SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Rapid Response Surveys

OMB Control Number 0910-0500—Extension

This generic information collection supports research conducted by FDA, as authorized under section 1003(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).

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.

In the Federal Register of April 20, 2023 (88 FR 24423), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment, which was generally supportive of FDA's use of RRS. (Comment) The comment suggested that FDA “authorize, develop, and implement a mechanism that provides States and the most local level of public health departments immediate notification and access to RRS results when the FDA issues a RRS wholly or partially in their areas of jurisdiction.” (Response) FDA already has in place mechanisms to share pertinent health information with State, local, and tribal authorities. We currently share aggregated data (without personally identifiable information) of hospital reporting RRS. However, FDA's use of RRS has not recently developed data about potential safety problems or risk management solutions that would require development of a new mechanism for immediate notification and access to RRS results. For example, FDA used a RRS to identify and maintain a list of drugs essential for the care and management of hospitalized patients with COVID-19, particularly for ventilated patients in the intensive care units. FDA used the information to help to identify drugs that may be at risk of a regional or national shortage, and to help ensure these drugs remain available to meet the needs of our nation. FDA also used a RRS to engage stakeholders when developing the food safety surveillance sampling assignments. FDA shared information with key external stakeholders on the hot pepper and cucumber sampling assignments and garnered industry feedback through survey questions to ensure that sample collection is done as effectively and efficiently as possible. Neither of these surveys developed information that would require development of a new mechanism for immediate notification and access to RRS results. The latest update survey data from FDA can be found here: https://www.fda.gov/​science-research/​fda-science-forum/​fda-covid-19-critical-care-drug-monitoring-survey-portal-ongoing-surveillance-critical-drugs-related. Please also note that if you or your hospital stakeholders are experiencing a drug shortage and need assistance on how to obtain supply, please refer to the information at Drugshortages@fda.hhs.gov. FDA Drug Shortage Staff responds to all reports received on a daily basis.

FDA estimates the burden of this collection of information as follows: ( printed page 60212)

We estimate that each rapid response survey will take no more than 30 minutes to complete.

Based on a review of the information collection since our last request, we have adjusted our burden estimate which has resulted in a decrease to the currently approved burden. We now estimate one response per respondent which results in a decrease in overall burden of 25,000 hours.