FDA Logo links to FDA home page
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

horizonal rule

COI CRITERIA GUIDANCE

A. STOCKS AND INVESTMENTS

In firms expected to be affected by the matters before the Committee; includes SGE's imputed interest* (spouse, minor child and general partner, organization or entity which the employee serves as officer, director, trustee, general partner or employee or with a person with whom the employee is negotiating for or has an arrangement concerning prospective employment)

Involvement Level Expected Action
Low Involvement

General Matters:

  • Stock value is less than or equal to $25,000 per entity/$50,000 in aggregate (5 CFR 2640.202(b) de minimis exemption)

Party Matters:

  • Stock value is less than or equal to $5,000 in aggregate (5 CFR 2640.202(a) de minimis exemption)

 


Cover memo

 

Cover memo

Medium Involvement

General Matters:

  • Stock value is greater than $25,000, but less than or equal to $100,000 per entity
  • Stock is 15-25% of SGE's net worth

Party Matters:

  • Stock value is greater than $5,000, but less than or equal to $100,000 per entity ($50,000 for homework)
  • Stock is less than 15% of SGE's net worth (less than 5% for homework)

Decision (W)
Decision (WC)



Decision (WC)
Decision (WC)

High Involvement

General Matters:

  • Stock value is greater than $100,000 per entity
  • Stock value is greater than 25% of SGE's net worth

Party Matters:

  • Stock value is greater than $100,000 for one entity OR greater than 15% of SGE's net worth

    (For homework: greater than $50,000 for one entity OR greater than 5% of net worth)

 

Decision (WC)
Decision (WC)

Exclusion

* CDER/CBER see 505 (n)(4) waiver

CIRCUMSTANCES FAVORING USE OF SGE:

| Table of Contents |

B. PRIMARY EMPLOYMENT

All SGEs (except non-voting industry representatives) including other Federal employees and family members* For consulting activities see Section C.

Involvement Level Expected Action
Low Involvement

General Matters:

  • Matters will not have a special or distinct effect on the SGE or employer, the Committee's decision may affect SGE/employer only as a part of a class of product manufacturers (5 CFR 2640.203 (g) exemption for non-Federal employment interests of SGEs on advisory committees)
  • SGE is a federal employee, and his agency is conducting research for one or more firms with an interest in the general matter before the Committee

Party Matters:

  • The SGE's spouse is employed (stock/stock options or pension plan) in a MEDIUM to LARGE sponsoring or competing firm, but his/her role in the firm is not connected with the product at issue and the employee is not in the management hierarchy. If stock is less than $5,000 - Cover memo, greater than $5,000 - Waiver
  • An individual with whom the SGE has a covered relationship is employed in a MEDIUM to LARGE sponsoring or competing firm, but his/her role in the firm is not connected with the product at issue and the employee is not in the management hierarchy

 

Cover memo


Cover memo




Decision (WC)


Decision (AC)

Medium Involvement

General Matters:

  • Matters will have a special or distinct effect on the SGE or employer

Party Matters:

  • SGE is a federal employee and his agency, not his organizational component, is conducting research on the product under review - funding from the sponsor is less than $500,000/per year
  • Within the past 12 months, the SGE was employed by the sponsor or competing firm, but had nothing to do with the issue before the Committee
  • An individual with whom the SGE has a covered relationship is employed in a MEDIUM to LARGE sponsoring or competing firm and his/her role is/was connected to the product at issue, but is not part of the management hierarchy of the firm AND has financial interest

 

Decision (WC)



Cover memo

Decision (AE)

Decision (AE)

High Involvement

Party Matters:

  • SGE is a federal employee and his agency is working on a large collaborative agreement or CRADA in which the sponsor or competitor is providing a large amount ($500,000) of monetary support.
  • SGE has a covered (appearance) relationship with individual, e.g., adult child, significant other, who is a party or represents a party to the matter before the Committee
  • The SGE's spouse is employed in a MEDIUM to LARGE sponsoring or competing firm and his/her role is/was connected to the product at issue, but is not part of the management hierarchy of the firm AND has financial interest
  • The SGE's spouse is employed by SMALL sponsoring or competing firm, his/her role is irrelevant
  • The SGE's spouse is an officer in the sponsoring or competing firm, or is the regulatory affairs officer or has significant administrative duties AND/OR has significant financial interests. (Size of the firm is irrelevant)

 

Decision (AE)

Decision (AE)

Decision (WC)

Exclusion

Exclusion

* CDER/CBER see 505(n)(4) waiver

B. PRIMARY EMPLOYMENT continued

CIRCUMSTANCES FAVORING USE OF SGE:

PROVIDED BELOW IS THE DEFINITION OF COVERED RELATIONSHIP (5 CFR PART 2635.502

| Table of Contents |

C. CONSULTANT/ADVISOR

With firms expected to be affected by the matter before the Committee* The table refers to current activities unless specified as "past".

