[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
_______________________________________________________________________
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
