70830 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

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immediate final rule published in the

‘‘Rules and Regulations’’ section of this

Federal Register.

Dated: October 20, 2000.

A. Stanley Meiburg,

Regional Administrator, Region 4.

[FR Doc. 00–30007 Filed 11–27–00; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

42 CFR Part 94

RIN 0905–AE71

Public Health Service Standards for

the Protection of Research Misconduct

Whistleblowers

AGENCY: Department of Health and

Human Services (HHS).

ACTION: Notice of proposed rulemaking.

SUMMARY: The Department proposes to

add a new Subchapter I, Part 94, to Title

42 of the Code of Federal Regulations to

implement section 493(e) of the Public

Health Service Act. Under this proposed

regulation, covered institutions must

follow certain requirements for

preventing or otherwise responding to

occurrences of retaliation against

whistleblowers. The purpose of this part

is to protect persons who make a good

faith allegation that a covered

institution or one of its members

engaged in or failed to respond

adequately to an allegation of research

misconduct and persons who cooperate

in good faith with an investigation of

research misconduct.

DATES: Submit comments on or before

January 29, 2001.

ADDRESSES: Address all comments

concerning this proposed rule to Chris

B. Pascal, J.D., Acting Director, Office of

Research Integrity, 5515 Security Lane,

Suite 700, Rockville, MD, 20852.

You may submit comments and data

by sending electronic mail (E-mail) to

whistlereg@osophs.dhhs.gov.

Submit comments as either a

WordPerfect file, version 5.1 or higher,

or a Microsoft Word 97 or 2000 file

format. Comments can also be submitted

as an ASCII file avoiding the use of

special characters and any form of

encryption.

FOR FURTHER INFORMATION, CONTACT:

Legal Information: Gail L. Gibbons,

301–443–3466 (This is not a toll-free

number).

Technical Information: Barbara

Bullman, 301–443–5300 (This is not a

toll-free number).

SUPPLEMENTARY INFORMATION: Section

493(e) of the PHS Act requires the

Secretary to establish regulatory

standards for preventing and responding

to occurrences of retaliation taken

against whistleblowers by entities

which have a research misconduct

assurance under § 493 and by those

entities’ officials and agents. These

entities and their officials and agents are

prohibited from retaliating against an

employee with respect to the terms and

conditions of employment when the

employee has in good faith (1) made an

allegation that the entity or its officials

or agents, has engaged in, or failed to

respond adequately to an allegation of,

research misconduct, or (2) cooperated

with an investigation of such an

allegation.

The Commission on Research

Integrity (established by section 162 of

the NIH Revitalization Act of 1993)

recommended that the standards stated

in its document, ‘‘Responsible

Whistleblowing: A Whistleblower’s Bill

of Rights’’ (Commission Report,

Department, 1995), be adopted by

regulation. Two of the seven principles

in the Whistleblower’s Bill of Rights

relate directly to the prevention of and

response to whistleblower retaliation.

These two are: protection from

retaliation (‘‘Institutions have a duty not

to tolerate or engage in retaliation

against good faith whistleblowers.’’),

and fundamentally fair procedures (‘‘In

cases of alleged retaliation * * *

whistleblowers should have an

opportunity to defend themselves in a

proceeding where they can present

witnesses and confront those they

charge with retaliation against them.

* * *’’). The substance of those two

provisions has been incorporated in this

proposed regulation. You may obtain

the full text of the Commission’s

proposed Whistleblower’s Bill of Rights

upon request at the Office of Research

Integrity address above, or on the ORI

web page at http://ori.dhhs.gov/

whistle.htm.

The proposed regulation represents a

considered effort by the Department to

implement the statutory directive on

whistleblower protections in accordance

with equitable principles, reason, and

sound policy. The Department strongly

supports good faith whistleblowers who

place themselves at potential risk in

disclosing apparent or actual research

misconduct involving projects

supported by PHS funds. The

Department also recognizes that

institutions bear a substantial burden in

ensuring the fair resolution of good faith

allegations that may ultimately prove to

be unwarranted. The proposed

regulation tries to strike a fair balance

among those persons and entities with

an interest in the regulation.

This proposed regulation does not

apply to Federal agencies. Federal

employees are offered separate

whistleblower protections under the

Federal Whistleblower Protection Act of

1989, 5 U.S.C. 1201, et seq.

When an institution receives a

retaliation complaint, the proposed

regulation allows the whistleblower and

the institution up to 30 days to negotiate

a settlement. The whistleblower and the

institution may agree to extend this

period for up to an additional 60 days.

During the negotiation period, the

parties may agree to use any means of

settlement that is legal and consistent

with this regulation, including

alternative dispute resolution

mechanisms such as mediation.

However, no settlement under the

proposed regulation may prohibit the

whistleblower from making allegations

of research misconduct or cooperating

with an investigation.

If the dispute is not resolved by the

end of the negotiation period, the

institution must make an administrative

proceeding available to the

whistleblower to address the retaliation

complaint. The proceeding offered by

the institution must meet all of the

standards in the proposed regulation. A

whistleblower may agree to have a

retaliation complaint resolved through

this proceeding or may elect to pursue

any other available remedy provided by

law.

Although certain settlement

mechanisms such as mediation may be

used during the negotiation period, they

might not qualify as an acceptable

administrative proceeding after the

negotiation period has terminated

because they do not meet the

regulation’s requirements. For example,

mediation does not constitute an

acceptable administrative proceeding

because it does not use an ‘‘objective

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70831

decisionmaker’’ who will make a final

determination on whether retaliation

occurred, as required by the regulation.

The proposed regulation gives

institutions wide latitude in the types of

administrative proceedings they may

choose to offer. However, the

proceeding must meet certain minimum

standards such as allowing the

whistleblower an opportunity to be

represented by counsel and having a

qualified, objective decisionmaker.

Although the terms ‘‘qualified’’ and

‘‘objective’’ are not defined in the

proposed regulation, the decisionmaker

should have significant training,

experience, or expertise in adjudicating

disputes. Moreover, the decisionmaker

must not have any real or apparent

conflict of interest in hearing or

deciding the case.

One type of administrative proceeding

that institutions may make available is

binding arbitration. Arbitration is

specifically encouraged in the

Conference Report recommendations

accompanying the NIH Revitalization

Act. The Conferees suggested that the

regulation should, ‘‘where the

whistleblower consents, allow for the

possible adjudication of disputes

through an arbitration proceeding

conducted under the auspices of the

American Arbitration Association.’’ H.R.

Conf. Rep. No. 100, 103d Cong., 1st

Sess. 19, 107 (1993).

Another type of administrative

proceeding that may be used for

resolving retaliation disputes is an

institutional fact-finding procedure

similar to an option allowed under the

ORI ‘‘Guidelines for Institutions and

Whistleblowers: Responding to Possible

Retaliation Against Whistleblowers in

Extramural Research’’ (November 20,

1995) (Whistleblower Guidelines) which

will be superseded when this part is

issued as a final rule. You may obtain

a copy of these interim Whistleblower

Guidelines by contacting ORI at the

above address, or on the ORI web page

at http://ori.dhhs.gov/whistle.htm.

Unlike the administrative proceedings

in the interim Whistleblower

Guidelines, an institutional fact-finding

procedure under the proposed

regulation must satisfy the minimum

standards specifically in this part.

Other possible administrative

proceedings that an institution may use

for resolving a retaliation complaint

under this part include an academic or

institutional employment hearing, a

state statutory whistleblower

proceeding, or any other administrative

proceeding that resolves the complaint.

A proceeding satisfies the requirements

of this part only if it meets the

minimum standards outlined in the

proposed regulation. Some states may

have whistleblower statutes that provide

recourse for a whistleblower but that

may not include every requirement of

this part. Therefore, the Department

requests comments on whether an

institution should be permitted to offer

a proceeding, whether administrative or

judicial, under a state whistleblower

law if the law generally parallels the

minimum standards of this part but

differs in some details.

Regardless of the type of

administrative proceeding used, the

decisionmaker’s final decision must be

based on the standards of proof set forth

in the regulation. The decisionmaker

must order an institutional remedy if

the whistleblower proves by a

preponderance of the evidence that the

act of good faith whistleblowing was a

contributing factor in the alleged

adverse action taken by the institution

or one of its members against the

whistleblower. However, even if the

whistleblower meets this burden, the

decisionmaker may not order an

institutional remedy if the institution

then proves by clear and convincing

evidence that it would have taken the

action at issue even in the absence of

the whistleblower’s allegation or

cooperation with an investigation. The

legislative history of the PHS Act

§ 493(e) shows that the Conferees

encouraged adoption of this specific

standard. Also, the proposed regulatory

standard is the same as that used in the

Federal Whistleblower Protection Act of

1989, 5 U.S.C. 1201, et seq.

