[Title 42 CFR H]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter H - HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS]
[From the U.S. Government Printing Office]
42PUBLIC HEALTH12008-10-012008-10-01falseHEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUSHSUBCHAPTER HPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SUBCHAPTER H_HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS
SUBSTANCES RELEASES AND FACILITIES
PART 90_ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES--Table of Contents
Sec.
90.1 Purpose and applicability.
90.2 Definitions.
90.3 Procedures for requesting health assessments.
90.4 Contents of requests for health assessments.
90.5 Acting on requests.
90.6 Notification of determination to conduct a health assessment in
response to a request from the public.
90.7 Decision to conduct health effects study.
90.8 Conduct of health assessments and health effects studies.
90.9 Public health advisory.
90.10 Notice and comment period.
90.11 Reporting of results of health assessments and health effects
studies.
90.12 Confidentiality of information.
90.13 Recordkeeping requirements.
90.14 Documentation and cost recovery.
Authority: 42 U.S.C. 9615; 42 U.S.C. 6939a(c).
Source: 55 FR 5138, Feb. 13, 1990, unless otherwise noted.
Sec. 90.1 Purpose and applicability.
The provisions of this part set forth the policies and procedures of
the Agency for Toxic Substances and Disease Registry (ATSDR) with
respect to its conduct of health assessments and health effects studies
under section 104(i) of Comprehensive Environmental Response,
Compensation, and Liability Act, as amended by the Superfund Amendments
and Reauthorization Act of 1986, and section 3019 of the Resource
Conservation and Recovery Act. These provisions apply to ATSDR, as well
as its contractors, agents, and those carrying out health assessments
and health effects studies pursuant to agreements with ATSDR, such as
other Federal agencies and States.
Sec. 90.2 Definitions.
Administrator means the Administrator of the Agency for Toxic
Substances and Disease Registry or designee.
ATSDR means the Agency for Toxic Substances and Disease Registry,
Public Health Service, U.S. Department of Health and Human Services.
CERCLA means the Comprehensive Environmental Response, Compensation,
and Liability Act of 1980 (42 U.S.C. 9601 et seq., Pub. L. 96-520), as
amended by the Superfund Amendments and Reauthorization Act of 1986
(Pub. L. 99-499).
EPA means the U.S. Environmental Protection Agency.
Facility is defined in 42 U.S.C. 9601(9).
Hazardous substance is defined in 42 U.S.C. 9601(14). In addition,
the term includes any pollutant or contaminant which the Administrator
determines is appropriate for the purposes of carrying out his or her
responsibilities under CERCLA.
Health assessment means the evaluation of data and information on
the release of hazardous substances into the environment in order to
assess any current or future impact on public health, develop health
advisories or other recommendations, and identify studies or actions
needed to evaluate and mitigate or prevent human health effects.
Health effects study means research, investigation, or study
performed by ATSDR or other parties pursuant to an agreement with ATSDR
to evaluate the health effects of exposure to hazardous substances at
specific sites. This term includes, but is not limited to,
epidemiological studies, exposure and disease registries, and health
surveillance programs. This term does not include health assessments.
Owner or operator is defined in 42 U.S.C. 9601(20).
Peer review means review for scientific quality by a panel
consisting of no less than three nor more than seven members, who shall
be disinterested scientific experts selected by the Administrator of
ATSDR on the basis of their reputation for scientific objectivity and
the lack of institutional ties
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with any person involved in the conduct of the study or research under
review.
Person means an individual, firm, corporation, association,
partnership, consortium, joint venture, commercial entity, United States
Government, State, municipality, commission, political subdivision of a
State, Indian tribe, or any interstate body.
Pollutant or contaminant is defined in 42 U.S.C. 9601(33).
Public health advisory is a statement by ATSDR containing a finding
that a release poses a significant risk to human health and recommending
measures to be taken to reduce exposure and eliminate or substantially
mitigate the significant risk to human health.
Release is defined in 42 U.S.C. 9601(22).
Sec. 90.3 Procedures for requesting health assessments.
(a) ATSDR will accept requests to perform health assessments for a
particular facility or release from any person or group of persons.
(b) All requests to ATSDR to perform health assessments should be
addressed to: Assistant Administrator, Agency for Toxic Substances and
Disease Registry, 1600 Clifton Road NE., Atlanta, GA 30333.
Sec. 90.4 Contents of requests for health assessments.
(a) Each request for a health assessment shall contain:
(1) The name, address (including zip code), and telephone number of
the requestor;
(2) The organization or group the requestor represents, if any;
(3) The name, location, and description of the facility or release
of concern;
(4) A statement providing information that individuals have been
exposed to a hazardous substance and that the probable source is a
release, or sufficient information to allow the Administrator to make
such a finding;
(5) A statement requesting ATSDR to perform a health assessment.
(b) At his or her discretion, consistent with the requirements of
CERCLA, the Administrator may decide not to require the preceding
information be submitted with a request for a health assessment.
(c) Each request for a health assessment should include, where
possible:
(1) Any other information pertaining to the facility or release,
such as the nature and amount of the hazardous substances of concern or
the identities of parties believed to be potentially responsible for the
release;
(2) Potential pathways for human exposure, including a description
of the media contaminated (e.g. soil, groundwater, air, etc.);
(3) The demographic nature and proximity of the potentially affected
human population; and
(4) Other Federal, State, or local governmental agencies which were
notified or that investigated the facility or release.
(d) This data collection has been reviewed and approved by OMB in
accordance with the Paperwork Reduction Act and assigned the control
number 0920-0204.
Sec. 90.5 Acting on requests.
(a) Upon receipt of a request for a health assessment submitted
under this part, ATSDR will determine, in its discretion, whether or not
there is a reasonable basis to justify conducting a health assessment.
ATSDR will base this determination on, among other factors:
(1) Whether individuals have been exposed to a hazardous substance,
for which the probable source of such exposure is a release;
(2) The location, concentration, and toxicity of the hazardous
substances;
(3) The potential for further human exposure;
(4) The recommendations of other governmental agencies; and
(5) The ATSDR resources available and other ATSDR priorities, such
as its responsibilities to conduct other health assessments and health
effects studies.
(b) Where appropriate, ATSDR will request information from other
Federal, State, and local governmental agencies, as well as other
persons, pertaining to a facility or release which is the subject of a
request from the public to ATSDR to conduct a health assessment.
[[Page 581]]
(c) The requestor will be notified in writing of ATSDR's
determination that either a health assessment will be performed, a
health assessment will not be performed, or that further information
concerning the facility or release is required before a decision can be
made whether a health assessment will be performed.
(d) If a health assessment is not initiated in response to a request
from the public, ATSDR shall provide a written explanation to the
requestor of why a health assessment is not appropriate.
Sec. 90.6 Notification of determination to conduct a health assessment in
response to a request from the public.
(a) Following a determination by ATSDR to conduct a health
assessment in response to a request from the public, ATSDR shall notify
in writing, at a minimum, the following parties of its intent to perform
a health assessment:
(1) The U.S. Environmental Protection Agency;
(2) The appropriate State government environmental agency;
(3) The appropriate State and local health departments;
(4) The requestor;
(5) The owner or operator of the facility of concern, if their
identity is readily available to ATSDR.
In addition, ATSDR will notify, in writing or by telephone, other
potentially responsible parties, if their identity is readily available
to ATSDR.
(b) At its discretion, ATSDR may notify any other persons which it
feels may be affected by the release or have information pertaining to
the release.
Sec. 90.7 Decision to conduct health effects study.
(a) ATSDR may decide, in its discretion, based upon the results of a
health assessment or other available information, to conduct a health
effects study for a particular site or sites. Such a decision may, in
appropriate circumstances, be made prior to the completion of a health
assessment for a site or sites. When deciding whether to conduct a
health effects study, ATSDR will consider such factors as the results
and recommendations of a health assessment for the site or sites and the
need for additional information to determine whether individuals have
been exposed to hazardous substances, the degree to which such exposure
has occurred, and any possible health effects resulting from such
exposure.
(b) Should ATSDR decide, in its discretion, to conduct a health
effect study, it will notify the parties as specified in Sec. 90.6.
Sec. 90.8 Conduct of health assessments and health effects studies.
(a) Any interested person or persons may submit data or information
to ATSDR for it to consider in its conduct of a health assessment or a
health effects study. In performing a health assessment or a health
effects study, ATSDR will consider data and information it has
independently generated or received from other parties, such as EPA,
other Federal agencies, State and local governmental agencies,
businesses, citizen organizations, and community groups.
(b) ATSDR may determine it is necessary to conduct a site visit in
connection with a health assessment or health effects study. The ATSDR
representative may allow the participation of any person in the site
visit which he or she, at his or her discretion, determines will aid in
the conduct of the health assessment or health effects study.
(c) In the event that the information necessary to perform a health
assessment or health effects study is not readily available from other
sources, ATSDR may arrange for sampling or additional data gathering at
a facility or release for the limited purpose of determining the
existence of current or potential health problems.
Sec. 90.9 Public health advisory.
ATSDR may issue a public health advisory based on the findings of a
health assessment, health effects, study, or other ATSDR involvement.
Sec. 90.10 Notice and comment period.
Following internal review by ATSDR and external peer review of a
draft final report of the results of a health effects study, ATSDR will
publish a notice that the draft final report is available for public
review and comment. At
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a minimum, the notice shall be published in at least one newspaper of
general distribution in the local where the site is located. The notice
shall describe how copies of the draft final report of the health
effects study can be obtained and set a reasonable time period for
interested persons to submit comments concerning the study. ATSDR may,
at its discretion, respond in writing to comments it receives.
Sec. 90.11 Reporting of results of health assessments and health effects
studies.
(a) ATSDR shall provide a report of the results of a health
assessment or health effects study to EPA, the appropriate State and
local governmental agencies, any person requesting ATSDR to conduct the
health assessment, and parties potentially responsible for the release,
if their identity is readily available to ATSDR. In addition, such
reports shall be available to the general public upon request.
(b) In the event that ATSDR or its representatives conduct medical
examinations of individuals in the course of a health effects study and
the examination reveals a positive significant medical finding, the
individual, and a physician if designated by the individual, will be
promptly notified of that significant medical finding by ATSDR.
(c) A summary of the findings of all medical examinations for each
individual will be sent by ATSDR to that individual.
(d) All studies and results of research conducted under this part
(other than health assessments) shall be reported or adopted only after
appropriate peer review.
Sec. 90.12 Confidentiality of information.
(a) ATSDR shall consider any medical information in individually
identifiable form to be confidential information and shall release such
information only in accordance with the Privacy Act (5 U.S.C. 552a) or
other applicable Federal law.
(b) As provided under section 104(e)(7) of CERCLA, any records,
reports, or information obtained from any person under this section
shall be available to the public, except that upon a showing
satisfactory to ATSDR by any person that records, reports, or
information, or particular part thereof (other than health or safety
effects data), to which any officer, employee, or representative of
ATSDR has access under this part if made public would divulge
information entitled to protection under the Trade Secrets Act (18
U.S.C. 1905), such information or particular portion thereof shall be
considered confidential in accordance with the purposes of that section,
except that such record, report, document, or information may be
disclosed to other officers, employees, or authorized representatives of
the United States concerned with carrying out statutorily mandated
duties.
(c) In submitting data to ATSDR, a person may designate the data
which such person believes is entitled to protection under paragraph (b)
of this section and submit such designated data separately from other
data submitted under this part. A designation under this paragraph shall
be made in writing to the Administrator. However, should ATSDR at any
time question such designation, not less than 15 days notice to the
person sumitting the information shall be given of the intention to
remove such trade secret designation from such information. The person
may submit a request to the Administrator to reconsider this intention
and may provide additional information in support of the trade secret
designation. The Administrator shall notify the person in writing of the
decision which will become effective no sooner than 15 days after the
date of such notice.
Sec. 90.13 Recordkeeping requirements.
(a) ATSDR shall maintain a record of all health assessments and
health effects studies. The Administrator shall, at his or her
discretion, determine the contents of the record. At a minimum, the
record shall include:
(1) The final ATSDR report of the health assessment or health
effects study;
(2) Nonconfidential data and other information upon which that
report is based or which was considered by ATSDR;
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(3) Nonconfidential data or other information submitted by
interested persons pertaining to the health assessment or health effects
study;
(4) The protocol for the health effects study;
(5) A list of the individuals responsible for external peer review
of the report of a health effects study, their comments, and ATSDR's
response to the comments; and
(6) For health effects study, the notice announcing the availability
of a draft final report for public review and comment, all comments
received in response to the notice, and any responses to the comments by
ATSDR.
