Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34839

contained in the agency’s annual report

to indicate the types of arbitration

issues, the average or median arbitration

fees and days spent on cases, and the

timeliness of the awards rendered.

Agency: Federal Mediation and

Conciliation Service.

Title: Notice to Mediation Agencies.

OMB Number: 3076–0004.

Agency Number: Form F–7.

Frequency: Once per collective

bargaining contract.

Affected Entities: Private sector

employers and labor unions involved in

interstate commerce who file notices for

mediation services to the FMCS and

state, local, and territorial agencies, who

receive copies of these notices filed.

Number of Respondents: 70,000.

Estimated Time Per Respondent: 10

minutes.

Total Burden Hours: 4,167

Total Annualized capital/startup

costs: $0.

Total annual costs (operating/

maintaining systems or purchasing

services): $0.

Description: The F–7 form was

created to establish conformity

throughout interstate commerce and to

allow FMCS to gather desired

information in a uniform manner. The

collection of such information,

including the name of employer or

employer association, address and

phone number, official contact,

bargaining unit and establishment size,

location of affected establishment and

negotiations, industry or type of

business, principal product or service,

union address, phone number, and

official contact, contract expiration date

or renewal date, whether the notice is

filed on behalf of the union or employer,

and whether this is health car industry

notice for initial contracts or existing

contracts, is critical for reporting and

mediation purposes.

Dated: June 27, 1996.

Wilma B. Liebman,

Deputy Director.

[FR Doc. 96–16984 Filed 7–2–96; 8:45 am]

BILLING CODE 6372–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Science Foundation

Frequently Asked Questions

Concerning the Department of Health

and Human Services Objectivity in

Research Regulations and the National

Science Foundation Investigator

Financial Disclosure Policy

AGENCIES: Public Health Service, and

Office of the Secretary, HHS; National

Science Foundation.

ACTION: Responses to questions.

SUMMARY: This document responds to

frequently asked questions regarding

PHS’ and NSF’s recently-issued rules on

investigator conflicts of interest. This

guidance document is intended to help

institutions implement conflict of

interest policies that comply with both

PHS and NSF requirements.

FOR FURTHER INFORMATION CONTACT: For

PHS: Geoffrey Grant, Acting Director,

Office of Policy for Extramural Research

Administration, National Institutes of

Health, Room 2192, 6701 Rockledge

Drive, MSC 7730, Bethesda MD 20817,

(301) 435–0949. For NSF: Christopher L.

Ashley, Assistant General Counsel,

National Science Foundation, 4201

Wilson Boulevard, Room 1265,

Arlington, VA 22230, (703) 306–1060.

SUPPLEMENTARY INFORMATION: On July

11, 1995, the Public Health Service

(PHS) and the Office of the Secretary of

the Department of Health and Human

Services (HHS) and the National

Science Foundation (NSF) issued rules

regarding investigator conflict of

interest. As explained in the preambles

to those rules, PHS and NSF have been

working together to ensure that the rules

impose consistent obligations on

institutions receiving PHS and NSF

funding. To that end, PHS and NSF

announced that the agencies would be

developing a set of questions and

answers (Q&As) to help institutions

implement conflict of interest policies

that comply with both PHS and NSF

requirements. This set of Q&As provides

answers to frequently asked questions

received by both agencies. Where there

are minor differences between the PHS

and NSF rules, they are clearly noted.

Q1: Does NSF or PHS have a

suggested format for investigator

disclosures?

A1: No. The rules are designed to

defer to the expertise of grantee

institutions in developing policies and

supporting documentation.

Q2: May an institution have different

conflict of interest policies that vary

among departments or professional

schools?

A2: Yes, as long as all policies meet

the minimum requirements of the NSF

and PHS rules.

Q3: Which offices within an

institution should be involved in

administering the conflict of interest

rules?

A3: An institution is free to

administer its policy through whatever

office or structure it wishes, as long as

the policy reaches all investigators on

NSF- and PHS-funded projects and the

requirements of the PHS and NSF rules

are met.

Q4: Must institutions routinely

require financial disclosures from

graduate students working on NSF- or

PHS-sponsored research?

A4: The term ‘‘investigator’’ is defined

to encompass individuals ‘‘responsible

for the design, conduct or reporting’’ of

NSF- or PHS-funded research. It is up to

the institution to decide whether

graduate student co-authors are

‘‘responsible for reporting’’ the research.

