Document ID: FDA-2014-N-1960-0031
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Safety Information and Adverse Event
Reporting Program
Posted Date: 2022-03-16T04:00Z

[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14894-14897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05514]

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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 Safety Information and Adverse Event Reporting 
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, 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 April 15, 2022.

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-45, 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 Safety Information and Adverse Event Reporting 
Program

OMB Control Number 0910-0291--Revision

I. Background

    MedWatch is FDA's program for reporting serious reactions, product 
quality problems, therapeutic inequivalence/failure, and product use 
errors associated with FDA-regulated

[[Page 14895]]

products. Examples of these products include prescription and over-the-
counter medicines; biologics such as blood components, blood/plasma 
derivatives, and gene therapies; medical devices such as hearing aids, 
breast pumps, and pacemakers; combination products such as pre-filled 
drug syringe, metered-dose inhalers, and nasal spray; special 
nutritional products such as dietary supplements, medical foods, and 
infant formulas; cosmetics such as moisturizers, makeup, shampoos, hair 
dyes, and tattoos; and food, such as beverages and ingredients added to 
foods.
    MedWatch receives reports from the public and, when appropriate, 
publishes safety alerts intended to protect the public health. More 
information regarding the MedWatch program, including user guides and 
consumer assistance on reporting problems to FDA, may be found on our 
website at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. Reports are submitted to FDA by 
health professionals, patients, and consumers, and FDA issues an 
acknowledgement upon receipt of the report. Forms may be downloaded 
from our website at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting and submitted by Fax or 
mail following the instructions; by completing and submitting forms 
online; or by calling FDA at 800-FDA-1088 (800-322-1088) and reporting 
by telephone.
    Some adverse event reports (AERs) are required to be submitted to 
FDA (mandatory reporting), while other reporting is done voluntarily 
(voluntary reporting). Upon receipt of the report, it is directed to 
the FDA center responsible for ensuring the product's compliance with 
statutory requirements under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) and/or any related authorities. Certain requirements 
regarding mandatory reporting of adverse events or product problems 
have been codified in Agency regulations, including those found in 21 
CFR parts 310, 314, 514, 600, 803, 1114, and 1271.
    We are revising the information collection to include electronic 
submission of AERs, currently approved in OMB control number 0910-0645. 
Most reports are submitted using the Electronic Submissions Gateway 
(ESG), our centralized system for securely receiving electronic 
submissions. Reports may also be submitted via the Safety Reporting 
Portal (SRP), found at https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=c16bcd94-42a8-4a68-9272-df4a62d8462c, which is intended 
to streamline the process of reporting product safety issues to FDA 
using ``Rational Questionnaires.''

II. MedWatch Reporting Forms

A. MedWatch Form FDA 3500 (Voluntary Reporting for Health 
Professionals)

    Form FDA 3500 is used by healthcare professionals as well as 
consumers to submit all reports not mandated by Federal law or 
regulation. Individual health professionals are not required to submit 
reports with the exception of certain adverse reactions following 
immunization with vaccines as mandated by the National Childhood 
Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Form FDA 3500 may be 
used to report serious adverse events, product problems, and product 
use errors and therapeutic failures. Reporting is supported for drugs, 
non-vaccine biologicals, medical devices, special nutritional products, 
cosmetics, and nonprescription (over-the-counter) human drug products 
marketed without an approved application. Form FDA 3500 may also be 
used to submit reports about tobacco products and dietary supplements.

