0645 MedWatch eReporting SSA 2019

UNITED STATES FOOD & DRUG ADMINISTRATION
Adverse Event and Products Experience Reports;
Electronic Submissions
OMB Control No. 0910-0645
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we) 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, the 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. These
reporting and recordkeeping requirements are found in FDA regulations, discussed in agency
guidance, and included in agency forms. 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. The MedWatch program provides for both paper-based and electronic reporting.
Paper-based MedWatch reporting is approved under OMB control number 0910-0291. This request
supports electronic adverse event reporting to FDA, including electronic MedWatch reporting and
other electronic adverse event reporting.
The FDA Safety Reporting Portal (the SRP) and the Electronic Submission Gateway (ESG) are the
agency’s electronic systems for collecting, submitting, and processing adverse event reports,
product problem reports, and other safety information for FDA-regulated products. To ensure the
safety and identify any risks, harms, or other dangers to health for all FDA-regulated human and
animal products, we need to be informed whenever an adverse event, product quality problem, or
product use error occurs. This risk identification process is the first necessary step that allows the
us to gather the information necessary to be able to evaluate the risk associated with the product and
take whatever action is necessary to mitigate or eliminate the public's exposure to the risk.
Some adverse event reports are required to be submitted to FDA (mandatory reporting) and some
adverse event reports are submitted voluntarily (voluntary reporting). Requirements regarding
mandatory reporting of adverse events or product problems have been codified in 21 CFR parts 310,
314, 514, 600, 803 and 1271, specifically §§ 310.305, 314.80, 314.98, 314.540, 329.100, 514.80,
600.80, 803.30, 803.40, 803.50, 803.53, 803.56 and 1271.350(a) (21 CFR 310.305, 314.80, 314.98,
314.540, 329.100, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56 and 1271.350(a)). While
adverse event reports submitted to FDA in paper format using FDA Forms FDA 3500, 3500A,
1932, and 1932a, are approved under OMB control numbers 0910-0284 and 0910-0291, this
information collection request concerns adverse event reports filed electronically via the SRP and
the ESG, and currently approved under OMB control number 0910-0645. Initital data input is
captured via electronic Form FDA 3800 and systematically directed to the appropriate agency
component(s).

We therefore request extension of OMB approval for the information collection provisions covered
in the applicable regulations, discussed in this supporting statement, and as outlined below.
The FDA Safety Reporting Portal Rational Questionnaires:
A. Reportable Food Registry Reports
The Food and Drug Administration Amendments Act of 2007 (Pub. L. 110–085) (FDAAA)
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by creating section 417 (21
U.S.C. 350f), Reportable Food Registry (RFR or the Registry). Section 417 of the FD&C Act
defines “reportable food” as an article of food (other than infant formula) for which there is a
“reasonable probability that the use of, or exposure to, such article of food will cause serious
adverse health consequences or death to humans or animals.” (See section 417(a)(2) of the FD&C
Act). The Secretary of Health and Human Services (the Secretary) has delegated to the FDA
Commissioner the responsibility for administering the FD&C Act, including section 417. The
purpose of the RFR is to enable the Agency to track patterns of adulteration in food to support its
efforts to target limited inspection resources to protect the public health. We designed the RFR
report rational questionnaire to enable FDA to quickly identify, track, and remove from commerce
an article of food (other than infant formula and dietary supplements) for which there is a
reasonable probability that the use of, or exposure to, such article of food will cause serious adverse
health consequences or death to humans or animals. Our Center for Food Safety and Applied
Nutrition (CFSAN) uses the information collected to help ensure that such products are quickly and
efficiently removed from the market to prevent foodborne illnesses. The data elements for RFR
reports remain unchanged in this request for extension of OMB approval.
B. Reports Concerning Experience With Approved New Animal Drugs
Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and § 514.80(b) of FDA’s regulations
(21 CFR 514.80) require applicants of approved new animal drug applications (NADAs) and
approved abbreviated new animal drug applications (ANADAs) to report adverse drug experiences
and product/manufacturing defects to the Center for Veterinary Medicine (CVM). This continuous
monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains
information regarding potential problems with the safety and efficacy of marketed approved new
animal drugs as well as potential product/manufacturing problems. Postapproval marketing
surveillance is important because data previously submitted to FDA may no longer be adequate, as
animal drug effects can change over time and less apparent effects may take years to manifest.
If an applicant must report adverse drug experiences and product/manufacturing defects and
chooses to do so using the Agency’s paper forms, the applicant is required to use Form FDA 1932,
“Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” Periodic drug
experience reports and special drug experience reports must be accompanied by a completed Form
FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs”
(see § 514.80(d)). Form FDA 1932a, “Veterinary Adverse Drug Reaction, Lack of Effectiveness or
Product Defect Report” allows for voluntary reporting of adverse drug experiences or
product/manufacturing defects by veterinarians and the general public. Collection of information
using existing paper Forms FDA 2301, 1932, and 1932a is approved under OMB control number
0910–0284.

