[Federal Register Volume 60, Number 236 (Friday, December 8, 1995)]
[Rules and Regulations]
[Pages 63372-63382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29904]
[[Page 63371]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 20
Public Information; Communications With State and Foreign Government
Officials; Final Rule
Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 /
Rules and Regulations
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[[Page 63372]]
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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations governing communications with State and foreign government
officials. This final rule permits FDA to receive and to disclose
nonpublic safety, effectiveness, or quality information concerning FDA-
regulated products to State government officials and to receive or to
disclose draft proposed rules and other nonpublic, predecisional
documents concerning regulatory requirements or activities to State or
foreign government officials. In both cases, disclosures to or by State
or foreign government officials would not require FDA to make the
information or documents available to the public. This action is
necessary to enhance cooperation in regulatory activities, to eliminate
unwarranted contradictory regulatory requirements, and to minimize
redundant application of similar requirements.
EFFECTIVE DATE: January 8, 1996.
FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3380.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 27, 1995 (60 FR 5530), FDA
published a proposed rule that would enable FDA to disclose to and
receive from State government officials confidential commercial
information without being compelled to make that information available
to the general public. The proposed rule would also enable the agency
to share and to receive nonpublic documents, such as draft rules, with
State and foreign government officials. Exchanges of information,
including nonpublic information, would enhance Federal-State
cooperation in regulatory activities, help eliminate unwarranted
contradictory regulatory requirements, and minimize redundant
application of similar requirements by domestic and foreign bodies.
The preamble to the proposed rule described the statutory and
regulatory provisions that had governed FDA's communications with State
and foreign government officials. Generally, FDA has always possessed
both statutory and regulatory authority to withhold some information
from public disclosure. For example, the Freedom of Information Act
(the FOIA) (5 U.S.C. 552) establishes categories of information that
are exempt from public disclosure. Such categories of information
relevant to FDA records 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 whose disclosure might invade personal privacy (5
U.S.C. 552(b)(6)); and
4. Investigatory files compiled for law enforcement purposes to
protect investigations into violations of the statutes and regulations
FDA enforces (5 U.S.C. 552(b)(7)).
In 1974, FDA issued regulations implementing the FOIA and other
laws (such as 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)) that affect public access to government records and
information. These regulations included a provision, now codified in
Sec. 20.21 (21 CFR 20.21), stating that any record that is disclosed in
an authorized manner to any member of the public is available for
disclosure to all members of the public. When FDA issued Sec. 20.21 in
1974, it expressly declined to make an exception for records disclosed
to foreign governments, stating that:
The Commissioner concludes that the same rules will apply with
respect to disclosure of [safety and effectiveness information] to
foreign governments as apply to disclosure to the public. This will
permit the Food and Drug Administration to provide full summaries of
all safety and effectiveness data for all approved [new drug
applications (NDA's)] and selected summaries for [investigational
new drug applications (IND's)] and pending NDA's of which the
existence of an IND has been publicly disclosed or acknowledged. The
Commissioner concludes that this will adequately satisfy the need
for international exchange of important regulatory information of
this type.
(See 39 FR 44602 at 44636 and 44637, December 24, 1974.)
However, since 1974, the regulatory environment has changed
significantly. Increased international commerce and diminishing
governmental resources have prompted public health regulatory agencies,
as well as the industries they regulate, to make efforts to enhance the
effectiveness and efficiency of their regulatory efforts. Public health
regulatory agencies have engaged in activities to harmonize regulatory
requirements, minimize duplicative regulations, and cooperate in joint
scientific, regulatory, and enforcement endeavors.
For example, FDA is active in a program known as the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH). ICH was organized to provide an
opportunity for harmonization initiatives to be developed with input
from both regulatory and industry representatives. ICH is concerned
with harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission, the European Federation of Pharmaceutical Industry
Associations, the Japanese Ministry of Health and Welfare, the Japanese
Pharmaceutical Manufacturers Association, FDA, and the Pharmaceutical
Research and Manufacturers of America. In addition, the ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA). The ICH Steering Committee includes
representatives from each organizing body and IFPMA, as well as
observers from the World Health Organization, the Canadian Health
Protection Branch, and the European Free Trade Area. The ICH expert
working groups prepare guidelines on a variety of drug safety,
efficacy, and quality matters, and FDA publishes these guidelines in
the Federal Register.
Simultaneously, FDA's interaction with State agencies has become
more important, particularly as Federal and State authorities have
shared responsibilities in certain programs and new authorities have
been added. For example, FDA and other Federal and State agencies
regulate narcotic treatment program clinics. When new treatments become
available, FDA must issue or amend its regulations regarding the new
treatment's use and any special conditions on the treatment programs
themselves. Yet, State government agencies may share responsibility for
ensuring that the treatment programs are licensed and operate in
accordance with the law and regulations. The current
[[Page 63373]]
degree of Federal-State cooperation was not contemplated back in 1974
when FDA first issued its public information regulations. New Federal
laws enacted since 1974 have also emphasized the importance of Federal-
State cooperation. Statutes such as the Prescription Drug Marketing Act
of 1987, the Nutrition Labeling and Education Act of 1990, and the
Mammography Quality Standards Act of 1992 have created regulatory
schemes in which the Federal government establishes programs and
standards and States play a major role in operations and enforcement.
This final rule is the second initiative in which FDA has amended
its public information regulations to reflect its growing involvement
in international activities. In the Federal Register of November 19,
1993 (58 FR 61598), FDA published a final rule amending its regulations
governing communications with foreign officials (hereinafter referred
to as the 1993 final rule). The 1993 final rule, which is now codified
in Sec. 20.89 (21 CFR 20.89), permits FDA, under certain safeguards, to
disclose confidential commercial information concerning FDA-regulated
products to foreign government officials who perform counterpart
functions to FDA ``as part of cooperative law enforcement or regulatory
efforts.'' Those safeguards include: (1) A written statement from the
foreign government agency establishing its authority to protect
confidential commercial information from public disclosure and a
written commitment not to disclose such information without the
sponsor's written permission or written confirmation from FDA that the
information is no longer confidential; and (2) a determination by FDA
that the sponsor has provided written authorization for the disclosure,
disclosure would be in the interest of public health, or disclosure is
to a foreign scientist visiting FDA, on FDA's premises, as part of a
joint review or long-term cooperative training effort and other
safeguards. Except in the case of foreign scientists working on FDA's
premises, the 1993 final rule did not authorize disclosure of trade
secret information without written permission from the person that had
submitted the trade secret information.