If the decisionmaker determines that

the institution or one of its members has

retaliated against the whistleblower, the

proposed regulation allows the

decisionmaker to authorize appropriate

remedies. For example, the

decisionmaker could order

reinstatement, back pay, rehabilitation

of reputation, or compensation to the

whistleblower for expenses, including

attorneys’ fees, incurred in the

administrative proceeding.

The proposed regulation allows both

the institution and whistleblower to

appeal an adverse finding or remedy by

the decisionmaker only if the

administrative proceeding used allows

for an appeal or an appeal is otherwise

provided by state law. The Department

has chosen this approach consistent

with the current misconduct regulation,

42 CFR part 50, subpart A, and the

Office of Science and Technology

Policy’s (OSTP) proposed governmentwide Federal policy for research

misconduct, 64 FR 55722, 55724, Oct.

14, 1999, which do not require offering

an opportunity to appeal at the

institution to a respondent found to

have committed misconduct. This is

also consistent with the general

approach of this regulation to allow

flexibility and to mandate only limited

requirements for the institutional

administrative proceeding. The

Department requests comments on

whether the availability of an appeal

should be required.

Covered institutions would also be

required to establish procedures for

preventing retaliation against good faith

whistleblowers. For example, under the

proposed regulation, an institution’s

preventive activities must include

informing all institutional members of

the institution’s whistleblower

procedures and the importance of

compliance. These whistleblower

procedures must describe the measures

that the institution intends to use to

prevent retaliation against good faith

whistleblowers. Although not specified

in the proposed regulation, these

measures may include, for example,

cautioning respondents or other

institutional members against

retaliation, relocating the whistleblower

when appropriate, and providing

educational materials or group

instruction on the topic of

whistleblower retaliation. We invite

suggestions for other steps institutions

may take to prevent retaliation against

good faith whistleblowers.

Section 493(e)(2) of the PHS Act

requires the Director of ORI to monitor

covered institutions’ implementation of

the proposed regulatory standards.

Moreover, § 493(e)(3) requires ORI to

establish remedies for noncompliance

with this whistleblower retaliation

regulation. Therefore, the proposed

regulation authorizes ORI to review any

covered institution’s compliance with

the regulation and to impose

appropriate administrative actions for

retaliation or other regulatory

noncompliance. Administrative actions

against noncompliant institutions may

include, but are not limited to,

termination or recovery of PHS funds.

Several of the definitions require brief

explanations. The proposed regulation

adopts the term ‘‘research misconduct’’

instead of ‘‘misconduct in science’’ as

currently used in PHS’ scientific

misconduct regulation at 42 CFR 50.102

(1989). Section 493(a)(3)(A) of the PHS

Act instructs the Secretary to establish

a definition for the new term ‘‘research

misconduct.’’ As discussed earlier, the

OSTP has published a proposed

government-wide Federal policy for

research misconduct for adoption and

implementation by agencies that

conduct and support research. This

policy includes a new proposed

definition of research misconduct. 64

70832 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

FR 55722, Oct.14, 1999. When the OSTP

policy is adopted in final form, the

Department will implement the policy,

including the new definition of

‘‘research misconduct,’’ through

rulemaking. In the meantime, the term

‘‘research misconduct’’ in this proposed

regulation will be defined in the same

manner as ‘‘misconduct in science,’’ as

used in the existing PHS misconduct

regulation.

The proposed regulation uses the term

‘‘whistleblower’’ despite negative

connotations that might be associated

with it. The common understanding of

the term’s meaning strongly supports its

continued usage, in keeping with the

authorizing statute, PHS Act § 493(e),

and consistent with other statutes such

as the Whistleblower Protection Act of

1989, 5 U.S.C. 1201, et seq. The

Department strongly disavows any

negative inference that might be drawn

from the term ‘‘whistleblower.’’

The proposed regulation does not

confine the use of the term

‘‘whistleblower’’ to those who raise an

initial allegation of research

misconduct. Rather, it defines a

whistleblower as any institutional

member, including a non-employee,

who makes an allegation that a covered

institution or one of its members has

engaged in, or failed to respond

adequately to an allegation of, research

misconduct, or who cooperates with an

investigation of the allegation. Although

the PHS Act § 493(e) specifically

protects an ‘‘employee’’ with respect to

the terms and conditions of

employment, the Department is

proposing that the regulation cover all

institutional members, i.e., all persons

who are employed by, affiliated with

under a contract or agreement, or under

the control of, a covered institution,

including students, fellows, and

contractors.

The Department may extend its

jurisdiction to protect non-employee

whistleblowers based upon its general

rulemaking authority as well as its

authority to establish the terms and

conditions of PHS support. Potential

whistleblowers include more than just

employees of the covered institution.

Students and research fellows at an

academic institution, for example, may

be in a position to allege research

misconduct or cooperate with a

misconduct investigation. The proposed

regulation’s more inclusive definition of

whistleblower is consistent with the

Department’s interpretation of the

current scientific misconduct regulation

which is not limited to employees of the

institution but requires protecting

‘‘those persons who, in good faith, make

allegations,’’ 42 CFR 50.103(d)(13).

Consistent with the proposed

definition of whistleblower, the

proposed regulation’s definition of

‘‘retaliation’’ focuses on adverse actions

that negatively affect the terms or

conditions of the whistleblower’s status

at the institution, including

employment, academic matriculation,

and institutional relationship under a

grant, contract, or cooperative

agreement.

An ‘‘adverse action’’ by an institution

or one of its members may also include

the threat of an adverse action if the

threat in and of itself negatively affects

the conditions of the whistleblower’s

institutional status. Whether a threat

constitutes an ‘‘adverse action’’ under

the proposed rule must be determined

on a case-by-case basis. However, the

Department believes that only

objectively credible and imminent

threats that substantially and negatively

inhibit the whistleblower’s normal

institutional activities would constitute

adverse actions.

The proposed regulation requires each

covered institution to submit an

assurance that the institution is in

compliance with this regulation. This

requirement will be incorporated in

PHS grant application (PHS Form 398)

or any other application for PHS

contracts or cooperative agreements.

PHS Form 398 and all other pertinent

application forms already include a

certification of compliance with this

part which will be changed to an

assurance at the next revision.

The proposed regulation applies only

to whistleblower retaliation complaints

that are made within 180 days of the

alleged adverse action, or its discovery.

This time limitation for filing retaliation

complaints is consistent with other

statutory and regulatory programs that

establish a date certain after which

complaints may not be filed, and

encourages whistleblowers to come

forward with a complaint promptly.

This improves the opportunity for a

rapid resolution of the dispute. See, e.g.,

29 U.S.C. 1855(b) (Migrant and Seasonal

Agricultural Worker Protection;

Discrimination prohibited); 10 CFR

50.7(b) (Nuclear Regulatory

Commission; Employee Protection). The

180-day limitation period is also

consistent with ORI’s interim

Whistleblower Guidelines, § IV.C.1.

In addition to cases of whistleblower

retaliation that occur after this

regulation’s promulgation, the

Department also proposes that the

regulation cover pending cases of

retaliation, if the retaliation complaint

and the underlying whistleblower

activity took place within one year

before the effective date of the

regulation. The Department has required

covered institutions to protect

whistleblowers since at least 1989

pursuant to 42 CFR 50.103(d)(13). The

proposed regulation merely prescribes

new procedural, as opposed to

substantive, requirements for

implementing an already established

duty. Thus, extending the applicability

of the proposed regulation to previously

filed, pending whistleblower complaints

does not violate the principle of

impermissible retroactivity. See

Landgraf v. USI Film Products, 511 U.S.

244 (1994); U.S. v. Riddick, 104 F.3d

1239 (10th Cir. 1997).

Analyses of Impacts

A. Review under Executive Order

12866, sections 202 and 205 of the

Unfunded Mandate Reform Act of 1995

(Pub. L. No. 104–4), and the Regulatory

Flexibility Act (5 U.S.C. 603–605).

The Department has examined the

potential impact of this proposed rule as

directed by Executive Order 12866,

sections 202 and 205 of the Unfunded

Mandates Reform Act of 1995 (Pub. L.