(b) The record may contain a confidential portion which shall
include all information determined to be confidential by the
Administrator under this part.
(c) The Administrator may determine other documents are appropriate
for inclusion in the record for health assessments or health effects
studies.
(d) Predecisional documents, including draft documents, are not
documents upon which ATSDR bases its conclusions in health assessments
or health effects studies, and are not usually included in the record
for health assessments or health effects studies.
(e) The record for ATSDR health assessments and health effects
studies will be available for review, upon prior request, at ATSDR
headquarters in Atlanta, Georgia.
(f) Nothing in this section is intended to imply that ATSDR's
decisions to conduct health assessments or health effects studies, or
the reports of health assessments or health effects studies, are subject
to judicial review.
Sec. 90.14 Documentation and cost recovery.
(a) During all phases of ATSDR health assessments and health effects
studies, documentation shall be completed and maintained to form the
basis for cost recovery, as specified in section 107 of CERCLA.
(b) Where appropriate, the information and reports compiled by ATSDR
pertaining to costs shall be forwarded to the appropriate EPA regional
office for cost recovery purposes.
PART 93_PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT--Table of
Contents
Sec.
93.25 Organization of this part.
93.50 Special terms.
Subpart A_General
93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Research misconduct.
93.104 Requirements for findings of research misconduct.
93.105 Time limitations.
93.106 Evidentiary standards.
93.107 Rule of interpretation.
93.108 Confidentiality.
93.109 Coordination with other agencies.
Subpart B_Definitions
93.200 Administrative action.
93.201 Allegation.
93.202 Charge letter.
93.203 Complainant.
93.204 Contract.
93.205 Debarment or suspension.
93.206 Debarring official.
93.207 Departmental Appeals Board or DAB.
93.208 Evidence.
93.209 Funding component.
93.210 Good faith.
93.211 Hearing.
93.212 Inquiry.
93.213 Institution.
93.214 Institutional member
93.215 Investigation.
93.216 Notice.
93.217 Office of Research Integrity or ORI.
93.218 Person.
93.219 Preponderance of the evidence.
93.220 Public Health Service or PHS.
93.221 PHS support.
93.222 Research.
93.223 Research misconduct proceeding.
93.224 Research record.
93.225 Respondent.
93.226 Retaliation.
93.227 Secretary or HHS.
Subpart C_Responsibilities of Institutions
Compliance and Assurances
93.300 General responsibilities for compliance.
93.301 Institutional assurances.
93.302 Institutional compliance with assurances.
93.303 Assurances for small institutions.
93.304 Institutional policies and procedures.
93.305 Responsibility for maintenance and custody of research records
and evidence.
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93.306 Using a consortium or person for research misconduct proceedings.
The Institutional Inquiry
93.307 Institutional inquiry.
93.308 Notice of the results of the inquiry.
93.309 Reporting to ORI on the decision to initiate an investigation.
The Institutional Investigation
93.310 Institutional investigation.
93.311 Investigation time limits.
93.312 Opportunity to comment on the investigation report.
93.313 Institutional investigation report.
93.314 Institutional appeals.
93.315 Notice to ORI of institutional findings and actions.
93.316 Completing the research misconduct process.
Other Institutional Responsibilities
93.317 Retention and custody of the research misconduct proceeding
record.
93.318 Notifying ORI of special circumstances.
93.319 Institutional standards.
Subpart D_Responsibilities of the U.S. Department of Health and Human
Services
General Information
93.400 General statement of ORI authority.
93.401 Interaction with other offices and interim actions.
Research Misconduct Issues
93.402 ORI allegation assessments.
93.403 ORI review of research misconduct proceedings.
93.404 Findings of research misconduct and proposed administrative
actions.
93.405 Notifying the respondent of findings of research misconduct and
HHS administrative actions.
93.406 Final HHS actions.
93.407 HHS administrative actions.
93.408 Mitigating and aggravating factors in HHS administrative actions.
93.409 Settlement of research misconduct proceedings.
93.410 Final HHS action with no settlement or finding of research
misconduct.
93.411 Final HHS action with a settlement or finding of misconduct.
Institutional Compliance Issues
93.412 Making decisions on institutional noncompliance.
93.413 HHS compliance actions.
Disclosure of Information
93.414 Notice.
Subpart E_Opportunity To Contest ORI Findings of Research Misconduct and
HHS Administrative Actions
General Information
93.500 General policy.
93.501 Opportunity to contest findings of research misconduct and
administrative actions.
Hearing Process
93.502 Appointment of the Administrative Law Judge and scientific
expert.
93.503 Grounds for granting a hearing request.
93.504 Grounds for dismissal of a hearing request.
93.505 Rights of the parties.
93.506 Authority of the Administrative Law Judge.
93.507 Ex parte communications.
93.508 Filing, forms, and service.
93.509 Computation of time.
93.510 Filing motions.
93.511 Prehearing conferences.
93.512 Discovery.
93.513 Submission of witness lists, witness statements, and exhibits.
93.514 Amendment to the charge letter.
93.515 Actions for violating an order or for disruptive conduct.
93.516 Standard and burden of proof.
93.517 The hearing.
93.518 Witnesses.
93.519 Admissibility of evidence.
93.520 The record.
93.521 Correction of the transcript.
93.522 Filing post-hearing briefs.
93.523 The Administrative Law Judge's ruling.
Authority: 42 U.S.C. 216, 241, and 289b.
Source: 70 FR 28384, May 17, 2005, unless otherwise noted.
Sec. 93.25 Organization of this part.
This part is subdivided into five subparts. Each subpart contains
information related to a broad topic or specific audience with special
responsibilities as shown in the following table.
------------------------------------------------------------------------
You will find provisions related to
In subpart . . . . . .
------------------------------------------------------------------------
A................................. General information about this rule.
B................................. Definitions of terms used in this
part.
C................................. Responsibilities of institutions
with PHS support.
D................................. Responsibilities of the U.S.
Department of Health and Human
Services and the Office of Research
Integrity.
[[Page 585]]
E................................. Information on how to contest ORI
research misconduct findings and
HHS administrative actions.
------------------------------------------------------------------------
Sec. 93.50 Special terms.
This part uses terms throughout the text that have special meaning.
Those terms are defined in Subpart B of this part.
Subpart A_General
Sec. 93.100 General policy.
(a) Research misconduct involving PHS support is contrary to the
interests of the PHS and the Federal government and to the health and
safety of the public, to the integrity of research, and to the
conservation of public funds.
(b) The U.S. Department of Health and Human Services (HHS) and
institutions that apply for or receive Public Health Service (PHS)
support for biomedical or behavioral research, biomedical or behavioral
research training, or activities related to that research or research
training share responsibility for the integrity of the research process.
HHS has ultimate oversight authority for PHS supported research, and for
taking other actions as appropriate or necessary, including the right to
assess allegations and perform inquiries or investigations at any time.
Institutions and institutional members have an affirmative duty to
protect PHS funds from misuse by ensuring the integrity of all PHS
supported work, and primary responsibility for responding to and
reporting allegations of research misconduct, as provided in this part.
Sec. 93.101 Purpose.
The purpose of this part is to--
(a) Establish the responsibilities of HHS, PHS, the Office of
Research Integrity (ORI), and institutions in responding to research
misconduct issues;
(b) Define what constitutes misconduct in PHS supported research;
(c) Define the general types of administrative actions HHS and the
PHS may take in response to research misconduct; and
(d) Require institutions to develop and implement policies and
procedures for--
(1) Reporting and responding to allegations of research misconduct
covered by this part;
(2) Providing HHS with the assurances necessary to permit the
institutions to participate in PHS supported research.
(e) Protect the health and safety of the public, promote the
integrity of PHS supported research and the research process, and
conserve public funds.
Sec. 93.102 Applicability.
(a) Each institution that applies for or receives PHS support for
biomedical or behavioral research, research training or activities
related to that research or research training must comply with this
part.
(b)(1) This part applies to allegations of research misconduct and
research misconduct involving:
(i) Applications or proposals for PHS support for biomedical or
behavioral extramural or intramural research, research training or
activities related to that research or research training, such as the
operation of tissue and data banks and the dissemination of research
information;
(ii) PHS supported biomedical or behavioral extramural or intramural
research;
(iii) PHS supported biomedical or behavioral extramural or
intramural research training programs;
(iv) PHS supported extramural or intramural activities that are
related to biomedical or behavioral research or research training, such
as the operation of tissue and data banks or the dissemination of
research information; and
(v) Plagiarism of research records produced in the course of PHS
supported research, research training or activities related to that
research or research training.
(2) This includes any research proposed, performed, reviewed, or
reported, or any research record generated from that research,
regardless of whether an application or proposal for
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PHS funds resulted in a grant, contract, cooperative agreement, or other
form of PHS support.
(c) This part does not supersede or establish an alternative to any
existing regulations or procedures for handling fiscal improprieties,
the ethical treatment of human or animal subjects, criminal matters,
personnel actions against Federal employees, or actions taken under the
HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR
subparts 9.4 and 309.4.
(d) This part does not prohibit or otherwise limit how institutions
handle allegations of misconduct that do not fall within this part's
definition of research misconduct or that do not involve PHS support.
Sec. 93.103 Research misconduct.
Research misconduct means fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting
research results.
(a) Fabrication is making up data or results and recording or
reporting them.
(b) 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.
(c) Plagiarism is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.
(d) Research misconduct does not include honest error or differences
of opinion.
Sec. 93.104 Requirements for findings of research misconduct.
A finding of research misconduct made under this part requires
that--
(a) There be a significant departure from accepted practices of the
relevant research community; and
(b) The misconduct be committed intentionally, knowingly, or
recklessly; and
(c) The allegation be proven by a preponderance of the evidence.
Sec. 93.105 Time limitations.
(a) Six-year limitation. This part applies only to research
misconduct occurring within six years of the date HHS or an institution
receives an allegation of research misconduct.
(b) Exceptions to the six-year limitation. Paragraph (a) of this
section does not apply in the following instances:
(1) Subsequent use exception. The respondent continues or renews any
incident of alleged research misconduct that occurred before the six-
year limitation through the citation, republication or other use for the
potential benefit of the respondent of the research record that is
alleged to have been fabricated, falsified, or plagiarized.
(2) Health or safety of the public exception. If ORI or the
institution, following consultation with ORI, determines that the
alleged misconduct, if it occurred, would possibly have a substantial
adverse effect on the health or safety of the public.
(3) ``Grandfather'' exception. If HHS or an institution received the
allegation of research misconduct before the effective date of this
part.
Sec. 93.106 Evidentiary standards.
The following evidentiary standards apply to findings made under
this part.
(a) Standard of proof. An institutional or HHS finding of research
misconduct must be proved by a preponderance of the evidence.
(b) Burden of proof. (1) The institution or HHS has the burden of
proof for making a finding of research misconduct. The destruction,
absence of, or respondent's failure to provide research records
adequately documenting the questioned research is evidence of research
misconduct where the institution or HHS establishes by a preponderance
of the evidence that the respondent intentionally, knowingly, or
recklessly had research records and destroyed them, had the opportunity
to maintain the records but did not do so, or maintained the records and
failed to produce them in a timely manner and that the respondent's
conduct constitutes a significant departure from accepted practices of
the relevant research community.
(2) The respondent has the burden of going forward with and the
burden of proving, by a preponderance of the evidence, any and all
affirmative defenses raised. In determining whether HHS or the
institution has carried the burden
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of proof imposed by this part, the finder of fact shall give due
consideration to admissible, credible evidence of honest error or
difference of opinion presented by the respondent.
(3) The respondent has the burden of going forward with and proving
by a preponderance of the evidence any mitigating factors that are
relevant to a decision to impose administrative actions following a
research misconduct proceeding.
Sec. 93.107 Rule of interpretation.
Any interpretation of this part must further the policy and purpose
of the HHS and the Federal government to protect the health and safety
of the public, to promote the integrity of research, and to conserve
public funds.
Sec. 93.108 Confidentiality.
(a) Disclosure of the identity of respondents and complainants in
research misconduct proceedings is limited, to the extent possible, to
those who need to know, consistent with a thorough, competent, objective
and fair research misconduct proceeding, and as allowed by law.