Involvement Level Expected Action
Low Involvement

SGE receives less than $10,000 per source per year

General Matters:

  • Consulting on related or unrelated issue completed within the past 12 months (all monies paid)
  • Consulting on unrelated issue is current or under negotiation
  • Consulting on related issue is current or under negotiation

Party Matters:

  • Consulting on unrelated issue in the past or completed within the past 12 months (all monies paid)
  • Consulting on unrelated issue is current or under negotiation
  • Consulting on related issue in the past
  • Consulting on related issue is current or under negotiation

 

 

Cover memo
Decision (W)
Decision (WC)



Cover memo
Decision (W)
Decision (AC)
Exclusion

Medium Involvement

SGE receives between $10,000 and $50,000 per source per year

General Matters:

  • Consulting on related or unrelated issue completed within the past 12 months (all monies paid)
  • Consulting on unrelated issue is current or under negotiation
  • Consulting on related issue is current or under negotiation

Party Matters:

  • Consulting on unrelated issue in the past or completed within the past 12 months (all monies paid)
  • Consulting on related issue in the past or completed within the past 12 months (all monies paid)
  • Consulting is general in nature and does not involve product development or research
  • Consulting is for a competitor's related issue, but SGE does not hold a prominent role
  • Consulting is current or under negotiation for product or related products

 

 


Cover memo
Decision (W)
Decision (WC)

Cover memo
Decision (AC)
Decision (W)
Decision (WC)
Exclusion

High Involvement

SGE receives more than $50,000 per source per year

General Matters:

  • Consulting on related or unrelated issue completed within the past 12 months (all monies paid)
  • Consulting on unrelated issue is current or under negotiation
  • Consulting on related issue is current or under negotiation

Party Matters:

  • Consulting on sponsor's or competitor's unrelated product
  • Consulting on sponsor's or competitor's product

 

 

Cover memo
Decision(W)
Decision (WC)


Exclusion **
Exclusion

* CDER/CBER see 505(n)(4) waiver

**SGE may be granted a limited waiver in cases where the expertise is otherwise not available

C. CONSULTANT/ADVISOR continued

CIRCUMSTANCES FAVORING USE OF SGE:

| Table of Contents |

D. CONTRACTS/GRANTS/CRADAS (DEPARTMENT CHAIR - SEE SECTION H

Involving SGE's University/Hospital/Employer and firms expected to be affected by the matter before the Committee*

The table refers to current activities unless specified as "past."

Involvement Level Expected Action
Low Involvement

Remuneration is less than $100,000 per source per year to institution /$10,000 per source per year as salary support to the SGE

General Matters:

  • Work on unrelated matter is current or completed within the past 12 months
  • Work on related matter has been completed over a year ago
  • Work on related matter

Party Matters:

  • Work on unrelated product is currently active or completed within the past 12 months
  • Work is general on related product or SGE will be the principal investigator (PI) on competitor's product
  • SGE is or will be the principal investigator (PI) on sponsor's product

 

 


Cover memo
Cover memo
Decision (W)


Cover memo
Decision (WC)
Exclusion**

Medium Involvement

Remuneration is between $100,000-$300,000 per source/year to institution/$10,000-$15,000 per source/year as salary support to the SGE

General Matters:

  • Work on unrelated matter is current or completed within past 12 months
  • Work on related matter

Party Matters:

  • Work on unrelated product is current or completed within past 12 months
  • SGE has a limited role in work on product or competing product
  • Work was on competitor's product with SGE as PI, but completed more than a year ago
  • SGE is or will be PI on sponsor's or competitor's product

 

 


Cover memo
Decision (WC)


Decision (AE)
Decision (WC)
Decision (AC)
Exclusion**

High Involvement

Remuneration is more than $300,000 per source/year to institution//$15,000 per source/year as salary support to the SGE

General Matters:

  • Work on unrelated product is current or completed within past 12 months
  • Work on related matter

Party Matters:

  • Work on unrelated product
  • SGE is PI on sponsor's product

 

 



Decision (AE)
Decision (WC)


Decision (AE)
Exclusion**

*CDER/CBER see 505(n)(4) waiver

** See next page

D. CONTRACTS/GRANTS/CRADAS continued

CIRCUMSTANCES FAVORING USE OF SGE:

EXCLUSION CRITERIA FOR INVESTIGATORS:

| Table of Contents |

E. PATENTS/ROYALTIES/TRADEMARKS

Since a patent is an intellectual property interest and a potential source of income, it may be considered a financial interest even if no licensing of the patent has occurred.