The 1993 final rule led the agency to consider whether the
privileges accorded to foreign government representatives should be
extended to State and local government officials. Although States carry
out relatively few product approval programs, they are significant
partners to FDA in such areas as bioresearch monitoring. The agency
ultimately decided that there are times when FDA needs to be able to
share confidential commercial information with State and local
government officials and that, when FDA grants such access, it should
be subject to the same restrictions and limitations on disclosure as in
cases where FDA grants foreign government officials access to
confidential commercial information. Also, cooperative regulatory
activities would be enhanced if FDA could provide nonpublic,
predecisional documents to State and foreign counterparts.
Consequently, FDA published a proposed rule (60 FR 5530) to amend
Sec. 20.88 (21 CFR 20.88) to: (1) Permit the agency to disclose
confidential commercial information submitted to FDA or incorporated
into FDA-prepared records to State government officials, and (2)
disclose to or receive from State government officials nonpublic
predecisional documents concerning FDA's or the State agency's
regulations, regulatory requirements, or other nonpublic information.
In both cases, disclosure would be subject to certain conditions or
restrictions, and the information exchanges would not require
disclosure to the public. For example, under proposed Sec. 20.88(d),
FDA would be authorized to disclose confidential commercial information
to State government officials provided that: (1) The State government
agency has provided a written statement establishing its authority to
protect confidential commercial information and a written commitment
not to disclose such information without written permission from FDA or
the sponsor of the confidential commercial information; and (2) the
agency found that the sponsor has provided written permission for the
disclosure, disclosure would be in the interest of the public health,
or disclosure would be to a visiting State government scientist on
FDA's premises. (See 60 FR 5530 at 5539.)
The proposed rule would also amend Sec. 20.89 to permit FDA to
disclose to or receive from foreign government officials nonpublic
predecisional documents, provided that certain conditions (such as
provision of a written statement establishing the foreign government's
authority to protect nonpublic documents from public disclosure) are
observed and that certain findings (such as a finding that the exchange
is ``reasonably necessary to facilitate global harmonization of
regulatory requirements, cooperative regulatory activities, or
implementation of international agreements'') are made.
II. Analysis of the Comments on the Proposed Rule
FDA received 20 comments on the proposed rule. Ten comments,
consisting of letters from nine States and one foreign country,
expressed strong support for the proposed rule. In general, these
comments indicated that the proposed rule would enhance
intergovernmental relations, help eliminate redundant regulatory
requirements, permit Federal and State agencies to respond more quickly
to potential public health problems, and aid efforts to combat health
fraud.
The remaining 10 comments were sent by individual citizens and
firms and opposed the proposed rule for the reasons described below. In
brief, five comments opposed withholding information from the general
public because they saw the proposed rule as undercutting openness in
government, whereas the other five comments opposed disclosures because
they felt the proposed rule lacked sufficient safeguards to prevent
State and foreign government officials from disclosing confidential
commercial information or trade secrets to third parties.
A. General Comments-
1. Two comments commended FDA for trying to increase
intergovernmental cooperation, but argued that, as FDA is not involved
in matters of national security or defense, it should not keep any
communications from the public. The comments asserted that withholding
information from public disclosure would not benefit the public and
might diminish public and industry respect for the agency. Similarly,
two other comments argued that the proposed rule violated the First
Amendment to the U.S. Constitution because it limited the amount of
information that the public could examine. The comments stated that the
agency had not justified or shown that its interest in denying public
access to information exchanged with State and foreign governments
exceeds the public's interest in access to that information.
The agency disagrees with the comments. The final rule does not in
any way reduce the information in FDA records that the public can
examine. Section 20.88(d) permits FDA to provide confidential
commercial information to State government officials. Confidential
commercial information has historically been exempt from public
disclosure requirements, so FDA's providing such information to State
government officials while withholding such information from the public
will not decrease the amount of information
[[Page 63374]]
available to the public. Sections 20.88(e) and 20.89(d) pertain to
exchanges of nonpublic, predecisional documents with State and foreign
government officials. Historically, FDA has generally withheld these
documents from public disclosure as well.
The agency also disagrees with any assertion that the final rule
violates the First Amendment. While courts have construed the First
Amendment as giving the public access to government proceedings, they
have declined to provide access to all government operations. Indeed,
as the Supreme Court stated in Press-Enterprise Co. v. Superior Court
of California, 478 U.S. 1, 9 (1986):
Although many governmental processes operate best under public
scrutiny, it takes little imagination to recognize that there are
some kinds of government operations that would be totally frustrated
if conducted openly.
In the present case, requiring FDA to publicly disclose confidential
commercial information and predecisional documents that it provides to
or receives from State and foreign governments would frustrate the
final rule's fundamental purposes. The final rule is intended to
encourage information exchanges between governments by assuring State
and foreign governments that the information or documents they receive
or provide will not be publicly available. The final rule also
reassures those who submit confidential commercial information to FDA
or to State or foreign governments that such information will be
protected. If public access to confidential commercial information were
required whenever FDA exchanged such information with a State or
foreign government, as the comments suggest, firms would then be
obliged to refuse requests for intergovernmental disclosure by FDA,
State governments, or foreign governments or even refuse to submit
confidential commercial information in order to protect it.
Additionally, courts have established a two-part test of
``experience'' and ``logic'' to determine whether the First Amendment
requires the governmental proceeding to be open to the public. The
first part, ``experience,'' asks whether the proceeding is one that has
historically been open to the public. The second part, ``logic,'' asks
whether public access would play a significant, positive role in the
governmental process. If the government process passes these tests,
then a qualified First Amendment right of public access exists; in
other words, the right of public access is not absolute or
unconditional. (See Press-Enterprise Co., 478 U.S. 8 and 9; United
States v. Simone, 14 F.3d 833, 837-839 (3d Cir. 1994).)
Applying the two-part test to the final rule leads to the
conclusion that the First Amendment does not require these exchanges of
information to be open to the public. Historically, the agency has
always protected confidential commercial information and indicated that
predecisional documents prepared by the agency are either not available
to the general public or available under limited conditions. (See,
e.g., 21 CFR 20.61 and 21 CFR 20.62 (nondisclosure of inter- or intra-
agency memoranda or letters); 21 CFR 20.64 (nondisclosure of records or
information compiled for law enforcement purposes); 21 CFR 10.80
(establishing conditions for release of draft notices and regulations).
