[Federal Register Volume 65, Number 235 (Wednesday, December 6, 2000)]
[Notices]
[Pages 76260-76264]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-30852]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Executive Office of the President; Federal Policy on Research 
Misconduct; Preamble for Research Misconduct Policy

AGENCY: Office of Science and Technology Policy.

ACTION: Notification of Final Policy.

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SUMMARY: The Office of Science and Technology Policy (OSTP) published a 
request for public comment on a proposed Federal research misconduct 
policy in the October 14, 1999 Federal Register (pp. 55722-55725). OSTP 
received 237 sets of comments before the public comment period closed 
on December 13, 1999. After consideration of the public comments, the 
policy was revised and has now been finalized. This notice provides 
background information about the development of the policy, explains 
how the policy has been modified, and discusses plans for its 
implementation.

EFFECTIVE DATE: December 6, 2000.

FOR FURTHER INFORMATION CONTACT: Holly Gwin, Office of Science and 
Technology Policy, Executive Office of the President, Washington, DC 
20502. Tel: 202-456-6140; Fax: 202-456-6021; e-mail: 
hgwin@ostp.eop.gov.

SUPPLEMENTARY INFORMATION: Advances in science, engineering, and all 
fields of research depend on the reliability of the research record, as 
do the benefits associated with them in areas such as health and 
national security. Sustained public trust in the research enterprise 
also requires confidence in the research record and in the processes 
involved in its ongoing development. For these reasons, and in the 
interest of achieving greater uniformity in Federal policies in this 
area, the National Science and Technology Council (NSTC) initiated 
discussions in April 1996 on the development of a research misconduct 
policy. The Office of Science and Technology Policy (OSTP) provided 
leadership and coordination. The NSTC approved the proposed draft 
policy in May 1999, clearing the way for the October 14, 1999 Federal 
Register notice. Public comments in response to that notice have been 
reviewed. The purpose of this notice is to provide information about 
the policy as it has now been finalized.
    This policy applies to federally-funded research and proposals 
submitted to Federal agencies for research funding. It thus applies to 
research conducted by the Federal agencies, conducted or managed for 
the Federal government by contractors, or supported by the Federal 
government and performed at research institutions, including 
universities and industry.
    The policy establishes the scope of the Federal government's 
interest in the accuracy and reliability of the research record and the 
processes involved in its development. It consists of a definition of 
research misconduct and basic guidelines for the response of Federal 
agencies and research institutions to allegations of research 
misconduct.
    The Federal agencies that conduct or support research will 
implement this policy within one year of the date of publication of 
this notice. An NSTC interagency research misconduct policy 
implementation group has been established to help achieve uniformity 
across the Federal agencies in implementation of the research 
misconduct policy. In some cases, this may require agencies to amend or 
replace extant regulations addressing research misconduct. In other 
cases, agencies may need to put new regulations in place or implement 
the policy through administrative mechanisms.
    The policy addresses research misconduct. It does not supersede 
government or institutional policies or procedures for addressing other 
forms of misconduct, such as the unethical treatment of human research 
subjects or mistreatment of laboratory animals used in research, nor 
does it supersede criminal or other civil law. Agencies and 
institutions may address these other issues as authorized by law and as 
appropriate to their missions and objectives.

Summary of Comments

    The Office of Science and Technology Policy received 237 comments 
on the proposed Federal Research Misconduct Policy. Letters were signed 
by individuals, and by representatives of universities, university 
associations, Federal agencies, and private entities. Comments are 
available for review. Comments that resulted in a modification of the 
policy are summarized below. A section that addresses other questions 
raised by the comments follows the summary of modifications.

Uniform Federal Policy

    Issue: Many comments recommended various mechanisms to ensure 
uniform implementation of this policy.
    Response: An NSTC research misconduct policy implementation group 
has been formed to foster uniformity among the agencies in their 
implementation of the policy.

