Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-5468]</DEPDOC> <SUBJECT>Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit written comments (including recommendations) on the collection of information by July 25, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to <E T="03">https://www.reginfo.gov/public/do/PRAMain</E> . Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0291. Also include the FDA docket number found in brackets in the heading of this document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, <E T="03">PRAStaff@fda.hhs.gov</E> . </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. <HD SOURCE="HD1">FDA's Adverse Event and Product Experience Reporting Program</HD> <HD SOURCE="HD2">OMB Control Number 0910-0291—Revision</HD> This information collection supports FDA laws and regulations governing adverse event reports and product experience reports for FDA-regulated products. The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b, 355, 360i, 360l, 379aa, and 393) and the Public Health Service Act (42 U.S.C. 262) authorize FDA to collect adverse event reports and product experience reports from regulated industry and to monitor the safety of drugs, biologics, medical devices, and dietary supplements. These reporting and recordkeeping requirements are found in FDA regulations, discussed in Agency guidance, and included in Agency forms. Although not all respondents to the information collection are required to submit reports, we encourage voluntary reporting of adverse experiences associated with any FDA-regulated product. To facilitate both consumer and industry reporting of adverse events and experiences with FDA-regulated products, we developed the MedWatch program. The MedWatch program allows anyone to submit reports to FDA on adverse events, including injuries and/or deaths, as well as other product experiences associated with the products we regulate. Requirements regarding mandatory reporting of adverse events or product problems have been codified in parts 310, 314, 329, 600, and 803 (21 CFR 310, 314, 600, and 803), and specified in sections 503B, 760, and 761 of the FD&C Act (21 U.S.C. 353b, 379aa, and 379aa-1). Mandatory reporting of adverse events for human cells, tissues, and cellular- and tissue-based products (HCT/Ps) have been codified in Sec. 1271.350 (21 CFR 1271.350). Other postmarketing reporting associated with requirements found in sections 201, 502, 505, and 701 (21 U.S.C. 321, 352, 355, and 371) of the FD&C Act and applicable to certain drug products with and without approved applications are accounted for in OMB control number 0910-0230. Mandatory reporting under 21 CFR part 803, associated with medical device products, using form FDA 3500a, is accounted for in OMB control number 0910-0437. Since 1993, mandatory adverse event reporting has been supplemented by voluntary reporting by healthcare professionals, patients, and consumers via the MedWatch reporting process. To carry out its responsibilities, the Agency needs to be informed when an adverse event, product problem, error with use of a human medical product, or evidence of therapeutic failure is suspected or identified in clinical use. When FDA receives this information from healthcare professionals, patients, or consumers, the report becomes data that will be used to assess and evaluate the risk associated with the product. FDA will take any necessary action to reduce, mitigate, or eliminate the public's exposure to the risk through regulatory and public health interventions. To implement these reporting provisions for FDA-regulated products (except vaccines) during their post-approval and marketed lifetimes, we developed the following three forms, available for download from our website or upon request to the Agency: (1) Form FDA 3500 may be used for voluntary ( <E T="03">i.e.,</E> not mandated by law or regulation) reporting by healthcare professionals; (2) Form FDA 3500A is used for mandatory reporting ( <E T="03">i.e.,</E> required by law or regulation); and (3) Form FDA 3500B, available in English and Spanish, is written in plain language and may be used for voluntary reporting ( <E T="03">i.e.,</E> not mandated by law or regulation) by consumers ( <E T="03">i.e.,</E> patients and their caregivers). Respondents to the information collection are healthcare professionals, medical care organizations and other user facilities ( <E T="03">e.g.,</E> extended care facilities, ambulatory surgical centers), consumers, manufacturers of biological, food products including dietary supplements and special nutritional products ( <E T="03">e.g.,</E> infant formula and medical foods), cosmetics, drug products or medical devices, and importers. <HD SOURCE="HD1">Use of Form FDA 3500, MedWatch—The Safety Information and Adverse Event Reporting Program (Voluntary Reporting)</HD> This voluntary version of the form may be used by health care professionals to submit all reports not mandated by Federal law or regulation. Individual health care professionals are not required by law or regulation to submit reports to the Agency or the manufacturer, with the exception of certain adverse events following immunization with vaccines as mandated by the National Childhood Vaccine Injury Act of 1986. Reports for vaccines are not submitted via MedWatch or MedWatch forms but are submitted to the Vaccines Adverse Event Reporting System (VAERS; see <E T="03">http://vaers.hhs.gov</E> ), which is jointly administered by FDA and the Centers for Disease Control and Prevention. Hospitals are not required by Federal law or regulation to submit reports associated with drug products, biological products, or special nutritional products. However, hospitals and other user facilities are required to report medical device-related deaths and serious injuries (accounted for in OMB control number 0910-0437). Under Federal law and regulation (section 761(b)(1) of the FD&C Act), a dietary supplement manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA any serious adverse event report it receives regarding use of the dietary supplement in the United States. However, FDA bears the burden to gather and review evidence that a dietary supplement may be adulterated under section 402 of the FD&C Act after that product is marketed. Therefore, the Agency depends on the voluntary reporting by healthcare professionals and especially by consumers of suspected serious adverse events and product quality problems associated with the use of dietary supplements. All dietary supplement reports were originally received by the Agency on paper versions of Form FDA 3500 (by mail or fax). Today, electronic reports may be sent to the Agency via an online submission route called the Safety Reporting Portal at <E T="03">http://www.safetyreporting.fda.gov/</E> . In that case, the Form FDA 3500 is not used. Form FDA 3500 may be used to report to the Agency adverse events, product problems, product use errors, and therapeutic failures. The form is provided in both paper and electronic formats. Reporters may mail or fax paper forms to the Agency. A fillable .pdf version of the form is available at <E T="03">https://www.accessdata.fda.gov/scripts/medwatch/</E> or electronically submit a report via the MedWatch Online Voluntary Reporting Form at <E T="03">https://www.accessdata.fda.gov/scripts/medwatch/</E> . Reporting using Form FDA 3500 in paper form is supported for drugs, non-vaccine biologicals, medical devices, food products, special nutritional products, cosmetics, and non-prescription human drug products marketed without an approved application, and dietary supplements. Electronic reports for FDA products, may be submitted to the Agency via an online submission route called the Safety Reporting Portal at <E T="03">http://www.safetyreporting.fda.gov/</E> . Electronic reports for tobacco products may be submitted to the Agency via the tobacco questionnaire within the online Safety Reporting Portal at <E T="03">http://www.safetyreporting.fda.gov/.</E> <HD SOURCE="HD1">Use of Form FDA 3500A, MedWatch for use by User-Facilities, Importers, Distributors, and Manufacturers (Mandatory Reporting)</HD> <HD SOURCE="HD2">Drug and Biological Products</HD> Sections 503B, 505(j), and 704 of the FD&C Act (21 U.S.C. 374) require that important safety information relating to all human prescription drug products be made available to FDA in the event it becomes necessary to take appropriate action to ensure protection of the public health ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 56k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━