Q5: Will a proposal be processed if it

does not contain the new certification

required by the NSF and PHS rules?

A5: NSF will not process a proposal

in the absence of the new certification,

but in most cases the institution will not

be required to re-submit the entire

proposal. An addendum page to the

Cover Sheet to the National Science

Foundation (NSF Form 1207) has been

developed that contains the required

certification. The NSF administrative

officer typically will forward a new

certification page to the institution, and

will process the proposal upon receipt

of a completed and executed new page.

The PHS would process the application

without the proper certification but no

award would be made until the

awarding component received the

certification in the form of a signed,

revised application face page.

Q6: Do the PHS and NSF conflict of

interest rules apply to all researchers

and faculty members at institutions that

receive NSF or PHS support?

A6. No. The NSF policy applies only

to grantee institutions that employ more

than fifty persons and the PHS rule

exempts Small Business Innovation

Research (SBIR) and Small Business

Technology Transfer (STTR) Phase I

applications. In those institutions

subject to the NSF policy and/or the

PHS rule, only persons involved in

PHS- or NSF-funded research are

subject to the rules. However,

institutions may choose to cover other

researchers or faculty members under

their policies for institution-specific

reasons.
34840 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

Q7: Do the PHS or NSF rules apply to

subgrantees of PHS or NSF grantees?

A7: Consistent with current

regulations and policies, the PHS rule

applies to subgrants; the NSF Policy

does not. Accordingly, institutions

conducting PHS-funded research

through subgrantees, contractors, or

collaborators must take reasonable steps

to ensure that investigators working for

such entities comply with the

regulations (42 C.F.R. § 50.604(a)) either

by requiring the investigators to comply

with the grantee institution’s policy or

by requiring the entities to provide

appropriate assurances to the grantee

institution. An institution conducting

NSF-funded research through

subgrantees must certify that the

institution itself has in place a written,

enforced policy on investigator conflicts

of interest, but is not required to ensure

that subgrantees comply with the NSF

Policy. However, the Policy may apply

to a subgrantee employing investigators

who collaborate on NSF-sponsored

research (see Q&A 14).

Q8: Do the NSF or PHS rules apply to

post-doctoral fellowships?

A8: Not in most cases. The NSF policy

applies only to grantee institutions that

employ more than 50 persons and

therefore would not apply to postdoctoral fellowships awarded to

individuals. The PHS rule applies to

PHS-funded research and to any person

who is responsible for the design,

conduct or reporting of research funded

by the PHS. Thus, if a post-doctoral

fellow served in such a capacity in PHSfunded research he or she would be

subject to the rule. The PHS rule would

apply to a postdoctoral fellowship

application to the PHS only if the

funding would be used for research and

the fellow served in one of the research

capacities described above.

Q9: Are investigators required to

disclose interests in mutual funds?

A9: An interest in a pooled fund such

as a diversified mutual fund may be

sufficiently remote that it would not

reasonably be expected to create a

conflict of interest for a NSF- or PHSfunded investigator. For example, an

investigator may own an interest in a

diversified mutual fund which has

assets placed in many securities. It is

possible that certain of the securities

held by the mutual fund were issued by

an entity whose interests would

reasonably appear to be affected by

activities proposed for funding by NSF

or PHS. However, because it is likely

that an investigator’s interest in a

mutual fund is only a small portion of

the fund’s total assets and because only

a limited portion of the fund’s assets are

placed in the securities of a single

issuer, it is unlikely that an

investigator’s activities on an NSF or

PHS award would affect his or her

interest in the mutual fund. Institutions

therefore may determine that certain

interests in a diversified mutual fund

could never directly and significantly

affect the design, conduct or reporting of

PHS- or NSF-funded research and

exempt such interests from disclosure

by the investigator on that basis.

The federal government’s Office of

Government Ethics has detailed

regulations regarding the treatment of

diversified mutual funds under the

government’s conflict of interest rules. 5

C.F.R. § 2634.310(c); see also 60 Fed.

Reg. 47,208 (Sept. 11, 1995) (proposed

rule). Institutions may consult these

regulations for guidance on how they

might wish to treat interests in mutual

funds under their policies.

Q10: Are investigators required to

disclose interests in ‘‘blind trusts’’?

