[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
=======================================================================
-----------------------------------------------------------------------

[[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.

-----------------------------------------------------------------------

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:
    <bullet> Provides a centralized Agencywide investigative resource 
for the Commissioner, the Deputy Commissioners, and top Agency 
management;
    <bullet> Provides a centralized investigative liaison between FDA 
and the Office of the Inspector General (OIG);
    <bullet> 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