Additionally, under the second prong, it is questionable whether
public access would play a significant, positive role in the
governmental process. For example, intergovernmental exchanges of
confidential commercial information will enable governments to learn
more about specific products and, as a result, to develop better and
more efficient regulatory or enforcement actions. At the same time,
disclosure of such confidential commercial information to the general
public does not further any regulatory process, and in any event, is
prohibited by 18 U.S.C. 1905. The law recognizes that public disclosure
of confidential commercial information may have a detrimental effect on
product development; providing a firm's competitors with access to
valuable information may create a disincentive for firms to develop
innovations or improve their products or methods. The result would be
diminished availability of useful products.
Furthermore, intergovernmental exchanges of nonpublic,
predecisional documents may help the agency decide whether a regulatory
approach it is considering is appropriate or even necessary. While the
agency may, in many cases, make draft documents available to the
general public (for example, in the Federal Register of July 24, 1995
(60 FR 37856), FDA published a notice announcing the availability of a
draft final rule on medical device good manufacturing practices to
members of the public as well as to State and foreign regulators), in
other cases, providing public access to predecisional documents during
the deliberative process could interfere with that process or create
misleading impressions about the agency's intentions.
In some cases, premature public disclosure of draft documents can
unnecessarily complicate regulatory actions and undermine public health
and safety. For example, if the agency developed a proposal on a
particular form of tamper evident packaging, such information could be
helpful to other foreign governments. However, premature disclosure of
that same information could ultimately prove harmful to the general
public if its disclosure would enable those who tamper with products to
alter their methods in order to evade detection or to defeat the
proposed solution.
FDA further emphasizes that, as stated in the preamble to the
proposed rule, if any State or foreign government official provides
information that the agency wishes to rely on in its published
proposals or the administrative record, the agency will include that
information unless inclusion would harm private or governmental
interests (see 60 FR 5530 at 5538). When a proposed rule is published,
therefore, the general public would be fully informed and have an
opportunity to comment on the substance of any advice from State or
foreign officials that FDA incorporated into the proposed rule.
The agency reiterates that nonpublic exchanges of information with
State and foreign government officials will not be a routine occurrence
and that FDA does not intend to prohibit public disclosure of
information received from State and foreign government officials if
such information can be disclosed without harm to any private or
governmental interests.
More importantly, the agency believes that the final rule will
result in significant public benefits because the final rule
facilitates FDA's access to information and expertise within State and
foreign governments and should result in better regulatory proposals
and actions. For example, if FDA and a State are considering whether to
issue proposed regulations on the same or similar subjects, exchanging
nonpublic, predecisional documents might lead both parties to
reexamine, modify, or harmonize their proposed regulatory strategy.
Preventing the issuance of redundant or unnecessary regulations should
benefit the public and the affected industries.
2. One comment claimed that the proposed rule violated the Tenth
Amendment to the Constitution. The Tenth Amendment states that, ``The
powers not delegated to the United States by the Constitution, nor
prohibited by it to the States, are reserved to the States
respectively, or to the people.'' The comment argued that the proposed
rule violated the Tenth
[[Page 63375]]
Amendment because citizens had not yielded to the Federal government
their ``rights of access to the information generated by our public
servants.''
The agency disagrees with the comment. The final rule concerns
FDA's ability to exchange certain confidential commercial information
or nonpublic, predecisional documents with State or foreign government
officials. Thus, the final rule pertains to information exchange and
access to FDA records and implements Federal authority without
impairing State or popular power. Indeed, the final rule can strengthen
States' regulatory roles.
3. Two comments said that the proposed rule violated procedural due
process because it would give State and foreign government officials
``preferential access'' to predecisional documents, such as draft
regulations, thereby giving those officials ``far greater influence
over the deliberative process by imparting selected information and
opinion'' to FDA.
The agency disagrees with the comments' assertion. As the Supreme
Court said in Mathews v. Eldridge, 424 U.S. 319, 332 (1976), procedural
due process ``imposes constraints on governmental decisions which
deprive individuals of `liberty' or property' interests within the
meaning of the Due Process Clause of the Fifth or Fourteenth
Amendment.'' However, ``[d]ue process, unlike some legal rules, is not
a technical conception with a fixed content unrelated to time, place
and circumstances * * * [d]ue process is flexible and calls for such
procedural protections as the particular situation demands.'' Id. p.
334 (citations omitted).
Here, the final rule does not impose any constraints or sanctions
nor does it deprive individuals of any liberty or property interest.
The final rule does not ``deprive'' the public of its access to
confidential commercial information or predecisional documents because
such information has always been protected from disclosure. Neither
does the final rule deprive the public of the opportunity to comment on
rulemaking. As stated in the preamble to the proposed rule:
* * * 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.
(See 60 FR 5530 at 5538.) This approach is consistent with due process
because ``[t]he fundamental requirement of due process is the
opportunity to be heard `at a meaningful time and in a meaningful
manner,''' Mathews, 424 U.S. 333 (citations omitted).
Moreover, judicial opinions concerning informal rulemaking have
focused on the need to ensure that ex parte contacts do not frustrate
judicial review or raise serious questions of fairness. (See Home Box
Office, Inc. v. FCC, 567 F.2d 9 (D.C. Cir. 1977), cert. denied 434 U.S.
829, rehearing denied 434 U.S. 988 (1977).) There is no per se
prohibition on ex parte contacts. (See Action for Children's Television
v. FCC, 564 F.2d 458, 475 n.28 (D.C. Cir. 1977).)
FDA reiterates that it will include in its published proposals any
information provided by State or foreign government officials upon
which FDA is relying. The agency will make such information available
at the time of publication. Thus, 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. FDA believes this is consistent with all
applicable legal requirements.
4. Two comments claimed that the proposed rule violated rights of
privacy and confidentiality because information supplied to FDA, with
the expectation that the information would remain confidential, would
be eligible for disclosure to officials outside FDA. The comments noted
that non-FDA officials may have interests and obligations that differ
from those of FDA, the public, or the regulated industry. The comments
said that requiring the State or foreign government to provide a
written statement establishing its authority to protect confidential
commercial information or nonpublic documents from public disclosure
was ``wholly inadequate'' because State and foreign officials are not
subject to FDA's management or control. The comments further asserted
that much information given to FDA is unreliable, fraudulent, or
defamatory and could be used by outside parties for ulterior purposes
and that the proposed rule would dissuade submission of confidential
information to FDA and encourage submission of false information.
Four other comments expressed similar objections to the proposed
rule, stating that foreign governments might use confidential
commercial information to benefit their own industries.