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Alternatively, respondents may choose to report adverse drug experiences and
product/manufacturing defects electronically. The electronic submission data elements to report
adverse drug experiences and product/manufacturing defects electronically remain unchanged in
this request for extension of OMB approval.
C. Animal Food Adverse Event and Product Problem Reports
Section 1002(b) of FDAAA directed 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. As part of the effort to fulfill that directive, the Secretary tasked FDA
with developing the instrument that would allow consumers to report voluntarily adverse events
associated with pet food. We developed the Pet Food Early Warning System rational questionnaire
as a user-friendly data collection tool, to make it easy for the public to report a safety problem with
pet food. Subsequently, we developed a questionnaire for collecting voluntary adverse event
reports associated with livestock food from interested parties such as livestock owners, managers,
veterinary staff or other professionals, and concerned citizens. Information collected in these
voluntary adverse event reports contribute to CVM’s ability to identify adulteration of the livestock
food supply and outbreaks of illness associated with livestock food. The Pet Food Early Warning
System and the Livestock Food Reports are designed to identify adulteration of the animal food
supply and outbreaks of illness associated with animal food to enable us to quickly identify, track,
and remove from commerce such articles of food. We use the information collected to help ensure
that such products are quickly and efficiently removed from the market to prevent foodborne
illnesses. The electronic submission data elements to report adverse events associated with animal
food remain unchanged in this request for extension of OMB approval.
D. Voluntary Tobacco Product Adverse Event and Product Problem Reports
FDA has broad legal authority under the FD&C Act to protect the public health, including
protecting Americans from tobacco-related death and disease by regulating the manufacture,
distribution, and marketing of tobacco products and by educating the public, especially young
people, about tobacco products and the dangers their use poses to themselves and others. The
Family Smoking Prevention and Tobacco Control Act of 2009 (Pub. L. 111-31) (Tobacco Control
Act) amended the FD&C Act by creating a new section 909 (21 U.S.C. 387i, Records and Reports
on Tobacco Products). Section 909(a) of the FD&C Act (21 U.S.C. 387i(a)) authorizes FDA to
establish regulations with respect to mandatory adverse event reports associated with the use of a
tobacco product. FDA collects voluntary adverse event reports associated with the use of tobacco
products from interested parties such as health care providers, researchers, consumers, and other
users of tobacco products. Information collected in voluntary adverse event reports contributes to
the Center for Tobacco Products’ (CTP's) ability to be informed of, and assess the real
consequences of, tobacco product use.
The need for this collection of information derives from our responsibility to obtain current, timely,
and policy-relevant information to carry out our statutory functions. The Commissioner of Food
and Drugs is authorized to undertake this collection as specified in section 1003(d)(2) of the FD&C
Act (21 U.S.C. 393(d)(2)). CTP has been receiving adverse event and product problem reports
through the Safety Reporting Portal since January 2014, when the Safety Reporting Portal for
tobacco products first became available to the public. CTP also receives adverse event and product
problem reports via paper forms, as approved under OMB Control number 0910-0291.
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CTP has two voluntary rational questionnaires on the Safety Reporting Portal. The first is utilized
by consumers and concerned citizens, manufacturers, and healthcare professionals 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. In addition to the
information collected by the first rational questionnaire for tobacco products, the second rational
questionnaire collects identifying information specific to the clinical trial or investigational product
such as clinical protocol numbers or other identifying features to pinpoint under which test or
protocol the adverse event occurred.
Both CTP voluntary rational questionnaires capture tobacco-specific adverse event and product
problem information from reporting entities such as health care providers, researchers, consumers,
and other users of tobacco products. To carry out its responsibilities, FDA needs to be informed
when an adverse event, product problem, or error with use is suspected or identified. FDA uses
tobacco-specific adverse event and product problem information to assess and evaluate the risk
associated with the product and to take whatever action is necessary to reduce, mitigate, or
eliminate the public's exposure to the risk through regulatory and public health interventions. The
burden for CTP remains unchanged.
E. Dietary Supplement Adverse Event Reports
The Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA)
(Pub. L. 109–462, 120 Stat. 3469) amended the FD&C Act with respect to serious adverse event
reporting and recordkeeping for dietary supplements and nonprescription drugs marketed without an
approved application.
Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa–1(b)(1)) requires the manufacturer, packer, or
distributor whose name (under section 403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1)) appears on
the label of a dietary supplement marketed in the United States to submit to FDA all serious adverse
event reports associated with the use of a dietary supplement, accompanied by a copy of the product
label. The manufacturer, packer, or distributor of a dietary supplement is required by the
DSNDCPA to use the MedWatch form (Form FDA 3500A) when submitting a serious adverse
event report to FDA. In addition, under section 761(c)(2) of the FD&C Act, the submitter of the
serious adverse event report (referred to in the statute as the “responsible person”) is required to
submit to FDA a followup report of any related new medical information the responsible person
receives within 1 year of the initial report.
As required by section 3(d)(3) of the DSNDCPA, we issued guidance to describe the minimum data
elements for serious adverse event reports for dietary supplements. The guidance 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,” discusses how, when, and where to submit
serious adverse event reports for dietary supplements and followup reports. The guidance also
provides FDA’s recommendation on records maintenance and access for serious and non-serious
adverse event reports and related documents. The reporting and recordkeeping requirements of the
FD&C Act for dietary supplement adverse event reports and the recommendations of the guidance
document were first approved in 2009 under OMB control number 0910-0635. The guidance is
now currently approved under OMB Control No. 0910-0291.
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Reporting of serious adverse events for dietary supplements to FDA serves as an early warning sign
of potential public health issues associated with such products. Without notification of all serious
adverse events associated with dietary supplements, FDA would be unable to investigate and follow
up promptly, which in turn could cause delays in alerting the public when safety problems are
found. In addition, the information received provides a reliable mechanism to track patterns of
adulteration in food that supports efforts by FDA to target limited inspection resources to protect the
public health. FDA uses the information collected to help ensure that such products are quickly and
efficiently removed from the market to prevent foodborne illnesses.
Paper mandatory dietary supplement adverse event reports are submitted to FDA on the MedWatch
form, Form FDA 3500A, and paper voluntary reports are submitted on Form FDA 3500. Forms
FDA 3500 and 3500A are available as fillable pdf forms. Dietary supplement adverse event reports
may be electronically submitted to the agency via the SRP. This method of submission is
voluntary. A manufacturer, packer, or distributor of a dietary supplement who is unable to or
chooses not to submit reports using the electronic system will still be able to provide their
information by paper MedWatch form, Form FDA 3500A (by mail or Fax). There is no change to
the mandatory information previously required on the MedWatch form. CFSAN is making
available the option to submit the same information via electronic means.
F. Food, Infant Formula, and Cosmetic Adverse Event Reports
We continue to work on proposed new rational questionnaire functionality that will be used
for food, infant formula and cosmetic adverse event reports over the SRP. Currently, voluntary
adverse event reports for such products are submitted on Form FDA 3500, which is available as a
fillable pdf form. We have now developed rational questionnaires by which these reports may be
electronically submitted to us via the SRP. In addition, MedWatch forms, although recently
updated with field labels and descriptions to better clarify for reporters the range of reportable
products, do not specifically include questions relevant for the analysis of adverse events related to
food, infant formula, and cosmetics. The proposed food, infant formula, and cosmetics rational
questionnaire functionality will operate in a manner similar to the dietary supplement rational
questionnaire and will include specific questions relevant for the analysis of adverse events related
to food, infant formula, and cosmetics. The electronic submission data elements to report adverse
events associated with food, infant formula, and cosmetics products remain unchanged in this
request for extension of OMB approval.
2. Purpose and Use of the Information Collection
FDA is charged with the responsibility for ensuring that the products it regulates are safe and
effective. To fulfill our public health protection responsibilities, we need to be informed whenever
an adverse event, product problem, or product use error occurs. Information collected in electronic
adverse event reports serves as an early warning sign of potential public health issues associated
with FDA-regulated products. We use the information to assess potential public health issues,
evaluate the risk, if any, associated with the product, and take whatever action is necessary to
reduce, mitigate, or eliminate the public's exposure to the risk. In addition, the information received
provides a reliable mechanism to track patterns of adulteration in FDA-regulated products and
supports efforts by FDA to target limited inspection resources to protect the public health. Without
notification of all adverse events associated with products it regulates, we are unable to investigate
5