A10: Institutions may determine that

the research will not be affected by

qualified blind trust assets not known to

the investigator that are managed by an

independent fiduciary. Because such

assets would not be known to an

investigator, they could not directly and

significantly affect the design, conduct

or reporting of the research. Of course,

an investigator is aware of the assets

originally placed in the trust at the time

of its formation and would be required

to disclose any such assets that would

reasonably appear to be affected by

NSF- or PHS-funded research. Only new

assets purchased with the proceeds from

the original assets would be unknown to

the investigator.

As with diversified mutual funds, the

Office of Government Ethics has

detailed regulations describing the type

of trusts that qualify for the ‘‘blind

trust’’ exception to the government’s

conflict of interest rules. 5 C.F.R. Part

2634 Subpart D. Institutions may

consult these guidelines in determining

how they wish to treat certain trusts

under their policies.

Q11: Are foreign investments (e.g.,

shares in a foreign corporation) covered

by the financial disclosure requirement.

A11: Yes, if they would reasonably

appear to be affected by NSF- or PHSfunded research and do not fall within

one of the exceptions to the definition

of ‘‘significant financial interest.’’

Q12: Which conflicts of interest must

be reported to the federal government?

A12: Neither the PHS nor NSF rules

require any institution to report to the

federal government the details of any

conflict of interest that has been

resolved pursuant to the institution’s

Policy. Consistent with the statute

authorizing its conflict of interest rule,

the PHS requires institutions, prior to

the institution’s expenditure of any

funds under an award, to report to the

PHS Awarding Component the

existence of any conflicting interests

and assure that the interest has been

managed, reduced or eliminated in

accordance with PHS regulations. NSF

requires that only conflicts that have not

been managed, reduced or eliminated

prior to the expenditure of funds under

an award be reported to NSF.

Q13: Will investigator financial

records be subject to public disclosure?

A13: No. Normally, neither PHS nor

NSF would possess records of the

financial interests of investigators,

because institutions are not required to

submit those records. However, in the

event NSF or PHS had such information

either as a result of an audit or

compliance review or in connection

with a conflict of interest that cannot be

managed satisfactorily under the

institution’s policy, it would not be

disclosed to the public. Where a

member of the public submits a request

under the federal Freedom of

Information Act (FOIA) for financial

information in the possession of NSF or

PHS, the agencies would assert all

applicable FOIA exemptions in

response to such a request.

Q14: Is the applicant institution

required to obtain financial disclosures

from investigators who are not

employed by the applicant institution?

A14: The PHS rule provides that if the

institution carries out the PHS-funded

research through a collaborator, the

institution must take reasonable steps to

ensure that investigators working for the

collaborator comply with the rule, either

by requiring those investigators to

comply with the applicant institution’s

policy or by requiring an assurance from

the collaborating institution which will

enable the applicant institution to

comply with the rule. NSF would

expect that where an investigator does

not work for the applicant institution,

the applicant institution would obtain

an assurance from the institution

employing the investigator indicating

that the investigator has complied with

the requirements of the policy at that

institution.

Q15: Are all ‘‘senior personnel’’ listed

in NSF proposals and ‘‘key personnel’’

listed in PHS proposals subject to the

financial disclosure requirements of the

conflict of interest rules?

A15: As explained in Q&A 4, the term

‘‘investigator’’ is defined functionally

rather than categorically. Although the

agencies believe that senior and key

personnel will be ‘‘responsible for the

design, conduct or reporting of

research’’ under the rules in almost all
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34841

cases, it is possible to conceive

situations in which senior or key

personnel might not meet the definition

of ‘‘investigator.’’ Institutions are also

responsible for obtaining financial

disclosures from persons other than

senior or key personnel who meet the

definition of ‘‘investigator.’’

Q16: How should institutions with

fewer than 50 employees complete the

certification page for NSF proposals?

A16: Such institutions should

annotate NSF Form 1207 or the

addendum page (See Q&A1 above) to

indicate that they have fewer than 50

employees and are therefore exempt

from the Investigator Financial

Disclosure Policy. These institutions are

not exempt from the PHS regulations.

Q17: Salary, royalties and other

payments that ‘‘are not expected to

exceed $10,000 over the next twelve

month period’’ are excluded from the

definition of ‘‘significant financial

interest.’’ How should an investigator

estimate expected income over the next

twelve months?

A17: The agencies have no preferred

estimation method. Investigators must

make their best reasonable estimates of

expected income in determining

whether salary, royalties or other

payments constitute ‘‘significant

financial interests.’’ This issue is

separate from an investigator’s ongoing

duty to update financial disclosures

either annually or as new significant

financial interests are obtained

throughout the period of the award.

