APPENDIX II

11.

RESTRICTION ON POST-EMPLOYMENT ACTIVITIES. 18 U.S.C. 207 prevents
individuals who have left Government service, including former SGE`s,
from representing another person in connection with certain matters
in which they participated personally and substantially on behalf of
the Government. The matters are those involving a specific party or
parties in which the United States is also a party or has a direct and
substantial interest.

The questions created by the application of this statutory provision to
specific situations are difficult. For example, FDA may appoint advisory
committee members to review an entire class of products used by a parti-
cular group of scientific or medical specialists. In such situations,
the prospective SGE cannot always foresee the particular matters with
which he may become involved to a personal and substantial degree.
Because the Conflict of Interest Statutes were not intended to deny
the Federal Government access to the highest quality scientific and
medical advice, the Agency will utilize the exemption provided in the
statutes when necessary. Section 207(b) of 18 U.S.C. permits the
government to grant an exemption from post-employment restrictions
when it is in the national interest. FDA anticipates that there will
be circumstances where it will be in the national interest to consider
granting such an exemption to advisory committee members and other
consultants and experts.

In addition to the previous restriction, 18 U.S.C. 207 also prevents
a former employee for a period of one year after his employment has
ceased, from appearing personally for another person before a court,
department or agency in any matter that was within the area of his
official responsibility at any time during the last year of his
Government service. FDA believes that this one year limitation on
all particular matters would not ordinarily apply to advisory com-
mittee members because they do not have "official responsibility" in
the sense intended by the statute. SGE's employed by FDA are usually
involved in either broad policy and procedures covering a number of
products (which are not considered a particular matter), or particular
matters that are not likely to recur.

Whenever an SGE believes his service may result in a post-employment
restriction, he should seek advice from FDA by contacting the parti-
cular FDA employee who has the administrative responsibility for his
employment. This same official should also be contacted whenever
a situation arises that pertains to an SGE's involvement with another
agency or court on behalf of a party other than the Government over a
matter regulated by FDA.

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12. SUMMARY OF RESTRICTIONS. Sections 7 through 10 discuss situations involving various categories of financial interests which could limit an SGE's participation. As an aid to prospective SGE's, the following table summarizes the general restrictions. For specific details and special circumstances, readers should refer to the sections of the guide noted in parentheses in the right hand column of the table.

1 Applies to interests in firms involved with products regulated by the particular FDA bureau/office employing the Special Government Employee.

2 Applies to advisory committee members only. Consultants and expert reviewers will be excluded from participation in matters involving firms in which they have any interest.

3f remunerated for services, criteria set forth in Section 8 will apply.

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