of

the FOIA include: Business sales statistics, customer and supplier

lists, research data, profit and loss data, and overhead and operating

costs. Under many circumstances, FDA also treats data supporting

product approval submissions as confidential commercial information

that is entitled to be prohibited from public disclosure

at may be exempt from public disclosure pursuant to this section of

the FOIA include: Business sales statistics, customer and supplier

lists, research data, profit and loss data, and overhead and operating

costs. Under many circumstances, FDA also treats data supporting

product approval submissions as confidential commercial information

that is entitled to be prohibited from public disclosure. Thus, under

the amended regulation, confidential commercial information submitted

to the agency that could be disclosed to State governments would

include information (other than trade secret information

prohibited from disclosure under section 301(j) of the act) in pending

and approved submissions for permission to perform studies on or to

market regulated articles such as new drugs, new animal drugs, medical

devices, and biological products, and information in agency-prepared

reviews of such submissions.

The proposed amendment to Sec. 20.88 would establish that State

government officials are not members of the public for purposes of

disclosure of confidential commercial information submitted to FDA or

incorporated into records prepared by the agency, and that such

disclosures would not invoke the requirements in Sec. 20.21 of uniform

access to records. Disclosure of confidential commercial information to

State government officials pursuant to the proposed amendment would be

an ``authorized'' disclosure. Accordingly, no FDA employee engaged in

such a nonpublic disclosure of confidential commercial information

would be in violation of the Trade Secrets Act, 18 U.S.C. 1905. That

statute makes the unauthorized disclosure of such information by a

Federal employee a crime.

The proposed amendment to Sec

government officials pursuant to the proposed amendment would be

an ``authorized'' disclosure. Accordingly, no FDA employee engaged in

such a nonpublic disclosure of confidential commercial information

would be in violation of the Trade Secrets Act, 18 U.S.C. 1905. That

statute makes the unauthorized disclosure of such information by a

Federal employee a crime.

The proposed amendment to Sec. 20.88 will enable FDA, in its

discretion and subject to the conditions imposed by this proposed

amendment, to provide or receive confidential commercial information

(whether provided by the sponsor or found in investigatory records) in

nonpublic exchanges with State government officials for use in

cooperative regulatory efforts or law enforcement efforts. FDA will be

able to make such exchanges of confidential commercial information

contained in submissions, in FDA- or State government-prepared reviews

and records of such submissions, and in FDA- or State government-

prepared investigatory records, without invoking the rule established

in Sec. 20.21 that any member of the public becomes entitled to the

same information.

The agency does not intend that disclosures of confidential

commercial information to State government officials will be a routine

occurrence. FDA intends to engage in the disclosure of nonpublic

confidential commercial information to State government officials only

when certain conditions are met, and only in its discretion. In every

case, the proposed rule (Sec. 20.88(d)(1)(i)) would require assurances

from the State government that the information will be held in

confidence. The proposed rule (Sec

s will be a routine

occurrence. FDA intends to engage in the disclosure of nonpublic

confidential commercial information to State government officials only

when certain conditions are met, and only in its discretion. In every

case, the proposed rule (Sec. 20.88(d)(1)(i)) would require assurances

from the State government that the information will be held in

confidence. The proposed rule (Sec. 20.88(d)(1)(ii)) would further

require that any one of three additional conditions be met: (1) Written

authorization by the submitter of the information; (2) a finding that

disclosure is in the interest of public health by reason of the State

government's possessing information concerning the safety,

effectiveness, or quality of the product or information concerning an

investigation, or by reason of the State government being able to

exercise its regulatory authority more expeditiously than the agency;

or (3) the disclosure is to a State government scientist visiting FDA

as part of a joint review or long-term cooperative training effort that

furthers FDA's regulatory mission. Thus, the circumstances and

safeguards under which FDA would exchange confidential commercial

information with State government officials pursuant to the proposed

amendment to Sec. 20.88 would be the same as those recently provided in

the 1993 amendment to Sec. 20.89 regarding FDA disclosure of

confidential commercial information to foreign government officials.

B. Proposals for Regulatory Provisions for Exchanging Predecisional

Documents and Other Nonpublic Information With State and Foreign

Government Officials

ent officials pursuant to the proposed

amendment to Sec. 20.88 would be the same as those recently provided in

the 1993 amendment to Sec. 20.89 regarding FDA disclosure of

confidential commercial information to foreign government officials.