Section I: Research Misconduct Defined

    Issue: A number of comments suggested that the definition of 
fabrication be modified to read as follows: ``Fabrication is making up 
data or results and recording or reporting them.'' (Italicized words 
are suggested addition.) This change is to clarify that the raw data 
collected or generated in the research process can be fabricated just 
as can the results of the research.
    Response: This change was accepted.
    Issue: A number of commenters interpreted the definition of 
plagiarism to imply that using material gathered during the peer review 
process was acceptable as long as it is cited.
    Response: The policy is intended to address the problem of 
reviewers who take material from the peer review process and use it 
without attribution. This constitutes plagiarism. We have deleted the 
phrase ``including those obtained through confidential review of 
others' research proposals and manuscripts'' to avoid any appearance of 
condoning a breach of confidentiality in the peer review process.
    Issue: Despite general support for the rationale for the phrase 
``does not include honest error or honest differences of opinion,'' 
several comments requested various clarifications.
    Response: This phrase is intended to clarify that simple errors or 
mere differences of judgment or opinion do not constitute research 
misconduct. The phrase does not create a separate element of proof. 
Institutions and agencies are not required to disprove possible 
``honest error or differences of opinion.'' The phrase has been 
retained, with the deletion of the second ``honest'' of the phrase as 
redundant.
    Issue: A number of comments raised questions about what fields of 
research are included in the definition of research. For example, some 
readers were unsure about the applicability of

[[Page 76261]]

the policy as written to medicine or the social sciences.
    Response: The policy applies to research funded by the Federal 
agencies. In order to be responsive to specific inquiries about what 
fields of research are covered by the policy, an illustrative, non-
exclusive list of selected fields of research is now included in the 
policy itself.

Section II: Findings of Research Misconduct

    Issue: Several comments stressed the need for greater precision in 
the phrase ``significant departure from accepted practices of the 
scientific community.''
    Response: This phrase is intended to make it clear that behavior 
alleged to involve research misconduct should be assessed in the 
context of community practices, meaning practices that are generally 
understood by the community but that may not be in a written form. For 
clarification purposes and in order to be more comprehensive, the term 
``scientific community'' has been modified to read ``relevant research 
community.'' The policy is not intended to ratify those ``accepted 
practices'' but rather to indicate that these may vary among different 
communities.
    Issue: Several comments requested clarification regarding the level 
of intent that is required to be shown in order to reach a finding of 
research misconduct.
    Response: Under the policy, three elements must be met in order to 
establish a finding of research misconduct. One of these elements is a 
showing that the subject had the requisite level of intent to commit 
the misconduct. The intent element is satisfied by showing that the 
misconduct was committed ``intentionally, or knowingly, or 
recklessly.'' Only one of these needs to be demonstrated in order to 
satisfy this element of a research misconduct finding.

Section III: Responsibilities of Federal Agencies and Research 
Institutions

    Issue: Some comments indicated that this section could be 
incorrectly construed to require appeal of the agency misconduct 
finding back to the institution.
    Response: The policy has been clarified to affirm that each agency 
should establish an appeals process for persons found by the agency to 
have engaged in research misconduct. The subject of the agency finding 
cannot appeal the agency decision back to the institution, although 
some institutions do offer an appeal of the institutional finding at 
the institutional level.

Section IV: Guidelines for Fair and Timely Procedures

    Issue: The comments indicated some uncertainty about to whom the 
actions section applied.
    Response: The actions delineated are those that may be taken by the 
Federal agencies if research misconduct has been shown to have 
occurred. The section has thus been renamed ``Agency Administrative 
Actions.''
    Issue: The suggestion was made that publications based on false or 
fabricated data, or including such data, should be required to be 
officially withdrawn.
    Response: Correction of the research record has been added to the 
list of possible actions to be taken if a researcher is found to have 
engaged in research misconduct.
    Issue: The suggestion was made that safeguards for informants and 
subjects of allegations be made more explicit.
    Response: More explicit safeguards have been added to the policy 
for both informants and subjects.