and follow up promptly, which in turn could cause delays in alerting the public when safety
problems are found. The need for this collection of information derives from our objective to obtain
current, timely, and policy-relevant information to carry out our statutory functions.
Description of Respondents: The respondents to this collection of information include all persons
submitting mandatory or voluntary adverse event reports electronically to FDA via the ESG or the
SRP regarding FDA-regulated products. Respondents include, unless otherwise exempt, individuals
and households, the private sector (including for-profit businesses, not-for-profit institutions and
farms), state local or tribal governments, as well as the Federal government.
3. Use of Improved Information Technology and Burden Reduction
This information collection request seeks OMB approval of electronic submission of all FDA
adverse event reports and other safety information submitted via the SRP and ESG. Thus, one
hundred percent (100%) of the respondents will use electronic means to submit the required
information.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Mandatory adverse event reporting of FDAregulated products is required by statute and mandated by Congress. In the event that we receive a
report on a product that is not under our jurisdiction, the report will be forwarded to the appropriate
Federal agency. For example, adverse event reports submitted for biologic products used for
animals will be forwarded to the U.S. Department of Agriculture.
5. Impact on Small Businesses or Other Small Entities
We estimate that fifty percent (50%) of respondents are small businesses. For mandatory reporters,
the same information is required from large and small firms by statute or regulation and is the
minimal amount needed. There is no special burden placed on small businesses by these
information collection provisions. We note that the SRP is available to all users through the
internet, without requiring the use of special software. However, FDA aids small businesses in
complying with its requirements through the Agency’s Regional Small Business Representatives
and through the scientific and administrative staffs within the Agency. FDA has provided a Small
Business Guide on the Agency’s website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. Original adverse event and safety reports are submitted only
once and therefore cannot be collected less frequently.

