2024-20814. Public Health Service Policies on Research Misconduct

Table 1—Costs of the Final Rule

[Constant 2023 dollars, 2% discount rate]

Year	Cost
2025	$11,331,191
2026	24,481,283
2027	24,481,283
2028	24,481,283
2029	24,481,283
Present Value	102,499,288
Annualized	21,746,084

Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to prepare a regulatory flexibility analysis describing the impact of the final rule on small entities (“institutions” for purposes of the final rule) unless they certify that a final rule will not, if promulgated, have a significant economic impact on a substantial number of small institutions. HHS generally considers a rule to have a significant impact on a substantial number of small institutions if it has at least a 3% impact on revenue on at least 5% of small institutions. We considered whether the final rule would result in effects that exceed these thresholds. This analysis below concludes, and the Secretary certifies that this final rule will not have a significant impact on a substantial number of small institutions, as defined by the Regulatory Flexibility Act, based on the following facts.

As of March 1, 2024, approximately 22 percent (1,412) of 6,394 institutions holding research integrity assurances are small institutions. The primary impact of the final rule on covered institutions results from the reporting and record keeping provisions, which are analyzed in detail under the heading “The Paperwork Reduction Act.” Potentially significant annual burdens apply only if an institution learns of possible research misconduct and begins an inquiry, investigation, or both.

Institutions covered by 42 CFR part 93 reported having conducted a total of 124 inquiries and 121 investigations during the 2023 reporting period. In total, one inquiry and three investigations were conducted by small institutions. Small institutions may be able to avoid developing and filing the full policies and procedures for addressing allegations of research misconduct required by § 93.304 by filing a Small Institution Statement. Under the 2005 regulation, this is called a Small Organization Statement. ORI or another appropriate HHS office will work with small institutions to develop and/or advise on a process for handling allegations of research misconduct consistent with 42 CFR part 93. The burden of filing the Small Institution Statement is 0.5 hour. Thus, the burden of developing and filing the full policies and procedures for addressing allegations of research misconduct required by § 93.304 will not fall on a substantial number of small entities.

A small entity that files the Small Institution Statement must still report allegations of research misconduct to ORI and comply with all provisions of the final rule except as described in § 93.303. The most significant burden that could fall on an entity filing a Small Institution Statement is in addressing allegations of research misconduct, which would include obtaining all research records and other evidence when there is an allegation of research misconduct, engaging persons to handle the process for addressing the allegations of research misconduct, and submitting reports and evidence to support the small institution's results and conclusions of inquiries or investigations of research misconduct. The average burden per response is estimated at 40 hours. Based on reports of research misconduct over the past five years, fewer than five small institutions will have to incur that burden in any year. Based on this analysis, HHS concludes that the regulations set forth in the final rule will not impose a significant burden on a substantial number of small institutions.

Paperwork Reduction Act

Sections 104, 301-303, 305-313, and 315-318 of this final rule contain information collection requirements that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521). These provisions involve the following institutional activities in addressing allegations of misconduct involving PHS-funded research:

Title: The title of the section of the Public Health Service Policies on Research Misconduct involving institutional activities.

Description: The relevant passage(s) of the section describing the institutional information collection requirements.

Description of Respondents: The “respondents” for the collection of information described in this regulation are institutions that apply for or receive PHS support through grants, contracts, or cooperative agreements for any project or program that involves the conduct of biomedical or behavioral research, biomedical or behavioral research training, or activities related to ( print page 76292) that research or training (see definition of “Institution” at § 93.216).

Subpart A—General

Section 93.104

(ii) For research misconduct that appears subject to the subsequent use exception, institutions must document their determination that the subsequent use exception does not apply. Such documentation must be retained in accordance with § 93.318.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —40 hours.

Total Annual Burden —9,200 hours.

Subpart C—Responsibilities of Institutions

Compliance and Assurances

Section 93.305

(b) Access to research records. Where appropriate, an institution must give the respondent copies of, or reasonable supervised access to, the research records that are sequestered in accordance with paragraph (a) of this section.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —25 hours.

Total Annual Burden —5,750 hours.

(c) Maintenance of sequestered research records and other evidence. An institution must maintain the sequestered research records and other evidence as required by § 93.318.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —80 hours.

Total Annual Burden —18,400 hours.

