Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2023-08297 · Docket No. FDA-2023-N-0940

Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of rapid response surveys to obtain data on safety information that supports quick turnaround decision making about potential safety problems or risk management solutions.

Dates

Either electronic or written comments on the collection of information must be submitted by June 20, 2023.

Supplementary Information

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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. 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 rapid response survey. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours FDA Rapid Response Surveys 10,000 1 10,000 0.5 (30 minutes) 5,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 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. Dated: April 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-08297 Filed 4-19-23; 8:45 am]