6

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Due to the nature of adverse event reporting, this information collection involves more than
quarterly submission of information and written responses in less than 30 days. The specific
reporting timeframes required by statute or regulation are provided in Table 1 for each report.
Name of Report:
Reportable Food
Registry Reports

Reports
Concerning
Experience With
Approved New
Animal Drugs
Animal Food
Adverse Event and
Product Problem
Reports
Voluntary Tobacco
Product Adverse
Event and Product
Problem Reports
and Investigator
Reports
Dietary
Supplement
Adverse Event
Reports

Food, Infant
Formula and
Cosmetic Adverse
Event Reports

Table 1.—Required Timeframes for Submitting Reports
Reporting Timeframe:
Under section 417(d)(1) of the FD&C Act, a responsible party is required to submit a
reportable food registry report to FDA as soon as practicable, but in no case later than
24 hours after determining that the food is 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 serious adverse health consequences
or death to humans or animals.” (See section 417(a)(2))
Pursuant to 21 CFR 514.80(b)(1), the applicant is required to submit product and
manufacturing defects that may result in serious adverse drug events are to be reported
within 3 working days of first becoming aware that a defect may exist. Pursuant to 21
CFR 514.80(b)(2)(i)-(ii), the applicant is required to submit initial and follow-up
reports within 15 working days. Pursuant to 21 CFR 514.80(b)(3), the non-applicant is
required to report adverse drug experiences to the applicant within 3 working days of
first receiving the information or if reported to FDA within 15 working days.
These are voluntary reports. There is no required timeframe for submission.