Provided, however, that:
(1) The institution must disclose the identity of respondents and
complainants to ORI pursuant to an ORI review of research misconduct
proceedings under Sec. 93.403.
(2) Under Sec. 93.517(g), HHS administrative hearings must be open
to the public.
(b) Except as may otherwise be prescribed by applicable law,
confidentiality must be maintained for any records or evidence from
which research subjects might be identified. Disclosure is limited to
those who have a need to know to carry out a research misconduct
proceeding.
Sec. 93.109 Coordination with other agencies.
(a) When more than one agency of the Federal government has
jurisdiction of the subject misconduct allegation, HHS will cooperate in
designating a lead agency to coordinate the response of the agencies to
the allegation. Where HHS is not the lead agency, it may, in
consultation with the lead agency, take appropriate action to protect
the health and safety of the public, promote the integrity of the PHS
supported research and research process and conserve public funds.
(b) In cases involving more than one agency, HHS may refer to
evidence or reports developed by that agency if HHS determines that the
evidence or reports will assist in resolving HHS issues. In appropriate
cases, HHS will seek to resolve allegations jointly with the other
agency or agencies.
Subpart B_Definitions
Sec. 93.200 Administrative action.
Administrative action means--
(a) An HHS action in response to a research misconduct proceeding
taken to protect the health and safety of the public, to promote the
integrity of PHS supported biomedical or behavioral research, research
training, or activities related to that research or research training
and to conserve public funds; or
(b) An HHS action in response either to a breach of a material
provision of a settlement agreement in a research misconduct proceeding
or to a breach of any HHS debarment or suspension.
Sec. 93.201 Allegation.
Allegation means a disclosure of possible research misconduct
through any means of communication. The disclosure may be by written or
oral statement or other communication to an institutional or HHS
official.
Sec. 93.202 Charge letter.
Charge letter means the written notice, as well as any amendments to
the notice, that are sent to the respondent stating the findings of
research misconduct and any HHS administrative actions. If the charge
letter includes a debarment or suspension action, it may be issued
jointly by the ORI and the debarring official.
Sec. 93.203 Complainant.
Complainant means a person who in good faith makes an allegation of
research misconduct.
[[Page 588]]
Sec. 93.204 Contract.
Contract means an acquisition instrument awarded under the HHS
Federal Acquisition Regulation (FAR), 48 CFR Chapter 1, excluding any
small purchases awarded pursuant to FAR Part 13.
Sec. 93.205 Debarment or suspension.
Debarment or suspension means the Government wide exclusion, whether
temporary or for a set term, of a person from eligibility for Federal
grants, contracts, and cooperative agreements under the HHS regulations
at 45 CFR part 76 (nonprocurement) and 48 CFR subparts 9.4 and 309.4
(procurement).
Sec. 93.206 Debarring official.
Debarring official means an official authorized to impose debarment
or suspension. The HHS debarring official is either--
(a) The Secretary; or
(b) An official designated by the Secretary.
Sec. 93.207 Departmental Appeals Board or DAB.
Departmental Appeals Board or DAB means, depending on the context--
(a) The organization, within the Office of the Secretary,
established to conduct hearings and provide impartial review of disputed
decisions made by HHS operating components; or
(b) An Administrative Law Judge (ALJ) at the DAB.
Sec. 93.208 Evidence.
Evidence means any document, tangible item, or testimony offered or
obtained during a research misconduct proceeding that tends to prove or
disprove the existence of an alleged fact.
Sec. 93.209 Funding component.
Funding component means any organizational unit of the PHS
authorized to award grants, contracts, or cooperative agreements for any
activity that involves the conduct of biomedical or behavioral research,
research training or activities related to that research or research
training, e.g., agencies, bureaus, centers, institutes, divisions, or
offices and other awarding units within the PHS.
Sec. 93.210 Good faith.
Good faith as applied to a complainant or witness, means having a
belief in the truth of one's allegation or testimony that a reasonable
person in the complainant's or witness's position could have based on
the information known to the complainant or witness at the time. An
allegation or cooperation with a research misconduct proceeding is not
in good faith if made with knowing or reckless disregard for information
that would negate the allegation or testimony. Good faith as applied to
a committee member means cooperating with the research misconduct
proceeding by carrying out the duties assigned impartially for the
purpose of helping an institution meet its responsibilities under this
part. A committee member does not act in good faith if his/her acts or
omissions on the committee are dishonest or influenced by personal,
professional, or financial conflicts of interest with those involved in
the research misconduct proceeding.
Sec. 93.211 Hearing.
Hearing means that part of the research misconduct proceeding from
the time a respondent files a request for an administrative hearing to
contest ORI findings of research misconduct and HHS administrative
actions until the time the ALJ issues a recommended decision.
Sec. 93.212 Inquiry.
Inquiry means preliminary information-gathering and preliminary
fact-finding that meets the criteria and follows the procedures of
Sec. Sec. 93.307-93.309.
Sec. 93.213 Institution.
Institution means any individual or person that applies for or
receives PHS support for any activity or program that involves the
conduct of biomedical or behavioral research, biomedical or behavioral
research training, or activities related to that research or training.
This includes, but is not limited to colleges and universities, PHS
intramural biomedical or
[[Page 589]]
behavioral research laboratories, research and development centers,
national user facilities, industrial laboratories or other research
institutes, small research institutions, and independent researchers.
Sec. 93.214 Institutional member.
Institutional member or members means a person who is employed by,
is an agent of, or is affiliated by contract or agreement with an
institution. Institutional members may include, but are not limited to,
officials, tenured and untenured faculty, teaching and support staff,
researchers, research coordinators, clinical technicians, postdoctoral
and other fellows, students, volunteers, agents, and contractors,
subcontractors, and subawardees, and their employees.
Sec. 93.215 Investigation.
Investigation means the formal development of a factual record and
the examination of that record leading to a decision not to make a
finding of research misconduct or to a recommendation for a finding of
research misconduct which may include a recommendation for other
appropriate actions, including administrative actions.
Sec. 93.216 Notice.
Notice means a written communication served in person, sent by mail
or its equivalent to the last known street address, facsimile number or
e-mail address of the addressee. Several sections of Subpart E of this
part have special notice requirements.
Sec. 93.217 Office of Research Integrity or ORI.
Office of Research Integrity or ORI means the office to which the
HHS Secretary has delegated responsibility for addressing research
integrity and misconduct issues related to PHS supported activities.
Sec. 93.218 Person.
Person means any individual, corporation, partnership, institution,
association, unit of government, or legal entity, however organized.
Sec. 93.219 Preponderance of the evidence.
Preponderance of the evidence means proof by information that,
compared with that opposing it, leads to the conclusion that the fact at
issue is more probably true than not.
Sec. 93.220 Public Health Service or PHS.
Public Health Service or PHS means the unit within the Department of
Health and Human Services that includes the Office of Public Health and
Science and the following Operating Divisions: Agency for Healthcare
Research and Quality, Agency for Toxic Substances and Disease Registry,
Centers for Disease Control and Prevention, Food and Drug
Administration, Health Resources and Services Administration, Indian
Health Service, National Institutes of Health, and the Substance Abuse
and Mental Health Services Administration, and the offices of the
Regional Health Administrators.
Sec. 93.221 PHS support.
PHS support means PHS funding, or applications or proposals
therefor, for biomedical or behavioral research, biomedical or
behavioral research training, or activities related to that research or
training, that may be provided through: Funding for PHS intramural
research; PHS grants, cooperative agreements, or contracts or subgrants
or subcontracts under those PHS funding instruments; or salary or other
payments under PHS grants, cooperative agreements or contracts.
Sec. 93.222 Research.
Research means a systematic experiment, study, evaluation,
demonstration or survey designed to develop or contribute to general
knowledge (basic research) or specific knowledge (applied research)
relating broadly to public health by establishing, discovering,
developing, elucidating or confirming information about, or the
underlying mechanism relating to, biological causes, functions or
effects, diseases, treatments, or related matters to be studied.
[[Page 590]]
Sec. 93.223 Research misconduct proceeding.
Research misconduct proceeding means any actions related to alleged
research misconduct taken under this part, including but not limited to,
allegation assessments, inquiries, investigations, ORI oversight
reviews, hearings, and administrative appeals.
Sec. 93.224 Research record.
Research record means the record of data or results that embody the
facts resulting from scientific inquiry, including but not limited to,
research proposals, laboratory records, both physical and electronic,
progress reports, abstracts, theses, oral presentations, internal
reports, journal articles, and any documents and materials provided to
HHS or an institutional official by a respondent in the course of the
research misconduct proceeding.
Sec. 93.225 Respondent.
Respondent means the person against whom an allegation of research
misconduct is directed or who is the subject of a research misconduct
proceeding.
Sec. 93.226 Retaliation.
Retaliation for the purpose of this part means an adverse action
taken against a complainant, witness, or committee member by an
institution or one of its members in response to--
(a) A good faith allegation of research misconduct; or
(b) Good faith cooperation with a research misconduct proceeding.
Sec. 93.227 Secretary or HHS.
Secretary or HHS means the Secretary of HHS or any other officer or
employee of the HHS to whom the Secretary delegates authority.
Subpart C_Responsibilities of Institutions
Compliance and Assurances
Sec. 93.300 General responsibilities for compliance.
Institutions under this part must--
(a) Have written policies and procedures for addressing allegations
of research misconduct that meet the requirements of this part;
(b) Respond to each allegation of research misconduct for which the
institution is responsible under this part in a thorough, competent,
objective and fair manner, including precautions to ensure that
individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional or
financial conflicts of interest with the complainant, respondent or
witnesses;
(c) Foster a research environment that promotes the responsible
conduct of research, research training, and activities related to that
research or research training, discourages research misconduct, and
deals promptly with allegations or evidence of possible research
misconduct;
(d) Take all reasonable and practical steps to protect the positions
and reputations of good faith complainants, witnesses and committee
members and protect them from retaliation by respondents and other
institutional members;
(e) Provide confidentiality to the extent required by Sec. 93.108
to all respondents, complainants, and research subjects identifiable
from research records or evidence;
(f) Take all reasonable and practical steps to ensure the
cooperation of respondents and other institutional members with research
misconduct proceedings, including, but not limited to, their providing
information, research records, and evidence;
(g) Cooperate with HHS during any research misconduct proceeding or
compliance review;
(h) Assist in administering and enforcing any HHS administrative
actions imposed on its institutional members; and
(i) Have an active assurance of compliance.
Sec. 93.301 Institutional assurances.
(a) General policy. An institution with PHS supported biomedical or
behavioral research, research training or activities related to that
research or research training must provide PHS with an assurance of
compliance with this part, satisfactory to the Secretary.
[[Page 591]]
PHS funding components may authorize funds for biomedical and behavioral
research, research training, or activities related to that research or
research training only to institutions that have approved assurances and
required renewals on file with ORI.
(b) Institutional Assurance. The responsible institutional official
must assure on behalf of the institution that the institution--
(1) Has written policies and procedures in compliance with this part
for inquiring into and investigating allegations of research misconduct;
and
(2) Complies with its own policies and procedures and the
requirements of this part.
Sec. 93.302 Institutional compliance with assurances.
(a) Compliance with assurance. ORI considers an institution in
compliance with its assurance if the institution--
(1) Establishes policies and procedures according to this part,
keeps them in compliance with this part, and upon request, provides them
to ORI, other HHS personnel, and members of the public;
(2) Takes all reasonable and practical specific steps to foster
research integrity consistent with Sec. 93.300, including--
(i) Informs the institution's research members participating in or
otherwise involved with PHS supported biomedical or behavioral research,
research training or activities related to that research or research
training, including those applying for support from any PHS funding
component, about its policies and procedures for responding to
allegations of research misconduct, and the institution's commitment to
compliance with the policies and procedures; and
(ii) Complies with its policies and procedures and each specific
provision of this part.
(b) Annual report. An institution must file an annual report with
ORI which contains information specified by ORI on the institution's
compliance with this part.
(c) Additional information. Along with its assurance or annual
report, an institution must send ORI such other aggregated information
as ORI may request on the institution's research misconduct proceedings
covered by this part and the institution's compliance with the
requirements of this part.
Sec. 93.303 Assurances for small institutions.