Other Comments

    Several comments and clarifications are addressed in the following 
question and answer format rather than through modification of the 
policy.
    Will agencies be required to announce the details of their 
implementation plans? Yes. Agencies will announce the details of their 
implementation plans, including those plans that do not require formal 
rulemaking.
    What types of misconduct are covered by this policy? This policy is 
limited to addressing misconduct related to the conduct and reporting 
of research, as distinct from misconduct that occurs in the research 
setting but that does not affect the integrity of the research record, 
such as misallocation of funds, sexual harassment, and discrimination. 
This policy does not limit agencies or research institutions from 
addressing these other issues under appropriate policies, rules, 
regulations, or laws. In addition, should the behavior associated with 
research misconduct also trigger the applicability of other laws 
(including criminal law) this policy is not intended to limit agencies 
or research institutions from pursuing these matters under separate 
authorities.
    Does this policy address misrepresentation of a researcher's 
credentials or publications? Yes, misrepresentation of a researcher's 
qualifications or ability to perform the research in grant applications 
or similar submissions may constitute falsification or fabrication in 
proposing research.
    Are authorship disputes covered by this policy? Authorship disputes 
are not covered by this policy unless they involve plagiarism.
    Does research misconduct include the mistreatment of human subjects 
or animals in research? This policy addresses activity that occurs in 
the course of human subjects or animal research that involves research 
misconduct as defined by the policy. Thus, falsification, fabrication, 
or plagiarism that occurs during the course of human or animal research 
is addressed by this policy. However, other issues concerning the 
ethical treatment of human or animal subjects are covered under 
separate procedures and are not affected by this policy.
    Why doesn't the policy provide immunity for research misconduct 
investigative committees? Providing immunity to research misconduct 
investigative committees and other participants in institutional and 
agency research misconduct proceedings would require significant 
statutory or regulatory initiatives which will be explored separately 
from this policy.
    Aren't there circumstances when omission of data or results is 
appropriate? A number of commenters suggested that there are 
circumstances when it may be appropriate to omit data in reporting 
research results. It is not the intent of this policy to call accepted 
practices into question. However, the omission of data is considered 
falsification when it misleads the reader about the results of the 
research.
    Does this policy supersede institutional policies regarding 
research misconduct? Non-federal research institutions have authority 
to establish policies for research and employee misconduct that serve 
their own institutional purposes. However, the Federal research 
misconduct policy (as implemented by the agencies) provides the 
relevant guidance to institutions for purposes of Federal action.
    Does this policy supersede other agency policies, procedures, 
rules, and regulations? Agencies must comply with all relevant Federal 
personnel policies and laws in responding to allegations of research 
misconduct. However, personnel actions may not adequately protect the 
public from the consequences of falsified, fabricated or plagiarized 
research. For example, Federal personnel policies may permit 
termination of an employee who commits research misconduct, but may not 
address the problem of research misconduct or seek to prevent it from 
recurring. The administrative actions available under the Federal 
research misconduct policy, such as debarment from federal funding, 
supervision and certification of research, and correction

[[Page 76262]]