The agency has given serious attention to the concerns expressed in
the comments, but disagrees that the safeguards are inadequate. As
stated earlier, FDA issued a final rule on November 19, 1993, to permit
the agency to disclose confidential commercial information to foreign
government officials, subject to certain conditions and safeguards to
protect the confidentiality of the information. Since issuing that
final rule, the agency is unaware of any misuse or unauthorized
disclosure of confidential commercial information supplied to a foreign
government. In almost all cases, disclosure occurred with the knowledge
and consent of the company that submitted the confidential commercial
information to FDA. Thus, FDA's experience with the 1993 final rule
indicates that confidential commercial information provided to a
foreign government official remains confidential and is not used to
benefit the foreign government's industry.
Furthermore, FDA emphasizes that the decision to share information
with a foreign government is discretionary and that the agency will
deny a foreign government's request for confidential commercial
information if the foreign government officials are unable to assure
FDA of their ability to protect the information. FDA will also deny
access where there is a lack of scientific data or regulatory expertise
to contribute to a product review or laboratory or clinical
investigation, unless the foreign government intends to use the
information for law enforcement purposes. (See 58 FR 61598 at 61600.)
Similar standards will apply to exchanges with State governments and
State government officials.
FDA also disagrees with the assertion that parties often submit
false information to the agency. Submitting false information to the
government is a Federal crime under 18 U.S.C. 1001. Submission of false
or misleading reports with respect to medical devices is prohibited
under section 301(q)(2) of the act (21 U.S.C. 331(q)(2)). Submission of
false information may also lead to debarment under section 306 of the
act (21 U.S.C. 335a) or assessment of civil money penalties under
section 303(g) or 307 of the act (21 U.S.C. 333(g) or 335b). FDA has
taken legal action against parties that have submitted false
information to the agency and emphasizes that it will not tolerate the
submission of false information to the agency.
5. Two comments asserted that the proposed rule was contrary to
congressional intent, as expressed in the FOIA, to provide information
to the public. The comments explained that the FOIA's exceptions to
disclosure represented a balance between the public's ``right to know''
and the government's interest in not disclosing certain types of
information. Thus, the comments claimed, only Congress can
[[Page 63376]]
alter that balance. Another comment claimed that an executive branch
agency cannot withhold information from the public, stating that only
Congress could authorize such action.
The agency disagrees with the comments. The preamble to the
proposed rule considered this issue and explained why the agency
believes that the proposed rule is consistent with the FOIA. FOIA (5
U.S.C. 552) is a disclosure statute and its exemptions are intended to
be discretionary. As stated earlier, those exemptions establish several
categories of information that can be withheld from public disclosure.
The categories relevant to FDA include: (a) Trade secret and
confidential commercial information to protect intellectual property
rights and research incentives (5 U.S.C. 552(b)(4)); (b) predecisional
documents to protect the deliberative process (5 U.S.C. 552(b)(5)); (c)
information whose disclosure might invade personal privacy (5 U.S.C.
552(b)(6)); and (d) investigatory files compiled for law enforcement
purposes to protect investigations (5 U.S.C. 552(b)(7)).
For disclosures of confidential commercial information under
Sec. 20.88(d), the preamble to the proposed rule explained that the
FOIA protects two broad categories of information from mandatory public
disclosure: Trade secret information and ``information that is: (1)
Commercial or financial, (2) obtained from a person, and (3) privileged
or confidential (`confidential commercial information').'' (See 60 FR
5530 at 5535.) The preamble to the proposed rule explained that the
proposed rule did not alter agency practice with respect to protecting
trade secret information (except to permit disclosure to visiting State
scientists) and that disclosures of confidential commercial information
to State government officials in accordance with the conditions of the
proposed rule would not be a public disclosure and would be
``authorized'' under the Trade Secrets Act. (See 60 FR 5530 at 5536.)
The preamble to the proposed rule also explained why the provisions
regarding predecisional documents and other nonpublic information are
consistent with the FOIA. The preamble characterized exchanges of
nonpublic, predecisional documents between FDA and State and foreign
governments as being of the same character as interagency memoranda and
letters that are exempt from disclosure under the FOIA. The preamble to
the proposed rule stated that:
* * * it is appropriate to assert the deliberative process
privilege [to disclosure under the FOIA] in response to requests for
public access to certain communications from State and foreign
government officials because the same policy reasons that support
nondisclosure of deliberative and predecisional memoranda generated
by Federal government agencies justify withholding, in many
circumstances, the advice and recommendations generated for FDA by
State and foreign government counterparts.
The agency's ability to make sound decisions about the
development and implementation of public health and harmonization
initiatives is enhanced by access to the advice and recommendations
of experts in State and foreign governments who are engaged in
similar efforts in their own jurisdictions. 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.
(See 60 FR 5530 at 5536 and 5537.) The preamble to the proposed rule
noted that courts have applied a ``functional'' test for assessing the
applicability of the exemption for intra- and interagency memoranda and
letters and have included ``nonagencies'' within the exemption. Id.
The preamble also noted that in circumstances where advice or
information is provided by foreign governments pursuant to
international agreements that require confidentiality as a condition of
exchange, FDA believes that a record so provided is not necessarily an
``agency record'' subject to FOIA. Id. at 60 FR 5537 through 5538. The
agency cited recent court decisions suggesting that FDA could honor
requests for confidentiality under these circumstances without
contravening public disclosure requirements established by Congress.
Id.
Thus, the final rule is consistent with the FOIA, and the agency
declines to amend the final rule to require public access to documents
beyond that required by the FOIA.
6. One comment said that FDA should discuss the proposed rule's
potential effects, costs, and implications in a public forum.
FDA believes that notice and comment rulemaking has provided a
satisfactory public forum for this issue.
7. Three comments said that FDA cannot ensure that no unauthorized
disclosures of confidential commercial information will occur and
cannot take effective action against State or foreign government
officials if unauthorized disclosures occur. Two comments added that
the agency should describe how it intends to monitor and investigate
reports of unauthorized disclosures and take action against those
employees making unauthorized disclosures. One comment suggested that
FDA establish a mechanism to track such unauthorized disclosures,
analyze and report any patterns or trends in unauthorized disclosures,
and, if FDA becomes aware of any unauthorized disclosures by State or
foreign government officials, notify the company whose confidential
commercial information was disclosed and cease information exchanges
with the State or foreign government.
