Summary of Phase III: Transparency to Regulated Industry
In January 2011, the Transparency Task Force released a report describing 19 action items FDA is implementing to improve its transparency to regulated industry. The report also proposed 5 additional draft proposals for public comment. FDA accepted public comment on the proposals on this website from January 6, 2011 through March 6, 2011.
Summary of Tasks: Draft Proposals for Public Comment
The action items and draft proposals for public comment fall under five broad topic areas:
- Communicating Information about Agency Procedures
- Product Application Review Process
- Guidance Development
- Regulations Development
- Import Process
Communicating Information about Agency Procedures
FDA has established various methods to inform industry about FDA’s procedures, via workshops, meetings, and online on the FDA Web site. Six action items will be implemented in 2011 to facilitate further communication of information about agency procedures:
- Action 1: FDA will develop a web-based resource called FDA Basics for Industry that will provide basic information online about the regulatory processgoverning FDA-regulated products, and include information that isfrequently requested by industry.
- Action 2: FDA will update the agency organizational charts and senior leadership personnel changes on the FDA Web site on at least a quarterly basis and ensure that the level of detail provided on the organizational charts is consistent across the agency.
- Action 3: Each Center has a process for industry to submit general regulatory questions, and for directing inquiries to individuals with additional expertise, if necessary. Links to these processes will be made available on FDA Basics for Industry.
- Action 4: If a general question about an existing policy, regulation, or the regulatory process is submitted to any of the email addresses specified below, whenever practicable, FDA should provide a response within 5 business days or acknowledge receipt of the inquiry and provide an approximate timeframe for response. This will be tracked on FDATRACK.
- Action 5: In September 2010, FDA issued its “Strategic Priorities FY 2011-2015” in draft form for public comment. FDA will issue a final version of the “Strategic Priorities FY 2011-2015” by March 2011.
- Action 6: FDA will post on the FDA Web site slide presentations that are delivered by FDA employees to external audiences at events sponsored by, or cosponsored by, the agency.
The Task Force proposes two draft proposals on communicating information about agency procedures for public comment:
Draft Proposal 1. FDA should maintain on the FDA Web site a list of presentations given
by FDA employees to external audiences.
Draft Proposal 2. When the Office of the Commissioner (OC) receives a request to reconsider a scientific decision of an FDA employee from an interested person outside the agency pursuant to 21 C.F.R. § 10.75, OC should inform the submitter within three weeks whether OC will review the request, and should inform the submitter when a decision or an update on the status of the review may be expected.
Each Center has existing systems that ensure product review consistency where possible. FDA has established avenues through which sponsors of medical products can meet with agency personnel during and after the review process. All Centers have published guidelines for meeting with sponsors of medical products. Four action items will be implemented in 2011 to facilitate further transparency in the product application review process:
- Action 7: FDA will compile all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on the web-based resource, FDA Basics for Industry.
- Action 8: As part of the FDA Basics for Industry web-based resource, FDA will describe the types of notifications it provides to industry (e.g., letter acknowledging receipt of the application, mid-cycle review meetings) associated with the product application review process. FDA will explain its practice of providing the sponsor with the name and contact information of the individual who should be contacted with questions about the product application. FDA will provide an overview of the processes used to strive for consistency of product application review.
- Action 9: FDA will communicate on the web-based resource, FDA Basics for Industry, general expectations about the circumstances, if any, underwhich it is appropriate to use secure email between FDA and amanufacturer when there is a question involving the manufacturer’sproduct.
- Action 10: FDA will explain via the FDA Basics for Industry web-based resource how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action on the application. FDA is also willing to hold further discussions with industry about application tracking systems, and explore the feasibility of implementing such a system at FDA.