Q18: How can an institution

determine that all required disclosures

have been made before submitting a

proposal to NSF or PHS?

A18: As part of the institution’s

routine proposal preparation procedures

institutions should require investigators

to ensure that they have made all

required financial disclosures in accord

with the regulations prior to the time

the organizational representative makes

the certification in an NSF or PHS

proposal. NSF and PHS staff, auditors

and others concerned with the proper

implementation of these regulations

would expect such an arrangement at

any institution that certifies to the

maintenance of an appropriate written,

enforced policy on conflict of interest.

Q19: Must an investigator report to

the institution a single share of stock?

A19: A single share of stock would

have to be reported only if (i) it is

valued at more than $10,000 or

represents more than a five percent

ownership interest in the corporation;

and (ii) it would reasonably appear that

the value of the stock could be affected

by the research for which funding is

sought or that the financial interest of

the corporation would be so affected.

The rules define a significant

financial interest as anything of

monetary value including equity

interests (e.g., stocks, stock options, or

other ownership interests) but the

definition excludes an equity interest

that does not exceed $10,000 in value

and represents no more than a 5%

ownership interest in any single entity.

This means that, under the rules, an

investigator would never have to report

an equity interest of $10,000 or less

which represents 5% or less ownership

interest in any single entity because that

combination of value and ownership is

excluded by definition from the term

‘‘significant financial interest.’’ On the

other hand, under the rules, an

investigator would always have to

report an equity interest exceeding

$10,000 or an ownership interest

exceeding 5% in any single entity,

regardless of value, if that equity

interest or ownership interest was held

in an entity whose financial interests

would reasonably appear to be affected

by the specified activities for which

funding is sought.

Q20: When and how will the NSF and

PHS rules be reviewed and revised?

A20: The agencies anticipate that after

two or three years of experience with

the rules, they will solicit public

comments regarding whether changes

are necessary or appropriate.

Dated: June 13, 1996.

Dr. Harold Varmus, M.D.,

Director, National Institutes of Health.

Lawrence Rudolph,

General Counsel, National Science

Foundation.

[FR Doc. 96–16974 Filed 7–2–96; 8:45 am]

BILLING CODE 7555–01–P, 4140–01–P

Centers for Disease Control and

Prevention

[INFO–96–18]

Proposed Data Collections Submitted

for Public Comment and

Recommendations

In compliance with the requirement

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

Centers for Disease Control and

Prevention (CDC) will publish periodic

summaries of proposed projects. To

request more information on the

proposed projects or to obtain a copy of

the data collection plans and

instruments, call the CDC Reports

Clearance Officer at (404) 639–7090.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

for other forms of information

technology. Send comments to Wilma

Johnson, CDC Reports Clearance Officer,

1600 Clifton Road, MS–D24, Atlanta,

GA 30333. Written comments should be

received within 60 days of this notice.

Proposed Projects

1. Survey of State-Based Diabetes

Control Cooperative Agreement

Programs—New—Diabetes mellitus and

related complications are the seventh

leading cause of death in the United

States, and accounts for $105 billion in

direct medical costs and lost

productivity each year. Approximately

14 million Americans have been

diagnosed with diabetes, a leading cause

of new blindness and end-stage renal

failure in the United States and a major

co-morbid factor in lower extremity

amputation, cardiovascular disease and

related death, and neonatal morbidity

and mortality.

Through the support of the Centers for

Disease Control and Prevention’s (CDC)

‘‘State-Based Program to Reduce the

Burden of Diabetes: A Health Systems

Approach,’’ public health departments

in 42 states and four U.S. territorial

affiliated jurisdictions have been

charged with providing leadership in

reducing the gap between what should

be and what is the current standard of

diabetes care.

CDC will collect information from

diabetes State Program Coordinators

regarding the four key areas of program

implementation. They are (1) capacity

building and infrastructure

development, (2) surveillance and data

collection, (3) health systems change,

and (4) working with local programs.

The survey has three main objectives:

1. Document the progress made by

Diabetes Control Programs in the four

main areas of program implementation.

2. Assess the relationship between the

level of infrastructure development, and

a program’s efforts to carry out

surveillance activities, health systems

change activities, and work with local

programs. Information will help

improve technical assistance (TA) and

guidance offered to states by CDC.