FDA cannot guarantee that no unauthorized disclosures of
confidential commercial information will ever occur, but it does note
that procedures already exist for investigating reports of unauthorized
disclosures. In 1994, the agency created the Office of Internal Affairs
(OIA). OIA consists of one Special Agent in Charge and a team of
Special Agents. These agents are trained criminal investigators and
report directly to the Commissioner of Food and Drugs or the Deputy
Commissioner/Senior Advisor. FDA described OIA's functions in a notice
published in the Federal Register of January 23, 1995 (60 FR 4417 and
4418). In brief, OIA:
Provides a centralized Agencywide investigative resource
for the Commissioner, the Deputy Commissioners, and top Agency
management;
Provides a centralized investigative liaison between FDA
and the Office of the Inspector General (OIG);
Serves as an FDA investigative resource to conduct
internal FDA investigations and to support OIG investigations; and
OIA is also responsible for investigating all allegations of misconduct
by FDA employees. (See 59 FR 67087, December 28, 1994.) To assist in
this task, the office uses a data base to track cases by type of
investigation. One investigation type is ``Unauthorized Release of
Information.''
Whenever OIA receives any report of unauthorized disclosures of
information, OIA investigates the report and works with the OIG where
appropriate. If the investigation suggests that Federal laws were
violated, this information is presented to the OIG and may be referred
to the Department of Justice for prosecution. These same resources and
procedures could be applied, in cooperation with State and
[[Page 63377]]
foreign governments, to allegations of inappropriate disclosures by
their officials.
Furthermore, when FDA issued the 1993 final rule authorizing
disclosure of confidential commercial information to foreign government
officials, the agency expressly stated that it would cease cooperative
ventures with any government that failed to honor its written
commitment to preserve the confidentiality of the information provided
by FDA. (See 58 FR 61598 at 61603.) The agency will expand this policy
to include State governments. FDA's extensive experience sharing
nonpublic investigative records with State government officials
indicates that unauthorized disclosures are unlikely to occur and that
any State employee misconduct will be expeditiously handled in order to
preserve cooperative efforts between FDA and State governments.
Moreover, after issuing the 1993 final rule, FDA established
internal procedures and model confidentiality agreements for
disclosures to foreign government officials. These procedures will be
expanded to apply to State government officials.
The agency also notes that, contrary to the comments' belief that
firms and individuals have no recourse if a foreign government official
makes an unauthorized disclosure of confidential commercial
information, Federal law does provide an avenue for relief. Under
section 301 of the Trade Act of 1974 as amended, the United States
Trade Representative is authorized to take appropriate action against
any act, policy, or practice of a foreign government that ``is
unjustifiable and burdens or restricts United States commerce.'' (See
19 U.S.C. 2411.) Such actions can be initiated by a petition to the
United States Trade Representative. (See 19 U.S.C. 2412.) Additionally,
as previously noted, FDA will not exchange information with any foreign
government that does not honor its commitment to protect confidential
commercial information. FDA believes that the value foreign governments
place on the continuing ability to exchange information will also help
assure that foreign government officials respect the confidentiality of
information that they receive.
8. Three comments suggested adding additional safeguards to
proposed Secs. 20.88 and 20.89 to decrease the likelihood that
unauthorized disclosures of confidential commercial information would
occur. In brief, these comments would require State and foreign
governments to provide written assurances that individuals who would
have access to the confidential commercial information: (1) Will not be
employees, consultants, or persons who have a professional relationship
with a drug manufacturer; and (2) will be subject to a confidentiality
agreement and/or appropriate laws and regulations prohibiting them from
disclosing any information. These comments also would require both FDA
and the firm that had submitted the confidential commercial information
to FDA to consent, in writing, to any release or disclosure by the
State or foreign government.
Under Sec. 20.88(d)(1)(i), a State government agency must provide a
written statement establishing its authority to protect confidential
commercial information from public disclosure. FDA will supplement this
requirement with guidance to States on conflicts of interest and
prohibitions against further disclosure.
FDA declines to amend the final rule to require the agency and the
party submitting the confidential commercial information to consent to
any release or disclosure by the State or foreign government. This
final rule and the 1993 final rule governing disclosures of
confidential commercial information to foreign government officials
already provide for written consent by the party submitting the
confidential commercial information (see Sec. 20.88(d)(1)(i); see also
Sec. 20.89(c)(1)(i)) or written permission from FDA before the State or
foreign government can make any disclosure. Thus, these rules already
would require a State or foreign government to obtain written
authorization from the party that submitted the confidential commercial
information, or written confirmation from FDA that the information was
no longer confidential. The comments' suggested changes, therefore, are
unnecessary.
As for disclosures to foreign government officials, since amending
Sec. 20.89 in 1993 to allow FDA to disclose confidential commercial
information to foreign government officials, the agency has not
received any reports of unauthorized disclosures by foreign government
officials. The agency acknowledges that, in some cases, firms have
requested additional safeguards, similar to those mentioned in the
comments, and that the foreign government officials have consented to
such additional safeguards. However, FDA's experience under Sec. 20.89
does not indicate that such additional safeguards are necessary.
9. One comment would expand Secs. 20.88 and 20.89 so that they
applied to State and foreign government officials and ``all agents
contracted by them for any part of the review and approval processes
involving confidential and trade secret information.'' The comment
would also have State and foreign government officials and agents
subject to the same confidentiality restrictions as FDA employees.
The agency agrees with the comment and has amended
Secs. 20.88(e)(3) and 20.89(d)(3) so that references to State or
foreign government officials are understood to include agents
contracted by those officials.
10. The agency, on its own initiative, has amended Secs. 20.88(e)
and 20.89(d) to permit the Deputy Commissioner for Policy to authorize
disclosures of nonpublic, predecisional documents to State or foreign
government officials. The Deputy Commissioner for Policy is authorized,
under 21 CFR 5.20(f), to perform any of the functions of the
Commissioner of Food and Drugs with respect to the issuance of notices,
proposed rules, and final rules.
11. FDA, on its own initiative, has also amended the authority
citation to include a reference to the Pesticide Monitoring
Improvements Act of 1988 (21 U.S.C. 1401-1403). FDA has taken this
action because that statute provides for cooperative agreements between
FDA and foreign governments and exchanges of certain information
between FDA and States.
B. Section 20.88--Communications With State and Local Government
Officials
12. Proposed Sec. 20.88(d)(1)(i) would require, as a condition of
authorizing disclosure of confidential commercial information to a
State government official, a written statement from the State
government agency ``establishing its authority to protect confidential
commercial information from public disclosure and a written commitment
not to disclose any such information'' without the sponsor's written
permission or FDA's written confirmation that the information was no
longer confidential. One comment would require that State agencies
provide written assurance that, notwithstanding their own State laws,
the State agency would protect any confidential commercial information
that it received ``in accordance with Federal law and FDA
regulations.''
