Aug 31 -- The Food and Drug Administration (FDA) invites comments to OMB by October 2, 2023 regarding the extension of Rapid Response Surveys (RRS).
FDA is requesting extension of OMB approval to conduct rapid response surveys (RRS). Through these surveys, FDA seeks to determine whether a problem impacts the public health and to quickly obtain vital information about risks and interventions. FDA will use the information gathered from these surveys to make quick turnaround decisions about safety problems or risk management solutions so the Agency may take appropriate public health action including dissemination of information as necessary. Participation in these surveys is voluntary.
Respondents may include manufacturers and distributors of biologics, drugs, food, animal food and drugs, dietary supplements, food additives, cosmetics, medical devices, and tobacco products; distributors; sponsors and importers; consumers; healthcare professionals; hospitals; specialized medical facilities (e.g., cardiac surgery, obstetrics/gynecology services, pediatric services, etc.) and other user facilities including nursing homes, ambulatory surgical and outpatient diagnostic and treatment facilities when FDA must quickly determine whether or not a problem impacts the public health. Once FDA understands the need for additional surveillance data to address a potential public health hazard, the appropriate respondents will be identified for each unique RRS.
FDA is responsible for regulating biologics, drugs, foods, cosmetics, medical products, radiological products, animal food and drugs, and tobacco. Important questions about FDA-regulated products, such as those concerning user experience, durability, and rare effects may not be answered until after the product has been marketed. To protect the public health, FDA must be able to rapidly collect information pertaining to adverse events associated with FDA-regulated products after they have been marketed.
Over the years, medical science and technology have become increasingly complex. Due to economic pressures and organizational changes within health care organizations, this science and technology is not only used by highly trained health care professionals but has also moved into facilities where the users may not be as sophisticated. Additionally, many of these increasingly complex drugs and medical products, for instance, are now found in the home. These changes have increased the need to obtain timely information from postmarket surveillance systems and to quickly disseminate information to the health care and consumer communities on public health safety issues.
Analysis of a potential health or medical problem often cannot be made based on the information contained in adverse event reports submitted through the MedWatch program. For instance, for devices, it can take up to 90 days before the surveillance plan is begun (the manufacturer has 30 days after receiving notification that FDA is requesting surveillance of a particular product to submit a surveillance plan, and FDA then has 60 days to accept the plan), and much longer until the plan has been completed. This link to the manufacturing community does not fulfill the need for rapid information when FDA must decide quickly if particular adverse event reports signal a widespread public health problem. FDA requires a timely link to the clinical community in order to obtain information for more emergent situations.
Also, the reports of adverse events that FDA receives from the clinical community typically are not complete and hence there is considerable underreporting. When necessary, FDA contacts the individual reporter of a particular adverse event to obtain more information than what was provided in the MedWatch report. However, there is often insufficient information from the reporter to determine whether an adverse event signals a potential public health hazard. Lack of sufficient information often hampers FDA's ability to understand quickly and thoroughly evaluate the problem; determine the factors that contributed to the adverse event; determine the scope of a possible public health problem; and determine what steps must be recommended to the health-care community to prevent further injury.
FDA will submit to OMB each survey (Gen IC) along with an abbreviated supporting statement using a template which is included in this ICR submission.
OMB will, in general, provide feedback or approve the individual collections within ten working days. In our experience, we have learned that some rapid response surveys are of a more significant nature than others and require very rapid turn-around by OMB to ensure FDA can be responsive to emerging public health emergencies. For those surveys it may be necessary to request a 5-day review and approval from OMB. FDA will flag submissions for which we request a quicker than normal review. FDA recognizes, however, that timing on any action may fluctuate based on several factors including the content of the particular GenIC, competing priorities, etc.
The purpose of the information collection is to provide a tool to obtain quickly important and vital information from appropriate sources so FDA may take suitable public health or regulatory action when needed.
There are a variety of ways FDA is alerted to potential problems with products, including consumer complaints, inspection data, test results, adverse event reports and reports of illness. We might also learn of a problem from industry, one of our state or federal partners or from governments of other countries. FDA monitors the reports of adverse events associated with the use of medical products that enter the MedWatch mandatory and voluntary reporting programs. Reports are triaged based on perceived risk to the patient. Some reports signal an immediate hazard, but more commonly it is the experienced FDA clinical analysts that detect product problems, particularly those related to product use, through careful investigation of reported incidents and searching for additional sources of information.
The data collected from these rapid response surveys will provide FDA with information to allow a more complete analysis of the problem; determine the existence and extent of a public health problem; and then, if necessary, to disseminate the information to the health care community. When FDA receives such information, the agency may have an immediate need for additional data to better understand potential vulnerabilities or to perform a risk/hazard analysis. All of these processes must be accomplished in a timeframe that limits, to the extent possible, further incidents causing injury or harm to the public. The degree of perceived risk to the public is the most important consideration for any FDA public health action (product recall, Safety Alert, Public Health Notification, Ad Hoc Committee, workshop, publication, etc.) It is imperative that these risk determinations are completed as quickly as possible to avoid further incidents causing death, injury or harm to the public.
When these data sources fail to provide enough information to perform a risk/hazard analysis, FDA proposes to use rapid response surveys to answer important questions. For example, an adverse event report describing an anaphylactic-type reaction during the use of a certain catheter may require a follow up rapid response survey. Possible questions include:
-- Was this reaction related to the patient's illness or the stress of the procedure and is, therefore, not medical product related?
-- Is there a biomaterial in this medical product that could cause this reaction?
Because the health care community often does not recognize that a product may have contributed to an adverse event and because there is significant underreporting, it is critically important to know whether other health care professionals may have seen this problem. These other professionals may have not reported a similar event because they did not recognize that the reaction might have been related to the product. Through rapid response surveys, FDA can quickly contact the appropriate user population, can immediately determine if the report was an isolated incident or had occurred more often and was a signal of a potentially serious problem with the product.
Another example includes the likelihood that a certain food caused an illness. Information FDA may need might include:
-- the severity of the illness,
-- any steps taken during production to reduce the likelihood of contamination.
FDA proposes to use the rapid response surveys to further develop tools and science necessary to better understand where vulnerabilities are and the most effective ways to minimize them, as well as to intervene and respond once a problem occurs.
FDA works with other government agencies and private sector organizations to help reduce the risk of tampering or other malicious, criminal, or terrorist actions on FDA-regulated products including food, dietary supplements, cosmetics, animal food and feed, medical devices, drugs, biologics, and any other products under FDA’s jurisdiction.
The problems encountered with a variety of FDA-regulated products dictates that each survey effort will be unique in that each will involve a different type of product used by different health care professionals.
Respondents to this collection of information will change depending on the particular product in question. For example, respondents could include facilities or professionals which have the most experience in the use of certain FDA-regulations products, foods, cosmetics, dietary supplements, animal food and feed, drugs, tobacco products, etc. Once FDA identifies the need for additional surveillance data to address a potential public health hazard, the appropriate respondents will be identified either through FDA’s list or through the appropriate professional organizations.
The data will be collected and analyzed by the offices conducting the rapid response survey. Public health analysts and epidemiologists, and when necessary, statisticians and other Agency scientists, will analyze the data to determine whether a public health risk exists, and how it must be addressed.
FDA submission to OMB:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202308-0910-001 Click View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN:
https://www.federalregister.gov/d/2023-18832
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at
https://www.aeaweb.org/content/file?id=5806