B. Proposals for Regulatory Provisions for Exchanging Predecisional

Documents and Other Nonpublic Information With State and Foreign

Government Officials

The agency is proposing to amend Secs. 20.88(e) and 20.89(d) to

cover the nonpublic exchange between FDA and State government officials

(Sec. 20.88(e)) and between FDA and foreign government officials

(Sec. 20.89(d)), of nonpublic predecisional documents concerning FDA's

and other governments' proposed regulations, impending regulatory

initiatives, or other nonpublic information relevant to agency

activities (including, but not limited to, draft regulations,

guidelines for technical issues to be addressed in sponsors'

submissions, draft staff manual guides, draft compliance policy guides,

strategy documents for inspection priorities, and draft MOU's between

State, Federal, and foreign government agencies).

FDA wants the ability, in some circumstances and only when specific

conditions are met, to exchange predecisional, preimplementation, or

other nonpublic documents with State government officials and foreign

government officials, without being compelled to disclose them to the

public.

For the purposes of Sec. 20.88(e) of this proposed regulation, the

term ``official of a State government agency'' may include an official

of an organization of State officials having responsibility to

facilitate harmonization of State standards and requirements in FDA's

areas of responsibility. Similarly, for the purposes of Sec. 20.89(d)

of this proposed regulation, the term ``foreign government official''

may include an official of an international organization having

responsibility to facilitate harmonization of global standards and

requirements in FDA's areas of responsibility

lity to

facilitate harmonization of State standards and requirements in FDA's

areas of responsibility. Similarly, for the purposes of Sec. 20.89(d)

of this proposed regulation, the term ``foreign government official''

may include an official of an international organization having

responsibility to facilitate harmonization of global standards and

requirements in FDA's areas of responsibility. Examples of

organizations whose officials may be given access to draft nonpublic

documents are the Association of Food and Drug Officials (AFDO) and the

Food and Agriculture Organization (FAO) of the United Nations.

The ability to exchange predecisional and preimplementation

documents with the officials in question will facilitate harmonization

of national and international regulatory requirements.

In every case, the proposed regulations (Secs. 20.88(e)(1)(i) and

20.89(d)(1)(i)) require assurances from the receiving government that

the information will be held in confidence. The proposed regulations

(Secs. 20.88(e)(1)(ii) and 20.89(d)(1)(ii)) further require the agency

to determine that it is reasonably necessary to exchange the nonpublic

documents to enhance Federal-State uniformity or to facilitate global

harmonization of regulatory requirements, cooperative regulatory

activities, or implementation of obligations resulting from

international agreements. When these conditions are met, the agency

believes that the records will be exempt from mandatory public

disclosure under the FOIA.

C. FDA Believes the Deliberative Process Privilege Should Protect

Certain Advice and Recommendations from Foreign and State Counterparts

ry requirements, cooperative regulatory

activities, or implementation of obligations resulting from

international agreements. When these conditions are met, the agency

believes that the records will be exempt from mandatory public

disclosure under the FOIA.

C. FDA Believes the Deliberative Process Privilege Should Protect

Certain Advice and Recommendations from Foreign and State Counterparts

The proposed amendments (Secs. 20.88(e)(2) and 20.89(d)(2)) would

establish that State and foreign government officials are not members

of the public for purposes of exchange of certain nonpublic

predecisional records, and that such exchanges will not invoke the

requirements in Sec. 20.21 of uniform access to records. FDA believes

that records of advice and recommendations between government officials

concerning public health and harmonization initiatives can be protected

from mandatory disclosure under exemption 5 of the FOIA, 5 U.S.C.

552(b)(5). That exemption incorporates common law discovery privileges

for intra- and interagency memoranda, including the deliberative

process privilege asserted by government agencies to protect the

process and quality of decisionmaking.

FDA believes it is appropriate to assert the deliberative process

privilege in response to requests for public access to

certain communications from State and foreign government officials

because the same policy reasons that support nondisclosure of

deliberative and predecisional memoranda generated by Federal

government agencies justify withholding, in many circumstances, the

advice and recommendations generated for FDA by State and foreign

government counterparts.

The agency's ability to make sound decisions about the development

and implementation of public health and harmonization initiatives is

enhanced by access to the advice and recommendations of experts in

State and foreign governments who are engaged in similar efforts in

their own jurisdictions

es, the

advice and recommendations generated for FDA by State and foreign

government counterparts.