(a) If an institution is too small to handle research misconduct
proceedings, it may file a ``Small Organization Statement'' with ORI in
place of the formal institutional policies and procedures required by
Sec. Sec. 93.301 and 93.304.
(b) By submitting a Small Organization Statement, the institution
agrees to report all allegations of research misconduct to ORI. ORI or
another appropriate HHS office will work with the institution to develop
and implement a process for handling allegations of research misconduct
consistent with this part.
(c) The Small Organization Statement does not relieve the
institution from complying with any other provision of this part.
Sec. 93.304 Institutional policies and procedures.
Institutions seeking an approved assurance must have written
policies and procedures for addressing research misconduct that include
the following--
(a) Consistent with Sec. 93.108, protection of the confidentiality
of respondents, complainants, and research subjects identifiable from
research records or evidence;
(b) A thorough, competent, objective, and fair response to
allegations of research misconduct consistent with and within the time
limits of this part, including precautions to ensure that individuals
responsible for carrying out any part of the research misconduct
proceeding do not have unresolved personal, professional, or financial
conflicts of interest with the complainant, respondent, or witnesses;
(c) Notice to the respondent, consistent with and within the time
limits of this part;
(d) Written notice to ORI of any decision to open an investigation
on or before the date on which the investigation begins;
[[Page 592]]
(e) Opportunity for the respondent to provide written comments on
the institution's inquiry report;
(f) Opportunity for the respondent to provide written comments on
the draft report of the investigation, and provisions for the
institutional investigation committee to consider and address the
comments before issuing the final report;
(g) Protocols for handling the research record and evidence,
including the requirements of Sec. 93.305;
(h) Appropriate interim institutional actions to protect public
health, Federal funds and equipment, and the integrity of the PHS
supported research process;
(i) Notice to ORI under Sec. 93.318 and notice of any facts that
may be relevant to protect public health, Federal funds and equipment,
and the integrity of the PHS supported research process;
(j) Institutional actions in response to final findings of research
misconduct;
(k) All reasonable and practical efforts, if requested and as
appropriate, to protect or restore the reputation of persons alleged to
have engaged in research misconduct but against whom no finding of
research misconduct is made;
(l) All reasonable and practical efforts to protect or restore the
position and reputation of any complainant, witness, or committee member
and to counter potential or actual retaliation against these
complainants, witnesses, and committee members; and
(m) Full and continuing cooperation with ORI during its oversight
review under Subpart D of this part or any subsequent administrative
hearings or appeals under Subpart E of this part. This includes
providing all research records and evidence under the institution's
control, custody, or possession and access to all persons within its
authority necessary to develop a complete record of relevant evidence.
Sec. 93.305 Responsibility for maintenance and custody of research records
and evidence.
An institution, as the responsible legal entity for the PHS
supported research, has a continuing obligation under this part to
ensure that it maintains adequate records for a research misconduct
proceeding. The institution must--
(a) Either before or when the institution notifies the respondent of
the allegation, inquiry or investigation, promptly take all reasonable
and practical steps to obtain custody of all the research records and
evidence needed to conduct the research misconduct proceeding, inventory
the records and evidence, and sequester them in a secure manner, except
that where the research records or evidence encompass scientific
instruments shared by a number of users, custody may be limited to
copies of the data or evidence on such instruments, so long as those
copies are substantially equivalent to the evidentiary value of the
instruments;
(b) Where appropriate, give the respondent copies of, or reasonable,
supervised access to the research records;
(c) Undertake all reasonable and practical efforts to take custody
of additional research records or evidence that is discovered during the
course of a research misconduct proceeding, except that where the
research records or evidence encompass scientific instruments shared by
a number of users, custody may be limited to copies of the data or
evidence on such instruments, so long as those copies are substantially
equivalent to the evidentiary value of the instruments; and
(d) Maintain the research records and evidence as required by Sec.
93.317.
Sec. 93.306 Using a consortium or other person for research misconduct
proceedings.
(a) An institution may use the services of a consortium or person
that the institution reasonably determines to be qualified by practice
and experience to conduct research misconduct proceedings.
(b) A consortium may be a group of institutions, professional
organizations, or mixed groups which will conduct research misconduct
proceedings for other institutions.
(c) A consortium or person acting on behalf of an institution must
follow the requirements of this part in conducting research misconduct
proceedings.
[[Page 593]]
The Institutional Inquiry
Sec. 93.307 Institutional inquiry.
(a) Criteria warranting an inquiry. An inquiry is warranted if the
allegation--
(1) Falls within the definition of research misconduct under this
part;
(2) Is within Sec. 93.102; and
(3) Is sufficiently credible and specific so that potential evidence
of research misconduct may be identified.
(b) Notice to respondent and custody of research records. At the
time of or before beginning an inquiry, an institution must make a good
faith effort to notify in writing the presumed respondent, if any. If
the inquiry subsequently identifies additional respondents, the
institution must notify them. To the extent it has not already done so
at the allegation stage, the institution must, on or before the date on
which the respondent is notified or the inquiry begins, whichever is
earlier, promptly take all reasonable and practical steps to obtain
custody of all the research records and evidence needed to conduct the
research misconduct proceeding, inventory the records and evidence, and
sequester them in a secure manner, except that where the research
records or evidence encompass scientific instruments shared by a number
of users, custody may be limited to copies of the data or evidence on
such instruments, so long as those copies are substantially equivalent
to the evidentiary value of the instruments.
(c) Review of evidence. The purpose of an inquiry is to conduct an
initial review of the evidence to determine whether to conduct an
investigation. Therefore, an inquiry does not require a full review of
all the evidence related to the allegation.
(d) Criteria warranting an investigation. An inquiry's purpose is to
decide if an allegation warrants an investigation. An investigation is
warranted if there is--
(1) A reasonable basis for concluding that the allegation falls
within the definition of research misconduct under this part and
involves PHS supported biomedical or behavioral research, research
training or activities related to that research or research training, as
provided in Sec. 93.102; and
(2) Preliminary information-gathering and preliminary fact-finding
from the inquiry indicates that the allegation may have substance.
(e) Inquiry report. The institution must prepare a written report
that meets the requirements of this section and Sec. 93.309.
(f) Opportunity to comment. The institution must provide the
respondent an opportunity to review and comment on the inquiry report
and attach any comments received to the report.
(g) Time for completion. The institution must complete the inquiry
within 60 calendar days of its initiation unless circumstances clearly
warrant a longer period. If the inquiry takes longer than 60 days to
complete, the inquiry record must include documentation of the reasons
for exceeding the 60-day period.
Sec. 93.308 Notice of the results of the inquiry.
(a) Notice to respondent. The institution must notify the respondent
whether the inquiry found that an investigation is warranted. The notice
must include a copy of the inquiry report and include a copy of or refer
to this part and the institution's policies and procedures adopted under
its assurance.
(b) Notice to complainants. The institution may notify the
complainant who made the allegation whether the inquiry found that an
investigation is warranted. The institution may provide relevant
portions of the report to the complainant for comment.
Sec. 93.309 Reporting to ORI on the decision to initiate an investigation.
(a) Within 30 days of finding that an investigation is warranted,
the institution must provide ORI with the written finding by the
responsible institutional official and a copy of the inquiry report
which includes the following information--
(1) The name and position of the respondent;
(2) A description of the allegations of research misconduct;
(3) The PHS support, including, for example, grant numbers, grant
applications, contracts, and publications listing PHS support;
[[Page 594]]
(4) The basis for recommending that the alleged actions warrant an
investigation; and
(5) Any comments on the report by the respondent or the complainant.
(b) The institution must provide the following information to ORI on
request--
(1) The institutional policies and procedures under which the
inquiry was conducted;
(2) The research records and evidence reviewed, transcripts or
recordings of any interviews, and copies of all relevant documents; and
(3) The charges for the investigation to consider.
(c) Documentation of decision not to investigate. Institutions must
keep sufficiently detailed documentation of inquiries to permit a later
assessment by ORI of the reasons why the institution decided not to
conduct an investigation. Consistent with Sec. 93.317, institutions
must keep these records in a secure manner for at least 7 years after
the termination of the inquiry, and upon request, provide them to ORI or
other authorized HHS personnel.
(d) Notification of special circumstances. In accordance with Sec.
93.318, institutions must notify ORI and other PHS agencies, as
relevant, of any special circumstances that may exist.
The Institutional Investigation
Sec. 93.310 Institutional investigation.
Institutions conducting research misconduct investigations must:
(a) Time. Begin the investigation within 30 days after determining
that an investigation is warranted.
(b) Notice to ORI. Notify the ORI Director of the decision to begin
an investigation on or before the date the investigation begins and
provide an inquiry report that meets the requirements of Sec. 93.307
and Sec. 93.309.
(c) Notice to the respondent. Notify the respondent in writing of
the allegations within a reasonable amount of time after determining
that an investigation is warranted, but before the investigation begins.
The institution must give the respondent written notice of any new
allegations of research misconduct within a reasonable amount of time of
deciding to pursue allegations not addressed during the inquiry or in
the initial notice of investigation.
(d) Custody of the records. To the extent they have not already done
so at the allegation or inquiry stages, take all reasonable and
practical steps to obtain custody of all the research records and
evidence needed to conduct the research misconduct proceeding, inventory
the records and evidence, and sequester them in a secure manner, except
that where the research records or evidence encompass scientific
instruments shared by a number of users, custody may be limited to
copies of the data or evidence on such instruments, so long as those
copies are substantially equivalent to the evidentiary value of the
instruments. Whenever possible, the institution must take custody of the
records--
(1) Before or at the time the institution notifies the respondent;
and
(2) Whenever additional items become known or relevant to the
investigation.
(e) Documentation. Use diligent efforts to ensure that the
investigation is thorough and sufficiently documented and includes
examination of all research records and evidence relevant to reaching a
decision on the merits of the allegations.
(f) Ensuring a fair investigation. Take reasonable steps to ensure
an impartial and unbiased investigation to the maximum extent
practicable, including participation of persons with appropriate
scientific expertise who do not have unresolved personal, professional,
or financial conflicts of interest with those involved with the inquiry
or investigation.
(g) Interviews. Interview each respondent, complainant, and any
other available person who has been reasonably identified as having
information regarding any relevant aspects of the investigation,
including witnesses identified by the respondent, and record or
transcribe each interview, provide the recording or transcript to the
interviewee for correction, and include the recording or transcript in
the record of the investigation.
(h) Pursue leads. Pursue diligently all significant issues and leads
discovered
[[Page 595]]
that are determined relevant to the investigation, including any
evidence of additional instances of possible research misconduct, and
continue the investigation to completion.
Sec. 93.311 Investigation time limits.
(a) Time limit for completing an investigation. An institution must
complete all aspects of an investigation within 120 days of beginning
it, including conducting the investigation, preparing the report of
findings, providing the draft report for comment in accordance with
Sec. 93.312, and sending the final report to ORI under Sec. 93.315.
(b) Extension of time limit. If unable to complete the investigation
in 120 days, the institution must ask ORI for an extension in writing.
(c) Progress reports. If ORI grants an extension, it may direct the
institution to file periodic progress reports.
Sec. 93.312 Opportunity to comment on the investigation report.
(a) The institution must give the respondent a copy of the draft
investigation report and, concurrently, a copy of, or supervised access
to, the evidence on which the report is based. The comments of the
respondent on the draft report, if any, must be submitted within 30 days
of the date on which the respondent received the draft investigation
report.
(b) The institution may provide the complainant a copy of the draft
investigation report or relevant portions of that report. The comments
of the complainant, if any, must be submitted within 30 days of the date
on which the complainant received the draft investigation report or
relevant portions of it.
Sec. 93.313 Institutional investigation report.
The final institutional investigation report must be in writing and
include:
(a) Allegations. Describe the nature of the allegations of research
misconduct.
(b) PHS support. Describe and document the PHS support, including,
for example, any grant numbers, grant applications, contracts, and
publications listing PHS support.
(c) Institutional charge. Describe the specific allegations of
research misconduct for consideration in the investigation.
(d) Policies and procedures. If not already provided to ORI with the
inquiry report, include the institutional policies and procedures under
which the investigation was conducted.
(e) Research records and evidence. Identify and summarize the
research records and evidence reviewed, and identify any evidence taken
into custody but not reviewed.