(g) Notifying ORI of special circumstances. At any time during a research misconduct proceeding, as defined in § 93.235, an institution must notify ORI immediately if it has reason to believe that any of the following conditions exist:

(1) Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.

(2) HHS resources or interests are threatened.

(3) Research activities should be suspended.

(4) There is reasonable indication of possible violations of civil or criminal law.

(5) Federal action is required to protect the interests of those involved in the research misconduct proceeding.

(6) HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —1 hour.

Total Annual Burden —230 hours.

The Institutional Assessment

Section 93.306

(c) Assessment results.

(2) If the RIO or another designated institutional official determines that requirements for an inquiry are met, they must: (i) document the assessment;

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —80 hours.

Total Annual Burden —18,400 hours.

(ii) promptly sequester all research records and other evidence, consistent with § 93.305(a), and promptly initiate the inquiry.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —160 hours.

Total Annual Burden —36,800 hours.

(3) If the RIO or another designated institutional official determines that requirements for an inquiry are not met, they must keep sufficiently detailed documentation of the assessment to permit a later review by ORI of the reasons why the institution did not conduct an inquiry. Such documentation must be retained in accordance with § 93.318.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —10 hours.

Total Annual Burden —2,300 hours.

The Institutional Inquiry

Section 93.307

(d) Sequestration of records. An institution must obtain all research records and other evidence needed to conduct the research misconduct proceeding, consistent with § 93.305(a).

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —80 hours.

Total Annual Burden —18,400 hours.

Section 93.308

(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 research integrity assurance.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —2 hours.

Total Annual Burden —460 hours.

Section 93.309

(a) Within 30 days of determining that an investigation is warranted, the institution must provide ORI with a copy of the inquiry report, which includes the following information:

(1) The names, professional aliases, and positions of the respondent and complainant;

(2) A description of the allegation(s) of research misconduct;

(3) The PHS support, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support;

(4) The composition of the inquiry committee, if used, including name(s), position(s), and subject matter expertise;

(5) Inventory of sequestered research records and other evidence and description of how sequestration was conducted;

(6) Transcripts of any transcribed interviews;

(7) Timeline and procedural history;

(8) Any scientific or forensic analyses conducted;

(9) The basis for recommending that the allegation(s) warrant an investigation;

(10) The basis on which any allegation(s) do not merit an investigation;

(11) Any comments on the inquiry report by the respondent or the complainant; and

(12) Any institutional actions implemented, including communications with journals or funding agencies.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —4 hours.

Total Annual Burden —920 hours.

(b) Institutions must keep detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the institution decided not to investigate. Such documentation must be retained in accordance with § 93.318.

Number of Respondents —230.

Number of Responses per Respondent —1. ( print page 76293)

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.316(a)(2).

Total Annual Burden —0 hours.

(c) In accordance with § 93.305(g), institutions must notify ORI of any special circumstances that may exist.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —2 hours.

Total Annual Burden —460 hours.

The Institutional Investigation

Section 93.310

Institutions conducting research misconduct investigations must: (b) Notify ORI 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 § 93.307 and § 93.309.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.309(a).

Total Annual Burden —0 hours.

(d) Notice to the respondent. Notify the respondent in writing of the allegation(s) within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.308(a).

Total Annual Burden —0 hours.

(g) Interviews. During the investigation, an institution must 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. (1) Interviews during the investigation must be recorded and transcribed.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —300 hours.

Total Annual Burden —69,000 hours.

(3) The transcript of the interview must be made available to the relevant interviewee for correction.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —4 hours.

Total Annual Burden —920 hours.

(5) The respondent must be provided a transcript of the interview.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —4 hours.

Total Annual Burden —920 hours.

(j) Pursue leads. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —2 hours.

Total Annual Burden —460 hours.

Section 93.310

(b) Extension of time limit. If unable to complete the investigation in 180 days, the institution must ask ORI for an extension in writing that includes the circumstances or issues warranting additional time.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —1 hour.

Total Annual Burden —230 hours.

(c) Progress reports. If ORI grants an extension, it may direct the institution to file periodic progress reports.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —1 hour.

Total Annual Burden —230 hours.

Section 93.312

(a) The institution must give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the research records and other evidence that the investigation committee considered or relied on. The respondent must submit any comments on the draft report to the institution within 30 days of receiving the draft investigation report.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —2 hours.

Total Annual Burden —460 hours.

Section 93.313

A final investigation report for each respondent must be in writing and include:

(a) Description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.