The agency's ability to make sound decisions about the development

and implementation of public health and harmonization initiatives is

enhanced by access to the advice and recommendations of experts in

State and foreign governments who are engaged in similar efforts in

their own jurisdictions. The agency views this kind of consultation as

functionally equivalent to the ``intra-'' or ``interagency''

deliberation more commonly protected by exemption 5 of the FOIA.

Indeed, it is frequently the case that advice from a State or foreign

health official whose responsibilities parallel those of FDA officials

concerning the feasibility of a particular technical or harmonization

regulation will be as relevant as similar recommendations solicited

from employees in other Federal government agencies.

In order to encourage the most candid and useful exchange of

information in these circumstances, FDA believes it is essential to

have discretion to protect from public disclosure the advice and

recommendations it receives from State or foreign government officials.

Again, the same policy considerations apply as would apply to

intraagency deliberations: State and foreign government officials are

at least as likely as Federal employees to be inhibited from giving

frank advice when they know that opinion will be made public.

The principle that documents generated outside a government

``agency'' may still qualify for protection from public disclosure

under exemption 5 of the FOIA has been endorsed by many courts. In

recognizing the practical necessity that requires agency decisionmaking

to depend on advice and opinions from sources beyond agency or Federal

personnel, courts have adopted a ``functional'' test for assessing the

applicability of exemption 5 protection, and included a variety of

``nonagencies'' within the threshhold definition of exemption 5

memoranda. (See, e.g., Formaldehyde Institute v

n

recognizing the practical necessity that requires agency decisionmaking

to depend on advice and opinions from sources beyond agency or Federal

personnel, courts have adopted a ``functional'' test for assessing the

applicability of exemption 5 protection, and included a variety of

``nonagencies'' within the threshhold definition of exemption 5

memoranda. (See, e.g., Formaldehyde Institute v. HHS, 889 F.2d 1118,

1123-1124 (D.C. Cir. 1989) (exemption 5's interagency threshold

requirement applied to opinions solicited from outside scientific

journal reviewers); Ryan v. Department of Justice, 617 F.2d 781, 790

(D.C. Cir. 1980) (exemption 5 applied to recommendations from Senators

to Attorney General); Mobil Oil Corp. v. FTC, 406 F. Supp. 305, 315

(S.D.N.Y. 1976) (exemption 5 rationale applies to advice from State as

well as Federal agencies). FDA believes the examples it has described

in this document demonstrate that it is appropriate and necessary for

FDA to be able to treat the exchange of advice and recommendations from

foreign and State government officials as a functional part of the

agency's deliberative process.

In addition to protecting certain advice and recommendations from

State and foreign government officials which FDA utilizes in its

decisionmaking processes, FDA also believes it should be able to

cooperate with State and foreign government officials who request FDA

input for deliberations within their own agencies.

Those State and foreign government agencies with which FDA most

frequently consults operate, as does FDA, within laws that constrain

their ability to share nonpublic information. In many circumstances,

these agencies require assurances that FDA will not disclose to the

public in response to a FOIA request certain information provided to

FDA by a State or foreign govenment official

agencies.

Those State and foreign government agencies with which FDA most

frequently consults operate, as does FDA, within laws that constrain

their ability to share nonpublic information. In many circumstances,

these agencies require assurances that FDA will not disclose to the

public in response to a FOIA request certain information provided to

FDA by a State or foreign govenment official. FDA has always been able

to give such assurances with respect to proprietary or law enforcement

information provided by State or foreign governments; under FDA's

public information regulations, such information is subject to the same

protection as if the information had been directly gathered or received

by FDA. (See Sec. 20.88(c)(1) and 20.89(a)). Indeed, FDA's regulations

have for 20 years permitted the agency to provide additional assurances

with respect to investigatory records that the State or foreign

government will provide only upon assurance that protection will

continue for some longer period of time. Id.

However, FDA has not been able to provide similar assurances of

confidentiality with respect to nonpublic information provided to FDA

by State or foreign governments that is of a deliberative nature,

reflecting internal deliberations of that other government entity or

predecisional drafts of records that are intended to implement public

health initiatives on the part of counterpart State or foreign

government agencies.