(f) Statement of findings. For each separate allegation of research
misconduct identified during the investigation, provide a finding as to
whether research misconduct did or did not occur, and if so--
(1) Identify whether the research misconduct was falsification,
fabrication, or plagiarism, and if it was intentional, knowing, or in
reckless disregard;
(2) Summarize the facts and the analysis which support the
conclusion and consider the merits of any reasonable explanation by the
respondent;
(3) Identify the specific PHS support;
(4) Identify whether any publications need correction or retraction;
(5) Identify the person(s) responsible for the misconduct; and
(6) List any current support or known applications or proposals for
support that the respondent has pending with non-PHS Federal agencies.
(g) Comments. Include and consider any comments made by the
respondent and complainant on the draft investigation report.
(h) Maintain and provide records. Maintain and provide to ORI upon
request all relevant research records and records of the institution's
research misconduct proceeding, including results of all interviews and
the transcripts or recordings of such interviews.
Sec. 93.314 Institutional appeals.
(a) While not required by this part, if the institution's procedures
provide for an appeal by the respondent that could result in a reversal
or modification of the findings of research misconduct in the
investigation report, the institution must complete any such appeal
within 120 days of its filing. Appeals from personnel or similar actions
that
[[Page 596]]
would not result in a reversal or modification of the findings of
research misconduct are excluded from the 120-day limit.
(b) If unable to complete any appeals within 120 days, the
institution must ask ORI for an extension in writing and provide an
explanation for the request.
(c) ORI may grant requests for extension for good cause. If ORI
grants an extension, it may direct the institution to file periodic
progress reports.
Sec. 93.315 Notice to ORI of institutional findings and actions.
The institution must give ORI the following:
(a) Investigation Report. Include a copy of the report, all
attachments, and any appeals.
(b) Final institutional action. State whether the institution found
research misconduct, and if so, who committed the misconduct.
(c) Findings. State whether the institution accepts the
investigation's findings.
(d) Institutional administrative actions. Describe any pending or
completed administrative actions against the respondent.
Sec. 93.316 Completing the research misconduct process.
(a) ORI expects institutions to carry inquiries and investigations
through to completion and to pursue diligently all significant issues.
An institution must notify ORI in advance if the institution plans to
close a case at the inquiry, investigation, or appeal stage on the basis
that the respondent has admitted guilt, a settlement with the respondent
has been reached, or for any other reason, except the closing of a case
at the inquiry stage on the basis that an investigation is not warranted
or a finding of no misconduct at the investigation stage, which must be
reported to ORI under Sec. 93.315.
(b) After consulting with the institution on its basis for closing a
case under paragraph (a) of this section, ORI may conduct an oversight
review of the institution's handling of the case and take appropriate
action including:
(1) Approving or conditionally approving closure of the case;
(2) Directing the institution to complete its process;
(3) Referring the matter for further investigation by HHS; or,
(4) Taking a compliance action.
Other Institutional Responsibilities
Sec. 93.317 Retention and custody of the research misconduct proceeding
record.
(a) Definition of records of research misconduct proceedings. As
used in this section, the term ``records of research misconduct
proceedings'' includes:
(1) The records that the institution secures for the proceeding
pursuant to Sec. Sec. 93.305, 93.307(b) and 93.310(d), except to the
extent the institution subsequently determines and documents that those
records are not relevant to the proceeding or that the records duplicate
other records that are being retained;
(2) The documentation of the determination of irrelevant or
duplicate records;
(3) The inquiry report and final documents (not drafts) produced in
the course of preparing that report, including the documentation of any
decision not to investigate as required by Sec. 93.309(d);
(4) The investigation report and all records (other than drafts of
the report) in support of that report, including the recordings or
transcriptions of each interview conducted pursuant to Sec. 93.310(g);
and
(5) The complete record of any institutional appeal covered by Sec.
93.314.
(b) Maintenance of record. Unless custody has been transferred to
HHS under paragraph (c) of this section, or ORI has advised the
institution in writing that it no longer needs to retain the records, an
institution must maintain records of research misconduct proceedings in
a secure manner for 7 years after completion of the proceeding or the
completion of any PHS proceeding involving the research misconduct
allegation under subparts D and E of this part, whichever is later.
(c) Provision for HHS custody. On request, institutions must
transfer custody of or provide copies to HHS, of any institutional
record relevant to a research misconduct allegation covered by this
part, including the research
[[Page 597]]
records and evidence, to perform forensic or other analyses or as
otherwise needed to conduct an HHS inquiry or investigation or for ORI
to conduct its review or to present evidence in any proceeding under
subparts D and E of this part.
Sec. 93.318 Notifying ORI of special circumstances.
At any time during a research misconduct proceeding, as defined in
Sec. 93.223, an institution must notify ORI immediately if it has
reason to believe that any of the following conditions exist:
(a) Health or safety of the public is at risk, including an
immediate need to protect human or animal subjects.
(b) HHS resources or interests are threatened.
(c) Research activities should be suspended.
(d) There is reasonable indication of possible violations of civil
or criminal law.
(e) Federal action is required to protect the interests of those
involved in the research misconduct proceeding.
(f) The research institution believes the research misconduct
proceeding may be made public prematurely so that HHS may take
appropriate steps to safeguard evidence and protect the rights of those
involved.
(g) The research community or public should be informed.
Sec. 93.319 Institutional standards.
(a) Institutions may have internal standards of conduct different
from the HHS standards for research misconduct under this part.
Therefore, an institution may find conduct to be actionable under its
standards even if the action does not meet this part's definition of
research misconduct.
(b) An HHS finding or settlement does not affect institutional
findings or administrative actions based on an institution's internal
standards of conduct.
Subpart D_Responsibilities of the U.S. Department of Health and Human
Services
General Information
Sec. 93.400 General statement of ORI authority.
(a) ORI review. ORI may respond directly to any allegation of
research misconduct at any time before, during, or after an
institution's response to the matter. The ORI response may include, but
is not limited to--
(1) Conducting allegation assessments;
(2) Determining independently if jurisdiction exists under this part
in any matter;
(3) Forwarding allegations of research misconduct to the appropriate
institution or HHS component for inquiry or investigation;
(4) Recommending that HHS should perform an inquiry or investigation
or issue findings and taking all appropriate actions in response to the
inquiry, investigation, or findings;
(5) Notifying or requesting assistance and information from PHS
funding components or other affected Federal and state offices and
agencies or institutions;
(6) Reviewing an institution's findings and process;
(7) Making a finding of research misconduct; and
(8) Proposing administrative actions to HHS.
(b) Requests for information. ORI may request clarification or
additional information, documentation, research records, or evidence
from an institution or its members or other persons or sources to carry
out ORI's review.
(c) HHS administrative actions. (1) In response to a research
misconduct proceeding, ORI may propose administrative actions against
any person to the HHS and, upon HHS approval and final action in
accordance with this part, implement the actions.
(2) ORI may propose to the HHS debarring official that a person be
suspended or debarred from receiving Federal funds and may propose to
other appropriate PHS components the implementation of HHS
administrative
[[Page 598]]
actions within the components' authorities.
(d) ORI assistance to institutions. At any time, ORI may provide
information, technical assistance, and procedural advice to
institutional officials as needed regarding an institution's
participation in research misconduct proceedings.
(e) Review of institutional assurances. ORI may review institutional
assurances and policies and procedures for compliance with this part.
(f) Institutional compliance. ORI may make findings and impose HHS
administrative actions related to an institution's compliance with this
part and with its policies and procedures, including an institution's
participation in research misconduct proceedings.
Sec. 93.401 Interaction with other offices and interim actions.
(a) ORI may notify and consult with other offices at any time if it
has reason to believe that a research misconduct proceeding may involve
that office. If ORI believes that a criminal or civil fraud violation
may have occurred, it shall promptly refer the matter to the Department
of Justice (DOJ), the HHS Inspector General (OIG), or other appropriate
investigative body. ORI may provide expertise and assistance to the DOJ,
OIG, PHS offices, other Federal offices, and state or local offices
involved in investigating or otherwise pursuing research misconduct
allegations or related matters.
(b) ORI may notify affected PHS offices and funding components at
any time to permit them to make appropriate interim responses to protect
the health and safety of the public, to promote the integrity of the PHS
supported research and research process, and to conserve public funds.
(c) The information provided will not be disclosed as part of the
peer review and advisory committee review processes, but may be used by
the Secretary in making decisions about the award or continuation of
funding.
Research Misconduct Issues
Sec. 93.402 ORI allegation assessments.
(a) When ORI receives an allegation of research misconduct directly
or becomes aware of an allegation or apparent instance of research
misconduct, it may conduct an initial assessment or refer the matter to
the relevant institution for an assessment, inquiry, or other
appropriate actions.
(b) If ORI conducts an assessment, it considers whether the
allegation of research misconduct appears to fall within the definition
of research misconduct, appears to involve PHS supported biomedical or
behavior research, research training or activities related to that
research or research training, as provided in Sec. 93.102, and whether
it is sufficiently specific so that potential evidence may be identified
and sufficiently substantive to warrant an inquiry. ORI may review all
readily accessible, relevant information related to the allegation.
(c) If ORI decides that an inquiry is warranted, it forwards the
matter to the appropriate institution or HHS component.
(d) If ORI decides that an inquiry is not warranted it will close
the case and forward the allegation in accordance with paragraph(e) of
this section.
(e) ORI may forward allegations that do not fall within the
jurisdiction of this part to the appropriate HHS component, Federal or
State agency, institution, or other appropriate entity.
Sec. 93.403 ORI review of research misconduct proceedings.
ORI may conduct reviews of research misconduct proceedings. In
conducting its review, ORI may--
(a) Determine whether there is HHS jurisdiction under this part;
(b) Consider any reports, institutional findings, research records,
and evidence;
(c) Determine if the institution conducted the proceedings in a
timely and fair manner in accordance with this part with sufficient
thoroughness, objectivity, and competence to support the conclusions;
[[Page 599]]
(d) Obtain additional information or materials from the institution,
the respondent, complainants, or other persons or sources;
(e) Conduct additional analyses and develop evidence;
(f) Decide whether research misconduct occurred, and if so who
committed it;
(g) Make appropriate research misconduct findings and propose HHS
administrative actions; and
(h) Take any other actions necessary to complete HHS' review.
Sec. 93.404 Findings of research misconduct and proposed administrative
actions.
After completing its review, ORI either closes the case without a
finding of research misconduct or--
(a) Makes findings of research misconduct and proposes and obtains
HHS approval of administrative actions based on the record of the
research misconduct proceedings and any other information obtained by
ORI during its review; or
(b) Recommends that HHS seek to settle the case.
Sec. 93.405 Notifying the respondent of findings of research misconduct and
HHS administrative actions.
(a) When the ORI makes a finding of research misconduct or seeks to
impose or enforce HHS administrative actions, other than debarment or
suspension, it notifies the respondent in a charge letter. In cases
involving a debarment or suspension action, the HHS debarring official
issues a notice of proposed debarment or suspension to the respondent as
part of the charge letter. The charge letter includes the ORI findings
of research misconduct and the basis for them and any HHS administrative
actions. The letter also advises the respondent of the opportunity to
contest the findings and administrative actions under Subpart E of this
part.
(b) The ORI sends the charge letter by certified mail or a private
delivery service to the last known address of the respondent or the last
known principal place of business of the respondent's attorney.
Sec. 93.406 Final HHS actions.
Unless the respondent contests the charge letter within the 30-day
period prescribed in Sec. 93.501, the ORI finding of research
misconduct is the final HHS action on the research misconduct issues and
the HHS administrative actions become final and will be implemented,
except that the debarring official's decision is the final HHS action on
any debarment or suspension actions.
Sec. 93.407 HHS administrative actions.
(a) In response to a research misconduct proceeding, HHS may impose
HHS administrative actions that include but are not limited to:
(1) Clarification, correction, or retraction of the research record.
(2) Letters of reprimand.
(3) Imposition of special certification or assurance requirements to
ensure compliance with applicable regulations or terms of PHS grants,
contracts, or cooperative agreements.
(4) Suspension or termination of a PHS grant, contract, or
cooperative agreement.
(5) Restriction on specific activities or expenditures under an
active PHS grant, contract, or cooperative agreement.
(6) Special review of all requests for PHS funding.
(7) Imposition of supervision requirements on a PHS grant, contract,
or cooperative agreement.
(8) Certification of attribution or authenticity in all requests for
support and reports to the PHS.
(9) No participation in any advisory capacity to the PHS.