No. 104–4), and the Regulatory

Flexibility Act (5 U.S.C. 603–605).

Executive Order 12866 directs

agencies to assess the costs and benefits

of available regulatory alternatives, and

when regulation is necessary, to select

regulatory approaches that maximize

net benefits. This proposed rule is

designed to establish regulatory

standards for institutions that apply for

or receive grants, contracts, or

cooperative agreements under the PHS

Act. (The proposal has been reviewed

by the Office of Management and

Budget (OMB) under the terms of the

Executive Order.)

The Unfunded Mandates Reform Act

of l995, in sections 202 and 205,

requires that agencies prepare several

analytic statements before proposing a

rule that may result in annual

expenditures of State, local, and tribal

governments, or by the private sector, of

$100 million. As any final rule resulting

from this proposal would not result in

expenditures of this magnitude, such

statements are not necessary.

The Regulatory Flexibility Act

requires agencies to prepare a regulatory

flexibility analysis describing the

impact of the proposed rule on small

entities, but also permits agency heads

to certify that a proposed rule will not,

if promulgated, have a significant

economic impact on a substantial

number of small entities. The primary

effect of this rule would be to require

covered institutions to implement

policies and procedures for preventing

and responding to whistleblower

retaliation in research misconduct cases.

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70833

Currently, ORI receives about 125

allegations of research misconduct a

year from the 3700 entities which file

assurances with ORI. Of these, only five

of the allegations were received from the

approximately 1000 entities which are

considered small. Therefore, the

Secretary certifies that this proposed

rule would not have a significant impact

on a substantial number of small entities

as defined by the Regulatory Flexibility

Act.

B. Impact of Proposed Actions on

Family Well-Being

The Department has examined the

potential impact of this proposed rule as

directed by section 654 of the Treasury

and General Government

Appropriations Act of 1999 and

determined that this proposed rule

would not have an impact on Family

Well-Being.

C. Estimated Annual Reporting and

Record Keeping Burden

Subchapter I, sections 94.215, 94.310,

94.315, 94.320, 94.340, 94.345(b),

94.380, and 94.425 of the proposed rule

contain information collection

requirements that are subject to review

by the OMB under the Paperwork

Reduction Act of l995. The title,

description, and respondent description

of the information collection

requirements are shown below with an

estimate of the annual reporting

burdens. Included in the estimates is the

time for reviewing instructions,

gathering and maintaining the data

needed, and completing and reviewing

the collection of information. With

respect to the following information

collection description, PHS invites

comments on (1) whether the proposed

collection of information is necessary

for the proper performance of PHS

functions, including whether the

information will have practical utility,

(2) the accuracy of the PHS estimate of

the burden of the proposed collection of

information including the validity of the

methodology and assumptions used, (3)

ways to enhance the quality, utility, and

clarity of the information to be

collected, and (4) ways to minimize the

burden of collection of information on

respondents, including the use of

automatic collection techniques or other

forms of information technology.

Title: Public Health Service Standards

for the Protection of Research

Misconduct Whistleblowers.

Description: This proposed rule

implements section 493(e) of the PHS

Act (added by section 163 of the NIH

Revitalization Act of 1993, Pub. L. No.

103–43). Section 493(e)(1) requires the

Secretary to establish standards for

preventing and responding to

occurrences of whistleblower retaliation

by entities, their officials or agents,

against an employee in the terms and

conditions of employment in response

to the employee having made a good

faith allegation or cooperated with an

investigation of such an allegation. In

addition, sections 493(e) (2) and (3) of

the PHS Act require that remedies be

established for regulatory

noncompliance by entities, their

officials or agents, and that procedures

be established for monitoring

implementation of the standards

established by the entities.

Description of Respondents: The

‘‘respondents’’ for the collection of

information described in this regulation

are (1) institutions that apply for or

receive grants, contracts, or cooperative

agreements under the PHS Act for any

project or program that involves the

conduct of biomedical or behavioral

research, and (2) whistleblowers who

seek protection from or restitution for

retaliation in accordance with the

regulation.

Section 94.200

See Section 94.215 for burden

statement.

Section 94.205

See Section 94.215 for burden

statement.

Section 94.210

See Section 94.215 for burden

statement.

Section 94.215(a), (b), and (c)

Number of Respondents—20.

Number of Responses per

Respondent—1.

To institute an action for

whistleblower protection, a

whistleblower must file a retaliation

complaint with the responsible official

of the covered institution. The

retaliation complaint must include (1) a

statement containing the required

elements listed in this section, and (2)

any supporting dates and facts. We

estimate that there will be

approximately 20 complaints filed by

whistleblowers annually. This estimate

is based on data that we have compiled

from the Annual Report on Possible

Research Misconduct (PHS–6349) form

submitted by the covered institutions

and from the number of actual cases

received by ORI.

Annual Average Burden per

Response—8 hours

Total Annual Burden—160 hours

Section 305(a) and (b)

See Section 94.320 for statement of

burden.

Section 94.310

Number of Respondents—244.

Number of Responses per

Respondent—1

Each covered institution that uses

subawardees or subcontractors to carry

out its PHS funded research must

ensure that the subawardees and

subcontractors comply with the

institution’s policies and procedures

under this part or obtain assurances

from them that will enable the

institution to comply with this part.

There are 3700 entities that are

currently applying for or receiving PHS

research funds, and each of these

entities could potentially use a

subawardee or subcontractor. We

estimate from reviewing the available

information that 25% of the covered

institutions use a subawardee or

subcontractor. In turn, we estimate that

only 25% of the subawardees and

subcontractors will establish their own

policies and procedures for addressing

whistleblower retaliation allegations.

The other 75% will use the covered

institution’s compliance procedures.

Annual Average Burden per

Response—8 hours.

Total Annual Burden—1848 hours.

Section 94.315

See Section 94.320 for statement of

burden.

Section 94.320

Number of Respondents—3700.

Number of Responses per

Respondent—1.

Each covered institution that applies

for or receives a grant, contract, or

cooperative agreement under the PHS

Act for any project or program that

involves the conduct of biomedical or

behavioral research is required to

establish written procedures that

include (1) specific strategies to prevent

whistleblower retaliation by the

institution or one of its members, and

(2) appropriate administrative actions

for verified cases of retaliation.

There are 3700 entities that currently

receive or are eligible to receive grants,

contracts, or cooperative agreements

that would be required to meet this

single-time requirement to establish and

maintain current policies and

procedures designed to prevent

whistleblower retaliation and provide a

mechanism to respond to a retaliation

complaint involving PHS funding or

applications therefor.

Annual Average Burden per

Response—40 hours.

Total Annual Burden—148,000 hours.

We estimate that it will take between

10–80 hours to establish these

70834 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

procedures with an average of 40 hours

per covered institution. This burden

estimate applies only to the first year

when all the covered institutions will be

required to establish procedures. In

subsequent years, the burden will only

be for new recipients or applicants of

PHS funding or to update a covered

entity’s procedures.

Section 94.325(a) and (b)

See Section 94.320 for statement of

burden.

Section 94.340

Number of Respondents—20.

Number of Responses per

Respondent—1.

After receipt of a retaliation

complaint, a covered institution is

required by this part to provide the

whistleblower with a copy of this

regulation, 42 CFR Part 94, and the

institution’s policies and procedures for

responding to retaliation complaints.

The institution must also provide the

whistleblower with written notification

of (1) the date the complaint was

received by the institution, (2) the date

the negotiation period will expire, and

(3) the institution’s determination

regarding the issue of jurisdiction as

discussed in § 94.215(b). The institution

is also required to process the complaint

in accordance with this part.

Annual Average Burden per

response—2 hours

Total Burden—40 hours.

Section 94.345(b)

Number of Respondents—1.

Number of Responses per

Respondent—1.

The responsible official of the covered

institution is required to notify the

whistleblower in writing of any decision

to provide temporary protection before

the final resolution of a retaliation

complaint.

This estimate is based on the number

of retaliation cases that have been

reported to ORI.

Annual Average Burden per

response—2 hours.

Total Annual Burden—2 hours.

Section 94.380

Number of Respondents—20.

Number of Responses per

Respondent—1.

Covered institutions are required by

this part to report to ORI any of the

following (1) the receipt of any

whistleblower retaliation complaint, (2)

the date received, (3) the date the

negotiation period under Section 94.365

expires, (4) any temporary protections

requested or provided to the

whistleblower, (5) the administrative

proceedings used or made available to

the whistleblower, and how the

institution met the standards of Section

94.420, and (6) the final disposition of

the complaint, including any settlement.