As discussed above, FDA believes that when such counterpart

officials provide advice to FDA on issues and initiatives that FDA is

deliberating, that advice is the functional equivalent of advice that

would be provided by experts within the agency or by other Federal

agency employees. Accordingly, under the amendments proposed to

Secs

part of counterpart State or foreign

government agencies.

As discussed above, FDA believes that when such counterpart

officials provide advice to FDA on issues and initiatives that FDA is

deliberating, that advice is the functional equivalent of advice that

would be provided by experts within the agency or by other Federal

agency employees. Accordingly, under the amendments proposed to

Secs. 20.88 and 20.89, FDA would protect as interagency memoranda under

exemption 5 of the FOIA the records it exchanged with foreign and State

government health officials as part of FDA's efforts to reach a

decision about initiatives it was considering. However, FDA believes

the public health and FDA's relationships with foreign and State

counterparts require that the agency be able to provide similar

consultations to counterpart officials when it is those State or

foreign government officials who request advice, and who require the

exchange to remain nonpublic in order to protect their own deliberative

processes. In most cases, because the foreign or State counterpart is

providing FDA with information that is confidential commercial or

investigatory information, FDA's published regulations permit FDA to

protect those records from public disclosure. There have been

situations, however, where a foreign government agency wishes to share

with FDA a document that will not qualify for protection under the FOIA

for proprietary or investigatory records, and which may not qualify

under the deliberative process privilege discussed above because the

decision that is being made is entirely within the jurisdiction of the

foreign government counterpart. FDA believes international comity and

the potential benefit to public health that may result from such

consultations require the agency to attempt to honor such requests for

confidentiality whenever it is possible to do so

under the deliberative process privilege discussed above because the

decision that is being made is entirely within the jurisdiction of the

foreign government counterpart. FDA believes international comity and

the potential benefit to public health that may result from such

consultations require the agency to attempt to honor such requests for

confidentiality whenever it is possible to do so.

In circumstances where advice or information is provided by foreign

governments pursuant to international agreements that provide for the

nondisclosure of such exchanges, FDA believes the record generated by

the foreign government and provided to FDA is not necessarily an

``agency record'' subject to FOIA and that FDA, therefore, might honor

requests for confidentiality without contravening public disclosure

requirements. The Supreme Court has delineated two broad tests for

determining whether a document is an agency record for purposes of

FOIA. The document: (1) Must be created or obtained by an agency, and

(2) must be under the control of the agency when a FOIA request for the

record is made. See United States Department of Justice v. Tax

Analysts, 492 U.S. 136 (1989). When a foreign government shares

documents pursuant to agreements that require

confidentiality before disclosure will be made, the record may not be

under the ``control'' of FDA. In those circumstances where a treaty,

agreement, or MOU between the United States and a foreign government

requires confidentiality in order to encourage international

consultation, FDA believes that control of the record may be governed

by the treaty or agreement under which the foreign government health

officials have shared the information with United States counterparts.

Two recent opinions by Federal District Courts in the District of

Columbia support this view. See Katz v. National Archives & Records

Administration, No. 92-1024 (D.D.C. March 2, 1994), reconsideration

denied (D.D.C

ly is not able to undertake.

FDA fully supports the Attorney General's Memorandum of October 4,

1993, establishing new standards of government openness, and FDA

intends to apply a ``foreseeable harm'' standard when applying FOIA

exemptions. Under this policy, government agencies are guided by the

principle that exempt information should not be withheld from a FOIA

requester unless it need be. FDA reiterates that the nonpublic exchange

of information with State and foreign government counterparts will not

be a routine occurrence; the proposed regulations, which require

specific assurances from the receiving official and a determination on

the part of FDA that the exchange is necessary, establish rigorous

prerequisites.

FDA has no intention of protecting from public disclosure any

information it shares with foreign or State counterparts that may be

disclosed to the public without harm to any private or government

interests. Nor does FDA believe that all State or foreign counterparts

will desire or require FDA to protect information they provide to this

agency. However, the agency also believes that its current public

information regulations are too rigid for effective exchange of

information in a national and increasingly international economy. These

proposals reflect FDA's determination that its public health mission

has been hampered in certain circumstances by the inability to exchange

nonpublic information with counterpart officials. The agency believes

the proposed changes have been drafted narrowly and with sufficient

safeguards to allow FDA to exchange nonpublic information when

necessary without damage to either proprietary interests or appropriate

public access to agency records.

