[Federal Register Volume 60, Number 18 (Friday, January 27, 1995)]
[Proposed Rules]
[Pages 5530-5540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2111]




[[Page 5529]]

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Part V





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 20



Public Information; Communications With State and Foreign Government 
Officials

  Federal Register / Vol. 60, No. 18 / Friday, January 27, 1995 / 
Proposed Rules   
[[Page 5530]] 

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.

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. 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.
    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. 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 [[Page 5531]] 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.
    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

    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.
    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.
    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). 
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 
[[Page 5532]] 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. 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

    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. 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. 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. 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 [[Page 5533]] 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. 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. 
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.
    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. 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. 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 [[Page 5534]] 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. 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. 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. 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. 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.
    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 [[Page 5535]] 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. 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

    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. 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.
    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. Thus, under 
the amended regulation, confidential commercial information submitted 
to the agency that could be disclosed to State governments would 
[[Page 5536]] 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. 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. 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

    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. 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

    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 [[Page 5537]] 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. 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. 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. 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. 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.
    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 
[[Page 5538]] 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. August 24, 1994) (appeal pending) (autopsy records not 
agency records because their disposition was governed by a Deed of Gift 
to National Archives); KDKA-TV v. Richard Thornburgh, et. al, No. 90-
1536 (D.D.C. September 30, 1992) (reports in possession of National 
Transportation Safety Board not agency record because disclosure is 
governed by conditions of International Convention).
    Similarly, FDA believes that in those rare instances where State 
governments initiate review of their own proceedings through 
consultation with FDA on conditions of confidentiality, FDA should be 
able to offer advice without jeopardizing public disclosure of records 
that would interfere with the deliberative processes of the State 
agency. FDA invites the submission of further information and views on 
this issue.

D. FDA's Proposals Will Not Reduce Public Access to Agency Records

    FDA believes these proposals will do nothing to diminish current 
public access to agency records. The purpose of these proposed 
amendments is not to reduce the number or types of records that will be 
available to the public from FDA, but to enhance the agency's access to 
information exchanges that it currently 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. 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. 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.

    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 [[Page 5539]] 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
    (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. 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:
    (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.

* * * * *
    (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.
    (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.

    [[Page 5540]] 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