Communicating Information About Agency Procedures - Background
FDA has established various methods to inform industry about FDA’s procedures. Information is command unicated at workshops and meetings, as well as online on the FDA Web site. A section of the FDA Web site, accessible via the main home page, contains information relevant to industry, including information about FDA’s dispute resolution process access to all of FDA’s published guidance documents.
In April 2010, FDA launched a web resource called FDA-TRACK that allows the public to track the agency’s progress on a range of measures. These measures are developed by the program offices across the FDA and reported on a monthly basis. Each quarter, monthly performance data is analyzed and senior managers present this data to FDA senior leadership. FDA-TRACK includes measures relevant to industry. For example, industry can track whether the agency is hitting its targets for completing reviews of product applications.
In addition, FDA has established a subscription service whereby members of the public can register to receive updates about FDA activities via email. For example, interested members of the public can receive emails notifying them when FDA warning letters are posted or when guidance documents are posted on the site. A list of the items for which members of the public can receive updates is accessible on the FDA home page by clicking “Email Updates.”
FDA also posts organizational charts for the entire agency and its seven centers and offices. This information is updated on a quarterly basis. In general, the organizational charts for the six Centers, one research center, and the Office of Regulatory Affairs (ORA) include information down to the office-level, and include the names of senior leadership in that office. Information about additional levels of the organization (e.g., divisions within a center and offices within that division, if applicable) is typically available elsewhere on the FDA Web site.
FDA has developed activities aimed at assisting and increasing communication about FDA’s procedures with the smaller members of regulated industry who interact with FDA. These activities include the establishment of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in the Center for Devices and Radiological Health (CDRH), Small Business Assistance Programs in FDA regional offices, and staff in the Centers who handle inquiries from industry, including small businesses. These units provide technical assistance to small companies, hold exchange meetings to hear the views and perspectives of small businesses, conduct educational workshops, develop informational materials, and provide an accessible, efficient channel through which small businesses can acquire information from the FDA. FDA has also posted a “Small Business Guide for FDA” on the FDA Web site.
Slide presentations used by FDA employees are provided to members of the public upon request. In some limited cases, slides used by FDA employees at meetings for external audiences are posted on the FDA Web site. For example, the Center for Drug Evaluation and Research (CDER) has posted a limited set of presentations on the FDA Web site.
All data provided on the FDA Web site, including slide presentations, must be in a form that can be accessed by all members of the public, including individuals with disabilities. Section 508 of the Rehabilitation Act requires that federal departments and agencies make electronic and information technology accessible to people with disabilities, unless an undue burden would be imposed on the department or agency. As a result of this requirement, all presentations must be made “508 compliant” prior to posting on the FDA Web site. In general, FDA does not make slide presentations given by FDA employees to external audiences available on the FDA Web site because of the time and resources needed to make them 508 compliant and post them.
Some Centers provide training information about the regulatory process via learning modules that are accessible online. For example, CDRH has developed an online industry education tool called “CDRH Learn.” CDRH Learn is a series of training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues. CDER offers online educational tutorials on specific topics in a series called “CDERLearn.”
FDA has established electronic and telephonic means for members of the public, including industry, to contact FDA with questions about the regulatory process. The contact information for each FDA Center is accessible by clicking on the “Contact Us” link on the bottom of any FDA Web page. On the resulting Web page, selecting the applicable “area of concern” from the drop-down box leads visitors to contact information for the appropriate FDA Centers. Visitors can also select a Center by name from the list provided on the page under the heading “FDA Centers and Offices.” Questions sponsors may have about specific product applications are dealt with via the review process, described in Section B.
Below is a description of the process used to handle inquiries about the regulatory process for specific product areas.
Animal and Veterinary
Members of the public can submit questions to an email inbox or call the Center for Veterinary Medicine (CVM) with an inquiry. If additional expertise is required, CVM’s Office of Communication refers the inquiry to a CVM employee who will respond to the requestor. CVM has target time frames for responding to questions.
The Center for Biologics Evaluation and Research (CBER) Manufacturers Assistance and Technical Training Branch responds to requests for information regarding CBER policies and procedures. Blood and tissue banks, clinical investigators, and other members of regulated industry can submit questions by email or by phone. If additional expertise is required, the inquiry is forwarded to the appropriate office for additional information. The response is then conveyed to the requester either by the Manufacturers Assistance and Technical Training Branch or by the appropriate product office. There are target time frames for responding to questions.
CDRH, as required by statute, has created a small manufacturers assistance program in the Division of Small Manufacturers, International and Consumer Assistance (DSMICA). Members of industry can call a general telephone number or submit an email with a question. Contact information for DSMICA employees is provided online and industry can contact a DSMICA employee directly with specific questions. Most DSMICA employees can answer questions in all medical device related areas. However, a list of DSMICA employees with their areas of expertise is also posted on the FDA Web site. DSMICA has target time frames for responding to questions.
The CDER Division of Drug Information (DDI) is responsible for calls that come in from companies and industry consultants to the drug information telephone number or email address. Questions related to specific products are directed to the review division responsible for handling the product application. Questions are directed to subject matter experts as appropriate. DDI has target time frames for responding to questions. If a response will not be provided within the established timeframe, an interim response is provided via phone or email.
The Center for Food Safety and Applied Nutrition (CFSAN) has an email inbox dedicated to questions from industry. Questions that require interpretation of existing policy or that are extremely technical in nature are referred to a program specialist. CFSAN informs the inquirer when questions are referred to a specialist. CFSAN has target time frames for responding to questions. CFSAN also receives many questions of a regulatory nature via the Center’s toll free information line. Most telephone inquiries are answered as they are received.