Format for Submitting Complaints
As described below, we intend to use existing complaint mechanisms to address complaints from the public concerning our information dissemination activities. You may use any of the mechanisms outlined below to request correction of information disseminated by FDA that you believe does not meet the applicable OMB or HHS Information Quality Guidelines, or this Guidance.
If you request a correction of any information disseminated by us, we would appreciate it if you clearly designate the request as a request for correction of information under this guidance and the OMB and HHS Guidelines. You should use the following format for your request:
- Your name, mailing address, fax number or e-mail address, telephone number, and organizational affiliation, if any, of the requestor,
- A detailed description of the specific material that needs to be corrected including where the material is located, i.e., the publication title, date, and publication number, if any, or the website and web page address (Uniform Resource Locator or url),
- The specific reasons for believing the information does not meet applicable OMB, HHS, or FDA guidelines and is in error, and supporting documentation,
- The specific recommendations for correcting the information,
- A description of how the person submitting the complaint is affected by the information error.
Procedures for Submitting Complaints
We have clear procedures in place to address complaints from the public. Requests should be submitted to the Agency in accordance with the procedures described below for dispute resolution (i.e., beginning with the employee or division that disseminated the information, or by contacting the center, the Agency, or an ombudsman). To help us track and monitor complaints, regardless of which procedures you use, we ask that you also send a copy of your request for correction to:
Office of the Ombudsman
Food and Drug Administration
10903 New Hampshire Avenue
WO Building 32, Room 4260
Silver Spring, MD 20993
It will also be helpful to those wishing to submit a request for correction electronically
if the Office e-mail address is included: OMBUDS@OC.FDA.HHS.gov
FDA regulations at 21 CFR 10.75 provide a mechanism for any interested person (a person who submits a petition, comment, or objection, or otherwise asks to participate in an informal or formal administrative proceeding or court action) to obtain formal review of any Agency decision or action by raising the matter with the supervisor of the employee who made the decision. These procedures can be used to submit an initial complaint about an FDA information dissemination. If the issue is not resolved at the primary supervisory level, the interested person may request that the matter be reviewed at the next higher supervisory level. This process may continue throughout the Agency's chain of command, through the centers to the Commissioner of the FDA.
Regulations for dispute resolution during the application review process (21 CFR 312.48; 314.103; and 814.42 (d), 814.46(c), 814.112(b), and 808.25 (e)) specify procedures similar to those outlined above. CDRH also established a Medical Devices Dispute Resolution Panel to hear scientific disputes. Regulations for CDER and CBER also provide that a sponsor may request that we seek the advice of outside experts. In addition, we may refer major issues to an appropriate advisory committee for its recommendations (§§ 312.48(c)(3) and 314.103(c)(3)).
Several guidances explaining the dispute resolution process also are available:
- Formal Dispute Resolution: Appeals Above the Division Level (for drug and biological products, February 2000),
- Resolving Scientific Disputes Concerning the Regulation of Medical Devices, a Guide to Use of the Medical Devices Dispute Resolution Panel (July 2001)
- Medical Device Appeals and Complaints: Guidance on Dispute Resolution (February 1998)
- A Suggested Approach to Resolving Least Burdensome Issues (September 2000)
Finally, 21 CFR 5.200 provides for the establishment of an Agency ombudsman. We have established an Ombudsman Office within the Office of the Commissioner, and each center has identified or is identifying an ombudsman. Information about when and how to contact an Agency or center ombudsman can be found on our Internet site 7. We encourage interested parties who may be reluctant to contact a program person in a specific program, division, office or center to feel free to contact a center or Agency ombudsman.
Existing public comment procedures for rule-makings and other formal agency actions already provide well established procedural safeguards that allow affected persons to raise information quality issues on a timely basis. Accordingly, FDA will use these existing procedures to respond to information quality complaints that arise in this process.
In cases where the agency disseminates a study, analysis, or other information prior to the final agency action or information product, requests for correction will be considered prior to the final agency action or information product in those cases where in the agency's judgment issuing an earlier response would not unduly delay issuance of the agency action or information product and the complainant has shown a reasonable likelihood of suffering actual harm from the agency's dissemination if the agency does not resolve the complaint prior to the final agency action or information product.
You should be aware that you bear the "burden of proof" with respect to your request for correction.
FDA's Response to Complaints
Based on a review of the information you provide in your complaint, we will determine whether a correction is warranted and, if so, what action, if any, we will take. We will respond to you in a manner appropriate to the nature and extent of your complaint (for example, by letter, e-mail, fax, press release, mass mailing) and will indicate whether, and if so how, we intend to correct the information. We will respond in accordance with the time frame specified in the complaint mechanism you use. Where a procedure does not specify a time frame for a response, we will respond within 60 days, in accordance with the OMB and HHS Guidelines. We will respond by either issuing a decision or by informing you that more time is required, explaining why, and providing you with an estimated decision date. In deciding how to respond, we will consider all of our legal obligations and policies.
Requests for Reconsideration
If you do not agree with FDA's decision about your complaint (including any corrective action), you may send a request for reconsideration within 30 days of receipt of our decision. You may use any of the Procedures for Submitting Complaints described above. A request for reconsideration should state the reasons why you believe the response is inadequate, should be designated as an "Information Quality Appeal," and should include a copy of your original request and the agency's decision. The agency will respond to all requests for appeals within the time frame specified in the procedure you use. Where a procedure does not specify a time frame for a response to your appeal, we will respond in a timely manner, in accordance with the OMB and HHS Guidelines.