Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 65

DECLARATION of Amy A. Barcelo in Support re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D (part 1 of 6), # 5 Exhibit D (part 2 of 6), # 6 Exhibit D (part 3 of 6), # 7 Exhibit D (part 4 of 6), # 8 Exhibit D (part 5 of 6), # 9 Exhibit D (part 6 of 6), # 10 Exhibit E (part 1 of 8), # 11 Exhibit E (part 2 of 8), # 12 Exhibit E (part 3 of 8), # 13 Exhibit E (part 4 of 8), # 14 Exhibit E (part 5 of 8), # 15 Exhibit E (part 6 of 8), # 16 Exhibit E (part 7 of 8), # 17 Exhibit E (part 8 of 8), # 18 Exhibit F, # 19 Exhibit G, # 20 Exhibit H, # 21 Exhibit I)(Barcelo, Amy)

CENTER FOR VETERINARY MEDICINE
PROGRAM POLICY AND PROCEDURES MANUAL

GUIDE 1240.2202

GENERAL PROCEDURAL POLICIES

VOLUNTARY COMPLIANCE
1.

Purpose:
This guide describes the types of educational activities undertaken by the Center for
Veterinary Medicine (CVM) to encourage increased compliance by the Food and Drug
Administration (FDA) regulated firms.

2.

Policy:
CVM will initiate and participate in discussions, meetings, and other activities to increase
understanding of FDA's policies and compliance with the Federal Food, Drug, and
Cosmetic Act.

3.

Types of Activities Associated with Voluntary Compliance:
a.

Conferences:
Individual firms or trade associations may request meetings or conferences to
discuss problems. The Center's objective in such meetings or conferences is to
advise on corrections needed and provide general guidance on how to achieve
compliance. (Refer to CVM Guide 1240.2600 Industry Conferences for the
policy on setting and holding conferences with industry representatives.)

b.

Public Meetings:
Public meetings may provide an ideal forum for stimulating questions and debate.
Speeches before various industry and consumer organizations provide an
excellent opportunity for the Center to discuss regulatory requirements and
expectations. Major changes in Center policy, regulations, or legislation often
warrant such forum to explain or clarify the effect of an action or proposed action.
In order to provide a basis for logical and reasonable discussions, it is important
that the issues or topics be well defined and background information be available
to the participants in advance.

Responsible Office: HFV-10
Date: 08/11/92, Minor changes 8/27/97

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GUIDE 1240.2202

c.

Symposia and Seminars:
The solutions to many issues facing CVM regulated industries may best be
achieved through cooperative efforts coordinated by the Center. The need for
these efforts can be identified, positive approaches developed and programs
initiated and promoted in public symposia and seminars sponsored by the Center.
The Communications Staff, HFV-12 is responsible for developing and
implementing these programs.

d.

Conventions and trade shows associated with meetings of industry associations
provide an excellent opportunity for CVM to promote its programs and
initiatives. Having CVM personnel staff an FDA exhibit at a major trade show
accomplishes several objectives. It raises industry awareness of FDA; it provides
a feedback mechanism based on one-to-one contact with industry in a neutral
setting; it allows for the dissemination of information; and it provides an
opportunity to learn about current equipment and practices in industry. The
Communications Staff, HFV-12, is responsible for coordinating the Center's
exhibit program for industry associations.

e.

Information/Education:
The Center through its Communications Staff, HFV-12 in the Office of Management
and Communications, regularly issues printed publications and informational releases
to associations, trade periodicals and educational outlets reaching the industries
affected by the Center actions. Additionally, the Staff coordinates an exhibit program
for professional organizations. The Staff also produces a subscription publication,
FDAVeterinarian, which provides up-to-date information on policies, regulatory
activities, drug approvals, upcoming meetings/hearings, etc. to subscribers. The
information disseminated through these various channels encourages voluntary
compliance by keeping the public informed about CVM regulations and policies.

f.

Guidelines:
Various operating units of the Center prepare guidelines on a number of issues as
a way of providing guidance to segments of the regulated industry. Availability of
new guidelines is announced in the FEDERAL REGISTER and the FDA
Veterinarian.

4.

Development of Educational Material:

Responsible Office: HFV-10
Date: 08/11/92, Minor changes 8/27/97

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GUIDE 1240.2202

Because of the nature of the educational activities, at any given time any unit or
individual within CVM may be asked to assist in the preparation of information materials
for industry. However, the Communications Staff, HFV-12 has primary responsibility for
overseeing their development.

Responsible Office: HFV-10
Date: 08/11/92, Minor changes 8/27/97

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