Communicating with CVM

Transcription

1 Communicating with CVM Diane L. Heinz, DVM, MBA Director, Policy and Regulations Staff Center for Veterinary Medicine, FDA CVM s s Website Information related to recalls, including pet food How to file pet food complaints How to report an adverse event Following CVM on Twitter Sign up to receive CVM Updates, notices, etc., via: Updates RSS Feed Links to a variety of CVM topics and offices CVM s s Website 1

2 Communication Staff Mailing address: Communications Staff (CVM) Food and Drug Administration 7519 Standish Place HFV-12 Rockville, MD Phone: Federal Register FDA announces most activity in the Federal Register, including but not limited to: Rules Guidances Meeting notices Requests for public comments Others ADDRESSES section of each FR notice specifies where you can send comments For Further Information Contact section provides contact information for the FDA employee who can assist with questions Federal Register 2

3 Federal Register Regulations Guidances Guidance documents represent the Agency's current thinking on a regulatory issue do not have the force and effect of law advisory You can comment on a guidance at both the draft and final stages or any time after publication of the final guidance 3

4 Guidances Guidances Guidances Under Development 4

5 Public Meetings FDA periodically holds meetings and workshops to which the public is invited Recent example - Veterinary Medical Advisory Committee Meeting related to Genetically Engineered Salmon, held September 19-20, 2010 FDA publishes notices of public meetings in the Federal Register in advance of each meeting Notices include date, time, location, and other relevant information Notices also include contact information for FDA staff who can assist if you have questions Public Meetings Citizen Petitions Citizen Petition process is used to request the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action Submit written petitions to the Division of Dockets Management (HFA-305) as instructed in 21 CFR Sec If petition complies with Sec , DDM will assign docket number and forward to the appropriate Center within FDA Policy and Regulations, my office, handles CVM s response to citizen petitions 5

6 Dockets Management Contact Information Dockets Management - the official repository for the administrative proceedings and rule-making documents Dockets Management is administered by the Federal Dockets Management System (FDMS) Your can search the Dockets Management database at Submit comments related to FDA actions to the docket specified in the Federal Register notice that announces that action Dockets Management Contact Information Submit written submissions (including Docket Number) to: Division of Dockets Management Food and Drug Administration 5630 Fishers Lane Room 1061, HFA-305 Rockville, MD Phone: Fax: Congressional Inquiries Members of Congress communicate through FDA s Office of Legislation Members of Congress have different and more requests than members of the public, including: requests for information on specific CVM programs or policies requests for information on behalf of constituents requesting witnesses to appear at hearings requesting technical assistance when drafting legislation 6

7 Freedom of Information Requests FOIA requests must be in writing and should include the following information: Requestor's name, address, and telephone number Description of the records being sought Separate requests for each firm or product involved A statement concerning willingness to pay fees, including any limitations. Freedom of Information Requests All FOIA requests must be in writing Requests should be mailed to the following address: Food and Drug Administration Division of Freedom of Information (HFI-35) Office of Shared Services Office of Public Information and Library Services 5600 Fishers Lane Rockville, MD You may fax your request to: or Address questions about FOI requests to the Division of the Freedom of Information Offices at FOIA Electronic Reading Room 7

8 CVM Ombudsman assists in resolving disputes with affected persons and groups both inside and outside the Center investigates complaints involving science, science- based policy decisions, and administrative procedures reports complaint findings and helps achieve equitable solutions serves as CVM s s contact for information on the dispute resolution process CVM s s Ombudsman When to Contact The Ombudsman: For complaints or disputes involving CVM science-based programs, policies and procedures, and guidance documents and for comments or suggestions on how they can be improved. When an applicant does not know where or how to begin an appeal, little progress is being made going up the chain of command, or about a matter that has not been resolved in the supervisory chain of command procedure. At any time before or during the dispute resolution process Remember: CVM s s Ombudsman does not handle matters that are already involved in litigation. 8

9 FDA Veterinarian CVM s s Website Questions? 9