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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

CONFIDENTIAL FINANCIAL DISCLOSURE REPORT FOR SPECIAL GOVERNMENT EMPLOYEES

Use the list of products/firms/issues in the cover memorandum to complete this form. Interests relating to these firms must be reported even if unrelated to products/indications listed.

Please answer all questions below to the best of your knowledge. If you are employed by a university or other research institution, you may have little or no personal knowledge about certain financial interests of your employer (e.g., the details of certain research grants in which you are not personally involved). In those cases, you are required to report only what you actually know about the interest, and you have no duty to inquire about further details from your employer. In some situations, however, you may hold a position (such as department chair) in which you exercise some authority with respect to research projects in which you are not personally involved as an investigator or researcher. In those cases, inquiry into additional information about the interest could be helpful in preventing unintentional conflicts of interest or appearances of impropriety.
1. CURRENT FINANCIAL INTERESTS

To your knowledge, do 1) you, your spouse, minor child, general partner, 2) organization in which you serve as an officer, director, trustee, general partner or employee, and/or 3) entity with whom you are negotiating or have any arrangement concerning prospective employment have any current involvement or financial link with the meeting/task issues (including competing companies)?
a. INVESTMENTS (e.g., stocks, bonds, retirement plans, trusts, partnerships, sector funds, etc.)
FIRM TYPE OF INVESTMENT OWNER (self, spouse, etc.)

NONE (If "none," skip to Item b.)
NUMBER OF SHARES CURRENT VALUE CHECK PERCENTAGE OF NET WORTH LESS MORE 5 - 15% THAN 5% THAN 15%

b. EMPLOYMENT (Full or Part Time) (Current or Under Negotiation)
FIRM RELATIONSHIP (self, spouse, etc.)

NONE (If "none," skip to Item c.)
POSITION IN FIRM DATE EMPLOYMENT OR NEGOTIATIONS BEGAN

c. CONSULTANT / ADVISOR (Current or Under Negotiation)
FIRM TOPIC / ISSUE

NONE (If "none," skip to Item d.)
AMOUNT RECEIVED DATE FROM DATE TO RELATED TO LISTED PRODUCTS / INDICATIONS / ISSUES YES NO

YES

NO

YES

NO

d. CONTRACTS / GRANTS / CRADAS (Current or Under Negotiation)
TYPE OF AGREEMENT (contract, grant, CRADA) PRODUCT UNDER STUDY AND INDICATIONS AMOUNT OF REMUNERATION TO INSTITUTION YOU TIME PERIOD

NONE (If "none," skip to Item e, next page.)
SPONSOR * YOUR ROLE AWARDEE RELATED TO LISTED PRODUCTS / INDICATIONS / ISSUES YES NO

YES

NO

YES

NO

YES

NO

* Government; Firm; Institution; Individual Site Investigator; Principal Investigator; Co-Investigator; Employee; Partner; No Involvement; or Other

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FORM FDA 3410 (10/01) (PAGE 1) Save Data

PSC Media Arts (301) 443-1090

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1. CURRENT FINANCIAL INTERESTS (Continued) e. PATENTS / ROYALTIES / TRADEMARKS
FOR FIRM RELATED TO LISTED PRODUCTS / INDICATIONS / ISSUES YES NO

NONE (If "none," skip to Item f.)
IF "YES," EXPLAIN BELOW AND INDICATE INCOME RECEIVED

YES

NO

YES

NO

f. EXPERT WITNESS (Last 12 months or under negotiation)
I appeared for or against the following listed firm(s) / issue(s).
FIRM / ISSUE AMOUNT RECEIVED RELATED TO LISTED PRODUCTS / INDICATIONS / ISSUES YES NO

NONE (If "none," skip to Item g.)
IF "YES," EXPLAIN BELOW

YES

NO

YES

NO

g. SPEAKING / WRITING (Last 12 months or under negotiation)
FIRM TOPIC / ISSUE

NONE (If "none," skip to Item 2.)
AMOUNT RECEIVED DATES HONORARIUM TRAVEL RELATED TO LISTED PRODUCTS / INDICATIONS / ISSUES YES NO

YES

NO

YES

NO

2. PAST FINANCIAL INTERESTS

a. To your knowledge, do any of the following persons have any past involvement with the meeting/task issues: You, your spouse, minor child, general partner, organization in which you serve as an officer, director, trustee, general partner or employee.
YES NO NOT TO MY KNOWLEDGE
RELATED TO LISTED PRODUCTS / INDICATIONS / ISSUES YES NO

b. If "Yes," describe involvement.
FIRM / PRODUCT FINANCIAL INVOLVEMENT (e.g., contract / consultant) ROLE DATES

YES

NO

YES

NO

YES

NO

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FORM FDA 3410 (10/01) (PAGE 2)

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3. OTHER INVOLVEMENTS (Other Kinds of Relationships) NONE (If "none," skip to Item 4.)

Using the list of products/firms/issues in the cover memorandum, identify anything that would give an "appearance" of a conflict, which has not been disclosed above (e.g., involvement in a law suit, researcher initiated study, gift of research materials, etc.).

4. CERTIFICATION STATEMENT

The above information is true and complete to the best of my knowledge. I have read and I understand the policies relating to my obligations as a special Government employee. If there are any changes, I will notify you before the meeting/task. My response contains pages.
SIGNATURE DATE

PLEASE RETURN BY:

To: COMMITTEE MANAGEMENT CONTACT

ADDRESS

TELEPHONE

FAX

(

)

(
PRIVACY ACT STATEMENT

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Title I of the Ethics in Government Act of 1978 (5 U.S.C. App.), Executive Order 12674, and 5 CFR Part 2634, Subpart I, of the Office of Government Ethics regulations require the reporting of this information. The primary use of the information on this form is for review by Government officials of your agency, to determine compliance with applicable Federal conflict of interest laws and regulations. Additional disclosures on the information on this report may be made: (1) to a Federal, State, or local law enforcement agency if the disclosing agency becomes aware of a violation or potential violation of law or regulation; (2) to a court or party in a court or Federal administrative proceeding if the Government is a party or in order to comply with a subpoena; (3) to a source when necessary to obtain information relevant to a conflict of interest investigation or decision; (4) to the National Archives and Records Administration or the General Services Administration in records management inspections; (5) to the Office of Management and Budget during legislative coordination on private relief legislation; and (6) in response to a request for discovery or for the appearance of a witness in a judicial or administrative proceeding, if the information is relevant to the subject matter. This confidential report will not be disclosed to any requesting person unless authorized by law. Falsification of information or failure to file or report information required to be reported may subject you to disciplinary action by your employing agency or other appropriate authority. Knowing and willful falsification of information required to be reported may also subject you to criminal prosecution.

FOR FDA USE ONLY
SIGNATURE OF REVIEWING OFFICIAL DATE

COMMENTS OF REVIEWING OFFICIAL

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