FDA sees no need to amend the final rule as suggested by the
comment. FDA would not disclose confidential commercial information to
a State government official unless State laws allow adequate protection
of that information. -
13. One comment would require FDA to notify and to obtain written
consent
[[Page 63378]]
from a party before disclosing confidential commercial information to
State government officials. The comment would have the notice describe
the information to be disclosed or provide sufficient detail to permit
the party to decide whether to withhold permission for disclosure. The
comment would also restrict any permission to disclose confidential
commercial information to the specific request.
As stated elsewhere in this document, FDA intends, in most cases,
to seek written approval from a party before disclosing confidential
commercial information. However, the agency declines to require such
written approval in all cases because there are situations, such as
enforcement actions, where it would be inappropriate to require written
approval prior to disclosure.
The agency does agree, however, that a party's written
authorization to disclosure of confidential commercial information is
limited to a specific request to disclose information and does not
constitute automatic authorization to disclose the information to any
subsequent State government official seeking to obtain that
information. (See 58 FR 61598 at 61602 (stating that ``in general, the
sponsor needs to authorize further disclosure of confidential
information'').)
14. Proposed Sec. 20.88(d)(1)(ii)(A) would authorize disclosure of
confidential commercial information if disclosure would be ``in the
interest of the 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 FDA. One comment objected to this provision,
arguing that it provided ``no objective criteria for determining when
the disclosure of confidential commercial information would be in the
interest of public health.'' The comment claimed that the agency had
not shown the State commissioned officials program to be inadequate,
that the provision gave no ``clear, objective standards outlining the
procedure for allowing disclosure,'' and that the proposed rule would
operate in an arbitrary and capricious fashion.
The agency declines to amend the final rule to provide the
``objective criteria'' requested by the comment. It would be extremely
difficult, if not impossible, to draft objective criteria that would
encompass all instances where disclosure of confidential commercial
information would be in the interest of public health, and any
``objective'' regulatory criteria would invite parties to dispute the
applicability of a particular criterion instead of examining public
health concerns and would prevent the final rule from operating in a
flexible manner.
FDA further notes that the phrase ``interest of public health'' is
modified by two criteria. Under Sec. 20.88(d)(1)(ii)(B), disclosure
would be in the interest of public health: (1) By reason of the State
government's possessing information concerning the safety,
effectiveness, or quality of a product or information concerning an
investigation; or (2) by reason of the State government being able to
exercise its regulatory authority more expeditiously than FDA. Thus,
Sec. 20.88(d)(1)(ii)(B) contemplates disclosures in the interest of
public health if a State government possesses information about a
product or an investigation or can exercise regulatory authority in a
particular situation more quickly than FDA; the provision does not
permit unconditional or unrestricted exchanges of confidential
commercial information. As stated in the preamble to the proposed rule,
disclosures to State governments will not be a routine occurrence, but
would occur only in limited situations and on a case-by-case basis.
(See 60 FR 5530 at 5535.)
As for the comment claiming that the agency had not shown the
commissioned officials program to be inadequate, the preamble to the
proposed rule described the commissioning process for State government
officials and explained why commissioned officials might not always be
the best or most appropriate persons to receive the types of
confidential commercial information or nonpublic, predecisional
documents contemplated by the rule. In brief, section 702(a) of the act
(21 U.S.C. 372(a)) authorizes FDA to conduct examinations and
investigations through employees of the Department of Health and Human
Services (HHS) or through any health, food, or drug officer or employee
of any State, territory, or political subdivision commissioned as an
officer of HHS. (See 60 FR 5530 at 5531.) State or local government
officials commissioned under this program have a status with respect to
disclosure of FDA records that permits the commissioned official to
review confidential investigative files and proposed policy statements
that are normally restricted to Federal employees. Thus, FDA can
solicit advice from these commissioned officials without public
disclosure.
The commissioning process, however, is too cumbersome to be
practical in the situations that led FDA to issue the proposed rule. A
commissioned official is authorized to perform one or more of the
following functions: (1) Conduct examinations, inspections, and
investigations under the act; (2) collect and obtain samples; (3) copy
and verify records; and (4) receive and review official FDA documents.
(See Regulatory Procedures Manual, chapter 3 (regarding commissioning
State and local officials).) A commissioned official is only authorized
to review FDA documents that fall within the scope of his or her
commission; the official may not necessarily have authorized access to
all the information that the agency may need to convey to the State.
Yet, even if commissioning a State government official would enable
an official to review FDA documents, such authority would not eliminate
the need for the final rule. Commissioning a State government official
does not confer any protection to documents supplied by a State
government to FDA, whereas Sec. 20.88(e) authorizes the agency to
receive nonpublic, predecisional documents from State government
officials and to protect those documents from public disclosure.
Similar provisions in documents provided to FDA by foreign government
officials are set forth in Sec. 20.89(d). If information exchanges are
to be valuable and meaningful, the agency must be able to protect State
or foreign government documents that it receives, as well as the
documents that it sends, and the final rule provides such protection to
information that FDA receives.
Additionally, as stated in the preamble to the proposed rule, the
commissioning process cannot be easily adapted for situations requiring
rapid exchange of information. (See 60 FR 5530 at 5532.) The process
involves identifying suitable candidates (and often requires
commissioning the candidates' supervisors or State agency heads as
well), reviewing the candidates' qualifications, conducting background
checks (if necessary), issuing certificates and credentials, and
accounting for credentials on a periodic basis. These procedures, even
if they were as streamlined as possible, might be both impractical and
unnecessary in situations where rapid information exchanges are
necessary. Consequently, the agency believes that the final rule gives
FDA needed authority to exchange information both quickly and
efficiently in situations when reliance on commissioned officials would
prove impractical.
15. Two comments would amend proposed Sec. 20.88(d)(1)(ii)(C) to
add new requirements to deter unauthorized
[[Page 63379]]
disclosures of information. The comments would require visiting State
scientists to confirm that they are not employees, consultants, or
persons that have any professional relationship with a drug
manufacturer and to provide a written commitment not to release or
disclose information without approval from FDA and the party submitting
the confidential commercial information. The comments would not permit
FDA to authorize disclosures unilaterally.
FDA declines to revise the final rule as suggested by the comments.