As stated earlier, any information provided by State or foreign

government officials upon which FDA is relying will be included in

published proposals

lieves

the proposed changes have been drafted narrowly and with sufficient

safeguards to allow FDA to exchange nonpublic information when

necessary without damage to either proprietary interests or appropriate

public access to agency records.

As stated earlier, any information provided by State or foreign

government officials upon which FDA is relying will be included in

published proposals. At that time, the general public will be fully

informed and have an opportunity to comment on the substance of any

advice from foreign or State officials that is incorporated into agency

proposals or initiatives.

III. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) 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 the proposed rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

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 net 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

principles identified in the Executive Order. In addition, the proposed

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under 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

with the regulatory philosophy and

principles identified in the Executive Order. In addition, the proposed

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under 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. Because this proposed rule promotes harmonized

regulatory requirements, nationally and internationally, thereby

reducing disparate regulatory requirements, the agency certifies that

the proposed rule will not have a significant economic impact on a

substantial number of small entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is required.

V. Comments

Interested persons may, on or before April 27, 1995, 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 docket number found in brackets in the heading of this document.

Received comments may be seen in the office above between 9 a.m. to 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 of 21 CFR part 20 is revised to read as

follows:

Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321-393); secs. 301, 302, 303, 307, 310, 311, 351,

352, 354-360F, 361, 362, 1701-1706, 2101 of the Public Health

Service Act (42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263,

263b-263n, 264, 265, 300u-300u-5, 300aa-1); 5 U.S.C. 552; 18 U.S.C.

1905; 19 U.S.C. 2531-2582.

part 20 is revised to read as

follows:

Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321-393); secs. 301, 302, 303, 307, 310, 311, 351,

352, 354-360F, 361, 362, 1701-1706, 2101 of the Public Health

Service Act (42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263,

263b-263n, 264, 265, 300u-300u-5, 300aa-1); 5 U.S.C. 552; 18 U.S.C.

1905; 19 U.S.C. 2531-2582.

2. Section 20.88 is amended by adding new paragraphs (d) and (e) to

read as follows:

Sec. 20.88 Communications with State and local government officials.

* * * * *

(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

tate 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 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

n, 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 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 Commissioner of the 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 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:

nt 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 provided both a written

statement establishing its authority to protect such nonpublic

documents from public disclosure and a written commitment not to

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 Commissioner of Food and Drugs or the Commissioner's

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 in 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 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

an official, the statement and commitment required by paragraph

(e)(1)(i) of this section shall be provided by both the organization

and the individual.

3. Section 20.89 is amended by adding new paragraph (d) to read as

follows:

Sec. 20.89 Communication with foreign government officials.

* * * * *

harmonization of State

standards and requirements in FDA's areas of responsibility. For such

an official, the statement and commitment required by paragraph

(e)(1)(i) of this section shall be provided by both the organization

and the individual.

3. Section 20.89 is amended by adding new paragraph (d) to read as

follows:

Sec. 20.89 Communication with foreign government officials.

* * * * *

(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 to, or receipt from, an official of a foreign 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 cooperative efforts to

facilitate global harmonization of regulatory requirements, cooperative

regulatory activities, or implementation of international agreements,

provided that:

(i) The foreign government agency has provided both a written

statement establishing its authority to protect such nonpublic

documents from public disclosure and a written commitment not to

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 Commissioner of Food and Drugs or the Commissioner's

designee makes the determination that the exchange is reasonably

necessary to facilitate global harmonization of regulatory

requirements, cooperative regulatory activities, or implementation of

international agreements.

(2) Any exchange under this section of nonpublic documents does not

invoke the rule established in Sec. 20.21 that such records shall be

made available to all members of the public.

e makes the determination that the exchange is reasonably

necessary to facilitate global harmonization of regulatory

requirements, cooperative regulatory activities, or implementation of

international agreements.

(2) Any exchange under this section of nonpublic documents does not

invoke the rule established in 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

foreign government agency'' includes, an employee of an international

organization having responsibility to facilitate global harmonization

of standards and requirements in FDA's areas of responsibility. For

such an official, the statement and commitment required by paragraph

(d)(1)(i) of this section shall be provided by both the organization

and the individual.

Dated: January 23, 1995.

William K. Hubbard,

Interim Deputy Commissioner for Policy.

[FR Doc. 95-2111 Filed 1-26-95; 8:45 am]

BILLING CODE 4160-01-F