This reporting estimate is an

approximation of the average time

expected to be necessary for collection

of this information by the covered

institution. The estimate is based on

past experiences of respondents

reporting similar information to ORI.

Annual Average Burden Per

Response—2 hours.

Total Annual Burden—40 hours.

Section 94.425

Number of Respondents—20.

Number of Responses per

Respondent—1.

At the time a covered institution

proposes an administrative proceeding,

it must inform the whistleblower of the

requirements, rights, procedures, and

possible consequences associated with

the proceeding.

Annual Average Burden Per

Response—1 hour.

Total Annual Burden—20 hours.

The Department will submit a copy of

this proposed rule to OMB for its review

and approval of this information under

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501–3520). Send comments

regarding this burden estimate or any

other aspect of this collection of

information, including suggestions for

reducing this burden, to the agency

official designated for this purpose

whose name appears in this preamble,

and to the Office of Information and

Regulatory Affairs, OMB, New

Executive Office Bldg., 725 17th Street,

N.W., Rm 10235, Washington, D.C.

20503, Attn: Allison Eydt. Submit

written comments by January 29, 2001.

List of Subjects in 42 CFR Part 94

Administrative practice and

procedure, Grant programs-science and

technology, Reporting and

recordkeeping requirements, Research,

Science and technology,

Whistleblowing.

Dated: July 17, 2000.

David Satcher,

Assistant Secretary for Health and Surgeon

General.

Approved: July 25, 2000.

Donna E. Shalala,

Secretary.

For reasons set out in the preamble,

the Public Health Service proposes to

add a new subchapter I, part 94, to title

42 of the Code of Federal Regulations as

follows:

Subchapter I—Policies Relating to

Research Misconduct

PART 94—PUBLIC HEALTH SERVICE

STANDARDS FOR THE PROTECTION

OF RESEARCH MISCONDUCT

WHISTLEBLOWERS

Subpart A—General

Sec.

94.100 What is the purpose of this part?

94.105 What is covered in this part?

94.110 Does this part apply to me?

94.115 What provisions of confidentiality

apply to this part?

Subpart B—Whistleblower Retaliation

Complaints

94.200 When must you file your retaliation

complaint?

94.205 Where do you file a retaliation

complaint?

94.210 Must your retaliation complaint be

in writing?

94.215 What information must you provide

in your retaliation complaint?

94.220 May you revise your retaliation

complaint?

94.225 May you ask the covered institution

to take actions to protect you?

94.230 May you negotiate or settle your

retaliation complaint?

Subpart C—Responsibilities of Covered

Institutions

Responsibilities and Procedures

94.300 What institutions are covered by this

part?

94.305 What responsibilities does a covered

institution have?

94.310 Are subawardees and subcontractors

of a covered institution included in this

part?

94.315 Must a covered institution establish

procedures for whistleblowers?

94.320 What procedures must a covered

institution establish?

94.325 Who must a covered institution

inform of these procedures?

94.330 What is an assurance of compliance?

94.335 Who designates the responsible

official, and what are the responsible

official’s duties?

94.340 How does a covered institution

process whistleblower complaints?

94.345 Must a covered institution provide

temporary protections to

whistleblowers?

94.350 What temporary protections may a

covered institution offer?

94.355 How long do temporary protections

last?

Negotiations and Settlements

94.360 How may a covered institution

negotiate and settle a retaliation

complaint?

94.365 How long may a covered institution

conduct negotiations on a retaliation

complaint?

94.370 What must a covered institution do

if it questions jurisdiction during

negotiations?

94.375 What happens if negotiations do not

resolve a retaliation complaint?

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Compliance

94.380 What information must a covered

institution report to ORI regarding

retaliation complaints?

94.385 Must a covered institution cooperate

with ORI compliance reviews?

94.390 What happens if a covered

institution retaliates or fails to comply

with this part?

Subpart D—Administrative Procedures

Election of Remedies

94.400 May a whistleblower elect remedies

other than an administrative proceeding?

94.405 What actions may a covered

institution take if a whistleblower elects

a remedy other than an administrative

proceeding?

Administrative Proceedings

94.410 Must a covered institution offer a

whistleblower an administrative

proceeding?

94.415 What types of administrative

proceedings may a covered institution

offer?

94.420 What elements must a covered

institution include in its administrative

proceeding?

94.425 What information must a covered

institution provide to a whistleblower?

94.430 What happens if a whistleblower

fails to timely file supporting

documentation for the administrative

proceeding?

94.435 May a covered institution or

whistleblower challenge the

decisionmaker’s qualifications?

94.440 May the decisionmaker be replaced?

Remedies

94.445 What remedies may a decisionmaker

impose?

Appeals

94.450 May a covered institution or

whistleblower appeal an adverse

decision or remedy?

Subpart E—Responsibilities of the Office of

Research Integrity

General Provisions

94.500 What are ORI’s responsibilities?

94.505 What does ORI do when it receives

a whistleblower retaliation complaint?

Compliance Reviews

94.510 When does ORI do an institutional

compliance review?

94.515 What factors does ORI consider in a

compliance review?

94.520 What administrative actions may

ORI take pursuant to a compliance

review?

94.525 May a covered institution appeal

administrative actions imposed by ORI

or the Department?

Subpart F—Definitions

94.600 Administrative proceeding

94.605 Adverse action

94.610 Allegation

94.615 Contributing factor

94.620 Covered institution

94.625 Decisionmaker

94.630 Good faith

94.635 Institutional member or member

94.640 Investigation

94.645 Office of Research Integrity or ORI

94.650 Public Health Service or PHS

94.655 PHS funds or PHS funding

94.660 Research misconduct

94.665 Responsible official

94.670 Retaliation

94.675 Secretary

94.680 Whistleblower

Authority: 42 U.S.C. 216, 241, and 289b.

Subpart A—General

§ 94.100 What is the purpose of this part?

(a) This part describes the standards

used by the Office of Research Integrity

(ORI) and covered institutions for

preventing and responding to retaliation

against whistleblowers who in good

faith—

(1) Allege that a covered institution or

institutional member has engaged in, or

failed to respond adequately to, an

allegation of research misconduct.

(2) Cooperate with an investigation of

the allegation in paragraph (a)(1) of this

section.

(b) These standards apply where the

allegation or cooperation regarding an

investigation concerns research

involving Public Health Service (PHS)

grants, contracts, or cooperative

agreements, or applications therefor.

§ 94.105 What is covered in this part?

This part explains—

(a) The rights and responsibilities of

whistleblowers who seek protection

from or remedies for retaliation under

this regulation and who comply with

the requirements of this part.

(b) Standards for covered institutions

and their members for preventing or

otherwise responding to retaliation

against whistleblowers.

(c) Procedures for ORI to determine

whether covered institutions have

established the required standards and

that those standards are being followed.

(d) Remedial actions that ORI may

administer when a covered institution

engages in an act of retaliation or

otherwise does not comply with this

regulation.

§ 94.110 Does this part apply to me?

(a) Portions of this part may apply to

you if you are a—

(1) Covered institution;

(2) Decisionmaker of a covered

institution;

(3) Institutional member of a covered

institution;

(4) ORI;

(5) Responsible official of a covered

institution;

(6) Subawardee or subcontractor of a

covered institution; or

(7) Whistleblower.

(b) The following table shows the

portions of this part that may apply to

you:

If you are a—

then the portions that

may apply to you

are—

(1) Covered institution

or subawardee or

subcontractor of a

covered institution.

Subparts A, C, D, E,

and F.

(2) Decisionmaker ..... Subparts A, D, and F

and §§ 94.420 and

94.435–94.450.

(3) Institutional member.Subparts A, C, and F

and §§ 94.410 and

94.445.

(4) ORI ...................... Subparts A, E, and F.

(5) Responsible official.Subparts A, C, and F

and §§ 94.205,

94.210, 94.225,

94.430, 94.505,

and 94.520.

(6) Whistleblower ...... Subparts A, B, D, and

F, and §§ 94.360–

94.375, and

94.505.

§ 94.115 What provisions of confidentiality

apply to this part?

(a) The provisions in this part for

filing whistleblower retaliation

complaints must not be construed to

encourage or allow whistleblowers or

covered institutions and their members

to disclose publicly information

regarding research misconduct cases

other than to the person(s) designated in

this part, or as otherwise provided by

law.

