[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62184-62187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24432]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1960]


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.

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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, 
[email protected].

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 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 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

[[Page 62185]]

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 Sec.  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

[[Page 62186]]

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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
 FDA center or 21 CFR section and/or FDA form     Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
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Center for Biologics Evaluation and Research/          14,727               1          14,727  0.66 (40 minutes)........................           9,720
 Center for Drug Evaluation and Research:
 Form FDA 3500.
Center for Devices and Radiological Health              5,233               1           5,233  0.66 (40 minutes)........................           3,454
 Form 3500 (voluntary reporting).
Center for Food Safety and Applied Nutrition:           1,793               1           1,793  0.66 (40 minutes)........................           1,183
 Form FDA 3500.
Form FDA 3500A...............................           1,659               1           1,659  1.21.....................................           2,007
Center for Tobacco Products: Form FDA 3500...              39               1              39  0.66 (40 minutes)........................              26
All Centers: Form 3500B......................          13,750               1          13,750  0.46 (28 minutes)........................           6,325
Written requests for temporary waiver under                 1               1               1  1........................................               1
 Sec.   329.100(c)(2).
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    Total....................................  ..............  ..............  ..............  .........................................          22,716
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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.

    Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24432 Filed 11-8-21; 8:45 am]
BILLING CODE 4164-01-P