Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations

Dates

Submit written comments (including recommendations) on the collection of information by May 30, 2024.

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.

FDA Recall Regulations-21 CFR Part 7

OMB Control Number 0910-0249-Extension

This information collection helps support implementation of section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371) pertaining to product recalls, and regulations in 21 CFR part 7, subpart C (21 CFR 7.40 through 7.59) promulgated to clarify and explain associated practices and procedures by FDA. Sections 7.49, 7.50, and 7.59 (21 CFR 7.49, 7.50, and 7.59) of the regulations apply specifically to product recalls, which may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Agency.

Recalls are terminated when all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy. The regulations also provide for corrective actions to be taken regarding violative products and establish specific guidelines that enable us to monitor and assess the effectiveness of a firm's efforts in this regard. The provisions include reporting to FDA on the initiation and termination of a recall, as well as submitting recall status reports and making required communication disclosures. The regulations also permit FDA to evaluate whether a recall has been completed in a manner which assures that unreasonable risk of substantial harm to the public health has been eliminated and that violative products have been corrected or removed from the market. Specific guidance regarding recalls is set forth in § 7.59, although product-specific guidance documents may also be developed to assist respondents to the information collection. Agency guidance documents are issued in accordance with our good guidance regulations in 21 CFR 10.115, which provide for public comment at any time.

Consistent with § 7.50, all recalls monitored by FDA are included in an "Enforcement Report" once they are classified and may be listed prior to classification when FDA determines the firm's removal or correction of a marketed product(s) meets the definition of a recall. Recall data in the Enforcement Report can be accessed through the weekly report publication, the quick and advanced search functionalities, and an Application Programming Interface (API). Instructions for navigating the report, accessing and using the API, and definitions of the report contents are found at https://www.fda.gov/safety/enforcement-reports/enforcement-report-information-and-definitions.

In the Federal Register of October 13, 2023, (88 FR 70995), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received offering general support for the information collection. The comment also suggested that reporting might be enhanced through the use of automated technology and that FDA monitor and utilize such technology to track improvement. Finally, the comment questioned the rationale for our estimate of the time necessary for preparing and submitting recall reports. Based on experience with compiling and submitting a report along with its attachments, the commenter communicated that less time was likely needed.

We appreciate this feedback and will continue to monitor burden associated with product recall activity. We also continue to look for ways to enhance our IT systems as our limited resources allow and public health priorities require. With regard to our current estimates, we note that our figures reflect what we believe to be the average burden incurred among more than 2,000 respondents, and in conjunction with more than 30,000 reports, annually, and therefore we have made no adjustment in our assumptions at this time.

We estimate the burden of the information collection as follows:

A review of Agency data shows that 6,928 recall events were conducted during fiscal years 2020 through 2022, for an average of 2,309 recalls annually. We assume an average of 25 hours is needed to submit the requisite notification to FDA, for a total annual burden of 57,725 hours. Similarly, during the same period, 6,385 recalls were terminated, for an average of 2,128 recall terminations annually, and we assume an average of 10 hours is needed for the corresponding information collection activity. To determine burden associated with recall status reports, we multiplied the average number of annual respondents (2,309) by the average number of status reports per recall (13), producing the number annual submissions (30,017), which, assuming 10 hours per response, results in a burden of 300,170 hours annually.

To determine burden associated with recall communication disclosures described in § 7.49, we calculated an average of 1,108 disclosures per recall and attribute 3 minutes for each disclosure, resulting in 127,960 burden hours annually. We provide no estimate for recordkeeping in § 7.59 as these activities are provided as guidance only, and we regard them to be usual and customary to these respondents.

Cumulatively, these adjustments reflect an overall decrease in our estimate, which we attribute to a corresponding decrease in FDA-regulated product recalls since our last evaluation of the information collection.