[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

[[Page 580]]

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

[[Page 582]]

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;

[[Page 583]]

    (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.

[[Page 584]]

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

[[Page 586]]

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

[[Page 587]]

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.