(b) A covered institution may take

appropriate administrative actions that

are consistent with this part in response

to breaches of confidentiality.

Subpart B—Whistleblower Retaliation

Complaints

§ 94.200 When must you file your

retaliation complaint?

(a) You, as a whistleblower, must file

your retaliation complaint within 180

calendar days of the alleged adverse

action or your discovery of the alleged

adverse action.

(b) The alleged adverse action must

have occurred within one calendar year

after you made your allegation or

cooperated with an investigation of the

allegation.

(c) However, if your retaliation

complaint was pending on the effective

date of this part, ORI will consider your

complaint to have been timely filed if—

(1) You have filed it within one

calendar year before the effective date of

this part;

(2) Your allegation or cooperation

with an investigation of the allegation

also occurred within that year; and

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(3) You refile your pending

complaint, using the procedures in this

subpart for filing complaints, within 120

calendar days of the date on which the

covered institution provides the

§ 94.325 written information to its

members about its whistleblower

policies and procedures.

§ 94.205 Where do you file a retaliation

complaint?

(a) You must file your whistleblower

retaliation complaint with the

responsible official at the covered

institution where the alleged adverse

action occurred.

(b) If the responsible official does not

acknowledge receipt of your complaint

within 10 business days of receiving it,

you may file the complaint with ORI.

ORI will review the complaint and

decide whether to refer it to the covered

institution.

§ 94.210 Must your retaliation complaint

be in writing?

Yes, your whistleblower retaliation

complaint must be made in writing to

the responsible official at the covered

institution or to ORI.

§ 94.215 What information must you

provide in your retaliation complaint?

To establish jurisdiction under this

part, you must include in your

whistleblower retaliation complaint a

statement containing all the following

information, including supporting dates

and facts:

(a) That you made an allegation that

the covered institution or one of its

members committed research

misconduct or failed to respond

adequately to an allegation of research

misconduct, or that you cooperated with

an investigation of such an allegation

that concerns research involving PHS

grants, contracts, cooperative

agreements, or applications therefor.

(b) That the covered institution or one

of its members committed an adverse

action against you within one year after

you made your allegation or cooperated

with an investigation.

(c) That the adverse action resulted

from your allegation or cooperation.

(d) That you are making the complaint

within 180 calendar days of the alleged

adverse action or your discovery of the

adverse action.

§ 94.220 May you revise your retaliation

complaint?

Yes, if your whistleblower retaliation

complaint does not contain all the

information required by § 94.215, you

may revise it to supply that information

at any time before the complaint is fully

resolved, dismissed, or otherwise closed

under this part.

§ 94.225 May you ask the covered

institution to take temporary actions to

protect you?

Yes, you may ask the responsible

official to take temporary actions under

§§ 94.345 through 94.355 to protect you

against an existing or threatened adverse

action by the covered institution or one

of its members at any time before your

whistleblower retaliation complaint is

fully resolved, dismissed, or otherwise

closed under this part.

§ 94.230 May you negotiate or settle your

retaliation complaint?

Yes, you may negotiate or settle your

whistleblower retaliation complaint

with the covered institution by using

the procedures described in §§ 94.360

through 94.375.

Subpart C—Responsibilities of

Covered Institutions

Responsibilities and Procedures

§ 94.300 What institutions are covered by

this part?

This part applies to any institution

that applies for or receives grants,

contracts, or cooperative agreements

under PHS Act, as amended (42 U.S.C.

201, et seq.) for any project or program

that involves biomedical or behavioral

research, research training, or research

related activities.

§ 94.305 What responsibilities does a

covered institution have?

(a) Covered institutions have primary

responsibility for preventing and

otherwise responding to occurrences of

whistleblower retaliation.

(b) A covered institution and its

members must—

(1) Comply with the standards in this

part for preventing or otherwise

responding to retaliation against

whistleblowers if the underlying

research misconduct allegation or act of

cooperation with an investigation

concerns research involving PHS grants,

contracts, cooperative agreements, or

applications therefor;

(2) Not retaliate against good faith

whistleblowers as defined by this part;

and

(3) Take all reasonable and necessary

steps to prevent or otherwise respond to

instances of whistleblower retaliation

within the institution.

§ 94.310 Are subawardees and

subcontractors of a covered institution

included in this part?

(a) Yes, if a covered institution carries

out PHS funded research through

subawardees or subcontractors, the

institution must take reasonable steps to

ensure that subawardees and

subcontractors and their members

comply with this part.

(b) An institution may either require

its subawardees and subcontractors to

comply with its whistleblower policies

and procedures or obtain assurances

from them sufficient to allow

compliance.

§ 94.315 Must a covered institution

establish procedures for whistleblowers?

Yes, a covered institution must

establish whistleblower protection

procedures and remedies consistent

with this part.

§ 94.320 What procedures must a covered

institution establish?

A covered institution must establish

written procedures for whistleblowers

that—

(a) Include specific strategies aimed at

preventing whistleblower retaliation by

the covered institution or its members;

(b) Provide a mechanism for

processing whistleblower complaints;

(c) Authorize appropriate

administrative actions for verified cases

of retaliation; and

(d) Ensure to a reasonable extent that

its institutional members do not

retaliate against whistleblowers,

including whistleblowers who are not

institutional members, such as persons

who are located at other institutions or

who are members of the general public.

§ 94.325 Who must a covered institution

inform of these procedures?

(a) Each covered institution must

provide written information informing

all of its members about the content of

this part and the institution’s

procedures to implement its

requirements and must emphasize the

importance of compliance with those

procedures.

(b) A covered institution must provide

its procedures to ORI and other

authorized representatives of the

Secretary upon request.

§ 94.330 What is an assurance of

compliance?

(a) Effective on [INSERT DATE 180

DAYS AFTER DATE OF PUBLICATION

OF THE FINAL RULE IN THE FEDERAL

REGISTER] each institution, as a

condition for receiving PHS funding, is

required to provide in its application for

that funding an assurance of compliance

with this part which is satisfactory to

the Secretary.

(b) The institution must assure that

it—

(1) Has established written

whistleblower protection procedures

consistent with this part;

(2) Will comply with and enforce

these procedures; and

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70837

(3) Will comply with all other

requirements of this part.

§ 94.335 Who designates the responsible

official, and what are the responsible

official’s duties?

(a) Each covered institution must—

(1) Appoint one person as the official

responsible for overseeing the

institution’s whistleblower protection

procedures;

(2) Authorize and direct the

responsible official to execute or

coordinate the implementation of the

institution’s policies and procedures in

compliance with this part; and

(3) Authorize the responsible official

to oversee each whistleblower

retaliation case that arises at the

institution, to oversee the negotiation

and settlement process described in

§§ 94.360 through 94.375, including

implementing and enforcing appropriate

institutional remedies as part of any

agreement with the whistleblower, and

to serve as a liaison between the covered

institution and ORI.

(b) If involvement of the responsible

official in a particular case creates a real

or apparent conflict of interest with the

covered institution’s obligation to

protect good faith whistleblowers, or

with a fair process for adjudicating the

retaliation proceeding, the institution

must appoint a substitute official to

oversee the case. If the institution is

unable to appoint a suitable substitute

from within the institution, it must

designate a person outside the

institution who has no real or apparent

conflict of interest.

§ 94.340 How does a covered institution

process whistleblower complaints?

(a) A covered institution must process

all whistleblower retaliation complaints

that are made to the responsible official

pursuant to this part.

(b) Within 20 calendar days of

receiving a whistleblower retaliation

complaint, the institution must provide

the whistleblower with copies of this

part, the institution’s policies and

procedures implementing this part,

including its administrative procedures

under § 94.415, and a written

notification, which includes—

(1) The dates the institution received

the retaliation complaint and on which

it believes the 30 day negotiation period

of § 94.365(a) expires; and

(2) The institution’s determination of

whether the retaliation complaint

satisfies the jurisdictional elements

required by § 94.215 and, if the

jurisdictional elements are not satisfied,

the specific basis for that determination.

§ 94.345 Must a covered institution

provide temporary protections to

whistleblowers?

(a) Consistent with § 94.350, a covered

institution must provide reasonable and

necessary temporary protections to

whistleblowers before the final

resolution of a retaliation complaint

under this part if, based on the

evidence, the responsible official

reasonably determines that protection is

warranted.