(10) Adverse personnel action if the respondent is a Federal
employee, in compliance with relevant Federal personnel policies and
laws.
(11) Suspension or debarment under 45 CFR Part 76, 48 CFR Subparts
9.4 and 309.4, or both.
(b) In connection with findings of research misconduct, HHS also may
seek to recover PHS funds spent in support of the activities that
involved research misconduct.
(c) Any authorized HHS component may impose, administer, or enforce
HHS administrative actions separately or in coordination with other HHS
[[Page 600]]
components, including, but not limited to ORI, the Office of Inspector
General, the PHS funding component, and the debarring official.
Sec. 93.408 Mitigating and aggravating factors in HHS administrative actions.
The purpose of HHS administrative actions is remedial. The
appropriate administrative action is commensurate with the seriousness
of the misconduct, and the need to protect the health and safety of the
public, promote the integrity of the PHS supported research and research
process, and conserve public funds. HHS considers aggravating and
mitigating factors in determining appropriate HHS administrative actions
and their terms. HHS may consider other factors as appropriate in each
case. The existence or nonexistence of any factor is not determinative:
(a) Knowing, intentional, or reckless. Were the respondent's actions
knowing or intentional or was the conduct reckless?
(b) Pattern. Was the research misconduct an isolated event or part
of a continuing or prior pattern of dishonest conduct?
(c) Impact. Did the misconduct have significant impact on the
proposed or reported research record, research subjects, other
researchers, institutions, or the public health or welfare?
(d) Acceptance of responsibility. Has the respondent accepted
responsibility for the misconduct by--
(1) Admitting the conduct;
(2) Cooperating with the research misconduct proceedings;
(3) Demonstrating remorse and awareness of the significance and
seriousness of the research misconduct; and
(4) Taking steps to correct or prevent the recurrence of the
research misconduct.
(e) Failure to accept responsibility. Does the respondent blame
others rather than accepting responsibility for the actions?
(f) Retaliation. Did the respondent retaliate against complainants,
witnesses, committee members, or other persons?
(g) Present responsibility. Is the respondent presently responsible
to conduct PHS supported research?
(h) Other factors. Other factors appropriate to the circumstances of
a particular case.
Sec. 93.409 Settlement of research misconduct proceedings.
(a) HHS may settle a research misconduct proceeding at any time it
concludes that settlement is in the best interests of the Federal
government and the public health or welfare.
(b) Settlement agreements are publicly available, regardless of
whether the ORI made a finding of research misconduct.
Sec. 93.410 Final HHS action with no settlement or finding of research
misconduct.
When the final HHS action does not result in a settlement or finding
of research misconduct, ORI may:
(a) Provide written notice to the respondent, the relevant
institution, the complainant, and HHS officials.
(b) Take any other actions authorized by law.
Sec. 93.411 Final HHS action with settlement or finding of research
misconduct.
When a final HHS action results in a settlement or research
misconduct finding, ORI may:
(a) Provide final notification of any research misconduct findings
and HHS administrative actions to the respondent, the relevant
institution, the complainant, and HHS officials. The debarring official
may provide a separate notice of final HHS action on any debarment or
suspension actions.
(b) Identify publications which require correction or retraction and
prepare and send a notice to the relevant journal.
(c) Publish notice of the research misconduct findings.
(d) Notify the respondent's current employer.
(e) Take any other actions authorized by law.
[[Page 601]]
Institutional Compliance Issues
Sec. 93.412 Making decisions on institutional noncompliance.
(a) Institutions must foster a research environment that discourages
misconduct in all research and that deals forthrightly with possible
misconduct associated with PHS supported research.
(b) ORI may decide that an institution is not compliant with this
part if the institution shows a disregard for, or inability or
unwillingness to implement and follow the requirements of this part and
its assurance. In making this decision, ORI may consider, but is not
limited to the following factors--
(1) Failure to establish and comply with policies and procedures
under this part;
(2) Failure to respond appropriately when allegations of research
misconduct arise;
(3) Failure to report to ORI all investigations and findings of
research misconduct under this part;
(4) Failure to cooperate with ORI's review of research misconduct
proceedings; or
(5) Other actions or omissions that have a material, adverse effect
on reporting and responding to allegations of research misconduct.
Sec. 93.413 HHS compliance actions.
(a) An institution's failure to comply with its assurance and the
requirements of this part may result in enforcement action against the
institution.
(b) ORI may address institutional deficiencies through technical
assistance if the deficiencies do not substantially affect compliance
with this part.
(c) If an institution fails to comply with its assurance and the
requirements of this part, HHS may take some or all of the following
compliance actions:
(1) Issue a letter of reprimand.
(2) Direct that research misconduct proceedings be handled by HHS.
(3) Place the institution on special review status.
(4) Place information on the institutional noncompliance on the ORI
Web site.
(5) Require the institution to take corrective actions.
(6) Require the institution to adopt and implement an institutional
integrity agreement.
(7) Recommend that HHS debar or suspend the entity.
(8) Any other action appropriate to the circumstances.
(d) If the institution's actions constitute a substantial or
recurrent failure to comply with this part, ORI may also revoke the
institution's assurance under Sec. Sec. 93.301 or 93.303.
(e) ORI may make public any findings of institutional noncompliance
and HHS compliance actions.
Disclosure of Information
Sec. 93.414 Notice.
(a) ORI may disclose information to other persons for the purpose of
providing or obtaining information about research misconduct as
permitted under the Privacy Act, 5 U.S.C. 552a.
(b) ORI may publish a notice of final agency findings of research
misconduct, settlements, and HHS administrative actions and release and
withhold information as permitted by the Privacy Act and the Freedom of
Information Act, 5 U.S.C. 552.
Subpart E_Opportunity To Contest ORI Findings of Research Misconduct and
HHS Administrative Actions
General Information
Sec. 93.500 General policy.
(a) This subpart provides a respondent an opportunity to contest ORI
findings of research misconduct and HHS administrative actions,
including debarment or suspension, arising under 42 U.S.C. 289b in
connection with PHS supported biomedical and behavioral research,
research training, or activities related to that research or research
training.
(b) A respondent has an opportunity to contest ORI research
misconduct findings and HHS administrative actions under this part,
including debarment or suspension, by requesting an
[[Page 602]]
administrative hearing before an Administrative Law Judge (ALJ)
affiliated with the HHS DAB, when--
(1) ORI has made a finding of research misconduct against a
respondent; and
(2) The respondent has been notified of those findings and any
proposed HHS administrative actions, including debarment or suspension,
in accordance with this part.
(c) The ALJ's ruling on the merits of the ORI research misconduct
findings and the HHS administrative actions is subject to review by the
Assistant Secretary for Health in accordance with Sec. 93.523. The
decision made under that section is the final HHS action, unless that
decision results in a recommendation for debarment or suspension. In
that case, the decision under Sec. 93.523 shall constitute findings of
fact to the debarring official in accordance with 45 CFR 76.845(c).
(d) Where a proposed debarment or suspension action is based upon an
ORI finding of research misconduct, the procedures in this part provide
the notification, opportunity to contest, and fact-finding required
under the HHS debarment and suspension regulations at 45 CFR part 76,
subparts H and G, respectively, and 48 CFR Subparts 9.4 and 309.4.
Sec. 93.501 Opportunity to contest findings of research misconduct and
administrative actions.
(a) Opportunity to contest. A respondent may contest ORI findings of
research misconduct and HHS administrative actions, including any
debarment or suspension action, by requesting a hearing within 30 days
of receipt of the charge letter or other written notice provided under
Sec. 93.405.
(b) Form of a request for hearing. The respondent's request for a
hearing must be--
(1) In writing;
(2) Signed by the respondent or by the respondent's attorney; and
(3) Sent by certified mail, or other equivalent (i.e., with a
verified method of delivery), to the DAB Chair and ORI.
(c) Contents of a request for hearing. The request for a hearing
must--
(1) Admit or deny each finding of research misconduct and each
factual assertion made in support of the finding;
(2) Accept or challenge each proposed HHS administrative action;
(3) Provide detailed, substantive reasons for each denial or
challenge;
(4) Identify any legal issues or defenses that the respondent
intends to raise during the proceeding; and
(5) Identify any mitigating factors that the respondent intends to
prove.
(d) Extension for good cause to supplement the hearing request. (1)
After receiving notification of the appointment of the ALJ, the
respondent has 10 days to submit a written request to the ALJ for
supplementation of the hearing request to comply fully with the
requirements of paragraph (c) of this section. The written request must
show good cause in accordance with paragraph (d)(2) of this section and
set forth the proposed supplementation of the hearing request. The ALJ
may permit the proposed supplementation of the hearing request in whole
or in part upon a finding of good cause.
(2) Good cause means circumstances beyond the control of the
respondent or respondent's representative and not attributable to
neglect or administrative inadequacy.
Hearing Process
Sec. 93.502 Appointment of the Administrative Law Judge and scientific
expert.
(a) Within 30 days of receiving a request for a hearing, the DAB
Chair, in consultation with the Chief Administrative Law Judge, must
designate an Administrative Law Judge (ALJ) to determine whether the
hearing request should be granted and, if the hearing request is
granted, to make recommended findings in the case after a hearing or
review of the administrative record in accordance with this part.
(b) The ALJ may retain one or more persons with appropriate
scientific or technical expertise to assist the ALJ in evaluating
scientific or technical issues related to the findings of research
misconduct.
(1) On the ALJ's or a party's motion to appoint an expert, the ALJ
must give the parties an opportunity to submit nominations. If such a
motion is
[[Page 603]]
made by a party, the ALJ must appoint an expert, either:
(i) The expert, if any, who is agreed upon by both parties and found
to be qualified by the ALJ; or,
(ii) If the parties cannot agree upon an expert, the expert chosen
by the ALJ.
(2) The ALJ may seek advice from the expert(s) at any time during
the discovery and hearing phases of the proceeding. The expert(s) shall
provide advice to the ALJ in the form of a written report or reports
that will be served upon the parties within 10 days of submission to the
ALJ. That report must contain a statement of the expert's background and
qualifications. Any comment on or response to a report by a party, which
may include comments on the expert's qualifications, must be submitted
to the ALJ in accordance with Sec. 93.510(c). The written reports and
any comment on, or response to them are part of the record. Expert
witnesses of the parties may testify on the reports and any comments or
responses at the hearing, unless the ALJ determines such testimony to be
inadmissible in accordance with Sec. 93.519, or that such testimony
would unduly delay the proceeding.
(c) No ALJ, or person hired or appointed to assist the ALJ, may
serve in any proceeding under this subpart if he or she has any real or
apparent conflict of interest, bias, or prejudice that might reasonably
impair his or her objectivity in the proceeding.
(d) Any party to the proceeding may request the ALJ or scientific
expert to withdraw from the proceeding because of a real or apparent
conflict of interest, bias, or prejudice under paragraph (c) of this
section. The motion to disqualify must be timely and state with
particularity the grounds for disqualification. The ALJ may rule upon
the motion or certify it to the Chief ALJ for decision. If the ALJ rules
upon the motion, either party may appeal the decision to the Chief ALJ.
(e) An ALJ must withdraw from any proceeding for any reason found by
the ALJ or Chief ALJ to be disqualifying.
Sec. 93.503 Grounds for granting a hearing request.
(a) The ALJ must grant a respondent's hearing request if the ALJ
determines there is a genuine dispute over facts material to the
findings of research misconduct or proposed administrative actions,
including any debarment or suspension action. The respondent's general
denial or assertion of error for each finding of research misconduct,
and any basis for the finding, or for the proposed HHS administrative
actions in the charge letter, is not sufficient to establish a genuine
dispute.
(b) The hearing request must specifically deny each finding of
research misconduct in the charge letter, each basis for the finding and
each HHS administrative action in the charge letter, or it is considered
an admission by the respondent. If the hearing request does not
specifically dispute the HHS administrative actions, including any
debarment or suspension actions, they are considered accepted by the
respondent.
(c) If the respondent does not request a hearing within the 30-day
time period prescribed in Sec. 93.501(a), the finding(s) and any
administrative action(s), other than debarment or suspension actions,
become final agency actions at the expiration of the 30-day period.
Where there is a proposal for debarment or suspension, after the
expiration of the 30-day time period the official record is closed and
forwarded to the debarring official for a final decision.