(b) Description and documentation of the PHS support, including, for example, any grant numbers, grant applications, contracts, and publications listing PHS support.

(c) Description of the specific allegation(s) of research misconduct for consideration in the investigation of the respondent.

(d) Composition of investigation committee, including name(s), position(s), and subject matter expertise.

(e) Inventory of sequestered research records and other evidence, except records the institution did not consider or rely on; and a description of how any sequestration was conducted during the investigation. This inventory must include manuscripts and funding proposals that were considered or relied on during the investigation.

(f) Transcripts of all interviews conducted, as described in § 93.310(g).

(g) Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other research records that allegedly contained the falsified, fabricated, or plagiarized material.

(h) Any scientific or forensic analyses conducted.

(i) If not already provided to ORI, the institutional policies and procedures under which the investigation was conducted.

(j) Any comments made by the respondent and complainant on the draft investigation report and the investigation committee's consideration of those comments.

(k) A statement for each separate allegation of whether the investigation committee recommends a finding of research misconduct.

(1) If the investigation committee recommends a finding of research misconduct for an allegation, the investigation report must, for that allegation:

(i) Identify the individual(s) who committed the research misconduct.

(ii) Indicate whether the research misconduct was falsification, fabrication, and/or plagiarism.

(iii) Indicate whether the research misconduct was committed intentionally, knowingly, or recklessly.

(iv) State whether the other requirements for a finding of research misconduct, as described in § 93.103, have been met.

(v) Summarize the facts and the analysis which support the conclusion ( print page 76294) and consider the merits of any explanation by the respondent.

(vi) Identify the specific PHS support.

(vii) Identify whether any publications need correction or retraction.

(2) If the investigation committee does not recommend a finding of research misconduct for an allegation, the investigation report must provide a detailed rationale.

(l) List of any current support or known applications or proposals for support that the respondent has pending with PHS and non-PHS Federal agencies.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —160 hours.

Total Annual Burden —36,800 hours.

Section 93.315

(a) If a respondent appeals an institution's finding(s) of research misconduct or institutional actions, the institution must promptly notify ORI.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —1 hour.

Total Annual Burden —230 hours.

(b) If the institution has not transmitted its institutional record to ORI in accordance with § 93.316 prior to the appeal, the institution must wait until the appeal is concluded to transmit its institutional record. The institution must ensure that the complete record of the appeal is included in the institutional record consistent with § 93.220(a)(5).

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —0 hours. Burden accounted for in § 93.316(a).

Total Annual Burden —0 hours.

(c) If the institution has transmitted its institutional record to ORI in accordance with § 93.316 prior to the appeal, the institution must provide ORI a complete record of the appeal once the appeal is concluded.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —2 hours.

Total Annual Burden —460 hours.

Section 93.316

After the Institutional Deciding Official has made a final determination of research misconduct findings in accordance with § 93.314, the institution must transmit the institutional record to ORI. The institutional record must be consistent with § 93.220 and logically organized.

Per § 93.220: The institutional record comprises:

(a) The records that the institution compiled or generated during the research misconduct proceeding, except records the institution did not consider or rely on. These records include, but are not limited to:

(1) Documentation of the assessment as required by § 93.306(c).

(2) If an inquiry is conducted, the inquiry report and all records (other than drafts of the report) considered or relied on during the inquiry, including, but not limited to, research records and the transcripts of any transcribed interviews conducted during the inquiry, information the respondent provided to the institution, and the documentation of any decision not to investigate as required by § 93.309(c).

(3) If an investigation is conducted, the investigation report and all records (other than drafts of the report) considered or relied on during the investigation, including, but not limited to, research records, the transcripts of each interview conducted pursuant to § 93.310(g), and information the respondent provided to the institution.

(4) Decision(s) by the Institutional Deciding Official, such as the written decision from the Institutional Deciding Official under § 93.314.

(5) The complete record of any institutional appeal consistent with § 93.315.

(b) A single index listing all the research records and evidence that the institution compiled during the research misconduct proceeding, except records the institution did not consider or rely on.

(c) A general description of the records that were sequestered but not considered or relied on.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —4 hours.

Total Annual Burden —920 hours.

Section 93.317

(a) Institutions must notify ORI in advance if the institution plans to close a research misconduct proceeding at the assessment, inquiry, investigation, or appeal stage on the basis that the respondent has admitted to committing research misconduct or a settlement with the respondent has been reached.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —1 hour.