of the literature, are designed to specifically address the problems 
raised by research misconduct.
    Must all three elements in the Finding of Research Misconduct 
section be present for there to be a finding of research misconduct? 
Yes.
    Who makes the final determination about whether or not there is a 
finding of research misconduct? The Federal agency will make the final 
decision about whether to make an agency finding of research 
misconduct. However, within its own internal jurisdiction, a non-
Federal research institution may establish policies and take actions as 
appropriate to its needs and as consistent with other relevant laws.
    Shouldn't the burden of proof be more stringent, e.g., require 
``clear and convincing evidence'' to support a finding of research 
misconduct? While much is at stake for a researcher accused of research 
misconduct, even more is at stake for the public when a researcher 
commits research misconduct. Since ``preponderance of the evidence'' is 
the uniform standard of proof for establishing culpability in most 
civil fraud cases and many federal administrative proceedings, 
including debarment, there is no basis for raising the bar for proof in 
misconduct cases which have such a potentially broad public impact. It 
is recognized that non-Federal research institutions have the 
discretion to apply a higher standard of proof in their internal 
misconduct proceedings. However, when their standard differs from that 
of the Federal government, research institutions must report their 
findings to the appropriate Federal agency under the applicable Federal 
government standard, i.e., preponderance.
    Why don't the Federal agencies conduct all inquiries and 
investigations? Research institutions are much closer to what is going 
on in their own institutions and are in a better position to conduct 
inquiries and investigations than are the Federal agencies. While the 
Federal agencies could have taken on the task of investigating all 
allegations of research misconduct, or established a separate agency 
for this purpose, this would have involved a substantial new Federal 
bureaucracy, which is not thought desirable. An agency may take steps, 
as appropriate, should a research institution demonstrate a lack of 
commitment to the policy's guidelines.
    How will a lead agency be identified? If more than one Federal 
agency has jurisdiction over allegations of research misconduct, those 
agencies should work together to designate a lead agency.
    What criteria will be used for selecting the research institution 
that will handle the response to the allegation of research misconduct? 
In most cases, agencies will rely on the researcher's home institution 
to respond to allegations of research misconduct. However, in cases 
where the subject has switched institutions, it may be more appropriate 
for the institution where the alleged research misconduct occurred to 
respond to the allegation. The institution where the questioned 
research was conducted may have better access to the evidence and 
witnesses and therefore will have the capability to undertake a more 
efficient and thorough response.
    Shouldn't the policy be more explicit about time lines for a 
response to allegations of misconduct? In establishing reasonable time 
lines the Federal agencies must balance the interests of concluding the 
process expeditiously while ensuring it has been conducted fairly and 
thoroughly. This will allow flexibility for the research institutions 
while at the same time ensuring that the process does not extend for an 
unreasonably long period. Research institutions should have the option 
to request reasonable extensions of agency timelines in individual 
cases.
    What can informants or subjects of allegations expect with regard 
to confidentiality? The policy strives for confidentiality for all 
involved to the extent consistent with a fair and thorough process and 
as allowed by law, including applicable Federal and state freedom of 
information and privacy laws.
    Should the policy punish informants who act in bad faith or 
individuals who harass informants? The principal aim of this policy is 
to communicate to the research community those behaviors that 
constitute research misconduct and to take actions where research 
misconduct is found to have occurred. As employers and managers of the 
research, non-Federal research institutions may adopt policies to 
address the consequences of false, malicious, or capricious allegations 
and to respond to retaliation against informants. Agencies may also 
address this issue in their implementation of this policy.
    How should the ``seriousness'' of the research misconduct be 
evaluated and how will this relate to any actions taken? In determining 
what action to take, agencies should fully consider the level of intent 
of the misconduct, the consequences of the behavior, and other 
aggravating and mitigating factors.

Next Steps

    The Federal agencies have up to one year from the date of 
publication of this notice to implement the policy. An interagency 
implementation group has been established under the auspices of the 
National Science and Technology Council to assist agencies in their 
implementation process and to strive for the highest level of 
uniformity possible and as appropriate in their implementation plans.

Federal Policy on Research Misconduct \1\

I. Research \2\ Misconduct Defined

    Research misconduct is defined as fabrication, falsification, or 
plagiarism in proposing, performing, or reviewing research, or in 
reporting research results.
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    \1\ No rights, privileges, benefits or obligations are created 
or abridged by issuance of this policy alone. The creation or 
abridgment of rights, privileges, benefits or obligations, if any, 
shall occur only upon implementation of this policy by the Federal 
agencies.
    \2\ Research, as used herein, includes all basic, applied, and 
demonstration research in all fields of science, engineering, and 
mathematics. This includes, but is not limited to, research in 
economics, education, linguistics, medicine, psychology, social 
sciences, statistics, and research involving human subjects or 
animals.
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     Fabrication is making up data or results and recording or 
reporting them.
     Falsification is manipulating research materials, 
equipment, or processes, or changing or omitting data or results such 
that the research is not accurately represented in the research 
record.\3\
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    \3\ The research record is the record of data or results that 
embody the facts resulting from scientific inquiry, and includes, 
but is not limited to, research proposals, laboratory records, both 
physical and electronic, progress reports, abstracts, theses, oral 
presentations, internal reports, and journal articles.
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     Plagiarism is the appropriation of another person's ideas, 
processes, results, or words without giving appropriate credit.
     Research misconduct does not include honest error or 
differences of opinion.