Involvement Level Expected Action
Low Involvement

SGE receives less than $15,000 in royalties per affected source annually

General Matters:

  • SGE has a patent that has been in existence for a long time but no licensing or potential commercial use is envisioned
  • SGE has a patent with relevance to general matters and receives or anticipates royalties

Party Matters:

  • SGE has a patent on an unrelated product, licensed by a competing firm, and receives royalties
  • SGE has a patent that could be used in products that would compete with the product at issue, but no firm has licensed it yet

 

 

Decision (W)

Decision (W)



Cover memo
Decision (W)

Medium Involvement

SGE receives between $15,000 - 100,000 in royalties per affected source annually

General and Party Matters:

  • SGE has a patent on an unrelated product, and receives royalties from a firm at issue
  • SGE has a patent on the product at issue or a competing product

 

 

Decision (AE)
Exclusion

High Involvement

SGE receives more than $100,000 in royalties per affected source annually

General Matters:

  • SGE has a patent on an unrelated product and receives royalties from a firm at issue

Party Matters:

  • SGE has a patent on an unrelated product and receives royalties from the sponsor or competing firms
  • SGE has a patent on the product at issue or a competing product




Decision (AE)


Exclusion
Exclusion

CIRCUMSTANCES FAVORING USE OF SGE:

| Table of Contents |

F. EXPERT WITNESS

NOTE: Apart from the considerations below, SGEs are subject to the following restriction on their expert witness activities: They may not serve as an expert witness in any proceeding of a federal court or agency, if they have participated in the same proceeding or particular matter that is the subject of the proceeding or particular matter as part of their official duties and if the U.S. is a party or has a direct and substantial interest. Additional restrictions, usually not applicable to FDA advisory committee members, apply to certain SGEs 5 C.F.R. section 2635.805.

Involvement Level Expected Action
Low Involvement

Remuneration is less than $5,000 per affected source per year

General:

  • SGE makes no statement for or against any product of a sponsor or competitor

Party Matters:

  • SGE makes no statement for or against any product of a sponsor or competitor

 

 

Cover memo

Decision (AC)

Medium Involvement

Remuneration is between $5,000 and $10,000 per affected source per year

General and Party Matters:

  • SGE makes no statement for or against any product of a sponsor or competitor
  • SGE testified more than one year ago for/against the sponsor or competitor on an unrelated or related product

 

 

Decision (AC)
Decision (AE)

High Involvement

Remuneration is more than $10,000 per affected source per year

General and Party Matters:

  • SGE has testified within the past 12 months or will testify for/against sponsor's or competitor's unrelated product
  • SGE has testified within the past 12 months or will testify for/against sponsor's or competitor's related product

 

 

Decision (AE)

Exclusion

CIRCUMSTANCES FAVORING USE OF SGE

| Table of Contents |

G. TEACHING/SPEAKING/WRITING

Teaching/speaking/writing activities actually pose two separate, although sometimes related, questions: (1) whether the SGE may accept any compensation for the activity, pursuant to 5 C.F.R. section 2635.807; and (2) whether the SGE may participate in an FDA matter affecting the interests of the person who offered the compensation.

  1. Acceptance of Compensation. Pursuant to 5 C.F.R. section 2635.807, an SGE may not accept compensation for teaching/speaking/writing related to his or her official duties. An activity may be related to an SGE's official duties in several different ways, see 5 C.F.R. section 2635.807(a)(2)(i)(A-E), but the most common problem encountered by FDA is teaching/speaking/writing where the offer or invitation came from a person who has interests that may be substantially affected by the SGE's duties, within the meaning of section 2635.807(a)(2)(i)(C). An SGE may not accept compensation for teaching/speaking/writing where the offer came from such a person after it was known that the SGE was assigned or scheduled to participate in the particular matter. As an exception to this ban on compensation, an SGE may accept the offer of compensation if, and only if, he or she recuses from the matter, pursuant to 5 C.F.R. section 5501.108.
  2. Recusal or Participation. There is only one situation in which an SGE absolutely must recuse him/herself: as described in the previous paragraph, an SGE must recuse if he or she decides to accept compensation for teaching/speaking/writing where the offer or invitation came from a person who has interests that may be substantially affected by the SGE's duties. As explained above, this requirement applies only where the offer or invitation came after the SGE was already assigned or scheduled to participate in the matter that would affect the person's interests.

In all other situations, FDA has discretion to authorize the participation of a person who has a current, past (i.e., within the past 12 months), or prospective teaching/speaking/writing engagement with a person whose interests may be affected by the matter in which the SGE might participate. The range of situations and some of the factors FDA may consider in making these determinations are set out in the table that follows.

