Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) 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.

DATES:

Submit written comments (including recommendations) on the collection of information by December 9, 2021.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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.

FOR FURTHER INFORMATION CONTACT:

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, PRAStaff@fda.hhs.gov.

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.

MedWatch: The FDA Medical Products Reporting Program

OMB Control Number 0910-0291—Extension

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 there are no laws or regulations mandating postmarket reporting for medical foods, infant formula, cosmetics, or tobacco products, we encourage voluntary reporting of adverse experiences associated with these products.

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. While the MedWatch program provides for both paper-based and electronic reporting, this information collection covers paper-based reporting using Forms FDA 3500, 3500A, and 3500B, available from our website at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. 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 § 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 approved under OMB control number 0910-0230.

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 ( i.e., not mandated by law or regulation) reporting by healthcare professionals; (2) Form FDA 3500A is used for mandatory reporting ( i.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 ( i.e., not mandated by law or regulation) by consumers ( i.e., patients and their caregivers). Respondents to the information collection are healthcare professionals, medical care organizations and other user facilities ( e.g., extended care facilities, ambulatory surgical centers), consumers, manufacturers of biological, food products including dietary supplements and special nutritional products ( e.g., infant formula and medical foods), cosmetics, drug products or medical devices, and importers.

Use of Form FDA 3500 (Voluntary Reporting)

This voluntary version of the form may be used by healthcare professionals to submit all reports not mandated by Federal law or regulation. Individual healthcare 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 https://vaers.hhs.gov ), which is jointly administered by FDA and the Centers for Disease Control and Prevention (CDC).

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 by Federal law to report medical device-related deaths and serious injuries.

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 (21 U.S.C. 342) 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 https://www.safetyreporting.hhs.gov/. 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 https://www.accessdata.fda.gov/scripts/medwatch/. Respondents can also electronically submit a report via the MedWatch Online Voluntary Reporting Form at https://www.accessdata.fda.gov/scripts/medwatch/. Reporting 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. The paper form may also be used to submit reports about dietary supplements. Electronic reports for dietary supplements may be submitted to the Agency via an online submission route called the Safety Reporting Portal at https://www.safetyreporting.hhs.gov/. Electronic reports for tobacco products may be submitted to the Agency via the tobacco questionnaire within the online Safety Reporting Portal at https://www.safetyreporting.hhs.gov/.

Use of Form FDA 3500A—Mandatory Reporting

Drug and Biological Products

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. Mandatory reporting of adverse events for HCT/Ps is codified in § 1271.350. Consistent with statutory requirements, information is required to be submitted electronically and therefore we account for most all reports under OMB control number 0910-0645, established to support electronic reporting to our MedWatch program. At the same time, regulations provided for waivers from the electronic submission requirements and we therefore account for paper-based reporting in this information collection.

Medical Device Products

Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers and importers, of devices intended for human use to establish and maintain records, make reports, and provide information as the Secretary of Health and Human Services may by regulation reasonably require to ensure that such devices are not adulterated or misbranded and to otherwise assure its safety and effectiveness. The Safe Medical Device Act of 1990 (Pub. L. 101-629), signed into law on November 28, 1990, amends section 519 of the FD&C Act. The amendment requires that user facilities such as hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities report deaths related to medical devices to FDA and to the manufacturer, if known. Serious illnesses and injuries are to be reported to the manufacturer or to FDA if the manufacturer is not known. These statutory requirements regarding mandatory reporting have been codified by FDA under 21 CFR part 803 (part 803). Part 803 mandates the use of the Form FDA 3500A for reporting to FDA on medical devices. While most reporting associated with medical device products is covered under OMB control number 0910-0437, we retain coverage for paper-based adverse experience report submissions in this collection, as well as coverage for MedWatch electronic reporting in OMB control number 0910-0645.

Dietary Supplements

Section 502(x) in the FD&C Act implements the requirements of The Dietary Supplement and Nonprescription Drug Consumer Protection Act, which became law (Pub. L. 109-462) on December 22, 2006. These requirements apply to manufacturers, packers, and distributors of nonprescription human drug products marketed without an approved application. The law requires reports of serious adverse events to be submitted to the Agency by manufacturers of dietary supplements. Electronic reports for dietary supplements may be submitted using the Safety Reporting Portal at http://www.safetyreporting.hhs.gov/. Paper-based dietary supplement reports may be submitted using the MedWatch Form FDA 3500A.