These are voluntary reports. There is no required timeframe for submission.

Mandatory reports - Serious adverse event reports received through the address or
phone number on the label of a dietary supplement, as well as all follow-up reports of
new medical information received by the responsible person within one year after the
initial report, must be submitted to FDA no later than 15 business days after the report
is received by the responsible person. Section 761(c)(1)-(2) of the FD&C Act (21
U.S.C. 379aa-1(c)(1)-(2)).
Voluntary reports - There is no required timeframe for submission of a voluntary
report.
These are voluntary reports. There is no required timeframe for submission.

Short timeframes for reporting are necessary so that FDA is informed as soon as possible of any
serious problems with products that it regulates. Delayed or less frequent reporting of some serious
adverse events to FDA would lessen the effectiveness of adverse event reporting as an early
warning sign of possible safety problems with FDA-regulated products. Without notification of all
serious adverse events, FDA would be unable to investigate and follow-up promptly, which in turn
could cause delays in alerting the public when safety problems are found.
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This collection of information does not involve submission of more than an original and 2 copies,
the use of statistical methods, pledges of confidentiality by FDA not supported by authority
established in statute or regulation, or require the disclosure of trade secrets or other confidential
information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), in the Federal Register of November 30, 2018 (83 FR 61653),
we published a 60-day notice requesting public comment on the proposed revision of this
information collection. We received two comment messages, each containing one or more
comments.
(Comment 1) One comment suggests that the electronic forms are hard to use and not user-friendly
and expresses concern that the public not be forced to mail adverse event reports due to the cost.
(Response 1) We continually strive to improve the usability of the rational questionnaires. The
rational questionnaire provides reporters, including voluntary reporters, with detailed navigation
instructions that include drop-down menus, lists of values, controlled vocabularies, and mouse over
help where possible. We develop new rational questionnaires with the assistance of professional
organizations and community interest groups and collect feedback during user acceptance testing.
To avoid postage costs for paper reporting, voluntary reporters may report adverse events by
telephone by calling the FDA toll free at 1-800-FDA-1088.
(Comment 2) Another comment generally supports the information collection.
(Response 2) We appreciate the general support that the comment expresses.
In addition, we received comments that were not responsive to the four collection of information
topics set forth in the notice. These comments express views about matters unrelated to the subject
matter of the notice and are therefore not addressed in this document.
9. Explanation of Any Payment or Gift to Respondents
No gifts or payments are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
This ICR collects personally identifiable information (PII). Depending on the type of FDAregulated product and whether the report is mandatory or voluntary, the rational questionnaires may
collect patient identifier, age, sex, date of birth, ethnicity, race, weight, first name, last name,
address, telephone number, email address, fax number, and information about the adverse event.
The HIPAA Privacy Rule (the Rule) recognizes the legitimate need for public health authorities and
others responsible for ensuring public health and safety to have access to protected health
information to carry out their public health mission. See Disclosures for Public Health Activities,
45 CFR 164.512(b). The Rule also recognizes that public health reports made by covered entities
are an important means of identifying threats to the health and safety of the public at large, as well
8

as individuals. Accordingly, the Rule permits covered entities to disclose protected health
information without authorization for specified public health purposes. Covered entities may
disclose protected health information to a person subject to FDA jurisdiction, for public health
purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity for
which that person has responsibility. Examples of purposes or activities for which such disclosures
may be made include, but are not limited to:





Collecting or reporting adverse events (including similar reports regarding food and dietary
supplements), product defects or problems (including problems regarding use or labeling),
or biological product deviations;
Tracking FDA-regulated products;
Enabling product recalls, repairs, replacement or look back (which includes locating and
notifying individuals who received recalled or withdrawn products or products that are the
subject of look back); and
Conducting post-marketing surveillance.