(b) The responsible official must

notify the whistleblower in writing of

the decision on whether to provide

temporary protections.

§ 94.350 What temporary protections may

a covered institution offer?

A covered institution must authorize

the responsible official to provide any

reasonable and necessary temporary

protection(s), including but not limited

to—

(a) Ensuring the confidentiality of an

ongoing research misconduct

investigation or retaliation proceeding;

(b) Protecting the whistleblower’s

institutional status; and

(c) Taking disciplinary actions against

institutional members who fail to

comply with the responsible official’s

orders.

§ 94.355 How long do temporary

protections last?

When a covered institution and a

whistleblower have fully resolved the

retaliation complaint, any temporary

protection(s) taken to protect the

whistleblower may be discontinued or

replaced with permanent remedies.

Negotiations and Settlements

§ 94.360 How may a covered institution

negotiate and settle a retaliation complaint?

(a) A covered institution and a

whistleblower may negotiate and settle

a retaliation complaint through any

legal means not inconsistent with this

part at any time after the institution

receives the complaint.

(b) If an institution and a

whistleblower agree, any alternative

dispute resolution mechanism, such as

mediation, may be used to facilitate a

resolution during the negotiation

period.

(c) Consistent with § 94.335(a)(3), a

covered institution must authorize its

responsible official to implement any

remedies as part of any agreement with

a whistleblower.

(d) However, any agreement to settle

the complaint must not restrict a

whistleblower’s right or opportunity to

make disclosures or to otherwise

cooperate with institutional officials,

ORI, or other Federal agencies with

respect to the underlying research

misconduct allegation(s).

§ 94.365 How long may a covered

institution conduct negotiations on a

retaliation complaint?

(a) Except as modified by paragraph

(b) of this section, a covered institution

has 30 calendar days after the

responsible official receives a written

whistleblower retaliation complaint in

which to negotiate a settlement with a

whistleblower.

(b) If an institution and a

whistleblower have not fully resolved

the retaliation complaint within the 30

day period of paragraph (a) of this

section, they may mutually agree in

writing to extend that period for up to

an additional 60 calendar days.

(c) If an institution and a

whistleblower fully resolve the

complaint during the negotiation

period, ORI considers the complaint

closed for purposes of this part. The

head of the institution, or designee, and

the whistleblower must sign an

agreement that the complaint has been

resolved, and the institution must notify

ORI of the agreement within 30 calendar

days of its execution, as required by

§ 94.380(d)(5).

§ 94.370 What must a covered institution

do if it questions jurisdiction during

negotiations?

If a covered institution provided the

§ 94.340(b)(2) notice to a whistleblower

that the retaliation complaint does not

contain the jurisdictional information

required by § 94.215, the whistleblower

has not adequately revised the

complaint, and the institution and the

whistleblower continue to dispute

whether the complaint falls within the

jurisdiction of this part, the institution

may, at its discretion, either—

(a) Continue settlement discussions

during the 30 to 90 day negotiation

period allowed under § 94.365 and

move to dismiss the complaint for lack

of jurisdiction during any

administrative proceeding under

subpart D of this part; or

(b) Immediately end the negotiation

period, offer the whistleblower an

administrative proceeding under

subpart D of this part, and in that

proceeding, make a preliminary motion

to dismiss the complaint for lack of

jurisdiction.

§ 94.375 What happens if negotiations do

not resolve a retaliation complaint?

(a) If a covered institution and a

whistleblower have not fully resolved

the retaliation complaint by the end of

the 30 to 90 day negotiation period, or

if they mutually agree to end

negotiations without a settlement, the

70838 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

institution must immediately offer the

whistleblower an administrative

proceeding under subpart D of this part.

(b) The administrative proceeding

must begin no later than 90 calendar

days after the negotiations have ended

unless the parties mutually agree

otherwise.

Compliance

§ 94.380 What information must a covered

institution report to ORI regarding

retaliation complaints?

A covered institution must report and

submit the following information and

items to ORI no later than 30 calendar

days after each of the following events

occur:

(a) Complaint filed. A copy of the

whistleblower retaliation complaint, the

date the institution received it, and the

expected expiration date of the

negotiation period under § 94.365.

(b) Temporary protection requested. A

description of any temporary protection

either provided to or requested by the

whistleblower and the responsible

official’s written decision regarding the

request.

(c) Proceeding held or offered. A

description of the administrative

proceeding used or made available to

resolve the complaint under subpart D

of this part, including an explanation of

how the institution met the procedural

standards of § 94.420.

(d) Final disposition of complaint. A

copy or description of the final

disposition of the retaliation complaint

including, where applicable—

(1) The dismissal of the complaint for

jurisdictional inadequacy;

(2) The whistleblower’s failure to

timely file any supporting

documentation required by the

proposed administrative proceeding;

(3) The whistleblower’s election of a

remedy other than that made available

by the institution;

(4) The outcome of the administrative

proceeding under subpart D of this part,

including any remedies imposed; and

(5) Any mutual settlement agreement

of the complaint including a statement

to that effect signed by the head of the

institution or designee and the

whistleblower. The terms of the

settlement agreement need not be

disclosed, but the agreement must

comply with § 94.360.

§ 94.385 Must a covered institution

cooperate with ORI compliance reviews?

Yes, a covered institution and its

members must cooperate with any ORI

compliance review conducted under

§ 94.510, including requests for

information, on-site visits, inspection of

relevant records, and interview of

institutional members.

§ 94.390 What happens if a covered

institution retaliates or fails to comply with

this part?

A covered institution that engages in

whistleblower retaliation or otherwise

fails to comply with any provision of

this part may be subject to any of the

PHS administrative actions provided

under § 94.520.

Subpart D—Administrative

Proceedings

Election of Remedies

§ 94.400 May a whistleblower elect

remedies other than an administrative

proceeding?

(a) Yes, a whistleblower may choose

to resolve a retaliation complaint either

through the administrative proceeding

made available by the covered

institution under this subpart or through

any other available remedy provided by

law, including remedies under any

applicable Federal or State law or other

institutional policy or employment

agreement.

(b) If the whistleblower elects a

remedy other than settlement or the

administrative proceeding made

available by the covered institution, the

whistleblower must provide the

institution with written notice of that

election.

(c) If the whistleblower does not make

an election of remedies under paragraph

(b) of this section before the final

disposition of the retaliation complaint,

whether by settlement, dismissal, or

final decision, ORI will consider that

the institution has fully satisfied the

requirements of this part.

§ 94.405 What actions may a covered

institution take if a whistleblower elects a

remedy other than an administrative

proceeding?

ORI will not require a covered

institution to complete any

administrative proceeding or otherwise

pursue a final resolution of the

complaint if a whistleblower elects a

remedy for the retaliation complaint

other than the administrative

proceeding made available under this

part.

Administrative Proceedings

§ 94.410 Must a covered institution offer a

whistleblower an administrative

proceeding?

Yes, for each case of possible

whistleblower retaliation to which this

part applies and which is not settled, a

covered institution must make available

and comply with an administrative

proceeding that meets the standards in

this part for resolving retaliation

complaints.

§ 94.415 What types of administrative

proceedings may a covered institution

offer?

A covered institution may resolve a

whistleblower retaliation complaint by

any of the following types of

administrative proceedings, if the

proceeding satisfies all of the elements

of § 94.420:

(a) An independent and binding

arbitration.

(b) An institutional fact-finding.

(c) An academic or institutional

employment hearing.

(d) A state statutory whistleblower

proceeding.

(e) Any other administrative

proceeding that addresses and resolves

the retaliation complaint.

§ 94.420 What elements must a covered

institution include in its administrative

proceeding?

A covered institution must have

written procedures for administrative

proceedings to resolve whistleblower

retaliation complaints. These

procedures must include all of the

following elements:

(a) A procedure for appointing a

qualified and objective decisionmaker.

(b) The opportunity for the

whistleblower and the institution to be

represented by counsel. The institution

may, but is not required by this part to,

provide counsel for the whistleblower.

(c) An equal opportunity for the

institution and the whistleblower to

present evidence in support of their

respective positions or in response to

contrary evidence, including having an

attorney present and cross-examining

witnesses.

(d) A presumption that the

whistleblower’s research misconduct

allegation or cooperation with an

investigation of the allegation was made

in good faith. If the institution rebuts

that presumption in a timely manner by

submitting prima facie evidence of a

lack of good faith, the whistleblower

then has the burden to prove good faith

by a preponderance of the evidence.