FDA has issued regulations that the development, issuance, and use of guidance documents. FDA will post on the FDA Web site a list of guidances the agency may work on during the next year. Members of the public can submit written comments to FDA about draft guidance documents. Two action items will be implemented in 2011 to facilitate further transparency in guidance development:
- Action 11: To examine suggestions for improving the guidance process, the Commissioner has formed a cross-agency working group under the leadership of the Office of Policy. This working group is examining the current process and will identify best practices for improving the agency’s work on guidance. Topics include streamlining guidance development, reducing the time between issuance of draft and final guidance, and making it easier to find guidance documents on the FDA Web site.
- Action 12: FDA will describe the ways in which interested individuals can provide input to the agency about guidance development as part of the web-based resource, FDA Basics for Industry. Links that provide industry with a list of guidance documents that have been withdrawn during the past year as well as possible topics for future guidance development or revision also will be made accessible in one location via FDA Basics for Industry.
The Task Force proposes one draft proposal on guidance development for public comment:
Draft Proposal 3. FDA will inform industry about the progress of certain high priority guidances in development by disclosing a timeline from the start of the agency’s work on draft guidance to publication of the final guidance.
Regulations are generally implemented using a two step process. First, the agency publishes a Notice of Proposed Rulemaking (NPRM) in the Federal Register and the public is given a specified period of time to comment on the rule. After comments are reviewed and analyzed, the agency publishes the final rule. Twice a year, the federal government issues the Unified Agenda of Federal Regulatory and Deregulatory Actions, which compiles regulatory agendaspublished by federal agencies. Two action items will be implemented in 2011 to facilitate further transparency in regulations development:
- Action 13: After FDA issues a final rule, FDA will conduct outreach to the affected stakeholders as part of implementing the final rule if the rule imposes substantial new obligations.
- Action 14: FDA, working with the Department of Health and Human Services and the Office of Management and Budget, will improve the accuracy of the timetables included in the agency’s regulatory agenda published as part of the Unified Agenda.
The Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities. The Division of Import Operations and Policy (DIOP) is the agency focal point for relationships between ORA Headquarters and the field on all import programs and operations. FDA works closely with the United States Customs and Border Protection to prevent the importation of adulterated, misbranded, or otherwise violative products into the country. Requirements and other information about importing products are set forth in the FD&C Act, FDA regulations, and in numerous agency documents and guidances. Additionally, a section of the FDA Web site contains information of interest to the importer community.
Five action items will be implemented in 2011 to facilitate further transparency related to the import process.
- Action 15: FDA will publish on the FDA Web site contact information for each Import Program Manager and update that list on a regular basis.
- Action 16: FDA will allow interested members of the public to receive email notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated.
- Action 17: As part of FDA’s efforts to implement the forthcoming Strategic Import Plan, FDA will develop and execute a project to promote more uniform processes and procedures across districts, when appropriate, and inform industry of district and port-specific practices and procedures. This project will be tracked on FDA-TRACK.
- Action 18: If a general question about the import process or existing policy is submitted to the Division of Import Operations and Policy (DIOP) in the Office of Regulatory Affairs (ORA) or to a FDA field office, DIOP or the field office should provide a response, if practicable, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time frame for response. DIOP will compile a list of answers to questions frequently asked by industry and post this information on the FDA Web site.
- Action 19: FDA will work with Customs and Border Protection to explore developing a process by which brokers and filers can correct inadvertent data errors submitted about imported products and FDA should post that process online.
The Task Force proposes two draft proposals on import process for public comment:
Draft Proposal 4. In order to foster a more uniform and efficient process, FDA should review existing procedures used to conduct evaluations of importers, or third parties working on behalf of importers, who file information electronically about products offered for import into the United States. This review of the overall process should include what to examine during the evaluation, the error rate classification, the process of discussing the findings with the firm, and the final classification. It should also include the process for handling evaluations of those filers who file entries without being physically located at the port where the product enters the United States.
Draft Proposal 5. FDA should initiate a planning process to develop a web-based system that would help importers more easily determine the proper requirements for importation, the correct data codes, and any special requirements. FDA will engage industry in the planning process.