Total Annual Burden —230 hours.

(b) The [respondent's written] admission statement must meet all elements required for a research misconduct finding under § 93.103 and must be provided to ORI before the institution closes its research misconduct proceeding.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —10 hours.

Total Annual Burden —2,300 hours.

(b—continued): The institution must also provide a statement to ORI describing how it determined that the scope of the misconduct was fully addressed by the admission and confirmed the respondent's culpability.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —10 hours.

Total Annual Burden —2,300 hours.

Section 93.318

(a) Maintenance of institutional record and all sequestered evidence. An institution must maintain the institutional record and all sequestered evidence including physical objects (regardless of whether the evidence is part of the institutional record) in a secure manner for seven years after completion of the proceeding or the completion of any HHS proceeding involving the research misconduct allegation under subparts D and E of this part, whichever is later, unless custody has been transferred to HHS under paragraph (b) of this section or ORI advises otherwise in writing.

Number of Respondents —230.

Number of Responses per Respondent —1.

Annual Average Burden per Response —8 hours.

Total Annual Burden —1,840 hours. ( print page 76295)

Estimated Annualized Burden Hour Table (9/3/2024)

Forms (If necessary)	Type of respondent	Number of respondents	Number of responses per respondent	Average burden hours per response	Total burden Hours
§ 93.104	Institutions	230	1	40	9,200
§ 93.305.b	Institutions	230	1	25	5,750
§ 93.305.c	Institutions	230	1	80	18,400
§ 93.325	Institutions	230	1	1	230
§ 93.306.c.2.i	Institutions	230	1	80	18,400
§ 93.306.c.2.ii	Institutions	230	1	160	36,800
§ 93.306.c.2.iii	Institutions	230	1	10	2,300
§ 93.307	Institutions	230	1	80	18,400
§ 93.308	Institutions	230	1	2	460
Sec 93.309.a	Institutions	230	1	4	920
Sec 93.309.c	Institutions	230	1	2	460
§ 93.310.g.1	Institutions	230	1	300	69,000
§ 93.310.g.3	Institutions	230	1	4	920
§ 93.310.g.5	Institutions	230	1	4	920
§ 93.310.j	Institutions	230	1	2	460
§ 93.310.b	Institutions	230	1	1	230
§ 93.310.c	Institutions	230	1	1	230
§ 93.312	Institutions	230	1	2	460
§ 93.313	Institutions	230	1	160	36,800
§ 93.315.a	Institutions	230	1	1	230
§ 93.315.c	Institutions	230	1	2	460
Total					221,030

Estimated annualized cost to respondents (9/3/2024) Forms (If necessary)	Type of respondent	Total burden hours	Hourly wage rate	Total respondent cost
§ 93.104	Institutions	9,200	$111	$1,018,992
§ 93.305.b	Institutions	5,750	111	636,870
§ 93.305.c	Institutions	18,400	111	2,037,984
§ 93.325	Institutions	230	111	25,475
§ 93.306.c.2.i	Institutions	18,400	111	2,037,984
§ 93.306.c.2.ii	Institutions	36,800	111	4,075,968
§ 93.306.c.2.iii	Institutions	2,300	111	254,748
§ 93.307	Institutions	18,400	111	2,037,984
§ 93.308	Institutions	460	111	50,950
Sec 93.309.a	Institutions	920	111	101,899
Sec 93.309.c	Institutions	460	111	50,950
§ 93.310.g.1	Institutions	69,000	111	7,642,440
§ 93.310.g.3	Institutions	920	111	101,899
§ 93.310.g.5	Institutions	920	111	101,899
§ 93.310.j	Institutions	460	111	50,950
§ 93.310.b	Institutions	230	111	25,475
§ 93.310.c	Institutions	230	111	25,475
§ 93.312	Institutions	460	111	50,950
§ 93.313	Institutions	36,800	111	4,075,968
§ 93.315.a	Institutions	230	111	25,475
§ 93.315.c	Institutions	460	111	50,950
Total				24,481,283

Following publication of the final rule, ORI will publish 60-day and 30-day notices in the Federal Register seeking public comment on these information collection requirements and associated burden estimates, and ORI will submit an Information Collection Request (ICR) to OMB seeking approval for these requirements under existing OMB Control Number 0937-0198, which currently covers the assurance and annual reporting requirements of 42 CFR part 93 (the Institutional Assurance and Annual Report on Possible Research Misconduct, PHS-6349, and the Assurance of Compliance by Sub-Award Recipients, PHS-6315). Before the applicability date of this final rule, ORI anticipates publishing a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove this ICR. This final rule does not make any substantive revisions to the Assurance or Annual Report that would require clearance under the PRA, but ORI anticipates making minor updates to these forms as part of the upcoming revision to 0937-0198.