Section 20.88(d)(1)(ii)(C) already contains sufficient safeguards that
accomplish the same purpose as those suggested by the comments. For
example, the final rule requires a visiting State government scientist
to provide 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 21 CFR
14.80(b)(1).'' Under Sec. 14.80(b)(1), advisory committee members are
subject to Federal conflict of interest laws and regulations. A
visiting State government scientist, therefore, could not truthfully
provide the written assurance required under Sec. 20.88(d)(1)(ii)(C) if
he or she were an employee or consultant of a drug manufacturer.
FDA also declines to amend the final rule to prevent FDA from
authorizing disclosure of confidential commercial information or trade
secrets to a visiting State government scientist. Section
20.88(d)(1)(ii)(C) authorizes disclosure to a visiting State government
scientist if, among other things: (1) The visiting State government
scientist signs a written commitment to protect the confidentiality of
the information; (2) the visiting State government scientist provides
written assurance that he or she has no financial interest in the
regulated industry of the type that would preclude participation in
review of the matter if the visiting State government scientist were
subject to FDA's conflict of interest rules; and (3) FDA retains
physical control over the information. The agency believes that these
safeguards provide sufficient protection to confidential commercial and
trade secret information in FDA's possession. The agency further notes
that a similar regulation has existed for visiting foreign government
scientists since 1993, and the agency has not experienced any
difficulties or problems with confidential commercial or trade secret
information disclosed to visiting foreign government scientists.
16. One comment said that firms that submitted confidential
commercial information should have the opportunity to purge ``highly
confidential'' information before disclosure to State government
officials. The comment explained that this would enable firms to
discuss why FDA should not release certain information to a State
government official.
The agency wishes to reassure regulated firms about its concerns
for proprietary information, but declines to accept the comment's
suggestion. While FDA intends, in most cases, to seek a firm's approval
before disclosing confidential commercial information, there are
situations where it would be inappropriate to permit firms to purge
information before its release to State government officials. For
example, if confidential commercial information in a marketing
application indicated that a firm might have engaged in fraud or
misrepresentation that violated both State and Federal laws, the agency
might want to notify its State government counterparts. Permitting a
firm to purge that information before its release to a State government
official would defeat any State regulatory action. Consequently, the
agency declines to amend the final rule as suggested by the comment.
C. Section 20.89--Communications With Foreign Government Officials
17. One comment from a foreign government official supported
proposed Sec. 20.89(d) but asked whether FDA would protect the
confidentiality of nonpublic, predecisional documents provided by a
foreign government.
Section 20.89(d) authorizes the agency to disclose and to receive
nonpublic, predecisional documents to or from foreign government
officials. Under Sec. 20.89(d)(2), such documents would not be made
available to all members of the public. Thus, FDA would maintain the
confidentiality of nonpublic, predecisional documents supplied by a
foreign government official. The basis for this position is explained
in detail in the preamble to the proposed rule (60 FR 5530 at 5536 and
5538).
18. Four comments suggested that FDA either permit firms that
submitted the confidential commercial information to purge those
records before their release or to decide whether release should occur,
or provide summaries to firms regarding the information disclosed to
the foreign government.
The agency addressed similar comments when it issued the 1993 final
rule permitting FDA to disclose confidential commercial information to
foreign government officials. The preamble to the 1993 final rule
stated that: (1) Any disclosure would be on a case-by-case basis under
assurances of continuing confidentiality; (2) the agency will, in most
circumstances, seek written authorization from the party submitting the
confidential commercial information to permit disclosure; and (3) there
are situations where it would be inappropriate to require consent from
a party that submitted confidential commercial information. (See 58 FR
61598 at 61601.)
The same rationale applies here. FDA reiterates that the final rule
authorizes disclosure only to those governments that have provided
written assurances that they have the authority to protect confidential
commercial information and nonpublic, predecisional documents from
public disclosure and that they will not disclose such documents or
information without the written permission of the sponsor or written
confirmation from FDA that the information or documents are no longer
confidential. Additionally, in most cases, FDA intends to seek written
consent from the party that submitted the confidential commercial
information before disclosing that information. To permit parties to
purge information would lessen the utility of any information provided
to a State or foreign government and invite such governments to
withhold information themselves.
Requiring FDA to give parties summaries of information disclosed to
a State or foreign government would also be inappropriate or
unnecessary. For example, if a State or foreign government were
considering whether to take action against a particular product,
requiring FDA to provide a summary to the product's manufacturer would
alert a violative firm of the potential enforcement action. In an
action to help a government identify fraudulent goods, the agency might
wish to provide confidential commercial information that would help
distinguish legitimate products from fraudulent ones; in such a
scenario, providing a summary to the product's manufacturer would be
worthless because the manufacturer would already know the information
that was the basis of the summary. Thus, the agency declines to accept
the comments' suggestions.
19. Proposed Sec. 20.89(d)(1)(i) would require, as a condition to
authorizing disclosure of confidential commercial information to a
foreign government official, a written statement from the foreign
government establishing its authority to protect nonpublic documents
from public disclosure and a
[[Page 63380]]
written commitment not to disclose any such documents without FDA's
written confirmation that the information was no longer confidential.
One comment would limit disclosures to foreign government officials
whose countries ``can reasonably be expected to maintain
confidentiality and patent protection at the level acceptable under
U.S. intellectual property protection agreements with foreign
nations.'' If the agency could not determine whether the foreign
country offered ``acceptable'' protection, the comment said that FDA
should be required to consult the firm that submitted the confidential
commercial information regarding that firm's prior experience with
intellectual property protection in the foreign country.
Although this comment pertains to the rulemaking completed in 1993
rather than the present final rule and is outside the scope of this
rulemaking, the agency considered similar comments in 1993 when it
issued a final rule authorizing the disclosure of confidential
commercial information to foreign government officials. The comments
asked FDA to restrict disclosures to countries with similar product
approval processes or to list foreign governments ``that have been
designated as appropriate for the sharing of confidential
information.'' (See 58 FR 61598 at 61602.) The agency declined to
accept the comments' recommendations, stating that a list of foreign
countries would not be useful, repeating that disclosures were subject
to certain safeguards, and stating that, ``in every case disclosure is
at the discretion of the agency and cannot be automatic for any
country.'' Id. The same rationale applies here. FDA will decide, on a
case-by-case basis, whether to disclose confidential commercial
information to a foreign government and, in most cases, will seek
written permission from the party that submitted the confidential
commercial information. Given these safeguards, there is no need to
establish a list of countries that would protect intellectual property
to an ``acceptable'' or ``appropriate'' level. Additionally, because
most disclosures would be preceded by written approval from the party
submitting the confidential commercial information, there is no need to
amend the final rule to require prior consultation with the party that
submitted the confidential commercial information.