B. MedWatch Form FDA 3500A (Mandatory Reporting)

    Form FDA 3500A is used by manufacturers, user facilities, 
distributers, importers, and other respondents subject to mandatory 
reporting. Mandatory reporting of adverse events or product experiences 
is governed by statute and often codified in Agency regulations. 
Mandatory reporting of adverse reactions for human cells, tissues, and 
cellular- and tissue-based products is codified at 21 CFR 1271.350.
    Reporting Under Sections 760 and 761 of the FD&C Act. The Dietary 
Supplement and Nonprescription Drug Consumer Protection Act of 2006 
(Pub. L. 109-462) amended the FD&C Act by adding sections 760 and 761 
(21 U.S.C. 379aa and 379aa-1). Section 760 of the FD&C Act defines 
``adverse event'' and ``serious adverse event'' for nonprescription 
drugs and prescribes specific reporting requirements, submission 
timing, and associated recordkeeping. The final guidance document 
entitled ``Postmarketing Adverse Event Reporting for Nonprescription 
Human Drug Products Marketed Without an Approved Application,'' 
available for download at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-nonprescription-human-drug-products-marketed-without-approved, 
discusses the statutory requirements and provides instructions on the 
reporting elements and the use of Form FDA 3500A. Similarly, section 
761 of the FD&C Act defines ``adverse event'' and ``serious adverse 
event'' for dietary supplements and prescribes specific reporting 
requirements, submission timing, and associated maintenance of 
reporting records. The document entitled ``Guidance for Industry; 
Questions and Answers Regarding Adverse Event Reporting and 
Recordkeeping for Dietary Supplements as Required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act,'' 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-adverse-event-reporting-and-recordkeeping-dietary, discusses these 
statutory requirements and provides instruction on the use and 
submission of Form FDA 3500A and discusses records required under 
section 761.

C. MedWatch Form FDA 3500B (Voluntary Reporting for Consumers)

    Form FDA 3500B is a consumer-friendly version of Form FDA 3500 and 
is used for voluntary reporting. Respondents with access to the 
internet may visit our website at https://www.fda.gov and download Form 
FDA 3500B or contact us for assistance with completing and submitting 
the information. Form FDA 3500B is available in both English and 
Spanish.

III. FDA Safety Reporting Portal Rational Questionnaires

    FDA currently receives several types of adverse event reports 
electronically via the SRP using rational questionnaires. These 
include:

1. Reportable Food Registry

    Section 417 of the FD&C Act (21 U.S.C. 350f) defines ``reportable 
food'' and establishes reporting requirements for articles of foods 
(other than infant formula or dietary supplements) for which there is a 
reasonable probability that the use of, or exposure to, will cause 
serious adverse health consequences or death to humans or animals. We 
designed the reportable food registry (RFR) rational questionnaire to 
enable us to quickly identify, track, and remove from commerce an 
article of food (other than infant formula or dietary supplements) for 
which there is a reasonable probability that the use of, or exposure 
to, such article of food will cause

[[Page 14896]]

serious adverse health consequences or death to humans or animals. 
FDA's Center for Food Safety and Applied Nutrition uses the information 
to help ensure that these products are quickly and efficiently removed 
from the market to prevent foodborne illnesses. Both mandatory and 
voluntary RFR reports must be submitted via the SRP.

2. Food, Infant Formula, and Cosmetic Adverse Event Reports

    Rational questionnaires have also been developed for submitting 
adverse event reports for dietary supplements, food, infant formula, 
and cosmetics.

3. Animal Food Adverse Event and Product Problem Reports

    Section 1002(b) of the FDA Amendments Act of 2007 (Pub. L. 110-85) 
directs the Secretary to establish an early warning and surveillance 
system to identify adulteration of the pet food supply and outbreaks of 
illness associated with pet food. We developed the Pet Food Early 
Warning System rational questionnaire as a user-friendly data 
collection tool, as well as a questionnaire for collecting voluntary 
adverse event reports associated with livestock food. Information 
collected in these voluntary adverse event reports contributes to our 
ability to identify adulteration of the livestock food supply and 
outbreaks of illness associated with livestock food. We use the 
information collected to help ensure that such products are quickly and 
efficiently removed from the market to prevent foodborne illnesses.