(d) If the ALJ grants the hearing request, the respondent may waive
the opportunity for any in-person proceeding, and the ALJ may review and
decide the case on the basis of the administrative record. The ALJ may
grant a respondent's request that waiver of the in-person proceeding be
conditioned upon the opportunity for respondent to file additional
pleadings and documentation. ORI may also supplement the administrative
record through pleadings, documents, in-person or telephonic testimony,
and oral presentations.
[[Page 604]]
Sec. 93.504 Grounds for dismissal of a hearing request.
(a) The ALJ must dismiss a hearing request if the respondent--
(1) Does not file the request within 30 days after receiving the
charge letter;
(2) Does not raise a genuine dispute over facts or law material to
the findings of research misconduct and any administrative actions,
including debarment and suspension actions, in the hearing request or in
any extension to supplement granted by the ALJ under Sec. 93.501(d);
(3) Does not raise any issue which may properly be addressed in a
hearing;
(4) Withdraws or abandons the hearing request; or
(b) The ALJ may dismiss a hearing request if the respondent fails to
provide ORI with notice in the form and manner required by Sec. 93.501.
Sec. 93.505 Rights of the parties.
(a) The parties to the hearing are the respondent and ORI. The
investigating institution is not a party to the case, unless it is a
respondent.
(b) Except as otherwise limited by this subpart, the parties may--
(1) Be accompanied, represented, and advised by an attorney;
(2) Participate in any case-related conference held by the ALJ;
(3) Conduct discovery of documents and other tangible items;
(4) Agree to stipulations of fact or law that must be made part of
the record;
(5) File motions in writing before the ALJ;
(6) Present evidence relevant to the issues at the hearing;
(7) Present and cross-examine witnesses;
(8) Present oral arguments;
(9) Submit written post-hearing briefs, proposed findings of fact
and conclusions of law, and reply briefs within reasonable time frames
agreed upon by the parties or established by the ALJ as provided in
Sec. 93.522; and
(10) Submit materials to the ALJ and other parties under seal, or in
redacted form, when necessary, to protect the confidentiality of any
information contained in them consistent with this part, the Privacy
Act, the Freedom of Information Act, or other Federal law or regulation.
Sec. 93.506 Authority of the Administrative Law Judge.
(a) The ALJ assigned to the case must conduct a fair and impartial
hearing, avoid unnecessary delay, maintain order, and assure that a
complete and accurate record of the proceeding is properly made. The ALJ
is bound by all Federal statutes and regulations, Secretarial
delegations of authority, and applicable HHS policies and may not refuse
to follow them or find them invalid, as provided in paragraph (c)(4) of
this section. The ALJ has the authorities set forth in this part.
(b) Subject to review as provided elsewhere in this subpart, the ALJ
may--
(1) Set and change the date, time, schedule, and place of the
hearing upon reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a
reasonable period of time;
(3) Hold conferences with the parties to identify or simplify the
issues, or to consider other matters that may aid in the prompt
disposition of the proceeding;
(4) Administer oaths and affirmations;
(5) Require the attendance of witnesses at a hearing;
(6) Rule on motions and other procedural matters;
(7) Require the production of documents and regulate the scope and
timing of documentary discovery as permitted by this part;
(8) Require each party before the hearing to provide the other party
and the ALJ with copies of any exhibits that the party intends to
introduce into evidence;
(9) Issue a ruling, after an in camera inspection if necessary, to
address the disclosure of any evidence or portion of evidence for which
confidentiality is requested under this part or other Federal law or
regulation, or which a party submitted under seal;
(10) Regulate the course of the hearing and the conduct of
representatives, parties, and witnesses;
[[Page 605]]
(11) Examine witnesses and receive evidence presented at the
hearing;
(12) Admit, exclude, or limit evidence offered by a party;
(13) Hear oral arguments on facts or law during or after the
hearing;
(14) Upon motion of a party, take judicial notice of facts;
(15) Upon motion of a party, decide cases, in whole or in part, by
summary judgment where there is no disputed issue of material fact;
(16) Conduct any conference or oral argument in person, by
telephone, or by audio-visual communication;
(17) Take action against any party for failing to follow an order or
procedure or for disruptive conduct.
(c) The ALJ does not have the authority to--
(1) Enter an order in the nature of a directed verdict;
(2) Compel settlement negotiations;
(3) Enjoin any act of the Secretary; or
(4) Find invalid or refuse to follow Federal statutes or
regulations, Secretarial delegations of authority, or HHS policies.
Sec. 93.507 Ex parte communications.
(a) No party, attorney, or other party representative may
communicate ex parte with the ALJ on any matter at issue in a case,
unless both parties have notice and an opportunity to participate in the
communication. However, a party, attorney, or other party representative
may communicate with DAB staff about administrative or procedural
matters.
(b) If an ex parte communication occurs, the ALJ will disclose it to
the other party and make it part of the record after the other party has
an opportunity to comment.
(c) The provisions of this section do not apply to communications
between an employee or contractor of the DAB and the ALJ.
Sec. 93.508 Filing, forms, and service.
(a) Filing. (1) Unless the ALJ provides otherwise, all submissions
required or authorized to be filed in the proceeding must be filed with
the ALJ.
(2) Submissions are considered filed when they are placed in the
mail, transmitted to a private delivery service for the purpose of
delivering the item to the ALJ, or submitted in another manner
authorized by the ALJ.
(b) Forms. (1) Unless the ALJ provides otherwise, all submissions
filed in the proceeding must include an original and two copies. The ALJ
may designate the format for copies of nondocumentary materials such as
videotapes, computer disks, or physical evidence. This provision does
not apply to the charge letter or other written notice provided under
Sec. 93.405.
(2) Every submission filed in the proceeding must include the title
of the case, the docket number, and a designation of the nature of the
submission, such as a ``Motion to Compel the Production of Documents''
or ``Respondent's Proposed Exhibits.''
(3) Every submission filed in the proceeding must be signed by and
contain the address and telephone number of the party on whose behalf
the document or paper was filed, or the attorney of record for the
party.
(c) Service. A party filing a submission with the ALJ must, at the
time of filing, serve a copy on the other party. Service may be made
either to the last known principal place of business of the party's
attorney if the party is represented by an attorney, or, if not, to the
party's last known address. Service may be made by--
(1) Certified mail;
(2) First-class postage prepaid U.S. Mail;
(3) A private delivery service;
(4) Hand-delivery; or
(5) Facsimile or other electronic means if permitted by the ALJ.
(d) Proof of service. Each party filing a document or paper with the
ALJ must also provide proof of service at the time of the filing. Any of
the following items may constitute proof of service:
(1) A certified mail receipt returned by the postal service with a
signature;
(2) An official record of the postal service or private delivery
service;
(3) A certificate of service stating the method, place, date of
service, and person served that is signed by an individual with personal
knowledge of these facts; or
(4) Other proof authorized by the ALJ.
[[Page 606]]
Sec. 93.509 Computation of time.
(a) In computing any period of time under this part for filing and
service or for responding to an order issued by the ALJ, the computation
begins with the day following the act or event, and includes the last
day of the period unless that day is a Saturday, Sunday, or legal
holiday observed by the Federal government, in which case it includes
the next business day.
(b) When the period of time allowed is less than 7 days,
intermediate Saturdays, Sundays, and legal holidays observed by the
Federal government must be excluded from the computation.
(c) Where a document has been filed by placing it in the mail, an
additional 5 days must be added to the time permitted for any response.
This paragraph does not apply to a respondent's request for hearing
under Sec. 93.501.
(d) Except for the respondent's request for a hearing, the ALJ may
modify the time for the filing of any document or paper required or
authorized under the rules in this part to be filed for good cause
shown. When time permits, notice of a party's request for extension of
the time and an opportunity to respond must be provided to the other
party.
Sec. 93.510 Filing motions.
(a) Parties must file all motions and requests for an order or
ruling with the ALJ, serve them on the other party, state the nature of
the relief requested, provide the legal authority relied upon, and state
the facts alleged.
(b) All motions must be in writing except for those made during a
prehearing conference or at the hearing.
(c) Within 10 days after being served with a motion, or other time
as set by the ALJ, a party may file a response to the motion. The moving
party may not file a reply to the responsive pleading unless allowed by
the ALJ.
(d) The ALJ may not grant a motion before the time for filing a
response has expired, except with the parties' consent or after a
hearing on the motion. However, the ALJ may overrule or deny any motion
without awaiting a response.
(e) The ALJ must make a reasonable effort to dispose of all motions
promptly, and, whenever possible, dispose of all outstanding motions
before the hearing.
Sec. 93.511 Prehearing conferences.
(a) The ALJ must schedule an initial prehearing conference with the
parties within 30 days of the DAB Chair's assignment of the case.
(b) The ALJ may use the initial prehearing conference to discuss--
(1) Identification and simplification of the issues, specification
of disputes of fact and their materiality to the ORI findings of
research misconduct and any HHS administrative actions, and amendments
to the pleadings, including any need for a more definite statement;
(2) Stipulations and admissions of fact including the contents,
relevancy, and authenticity of documents;
(3) Respondent's waiver of an administrative hearing, if any, and
submission of the case on the basis of the administrative record as
provided in Sec. 93.503(d);
(4) Identification of legal issues and any need for briefing before
the hearing;
(5) Identification of evidence, pleadings, and other materials, if
any, that the parties should exchange before the hearing;
(6) Identification of the parties' witnesses, the general nature of
their testimony, and the limitation on the number of witnesses and the
scope of their testimony;
(7) Scheduling dates such as the filing of briefs on legal issues
identified in the charge letter or the respondent's request for hearing,
the exchange of witness lists, witness statements, proposed exhibits,
requests for the production of documents, and objections to proposed
witnesses and documents;
(8) Scheduling the time, place, and anticipated length of the
hearing; and
(9) Other matters that may encourage the fair, just, and prompt
disposition of the proceedings.
(c) The ALJ may schedule additional prehearing conferences as
appropriate, upon reasonable notice to or request of the parties.
(d) All prehearing conferences will be audio-taped with copies
provided to the parties upon request.
[[Page 607]]
(e) Whenever possible, the ALJ must memorialize in writing any oral
rulings within 10 days after the prehearing conference.
(f) By 15 days before the scheduled hearing date, the ALJ must hold
a final prehearing conference to resolve to the maximum extent possible
all outstanding issues about evidence, witnesses, stipulations, motions
and all other matters that may encourage the fair, just, and prompt
disposition of the proceedings.
Sec. 93.512 Discovery.
(a) Request to provide documents. A party may only request another
party to produce documents or other tangible items for inspection and
copying that are relevant and material to the issues identified in the
charge letter and in the respondent's request for hearing.
(b) Meaning of documents. For purposes of this subpart, the term
documents includes information, reports, answers, records, accounts,
papers, tangible items, and other data and documentary evidence. This
subpart does not require the creation of any document. However,
requested data stored in an electronic data storage system must be
produced in a form reasonably accessible to the requesting party.
(c) Nondisclosable items. This section does not authorize the
disclosure of--
(1) Interview reports or statements obtained by any party, or on
behalf of any party, of persons whom the party will not call as witness
in its case-in-chief;
(2) Analyses and summaries prepared in conjunction with the inquiry,
investigation, ORI oversight review, or litigation of the case; or
(3) Any privileged documents, including but not limited to those
protected by the attorney-client privilege, attorney-work product
doctrine, or Federal law or regulation.
(d) Responses to a discovery request. Within 30 days of receiving a
request for the production of documents, a party must either fully
respond to the request, submit a written objection to the discovery
request, or seek a protective order from the ALJ. If a party objects to
a request for the production of documents, the party must identify each
document or item subject to the scope of the request and state the basis
of the objection for each document, or any part that the party does not
produce.
(1) Within 30 days of receiving any objections, the party seeking
production may file a motion to compel the production of the requested
documents.
(2) The ALJ may order a party to produce the requested documents for
in camera inspection to evaluate the merits of a motion to compel or for
a protective order.
(3) The ALJ must compel the production of a requested document and
deny a motion for a protective order, unless the requested document is--
(i) Not relevant or material to the issues identified in the charge
letter or the respondent's request for hearing;
(ii) Unduly costly or burdensome to produce;
(iii) Likely to unduly delay the proceeding or substantially
prejudice a party;
(iv) Privileged, including but not limited to documents protected by
the attorney-client privilege, attorney-work product doctrine, or
Federal law or regulation; or
(v) Collateral to issues to be decided at the hearing.