II. Findings of Research Misconduct

    A finding of research misconduct requires that:
     There be a significant departure from accepted practices 
of the relevant research community; and
     The misconduct be committed intentionally, or knowingly, 
or recklessly; and
     The allegation be proven by a preponderance of evidence.

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III. Responsibilities of Federal Agencies and Research Institutions 
\4\

    Agencies and research institutions are partners who share 
responsibility for the research process. Federal agencies have ultimate 
oversight authority for Federally funded research, but research 
institutions bear primary responsibility for prevention and detection 
of research misconduct and for the inquiry, investigation, and 
adjudication of research misconduct alleged to have occurred in 
association with their own institution.
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    \4\ The term ``research institutions'' is defined to include all 
organizations using Federal funds for research, including, for 
example, colleges and universities, intramural Federal research 
laboratories, Federally funded research and development centers, 
national user facilities, industrial laboratories, or other research 
institutes. Independent researchers and small research institutions 
are covered by this policy.
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     Agency Policies and Procedures. Agency policies and 
procedures with regard to intramural as well as extramural programs 
must conform to the policy described in this document.
     Agency Referral to Research Institution. In most cases, 
agencies will rely on the researcher's home institution to make the 
initial response to allegations of research misconduct. Agencies will 
usually refer allegations of research misconduct made directly to them 
to the appropriate research institution. However, at any time, the 
Federal agency may proceed with its own inquiry or investigation. 
Circumstances in which agencies may elect not to defer to the research 
institution include, but are not limited to, the following: the agency 
determines the institution is not prepared to handle the allegation in 
a manner consistent with this policy; agency involvement is needed to 
protect the public interest, including public health and safety; the 
allegation involves an entity of sufficiently small size (or an 
individual) that it cannot reasonably conduct the investigation itself.
     Multiple Phases of the Response to an Allegation of 
Research Misconduct. A response to an allegation of research misconduct 
will usually consist of several phases, including: (1) an inquiry--the 
assessment of whether the allegation has substance and if an 
investigation is warranted; (2) an investigation--the formal 
development of a factual record, and the examination of that record 
leading to dismissal of the case or to a recommendation for a finding 
of research misconduct or other appropriate remedies; (3) 
adjudication--during which recommendations are reviewed and appropriate 
corrective actions determined.
     Agency Follow-up to Institutional Action. After reviewing 
the record of the investigation, the institution's recommendations to 
the institution's adjudicating official, and any corrective actions 
taken by the research institution, the agency will take additional 
oversight or investigative steps if necessary. Upon completion of its 
review, the agency will take appropriate administrative action in 
accordance with applicable laws, regulations, or policies. When the 
agency has made a final determination, it will notify the subject of 
the allegation of the outcome and inform the institution regarding its 
disposition of the case. The agency finding of research misconduct and 
agency administrative actions can be appealed pursuant to the agency's 
applicable procedures.
     Separation of Phases. Adjudication is separated 
organizationally from inquiry and investigation. Likewise, appeals are 
separated organizationally from inquiry and investigation.
     Institutional Notification of the Agency. Research 
institutions will notify the funding agency (or agencies in some cases) 
of an allegation of research misconduct if (1) the allegation involves 
Federally funded research (or an application for Federal funding) and 
meets the Federal definition of research misconduct given above, and 
(2) if the institution's inquiry into the allegation determines there 
is sufficient evidence to proceed to an investigation. When an 
investigation is complete, the research institution will forward to the 
agency a copy of the evidentiary record, the investigative report, 
recommendations made to the institution's adjudicating official, and 
the subject's written response to the recommendations (if any). When a 
research institution completes the adjudication phase, it will forward 
the adjudicating official's decision and notify the agency of any 
corrective actions taken or planned.
     Other Reasons to Notify the Agency. At any time during an 
inquiry or investigation, the institution will immediately notify the 
Federal agency if public health or safety is at risk; if agency 
resources or interests are threatened; if research activities should be 
suspended; if there is reasonable indication of possible violations of 
civil or criminal law; if Federal action is required to protect the 
interests of those involved in the investigation; if the research 
institution believes the inquiry or investigation may be made public 
prematurely so that appropriate steps can be taken to safeguard 
evidence and protect the rights of those involved; or if the research 
community or public should be informed.
     When More Than One Agency is Involved. A lead agency 
should be designated to coordinate responses to allegations of research 
misconduct when more than one agency is involved in funding activities 
relevant to the allegation. Each agency may implement administrative 
actions in accordance with applicable laws, regulations, policies, or 
contractual procedures.