20. One comment said that proposed Sec. 20.89 would delay public
participation in reviewing or commenting on predecisional documents and
permit public comment ``only after the agency has more invested in its
own viewpoint.''
The agency disagrees with the comment. The agency believes that
exchanges of nonpublic, predecisional documents with State and foreign
government officials will neither significantly delay public review of
such documents nor make any public review less meaningful. FDA will be
just as interested in hearing what the public thinks about a proposal,
whether or not that proposal was previously shared with a regulatory
counterpart. Nor will the agency's obligation to consider or respond to
public comments in any way diminish because of this rule.
FDA stresses that the purpose behind exchanging nonpublic,
predecisional documents is not to diminish the role of any participant
in rulemaking, but to enhance Federal-State uniformity and facilitate
global harmonization of regulatory requirements. Although FDA often
considers State or foreign regulatory requirements when drafting its
own predecisional documents, mutual exchanges between FDA and a State
or foreign government will enable refinements in the documents to
account for new requirements or developments. The agency believes that,
in most cases, the changes that would be made would probably be minor
technical adjustments or revisions to a document before publication or
release, but, in any event, there should be no significant delay in
publication for general review and comment.
The final rule also promotes efficiency during any public review
period. Mutual exchanges between FDA and State or foreign governments
should result in documents that reflect greater consideration of State
or foreign requirements and resources, thereby reducing the possibility
that the agency would have to substantially revise or even repropose a
proposed regulatory approach due to an inconsistent or conflicting
State or foreign requirement identified by comments submitted during a
comment period. For example, providing a nonpublic, predecisional
document to State governments could alert FDA that its proposed
enforcement scheme would overly burden State resources; FDA could then
revise the enforcement scheme and publish or release a document that
contained the revised enforcement scheme. FDA also reiterates that any
document that it publishes in the Federal Register will inform the
public of any information from State or foreign government officials
that affected the document and provide an opportunity for public
comment.
In contrast, if FDA cannot exchange a nonpublic, predecisional
documents with State governments, the agency may publish a document
proposing an enforcement scheme that places unrealistic burdens on
State governments, await comments, publish a second document proposing
a revised enforcement scheme, await comments again, and then issue a
final document. Under this scenario, public participation might occur
earlier, but final action on the initiative would occur later, with
attendant delays to the program in question and waste of public
resources.
III. Description of the Final Rule
Section 20.88(d) of the final rule authorizes FDA to disclose
confidential commercial information submitted to FDA or incorporated
into FDA-prepared records to State government officials as part of
cooperative law enforcement or regulatory efforts, provided that: (1)
The State government agency has provided a written statement
establishing its authority to protect the information from public
disclosure and has provided a written commitment not to disclose such
information without the sponsor's written permission or written
confirmation from FDA that the information is no longer confidential;
and (2) FDA has determined that the sponsor has consented, in writing,
to disclosure, disclosure would be in the interest of public health, or
disclosure would be to a visiting State scientist, subject to certain
additional conditions (such as a written assurance that the visiting
State scientist has no financial interest in the regulated industry
that would preclude him or her from participating in the matter under
review). Information exchanged under Sec. 20.88(d) would not be
available to the public.
Sections 20.88(e) and 20.89(d) permit the agency to disclose or to
receive nonpublic, predecisional documents to or from State or foreign
government officials as part of efforts to improve intergovernmental
cooperation and uniformity or to implement intergovernmental
agreements. The disclosure or receipt of nonpublic, predecisional
documents is subject to two conditions: (1) The State or foreign
government agency has provided a written statement establishing its
authority to protect nonpublic documents from public disclosure and has
provided a written commitment not to disclose such documents without
FDA's written confirmation that the information no longer has nonpublic
status; and (2) the agency has determined that exchange is reasonably
[[Page 63381]]
necessary to cooperative regulatory activities or to improve Federal-
State uniformity or to facilitate international harmonization of
regulatory requirements. Information exchanged under Secs. 20.88(e) or
20.89(d) will not be available to the public.
IV. 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.
V. Analysis of Impacts
FDA has examined the impacts of the final 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 final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
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 the final rule promotes harmonized
regulatory requirements, nationally and internationally, thereby
reducing disparate regulatory requirements, the agency certifies that
the final 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.
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, 21 CFR part
20 is amended as follows:
PART 20--PUBLIC INFORMATION-
1. The authority citation for 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; 21 U.S.C. 1401-1403.
2. Section 20.88 is amended by adding new paragraphs (d) and (e) to
read as follows:
Sec. 20.88 Communications with State and local government officials.
* * * * *
(d)(1) The Commissioner of Food and Drugs, or any other officer or
employee of the Food and Drug Administration whom the Commissioner may
designate to act on his or her behalf for the purpose, may authorize
the disclosure of confidential commercial information submitted to the
Food and Drug Administration, or incorporated into agency-prepared
records, to State government officials as part of cooperative law
enforcement or regulatory efforts, provided that:
(i) The State government agency has provided both a written
statement establishing its authority to protect confidential commercial
information from public disclosure and a written commitment not to
disclose any such information provided without the written permission
of the sponsor or written confirmation by the Food and Drug
Administration that the information no longer has confidential status;
and
(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 Federal Food, Drug, and Cosmetic Act (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 Deputy Commissioner for Policy, or any other officer or
employee of the Food and Drug Administration whom the Deputy
Commissioner for Policy 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
[[Page 63382]]
(ii) The Deputy Commissioner for Policy or the Deputy Commissioner
for Policy'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 at 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, but is not limited to, an agent
contracted by the State government, and 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 officials, 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 Communications with foreign government officials.
* * * * *
(d)(1) The Deputy Commissioner for Policy, or any other officer or
employee of the Food and Drug Administration whom the Deputy
Commissioner for Policy 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 Deputy Commissioner for Policy or the Deputy Commissioner
for Policy'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, but is not limited to, an agent
contracted by the foreign government, and an employee of an
international organization having responsibility to facilitate global
harmonization of standards and requirements in FDA's areas of
responsibility. For such officials, the statement and commitment
required by paragraph (d)(1)(i) of this section shall be provided by
both the organization and the individual.
Dated: November 30, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-29904 Filed 12-7-95; 8:45 am]
BILLING CODE 4160-01-F