Use of Form FDA 3500B—Consumer Voluntary Reporting

This voluntary version of the form may be used by consumers, patients, or caregivers to submit reports not mandated by Federal law or regulation. Individual consumers, patients, or caregivers are not required by law or regulation to submit reports to the Agency or the manufacturer. FDA supports and encourages direct reporting to the Agency by consumers of suspected adverse events and other product problems associated with human medical products, food, dietary supplements, and cosmetic products and invite these respondents to visit our website at https://www.fda.gov/safety/report-problem-fda for more information. Since the inception of the MedWatch program in July 1993, the program has been promoting and facilitating voluntary reporting by both the public and healthcare professionals. FDA has further encouraged voluntary reporting by requiring inclusion of the MedWatch toll-free phone number or the MedWatch internet address on all outpatient drug prescriptions dispensed, as mandated by section 17 of the Best Pharmaceuticals for Children Act (Pub. L. 107-109).

Section 906 of the FDA Amendments Act amended section 502(n) of the FD&C Act, mandating that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text (this includes vaccine products): “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch,, or call 1-800-FDA-1088.” Most private vendors of consumer medication information, the drug product-specific instructions dispensed to consumers at outpatient pharmacies, remind patients to report “side effects” to FDA and provide contact information to permit MedWatch reporting.

Since 2013, FDA has made available the 3500B form. Proposed during the previous authorization in 2012, the Form FDA 3500B is a version of the 3500 form that is tailored for consumers and written in plain language in conformance with the Plain Writing Act of 2010 (Pub. L. 111-274) ( https://www.govinfo.gov/content/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf ). The Form FDA 3500B evolved from several iterations of draft versions, with input from human factors experts, from other regulatory agencies and with extensive input from consumer advocacy groups and the public. Since 2019, the Form FDA 3500B has been available in Spanish at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda and available to upload electronically since 2021 at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish.

Form FDA 3500B, may be used to report adverse events, product problems, product use errors and problems after switching from one product maker to another maker to the Agency. The form is provided in both paper and electronic formats. Respondents may submit reports by mail or fax paper forms to the Agency or electronically submit a report via the MedWatch Online Voluntary Reporting Form at https://www.accessdata.fda.gov/scripts/medwatch/. A fillable .pdf version of the form, available at https://www.fda.gov/media/85598/download may be downloaded, completed, and mailed or faxed to the Agency. Reporting 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. The paper form may also be used to submit reports about dietary supplements. Electronic reports for dietary supplements may be submitted to the Agency via an online submission route called the Safety Reporting Portal at https://www.safetyreporting.hhs.gov/. Electronic reports for tobacco products may be submitted to the Agency via the tobacco questionnaire within the online Safety Reporting Portal at https://www.safetyreporting.hhs.gov/.

In the Federal Register of June 30, 2021 (86 FR 34754), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received requesting clarification with regard to certain terms applicable to medical device reporting and exemptions from reporting. The comment also discussed electronic reporting considerations. We note this information collection supports paper-based reporting, however, we inadvertently included estimates associated with electronic reporting elements required under certain device product regulations. Electronic reporting of adverse experiences associated with FDA-regulated products is currently approved in OMB control number 0910-0645. We also note that information collection associated with additional medical device reporting requirements is currently approved in OMB control number 0910-0437.

At the same time, we appreciate the request for clarification as we continually evaluate our MedWatch forms to increase their utility for the Agency and ease of reporting for respondents. To that end, we are considering making the following revisions and invite comment:

1. Revising the “gender” field to Forms FDA 3500, 3500A, and 3500B; to align with the CDC's use of these terms.

2. Revising Section B of Form FDA 3500 to the “product problem” field to include information about the root cause(s) of problem(s);

3. Revising instructions to clarify reporting instructions for paper-based reporting pertaining to adverse events associated with tobacco products; and

4. Revising instructions to replace the term “smoking” with the term “tobacco product use,” to clarify that this information applies to the use combusted and non-combusted tobacco products.

We estimate the burden of the information collection as follows:

While we have retained the currently approved burden estimates for the individual information collection elements, we have removed those elements associated with mandatory electronic reporting inadvertently included in our 60-day notice, as these elements are currently approved under OMB control number 0910-0645.