IV. Guidelines for Fair and Timely Procedures

    The following guidelines are provided to assist agencies and 
research institutions in developing fair and timely procedures for 
responding to allegations of research misconduct. They are designed to 
provide safeguards for subjects of allegations as well as for 
informants. Fair and timely procedures include the following:
     Safeguards for Informants. Safeguards for informants give 
individuals the confidence that they can bring allegations of research 
misconduct made in good faith to the attention of appropriate 
authorities or serve as informants to an inquiry or an investigation 
without suffering retribution. Safeguards include protection against 
retaliation for informants who make good faith allegations, fair and 
objective procedures for the examination and resolution of allegations 
of research misconduct, and diligence in protecting the positions and 
reputations of those persons who make allegations of research 
misconduct in good faith.
     Safeguards for Subjects of Allegations. Safeguards for 
subjects give individuals the confidence that their rights are 
protected and that the mere filing of an allegation of research 
misconduct against them will not bring their research to a halt or be 
the basis for other disciplinary or adverse action absent other 
compelling reasons. Other safeguards include timely written 
notification of subjects regarding substantive allegations made against 
them; a description of all such allegations; reasonable access to the 
data and other evidence supporting the allegations; and the opportunity 
to respond to allegations, the supporting evidence and the proposed 
findings of research misconduct (if any).
     Objectivity and Expertise. The selection of individuals to 
review allegations and conduct investigations who have appropriate 
expertise and have no unresolved conflicts of interests help to ensure 
fairness throughout all phases of the process.
     Timeliness. Reasonable time limits for the conduct of the 
inquiry, investigation, adjudication, and appeal

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phases (if any), with allowances for extensions where appropriate, 
provide confidence that the process will be well managed.
     Confidentiality During the Inquiry, Investigation, and 
Decision-Making Processes. To the extent possible consistent with a 
fair and thorough investigation and as allowed by law, knowledge about 
the identity of subjects and informants is limited to those who need to 
know. Records maintained by the agency during the course of responding 
to an allegation of research misconduct are exempt from disclosure 
under the Freedom of Information Act to the extent permitted by law and 
regulation.

V. Agency Administrative Actions

     Seriousness of the Misconduct. In deciding what 
administrative actions are appropriate, the agency should consider the 
seriousness of the misconduct, including, but not limited to, the 
degree to which the misconduct was knowing, intentional, or reckless; 
was an isolated event or part of a pattern; or had significant impact 
on the research record, research subjects, other researchers, 
institutions, or the public welfare.
     Possible Administrative Actions. Administrative actions 
available include, but are not limited to, appropriate steps to correct 
the research record; letters of reprimand; the imposition of special 
certification or assurance requirements to ensure compliance with 
applicable regulations or terms of an award; suspension or termination 
of an active award; or suspension and debarment in accordance with 
applicable government-wide rules on suspension and debarment. In the 
event of suspension or debarment, the information is made publicly 
available through the List of Parties Excluded from Federal Procurement 
and Nonprocurement Programs maintained by the U.S. General Services 
Administration. With respect to administrative actions imposed upon 
government employees, the agencies must comply with all relevant 
federal personnel policies and laws.
     In Case of Criminal or Civil Fraud Violations. If the 
funding agency believes that criminal or civil fraud violations may 
have occurred, the agency shall promptly refer the matter to the 
Department of Justice, the Inspector General for the agency, or other 
appropriate investigative body.

VI. Roles of Other Organizations

    This Federal policy does not limit the authority of research 
institutions, or other entities, to promulgate additional research 
misconduct policies or guidelines or more specific ethical guidance.

Barbara Ann Ferguson,
Assistant Director for Budget and Administration, Office of Science and 
Technology Policy.
[FR Doc. 00-30852 Filed 12-5-00; 8:45 am]
BILLING CODE 3170-01-P