(e) A final written decision made

according to the following standards of

proof:

(1) Subject to paragraph (e)(2) of this

section, the decisionmaker must order a

binding institutional remedy according

to § 94.445 if the whistleblower proves

by a preponderance of the evidence that

the whistleblower’s research

misconduct allegation or cooperation

with an investigation of the allegation

was a contributing factor in an adverse

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70839

action taken by the institution or one of

its members.

(2) Even if the whistleblower meets

the burden of proof required by

paragraph (e)(1) of this section, the

decisionmaker must not order an

institutional remedy if the institution

proves by clear and convincing

evidence that the institution or one of

its members would have taken the

action at issue in the absence of the

whistleblower’s research misconduct

allegation or cooperation with an

investigation of the allegation.

§ 94.425 What information must a covered

institution provide to a whistleblower?

At the time a covered institution

proposes an administrative proceeding,

it must provide the whistleblower with

a copy of the procedures for the

proceeding, and it must fully inform the

whistleblower of the requirements,

rights, procedures, and possible

consequences associated with that

proceeding.

§ 94.430 What happens if a whistleblower

fails to timely file supporting

documentation for the administrative

proceeding?

(a) A whistleblower must timely file

any supporting documentation required

by the proposed administrative

proceeding, or the decisionmaker may

dismiss the retaliation complaint for

purposes of this part. The applicable

filing period will be 60 calendar days

from the day the covered institution

proposed the proceeding if the

institution has not specified a filing date

or if the specified date is less than 10

calendar days.

(b) However, the whistleblower’s

failure to timely file will not be grounds

for dismissal of the retaliation

complaint if either—

(1) The institution failed to inform the

whistleblower of the proposed

administrative proceeding and its

procedures, requirements, rights, and

possible consequences in a full and

timely manner; or

(2) If the decisionmaker determines

there is good cause for the

whistleblower’s failure to timely file.

§ 94.435 May a covered institution or

whistleblower challenge the

decisionmaker’s qualifications?

(a) Either the whistleblower or the

covered institution may challenge the

qualifications or objectivity of the

administrative proceeding’s

decisionmaker.

(b) Any challenge must be made

within 30 calendar days of the notice of

the appointment of the decisionmaker.

(c) If either party challenges the

decisionmaker’s qualifications or

objectivity, the challenge must be made

part of the record, and may be subject

to any ORI compliance review under

§ 94.510.

§ 94.440 May the decisionmaker be

replaced?

The covered institution may replace

the decisionmaker for good cause before

final resolution of the retaliation

complaint. Good cause includes—

(a) The decisionmaker dies or

becomes incapacitated;

(b) The decisionmaker is determined

to have a conflict of interest under

§ 94.435;

(c) The parties mutually agree to a

replacement; or

(d) The administrative proceedings’

procedures otherwise allow

replacement.

Remedies

§ 94.445 What remedies may a

decisionmaker impose?

(a) If the decisionmaker in an

administrative proceeding determines

that the covered institution or one of its

members retaliated against the

whistleblower, the decisionmaker must

order one or more remedies based on

the findings. The decisionmaker has

broad discretion in determining whether

all or any of the following remedies are

appropriate and warranted:

(1) Reinstate the terms and conditions

of the whistleblower’s status at the

institution that existed before the

retaliatory action, including but not

limited to employment (including

tenure eligibility and promotion

potential), academic matriculation,

awarding of degree, or relationship

established by grant, contract, or

cooperative agreement.

(2) Offer a position within the

institution that is comparable

financially, vocationally, and otherwise

to the position the whistleblower held

before the retaliatory action.

(3) Compensate the whistleblower for

any financial or other loss incurred

between the retaliatory action and the

provision of a remedy or remedies

under this part.

(4) Restore the whistleblower’s

reputation, to the greatest extent

feasible, within the institution and the

broader scientific community. If the

whistleblower agrees, this may include

an official retraction of negative

references or the publication of an

exoneration.

(5) Protect the whistleblower against

further potential retaliation. This may

include monitoring the retaliator for a

period of time.

(6) Compensate the whistleblower for

part or all expenses, if any, incurred

pursuant to the administrative

proceeding.

(7) Take any other action allowed

under law that reasonably restores the

whistleblower’s status and reputation.

(b) The institution must implement in

a timely manner the remedy(s) ordered

by the decisionmaker unless the order is

revoked or otherwise modified by an

appeal under § 94.450.

Appeals

§ 94.450 May a covered institution or

whistleblower appeal an adverse decision

or remedy?

Either the covered institution or the

whistleblower may appeal an adverse

finding or remedy by the decisionmaker

only if the administrative proceeding

allows an appeal or an appeal is

provided by state or other applicable

law.

Subpart E—Responsibilities of the

Office of Research Integrity

General Provisions

§ 94.500 What are ORI’s responsibilities?

(a) ORI is responsible for monitoring

covered institutions to determine

whether they have established

administrative procedures and are

following them in accordance with this

part and the institution’s certification of

compliance under § 94.330.

(b) ORI may take the remedial

administrative actions, specified in

§ 94.520, against covered institutions

that retaliate against good faith

whistleblowers or that otherwise do not

comply with the standards and

procedures of this part.

§ 94.505 What does ORI do when it

receives a whistleblower retaliation

complaint?

Consistent with § 94.205, if a

whistleblower brings a retaliation

complaint directly to ORI, ORI reviews

the complaint to determine if, on its

face, it meets the requirements of this

part. If so, ORI will instruct the

whistleblower to send the complaint to

the covered institution’s responsible

official or notify the responsible official

directly.

Compliance Reviews

§ 94.510 When does ORI do an

institutional compliance review?

(a) ORI may review a covered

institution’s compliance with the

provisions of this part at any time. ORI’s

decision to begin a compliance review

may be based on the institution’s

written whistleblower procedures, its

certification of compliance, its

submissions to ORI regarding

whistleblower retaliation complaints, or

70840 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

any other information ORI considers

relevant to the institution’s compliance

with this part.

(b) ORI’s review may include, but is

not limited to, requests for information,

on-site visits, inspection of relevant

records, and interviews with

institutional members.

§ 94.515 What factors does ORI consider

in a compliance review?

(a) If a covered institution complies

with each provision of this part, ORI

will consider the institution to be in

compliance with the institution’s

certification of compliance and this

part.

(b) ORI may consider a covered

institution’s failure to comply with the

provisions of this part to be a material

failure to comply with the institution’s

certification of compliance and with the

terms and conditions of any PHS

funding provided under an application

in which that certification is made.

§ 94.520 What administrative actions may

ORI take pursuant to a compliance review?

If ORI determines that a covered

institution has engaged in

whistleblower retaliation or has failed to

comply with any provision of this part,

ORI may impose, or recommend to the

appropriate authorized Department

official, imposition of one or more of the

following administrative actions:

(a) A corrective action plan including,

where applicable, oversight of the

institution’s responsible official and its

whistleblower protection procedures.

(b) Probationary status under which

the noncompliant institution could be

subject to cumulative administrative

actions if future incidents of

institutional noncompliance occur

including loss of PHS funding.

(c) Special conditions imposed upon

any future PHS awards of grants,

contracts, or cooperative agreements to

the institution.

(d) Recovery of PHS funds misspent

in connection with a retaliatory action

or other institutional noncompliance

with this part.

(e) Termination of PHS current or

future funding to the institution or any

part thereof.

(f) Public notice of the determination.

(g) Any other action that ORI finds

reasonable and appropriate to correct

the noncompliance.

§ 94.525 May a covered institution appeal

administrative actions imposed by ORI or

the Department?

A covered institution may appeal any

administrative actions imposed by ORI

or the Department under § 94.520 only

if an appeal is specifically allowed by

an existing Departmental regulation.

The institution must appeal under the

terms of the applicable regulation.

Subpart F—Definitions

§ 94.600 Administrative proceeding.

Administrative proceeding means the

procedure that a covered institution

employs or offers to employ to resolve

a whistleblower retaliation complaint in

compliance with the provisions of this

part.

§ 94.605 Adverse action.

Adverse action means any action

taken or threatened by a covered

institution or its member(s) that

negatively affects the terms or

conditions of the whistleblower’s status

at the institution, including but not

limited to employment, promotion,

academic matriculation, awarding of a

degree, financial aid, or relationship

established by grant, contract, or

cooperative agreement.

§ 94.610 Allegation.