The “person” subject to the jurisdiction of the FDA does not have to be a specific individual.
Rather, it can be an individual or an entity, such as a partnership, corporation, or association.
Release of information submitted to FDA in voluntary adverse experience reports is governed by 21
CFR 20.63(f), which prohibits FDA and a manufacturer in possession of such reports from releasing
to the public the names of patients, individual reporters, health care practitioners, hospitals, and any
geographic identifiers.
Confidential commercial information is protected from disclosure under FOIA under sections
552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of our regulations (21 CFR part 20). To the
extent 21 CFR 20.64 applies, we will honor the confidentiality of any data in investigation records
compiled for law enforcement purposes.
We have also determined that, although PII is collected, the notice and statement provisions of the
Privacy Act of 1974 do not apply to the instant ICR. Specifically, we do not use name or any other
personal identifier to routinely retrieve records from information submitted via Forms FDA 3500
and 1932a, or otherwise in relation to this collection.
11. Justification for Sensitive Questions
This information collection does not contain questions of a sensitive nature (e.g., those regarding
sexual behavior and attitudes, religious beliefs, etc).
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:

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Activity
Voluntary Adverse Event
Report via the SRP
(Other than RFR Reports)
Mandatory Adverse
Event Report via the SRP
(Other than RFR Reports)
Mandatory Adverse
Event Report via the ESG
(Gateway-to-Gateway
transmission)
Mandatory and Voluntary
RFR Reports via the SRP
TOTAL
1

Table 2 – Estimated Annual Reporting Burden1
FDA
No. of
No. of
Total
Average
Total
Form
Respondents Responses per
Annual
Burden per Hours
No.
Respondent
Responses Response
3800
1,800
1
1,800
0.6
1,080
(36 mins.)
3800

3,360

1

3,360

1

3,360

3800

3,007,000

1

3,007,000

0.6
(36 mins.)

1,804,200

3800

1,260

1

1,260

0.6
(36 mins.)

756

3,013,420

1,809,396

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 in Table 2, Estimated
Annual Reporting Burden, is based primarily on mandatory and voluntary adverse event reports
electronically submitted to the Agency. The estimated total annual responses is based on initial
reports. Followup reports, if any, are not counted as new reports. Based on our experience with
adverse event reporting, we estimate that it will take a respondent 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,
and 0.6 hour to submit a mandatory adverse event report via the ESG (gateway-to-gateway
transmission). Both mandatory and voluntary RFR reports must be submitted via the SRP. We
estimate that it will take a respondent 0.6 hour to submit a RFR report, whether the submission is
mandatory or voluntary.
The burden hours required to complete paper FDA reporting forms (Forms FDA 3500, 3500A,
1932, and 1932a) are reported under OMB control numbers 0910-0284 and 0910-0291. While we
do not charge for the use of the ESG, respondents are required to obtain a public key infrastructure
certificate to set up the account. This can be obtained in-house or outsourced by purchasing a
public key certificate that is valid for 1 year to 3 years. The certificate typically costs from $20 to
$30.
12b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $141,386,203 per year. We
estimate that the average hourly wage for the employee preparing and submitting the report is
equivalent to a GS-12/Step-1 level in the locality pay area of Washington-Baltimore in 2019,
approximately $39.07/hour. Doubling this wage to account for overhead costs, we estimate the
average hourly cost to respondents to be $78.14/hour. Thus, the overall estimated cost incurred by
the respondents is $141,386,203 (1,809,396 burden hours x $78.14/hr = $141,386,203.44).

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13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
Our internal assessment estimates that the cost for processing an electronic submission is $19.00 per
report. The total annual responses (table 2) are estimated at 3,013,420 reports per year. Thus,
$19.00 x 1,867,657 reports = $57,254,980 per year.
15. Explanation for Program Changes or Adjustments
Our estimated burden for the information collection reflects an overall increase of 688,547 hours
and a corresponding increase of 1,145,763 responses. The majority of these adjustments is
attributed to the shift in mandatory reports associated with medical devices (mandatory reports via
the ESG), which had previously been counted under OMB Control 0910-0291, MedWatch paper
reporting. We attribute the remaining adjustments to an increase in the number of submissions we
have received over the last three years. We have also input the associated costs found at Question
12b. that, although were previously and are currently reported, were not uploaded to appear at
www.reginfo.gov.
16. Plans for Tabulation and Publication and Project Time Schedule
No comprehensive statistical reporting, tabulation, or publication of the data are planned. However,
we do plan to post redacted, publically available adverse event data on the FDA website that can be
used by others for informational and analytic purposes.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB expiration date is provided as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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