(4) If any part of a document is protected from disclosure under
paragraph (d)(3) of this section, the ALJ must redact the protected
portion of a document before giving it to the requesting party.
(5) The party seeking discovery has the burden of showing that the
ALJ should allow it.
(e) Refusal to produce items. If a party refuses to provide
requested documents when ordered by the ALJ, the ALJ may take corrective
action, including but not limited to, ordering the noncompliant party to
submit written answers under oath to written interrogatories posed by
the other party or taking any of the actions at Sec. 93.515.
Sec. 93.513 Submission of witness lists, witness statements, and exhibits.
(a) By 60 days before the scheduled hearing date, each party must
give the ALJ a list of witnesses to be offered during the hearing and a
statement describing the substance of their proposed testimony, copies
of any prior
[[Page 608]]
written statements or transcribed testimony of proposed witnesses, a
written report of each expert witness to be called to testify that meets
the requirements of Federal Rule of Civil Procedure 26(a)(2)(B), and
copies of proposed hearing exhibits, including copies of any written
statements that a party intends to offer instead of live direct
testimony. If there are no prior written statements or transcribed
testimony of a proffered witness, the party must submit a detailed
factual affidavit of the proposed testimony.
(b) A party may supplement its submission under paragraph (a) of
this section until 30 days before the scheduled hearing date if the ALJ
determines:
(1) There are extraordinary circumstances; and
(2) There is no substantial prejudice to the objecting party.
(c) The parties must have an opportunity to object to the admission
of evidence submitted under paragraph (a) of this section under a
schedule set by the ALJ. However, the parties must file all objections
before the final prehearing conference.
(d) If a party tries to introduce evidence after the deadlines in
paragraph (a) of this section, the ALJ must exclude the offered evidence
from the party's case-in-chief unless the conditions of paragraph (b) of
this section are met. If the ALJ admits evidence under paragraph (b) of
this section, the objecting party may file a motion to postpone all or
part of the hearing to allow sufficient time to prepare and respond to
the evidence. The ALJ may not unreasonably deny that motion.
(e) If a party fails to object within the time set by the ALJ and
before the final prehearing conference, evidence exchanged under
paragraph (a) of this section is considered authentic, relevant and
material for the purpose of admissibility at the hearing.
Sec. 93.514 Amendment to the charge letter.
(a) The ORI may amend the findings of research misconduct up to 30
days before the scheduled hearing.
(b) The ALJ may not unreasonably deny a respondent's motion to
postpone all or part of the hearing to allow sufficient time to prepare
and respond to the amended findings.
Sec. 93.515 Actions for violating an order or for disruptive conduct.
(a) The ALJ may take action against any party in the proceeding for
violating an order or procedure or for other conduct that interferes
with the prompt, orderly, or fair conduct of the hearing. Any action
imposed upon a party must reasonably relate to the severity and nature
of the violation or disruptive conduct.
(b) The actions may include--
(1) Prohibiting a party from introducing certain evidence or
otherwise supporting a particular claim or defense;
(2) Striking pleadings, in whole or in part;
(3) Staying the proceedings;
(4) Entering a decision by default;
(5) Refusing to consider any motion or other action not timely
filed; or
(6) Drawing the inference that spoliated evidence was unfavorable to
the party responsible for its spoliation.
Sec. 93.516 Standard and burden of proof.
(a) Standard of proof. The standard of proof is the preponderance of
the evidence.
(b) Burden of proof. (1) ORI bears the burden of proving the
findings of research misconduct. The destruction, absence of, or
respondent's failure to provide research records adequately documenting
the questioned research is evidence of research misconduct where ORI
establishes by a preponderance of the evidence that the respondent
intentionally, knowingly, or recklessly had research records and
destroyed them, had the opportunity to maintain the records but did not
do so, or maintained the records and failed to produce them in a timely
manner and the respondent's conduct constitutes a significant departure
from accepted practices of the relevant research community.
(2) The respondent has the burden of going forward with and the
burden of proving, by a preponderance of the evidence, any and all
affirmative defenses raised. In determining whether ORI has carried the
burden of proof imposed by
[[Page 609]]
this part, the ALJ shall give due consideration to admissible, credible
evidence of honest error or difference of opinion presented by the
respondent.
(3) ORI bears the burden of proving that the proposed HHS
administrative actions are reasonable under the circumstances of the
case. The respondent has the burden of going forward with and proving by
a preponderance of the evidence any mitigating factors that are relevant
to a decision to impose HHS administrative actions following a research
misconduct proceeding.
Sec. 93.517 The hearing.
(a) The ALJ will conduct an in-person hearing to decide if the
respondent committed research misconduct and if the HHS administrative
actions, including any debarment or suspension actions, are appropriate.
(b) The ALJ provides an independent de novo review of the ORI
findings of research misconduct and the proposed HHS administrative
actions. The ALJ does not review the institution's procedures or
misconduct findings or ORI's research misconduct proceedings.
(c) A hearing under this subpart is not limited to specific findings
and evidence set forth in the charge letter or the respondent's request
for hearing. Additional evidence and information may be offered by
either party during its case-in-chief unless the offered evidence is--
(1) Privileged, including but not limited to those protected by the
attorney-client privilege, attorney-work product doctrine, or Federal
law or regulation.
(2) Otherwise inadmissible under Sec. Sec. 93.515 or 93.519.
(3) Not offered within the times or terms of Sec. Sec. 93.512 and
93.513.
(d) ORI proceeds first in its presentation of evidence at the
hearing.
(e) After both parties have presented their cases-in-chief, the
parties may offer rebuttal evidence even if not exchanged earlier under
Sec. Sec. 93.512 and 93.513.
(f) Except as provided in Sec. 93.518(c), the parties may appear at
the hearing in person or by an attorney of record in the proceeding.
(g) The hearing must be open to the public, unless the ALJ orders
otherwise for good cause shown. However, even if the hearing is closed
to the public, the ALJ may not exclude a party or party representative,
persons whose presence a party shows to be essential to the presentation
of its case, or expert witnesses.
Sec. 93.518 Witnesses.
(a) Except as provided in paragraph (b) of this section, witnesses
must give testimony at the hearing under oath or affirmation.
(b) The ALJ may admit written testimony if the witness is available
for cross-examination, including prior sworn testimony of witnesses that
has been subject to cross-examination. These written statements must be
provided to all other parties under Sec. 93.513.
(c) The parties may conduct direct witness examination and cross-
examination in person, by telephone, or by audio-visual communication as
permitted by the ALJ. However, a respondent must always appear in-person
to present testimony and for cross-examination.
(d) The ALJ may exercise reasonable control over the mode and order
of questioning witnesses and presenting evidence to--
(1) Make the witness questioning and presentation relevant to
deciding the truth of the matter; and
(2) Avoid undue repetition or needless consumption of time.
(e) The ALJ must permit the parties to conduct cross-examination of
witnesses.
(f) Upon request of a party, the ALJ may exclude a witness from the
hearing before the witness' own testimony. However, the ALJ may not
exclude--
(1) A party or party representative;
(2) Persons whose presence is shown by a party to be essential to
the presentation of its case; or
(3) Expert witnesses.
Sec. 93.519 Admissibility of evidence.
(a) The ALJ decides the admissibility of evidence offered at the
hearing.
(b) Except as provided in this part, the ALJ is not bound by the
Federal Rules of Evidence (FRE). However, the ALJ may apply the FRE
where appropriate (e.g., to exclude unreliable evidence).
[[Page 610]]
(c) The ALJ must admit evidence unless it is clearly irrelevant,
immaterial, or unduly repetitious. However, the ALJ may exclude relevant
and material evidence if its probative value is substantially outweighed
by the danger of unfair prejudice, confusion of the issues, or by
considerations of undue delay or needless presentation of cumulative
evidence under FRE 401-403.
(d) The ALJ must exclude relevant and material evidence if it is
privileged, including but not limited to evidence protected by the
attorney-client privilege, the attorney-work product doctrine, or
Federal law or regulation.
(e) The ALJ may take judicial notice of matters upon the ALJ's own
initiative or upon motion by a party as permitted under FRE 201
(Judicial Notice of Adjudicative Facts).
(1) The ALJ may take judicial notice of any other matter of
technical, scientific, or commercial fact of established character.
(2) The ALJ must give the parties adequate notice of matters subject
to judicial notice and adequate opportunity to show that the ALJ
erroneously noticed the matters.
(f) Evidence of crimes, wrongs, or acts other than those at issue in
the hearing is admissible only as permitted under FRE 404(b) (Character
Evidence not Admissible to Prove Conduct; Exceptions, Other Crimes).
(g) Methods of proving character are admissible only as permitted
under FRE 405 (Methods of Proving Character).
(h) Evidence related to the character and conduct of witnesses is
admissible only as permitted under FRE Rule 608 (Evidence of Character
and Conduct of Witness).
(i) Evidence about offers of compromise or settlement made in this
action is inadmissible as provided in FRE 408 (Compromise and Offers to
Compromise).
(j) The ALJ must admit relevant and material hearsay evidence,
unless an objecting party shows that the offered hearsay evidence is not
reliable.
(k) The parties may introduce witnesses and evidence on rebuttal.
(l) All documents and other evidence offered or admitted into the
record must be open to examination by both parties, unless otherwise
ordered by the ALJ for good cause shown.
(m) Whenever the ALJ excludes evidence, the party offering the
evidence may make an offer of proof, and the ALJ must include the offer
in the transcript or recording of the hearing in full. The offer of
proof should consist of a brief oral statement describing the evidence
excluded. If the offered evidence consists of an exhibit, the ALJ must
mark it for identification and place it in the hearing record. However,
the ALJ may rely upon the offered evidence in reaching the decision on
the case only if the ALJ admits it.
Sec. 93.520 The record.
(a) HHS will record and transcribe the hearing, and if requested,
provide a transcript to the parties at HHS' expense.
(b) The exhibits, transcripts of testimony, any other evidence
admitted at the hearing, and all papers and requests filed in the
proceeding constitute the record for the decision by the ALJ.
(c) For good cause shown, the ALJ may order appropriate redactions
made to the record at any time.
(d) The DAB may return original research records and other similar
items to the parties or awardee institution upon request after final HHS
action, unless under judicial review.
Sec. 93.521 Correction of the transcript.
(a) At any time, but not later than the time set for the parties to
file their post-hearing briefs, any party may file a motion proposing
material corrections to the transcript or recording.
(b) At any time before the filing of the ALJ's decision and after
consideration of any corrections proposed by the parties, the ALJ may
issue an order making any requested corrections in the transcript or
recording.
Sec. 93.522 Filing post-hearing briefs.
(a) After the hearing and under a schedule set by the ALJ , the
parties may file post-hearing briefs, and the ALJ may allow the parties
to file reply briefs.
(b) The parties may include proposed findings of fact and
conclusions of law in their post-hearing briefs.
[[Page 611]]
Sec. 93.523 The Administrative Law Judge's ruling.
(a) The ALJ shall issue a ruling in writing setting forth proposed
findings of fact and any conclusions of law within 60 days after the
last submission by the parties in the case. If unable to meet the 60-day
deadline, the ALJ must set a new deadline and promptly notify the
parties, the Assistant Secretary for Health and the debarring official,
if debarment or suspension is under review. The ALJ shall serve a copy
of the ruling upon the parties and the Assistant Secretary for Health.
(b) The ruling of the ALJ constitutes a recommended decision to the
Assistant Secretary for Health. The Assistant Secretary for Health may
review the ALJ's recommended decision and modify or reject it in whole
or in part after determining it, or the part modified or rejected, to be
arbitrary and capricious or clearly erroneous. The Assistant Secretary
for Health shall notify the parties of an intention to review the ALJ's
recommended decision within 30 days after service of the recommended
decision. If that notification is not provided within the 30-day period,
the ALJ's recommended decision shall become final. An ALJ decision that
becomes final in that manner or a decision by the Assistant Secretary
for Health modifying or rejecting the ALJ's recommended decision in
whole or in part is the final HHS action, unless debarment or suspension
is an administrative action recommended in the decision.
(c) If a decision under Sec. 93.523(b) results in a recommendation
for debarment or suspension, the Assistant Secretary for Health shall
serve a copy of the decision upon the debarring official and the
decision shall constitute findings of fact to the debarring official in
accordance with 45 CFR 76.845(c). The decision of the debarring official
on debarment or suspension is the final HHS decision on those
administrative actions.