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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Offers Several Lines of Communications for Constituents

by Dr. Charlotte Spires, Office of New Animal Drug Evaluation; Dr. Marcia Larkins, Ombudsman; Linda Grassie, Director, Communications Staff
FDA Veterinarian Newsletter 2006 Volume XXI, No I

The Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) works to educate animal health stakeholders and consumers, and to develop and disseminate information as it carries out its consumer protection mission.

CVM operates under and enforces applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. The Center is responsible for the evaluation, approval, and surveillance of animal drugs, food additives, feed ingredients, and marketed animal devices.

The Center has developed a variety of mechanisms for communicating with its constituencies to foster open and collegial partnerships, respond to stakeholder concerns, and to keep the public abreast of Center activities, so that the Center can better carry out its mission.

Here are some of the sources of information available to the public.

Website

The most comprehensive source for publicly available information about CVM of interest to the animal health community is CVM’s website. It contains a variety of educational booklets and other information for free download.

The resources available on CVM’s website include publications such as: the FDA Veterinarian newsletter (previous issues as well as this edition); CVM Updates, which are like press releases for the trade press; CVM Annual Reports; CVM Program Policy and Procedures Manual; a list of FDA Approved Animal Drugs in the “Green Book;” guidance documents; and other information and publications on issues of interest to veterinarians and animal owners, some in Spanish.

One of the major revisions to the CVM website this year was to the Adverse Drug Experience Reporting page.This page -includes a Cumulative Adverse Drug Experiences Summaries Report, which is posted so that veterinarians and animal owners can have easy access to information about signs that have been associated with drugs. At CVM, we encourage veterinarians to let us know about additional information they would like to see on our website. They can send their comments to the CVM Home Page at: CVMHomeP@cvm.fda.gov.

Electronic reading rooms

Certain 1996 amendments to the Freedom of Information (FOI) Act mandate publicly available electronic reading rooms with FOI response materials and other materials. The Freedom of Information Act (FOIA) was the first law to establish an effective legal right of access to government information, underscoring the crucial need in a democracy for open access to government information by citizens. A statement issued by President Clinton upon signing the 1996 FOIA amendments into law on October 2, 1996, said that the amendments apply to records maintained in an electronic format, and broadens public access to government information by placing more material on-line and expanding the role of the agency reading room.

Freedom of Information materials of interest to animal health stakeholders include FOI Summaries (of approved New Animal Drug Applications), animal drug environmental assessments, significant new animal drug approvals, Veterinary Master Files, Veterinary Medicine Advisory Committee information (such as transcripts), and information on other CVM regulatory activities. Many of these materials are posted on the CVM website.

Communications Staff

CVM’s Communications Staff provides information to individual constituents, manages the CVM website content, works with other FDA offices to provide information to the major media, provides information to the trade press, conducts outreach education activities, conducts the Center’s Freedom of Information activities, and works with FDA Public Affairs Specialists throughout the United States to provide information on CVM issues.

The Communications Staff also produces materials on CVM issues, such as booklets and videos on judicious use of antimicrobials in food producing animals, FDA and the Veterinarian, which provides information on FDA’s jurisdiction and regulations, information for consumers and individuals who want to market products such as pet foods, an animation on antimicrobial resistance, and a DVD which demonstrates CVM’s method for detecting nitrofuran residues in shrimp.

The Communications Staff is currently working with veterinary associations to increase awareness about non-steroidal anti-inflammatory drugs (NSAID), particularly about the Client Information Sheets (CIS) that are included with every FDA-approved NSAID for oral use in dogs (see the article “What Veterinarians Should Tell Clients about Pain Control and Their Pets” in this issue).

Members of the public can call the Communications Staff, at 240-276-9300, for general information.

The Communications Staff also routinely answers questions sent to the CVM homepage. The Staff normally receives 15-30 e-mails through the homepage each week.

The Communications Staff can also help veterinarians and others find Center publications, approved animal drugs in the “Green Book,” FOI Act summaries, Adverse Drug Experience summary reports, information on pet foods, and many other types of information.

The Communications Staff also helps veterinarians in contacting Center experts on particular topics for help with very specific or technical questions.

Ombudsman

One of CVM’s official points of contact is its Ombudsman, Dr. Marcia Larkins. The Ombudsman’s primary responsibility is dispute resolution related to regulated drug products. However, the Ombudsman also serves as a conduit to resources within CVM for answers to questions involving specific Center policies and procedures, general questions involving veterinary product jurisdiction issues, and general complaints or comments on current CVM science-based programs.

The Ombudsman’s position is also an avenue you can use to offer suggestions on how policies, procedures, and guidance documents can be improved.

Communications to the Center

Most of the information sources listed above are ways for the public to obtain information from the Center. Conversely, the public may provide information to CVM through a number of mechanisms including the Ombudsman, public meetings, adverse (drug) event reporting, and petitions.

The public may express its viewpoint to CVM via several mechanisms including proposed rules, petitions, public meetings, and public hearings.

FDA will publish a notice of proposed rulemaking in the Federal Register. This notice describes the proposed regulation and gives information on where to submit written comments.

Individuals or organizations may also petition the FDA to issue or change a regulation or to take some other action. Information on submitting petitions is found in Title 21 of the Code of Federal Regulations, Sections 10.30, 10.33, and 10.35.

FDA uses public meetings to discuss significant issues with the public and offer an opportunity for an exchange of ideas before the rulemaking process begins. Public hearings are an opportunity for the public to participate in a rulemaking proceeding. In a public hearing, the public can present testimony on issues included in an Agency proposal orally or in writing. Individuals or organizations must register to present orally at a hearing by submitting a written notice of participation to the Center.

Written comments for both public meetings and hearings are welcome at any time; however, the official record of a hearing will remain open to receive written comments for only a specified time period. Written comments are submitted to the FDA Dockets Management Branch. The addresses for sending comments on paper or electronically are always provided in a notice requesting the comments.

Public meetings and public hearings are open to everyone, although seating may be limited and free registration is required. These meetings are announced in the Federal Register, the FDA Veterinarian, and various trade publications.

(Dr. Spires will present a seminar at this year’s American Veterinary Medical Association meeting about accessing information from CVM. At the seminar, she will explain the methods discussed in this article, and be able to answer any questions you have. The seminar is scheduled for July 19, 2006, 7:00-7:30 a.m., in room 325B of the Hawaii Convention Center.)