Allegation means any disclosure,

whether by written or oral statement, or

other communication, to an institutional

or Departmental official, that a covered

institution or one of its members has

engaged in, or failed to respond

adequately to an allegation of, research

misconduct as defined by this part and

that involves the use of PHS funds or

the application for PHS funds.

§ 94.615 Contributing factor.

Contributing factor means any

whistleblower activity protected under

this part that alone or in combination

with other factors results in an adverse

action against the whistleblower.

§ 94.620 Covered institution.

Covered institution means any entity,

whether individual or corporate, that

applies for or receives grants, contracts,

or cooperative agreements under the

PHS Act, as amended (42 U.S.C. 201, et

seq.), for any program that involves the

conduct of biomedical or behavioral

research, research training or research

related activity. Covered institutions do

not include Federal agencies.

§ 94.625 Decisionmaker.

Decisionmaker means the person(s)

designated by the covered institution,

according to the rules of the

administrative proceeding made

available under this part, to preside over

the proceeding, to make preliminary

decisions of jurisdictional adequacy, to

make a final determination of whether

retaliation against the whistleblower

occurred based on the evidence

presented, and to order appropriate

remedies consistent with this part.

§ 94.630 Good faith.

(a) Good faith means having a belief

in the truth of one’s allegation or

testimony that a reasonable person in

the whistleblower’s position could have

based upon the information known to

the whistleblower at the time the

allegation was made.

(b) An allegation or cooperation with

an investigation is not in good faith if

made with knowing or reckless

disregard of information that would

negate the allegation or testimony.

§ 94.635 Institutional member or member.

(a) Institutional member or member

means a person who is employed by, is

affiliated with under a contract or

agreement, or is under the control of a

covered institution.

(b) Institutional members include, but

are not limited to, teaching and support

staff, researchers, clinicians,

technicians, fellows, students,

volunteers, and contractors,

subcontractors, and subawardees and

their employees.

§ 94.640 Investigation.

Investigation, solely for the purpose of

this part, means—

(a) An initial assessment by ORI, the

Department, or a covered institution.

(b) An inquiry or investigation by the

Department or a covered institution.

(c) Any institutional appeal of an

allegation of research misconduct

involving PHS funds or applications

therefor, including preparation for and

conduct of any research misconduct

hearing.

(d) A review, recommendation, or

decision regarding an assessment,

inquiry, or investigation by ORI or the

Department.

(e) An appeal to the Departmental

Appeals Board.

(f) An investigation of an alleged

inadequate response to an allegation of

research misconduct.

§ 94.645 Office of Research Integrity or

ORI.

Office of Research Integrity or ORI

means the office to which the Secretary

has delegated responsibility for

addressing research misconduct issues

related to PHS activities, including the

protection of whistleblowers.

§ 94.650 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,

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70841

Centers for Disease Control and

Prevention, Food and Drug

Administration, Health Resources and

Services Administration, Indian Health

Service, National Institutes of Health,

the Substance Abuse and Mental Health

Services Administration, and the offices

of the Regional Health Administrator.

§ 94.655 PHS funds or PHS funding.

PHS funds or PHS funding means

Public Health Service grants, contracts,

or cooperative agreements.

§ 94.660 Research misconduct.

Research misconduct means

fabrication, falsification, plagiarism, or

other practices that seriously deviate

from those that are commonly accepted

within the scientific community for

proposing, conducting, or reporting

research. It does not include honest

error or honest differences in

interpretations or judgments of data.

§ 94.665 Responsible official.

Responsible official means the official

designated by a covered institution to

establish and implement the

institution’s whistleblower protection

procedures as required by this part.

§ 94.670 Retaliation.

Retaliation for the purpose of this part

means an adverse action taken against a

whistleblower by a covered institution

or one of its members in response to—

(a) A good faith allegation that the

covered institution or one of its

members has engaged in, or failed to

respond adequately to an allegation of,

research misconduct; or

(b) A good faith cooperation with an

investigation of an allegation in

paragraph (a) of this section.

§ 94.675 Secretary.

Secretary means the Secretary of the

Department of Health and Human

Services or any other officer or

employee of the Department of Health

and Human Services to whom the

Secretary has delegated authority.

§ 94.680 Whistleblower.

Whistleblower means an institutional

member who in good faith—

(a) Makes an allegation that the

covered institution or one of its

members has engaged in, or failed to

respond adequately to an allegation of,

research misconduct; or

(b) Cooperates with an investigation

of an allegation in paragraph (a) of this

section.

[FR Doc. 00–29988 Filed 11–27–00; 8:45 am]

BILLING CODE 4160–17–U

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 697

[I.D. 112100A]

American Lobster Fishery

Management

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Notice of public meetings;

request for comments.

SUMMARY: NMFS has prepared a draft

supplemental environmental impact

statement (DSEIS) which identifies

several preferred management actions

and alternatives for the American

lobster fishery in Federal waters. These

measures are based upon

recommendations in Addendum 1 to

Amendment 3 of the Interstate Fishery

Management Plan for American Lobster

(ISFMP) made by the Atlantic States

Marine Fisheries Commission

(Commission) for management of the

American lobster resource in Federal

waters. NMFS will hold public meetings

to receive comments on the biological,

economic, and social impacts addressed

in the DSEIS.

DATES: Written comments on the

preferred lobster management measures

and alternatives discussed in the DSEIS

must be received at the appropriate

address or facsimile (fax) number (see

ADDRESSES), no later than 5 p.m.,

eastern standard time, on Tuesday,

January 9, 2001. Also, verbal comments

may be presented at public meetings

which are scheduled to be held from

Tuesday, December 12 through Friday,

December 15, 2000, in Maine, Rhode

Island, New York and New Jersey. See

SUPPLEMENTARY INFORMATION for times

and locations of the meetings and

special accommodations.

ADDRESSES: Written comments and

direct requests for copies of the lobster

public meeting document and DSEIS

should be sent to the State, Federal and

Constituent Programs Office, National

Marine Fisheries Service, Northeast

Region, One Blackburn Drive,

Gloucester, MA 01930-2298. Comments

may also be sent via fax to (978) 281-

9117. Comments submitted via email or

Internet will not be accepted.

FOR FURTHER INFORMATION CONTACT:

Peter Burns, NMFS, Northeast Region,

telephone (978) 281-9144, fax (978) 281-

9117.

SUPPLEMENTARY INFORMATION: NMFS is

considering several new management

measures for the American lobster

fishery in Federal waters in response to

the Commission’s recommendations in

Addendum 1 to Amendment 3 of the

ISFMP. Specifically, NMFS is

considering a preferred alternative to

control fishing effort in the lobster trap

fishery in LCMAs 3, 4 and 5 by limiting

access to only those Federal permit

holders who can substantiate a history

of trap fishing in these areas. The

eligibility criteria for access to these

management areas would be based upon

industry advice developed by the

ISFMP’s lobster conservation

management teams. In LCMA 3, eligible

permit holders would have to meet all

of the following criteria:

1. Possession of a current Federal

limited access lobster permit.

2. Provision of documentation to

demonstrate a history of 2 consecutive

calendar-months of active lobster trap

fishing in LCMA 3 in any calendar year

during the March 25, 1991 through

September 1, 1999 qualification period

(qualification period). A history of

active trap fishing is defined as the

fishing of at least 200 traps set in LCMA

3 for the duration of the 2-month

qualifying period. Documentation may

include copies of vessel logbooks, state

or Federal Fishing Trip Reports, permit

applications, or any other form of

certification that denotes area fished

and harvest information.

3. Provision of sales receipts or

records showing the landing of at least

25,000 lb (11,370 km) of lobster from

any area throughout the range of the

resource during the year used as the

qualifying year referenced in the

preceding paragraph (Criterion number

2).

Under the preferred alternative

Federal permit holders who qualify for

participation in LCMA 3 based on the

preceding criteria would be required to

submit a signed affidavit to NMFS

certifying the number of traps they have

historically fished in LCMA 3.

Qualifying permit holders would be

restricted to the number of traps they

have historically fished in that area, but

limited to no more than 3,250 traps, and

would be required to comply with

annual trap reductions over a 5-year

period.

In LCMA 4 and LCMA 5, the preferred

alternative would require eligible permit

holders to meet all of the following

criteria to participate in the trap fishery

in either of these areas:

1. Possession of a current Federal

limited access lobster permit.

2. Provision of documentation to

demonstrate a history of 2 consecutive