G. TEACHING/SPEAKING/WRITING continued

<
Involvement Level Expected Action
Low Involvement

SGE receives less than $5,000 per source per year

  • Topic is unrelated to the particular matter and SGE receives no compensation
  • Topic is unrelated and SGE is compensated
  • Topic is related but SGE receives no compensation (including travel)
  • Topic is related but not specific to the matter under discussion by the committee and SGE is compensated


Cover memo
Cover memo
Cover memo
Cover memo

Medium Involvement

SGE receives between $5,000 - $10,000 per source per year

  • Topic is unrelated to the particular matter at issue
  • Topic is related but not specific to matter under discussion

 

Decision (AC)
Decision (WC)

High Involvement

SGE receives more than $10,000 per source per year

  • Topic is unrelated to the particular matter at issue
  • Topic concerns a highly sensitive or controversial subject and relates to particular matter at issue
  • Performance or nonperformance of official duties will substantially affect the continuing relationship between SGE and the organization
  • Arrangement is with an organization that would be substantially affected by a matter currently assigned

 

Decision (AE)
Exclusion
Exclusion

Exclusion

CIRCUMSTANCES FAVORING USE OF SGE:

| Table of Contents |

H. DEPARTMENT HEADS - CONTRACTS/GRANTS/ CRADAS

With firms expected to be affected by the matter before the Committee
NOTE: Administrative role means managerial duties unrelated to the conduct of studies.

Involvement Level Expected Action
Low Involvement

Remuneration is less than $300,000 per source per year to SGE's department

General Matters:

  • Work on unrelated matter is current or has been completed within the past 12 months
  • Work on related matter has been completed within the past 12 months, and SGE had only an administrative role
  • SGE's department is currently working on a related matter, but SGE has only an administrative role

Party Matters:

  • Work on unrelated matter is current or has been completed within the past 12 months
  • Work on related matter has been completed within the past 12 months and SGE had only an administrative role
  • SGE's department is currently working on a related matter, but SGE has only an administrative role

 



Cover memo
Cover memo

Decision (W)


Cover memo
Cover memo

Decision (W)

Medium Involvement

Remuneration is between $300,000 -$600,000 per source per year to SGE's department

General Matters:

  • Work on unrelated matter is current or has been completed within the past 12 months
  • Work on related matter has been completed within the past 12 months and SGE had only an administrative role
  • SGE's department is currently working on a related matter, but SGE has only an administrative role

Party Matters:

  • Work on an unrelated matter is current or has been completed within the past 12 months
  • Work on related matter has been completed within the past 12 months and SGE had only an administrative role
  • SGE's department is currently working on a related matter and SGE has only an administrative role
  • SGE's department is negotiating on a related matter and SGE will have only an administrative role







Cover memo
Cover memo

Decision (W)



Cover memo
Decision (AC)

Decision (W)
Exclusion

High Involvement

Remuneration is more than $600,000 per source per year to the SGE's department

General Matters:

  • Work on unrelated matter is current or completed within the past 12 months
  • Work on related matter has been completed within the past 12 months and SGE had only an administrative role
  • SGE's department is currently working on a related matter and SGE has an administrative role

Party Matters:

  • Work on unrelated matter is current or completed within the past 12 months
  • Work on related matter has been completed within the past 12 months and SGE had only an administrative role
  • SGE's department is currently working on a related matter and SGE has only an administrative role
  • SGE's department is negotiating on a related matter and SGE will have only an administrative role

 

 

Decision (AE)
Decision (AE)

Decision (WC)


Decision (AE)
Decision (AE)

Decision (WC)
Exclusion

H. DEPARTMENT HEADS - CONTRACTS/GRANTS/CRADAS continued

CIRCUMSTANCES FAVORING USE OF SGE:

| Table of Contents |

I. EXCEPTIONS FOR INSTITUTIONAL DIRECTORS

Funding in support of Contracts/Grants/Continuing Medical Education (CME) Seminars is received from firms expected to be affected by the decisions of the Committee.

NOTE: SGE does not or will not receive any personal remuneration or salary support from the funds received by the institution. SGE's role is administrative only.

If addressing a party matter that is related to the meeting topic, use Table D.

Involvement Level Expected Action
Low Involvement

General Matters: (no dollar threshold limits)

  • The interests reported are from firms that potentially could be affected by the particular matters of general applicability. These interests may or may not be related to the general matter at hand.

Party Matters: (up to $750,000 per source per year)

  • The interests reported are unrelated to the product at issue or to the competing products



Decision (WC)




Cover memo

Medium Involvement

Party Matters: ($750,001 - $1,000,000 per source per year)

  • The interests reported are unrelated to the product at issue or to the competing products

 

Decision (AC)

High Involvement

Party Matters: (more than $1,000,000 per source per year)

  • The interests reported are unrelated to the product at issue or to the competing products, however, based upon the magnitude of dollars involved, this situation could present appearance concern


Decision (AE)

CIRCUMSTANCES FAVORING USE OF SGE:

| Table of Contents |

horizonal rule