4. Voluntary Tobacco Product Adverse Event and Product Problem Reports

    The Center for Tobacco Products (CTP) has developed two voluntary 
rational questionnaires on the SRP. The first is utilized by consumers 
and concerned citizens to report tobacco product adverse event or 
product problems. A second rational questionnaire is used by tobacco 
product investigators in clinical trials with investigational tobacco 
products. Both CTP voluntary rational questionnaires capture tobacco-
specific adverse event and product problem information from reporting 
entities such as healthcare providers, researchers, consumers, and 
other users of tobacco products.
    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. We note that information 
collection pertaining to medical device reporting is approved under OMB 
control number 0910-0437. The comment also discussed electronic 
reporting currently approved in OMB control number 0910-0645. Upon 
consideration of the comment and to help increase our organizational 
efficiency, we are consolidating the related reporting activities 
currently approved in OMB control number 0910-0645 into this single 
information collection request. Upon OMB approval of our request, we 
will discontinue OMB control number 0910-0645. In consideration of the 
comment, we have also proposed the following updates to the information 
collection instruments to help clarify information to be included in 
the corresponding data fields:
    1. Revising the ``gender'' field to Forms FDA 3500, 3500A, and 
3500B; to align with Centers for Disease Control and Prevention's use 
of these terms (https://www.cdc.gov/hiv/clinicians/transforming-health/health-care-providers/collecting-sexual-orientation.html), with the 
exception of the term ``Undifferentiated,'' which is included in the 
CDISC (Clinical Data Interchange Standards Consortium) language 
(premarket) standards (https://www.cdisc.org/kb/articles/sex-and-gender);
    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 clarify the term ``smoking'' refers to 
use of combusted products (cigarettes, cigars, pipes) to ``tobacco 
product use,'' which encompasses 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 form                       Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
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Reportable Foods Registry--Mandatory Reports.             875               1             875  0.6 (36 minutes).........................             525
Reportable Foods Registry--Voluntary Reports.               5               1               5  0.6 (36 minutes).........................               3
Food, Infant Formula, and Cosmetic Adverse              1,165             1.2           1,398  0.6 (36 minutes).........................             839
 Event Reports.
Voluntary Dietary Supplement Adverse Event                360             1.2             432  0.6 (36 minutes).........................             259
 Reports.
Mandatory Dietary Supplement Adverse Event                 80              12             960  1........................................             960
 Reports.
Animal Food: Pet Food Reports................           2,024               1           2,024  0.6 (36 minutes).........................        1,214.40
Animal Food: Livestock Food Reports..........              25               1              25  0.6 (36 minutes).........................              15
Voluntary Tobacco Product Health Problem or               204               1             204  0.6 (36 minutes).........................             122
 Product Problem (i.e., adverse experience)
 Reports to SRP (both questionnaires).
Mandatory Tobacco Product Health Problem or                 1               1               1  0.6 (36 minutes).........................               1
 Product Problem (i.e., adverse experience)
 Reports.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............           5,924  .........................................         3,938.4
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate of the number of respondents and the total annual 
responses is based primarily on mandatory and voluntary adverse event 
reports submitted to the Agency. The estimated total annual responses 
are based on initial reports. Followup reports, if any, are not counted 
as new reports. Based on our experience with

[[Page 14897]]

adverse event reporting, we assume it takes respondents 0.6 hour to 
submit a voluntary adverse event report via the SRP, 1 hour to submit a 
mandatory adverse event report via the SRP (except CTP, which estimates 
0.6 hour), and 0.6 hour to submit a mandatory AER via the ESG (gateway-
to-gateway transmission).
    CTP used two data sources to estimate the reporting burden for 
tobacco product AEs. CTP researched the number of voluntary AE reports 
submitted to the center since the launch of the first tobacco 
questionnaire in the SRP in 2014. Our records indicated a total of 
1,426 initial reports over the last 7 full calendar years. We used the 
total number of reports to average the number of yearly reports to 204. 
As referenced above, the premarket tobacco product application rule 
requires firms to submit adverse experience reports for tobacco 
products with marketing orders. The burden for these mandatory reports 
has been approved under OMB control number 0910-0879. For this 
collection, we have included 1 hour to acknowledge the inclusion under 
this collection. Therefore, the estimate for CTP voluntary and 
mandatory reports is expected to be 123 hours.
    The submission of mandatory reports associated with drug products 
and biological drug products is accounted for and approved under OMB 
control number 0910-0230; the submission of mandatory reports 
associated with the Vaccine Adverse Event Reporting System is accounted 
for and approved under OMB control number 0910-0308; medical device 
report submissions are accounted for and approved under OMB control 
number 0910-0437; and the submission of mandatory reports associated 
with animal drug products is accounted for and approved under OMB 
control number 0910-0284.

    Dated: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05514 Filed 3-15-22; 8:45 am]
BILLING CODE 4164-01-P