An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

List of Subjects in 42 CFR Part 93

• Government contracts
• Grant programs
• Reporting and recordkeeping requirements
• Research
• Science and technology

For reasons discussed in the preamble, HHS is revising 42 CFR part 93 to read as follows:

( print page 76296)

PART 93—PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

93.25

Organization of this part.

93.50

Special terms.

93.75

Application of effective date to research misconduct proceedings.

Subpart A—General

93.100

General policy.

93.101

Purpose.

93.102

Applicability.

93.103

Requirements for findings of research misconduct.

93.104

Time limitations.

93.105

Evidentiary standards.

93.106

Confidentiality.

93.107

Coordination with other agencies.

Subpart B—Definitions

93.200

Accepted practices of the relevant research community.

93.201

Administrative action.

93.202

Administrative record.

93.203

Allegation.

93.204

Assessment.

93.205

Charge letter.

93.206

Complainant.

93.207

Contract.

93.208

Day.

93.209

Departmental Appeals Board or DAB.

93.210

Evidence.

93.211

Fabrication.

93.212

Falsification.

93.213

Funding Component.

93.214

Good Faith.

93.215

Inquiry.

93.216

Institution.

93.217

Institutional Certifying Official.

93.218

Institutional Deciding Official.

93.219

Institutional member.

93.220

Institutional record.

93.221

Intentionally.

93.222

Investigation.

93.223

Knowingly.

93.224

Notice.

93.225

Office of Research Integrity or ORI.

93.226

Person.

93.227

Plagiarism.

93.228

Preponderance of the evidence.

93.229

Public Health Service or PHS.

93.230

PHS support.

93.231

Recklessly.

93.232

Research.

93.233

Research Integrity Officer or RIO.

93.234

Research misconduct.

93.235

Research misconduct proceeding.

93.236

Research record.

93.237

Respondent.

93.238

Retaliation.

93.239

Secretary or HHS.

93.240

Small institution.

93.241

Suspension and Debarment Official or SDO.

Subpart C—Responsibilities of Institutions Compliance and Assurances

93.300

General responsibilities for compliance.

93.301

Research integrity assurances.

93.302

Maintaining active research integrity assurances.

93.303

Research integrity assurances for small institutions.

93.304

Institutional policies and procedures.

93.305

General conduct of research misconduct proceedings.

The Institutional Assessment

93.306

Institutional assessment.

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 draft investigation report.

93.313

Investigation report.

93.314

Decision by the Institutional Deciding Official.

93.315

Institutional appeals.

93.316

Transmittal of the institutional record to ORI.

93.317

Completing the research misconduct process.

Other Institutional Responsibilities

93.318

Retention and custody of the institutional record and all sequestered evidence.

93.319

Institutional standards of conduct.

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 entities 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 HHS administrative actions.

93.405

Notifying the respondent of findings of research misconduct and proposed 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

ORI compliance actions.

Disclosure of Information

93.414

Notice.

Subpart E—Opportunity to Contest ORI Findings of Research Misconduct and Proposed HHS Administrative Actions General Information

93.500

General policy.

Process for Contesting Research Misconduct Findings and/or Proposed HHS Administrative Actions

93.501

Notice of appeal.

93.502

Appointment of the Administrative Law Judge.

93.503

Filing of the administrative record.

93.504

Standard of review.

93.505

Rights of the parties.

93.506

Authority of the Administrative Law Judge.

93.507

Ex parte communications.

93.508

Filing, format, and service.

93.509

Filing motions.

93.510

Conferences.

93.511

The Administrative Law Judge's ruling.

Authority: 42 U.S.C. 216 and 289b

§ 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.

Table 1 to § 93.25

In subpart . . .	You will find sections related to . . .
A	General information about this part.
B	Definitions 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.
E	Information on how to contest ORI research misconduct findings and proposed HHS administrative actions.